美国《泌尿学杂志》质疑“肖氏手术”

9 08 2010年

美国《泌尿学杂志》最近登了“肖氏手术”在美国首批9个病人试验的结果,同时刊登了两篇负面的编辑评论。特别指出该结果与肖传国所说的在中国的成功结果不符,缺乏对照组,结果无统计学意义、自相矛盾,某些病人出现的改善可能是别的原因引起的,该手术应该只用于探索性研究,如果迅速用于临床会有巨大的危险。

THE JOURNAL OF UROLOGY, Vol. 184, 702-708, August 2010

EDITORIAL COMMENTS

The authors present the first North American experience with lumbar to sacral nerve rerouting for patients with spina bifida. The results from this study and previous animal and clinical studies by Xiao clearly demonstrate that nerve rerouting produces a somatic-autonomic or cutaneous/bladder reflex with stimulation of the lower extremity dermatome.1 What is also clear is that the clinical benefit of the procedure is not at all similar to previous reports.Although the authors did an excellent job of following the patients and characterizing their changes, the results are hard to validate without a control population going through the same rigorous surveillance regimen. In particular the improved bowel continence and minimal changes in bladder compliance may not be statistically significant. The fact that most patients were still on clean intermittent catheterization and none achieved complete urinary continence is troubling in light of the report of 87% success with 110 children with spina bifida presented by Xiao.1 One has to wonder if most of these children are not voiding volitionally or using the newly developed cutaneous reflex, and how much reinnervation has a role in this surgery. Is it possible that unilateral denervation of the S3 ventral motor nerve produced improved compliance and continence, as previously reported in numerous clinical series?2,3I congratulate the authors for taking on this challenge. I hope this study leads to a rebirth or refocus regarding neurosurgical treatments of neuropathic bowel and bladder. I strongly agree with the authors that this procedure should remain on a research protocol only.

Eric A. Kurzrock
Pediatric Urology
U. C. Davis Children’s Hospital
Sacramento, California

One of the most curious findings is the discrepancy between urodynamic data and subjective voiding. One patient exhibited a decrease in capacity and an absence of reflex arc, and yet he subjectively reported improved bladder and bowel function! I could not help but speculate that his voiding after the procedure could simply be the bladder emptying via intra-abdominal pressure generation against an open bladder neck, given his preoperative stress incontinence. Xiao reported that more than 87% of 110 patients gained sensation and continence within 1 year (reference 7 in article). In comparison, the current patients undergoing the identical procedure with the help of Xiao himself only showed a modest improvement in objective urodynamic studies and subjective reporting. Unless the innovators provide a sound argument and data for the validity of the procedure, there is a great danger of its improper and rapid adaptation by patients and the medical community at large.

John M. Park
Department of Urology
University of Michigan Medical School
Ann Arbor, Michigan

REPLY BY AUTHORS

We agree this is a challenging study on many levels. The intent of publishing these 1-year data was to understand the potential complications associated with lumbar to sacral nerve rerouting, demonstrate that a cutaneous to bladder reflex is achievable and, given the nationwide interest in this procedure, reinforce the need to continue this rigorous research protocol until more is known about the risk-benefit profile. Hopefully our 36-month data will shed more light on the clinical usefulness of this innovative procedure.


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