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。