科学网网友许培扬上月曾就美国撤销肖氏手术临床试验的事情发过一篇博文，后来不知是否由于肖传国提出异议而撤掉了。

肖传国在科学网发博文“NIH扩大评估肖氏手术有效病种，继续资助肖氏手术研究”

http://blog.sciencenet.cn/home.php?mod=space&uid=385748&do=blog&id=713793

对为什么撤销临床研究做了解释。肖的博文还给出他称之为“真实情况”的一个网页链接http://www.clinicaltrials.gov/ct2/results?term=rerouting

上述链接的网页上有两项临床试验与肖氏手术有关，一个名为Lumbar to Sacral Ventral Nerve Re-Routing(临床试验识别号NCT00378664)仍在进行中，但不再招募患者。这是2006年开始的一项私人基金支持的研究，不是被撤销的临床试验。

被撤销的临床试验的识别号是NCT01096459，名称为Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida。这是美国政府出资支持的研究。由于对肖氏手术的争议，美国国家糖尿病暨消化系统及肾脏疾病研究所(NationalInstitute of Diabetes, Digestive and Kidney Diseases, 简称NIDDK)在2010年底暂停了该临床试验，要求对治疗方法做进一步的评估。

《科学》曾对要求重新评估做过报道：“来自中国的疑问给美国的临床试验带来麻烦”。http://blog.sciencenet.cn/blog-714-380535.html

评估的结果导致了肖氏手术的临床试验上月被撤销。临床试验信息网站上给出的理由是 Protocol as presented by investigator was not approved by the NIDDK. 研究者提出的治疗方案未被NIDDK批准。

NIDDK上周五回答了我就撤销临床试验提出的几个问题， 全部登载并翻译如下。

Q: Why was the proposal not approved?  Was it safety concerns? What are the specific reasons?

问: 为什么提出的治疗方案没有获得批准？是出于安全考虑吗？有哪些具体原因？

A: The Institute discussed the proposed study protocol (a prospective case-series study of surgical nerve rerouting in children with spina bifida) and received advice from experts at other institutes at NIH and an externalexpert panel.  The experts thought that the proposed trial and its primary outcome measures were inadequately designed.  After an extensive review, NIDDK decided not to fund the prospective case-series study of surgical nerve rerouting in children with spina bifida.

答:  研究所讨论了该项目提出的治疗方案(一项对脊柱裂儿童进行外科神经改道的前瞻性病例分析研究)，收到了来自NIH内部其他研究所的专家、以及外部专家组的建议。专家们认为，研究提出的治疗方案、以及衡量其主要结果的指标设计不足。经过广泛评估之后，NIDDK决定不支持这项对脊柱裂儿童进行外科神经改道的前瞻性病例分析研究。

Q: Now that the trial will not advance, will the trial continue to get funded?

问: 现在临床试验不再进行，对这项临床研究的资助是否仍继续下去？

A: NIH is no longer funding the trial, “Nerve ReroutingTreatment for Neurogenic Bladder in Spina Bifida”.

答:  NIH不再资助这项名为“Nerve ReroutingTreatment for Neurogenic Bladder in Spina Bifida”的临床试验。

Q: What will the money already received be used for?

问: 项目已经得到的经费将如何使用？

A: The investigators at Beaumont Hospital in Royal Oak, Michigan, are able to use NIDDK funds to study the longer-term effects of nerve rerouting in children who had the nerve rerouting operation performed in a previous study that was not supported by the U.S. government.

答:  密歇根州RoyalOak市的威廉·博蒙特医院的研究者能把来自NIDDK的经费用于研究儿童神经改道的长期效果上，这些儿童在此前一项不是由美国政府资助的研究中已经接受了神经改道的手术。

Q: What is NIDDK’s perspective regarding the nerve re-routing procedure?

问: NIDDK怎么看神经改道手术？

A: In addition to research on the long-term effects that the investigators will examine (described above), more animal studies are needed to demonstrate that the created reflex arc improves voiding.  If those are positive, then more mechanistic studies in animals would be needed to explain how the arc functions.

答:  除了上面提到对其长期效果的研究之外，还需要更多的动物研究来证实建立起来的反射弧改善了排尿。如果动物实验结果是肯定的，仍需要在动物身上进行更多的机制性研究，以解释反射弧如何工作的问题。

Q: Is the following statement, posted on Dr. Xiao’s blog, true or false?

"The NIH has affirmed the safety of the procedure and considered the number of surgeries carried out so far statistically sufficient; therefore, the planned trial which will enroll 15 additional patients has been withdrawn.  The study will continue as planned with further funding for the next two years."

问: 肖传国博士在其博客上写道：“NIH已经认定肖氏手术安全”，而且“认定现有SB肖氏手术例数及结果已足够得出统计学结论，本研究不需再增加病例数；所以将原计划请NIH出资再作15例的部分撤销，改成现在的题目和内容继续进行、资助。”请问这否属实？

A: No, NIH did not affirm the safety of the procedure or indicate that the number of surgeries is statistically sufficient.  NIDDK feels the safety and efficacy of this experimental surgical intervention are unknown.

答:  不属实。NIH没有认定过手术的安全性，或表示过已有的手术例数有统计学的意义。NIDDK认为用这个试验手术进行干预的安全性和效果尚属未知。