◇◇新语丝(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)◇◇   肖传国在论文中捏造、篡改数据   作者:羽矢   肖传国在美国《泌尿学杂志》上共发表两篇肖氏手术人体试验结果的论文。 此前,肖传国曾发表有关会议摘要、中文论文、以及其他中文报告。将肖的两篇 论文与其他来源的结果进行比较,清楚地表明肖传国捏造、篡改了数据。   肖传国在2003年论文[1]报告了“自1995年开始……首期15例脊髓损伤患者” 的结果。此前,在1998年会议摘要[2]中,则报告了“自1995年开始”的14例脊 髓损伤患者的结果。总的病例人数有1人之差,这并非问题所在。问题是,2003 论文报告的15例都是高反射膀胱患者,而1998摘要却仅报告了6例高反射膀胱患 者(其余8例为无反射膀胱患者)。2003年论文中的其余9例高反射膀胱患者是从 哪里来的?同样,1998摘要中的8例无反射膀胱患者又到哪里去了?   无论随访时间有多长,患者的术前余尿数据不会有变化。然而,肖传国的数 据并非如此。1998摘要中的6例高反射膀胱患者的术前余尿为300毫升,而在其 2002年何梁何利奖获奖成就[3]所描述的“1995年开始……首期治疗截瘫病人14 例”中的6例高反射膀胱患者,术前余尿竟然变成了317毫升。   肖传国2005年论文[4]“首次”报告了20例脊柱裂患者18个月回访结果,其 中6例为高反射膀胱患者,其中1例失败。此前,肖传国2003年曾在《临床泌尿外 科杂志》上发表中文论文[5],报告了“自2000年开始”的13例脊柱裂患者1年回 访结果,其中6例也是高反射膀胱患者。不同之处在于,这6例全部成功。两篇中 英文论文的上下文表明,这是相同的6例高反射膀胱患者。肖传国未在其2005论 文[4]中提到有一病例先成功后失败,而这意味着此手术长期预后存在问题。   肖传国这两篇脊柱裂论文也同样存在术前余尿数据矛盾。2005论文中的6例 高反射膀胱患者的术前余尿为70.17毫升,而2003中文论文中的同样6例患者的术 前余尿却为102毫升。   上述不同出处的病例类型人数、术前余尿数据的矛盾,只能说明一个问题: 肖传国捏造、篡改了数据。   我们对发现肖传国的上述学术不端行为并不感到惊讶。我们早就发现,他曾 捏造了一份正式文件,证明他的私营医院的117名患者8个月随访的成功率为85%, 而这家医院本身成立不到8个月。   我们将向《泌尿学杂志》举报此数据捏造、篡改行为,并将通报给有关机构。 《临床泌尿外科杂志》就免了。那是肖传国任主编的杂志。   论文中还存在其他矛盾。肖传国1998摘要[2]中注明资金来源为NIH和PVA, 而其2003论文[1]则变成了来自中国的4项资金。肖传国于1994年首次获得NIH资 金用于狗的动物研究,因此,如果此项资金确实用于其1995年开始在中国的人体 试验,则NIH应当调查其滥用资金,而OHRP则应当调查其违反医学伦理。   另外,论文共同作者前后也有增删。与1998摘要[2]相比,2003论文[1]的作 者多了Victor Nitti和William C. de Groat。与2003中文论文[5]相比,2005英 文论文[4]的作者则多了Ellen Shapiro和Herbert Lepor。肖传国自1999年起获 得了用于在纽约大学开展SCI患者临床试验的第二项NIH资金,而这些美国作者大 部分来自资金获得机构纽约大学。他们在中国的临床试验中扮演了什么角色?在 临床试验初步结果已经由他人报告[2,5]后,他们对后来的论文[1,4]作出了什么 “贡献”?在享有署名权的同时,他们是否应当对滥用资金和违反医学伦理负责?   除此之外,中国有位专家还曾发现了肖2005论文[4]中尿流动力学图的矛盾。 专家指出[7],论文中的术后尿流动力学图3B和图4B表明病人排尿是靠腹压而不 是靠膀胱逼尿肌压力。这说明了反射弧无效。而肖却错误解释为反射弧引起的排 尿。   肖的2003年论文[1]和2005年论文[4]后来被其2006年综述文章[8](NIH是资 助者之一)引用。除了这两篇论文,肖在这篇综述中还引用了一份文献中根本不 存在的会议报告[9]。后来,该综述文章成为Beaumont医院初步临床试验[10]的 主要参考资料,而那份未发表过的报告中的号称超过85%的成功率成为Beaumont 医院申请NIH资金的主要支持材料[11]。   Xiao Chuanguo Fabricates and Falsifies Data in his Clinical Reports   Xiao Chuanguo published two papers on his clinical trials of his procedure in the Journal of Urology. Before the papers published, he also published related results in conference abstracts, articles in Chinese and other reports in Chinese. By comparing the results in the two papers with that from other sources, we clearly demonstrate that he fabricated and falsified his data.   Xiao reported his results of "the first 15 patients with SCI" ("clinical trial was started in 1995") in his 2003 paper [1]. Before that, he also reported the results of "14 SCI patients since 1995" in his 1998 abstract [2]. It is not the problem that there is a difference of one in the total numbers of patients. The problem is that all 15 patients are of hyperreflexic bladder in the 2003 paper, whereas only 6 patients are of hyperreflexic bladder in the 1998 abstract. Where did the other 9 patients with hyperreflexic bladder in [1] come from? and where had the 8 patients with areflexic bladder in [2] gone?   The pre-operative residual urine should remain the same no matter how long the follow-up is. But this is not the case in Xiao's data. The pre-operative residual urine of his 6 patients with hyperreflexic bladder is 300 ml in his 1998 abstract, but this data becomes 317 ml in his 6 patients with hyperreflexic bladder, among the same "first 14 SCI patients", described in his achievement [3] that was presented to the Holeung Ho Lee Foundation when he applied for the award from the Foundation in 2002.   Xiao reported the 18-month follow-up results of the "first" 20 patients with spina bifida in his 2005 paper [4], one failed among 6 patients with hyperreflexic bladder. Before that, he reported the 12-month results of 13 patients with spina bifida, published in Chinese in the Journal of Clinical Urology [5]. There are also 6 patients with hyperreflexic bladder. The difference is that the 6 cases in [5] are all successful. From the context of both two papers, the 6 cases are the same. Xiao did not mention in [4] that there was one case that was once successful but then failed later, which may suggest that there exists a problem in long-term prognosis of the procedure.   There is also an inconsistency in residual urine between his 2005 paper in English [4] and 2003 paper in Chinese [5]. The residual urine of the 6 patients with hyperreflexic bladder is 70.17 ml in [4], whereas that of the same 6 patients is 102 ml in [5].   The above described inconsistencies in the numbers of patients and the residual urine reveal that Xiao Chuanguo fabricated and falsified his data.   We are not surprised to find out that Xiao committed the forementioned academic misconducts. It has already been discovered that he once fabricated an official document [6] testifying the 85% success rate of 117 patients in his private hospital after 8 months of follow-up, but the hospital itself came into existence less than 8 months before.   We will file a complaint to the Journal of Urology on Xiao's fabrication and falsification, and we will also present this case to related authorities. But we are reluctant to report it to the Journal of Clinical Urology, as Xiao is the Editor in Chief of the journal.   There are other inconsistencies in Xiao's papers. The source of funding is indicated to be NIH and PVA in Xiao's 1998 abstract [2], while it becomes 4 grants from China in his 2003 paper [1]. Xiao was awarded his first NIH grant in 1994 to study dogs. If the grant was indeed used for his human trial in China started in 1995, then the NIH should investigate the grant misuse, and the OHRP should investigate the ethical violation.   In addition, there are changes in the lists of authors. Comparing to 1998 abstract [2], Victor Nitti and William C. de Groat were added in 2003 paper [1]. Comparing to 2003 paper in Chinese [5], Ellen Shapiro and Herbert Lepor were added in 2005 paper in English [4]. Most of those U.S. co-authors are from New York University, the recipient of Xiao's second NIH grant for a clinical trial of SCI patients started in 1999 at NYU. What are their roles in the clinical trial in China? What are their contributions to the papers [1,4], after the preliminary results had already been reported in [2,5] by others? Are they responsible for the grant misuse and the ethical violation while enjoying the right of authorship?   Besides these, an Chinese expert also found contradiction of urodynamic data in Xiao's 2005 paper [4]. The expert pointed out [7] that the postoperative urodynamic studies in Fig. 3B and Fig. 4B clearly show that the patients urinated by intra-abdominal pressure instead of the detrusor pressure, suggesting the failure of establishment of the reflex arc. But Xiao misrepresented that it is the reflex arc that causes the urination.   Xiao's 2003 and 2005 papers [1,4] were cited by his 2006 review article [8] (NIH is one of sponsors). Besides these two papers, he also cited a conference report [9] that does not exist in the literature. Later on, the review article became the major reference of Beaumont Hospital's pilot clinical trial [10], while the claim of more than 85% success rate originated from the unpublished report became the major supporting data in Beaumont Hospital's application to the NIH grant [11].   References   [1] 2003 article   Xiao CG, Du MX, Dai C, Li B, Nitti VW, de Groat WC.: An artificial somatic-central nervous system-autonomic reflex pathway for controllable micturition after spinal cord injury: preliminary results in 15 patients. J Urol 2003; 170: 1237.   A total of 15 male volunteers with hyperreflexic neurogenic bladder...Of the 15 patients 10 (67%) regained satisfactory bladder control within 12 to 18 months after VR micro anastomosis. Average residual urine decreased from 332 to 31 ml and   urinary infection as well as overflow incontinence disappeared. Urodynamic studies revealed a change from detrusor hyperreflexia with DESD and high detrusor pressure to almost normal storage and synergic voiding without DESD.   ...After successful experiments in animals, clinical trial was started in 1995. We report results in the first 15 patients with SCI.   [2] 1998 conference abstract   http://xysblogs.org/wp-content/blogs/107/uploads/1998xiao14sci.gif   Xiao CG, Godec CJ, Du MX, Dai C, and Zhu X.: A new procedure to restore bladder functions after SCI: Preliminary report on 14 patients. J.Urol. 159:304A, 1998   We have performed this procedure on 14 SCI patients since 1995 to try to restore controllable voiding....   Of 6 patient with hyperreflexic badder, 5 had successful recovery of bladder function. They are able to void by initiating the skin-CNS-Bladder reflex, which became functional from the 10th to 12th month postoperatively. Residual urine decreased from 300 ml to 31 ml in average, and no UTI occurred since the sixth month postsurgically. CMG study documented the changes of the bladder from hyperreflexia and high pressure to relatively normal.... Among 8 patients with areflexic bladder, 3 showed remarkable recovery and 1 had patial recovery.   SOURCE OF FUNDING: NIH, PVA   [3] Achievement of Xiao Chuanguo, from the Holeung Ho Lee Foundation   http://www.hlhl.org.cn/news/findnews/showsub.asp?id=476   1995年开始临床应用研究,首期治疗截瘫病人14例,术后经2.5~3.5年随 访,结果6例高反射性神经原性膀胱患者中,5例恢复膀胱储尿排尿功能。平均残 余尿由317毫升下降到29毫升,术后6个月起即无泌尿系统感染复发。1例因其他 原因治疗失败。另8例无反射性神经原性膀胱患者中,术后5例完全恢复膀胱储尿 排尿功能,1例部分恢复,平均残余尿由288毫升降到32毫升,1例因瘢痕过多放 弃手术,1例失去随访。   (Translation) We started the clinical study in 1995 and have treated 14 SCI patients, and conducted 2.5 to 3.5 years of follow-up. Of 6 patient with hyperreflexic bladder, 5 restored bladder storage and emptying function. Average residual urine decreased from 317 ml to 29 ml. Six months after operations, they no longer suffer urinary tract infection. One case failed because of other reasons. Among 8 patients with areflexic bladder, 5 completely restored bladder storage and emptying function, 1 had partial recovery, average residual urine decreased from 288 ml to 32 ml.   [4] 2005 article   http://www.ncbi.nlm.nih.gov/pubmed/15879861   Xiao CG, Du MX, Li B, Liu Z, Chen M, Chen ZH, Cheng P, Xue XN, Shapiro E, Lepor H.: An artificial somatic-automonic reflex pathway procedure for bladder control in children with spina bifida. J Urol 2005; 173: 2112.   Preoperative urodynamic studies revealed 2 types of bladder dysfunction— areflexic bladder (14 patients) and hyperreflexic bladder with detrusor external sphincter dyssynergia (6). All children were incontinent. Of the 20 patients 17 gained satisfactory bladder control and continence within 8 to 12 months after VR microanastomosis. Of the 14 patients with areflexic bladder 12 (86%) showed improvement. In these cases bladder capacity increased from 117.28 to 208.71 ml, and mean maximum detrusor pressure increased from 18.35 to 32.57 cm H2O. Five of the 6 patients with hyperreflexic bladder demonstrated improvement, with resolution of incontinence.....In these cases mean bladder capacity increased from 94.33 to 177.83 ml, and post-void residual urine decreased from 70.17 to 23.67 ml. Overall, 3 patients failed to exhibit any   improvement.   Based on our success in restoring bladder function and continence associated with spinal cord injury (SCI) by means of artificial somatic-central nervous system (CNS)-autonomic reflex pathway surgery, we investigated the effectiveness of this innovative surgical procedure in children with spina bifida and neurogenic bladder. To our knowledge this report represents the first published experience applying this technique to the management of spina bifida.   [5] 2003 article in Chinese   http://www.cnki.com.cn/Article/CJFDTOTAL-LCMW200311001.htm   肖传国, 杜茂信, 刘钊, 李兵, 陈朝晖, 程平, 陈敏. 人工体神经-内脏神 经反射弧治疗脊髓脊膜膨出患者大小便功能障碍. 临床泌尿外科杂志2003年11月 第18卷第11期   摘要   对30例大小便功能障碍的脊髓脊膜膨出患者,手术建立人工反射弧。进行术 前与术后6~18个月的尿动力学比较。结果:30例中13例获得了至少1年的随访。7 例无反射型患者中4例获得控尿和自主排尿功能,……6例高反射型患者全部于术 后1年左右恢复可控排尿,剩余尿逐渐减至(22+/-15) ml,充盈性尿失禁消失。 10例获得膀胱功能控制者,直肠功能转为基本正常。下肢功能损伤较小。结论: 人工反射弧能安全有效地治愈先天性脊髓脊膜膨出所致大小便失禁。   ……从1995年起治疗截瘫所致的大小便功能障碍获得成功后,2000年起应用 该理论和技术治疗脊柱裂所致大小便功能障碍已30例,其中13例已获随访至少1 年。   【注:中文摘要中未提及6例高反射型患者术前剩余尿量。但有作者提供的 英文摘要中有此数据:“余尿由(102+/-39) ml 减至(22+/-15) ml”】   http://en.cnki.com.cn/Article_en/CJFDTOTAL-LCMW200311001.htm   Xiao CG, Du X-X, Liu Z, Li B, Chen ZH, Cheng P, Chen M.: An artificial somatic-central nervous system-autonomic reflex pathway for spina bifida patients with neurogenic bladder and bowel. Journal of Clinical Urology 18(11).   Abstract (provided by authors)   A total of 30 patients with bladder and bowel dysfunctions caused by spina bifida underwent linited laminectomy and ventral root microanastomosis since 2000.... 13 patients had been followed up for at least one year. Four of 7 cases with areflexia bladder gained bladder control and automatic micturition abiliti within 6 months and 1 year after surgery.... All 6 cases with hyperreflexia bladder achieved controllable voiding, whose residual urine decreased from (102+/-39) ml to (22+/-15) ml and the detrusor external sphincter dyssynergia (DESD) disappeared.   (Translation) After our success in treating bladder and bowel dysfunction in patients with spinal cord injury started in 1995, we have applied the theory and the technique to treat bladder and bowel dysfunction in 30 patients with spina bifida. So far we have followed up 13 cases for at least 1 year.   [6] Faked certificate of cure rate supporting Xiao's membership application to the Chinese Academy of Sciences.   http://xysblogs.org/wp-content/blogs/107/uploads/shenyuan.jpg   肖传国2007年申报院士证明   证明   郑州大学神经泌尿外科研究中心,自2006年1月开始应用肖传国教授发明的 “人工体神经-内脏神经反射弧”技术,治疗脊柱裂、脊髓脊膜膨出所致的神经 原性膀胱患者117例,术后随访8个月以上60例,85%的患者大小便已恢复正常。   特此证明   2007年2月28日   郑州大学神经泌尿外科研究中心   (Tanslation) Neuro-Urologic Surgery Research Center (a.k.a Shenyuan Hospital) at Zhengzhou University, February 28, 2007   Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University has applied the "artificial somatic-autonomic reflex arc" technique invented by Professor Xiao Chuanguo to 117 patients with neurogenic bladder caused by spina bifida or meningomyelocele. Sixty cases were followed up for more than eight months. 85% of the patients have regained normal bladder and bowel functions.   (Note: The hospital was established in Auguest 2006.)   [7] Contradiction of urodynamic data found by a Chinese expert   http://www.sciencenet.cn/m/user_content.aspx?id=280348   众说“肖氏反射弧”   科学新闻 2009年12月8日   图3B和图4B是手术后复查的尿流动力学图,检查结果明确地表示病人是靠腹 压排尿,肖却解释为反射弧引起的膀胱排尿,并且被杂志编辑忽略。证据是腹压 图形(Pabd)与膀胱压图形(Pves)一样(有腹压时才有膀胱压),而膀胱逼尿 肌压力(Pdel)非常低(一条直线嘛),几乎为零。排尿也是在有腹压时排出来 的。   (Translation) Opinions on Xiao’s Reflex Arc   Science News. Dec 8, 2009   The figures reveal the truth inside the reflec arc. The postoperative urodynamic studies in Fig. 3B and Fig. 4B clearly show that the patients urinated by intra-abdominal pressure. But Xiao explained that it is the reflex arc that causes the urination. The flaw was ignored by editors. The evidence is that the intra-abdominal pressure (Pabd) is the same as intravesical pressure (Pves). And the detrusor pressure (Pdel) is very low (a flat line), nearly zero. Voiding happened only when intra-abdominal pressure existed.   [8] 2006 review   http://www.ncbi.nlm.nih.gov/pubmed/16314037/   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; 49: 22.   [9] Xiao CG. A somatic-autonomic reflex pathway procedure for neurogenic bladder and bowel: results on 92 patients with SCI and 110 children with spina bifida. In: Proceedings of the International Conference of Urology; Shanghai, July 2-4, Shanghai, China; 2005.   [10] Clinical trial information of Beaumont Hospital's pilot study   Lumbar to Sacral Ventral Nerve Re-Routing.   Identifier: NCT00378664   http://www.clinicaltrials.gov/ct/show/NCT00378664   [11] Project information of Beaumont Hospital's NIH grant    http://projectreporter.nih.gov/project_info_description.cfm?aid=769632 1   Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida.   Project Number: 1R01DK084034-01   He has reported that in 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, reported success in 87% at one year. (XYS20101111) ◇◇新语丝(www.xys.org)(xys5.dxiong.com)(www.xinyusi.info)(xys2.dropin.org)◇◇