肖传国和方舟子就肖氏手术（“肖氏手术”）试验项目在美国的境遇各执一词。到底真相如何？由于肖方是宿敌，双方观点皆不可采信。其真相或可从文献研读做点判断。由于涉及非常专门知识，先从英文词汇开始，然后呈现双方证据，再提一些疑惑，希望有人解惑，以期得出结论。

Vocabulary：

lumbar [英][ˈlʌmbə] [美][ˈlʌmbɚ, -ˌbɑr]

adj.腰部的

n.腰动（静）脉，腰神经，腰椎

sacral [英][ˈseikrəl] [美][ˈsekrəl]

adj.祭典的，圣礼的，荐骨的；骶椎

ventral [英][ˈventrəl] [美][ˈvɛntrəl]

adj.腹的，腹部的，腹侧的

n.腹鳍

recruit [英][riˈkru:t] [美][rɪˈkrut]

n.新兵；（机构中的）新成员；新学生

vt.招聘，征募；吸收某人为新成员；动员……（提供帮助）；雇用

vi.征募新兵；得到补充，得到补偿；恢复健康

现在分词：recruiting；过去式：recruited；第三人称单数：recruits；

interventional treatment 介入治疗 ; 干预治疗 ; 介入性方法

Spina Bifida 脊柱裂，系指因脊椎圆柱关节缺陷,以致有不同程度的组织自骨裂开处 凸出,并经脑神经专科医师诊断确定者.

neurogenic [英][njuərəuˈdʒenik] [美][ˌnʊrəˈdʒɛnɪk, ˌnjʊr-]

adj.起源于神经组织的，神经性的

bladder [英][ˈblædə] [美][ˈblædɚ]

n.<解>膀胱；囊，袋；[植物学] 囊状物；[病理学] 水疱，包囊

复数：bladders；

enrollment [英][ɪnˈrəʊlmənt]

n.登记；注册；入会

urologist [juəˈrɔlədʒist]

n.泌尿科医师

eligibility

n.适任，合格；被选举资格

William Beaumont Hospitals  威廉博蒙特医院

========================================================

假设肖传国和方舟子争执的是下图所列的Rank 1 和 Rank 2：

=============================================================

肖传国：

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/blog-385748-713793.html

Lumbar to Sacral Ventral Nerve Re-Routing(NCT00378664)

Conditions:  Urinary Incontinence;   Spinal Cord Injury;   Spina Bifida

Intervention:  Procedure: lumbar to sacral ventral nerve re-routing procedure

Lumbar to Sacral Ventral Nerve Re-Routing

This study is ongoing, but not recruiting participants.

Sponsor:

Kenneth Peters, MD

Collaborator:

William Beaumont Hospitals

Information provided by (Responsible Party):

Kenneth Peters, MD, William Beaumont Hospitals

ClinicalTrials.gov Identifier: NCT00378664

First received: September 19, 2006

Last updated: June 26, 2013

Last verified: June 2013

=======================================================

方舟子：

美国国家卫生院（NIH）撤销了“肖氏手术”试验项目
http://blog.sina.com.cn/s/blog_474068790102e915.html

Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida(NCT01096459)

Condition:  Spina Bifida

Intervention:  Procedure: Nerve Rerouting

Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida

This study has been withdrawn prior to enrollment.

(Protocol as presented by investigator was not approved by the NIDDK.)

Sponsor:

Kenneth Peters, MD

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Kenneth Peters, MD, William Beaumont Hospitals

ClinicalTrials.gov Identifier: NCT01096459

First received: March 23, 2010

Last updated: July 31, 2013

Last verified: July 2013

=============================================================

疑惑：

1、双方的依据是否真实？

2、两个项目的关系是什么？

3、方舟子提到的项目为什么是“Withdrawn” 而不像下列图中有的的项目是“Completed”？

4、科学原理是谁首先提出？（将来如果获诺贝尔奖，他是首位获奖者）

5、科学原理转化为实用技术还需要做很多实验研究。这些研究的成果的知识产权归谁？归美国的话，肖教授是不是不能无偿地在中国应用？

6、从项目名称上看，不涉及膀胱（Bladder）的项目是处于“ongoing”，而涉及膀胱（Bladder）的项目是处于“withdrawn”，是不是这样？

=============================================================

最新资料：

◇◇新语丝(www.xys.org)(xys7.dxiong.com)(xys.ebookdiy.com)(xys2.dropin.org)◇◇　　

美国国家卫生院称肖氏手术的试验方案是不可接受的

　　作者：新语丝志愿者

http://xys.ss156.net/xys/ebooks/others/science/dajia14/xiaochuanguo12.txt

　　三年前，美国卫生与人类服务部（HHS）人类研究保护办公室（OHRP）回复新语丝志愿者代表程鹗，该办公室已开始调查评估新语丝志愿者所举报的有关“肖氏手术”事项（见《美国开始调查肖氏手术临床试验，停止招募病人参与临床研究（XYS20101022）》，并称待调查评估结束后将通知结果。近日，该办公室致函程鹗：美国国家卫生院（NIH）决定，经过对试验方案的长时间评估，根据外部专家组的意见建议，招募患者参加神经改道手术（即“肖氏手术”）的试验方案被认定为不可接受。对此前已由民间资助做过肖氏手术的儿童，研究者将研究其长期影响。　　

该NIH资助的多中心临床试验项目，由William Beaumont医院牵头，原计划由多家医院参加，原定2009年底启动。2010年6月，Duke大学Wiener医生在学术会议中透露，NIH担心手术可能伤害患者而搁置该项目。2010年10月，人类研究保护办公室接受新语丝志愿者举报后回复，该试验已停止招募患者。2010年11月，试验主持人Peters医生向《科学》确认，NIH已成立监督委员会复核该试验，该医院将提交修改过的试验方案。2011年8月，该项目临床试验信息表明，参与该项目的亚特兰大Emory大学已退出，“多中心临床试验”参与者仅剩Beaumont医院。2012年3月，Peters医生在学术会议中透露，该试验已搁置两年，他们一直与出资机构密切合作，希望尽快解除搁置。2012年3月，该项目临床试验信息中的试验目标被删改，观察指标降低。2013年8月，该项目临床试验信息注明，“本研究已于注册患者前撤销”，试验终止原因是“研究者提供的试验方案未获NIDDK【NIH下属出资机构】批准”。　　

关于该试验项目及其他肖氏手术试验项目近年来的状况，请参考《肖氏手术国外临床试验情况》http://xysblogs.org/yush/archives/9774　　

我们将向有关机构索取该试验的详细资料，特别是该项目的复核评估文件及专家组的意见建议。　　

附录：OHRP邮件翻译及原文　　

亲爱的程先生：　　

关于你所关注的William Beaumont医院的“肖氏神经改道手术”，人类研究保护办公室（OHRP）已接到国家卫生研究院国立糖尿病、消化道和肾脏疾病研究所（NIDDK）的通知：经过长时间评估主持人Kenneth Peters博士所提出的试验方案，以及外部专家组（EEP）成员们提出的意见建议，该研究所决定，招募患者参加该外科手术的试验方案被认定为不可接受。当然，对于此前由非政府机构资助的研究中已做过神经改道手术的儿童，研究者们将研究神经改道的更长期影响。　　

OHRP认为这些措施得当。我们预计不再参与此事。　　

OHRP感谢你对人类研究受试者保护的关注。如果你有任何疑问，或希望提供更多信息，请尽管随时与我联系，　　

真诚的，　　

Kristina C. Borror，博士　　

人类研究保护办公室合规监督处主任　　

From: Borror, Kristina C (HHS/OASH)　　

Sent: Wed, Aug 21, 2013 at 5:14 PM　　

To: Eddie Cheng　　

Cc: Menikoff, Jerry (HHS/OASH)　　

Subject: "Xiao Procedure"　　

Dear Mr. Cheng:　　

Regarding your concerns about the "Xiao nerve-rerouting procedure" at William Beaumont Hospital, the Office for Human Research Protections (OHRP) has been informed by the National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) that after lengthy evaluations of the protocols proposed by Dr. Kenneth Peters, the PI, and the advice NIDDK received from the members of the External Expert Panel (EEP), the Institute decided that the protocol submitted to enroll patients for this surgical procedure was not found acceptable. However, the investigators will study the longer term effects of nerve rerouting in children who had the nerve rerouting operation performed in a previously conducted study not supported by the government.　　

OHRP finds these actions to be appropriate.  We anticipate no further involvement in the matter.　　

OHRP appreciates your concern about the protection of human research subjects.  Please do not hesitate to contact me at any time should you have any questions or wish to provide additional information.　　

Sincerely,　　

Kristina C. Borror, Ph.D.　　

Director　　

Division of Compliance Oversight　　

Office for Human Research Protections　　

1101 Wootton Parkway, Suite 200　　

The Tower Building　　

Rockville, MD 20852

(XYS20130905)

◇◇新语丝(www.xys.org)(xys7.dxiong.com)(xys.ebookdiy.com)(xys2.dropin.org)◇◇

===================================

更多资料：

============================

肖传国：

Purpose

To assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in Spinal Cord Injury and spina bifida patients

Condition Intervention Phase

Urinary Incontinence

Spinal Cord Injury

Spina Bifida

Procedure: lumbar to sacral ventral nerve re-routing procedure

Phase 2

Study Type: Interventional

Study Design: Endpoint Classification: Efficacy Study

Intervention Model: Single Group Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:Lumbar to Sacral Ventral Nerve Re-Routing

Resource links provided by NLM:

Genetics Home Reference related topics: spina bifida

MedlinePlus related topics: Spina Bifida Spinal Cord Injuries Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients. [ Time Frame: evaluated at 6 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients [ Time Frame: evaluated at 6 month and 1 year visit ] [ Designated as safety issue: No ]

Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients [ Time Frame: evaluate at 6 month and 1 year ] [ Designated as safety issue: No ]

Assess the effect of the lumbar to sacral ventral nerve re-routing on ability to perform activities of daily living in SCI and spina bifida patients [ Time Frame: evaluate at 6 month and 1 year visit ] [ Designated as safety issue: No ]

Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older [ Time Frame: evaluate at 6 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:12

Study Start Date:September 2006

Estimated Study Completion Date:November 2013

Estimated Primary Completion Date:November 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

Experimental: Intervention

All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.

Procedure: lumbar to sacral ventral nerve re-routing procedure

surgical nerve re-routing procedure

Detailed Description:

Spinal cord injury (SCI) and spina bifida is a source of irreversible injury to the spinal cord often resulting in paralysis and loss of sensation below the waist. The inability to urinate normally is a consequence of both conditions (neurogenic voiding dysfunction). In spina bifida and spinal cord injury, the nerve that controls the bladder and sphincter (the muscle that squeezes the bladder neck to prevent leaking) may no longer work properly resulting in patients who cannot urinate or are constantly wet.

Most patients will maintain high pressures in their bladder and these elevated pressures will eventually take its toll by causing recurrent urinary tract infections, backup of urine to the kidneys, and marked dilatation of possible further damage to the kidneys. Many patients eventually suffer from irreversible renal (kidney) damage, where dialysis or kidney transplant is the only way to sustain life.

Spinal bifida (present at birth) and SCI (occurs most often early in the fourth decade of life) predominately affect young individuals and longevity and quality of life may be greatly reduced by the presence of bladder, bowel, and sexual dysfunction. In the recent past, medications and catheters were the only way to help cord injured patients empty their bladders. Although clean intermittent catheterization (CIC) provides good maintenance results, medications can help conserve low bladder pressures, and antibiotics sustain an infection free urinary tract, these are difficult bladder management programs to uphold. They are expensive, time consuming, and outcomes are inconsistent.

A new surgical procedure has potential for treatment of spinal cord injuries/ spinal bifida. Recently, Dr. Chuan-Guo Xiao from China developed a surgical procedure of rewiring the nerves in the spinal cord to gain better control of urination and avoid complications of neurogenic bladder. The procedure reconnects live wires (nerves) to dead wires.

Eligibility

Ages Eligible for Study:  6 Years and older

Genders Eligible for Study:  Both

Accepts Healthy Volunteers:  Yes

Criteria

Inclusion Criteria:

Male and female paraplegics 18 years and older with spinal cord lesion above L1 on a CIC program for bladder management and a score of "A" on ASIA scale.

Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management.

Neurogenic bladder documented by urodynamic testing.

Stable neurogenic bladder dysfunction of at least 1 year or more.

Compliant bladder wall.

Normal renal function.

Exclusion Criteria:

History of bladder cancer, augmentation, or radiation.

Bladder capacity less than 100 milliliters (ml).

Anatomic outlet obstruction or urethral strictures.

Vesico-ureteric reflux grade 2 or higher.

Presence of an ileal conduit or supra-pubic catheter drainage.

Contraindications to general anesthesia or surgery.

Inability to complete follow up visits for 3 years.

Inability to comprehend and answer self-administered questionnaires.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378664

Locations

United States, Michigan

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

Kenneth Peters, MD

William Beaumont Hospitals

Investigators

Principal Investigator:Kenneth M Peters, M.D.William Beaumont Hospitals

More Information

Publications:

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 Jan;49(1):22-8; discussion 28-9. Epub 2005 Nov 2. Review.

Liu Z, Liu CJ, Hu XW, Du MX, Xiao CG. [An electrophysiological study on the artificial somato-autonomic pathway for inducing voiding] Zhonghua Yi Xue Za Zhi. 2005 May 25;85(19):1315-8. Chinese.

Mathews TJ, Honein MA, Erickson JD. Spina bifida and anencephaly prevalence--United States, 1991-2001. MMWR Recomm Rep. 2002 Sep 13;51(RR-13):9-11.

Muller T, Arbeiter K, Aufricht C. Renal function in meningomyelocele: risk factors, chronic renal failure, renal replacement therapy and transplantation. Curr Opin Urol. 2002 Nov;12(6):479-84. Review.

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals

ClinicalTrials.gov Identifier: NCT00378664    

Other Study ID Numbers:2006-124

Study First Received:September 19, 2006

Last Updated:June 26, 2013

Health Authority:United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

urinary incontinence

spinal cord injury

spina bifida

Additional relevant MeSH terms:

Spinal Cord Injuries

Urinary Incontinence

Spinal Dysraphism

Spinal Cord Diseases

Central Nervous System Diseases

Nervous System Diseases

Trauma, Nervous System

Wounds and Injuries

Urination Disorders

Urologic Diseases

Urological Manifestations

Signs and Symptoms

Neural Tube Defects

Nervous System Malformations

Congenital Abnormalities

ClinicalTrials.gov processed this record on August 01, 2013

===============================

方舟子：

Purpose

The goal of this study is to evaluate a surgical procedure (operation) that reroutes lumbar to sacral nerves in the spinal column to improve the bladder's ability to empty properly in patients born with Spina Bifida.

ConditionIntervention

Spina Bifida

Procedure: Nerve Rerouting

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study

Intervention Model: Single Group Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida

Resource links provided by NLM:

Genetics Home Reference related topics: spina bifida

MedlinePlus related topics: Spina Bifida

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

Reproducible bladder contraction [ Time Frame: 6 to 24 months post procedure ] [ Designated as safety issue: Yes ]

The primary aim of this study is reproducible bladder contraction of 15cm/H20 or more with scratching the cutaneous dermatome and no significant contraction with stimulation of the non-operated side.

Enrollment:0

Study Start Date:January 2013

Study Completion Date:January 2013

Primary Completion Date:January 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Procedure: Nerve Rerouting

All subjects will receive the unilateral nerve rerouting procedure.

Detailed Description:

Spina Bifida (a congenital defect of the spinal cord), causes nerve damage and a loss of sensation and muscle function below the waist resulting in bowel and bladder dysfunction. Patients cannot urinate or are constantly wet, and this continues throughout life causing major quality of life and health problems. Clean intermittent catheterization (draining urine from the bladder with a tube) is usually needed to empty the bladder properly. Medications are routinely required to alleviate high urinary tract pressures that can cause irreversible kidney damage, where dialysis or kidney transplant is the only way to sustain life.

A Chinese urologist developed a novel procedure to connect a functioning, healthy lumbar spinal nerve to the sacral nerve that controls the bladder. Hundreds of these procedures have been done in China. The end result is the creation of a new reflex where the bladder can be emptied by scratching or stimulating the skin (over the hip or thigh) supplied by that spinal nerve root. The Chinese physician had reported that of 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, the reported success was 87% at one year. However, in China rigorous follow up is challenging, therefore much is still unknown about how the nerves regenerate post surgery, complications and results occurring in the first year in particular, and the potential role that central nervous system remodeling may play in achieving successful outcomes. Beaumont urologists were the first in the US to perform this surgery on children with spina bifida. Our preliminary data are very promising, and in 9 subjects at 12 months post procedure, 7/9 subjects could void either voluntarily or by stimulating the new reflex mechanism.

This current project aims to expand upon our pilot experience to conduct a larger and more rigorous study to establish the safety and effectiveness of the proposed somatic-autonomic reflex pathway procedure in gaining bladder and bowel control in patients with spina bifida. We will also collaborate with and train investigators at another site(s) to determine the training needed to achieve similar safety and effectiveness outcomes, and evaluate possible methods to stimulate the new reflex to improve bladder emptying. Achieving the aims outlined in this multicenter proposal will help firmly establish the procedure as safe and effective, and revolutionize the treatment of bladder and bowel dysfunction in patients with spina bifida in the US.

Eligibility

Ages Eligible for Study:  5 Years and older

Genders Eligible for Study:  Both

Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:

Male and female patients age 5 and older with spinal dysraphism (ie. myelomeningocele , lipomyelomeningocele, myelocele,meningocele, occulta) with voiding dysfunction on a CIC program for bladder management for at least one year prior to screening.

Atonic or hyperreflexic bladder documented by urodynamic testing during screening. .

Documented history of no more than one tethered cord surgery/release in the past; must be > 2 years post tethered cord surgery/release

Stable neurogenic bladder dysfunction of at least 1 year or more

Normal renal function (cr<1.5 mg/dl or GFR >75)

Ambulate independently with or without ankle-foot orthotics (AFOs).

Catheterized volume must be at least 50% of total bladder capacity.

Exclusion Criteria:

History of bladder cancer, augmentation, or radiation

Anatomic outlet obstruction or urethral strictures

History of untreated vesico-ureteric reflux grade 4 or higher documented on screening video UDT

Hydronephrosis grade 3 or higher

Presence of an ileal conduit or supra-pubic catheter drainage

Subjects with an artificial bladder sphincter

Subjects who have had a sling procedure

Subjects who have had the mitrofanoff procedure

Bladder botox injections within last 12 months

Spina Bifida subjects who underwent intrauterine closure of their myelomeningocele

Unable to ambulate independently with or without AFOs.

Subject is pregnant

Contraindications to general anesthesia or surgery

Inability to complete follow up visits for 2 years

Inability to complete (or have parent complete) self administered questionnaires

Subject possesses any other characteristics that, per investigator's judgment, deems them unsuitable (eg increases risk, impairs data collection, etc) for the procedure/study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096459

Sponsors and Collaborators

Kenneth Peters, MD

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:Kenneth Peters, MDWilliam Beaumont Hospitals

More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals

ClinicalTrials.gov Identifier: NCT01096459    

Other Study ID Numbers: 2010-029, RO1DK084034

Study First Received: March 23, 2010

Last Updated: July 31, 2013

Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:

spina

bifida

restore

urinary

function

nerve

reroute

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic

Spinal Dysraphism

Neurologic Manifestations

Nervous System Diseases

Urinary Bladder Diseases

Urologic Diseases

Signs and Symptoms

Neural Tube Defects

Nervous System Malformations

Congenital Abnormalities

ClinicalTrials.gov processed this record on August 01, 2013

============================================================