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【肖传国的公开信】美国所谓肖氏手术双盲实验失败原因 (922 查看)
日期: May 30, 2016 10:50AM


尊敬的美国神经外科杂志主编:

此信是关于Gerald Tuite 等2016年5月3号发表在贵刊的那篇关于肖氏手术“双盲实验”的文章。

一、此文及其伴发的评论在事实上、科学上和伦理上都存在许多问题。

这是历史上首次将一特大外科手术用残疾儿童进行所谓“双盲”实验。我首先阐明一下我和该实验 的关系:Dr. Tuite’s 团队2009年来到中国学习肖氏手术,亲自检查了十多例术后3年肖氏手术病人,均能自行解尿,基本排空膀胱,无尿失禁。后来,首届国际脊膜膨出学会在佛罗里达奥兰多召开,邀请我作大会主旨讲座,Dr.Tuite则邀请我提前2天去他们医院帮助他们开展肖氏手术。

手术第一天,他们在2个手术室同时安排了2个病人,我旁观并帮助他们鉴别正确的神经根。这时,手术突然停止,我被告知他们要为病人抽签作双盲实验!我立即 强烈反对,并列出2个主要理由:

1,肖氏手术已被许多医学中心证明有效,包括3家著名美国医院(Beaumont医院,纽约大学医学中心,路易桑拿州立大学医院),并均有高水平专业学术文章发表,所以还将此特大手术在儿童,而且还是脊膜膨出残疾儿童,进行双盲实验,既不需要,更违反医学伦理;

2,对任何非常复杂的大手术进行双盲实验在理论上和技术上都是不可能的。尤其是脊膜膨出病儿,其病史、膨出部位和解剖、神经受损程度、膀胱病变情况,以及以往排尿方式(导尿?造瘘?纸尿裤?)每人都千差万别。执刀医生的水平也各有不同。

最不可能双盲的则是术后处理:肖氏手术病人必须在术后3月起完全停止间歇导尿和神经阻断剂,以让再生的神经来支配协调膀胱和尿道;但没作肖氏手术的病人必须按照这种疾病的80年的治疗指南金标准继续应用神经阻断剂(用于瘫痪膀胱防止漏尿)加上清洁导尿,以保护肾功能不受进一步损坏。如果双盲,术后3年随访如何解决这个矛盾?

尽管我强力反对,Tuite团队一意孤行。我当即宣布退出,不再参与他们任何实验。所以,我仅仅参与了第一天的2个病人,而非文章所说的首批7个病人。而且头天这两个病人中,有一个的神经供枝被错误的沿脊髓剪断,我发现指出后,他们不得不作脊髓~神经根吻合。然后再作末端神经根交叉吻合(肖氏手术)。这种事故若发生,病人应列为手术失败并排除在研究病人之外,因为脊髓/神经根吻合很难成功,可直接导致下游的肖氏手术失败。但文章中该病人仍列为5号肖氏手术病人。

二,该研究在科学上、方法学上、和统计学上都毫无可信度,没有价值。

双盲研究要求最严格的方法学、最客观的质量和数量空白对照控制。但在Tuite’s 双盲研究中,他们用另一种手术过程和结果都变化极大的大手术栓系松解作为对照;样板数更是极小根本达不到双盲最低要求;每个入选患者其术前的尿路情况、发病部位、神经受损情况及结果、已做过的手术等都各不相同;4个做手术的神经外科医师的手术水平和经验也各不相同。

但此“双盲实验”最不可思议的致命缺陷是术后治疗措施,特别是神经阻断剂和间隙导尿,竟然是不同的。 作者为自圆其说,掩盖此致命缺陷,在文中两次强调:“神经阻断剂和间歇清洁导尿在术前评估前两周停止,大多数病人都能在术后3年不用神经阻断剂和清洁导尿。”

但是,这“大多数”是多少?11例?15例?还是18例?Tuite 在文章中没有给出这一最重要的数据。即使如此,这一个“most”也已足够判断该双盲实验的根本性错误和数据及结论毫无价值:你不能在3年术后随访期间,部分病人用神经阻断剂瘫痪膀胱,而另一部分不用,然后混合收集资料一起进行“统计学”分析。 三, 但是,我根本不相信“神经阻断剂和间歇清洁导尿在术前评估前两周停止,大多数病人都能在术后3年不用神经阻断剂和清洁导尿。”

基于我和美国贝蒙特医院Peters’ 团队合作,进行美国首次肖氏手术临床研究的经历和经验,要想让美国的医生,特别是每个病人的家庭医生对脊膜膨出患儿在肖氏手术后不用神经阻断剂,不用间歇导尿,极度困难。我找到当年如何近乎绝望地试图说服Peters团队和家庭医生们停用神经阻断剂和间歇导尿的一些电子邮件。非常幸运的是,他们非常勉强的同意了,然后,所期待的自主排尿好结果出来了!

"Xiao, Chuan-Guo" <Chuan-Guo.Xiao@nyumc.org> 2/13/2009 6:44 AM:
肯: 我一直在思考你们的病人。你告知的目前结果对我而言太糟糕了。在我们讨论可能得原因之前,我想先让你看看我是如何处理路易桑拿州立大学女孩凯莉的,我从中国直接遥控指导了她术后治疗。

1,术后2个月停止神经阻断剂,穿纸尿裤,不必在意漏不漏尿;
2, 术后3个月停止常规间歇导尿,仅仅睡前导尿一次。然后,她发生过一次轻度泌尿系感染,但无需改变导尿,仅仅鼓励她试图自己拉尿,不管是用腹压还是其它办法。
3, 现在是仅仅术后4个月,她已能够自主排尿,完全不需导尿。

在中国,没有任何病人在肖氏手术术前和术后前用过神经阻断剂,也没得到过正规的膀胱和肠道医疗治理,例如间歇导尿等。但是,1300个肖氏手术患儿 中,80~86%获得自主排尿,不再尿失禁。所以,我认为:你们美国医生对这些患儿治理得非常好,但是太好过度了,以至于没给膀胱和新成立的神经反射以及和大脑之间有时间有机会互相作用、交流、协调。你们医生永远在掌控全局而不是让大脑来取代、掌控。为何你们病人的肠道功能恢复比膀胱功能好?因为你们治理肠道不如治理膀胱那么彻底。
所以,我的建议是:所有肖氏手术病人立即停止导尿,让他们穿纸尿裤,想拉自己拉!(特别是上了电视的小男孩比尔)然后,你们可以在1月内看到结果。我一直对你们讲:脊膜膨出患者作肖氏手术后完全不需抓绕刺激腿部来诱发排尿。他们都应能自主排尿!
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"Xiao, Chuan-Guo" <Chuan-Guo.Xiao@nyumc.org> 2/17/2009 10:43 PM >
肯, 我特转发【这女孩刚停神经阻断剂和导尿后,残余尿为200,其家庭医生有点担心,和我联系。我告诉他不需处理,会每天很快减少至正常。2周后,如我所料】 报告这个路易桑拿女孩情况的邮件给你,以支持我的观点。如果是你,肯定要继续导尿加神经阻断剂因为她有200毫升残余尿排不净。但事实是:肖氏手术后,如果让大脑而不是医生来控制,残余尿会每天减少直至正常。
所以,请你命令停止神经阻断剂和导尿。 OK,我作个让步:你可以对这些患儿每天睡前导尿一次。
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我也同时摘录一段丹麦肖氏手术团队关于为什么不停用神经阻断剂的解释,以进一步证明在欧美泌尿外科医生中,把停用神经阻断剂看得多么严重、危险。

“尽管肖氏手术临床研究的标准程序是在我们丹麦肖氏手术研究开始后才正式发表,我们基本上遵从了这些标准,但没有执行膀胱容量上限和停用神经阻断剂这两项。我们认为在18个月的研究期间必须继续使用神经阻断剂,若停用会对病人健康产生严重影响”。【9】

现在看来Tuite’s 的研究病人处于当年贝蒙特医院Peters’的病人们同样情况:这些病人都分散在美国各州,他们的家庭医生也绝对不敢术后停用神经阻断剂和间歇导尿3年!

所以,我建议作者或者你们神经外科杂志编辑部,从每个病人的家庭医生处收集3年的用药和治疗档案,这就会让术后3年病人到底是否停用神经阻断剂和间歇导尿 真相大白。实际上,我在退出其研究后,去年和Tuite有过一次唯一联系询问过这些数据,他在回复中没有回答。

“哈罗,Jerry 和 YVES:我翻出09年说服Peters停用神经阻断剂和CIC的电邮,希望我也能说服你。我仍然再想神经阻断剂的问题。所有病孩都是泌尿外科Yves医生一人管吗?真的完全没用神经阻断剂吗?若真的没用,我非常感谢,因为当时我强烈反对你们双盲研究的原因之一就是所有肖氏手术术后患儿必须停用神经阻断剂,但没做肖氏手术者则必须常规使用。但我怀疑:是否有些孩子的家庭医生没有停用神经阻断剂?

无论如何,为了成百上千万脊膜膨出孩子们的最佳利益,我真心希望找出你们失败的原因。肖氏手术的效果,至少在中国,包括我的医院和上海、武汉等医院,一直非常好,越来越好。我对你们的结果深感遗憾。

四、但是,别把这篇文章当成这双盲研究的终点。

我非常有把握不同程度地逆转现在的阴性结果。我已投入我的所有积蓄在中国建立了一家私立医院,共有300张床, 其中30张专门收治脊髓损伤和脊膜膨出所致大小便失禁的病人。每位这种病人最高付费8千美元(穷人更少甚至免费)包括所有费用:手术费、麻醉费,手术室费用,电生理检查和术中电生理监控,尿流动力学检查、术前检查,放射科X片核磁CT和B超、耗材、药品、无限制的住院天数等等等等。

我有两点建议
1, 因为双盲已经解除,请让做过肖氏手术的10个病人穿纸尿裤、停用神经阻断剂、让他们不管是用腹压还是滴沥还是其它方式努力自己排尿,检查最多两个月,让我们看看效果?考虑到新作肖氏手术的几位神经外科医师有个学习过程,假设吻合成功率只有一半,那也至少有3~4个孩子可以自主排尿而不再有尿失禁或需要导尿。

2.在中国,我的肖传国医院有项公开政策:如果任何病人做了肖氏手术无效,不管在什么医院做的手术,不管谁做的手术(脊髓损伤成人以1年半为期,儿童一一年为期),肖传国教授将亲自免费重作。现在,我把这项政策适用范围推广到全世界。我愿意为该双盲实验中所有无效的患儿,包括那10位没 做肖氏手术的患儿免费重作肖氏手术。病人仅需自付从美国到香港的来回机票。我有把握在一年内让他们80%能自主排尿,至少达到贝蒙特医院Peters肖氏手术临床研究的结果【10】。否则,我在贵刊公开道歉。其实有效率完全可能比80%更好,但由于这些患儿已至少在相同神经部位反复手术2次以上,我需要稍微谨慎点预估结果。

五、肖氏手术在美国尚属于临床研究阶段,所谓双盲实验更说明了这一点,必须由研究基金支付,不能收费。

但是从政府医保基金、政府医疗救助基金和其它医疗保险基金收费,而且是用另一个手术栓系松解术的名义收取巨额费用,这在法律上、财务上是否违法?这在伦理上的确让人不得不怀疑设计这个在残疾儿童做此创伤极大复杂手术之双盲实验的真实原因。【在美国,不论父母有无医保,所有儿童均享有政府医保,凡是列入医保项目(code) 的手术政府买单----肖传国注】

六、我感谢Dr. Kestle 的评论。这是一位颇有经验的外科医生客观有益之言。至于其它,由于贵刊应该纯属学术平台,我会在更合适的平台讨论。

您忠实的,
肖传国

Dear Editor:
I am writing regarding the article “Lack of efficacy of an intradural somatic-to-autonomic nerve anastomosis (Xiao procedure) for bladder control in children with results of a prospective, randomized, double-blind study. Gerald F. Tuite, MD ,et al Division of Pediatric Neurosurgery, Neuroscience Institute, Johns Hopkins All Children’s Hospital, St. Petersburg, Florida; (Published online May 3, 2016; DOI: 10.3171/2015.10.PEDS15271. J Neurosurg Pediatr)
There are major factual, scientific and ethical problems in this article, and its editorials. I will start by clarifying fact about my involvement in “the first in the history” double-blind clinical trial for a major surgery on disabled children.

1, My involvement with the trial: Dr. Tuite’s team went to China in 2009, and personally checked more than a dozen myelomeningocele and lipomyelomeningocele children who were cured by Xiao procedure 2~3 years ago, voiding voluntarily and emptying almost completely without incontinence. They then invited me to All Children’s Hospital to help them to start Xiao procedure two days before my keynote speak on the first international spina bifida conference in Orlando, 2009. They scheduled 2 cases in 2 ORs on same time. I observed and helped in identifying correct roots, then they stopped and I was informed first time they were doing “randomized, double-blind trial”. I immediately expressed my strong objection based on two reasons: First, Xiao procedure had been proved to be a very effective procedure by many centers with thousand cases and formal publications [123] including those in USA: Beaumont Hospital, NYU medical center, and Louisiana State University [456]. It is unnecessary and unethical to have a double blind trial on a major surgery on children, especially these disabled children. Second, it is impossible scientifically and technically to have a double-blind trail for a very complicated major surgery on spina bifida children whose history, anatomy, neural defect,bladder situation and voiding management may be quite different for each other. The major technical dilemma was that children who had Xiao procedure have to stop CIC and anticholinergics 3 month postoperatively, to allow regenerated axons working with bladder and urethra, while children did not have Xiao procedure should still keep using CIC and anticholinergics as guideline indicated to protect the upper urinary system. How could you manage this dilemma in a double-blind trial for 3 years?

Despite of my strong objection, Dr. Tuite’s team decided to go on the double blind trial. I immediately withdrew my involvement in the “double blind” trial forever at the very first day. So, I did not personally help the first 7 cases, but only 2 in the first day. I had to tell with sorry that I found the donor ventral root was cut wrongly and closely form the cord at one of the 2 cases, and the root had to be reattached to cord by microanastomosis and then its distal end was anastomosed to S3 root as Xiao procedure did. If this kind of accident happened, the patient should be excluded from any type of trials, since the root re-attached to cord may not work at all and jeopardize the down stair Xiao procedure. But I found the child was still listed as #5 (DT+X) in the article.

2,The trial and the article have no creditability and value in terms of methodology, science, and statistics. Randomized, double-blind study requests strictest methodology, and most objective quantity and quality control. While in the Tuite’s trial, in addition to using another result-variable surgery as control, and very small sample size which can not meet statistical request, each subject’s preoperative lower urinary tract condition, abnormal anatomy, neural defects and prior surgical history was different from any others; each of the 4 neurosurgeons performed procedure had different level and experience in surgical skills. But most horrible defect was that the postoperative care was different among the enrolled children regarding anticholinergics and CIC. The authors tried to smooth up the defect by stated in the article twice “CIC and the use of BAMs were terminated 2 weeks prior to preoperative evaluations, and most patients were able to refrain from both of these modalities for the entire 3-year follow-up.” This statement destroyed completely the scientific and methodological ground of this so called double blind study: Post care must be strictly the same, i.e., either all use CIC and same dosage BAMs, or all do not use CIC and BAMs. How many was the “most”, 11? 15? or 18? Authors did not report this critical and most important data. But nevertheless, it was fundamentally wrong to paralyze some patient bladder by BAMs while not to paralyze other’s in postoperative follow-ups in a double blind trial, and then collect and analysis their data together.

3, However, I don’t believe at all it was the truth that “CIC and the use of BAMs were terminated 2 weeks prior to preoperative evaluations, and most patients were able to refrain from both of these modalities for the entire 3-year follow-up.” With experience during the first USA pilot study of Xiao procedure in Beaumont hospital, I know how hard and difficult in trying to convince Peters’ team and local primary care doctors to stop anticholinergics and CIC for spina bifida children underwent Xiao procedure. I would just post the emails below to show how desperate when I tried to ask them to follow my way. Fortunately, they reluctantly agreed and then, got the expected good results.

"Xiao, Chuan-Guo" <Chuan-Guo.Xiao@nyumc.org> 2/13/2009 6:44 AM
Ken,
I have been thinking about the cases in Beaumont, The results as you mentioned are really not good to me..Before I talk about the possible causes, I want to tell you how I deal with Kelly, the Louisana girl. I remote controlled all her treatment after the surgery.
1, Stopped detropen exactly 2 months after surgery.(She was operated on Oct. 8, 2008.) Wear diaper, DON'T care leaking or not.

2 ,Stopped regular catherterization since the 3 months after surgery(Jan.8.2009), Just once before going to bed. Then, she got one mild UTI but no change on catheraization. Ask the girl to try to void, by pushing or whatever ways.
3, Now, it is just more than 4 months after surgery, she seems to have got it.

In China, none of the patients has ever used Detropen before or after surgery; None of them has had any formal medical management of bladder and bowel, like regular catherizaton or so on after the surgery. But, 80-86% of more than 1300 kids gained continence and voluntary voiding.

So, my opinion is: You guys take care of these kids very good,TOO GOOD to let the bladder and the new reflex and the brain to have chances to communicate with each other. You Doctors are always on control instead of allowing the brain to takeover the control. Why the bowel function improvement is better than bladder? Doctors did not take care of the bowel as good as the bladder.

Then, my suggestion is: immediately stop cathertrization on all the kids underwent the surgery, just ask them to try to void, and wear diaper! (especially Bill, the boy on the News.) Then let's see what will happen in a month before you go to Orlando. As I always say, spina bifida kids do not need to scratch the leg to initiate the reflex for voiding, including Natasha. They should be able to void voluntarily.
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"Xiao, Chuan-Guo" <Chuan-Guo.Xiao@nyumc.org> 2/17/2009 10:43 PM
Ken,
I am forwarding the email to you to support my point. If it were you, you most possibly would keep using Detropen and cathing her because she has a 200cc residual. The fact is: the residual will decrease every day if we let the brain to take control.

So, please order those kids to stop Detropen and catherization. OK, my compromise: you can let them cath once per day just before going to bed.

I would also quote from Denmark paper regarding anticholinergics in Xiao Procedure, to show how urologists deal with anticholinergics seriously in USA and Europe :

" Although these criteria were first published after the current study began, most of them were met in our series except the upper limit of bladder capacity and the cessation of anticholinergic medication. In regard to the latter we deemed that the medication was essential for patient well-being throughout the 18-month study period.” 【9】

It seems to be the similar situation with Tuite’s trial patients: They were scatted over different states under care of their local primary care doctors who would not dare to not use anticholinergics and CIC for 3 years. So I would suggest the authors, or the editor of JNS, collect data from these children’s local doctors and provide the real fact regarding the post operative usage of CIC and anticholinergics in 3 years. In fact, I did ask Dr. Tuite about this information last year during the only contact after my withdrew ,but he did not provide details in his response.

Hello, Jerry, and Yves:
I looked back and find those emails to Ken Peters when I tried very hard to convince him to stop CIC and Detropen in 2009.I hope I can convince you, too.

I am still having some concerns about the anticholinergics. Did Yves take care of all those kids and did not use anticholinergics at all? If so, I really appreciate , because one of the reasons I argued against your double blind trial plan is that no Detropen should be used for Xiao procedure kids, but need to be used routinely for those control kids. BUT, were there any kids under the care of their primary care doctors who would definitely not stop using anticholinergics?
Any way, for the best interests of millions spina bifida kids, I really hope to clarify problems underlying your trial results. The effect of Xiao Procedure, at least in China including my hospital and other institutions in Shanghai\Wuhan etc, has been very reliable and better and better. I really feel sorry for your results.
Best regards,
CG Xiao
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4, The article, however, is not the end of this trial. I am confident to reverse the negative results to some degree. I put all my saving in and established a private hospital in China. Of the 300 beds, 30 are for spina bifida and SCI patients with neurogenic bladder and bowel, and each such patient only pay 8,000USD (less or free for poor people) for all costs including surgery, anesthetic, OR hours, electrophysiology test and in OR monitoring, urodynamic, pre-surgery tests, MRI and X ray, Ultrasound,pathology, exhaustible, medicines, ward for unlimited in-hospital days and so on.

My suggestion is:

(1), Since it has been out of double-blind, please let the 10 children who underwent Xiao procedure wear diaper and stop anticholinergics and let them try to void by push, leak or whatever means for 2 months, then see what happen. Giving the neurosurgeons a 50% learning curve deduction, it should still have at least 3~4 children who will able to void voluntarily without incontinence and CIC. All spina bifida kids after Xiao procedure do not need scratch to pee. For 3000 kids who had Xiao procedure, none of them needs bladder augmentation.

(2), In China, my hospital has an open policy regarding Xiao procedure patients: If the patient can not void voluntarily within one year (for child) or 18 month(for adult) post Xiao procedure, Prof. Xiao will redo the procedure himself for you free, no matter where and who did the Xiao procedure. Now, I would like to extend this policy internationally. I will redo the Xiao Procedure free for all children failed in Tuite’s trial, including those served as control. The patients only need to take care of their round trip air tickets between USA and Hong Kong airport. if I can not get about 80% effective rates for those children within a year, or at least as good as Peters’ trial results[10], I will apologize formally in J Neurosurg Pediatr. It can be better than 80%, but I have to be cautious due to they had had intradural neurosurgery at least 2 times on the same location.

5, Is it legal and financially appropriate to bill Medicare, Medicaid or other Medical insurances for extra costs of Xiao procedure under the name of another surgery DT? This should also raise more ethical concern on the real reason of this very hazardous double-blind study of a major surgery on disabled children.

6, I appreciate Dr. John R. W. Kestle’ s comments. It is objective and helpful from an experienced surgeon. As for other issue, there will be more appropriate platform to discuss than on the academic platform that your journal supposed to be.

Sincerely yours,
Chuan-Guo Xiao, M.D.

President
C.G. XIAO HOSPITAL

Shenzhen, China
Emai: ***@163.com

References
1, Xiao CG, Du MX, Li B et al: An artificial somatic-autonomic reflex pathway procedure for bladder control in children with spina bifida. J Urol 2005; 173: 2112.
2, Lin H, Hou C, Zhen X et al: Clinical study of reconstructed bladder innervations below the level of spinal cord injury to produce urination by Achilles tendon-to-bladder reflex contractions. J Neurosurg Spine 2009; 10: 452.
3, Lin H, Hou CL, Zhong G et al: Reconstruction of reflex pathways to the atonic bladder after conus medullaris injury: preliminary clinical results. Microsurgery 2008; 28: 429.
4. Lin H and Hou C: Transfer of normal S1 nerve root to reinnervate atonic bladder due to conus medullaris injury. Muscle Nerve 2013; 47: 241.
5, Kelley CE, Xiao CG, Weiner H et al: bladder in patients with spinal cord injury: preliminary results of first 2 USA patients. J Urol, suppl., 2005; 173: 1132A.
6, Peters KM, Girdler B, Turzewski C et al: Outcomes of lumbar to sacral nerve rerouting for spina bifida. J Urol 2010; 184: 702.
7, Peters K, Feber K, Girdler B et al: Three-year clinical outcomes with lumbar to sacral nerve rerouting in spina bifida. J Urol 2011; 185: e602.
8, Ravish Patwardhan, M. D. & John Mata, M.D. ( LSU): Case report on Xiao procedure for a 6 year old SCI girl to gain bladder control. Supplement of First international Neural Regeneration Conference, 2009 Detroit, USA
9, Rasmussen MM, Rawashdeh YF, Clemmensen D, Tankisi H, Fuglsang-Frederiksen A, Krogh K, et al: The artificial somato-autonomic reflex arch does not improve lower
urinary tract function in patients with spinal cord lesions. J Urol 193:598–604, 2015
10, Peters KM, Gilmer H, Feber K, Girdler BJ, Nantau W, Trock G, et al: US pilot study of lumbar to sacral nerve rerouting to restore voiding and bowel function in spina bifida: 3-year experience. Adv Urol 2014:863209, 2014

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5月,南佛罗里达儿童医院团队在《神经外科杂志:儿科》上发表了肖氏手术双盲研究无效的文章。5个月后,10月份,该团队在《美国泌尿外科杂志》上再次发文,承认肖氏手术有效,肖氏手术的病人组在膀胱容量、膀胱尿动力学检查,以及生活质量均显著优于没做肖氏手术的对照组病人。

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