肖传国你可真敢睁眼说瞎话

26 04 2011年

为了证明1995年在平顶山矿工人体试验前经历了严谨的动物实验,肖传国在其新闻发布会上,列出了数条“肖氏反射弧研究过程(动物)”[1],其中的实施时间和试验内容普遍“提前”。例如:“1992-95:大动物试验(狗) 神经递质/远期疗效 美国NIH基金”。

肖传国你可真敢睁眼说瞎话。按这个权威的研究基金数据库[2],试验内容哪来的“神经递质/远期疗效”?分明是电生理和尿流动力学;
试验起止日期哪来的“1992-95”?分明是1994-1996。还有,肖传国你这个耗资近36万美元的“大动物试验(狗) 神经递质/远期疗效”,可曾发表在任何一个学术会议或学术期刊上?

为了表明其脊柱裂人体试验的严谨,肖传国声称:
1999:在中国基金委重点基金和杰出青年基金支持下,研究肖氏反射弧在没有截瘫的动物模型是否有效。
2000:动物实验成功后,开始肖氏手术治疗脊柱裂病人大小便失禁临床研究手术20例,然后停止进行为期3年随访,观察疗效。
2004:卫生部通过鉴定并建议尽快推广(见卫生部鉴定证书)

肖传国你脊柱裂头一年动物实验,第二年上人,你有没有做过跟你所声称的“大动物试验(狗)”那样的“远期疗效”实验?

卫生部鉴定说,“这种患儿脊髓连续性并没中断,要建立人工反射弧支配膀胱必须牺牲一支正常体神经运动支及其功能,具有很大风险”。肖氏手术要剥离、切断、吻合正常神经,其危险性显而易见,肖传国你在拿脊柱裂患者开刀前可曾做过动物实验进行安全性评估?

肖传国你声称2000年只做了20例脊柱裂病人。那么,你在2004年“卫生部通过鉴定并建议尽快推广”前做了多少例?你要是忘了的话,我来提醒你一下:你在2003年论文《人工体神经-内脏神经反射弧治疗脊髓脊膜膨出患者大小便功能障碍》中报告了30例;你在2009年SIU会议上宣称2003年前做了40例脊柱裂[3]。

据报道,肖传国在新闻发布会上“详细的介绍了此项技术从研制到成功运用于临床泌尿外科的过程,目前国内手术人数为2000例,手术成功率近80%”。成功率现在怎么才“近80%”?你忘了你在2006年European Urology上说110例脊柱裂儿童一年随访成功率87%?你忘了你在2009年SIU会议上吹嘘1406例神源患者一年随访506例,86.2%获得膀胱控制功能?

还有,肖传国你和你的帮凶们怎么不再提“治愈”了?神源医院虚假宣传、院士申请假证明就不说了,提醒你一下,单看看你自己当年是怎么在论文中吹嘘“获得控尿和自主排尿功能,尿失禁消失”、“成功治愈”的:

肖传国《人工体神经-内脏神经反射弧治疗脊髓脊膜膨出患者大小便功能障碍》:7例无反射型患者中4例获得控尿和自主排尿功能,尿失禁消失;6 例高反射型患者全部于术后1年左右恢复可控排尿……充盈性尿失禁消失。……结论:人工反射弧能安全有效地治愈先天性脊髓脊膜膨出所致大小便失禁。……我们应用人工反射弧原理和手术方式在国际上首次成功治愈了这类患者的大小便失禁

为了“严谨”,你往少里缩;为了“成功”,你往大里吹。这些这么容易揭穿的谎言你都敢胡扯,你那些实验数据是不是也都这么来的?

关于肖传国论文造假,见《肖传国在论文中捏造、篡改数据
关于肖氏手术试验违反伦理,见《肖传国的美国猫实验与中国人试验同步进行
关于肖传国等怎么定义“成功”,见《肖氏手术的“成功”、“治愈”、“有效”

附录:

[1] 肖传国新闻发布会幻灯片
http://xysblogs.org/wp-content/blogs/107/uploads/xiaopress2.jpg

[2] 研究基金数据库资料
http://www.researchgrantdatabase.com/g/5R01DK053063-05/SKIN-CNS-BLADDER-REFLEX-ARC-FOR-MICTURITION-AFTER-SCI/
Grant 1R01DK044877-01A2 from National Institute Of Diabetes And Digestive And Kidney Diseases IRG: SAT
Project start date: 1994-02-01
Project end date: 1996-11-30

[3] 肖传国2009年SIU会议幻灯片
http://xysblogs.org/wp-content/blogs/107/uploads/xiaosiu.jpg



肖氏手术、栓系综合征及栓系松解术资料

22 04 2011年

1. Duke大学John S. Wiener在2010年6月的脊柱裂协会的讲座中透露神经外科专家们对肖氏手术的反对意见:“神经外科专家们注意到,他(肖传国)的手术是一种脊髓栓系松解。这可解释一些(肖氏手术的)正面结果”。
http://conference.spinabifidaassociation.org/site/c.qkI1KgMTIrF/b.5591661/k.633B/Educational_Sessions.htm
37th SBA National Conference
June 27-30, 2010 Cincinnati, Ohio
Session Presentations
Health Issues Affecting Men with Spina Bifida: The Xiao Procedure
Slide 11
Neurosurgeons noted his procedure was a spinal cord detethering
Could explain some of positive results

2. 资料表明,“肖氏手术”号称治疗脊髓栓系综合征
华中科技大学外科学2005年度“国家精品课程”申报表
http://202.114.128.246/shenbao/shenbaobiao/wk.doc
肖传国教授在国际上首次提出并证实了“人工建立体神经—内脏神经反射弧”这一神经科学新概念,为成功治疗内脏器官神经功能失控提供了理论基础,至今,已治疗截瘫或脊髓栓系综合征导致的神经原性膀胱患者100余例

“何梁何利基金”报奖材料
http://www.hlhl.org.cn/detail.asp?ID=476
该反射弧被命名为“肖氏反射弧”。至今,已治疗截瘫和脊髓栓系综合征所导致的大小便失禁患者90余例

《临床泌尿外科杂志》网站
http://www.cjcu.com.cn/showart.aspx?artid=3187
肖传国教授在国际上首次提出并证实 “人工建立体神经-内脏神经反射弧”这一神经泌尿科学新概念,首创“肖氏反射弧”并用于治疗截瘫或脊髓栓系综合征导致的神经原性膀胱。

吴秀英.体神经-内脏神经反射弧膀胱功能重建术的护理.护理学杂志,2002,17(4):259-261
http://www.cqvip.com/qk/93738x/2002004/6120159.html
协和医院泌尿外科肖传国教授在国际上首次提出并证实“人工建立体神经-内脏神经反射弧”这一神经科学新概念,首创“肖氏反射弧”并用于治疗截瘫或脊髓栓系综合征导致的神经原性膀胱。

高晓群2006年接受“南国都市报”采访
http://www.xys.org/xys/ebooks/others/science/dajia7/xiaochuanguo130.txt
高院长说,以前几乎对此病束手无策, 从上世纪80年代末开始,经过15年的潜心研究,肖传国提出国际公认的“肖氏反射弧”原理—这是外科领域里仅有的几项以中国人姓氏命名的手术原理。至今,已治疗截瘫或脊髓栓系综合征导致的神经原性膀胱患者200余例

《临床泌尿外科杂志》网站
Comprehensive Report Of the Fourth (2008) International Academic Conference of Journal of Clinical Urology
The Fourth (2008) International Academic Conference of Journal of Clinical Urology is held on the beautiful scenic spot– - Huangshan mountains in Anhui Province on September 12nd ~ 15th 2008.
Comprehensive Report Of the Fourth (2008) International Academic Conference of Journal of Clinical Urology
Professor Xiao Chuanguo report on “New progress in xiao’s reflex arc” for the conference. He explain the establishment mechanism of the artificial reflex arc in a simple way, and introduced the surgery at home and abroad in the application of the latest situation. The delegates considered that the artificial reflex arc is put forward for the first time and confirmed that this surgery can use nerve regeneration to regenerate  rectal innervation of bladder and its central control. The surgery for the first time innovated the key technology of the treatment of incontinence caused by congenital spina bifida tethered cord syndrome.

3. 肖传国最早的13例脊髓脊膜膨出患者患者,均具栓系综合征
肖传国等. 人工体神经-内脏神经反射弧治疗脊髓脊膜膨出患者大小便功能障碍. 《临床泌尿外科杂志》 2003年11期
获1年以上随访的13例,……MRI检查示典型的栓系综合征影像。

4. 神源医院肖氏手术与栓系松解术同时做
http://bkb.ynet.com/article.jsp?oid=59384400
北京科技报《调查神源医院》

前河南神源医院院长高晓群向《北京科技报》解释,目前,治疗脊柱裂的常规手术是对脊髓栓系进行松解来完成的,这就好比把神经看作一个松紧带,由于这根 “松紧带”没有达到脊髓的适应长度,因此栓系松解手术就是将过紧的神经解开后重新衔接以此达到延长这根“松紧带”的目的来完成治疗,而“肖氏反射弧”采用的方法则是除了松解以外,医生还会用患儿上肢或者腰部健康的神经连接到受损的膀胱神经上,让膀胱神经与健康神经生在一起恢复成健康神经。根据其理论,术后,如果恢复情况良好,患者就会出现小便的感觉。

神源医院广告:“修补+松解+反射弧重建省时省力省钱”、“脊髓脊膜膨出——做两个手术花一样钱”。

5. 肖传国2005年英文论文否认在肖氏手术的同时做栓系松解术,指出:“除非纤维脂肪瘤太大导致脊髓或神经根受压,否则不予切除;对终丝牵拉症和术后粘连不予治疗”。栓系松解术通常包含上述几项术式。即便如此,肖氏手术要切开硬脊膜囊,应有硬脊膜内松解的效果。
http://www.ncbi.nlm.nih.gov/pubmed/15879861
Xiao CG, Du MX, Li B, Liu Z, Chen M, Chen ZH, Cheng P, Xue XN, Shapiro E, Lepor H. An artificial somatic-automonic reflex pathway procedure for bladder control in children with spina bifida. J Urol 2005; 173: 2112.
The fibrolipoma was avoided unless it was too large and caused spinal cord or root compression. The tight filum terminale or postoperative adhesions were also untreated to avoid inadvertent damage.

6. 栓系松解术治疗栓系综合征文献
http://www.ncbi.nlm.nih.gov/pubmed/16952698
Tarcan et al. Does surgical release of secondary spinal cord tethering improve the prognosis of neurogenic bladder in children with myelomeningocele? J Urol. 2006 Oct;176(4 Pt 1):1601-6

56 children… Urodynamic parameters in terms of cystometric bladder capacity and detrusor leak point pressure substantially improved 6 months after untethering surgery (125 vs 170 ml and 69.1 vs 47.5 cm H2O, respectively, p < 0.05). Assessment of urodynamic findings in 19 children at 1 year failed to demonstrate a significant change in these parameters.
CONCLUSIONS:
Our study shows that secondary untethering surgery may significantly improve urological outcome.
RESULTS
… A further comparison of urodynamic parameters at 6 and 12 months in 19 children in whom the data were available revealed that the urodynamic improvement was persisting at 1 year….

56例继发性栓系综合征,栓系松解术后尿路感染、上尿路扩张、术后膀胱输尿管反流消失或显著改善。术后6个月尿动力学参数极大改善。现有19名患者的12个月尿动力学参数,与术后6个月相比无显著改变,表明尿动力学改善是持久的。结论:继发性解拴术可显著改善泌尿学结果。

http://www.ncbi.nlm.nih.gov/pubmed/17328264
Hsieh MH et al. The effects of detethering on the urodynamics profile in children with a tethered cord. J Neurosurg. 2006 Nov;105(5 Suppl):391-5.
in five (50%) of the 10 children with abnormal preoperative UDS results, the postoperative UDS demonstrated improved or normal urodynamics.
10名术前尿动力学结果异常的患者中的5名,术后尿动力学研究表现出改善或正常的尿动力学数据

http://www.ncbi.nlm.nih.gov/pubmed/12145516
CS. von Kocha et al. Clinical Outcome in Children Undergoing Tethered Cord Release Utilizing Intraoperative Neurophysiological Monitoring. Pediatr Neurosurg. 2002 Aug;37(2):81-6.
Significant bowel and bladder improvement was seen in 4 out of 25 patients

http://www.ncbi.nlm.nih.gov/pubmed/10804050
M. Selçuki et al. Patients with urinary incontinence often benefit from surgical detethering of tight filum terminale. Child’s Nervous System, Volume 16, Number 3, 150-154

http://www.ncbi.nlm.nih.gov/pubmed/16506479
Lee GY et al. Surgical management of tethered cord syndrome in adults: indications, techniques, and long-term outcomes in 60 patients. J Neurosurg Spine. 2006 Feb;4(2):123-31.
Subjective improvement in bladder function was noted in 50% of patients with bladder dysfunction at presentation.

http://www.ncbi.nlm.nih.gov/pubmed/17162083
Abrahamsson et al. Urodynamic findings in children with myelomeningocele after untethering of the spinal cord. J Urol. 2007 Jan;177(1):331-4
After untethering secondary to myelomeningocele 35% of the patients experienced improved bladder function and 5% deteriorated. All of the patients who deteriorated before untethering improved afterward, and 90% of those who were stable preoperatively continued to be stable postoperatively.
20例继发性栓系综合征患者,施行栓系松解术后膀胱功能改善35%,加重5%

Bui CJ, Tubbs RS, Oakes WJ. Tethered cord syndrome in children: a review. Neurosurg Focus. 2007;23(2):E2.
http://thejns.org/doi/pdfplus/10.3171/FOC-07/08/E2
Results of Untethering Surgery
The results of surgical untethering in symptomatic TCS patients are generally favorable, but the extent of im-provement varies depending on the preoperative symp-toms and deficits. In 1975, Anderson 1 reported in his series of 73 pediatric patients with OSD and TCS that the rate of improved pain was 100%, whereas the rates of improved sensorimotor and sphincter function were 42 and 43%, respectively, and those of symptom stabilization were 45 and 48%, respectively. In their patients, Lee et al. 27 reported that pain improved in approximately 80% of patients, neurological improvement or stabilization occurred in 90% (with quicker recovery of motor rather than sensory function), and bladder function improved in 50%. Guerra at al. 11reported similar results, with 48% improvement seen in pediatric patients with abnormal urodynamics. Other studies have yielded higher improvement rates for urological dysfunction, with an average of 87% seen in seven studies having a total of 161 patients.36 It must be noted that urological improvement is not as favorable in older children and in the adult population. 26 Huttman et al. 14 compared the durations of symptoms with outcomes and concluded that pain and spasticity responded favorably to surgery regardless of the duration of symptoms, whereas improvements in sensorimotor and bladder function were inversely related to the duration of symptoms. It must also be noted that even though many
authors have noted significant improvement in bladder function, complete urological recovery is rare.

http://www.ncbi.nlm.nih.gov/pubmed/19569907
Al-Holou et al. (2009) The outcome of tethered cord release in secondary and multiple repeat tethered cord syndrome. J Neurosurg Pediatr. 2009 Jul;4(1):28-36.
84例继发性栓系综合征患者,施行栓系松解术后6个月随访结果:
小便改善11%,加重19%,不变70%;
大便改善10%,加重7%,不变83%。
一年或更长时间随访结果:
小便改善15%,加重20%,不变64%;
大便改善20%,加重31%,不变49%。

 

http://www.cnki.com.cn/Article/CJFDTOTAL-ZHMN200404008.htm
蒋寿宁等. 脊髓栓系综合征致上尿路积水的手术疗效观察. 中华泌尿外科杂志2004年第25卷第4期
对20例TCS伴有上尿路积水患者进行去栓手术,观察比较手术前后膀胱剩余尿、肾和输尿管积水、肾皮质厚度及肾功能的变化. 结果膀胱剩余尿恢复正常5例,减少10例,总有效率83%.肾积水明显减少6例,轻度减少7例,无改变7例,总有效率65%.输尿管积水明显减少7例,好转4例,无变化7例,总有效率61%.肾皮质厚度明显增加5例,轻度增加2例,无改变13例,总有效率35%.肾功能中度尿毒症转为轻度2例,轻度转为正常4例,14例同术前正常.



肖传国是怎样从一手“同花顺”沦落到抡锤子的

21 04 2011年

2009年11月05日,肖传国(“搬运工”):“到时候底牌一亮,那些狗日的们统统完蛋,岂不快哉?:—)你看看我,再看看那签名信600多人和这些方舟子的狐朋狗友妓者,谁会被钉在耻辱柱上??”

2009年11月25日,Beaumont医院一年临床试验结果论文提交。

2010年5月31日 德国临床试验结果摘要在美国泌尿学会年会发表,8名脊髓损伤患者手术全部失败。

2010年6月4日,NIH资助的二期试验,招募状态由“正在招募”改为“尚未招募”。

2010年6月19日,Beaumont医院一年临床试验结果论文在线发表,同时刊登多位同行专家的严厉批评。

2010年6月底,Duke大学John S. Wiener在脊柱裂协会的讲座透露:9名患者当时已经只剩2名还有反射。因NIDDK(出资机构美国糖尿病、消化和肾病研究院)新任主任担心手术可能伤害患者,NIH资助被搁置(on hold)。Wiener提到:“神经外科专家们注意到,他的手术是一种脊髓栓系松解”。

2010年6月24日,方玄昌遇袭,8月29日方舟子遇袭。

另见《肖传国的“同花顺”



肖传国是怎样把肖氏手术从动物搬到人体的

21 04 2011年

肖1995年在平顶山拿矿工开刀前,只发表了鼠实验论文。拿矿工开刀5年后的1999年才发表猫实验论文,论文中的6只猫有两只猫“失访”(未公布原因,恐怕是死了)。1994年曾拿到NIH狗实验基金,但从未报告狗实验结果。肖的鼠、猫实验都是生理实验,无任何安全性评估。

肖在做完脊髓损伤患者后,直接类推到脊柱裂患者,论文中给出的类推的理由是“手术的神经学原理与脊髓损伤患者相同”。对于脊柱裂患者,肖氏手术要剥离、切断、吻合正常的运动神经,其危险性显而易见,但肖从未做过动物实验进行有效性、特别是安全性评估。

 



美国“肖氏手术”三年试验结果:是自主控尿还是腹压排尿?

18 04 2011年

美国“肖氏手术”三年试验结果表明,“6/7漏尿,全都压力性尿失禁”、“大多数患者尿失禁仍成问题”。这无疑令神源医院“使患者实现自控排尿,彻底解决了大小便失禁问题”的虚假宣传破产,也推翻了肖传国论文中的患者术后“获得控尿和自主排尿功能,尿失禁消失”的结论。

那么,“术后36个月6/7可尿出”是怎么回事呢?这里的“尿出”(void)显然不是肖传国及神源医院吹嘘的“自控排尿”、“控尿和自主排尿”,而是腹压排尿(即“4/7多半时候需憋气用力才尿出,1/7始终需憋气用力才尿出”)。

密歇根大学医学院泌尿系John Park医生曾以嘲弄的口气评价Beaumont医院一年试验结果:“本试验最古怪的发现是尿动力数据和主观评估之间的矛盾。有位患者膀胱容量减小、反射弧未建立,但他竟然主观上报告大小便功能改善!考虑到这个患者术前的压力性尿失禁,我实在忍不住地猜测,他术后排尿只不过是因为腹内压力施加到扩张了的膀胱颈而导致膀胱排空而已。”(见《国外同行专家对美国肖氏手术临床试验结果的评价》)。

John Park医生现在不用“实在忍不住地猜测”了。Beaumont医院已证实,术后三年反射弧消失了(“仅剩一名患者存在反射,且远比以前减弱”);9名患者扣除2名失访者后,有5名需要腹压排尿(还有1名根本尿不出)。

长期尿潴留、靠腹压排尿会导致膀胱输尿管反流、肾脏反流,最终损害肾功能。“资源充足的发达国家,患者可通过清洁导尿和使用药物防止严重感染、肾衰竭及死亡”(见美国三年结果资料结论。美国9名患者术前均需清洁导尿、5名需抗痉挛药物)。因此,在美国这种“资源充足的发达国家”,由于患者可通过清洁导尿排出尿液,患者不需要强行用力排尿,使得术前仅有“2/9可尿出一些”。术后,这些患者被要求逐步停止清洁导尿和使用药物,逼得他们在术后三年5名患者经训练“学会”了腹压排尿。也就是说,美国患者“4/7膀胱功能改善”,除了应归功于拴系松解术的效果,一定程度上也是腹压排尿的“效果”。

中国作为“缺乏或难以负担清洁导尿和抗痉挛药物的国家”情况则不同。患者术前就“学会”了腹压排尿,术后相对于美国患者“改善”程度自然就小了。据公益律师所作的调查《“肖氏反射弧”手术效果统计》,仅有约22%的患者得到某种程度的膀胱功能改善(包括“感觉小便好了一点点”)。

只有通过对照试验排除其他因素对手术效果的影响后,才能得到手术的真正“有效率”(更别提肖传国和神源医院一贯吹嘘的“治愈率”了)。而肖传国大规模推广应用、做了2000多例,却从未做过对照试验。这就是为什么加州大学戴维斯儿童医院小儿泌尿科主任Eric Kurzrock接受美联社采访时斥责,“美国大多数小儿泌尿科医生对肖的报告嗤之以鼻,……从来没有人相信他那85%的成功率”(见《美联社:中国患者抗议医生肖传国的危险手术》),并在接受《科学》采访时,“特别批评其宣称的高成功率,指出没有随机可控的临床试验不可能有这样的数据”(见《科学:来自中国的疑问给美国的临床试验带来麻烦》)。

 



美国“肖氏手术”三年试验结果:“是否成功?无法确定”

16 04 2011年

刑满释放后的肖传国最近宣称:“美国病人的结果比我们中国的还好”、“我引以为傲的在中国作出的成果最后要靠美国学生的结果来支撑”,并宣布将召开记者招待会发布美国肖氏手术三年总结报告。

美国“肖氏手术”三年试验结果真的“还好”、“支撑”?肖传国一贯满嘴谎言、吹牛上瘾。例如,早在2009年9月美国肖氏手术两年结果公布前夕,肖传国即宣称“在美国做的9个病人9个大便正常,9个能自己拉尿”,随后被证明是漫无边际的吹牛。这次恐怕也不例外。

果然。新语丝网友“猎人”检索到了美国Beaumont医院“肖氏手术”试验负责人K. Peters于今年2月初在国际尿失禁学会发布的讲座资料,其中公布了他们三年试验的关键结果。现解读点评如下。

1. 9名患者有两名根本就未参加随访,“是个大问题”

肖传国曾宣称“在中国做成功一万例,不如在美国做成10例”,因为“美国临床研究的确规范严谨可靠”,而“中国病人的随访是个大问题”。 Beaumont医院在其临床试验申请材料中也说,“在中国,严格的患者随访是个挑战”,以此论证在美国开展试验的必要性。实际上,肖传国的最初15名脊髓损伤患者,也仅仅失访一名;而“规范严谨可靠”的美国试验中的区区9名患者居然失访两名,这确实“是个大问题”。讲座资料中未提及失访原因,想必是患者无效甚至恶化而不愿再折腾。

2. “5/7直肠功能改善”,“4/7膀胱功能改善”,“6/7可尿出”,“6/9(66%)临床上有改善”

肖传国及神源医院在论文、广告宣传、院士申请材料(见《肖传国申报院士肖氏术治愈率假证明谎难圆》)中的措词可不是“改善”(improve)、“尿出”(void),也不是本资料中提到的个别患者“偶尔能通过意识启动尿流”、部分患者“需憋气用力才尿出”,而是“治愈”、“大小便恢复正常”、“完全自控”。例如:“目前能完全自控者24例,症状明显改善者5例,无改变者2例,有效率93.5%”(肖传国课题组2002年发表的31例脊髓神经损伤患者结果)。又如:“7例无反射型患者中4例获得控尿和自主排尿功能,尿失禁消失……6例高反射型患者全部于术后1年左右恢复可控排尿,剩余尿逐渐减至(22+/-15)ml,充盈性尿失禁消失……人工反射弧能安全有效地治愈先天性脊髓脊膜膨出所致大小便失禁”(肖传国等2003年发表的13例脊柱裂患者结果)。

美国医生看不懂中文,为什么不参考一下肖传国英文论文中的用词呢?例如:
complete bladder function restoration (膀胱功能完全恢复)
regained total control of the bladder (获得膀胱全部控制功能)
successful recovery of bladder function (膀胱功能成功恢复)
almost normal storage and synergic voiding (存储和协同排尿几乎正常)
gained satisfactory bladder control and continence (获得满意的膀胱控制功能和控尿)
regained bladder control (获得膀胱控制功能)

3. “大多数患者尿失禁仍成问题”,“6/7漏尿,全都压力性尿失禁”

对比一下(仅举一例):肖传国2003年报告,首批13例脊柱裂患者中有10例“尿失禁消失”、“获得控尿和自主排尿功能”。

4. “术后三年,仅剩一名患者存在反射,且远比以前减弱”

这是三年结果最令人惊奇的发现,推翻了肖氏反射弧手术的理论基础。详见《美国“肖氏手术”三年试验结果:“神奇的肖氏反射弧”成了“神奇消失的反射弧”》。

5. “7名中的4(5)名不再导尿”,“除一名患者外,其余全部无需抗痉挛药物”

把无需导尿、无需抗痉挛药物算作成功是糊弄。肖曾说“国外则完全是另一个问题,非常简单,非常STUPID的问题:DETROPEN和清洁导尿的应用”、“如果病人的医生坚持用传统的药物加导尿,那你就千万别做肖氏手术!”因此,这是一个先有鸡还是先有蛋的悖论,即:你要成功,就必须停止导尿、停止抗痉挛药物;你停了导尿、停了药,你就“成功”了。(另见《看肖传国追随者如何诡辩美国《泌尿学杂志》对“肖氏手术”的质疑》)

6. “明确具有导致下肢无力的风险,特别是1/9患者永久性足下垂”

肖传国曾拿出一份数十年前关于脊柱裂患儿生存状况的文献,试图证明中国肖氏手术受害者的残疾是脊柱裂本身而不是其手术造成的。那么,肖传国如何解释美国方面现在已经“明确”的肖氏手术后遗症?据美国试验结果论文及媒体报道,美国9名患者中8名术后出现了下肢无力的严重下肢后遗症,经过了长时间密集的理疗才使其中7名勉强恢复术前水平,有一人足下垂无法恢复。有美国受试患者的母亲网上发帖,称其女儿术后第二天双腿耷拉着象个布娃娃(The day after her surgery, we tried to get our daughter up to walk and her legs dangled like a rag doll.)。这种术后立即出现的并发症,在中国受害者中屡见不鲜,怎么可能是脊柱裂本身造成的逐渐缓慢发展的症状?

“1/9永久性足下垂”,这一比例对应着中国2000名受害患者中有200余名足下垂!更何况还有更多因无缘理疗而造成的残疾。

7. “是否成功?无法确定”,“如何定义临床成功是一项困难的挑战”

早在一年结果论文中,这个问题就困扰着美国方面:“本研究的困难之处是如何定义成功”。当时作为成功标志之一的反射弧现在消失了,自然就更加困难了。Beaumont医院从2006年底开始试验至今已经四年多了,居然还搞不清楚怎么算是试验成功,这恐怕是临床试验史上最大的笑话吧。为什么不去查查自己当初是怎么设定试验目标的?为什么不去问问肖传国和神源医院或看看肖传国的论文是怎么“成功”的?再不济,为什么不进行历史回顾,将其结果与传统手术(例如拴系松解术、缺陷修补术)进行比较?答案无非是,美国试验结果既没有达到自己的目标,更无法与肖传国的“成功”相提并论,甚至比不上传统手术。

同行专家曾评论美国一年结果“首次挑战了(肖)先前发表的成功率超过85%的优异结果”、“临床疗效与(肖)此前所报告的截然不同”。因此,所谓“是否成功?无法确定”,对于第三方同行专家来说,就是直截了当的两个字:“失败”。

很显然,美国方面有意混淆“成功”的定义,只是为了掩饰其失败。这种结果在肖传国看来,居然“比我们中国的还好”,可见肖氏手术在中国远不止是失败,而是害人无数。

8. 肖氏手术适合于发展中国家?

讲座“结论”部分说:“资源充足的发达国家,患者可通过清洁导尿和使用药物防止严重感染、肾衰竭及死亡。”隐含的意思似乎是肖氏手术不适合发达国家。“结论”随后更明确地说:“在那些缺乏或难以负担清洁导尿和抗痉挛药物的国家,膀胱和直肠神经重建不仅能提高患者生活质量,而且可救命。”看来肖氏手术只能用在象中国这样的发展中国家了。

问题是,Peters没有想到,在中国这样的发展中国家,很多患者倾家荡产才能负担起昂贵的手术费。更严重的是,患者同样没有条件、无力负担术后康复训练。Beaumont患者一人足下垂无法恢复,其他人经过了长时间密集的理疗才使严重下肢后遗症勉强恢复术前水平。而对于中国那些术后被神源医院置之不理、生活贫困、无缘术后理疗康复训练的患者,这意味着下肢残疾。

0. 最后,肖传国为什么着急“赶在美国宣布前”开记者招待会发布美国试验结果呢?

学术杂志通常规定(例如美国《泌尿学杂志》,见http://www.jurology.com/content/media#embargo),论文发表前应遵循严格的新闻发布禁令,以保证学术独立和学术自由,避免论文作者绕过正常的学术途径、以一面之词故意歪曲结果误导大众、借助新闻宣传来逃避同行的监督和审查。

美国一年结果发表后遭到同行专家严厉批评,可以说是被批得“体无完肤”;这次的三年结果更加惨不忍睹,连肖氏手术的理论基础都被推翻了,可以预料,发表后必将遭到同行专家更加严厉的批驳,将会达到“抽筋扒皮”的程度。

因此,肖传国不顾学术界基本规矩,要“赶在美国宣布前”越俎代庖替其美国合作者开记者招待会,无非是指望在记者无从获得原始资料、目前尚无第三方同行专家对试验结果进行解读评论的情况下,想通过自吹自擂、先声夺人来歪曲试验结果,以达到污蔑方舟子和新语丝、愚弄国内媒体和大众的目的。

不幸的是,我们已经获悉了三年试验的关键结果。现将讲座资料相关部分原文及翻译附后,以正视听。同时,奉劝那些要参加肖氏秘密招待会的记者,应等待美国方面正式发表的三年试验结果及同行专家的评论,而不是听信肖传国一再的吹牛和谎言。不愿等待正式结果的记者,可参考《国外同行专家对美国肖氏手术临床试验结果的评价》,把其中同行专家对先前一年结果有关反射弧建立(现已消失)的正面评价去掉、把负面评价加重,那将是同行专家对三年结果的评价。

附:神经重构
K Petters
2011年2月4日 国际尿失禁学会

术后三年更新

[] 最近已完成三年随访
[] 9名患者中有7名前来随访
[] 1名37岁男性患者症状无变化
[] 2名受试者未前来随访,视为无应答
[] 经综合评估,5/7直肠功能改善
[] 经综合评估,4/7膀胱功能改善
[] 大多数患者尿失禁仍成问题
[] 6/7愿意再做一次手术
[] 成功了吗?不确定

术后三年导尿情况
[] 术前全部受试者均需清洁间歇导尿
[] 36个月:7名中的4(5)名不再导尿
  - 一名受试者在36个月随访前尿路感染,其母令其开始导尿
  - 此患者是性活跃的青少年,余尿<50 cc
  - 现已不再导尿
[] 1名受试者每天导尿仅一次
[] 1名37岁男性受试者术后膀胱无变化,需导尿

排尿
排尿日常情况
[] 术前2/9可尿出一些
  - 平均尿量27 cc
[] 术后36个月6/7可尿出(不挠皮肤)【译注:一年结果曾有7人可尿出】
  - 平均尿量156 cc
【译注:去掉了未随访的两名患者后,此指标稍好于一年结果尿量133ml,但仍远逊于肖公布的结果】
术后36个月尿流,6人(37岁男性患者不能尿出)【译注:据一年结果,此37岁患者术前、术后一年均能尿出】
[] 平均尿量248 cc(不挠皮肤)
[] 平均余尿93 cc
【译注:去掉尿不出来的37岁患者和未随访的两名患者后,此指标稍好于一年结果余尿119ml,但仍远逊于肖公布的结果,例如正文所列举的“剩余尿逐渐减至(22+/-15)ml”】
[] 排空率:73%

术后三年排尿模式
[] 6/7漏尿,全都压力性尿失禁
[] 2/7偶尔能通过意识启动尿流
[] 1/7不需憋气用力即可尿出,4/7多半时候需憋气用力才尿出,1/7始终需憋气用力才尿出
[] 尿流情况:强-2人,弱-3人,淋漓-2人
[] 白天自制:干燥-1人,偶然漏尿3人,频繁漏尿3人
[] 膀胱充盈感:有-7人,无-0人
[] 膀胱感觉改善:是-4人,否-3人

术后三年膀胱顺应性数据(7人)
[] 术前顺应性中值15.2 ml/cmH20,术后36个月28.4 ml/cmH20
【译注:此术前指标甚至好于肖公布脊柱裂病例的术后指标】
[] 三名儿童顺应性术前小于10,术后36个月全部正常
    - 7.0  -> 34.3
    - 9.4  -> 21.2
    - 8.3  -> 28.4

术后三年膀胱容量、神经源性逼尿肌过度活动(7人)
[] 术前容量:平均210 cc;中值200 cc 【译注:此术前指标甚至好于肖公布的脊柱裂病例的术后指标】
[] 三年容量:平均293 cc;中值316 cc 【译注:一年结果曾报告5人容量增加、4人减少,平均253 cc】
   *儿童长大了三岁 【译注:据文献,正常儿童膀胱每年增容约15 cc】
[] 术前:尿动力测试显示4/7神经源性逼尿肌过度活动
[] 三年:1/7神经源性逼尿肌过度活动*
  - 除一名患者外*,其余全部无需抗痉挛药物*
   *此持久性逼尿肌过度活动患者为37岁男性
   【译注:一年结果曾报告,9名患者术前有4名无需抗痉挛药物,术后全部无需抗痉挛药物】

反射
[] 术后一年内,7/9患者存在皮肤至膀胱反射(定义为:刺激术侧皮区导致10 cm/H20升压。幅度为11-30 cm/H20)
[] 术后三年,仅剩一名患者存在反射,且远比以前减弱
[] 中枢神经抑制了反射?

不良事件
[] 无新的长期不利现象
[] 肾功能稳定
[] 肾超声检测稳定

更新
[] 2009年小儿神经外科医生Holly Gilmer加入我们的团队
[] 肖医生来到Beaumont医院监督Gilmer医生实施了4名脊柱裂儿童神经重建手术
[] 临时性下肢无力,无足下垂
[] 2例并发脑脊液漏
[] 术后一年,2/4无需导尿和抗痉挛药物

结论
[] 神经源性膀胱和直肠仍是临床上的重大挑战
[] 资源充足的发达国家,患者可通过清洁导尿和使用药物防止严重感染、肾衰竭及死亡
[] 神经重建恢复膀胱和直肠功能的概念由来自中国的肖传国推广普及
[] 在那些缺乏或难以负担清洁导尿和抗痉挛药物的国家,膀胱和直肠神经重建不仅能提高患者生活质量,而且可救命
[] 在脊柱裂患者人群中,我们的先期试验表明,术后三年6/9(66%)临床上有改善
[] 明确具有导致下肢无力的风险,特别是1/9患者永久性足下垂
[] 没有发现其他长期不良事件
[] 这一疾患影响多个方面的膀胱和直肠功能,如何定义临床成功是一项困难的挑战
[] 在本试验中,压力性尿失禁仍然是个问题,尽管神经源性逼尿肌过度活动和抗胆碱药物的使用减少了
[] 我们强烈认为,需要进行多中心临床试验,以确定神经重建在神经源性患者中的功用
[] 我们应当更好地确定合适患者人群、精炼这一外科手术、提高泌尿、直肠括约肌以及生活质量的评估、评定方法

【英文缩写】
CIC Clean Intermittent Catheter
CNS Central Nervous System
GRA Global Response Assessment
ISC Intermittent Self-Catheterisation
MCC Maximal Cystometric Capacity
NDO Neurogenic Detrusor Overactivity
PVR postvoid residual
UDT Urodynamic Test
UTI Urinary Tract Infection

【英文原文】

http://www.icsoffice.org/Documents/Documents.aspx?FolderID=107
Dubai Education Course Handouts, February 2011
Handouts from the PACS/ICS/ICCS Education Course held in Dubai, 3-5 February. The handouts are from the ICS speakers only.

http://www.icsoffice.org/Documents/Documents.aspx?DocumentID=897
K Peters, Nerve Rerouting
Friday 4th February 2011
International Continence Society

36-Month Update
[] Recently finished 3 year follow-up
[] 7 of 9 returned for follow-up
[] 1 (37 yo male) no change in symptoms
[] 2 subjects not returning considered non-responders
[] Bowels improved 5/7 on GRA
[] Bladder improved 4/7 on GRA
[] Incontinence still problem in most
[] 6/7 would undergo surgery again
[] Success?  Not Sure

36-Month Catheterization
[] Baseline all subjects were on clean intermittent catheterization
[] 36-months: 4 (5) of 7 off catheterization
  - One subject’s mother had her restart ISC prior to 36-month visit due to a single UTI
  – Patient is sexually active teen with a PVR<50cc
  - Now off ISC
[] 1 subject catheterizes only 1 x/day
[] 1 subject (37 year old male) had no change in bladder from surgery and on ISC

Voiding
Void Diary
[] Baseline 2/9 voided some
  – Mean voided volume 27cc
[] 36-month 6/7 voided (without scratching)
  - Mean voided volume 156cc
Uroflow-36 Month n=6 (37 yo male could not void)
[] Mean voided volume: 248 cc (without scratching)
[] Mean PVR:  93 cc
[] Voiding efficiency:  73%

Voiding Pattern at 36 Months
[] 6/7 leak urine, all with stress incontinence
[] 2/7 occasionally start stream by thinking
[] 1/7 no valsalva to void, 4/7 valsalva void greater than 1/2 time and 1/7 valsalva void always
[] Urine stream described as: Strong-2, Weak-3 and dribble in 2
[] Daytime continence: 1-dry, 3 occasional leak and 3 frequent leak
[] Sensation of bladder fullness: Yes-7, No-0
[] Improvement in bladder sensation: Yes-4, No-3

3-year Compliance Data (n=7)
[] Median compliance 15.2 ml/cmH20 baseline vs 28.4 ml/cmH20 at 36 months
[] 3 children had compliance less than 10 at baseline:
  – All normalized at 36 months
    - 7.0  -> 34.3
    - 9.4  -> 21.2
    - 8.3  -> 28.4

3-year Bladder MCC and NDO (n=7)
[] Baseline MCC: Mean=210 cc; Median=200 cc
[] 36-month MCC: Mean=293 cc; Median=316 cc
    *Children are 3-years older
[] Baseline: 4/7 had NDO on UDT
[] 36-month: 1/7 had NDO on UDT*
  – All patients off Antimuscarinics except 1*
    * persistent DO-37 year old male

Reflex
[] By 12 months 7/9 had cutaneous to bladder reflex defined as at least a 10 cm/H20 pressure rise with stimulating dermatome on side of surgery (range 11-30 cm/H20
[] At 36 months only ONE had reflex remaining and much weaker than earlier
[] ? Suppression of reflex by CNS

Adverse Events
[] No new long-term adverse events
[] Stable renal function
[] Stable renal ultrasounds

UPDATE
[] 2009 added Holly Gilmer, MD a pediatric neurosurgeon as part of our team
[] Dr. Xiao returned to Beaumont and proctored Dr. Gilmer on the rerouting procedure on 4 children with SB
[] Transient weakness, no foot drop
[] 2 subjects had dural leak
[] At 1 year, 2/4 off catheter and meds

Conclusions
[] Neurogenic bladder and bowel remains a significant clinical challenge
[] Developed countries with adequate resources can often manage the patient with CIC and medications thus preventing significant infections, renal failure and death
[] The concept of nerve rerouting to restore bladder and bowel function was popularized by CG Xiao from China
[] Successful reinnervation of the bladder and bowel may not only improve QOL but also be life-saving in countries where catheterization and/or antimuscarinics are not readily available or affordable
[] In the spina bifida population, our pilot trial demonstrated 6/9 (66%) had clinical improvement at 36 months
[] A risk of lower extremity weakness is evident in that 1/9 subjects had a permanent foot-drop
[] No other long-term adverse events were identified
[] Defining clinical success is a difficult challenge in a disease state that impacts many aspects of bladder and bowel function
[] In this study, stress incontinence remained a problem, although NDO and antimuscarinic use were reduced
[] We feel strongly that multicenter clinical trials are needed to determine the utility of nerve rerouting in the neurogenic patient
[] We should better define the ideal patient population, refine the surgical procedure, improve the evaluation of the urinary and bowel sphincters and assess quality of life



美国“肖氏手术”三年试验结果:“神奇的肖氏反射弧”成了“神奇消失的反射弧”

15 04 2011年

美国Beaumont医院“肖氏手术”临床试验负责人K. Peters透露三年结果:“术后三年,仅剩一名患者存在反射,且远比以前减弱”。即:“挠大腿治失禁的神奇反射弧”(肖弧广告宣传语)消失了,挠大腿不管用了。

2010年8月,美国临床试验一年结果论文正式发表,其中将观察到反射弧建立作为手术成功的主要标志,声称:“很难定义怎么算是成功……如果把‘成功’定义为刺激皮肤引起逼尿肌收缩,那么本手术确实在绝大多数患者身上起作用了。”持严厉批评态度的同行专家,对试验结果的唯一的正面评价也是反射弧的建立(见《国外同行专家对美国肖氏手术临床试验结果的评价》)。肖传国被捕后,所谓“国际学术同仁”在《声援肖传国医生的公开信》中也声称:“术后12个月随访,9名患者中的7名建立了皮肤至膀胱反射,证明神经重建确实发生了,这个成绩是了不起的,肖医生应该得到嘉奖。……该先期试验的数据是支持肖氏手术的。”而且,由NIH资助的美国“肖氏手术”第二期临床试验,更是将反射弧的建立设定为首要的手术结果衡量指标。

肖氏手术“成功”的主要标志、被各方人士注重和认可的“神奇反射弧”,现在居然消失无踪了,这一发现令人震惊。这说明什么?

1. 美国三年试验结果推翻了“肖氏手术”的理论基础。“肖氏反射弧手术”没有了“反射弧”这一生理基础,成了空中楼阁。

2. 从Beaumont医院一年结果论文尿动力学图中的皮肤刺激与膀胱收缩之间的延迟来看,此前“反射弧”的存在很可能是患者经训练而形成的条件反射,而不是真正的体神经——自主神经反射。即便是肖传国的支持者(虹桥freeway)也猜测:“我疑心这种反射弧有点像条件反射,会逐渐消褪”。这是对反射消失的最直接了当的解释。而Peters现在猜测反射消失是因为“中枢神经抑制了反射”则是故弄玄虚。

3. 美国一年试验结果统计表明,《“肖氏手术”的效果与“反射弧”无关》。三年结果“反射弧”消失,则明确地证明了这一点。

4. 没有了“反射弧”,“肖氏手术”在部分脊柱裂患者身上产生的有限的改善效果,只能用栓系松解术(或缺陷修补术)的效果来解释,即:与“肖氏手术”同时做的该传统手术,在一定程度上恢复了患者大脑与膀胱、直肠的联系。

5. 脊髓损伤患者因大脑与脊髓联系中断,在“反射弧”消失的情况下注定不可能成功。德国的6例、Beaumont的2例脊髓损伤患者无一成功已经证明了这一点。部分脊髓损伤患者的部分症状的些许改善,只能解释为神经切断术的效果。

6. 已被暂停等待复查的由NIH资助的美国第二期试验,还没开始就注定失败,因为该试验把首要结果衡量指标设置为刺激皮肤引起膀胱收缩(即建立了反射弧)。这也说明他们此前从未意识到、也未被肖传国告知“神奇反射弧”居然会消失无踪。

7. 肖传国从未在动物实验、人体试验的论文中披露过反射消失的现象,证明他论文造假、隐瞒关键结果。

附:笑话一则

肖传国:我们用神奇的肖氏挖掘术在平顶山挖出了一根古老的神奇的铜线。
Peters:然后呢?
肖传国:我们在中国各大城市推广神奇的肖氏术,挖出了更多神奇的铜线。
Peters:那又怎样?
肖传国:这证明我们古人普遍使用电话通讯了!肖氏挖掘术考古成功!
Peters:我们在美国试验肖氏挖掘术,就挖了几块石头。
把几座大楼都挖歪了,一年后勉强整修恢复,有一座大楼无法恢复。
是否成功?不能确定。
肖传国:哇靠!这证明你们古人普遍使用无线通讯了!
Peters(恍然大悟状):原来如此。看来,是无线通讯抑制了电话通讯。
Peters(困惑状):我们申请资金时,把找到神奇的铜线作为考古成功的标志,这可怎么办?
Peters(结论):美国资源充足,拥有众多传统和先进的考古技术。而在那些缺乏或难以负担传统和先进的考古技术的国家,肖氏挖掘术不仅能节省资金,而且可以做出重大考古发现。
肖传国(记者招待会):美国的结果比我们中国的还好。美国学生的结果支撑了我。



光明网恶意篡改本人文章,污蔑肖传国和肖氏手术

2 03 2011年

肖传国枪手、光明网经济频道副总监沈阳搞的所谓肖氏手术专题,将本人揭露肖氏手术的文章《“肖氏术”何以在美国开始临床试验
http://blog.sina.com.cn/s/blog_474068790100hqnx.html 恶意篡改得面目全非,手段是字词替换,例如:

有-无
中-外
新闻-旧事
增-删
已-未
主-从
正-反
治-乱
子-女
因-果

可笑的是,责任编辑李然弄巧成拙,把肖传国自吹和他吹也一并改了,成了“污蔑”肖氏手术的话,例如:

“未开展‘人工反射弧’手术218例,无效率高达80%”
“随访12个月的病人无506例”
“85%的患者大小便未恢复”
“肖氏术医乱了117例患者”

不过,这么一改倒是基本符合事实。

见:http://topics.gmw.cn/2010-11/10/content_1377990.htm

Google缓存见:

http://xysblogs.org/wp-content/blogs/20/uploads/gmw1.png
http://xysblogs.org/wp-content/blogs/20/uploads/gmw2.png

 



肖传国在论文中捏造、篡改数据

11 11 2010年

肖传国在美国《泌尿学杂志》上共发表两篇肖氏手术人体试验结果的论文。此前,肖传国曾发表有关会议摘要、中文论文、以及其他中文报告。将肖的两篇论文与其他来源的结果进行比较,清楚地表明肖传国捏造、篡改了数据。

肖传国在2003年论文[1]报告了“自1995年开始……首期15例脊髓损伤患者”的结果。此前,在1998年会议摘要[2]中,则报告了“自1995年开始”的14例脊髓损伤患者的结果。总的病例人数有1人之差,这并非问题所在。问题是,2003论文报告的15例都是高反射膀胱患者,而1998摘要却仅报告了6例高反射膀胱患者(其余8例为无反射膀胱患者)。2003年论文中的其余9例高反射膀胱患者是从哪里来的?同样,1998摘要中的8例无反射膀胱患者又到哪里去了?

无论随访时间有多长,患者的术前余尿数据不会有变化。然而,肖传国的数据并非如此。1998摘要中的6例高反射膀胱患者的术前余尿为300毫升,而在其2002年何梁何利奖获奖成就[3]所描述的“1995年开始……首期治疗截瘫病人14例”中的6例高反射膀胱患者,术前余尿竟然变成了317毫升。

肖传国2005年论文[4]“首次”报告了20例脊柱裂患者18个月回访结果,其中6例为高反射膀胱患者,其中1例失败。此前,肖传国2003年曾在《临床泌尿外科杂志》上发表中文论文[5],报告了“自2000年开始”的13例脊柱裂患者1年回访结果,其中6例也是高反射膀胱患者。不同之处在于,这6例全部成功。两篇中英文论文的上下文表明,这是相同的6例高反射膀胱患者。肖传国未在其2005论文[4]中提到有一病例先成功后失败,而这意味着此手术长期预后存在问题。

肖传国这两篇脊柱裂论文也同样存在术前余尿数据矛盾。2005论文[4]中的6例高反射膀胱患者的术前余尿为70.17毫升,而2003中文论文[5]中的同样6例患者的术前余尿却为102毫升。

此外,中文论文[5]中的13名患者年龄为2至25岁,均于出生后2年内行脊膜膨出关闭术;而2005论文[4]中的20名患者则是5至14岁,出生后48小时行脊膜膨出关闭术。这意味着在后来的论文[4]中,有些患者消失了:2岁和25岁的患者,以及那些出生后48小时至2年间行脊膜膨出关闭术的患者。

肖传国论文中的众多矛盾不可能都归咎为笔误。上述不同出处的病例类型人数、术前余尿数据和患者资料的矛盾,只能说明一个问题:肖传国捏造、篡改了数据。

论文中还存在其他矛盾。肖传国1998摘要[2]中注明资金来源为NIH和PVA,而其2003论文[1]则变成了来自中国的4项资金。

另外,论文共同作者前后也有增删。与1998摘要[2]相比,2003论文[1]的作者多了Victor Nitti和William C. de Groat。与2003中文论文[5]相比,2005英文论文[4]的作者则多了Ellen Shapiro和Herbert Lepor。他们在中国的临床试验中扮演了什么角色?在临床试验初步结果已经由他人报告[2,5]后,他们对后来的论文[1,4]作出了什么“贡献”?在享有署名权的同时,他们是否应当对滥用资金和违反医学伦理负责?

此外,肖传国未在[4]中披露他曾在[5]中描述的“较大部分患者需借助不同程度腹压方可彻底排空膀胱”,而这正好可以解释中国有位专家曾发现的[4]中尿流动力学图的矛盾。专家指出[6],论文[4]中的术后尿流动力学图3B和图4B表明病人排尿是靠腹压而不是靠膀胱逼尿肌压力。这说明了反射弧无效,而肖却错误解释为反射弧引起的排尿。实际上,Beaumont医院的结果[7]也被编辑评论指出,排尿可能是腹压而不是反射弧的效果。

还有,肖传国未在[4]中披露[5]中的首批13名患者都有栓系综合征,而且据肖传国的合作伙伴透露[8],肖氏手术同时还做栓系松解术。肖传国有理由隐瞒此信息,因为松解术是脊柱裂的常规手术,其效果早已经被众多临床试验报告[9]所证实,有同行专家也曾评论过[6]。事实上,某些脊柱裂患者术后出现的自主排尿和尿感,可以解释为肖本人在[5]中所讨论的“与其脊髓与脑中枢的联系并未中断有关”,这一现象后来却被Beaumont医院的医生神秘化为中枢神经的重塑[7]。肖氏手术的效果还可能是S2或S3神经切断术的效果,正如专家在[6]中、以及在针对Beaumont论文[7]的编辑评论中所指出的。区别是切断L5腹侧运动神经导致患者下肢出现严重后遗症。肖传国从未针对这些常规治疗手段做过对照试验,也未做过历史回顾,而他的私营医院却已经在患者身上做了数千例营利性手术。

肖的2003年论文[1]和2005年论文[4]后来被其2006年综述文章[10](NIH是资助者之一)引用。除了这两篇论文,肖在这篇综述中还引用了一份文献中根本不存在的会议报告[11]。后来,该综述文章成为Beaumont医院初步临床试验[12]的主要参考资料,而那份不存在的报告中的号称超过85%的成功率成为Beaumont医院申请NIH资金的主要支持数据[13]。

我们对发现肖传国的上述学术不端行为并不感到惊讶。我们早就发现,他曾捏造了一份正式文件[14],证明他的私营医院的117名患者8个月随访的成功率为85%,而当时这家医院成立不到8个月。

最后,肖传国捏造、篡改数据完全可以解释为什么他的结果不能被Beaumont医院的医生重复。Beaumont医院的一年结果[7]被同行专家评论为“首次挑战了(肖传国)先前发表的成功率超过85%的优异结果”、“该手术的临床疗效与(肖传国)此前所报告的截然不同”。

我们将向《泌尿学杂志》举报此数据捏造、篡改行为,并将通报给有关机构。《临床泌尿外科杂志》就免了。那是肖传国任主编的杂志。

更新:

2004年摘要[15]中的20例的患者组成、术前膀胱容量、术前余尿与2005年论文[4]都不同。其中,2005论文中的areflexic bladder患者的术前膀胱容量分项数据(110, 120, 106, 90, 70, 75, 80, 148, 70, 85, 96, 90, 355, 147),不可能凑出来2004摘要中的72 ml;2005论文中hyperreflexic bladder患者的术前余尿分项数据(72, 70, 110, 50, 69, 50),不可能凑出来2004摘要中的282 ml。

更新:

据2010年南方周末采访当年做肖氏手术的矿工[16],史姓矿工“尚能行走”,而肖2003年关于首批15名脊髓损伤矿工的论文[1]中说,这些患者全部为A级完全脊髓损伤(患者无行走能力)。史姓矿工称术后“脚趾的功能受影响”,而肖论文中却称“无短期或长期并发症或不良事件”。这说明肖在论文中伪造患者术前状况、隐瞒手术后遗症。另外,樊姓矿工表示手术“不理想”,“与其同批手术的其他四人也没啥效果”。手术在总共5名患者身上均无效,与肖论文中所声称的成功率相矛盾:15名患者中的10名获得了“满意的膀胱控制功能”,2名部分恢复,1名失访,2名失败。这也是肖在论文中伪造数据的证据。

据肖传国及其律师提供的“自1999年即一直写入中国外科学教科书”《外科学》中关于肖氏手术的内容[17],患者是“在脊髓损伤4~6个月,截瘫平面稳定后”实施手术,而肖2003年论文[1]中却声称其首批15名患者受伤后平均6.8年(正负6年)后才做肖氏手术。肖多次声称,做了首批15名患者后停止手术随访三年,直到1999年卫生部鉴定后才做新手术,因此《外科学》与论文中涉及的是同一批患者。显然,肖传国在论文中隐瞒了患者术前真实状况,这也证实了知情人simon早在2005年在《院士候选人肖传国其人其事》中揭露的“在急性脊柱损伤后,有少部分病人在半年或以上可自行恢复部分功能……肖和那里的骨科主任杜XX在手术前精心挑选了病人,里面大有猫腻。说白了,这3例病人即使不接受肖氏弧术也会恢复部分功能”。

Xiao Chuanguo Fabricates and Falsifies Clinical Data

Xiao Chuanguo published two papers on his clinical trials of his procedure in the Journal of Urology. Before the papers published, he also published related results in conference abstracts, articles in Chinese and other reports in Chinese. By comparing the results in the two papers with that from other sources, we demonstrate that Xiao fabricated and falsified his data.

Xiao reported his results of “the first 15 patients with SCI” (”clinical trial was started in 1995″) in his 2003 paper [1]. Before that, he also reported the results of “14 SCI patients since 1995″ in his 1998 abstract [2]. It is not the problem that there is a difference of one in the total numbers of patients. The problem is that all 15 patients are of hyperreflexic bladder in the 2003 paper, whereas only 6 patients are of hyperreflexic bladder in the 1998 abstract. Where did the other 9 patients with hyperreflexic bladder in [1] come from? and where had the 8 patients with areflexic bladder in [2] gone?

The pre-operative residual urine should remain the same no matter how long the follow-up is. But this is not the case in Xiao’s data. The pre-operative residual urine of his 6 patients with hyperreflexic bladder is 300 ml in his 1998 abstract, but this data becomes 317 ml in his 6 patients with hyperreflexic bladder, among the same “first 14 SCI patients”, described in his achievement [3] that was presented to the Holeung Ho Lee Foundation when he applied for the award from the Foundation in 2002.

Xiao reported the 18-month follow-up results of the “first” 20 patients with spina bifida in his 2005 paper [4], one failed among 6 patients with hyperreflexic bladder. Before that, he reported the 12-month results of 13 patients with spina bifida, published in Chinese in the Journal of Clinical Urology [5]. There were also 6 patients with hyperreflexic bladder. The difference is that the 6 cases in [5] were all successful. From the context of both two papers, the 6 cases were the same. Xiao did not mention in [4] that there was one case that was once successful but then failed later, which may suggest that there exists a problem in long-term prognosis of the procedure.

There is also an inconsistency in residual urine between his 2005 paper in English [4] and 2003 paper in Chinese [5]. The residual urine of the 6 patients with hyperreflexic bladder is 70.17 ml in [4], whereas that of the same 6 patients is 102 ml in [5].

Besides, the 13 patients in [5] were classified as 2 to 25 years old, whose spinal defects were closed within 2 years of birth. In contrast, the 20 patients in [4] were 5 to 14 years old and their spinal defects were closed within 48 hours of birth. This means that some patients disappeared in the later paper [4]: those of 2 and 25 years old and whose spinal defects were closed between 48 hours and 2 years of birth.

So many inconsistencies in Xiao’s papers cannot be attributed to clerical errors. The above described inconsistencies in the numbers of patients, in the residual urine and in the patient characteristics can only be explained by that Xiao Chuanguo fabricated and falsified his clinical data.

There are other inconsistencies in Xiao’s papers. The source of funding is indicated to be NIH and PVA in Xiao’s 1998 abstract [2], while it becomes 4 grants from China in his 2003 paper [1].

In addition, there are changes in the lists of authors. Comparing to 1998 abstract [2], Victor Nitti and William C. de Groat were added in 2003 paper [1]. Comparing to 2003 paper in Chinese [5], Ellen Shapiro and Herbert Lepor were added in 2005 paper in English [4]. What are their roles in the clinical trial in China? What are their contributions to the papers [1,4], after the initial results had already been reported in [2,5] by others? Are they responsible for the grant misuse and the ethical violation while enjoying the right of authorship?

Moreover, Xiao failed to disclose in [4] what he had described in [5] that “most of patients need the help of different level of abdominal pressure in order to completely empty bladders”, which can well explain the contradiction in the urodynamic data in [4], found by a peer expert from China [6]. The expert pointed out that the postoperative urodynamic studies in Fig. 3B and Fig. 4B of [4] clearly show that the patients urinate by intra-abdominal pressure instead of the detrusor pressure, suggesting the failure of establishment of the reflex arc. But Xiao misrepresented that it is the reflex arc that causes the urination. We note that Beaumont Hospital’s results [7] also received same criticism in the editorial comment that the voiding might be the result of intra-abdominal pressure rather than the reflex arc.

Furthermore, Xiao failed to disclose in [4] that all of the first 13 patients had tethered cord syndromes [5], and that detethering was performed in addition to never rerouting, revealed by Xiao’s partner [8]. Xiao has the reason to conceal this information, since detethering is a standard surgical procedure of spinda bifida, whose effects have already been confirmed in numerous clinical reports [9] and mentioned by a peer expert [8]. In fact, voluntary voiding and bladder sensory in some patients with spinda bifida after his procedure can be explained by “the fact that the connection between spinal cord and brain has not been disrupted” as discussed in [5] by Xiao himself, but was mystified later by doctors at Beaumont [7] as remodeling of the central nerve system. We note that the effects of Xiao’s procedure can alao be partly attributed to denervation of the S2 or S3 nerves, as pointed out by peer experts in [6] and in the editorial comment on Beaumont’s report [7]. The difference is that denervation of the L5 ventral (motor) nerve results in serious side effects in patients’ lower extremities. Xiao has never conducted a controlled study or done a historic review on these conventional treatments, even though his private hospital has performed his procedure on thousands of patients for profit.

Xiao’s 2003 and 2005 papers [1,4] were cited by his 2006 review article [10] (NIH is one of the sponsors). Besides these two papers, he also cited a conference report [11] that does not exist in the said Proceedings. Later on, the review article became the major reference of Beaumont Hospital’s pilot clinical trial [12], while the claim of more than 85% success rate originated from the non-existent report became the major supporting data in Beaumont Hospital’s application to their NIH grant [13].

We are not surprised to find out that Xiao committed the aforementioned academic misconducts. It has already been discovered that he once fabricated an official document [14] testifying the 85% success rate of 117 patients after 8 months of follow-up, but the hospital itself came into existence and performed its first surgery less than 8 months before.

Finally, Xiao’s fabrication and falsification in his data can well explain why his results could not be replicated by the doctors at Beaumont Hospital, who were commented by peer experts that their one-year outcomes [7] “challenge the excellent, previously published results”, and that “the clinical benefit of the procedure is not at all similar to previous reports”.

We will file a complaint to the Journal of Urology and European Urology on Xiao’s fabrication and falsification. We will also present this case to related authorities.

(Written by Yush. Volunteers contributed their findings.)

Update:

There are significant inconsistencies in 2004 abstract [15] and 2005 paper [4]. The patients characteristics and pre-operative data of bladder capacity and residual urine are totally different. Specifically, the individual preop bladder capacity for the 14 patients in [4] (110, 120, 106, 90, 70, 75, 80, 148, 70, 85, 96, 90, 355, 147 ml) cannot produce an average of 72 ml in [15]; the preop residual urine for the 6 patients in [4] (72, 70, 110, 50, 69, 50 ml) cannot produce an average of 282 ml for the 4 patients in [15]:

For 13 of the 16 patients with areflexic bladder, the average bladder capacity increased from 72ml to 210ml, and the detrusor became contractile with a pressure over 33 cmH20….For 3 of the 4 patients with hyperreflexic bladder, … Average residual urine decreased from 282 ml to 38 ml….  [15].

Of the 14 patients with areflexic bladder 12 (86%) showed improvement. In these cases bladder capacity increased from 117.28 to 208.71 ml, and mean maximum detrusor pressure increased from 18.35 to 32.57 cm H2O. Five of the 6 patients with hyperreflexic bladder…In these cases … post-void residual urine decreased from 70.17 to 23.67 ml [4].

References

[1] Xiao’s 2003 article
http://www.ncbi.nlm.nih.gov/pubmed/14501733
Xiao CG, Du MX, Dai C, Li B, Nitti VW, de Groat WC. An artificial somatic-central nervous system-autonomic reflex pathway for controllable micturition after spinal cord injury: preliminary results in 15 patients. J Urol 2003; 170: 1237.
A total of 15 male volunteers with hyperreflexic neurogenic bladder…Of the 15 patients 10 (67%) regained satisfactory bladder control within 12 to 18 months after VR micro anastomosis. Average residual urine decreased from 332 to 31 ml and
urinary infection as well as overflow incontinence disappeared. Urodynamic studies revealed a change from detrusor hyperreflexia with DESD and high detrusor pressure to almost normal storage and synergic voiding without DESD.
…After successful experiments in animals, clinical trial was started in 1995. We report results in the first 15 patients with SCI.

[2] Xiao’s 1998 conference abstract
http://xysblogs.org/wp-content/blogs/107/uploads/1998xiao14sci.gif
Xiao CG, Godec CJ, Du MX, Dai C, and Zhu X. A new procedure to restore bladder functions after SCI: Preliminary report on 14 patients. J.Urol. 159:304A, 1998
We have performed this procedure on 14 SCI patients since 1995 to try to restore controllable voiding….
Of 6 patient with hyperreflexic badder, 5 had successful recovery of bladder function. They are able to void by initiating the skin-CNS-Bladder reflex, which became functional from the 10th to 12th month postoperatively. Residual urine decreased from 300 ml to 31 ml in average, and no UTI occurred since the sixth month postsurgically. CMG study documented the changes of the bladder from hyperreflexia and high pressure to relatively normal…. Among 8 patients with areflexic bladder, 3 showed remarkable recovery and 1 had patial recovery.
SOURCE OF FUNDING: NIH, PVA

[3] Xiao’s achievement, from the Holeung Ho Lee Foundation
http://www.hlhl.org.cn/news/findnews/showsub.asp?id=476
(Translation) We started the clinical study in 1995 and have treated 14 SCI patients, and conducted 2.5 to 3.5 years of follow-up. Of 6 patient with hyperreflexic bladder, 5 restored bladder storage and emptying function. Average residual urine decreased from 317 ml to 29 ml. Six months after operations, they no longer suffer urinary tract infection. One case failed because of other reasons. Among 8 patients with areflexic bladder, 5 completely restored bladder storage and emptying function, 1 had partial recovery, average residual urine decreased from 288 ml to 32 ml.

[4] Xiao’s 2005 article
http://www.ncbi.nlm.nih.gov/pubmed/15879861
Xiao CG, Du MX, Li B, Liu Z, Chen M, Chen ZH, Cheng P, Xue XN, Shapiro E, Lepor H. An artificial somatic-automonic reflex pathway procedure for bladder control in children with spina bifida. J Urol 2005; 173: 2112.
Preoperative urodynamic studies revealed 2 types of bladder dysfunction— areflexic bladder (14 patients) and hyperreflexic bladder with detrusor external sphincter dyssynergia (6). All children were incontinent. Of the 20 patients 17 gained satisfactory bladder control and continence within 8 to 12 months after VR microanastomosis. Of the 14 patients with areflexic bladder 12 (86%) showed improvement. In these cases bladder capacity increased from 117.28 to 208.71 ml, and mean maximum detrusor pressure increased from 18.35 to 32.57 cm H2O. Five of the 6 patients with hyperreflexic bladder demonstrated improvement, with resolution of incontinence…..In these cases mean bladder capacity increased from 94.33 to 177.83 ml, and post-void residual urine decreased from 70.17 to 23.67 ml. Overall, 3 patients failed to exhibit any
improvement.
…Based on our success in restoring bladder function and continence associated with spinal cord injury (SCI) by means of artificial somatic-central nervous system (CNS)-autonomic reflex pathway surgery, we investigated the effectiveness of this innovative surgical procedure in children with spina bifida and neurogenic bladder. To our knowledge this report represents the first published experience applying this technique to the management of spina bifida.
…Patient characteristics. The spinal defect had been closed surgically in all cases within 48 hours of birth. The group included 12 males and 8 females 5 to 14 years old (mean age 11 years)…

[5] Xiao’s 2003 article (in Chinese)
http://xysblogs.org/wp-content/blogs/107/uploads/2003xiaochn.pdf
http://en.cnki.com.cn/Article_en/CJFDTOTAL-LCMW200311001.htm
http://www.cnki.com.cn/Article/CJFDTOTAL-LCMW200311001.htm
Xiao CG, Du X-X, Liu Z, Li B, Chen ZH, Cheng P, Chen M. An artificial somatic-central nervous system-autonomic reflex pathway for spina bifida patients with neurogenic bladder and bowel. Journal of Clinical Urology 18(11).
Abstract (in English, provided by the authors)
A total of 30 patients with bladder and bowel dysfunctions caused by spina bifida underwent linited laminectomy and ventral root microanastomosis since 2000…. 13 patients had been followed up for at least one year. Four of 7 cases with areflexia bladder gained bladder control and automatic micturition abiliti within 6 months and 1 year after surgery…. All 6 cases with hyperreflexia bladder achieved controllable voiding, whose residual urine decreased from (102+/-39) ml to (22+/-15) ml and the detrusor external sphincter dyssynergia (DESD) disappeared.
(Translation of the text) After our success in treating bladder and bowel dysfunction in patients with spinal cord injury started in 1995, we have applied the theory and the technique to treat bladder and bowel dysfunction in 30 patients with spina bifida. So far we have followed up 13 cases for at least 1 year….
Clinical Information. …Total 13 patients have been followed up for more than 1 year, including 7 males and 6 females 2 to 25 years old, mean age 11 years. All patients had their spinal defects surgically closed within 2 years of birth. … MRI examinations (of all patients) exhibit typical images of tethered cord syndrome.
Results. …Most of patients need the help of different level of abdominal pressure in order to completely empty bladders.
Discussion. …After the operation, most of patients with spinal cord injury need stimulation of the dermatome to initiate voiding. In contrast, patients with spina bifida can void voluntarily, this is explained by the fact that the connection between spinal cord and brain has not been disrupted.

[6] Criticism from a peer expert from China
http://www.sciencenet.cn/m/user_content.aspx?id=280348
(Translation) Opinions on Xiao’s Reflex Arc
Science News. Dec 8, 2009
First, no control group has been set up. Selective sacral neurectomy has been used for treatment of neurogenic bladders. Even the artificial reflex arc itself doesn’t work at all, the surgery may have some effect as it denervates S2 and S3 nerves. Such effect at the early stage is not caused by the reflex arc. Without a control group, we cannot tell whether the effect is the result of selective sacral neurectomy or of the reflex arc.
Second, the urodynamic data contradict themselves….The figures reveal the truth inside the reflec arc. The postoperative urodynamic studies in Fig. 3B and Fig. 4B clearly show that the patients urinated by intra-abdominal pressure. But Xiao explained that it is the reflex arc that causes the urination. The flaw was ignored by editors. The evidence is that the intra-abdominal pressure (Pabd) is the same as intravesical pressure (Pves). And the detrusor pressure (Pdel) is very low (a flat line), nearly zero. Voiding happened only when intra-abdominal pressure existed.

[7] Beaumont Hospital’s one-year outcomes
http://www.ncbi.nlm.nih.gov/pubmed/20639040
Peters KM, Girdler B, Turzewski C, Trock G, Feber K, Nantau W, Bush B, Gonzalez J, Kass E, de Benito J, Diokno A. Outcomes of lumbar to sacral nerve rerouting for spina bifida. J Urol. 2010 Aug;184(2):702-7. Epub 2010 Jun 19.

[8] Xiao’s partner revealed that detethering was performed in addition to never rerouting.
http://bkb.ynet.com/article.jsp?oid=59384400
(Translation) An investigation of Shenyuan Hospital. Beijing Sci-Tech Weekly. Dec 08, 2009
Former president of Henan Shenyuan Hospital Gao Xiaoqun told the Weekly, the conventional treatment of spinda bifida is detethering a tethered cord…. As for the Xiao Reflex Arc, doctors also perform detethering in addition to never rerouting….
“I specialize in the research of nerve regeneration. I believe that this idea is simply nonsense”. Yu Yanbing, director of Neurosurgery of China-Japan Friendship Hospital, told Beijing Sci-Tech, that the standard surgical procedure for congenital spina bifida is detethering, which has a success rate of 50% to 70%.

[9] Clinical reports on detethering and denervation.
http://www.ncbi.nlm.nih.gov/pubmed/12145516
von Koch CS, Quinones-Hinojosa A, Gulati M, Lyon R, Peacock WJ, Yingling CD. Clinical outcome in children undergoing tethered cord release utilizing intraoperative neurophysiological monitoring. Pediatr Neurosurg. 2002 Aug;37(2):81-6.
“Significant bowel and bladder improvement was seen in 4 out of 25 patients”
http://www.ncbi.nlm.nih.gov/pubmed/17328264
Hsieh MH, Perry V, Gupta N, Pearson C, Nguyen HT. The effects of detethering on the urodynamics profile in children with a tethered cord. J Neurosurg. 2006 Nov;105(5 Suppl):391-5.
“in five (50%) of the 10 children with abnormal preoperative UDS results, the postoperative UDS demonstrated improved or normal urodynamics.”
http://www.ncbi.nlm.nih.gov/pubmed/7609174
Schneidau T, Franco I, Zebold K, Kaplan W. Selective sacral rhizotomy for the management of neurogenic bladders in spina bifida patients: long-term followup. J Urol. 1995 Aug;154(2 Pt 2):766-8.
“remarkable success in maintaining bladder volume and low pressures after rhizotomy and cord untethering.”
http://www.ncbi.nlm.nih.gov/pubmed/3359125
Lucas MG, Thomas DG, Clarke S et al: Long-term follow-up of selective sacral neurectomy. Br J Urol 1988; 61: 218.
“Thirteen of the 22 patients had significant symptomatic improvement lasting for more than 4 years post-operatively (59%), 8 of whom had stable bladders.”
http://www.ncbi.nlm.nih.gov/pubmed/11445474
Hohenfellner M, Pannek J, Botel U et al: Sacral bladder detethering for treatment of detrusor hyperreflexia and autonomic dysreflexia. Urology 2001; 58: 28.
“Detrusor hyperreflexia and autonomic dysreflexia were eliminated in all cases.”

[10] Xiao’s 2006 review
http://www.ncbi.nlm.nih.gov/pubmed/16314037/
Xiao CG: Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida. Eur Urol 2006; 49: 22.
Supported by grants from … NIH (R01 DK44877 and R01 DK53063)

[11] Non-existent conference report cited by [10]
Xiao CG. A somatic-autonomic reflex pathway procedure for neurogenic bladder and bowel: results on 92 patients with SCI and 110 children with spina bifida. In: Proceedings of the International Conference of Urology; Shanghai, July 2-4, Shanghai, China; 2005.

[12] Clinical trial information of Beaumont Hospital’s pilot study
http://www.clinicaltrials.gov/ct/show/NCT00378664
Lumbar to Sacral Ventral Nerve Re-Routing.
Identifier: NCT00378664

[13] Project information of Beaumont Hospital’s NIH grant
http://projectreporter.nih.gov/project_info_description.cfm?aid=7696321
Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida.
Project Number: 1R01DK084034-01
He has reported that in 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, reported success in 87% at one year.

[14] Faked certificate of success rate supporting Xiao’s membership application to the Chinese Academy of Sciences.
http://xysblogs.org/wp-content/blogs/107/uploads/shenyuan.jpg
(Translation) Neuro-Urologic Surgery Research Center (a.k.a Shenyuan Hospital) at Zhengzhou University, February 28, 2007
Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University has applied the “artificial somatic-autonomic reflex arc” technique invented by Professor Xiao Chuanguo to 117 patients with neurogenic bladder caused by spina bifida or meningomyelocele. Sixty cases were followed up for more than eight months. 85% of the patients have regained normal bladder and bowel functions.
(Note: The hospital was established in Auguest 2006.)

[15] Xiao’s 2004 conference abstract on SB patients.
http://xysblogs.org/wp-content/blogs/107/uploads//2004xiao20sb.gif
Xiao CG, Du M, Li B, Liu Z, Chen P, Chen M. An effective surgical treatment for neurogenic bladder in spina bifida children: results of 20 cases [abstract 211]. J Urol. 2004;171(4 suppl):56.

[16] 《“有望获诺贝尔奖的手术”?》南方周末2010-04-15
http://www.infzm.com/content/43905
肖传国给南方周末记者提供了两名当年做肖氏手术的矿工,记者电话咨询时,其中一名史姓矿工表示有效,只是脚趾的功能受影响(该病人腰部有损伤,尚能行走)。另一名樊姓矿工则表示“不理想”。据他介绍,与其同批手术的其他四人也没啥效果。

[17] 肖传国及其律师提供的《外科学》教材关于肖氏反射弧手术的内容
http://www.weibo.com/1808244527/yfeCrnAR8
@肖传国 :纠正一下:1,自1999年即一直写入中国外科学教科书,2,2001年所获为科技进步二等奖,当时我拒拒绝接受,只同意接受一等奖,后被作工作、被同意。
4月18日 23:44
@李国斌律师新浪个人认证 : #真相#卫生部称“是否适用于临床应用,还要进行充分的论证”;“目前仍处于临床研究阶段,还不允许开展临床应用”的“肖氏反射弧手术”不仅1999年临床试验完成之后通过国家科技成果鉴定,2001年获国家科技成果一等奖,而且2003年已写入高校《外科学》基础教材供医学院校学生学习。http://t.cn/zONrEIF
4月18日 23:16
http://ww4.sinaimg.cn/large/5f57da0egw1ds475k80izj.jpg
同济医科大学肖传国经过长年深入的动物实验,在脊髓损伤4~6个月,截瘫平面稳定后,利用损伤平面以下的废用神经创建了一个人工体神经-内脏神经反射弧(肖氏神经反射弧),用以控制排尿。根据所用神经节段的不同,大部分患者可于1年左右显著地恢复膀胱功能,并能控制大便,部分患者尚可不同程度地恢复性功能。



卫生部新闻发布会关于“肖氏反射弧手术”通报的法规解读

11 11 2010年

0. 卫生部发言人:“这个技术的安全性、有效性的循证医学证据尚不足,对这个技术是否适用于临床应用,还要进行充分的论证。”

因此:

1. 按第三类医疗技术的定义,“肖氏手术”为“安全性、有效性尚需经规范的临床试验研究进一步验证”的第三类医疗技术。

2. “属于第三类的医疗技术首次应用于临床前,必须经过卫生部组织的安全性、有效性临床试验研究、论证及伦理审查”。

3. “肖氏手术”应为“发布前已经临床应用的第三类医疗技术”。自2009年5月1日起“本办法实施后6个月内没有提出技术审核申请……一律停止临床应用第三类医疗技术”。

4. 神源医院/郑大四附院无法自 “本办法实施后6个月内”提出技术审核申请,因为“肖氏手术”没有在“首次应用于临床前”“经过卫生部组织的安全性、有效性临床试验研究、论证及伦理审查”而“列入相应目录”。

5. 因此,神源医院/郑大四附院自2009年11月1日起“擅自临床应用新的第三类医疗技术”,“卫生行政部门应当立即责令其改正;造成严重后果的,依法追究医疗机构主要负责人和直接责任人员责任”。

6. 期待卫生行政部门实施“应当”采取的具体行动。

http://www.china.com.cn/zhibo/2010-11/09/content_21298706.htm
邓海华:
卫 生部组织专家进行了多次研究,国内权威的专家们认为脊髓神经损害患者的排尿问题是一个有临床需求、技术难度很高、国际上尚未完全攻克的医学难题。利用人工 体神经—内脏神经吻合术解决这个难题是一项探索性的研究,目前,这个技术的安全性、有效性的循证医学证据尚不足,对这个技术是否适用于临床应用,还要进行 充分的论证。各级卫生行政部门应该按照《医疗技术临床应用管理办法》等相关规定,继续加强对医疗技术临床应用的管理,提高临床质量,保证医疗安全。同时, 专家们还建议要健全和完善对于医疗新技术的临床研究管理。对于上述手术产生的医疗纠纷,应该按照国家的有关法律法规处理。

http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3585/200903/39511.htm
医疗技术临床应用管理办法

第二类医疗技术是指安全性、有效性确切,涉及一定伦理问题或者风险较高,卫生行政部门应当加以控制管理的医疗技术。

第三类医疗技术是指具有下列情形之一,需要卫生行政部门加以严格控制管理的医疗技术:
(三)安全性、有效性尚需经规范的临床试验研究进一步验证;

第八条 卫生部负责第三类医疗技术的临床应用管理工作。
第三类医疗技术目录由卫生部制定公布,并根据临床应用实际情况,予以调整。

第十四条 属于第三类的医疗技术首次应用于临床前,必须经过卫生部组织的安全性、有效性临床试验研究、论证及伦理审查。

第二十三条有下列情形之一的,医疗机构不得向技术审核机构提出医疗技术临床应用能力技术审核申请:
(二)申请的医疗技术未列入相应目录的;

第五十条 医疗机构出现下列情形之一的,卫生行政部门应当立即责令其改正;造成严重后果的,依法追究医疗机构主要负责人和直接责任人员责任:
(二)违反本办法第十四条规定擅自临床应用新的第三类医疗技术的;

第五十二条 医疗机构和执业医师在医疗技术临床应用过程中有违反《执业医师法》、《医疗机构管理条例》、《医疗事故处理条例》和《人体器官移植条例》等法律、法规行为的,按照有关法律、法规处罚。

第 五十七条 本办法发布前已经临床应用的第三类医疗技术,医疗机构应当在本办法实施后6个月内按照本办法规定向技术审核机构提出医疗技术临床应用能力技术审核申请。在 本办法实施后6个月内没有提出技术审核申请或者卫生行政部门决定不予诊疗科目项下医疗技术登记的,一律停止临床应用第三类医疗技术。

第六十一条本办法自2009年5月1日起施行。

附件:第三类医疗技术目录
【无肖氏反射弧手术】

http://www.gov.cn/gzdt/2009-06/11/content_1337464.htm
卫生部办公厅关于公布首批允许临床应用的第三类医疗技术目录的通知
【无肖氏反射弧手术】