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本帖最後由 在美一方 於 2010-9-24 21:32 編輯
貼一下Journal of Urology發表肖術美國trial (就是Peters et al 的數據) 中期數據時候的幾段專家點評:
Editorial from Piet Hoebekea, Department of Urology, Ghent University Hospital, Ghent, Belgium
Finally, in this issue of The Journal the results of the study by Peters et al (page 702) are the first to challenge the excellent, previously published results of nerve rerouting that showed up to 85% success.8 Despite proof that nerve rerouting can create a novel reflex arc generating a detrusor contraction, this group learned that after 1 year no patient became continent and only 2 of 9 were able to stop catheterization. Effects on bladder compliance and cystometric bladder capacity were remarkable despite stopping antimuscarinic treatment. Persistent foot drop cannot be considered a minor complication in children who are already motor disabled. Although promising, this study cautions us that further controlled studies are needed before this nerve rerouting procedure can be used more routinely.
這段評語明確指出美國Peters et al 的 trial 數據質疑了肖以前報道的85%的成功率。有趣吧,肖術的臨床trial質疑了肖氏自己原來的高成功率數據。是不是美國人和中國人長得不一樣呢?
Editorial comment from Eric A. Kurzrocka, Pediatric Urology, U. C. Davis Children's Hospital, Sacramento, California
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] and [3]
I 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.
這位專家不僅繼續說明這個trial的數據質疑肖以前87%的成功率報道,而且強調這個手術should remain on a research protocol ONLY.
Editorial comment from John M. Parka, Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan
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.
這位更兇狠,從數據上質疑客觀數據和病人主觀感覺的不一致,而且提到腹壓排尿的問題。同樣,這位也強調這個美國trial即使是在肖本人親自指點下進行的完全一模一樣的手術(identical)居然根本不能達到肖以前報道的成功率。
一篇報道臨床中期數據的論文在發表時候居然配了3篇編輯/專家點評並且都是強烈負面並一致強調這個數據不支持肖以前的高成功率,難道還不說明,方打肖是打到點子上了么? |
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