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֬͵Ⱥֲ֬⻯ֲͣͬԽк
ֲ͡ȻãȻҲñ⡣ڷʹ÷ʽ֬ͬʱ
Ҫᳫʹ˳ʽ֬ᣬǽ֮

2010.11.8.

й걨2010.11.10

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http://tech.gmw.cn/2010-11/10/content_1378775.htm

פʹ֪ʶȨش
¦ ʱ䣺2010-11-10 18:47:40 [壺  
С]


ͼΪפʹ鲩ࡣ



ͼΪ鲩ʡ

һȴʹй֪ʶȨԻ20101110ٿ
ԻΪ֪ʶȨʶִʵΪ֪ʶȨ
طԱ֮乹һĶԻƽ̨Ըõر֪ʶȨ

˴ξ۽֪ʶȨִĶԻ˳150й
ҵĵĹԱ˽ӪŴ֪ʶȨִ
̽ȨͼðܼðҩƷ˺;Ի
߻ع˽Ͷಿź̽Щĳɹսԡǿַ֪
ʶȨԹҵĹͬвǿ֪ʶȨй⣬
ҪһϵķӦ

鲩ʹ񲿲µ֪ʶȨ־ֳաҹ
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ּ֮פʹ鲩ͬԼ10ý
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 http://www.21cbh.com/HTML/2009-9-1/HTML_8DIYP0Q1G8X5.html 

ڶйѧԺоġԪᡱרȨһͶ
ҵҵ͵͵ȥйררйѧԺ
ȨйԪᡱҵ˰йѧԺͬȨй
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ר˫Ͷʼʮ񎉵Ĵͻǣй˺
( http://health.gmw.cn/2010-09/21/content_1269224.htm );

йýкܹڹעһλ̿С
ӡ ͬһλصйĽСФڣһ
С˿վָФNIHоĿ
٣ȴûа취й˾;άԼĺϷȨ档о
ĿŷҲ϶һһ
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http://topics.gmw.cn/node_10053.htm )

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ҹ涨ֻ϶ĴѧȨܲŻ·ָ
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һЩ۵Ĵѧֻݸ߿ɼУͿ
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ǰФйػժҪġԼı档Фƪ
ԴĽбȽϣرФ졢۸ݡ

Ф2003[1]ˡ1995꿪ʼ15˻ߡ
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ͬĲǰݵìܣֻ˵һ⣺
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ǶԷФѧΪеȡͷ֣
һʽļ֤˽ӪҽԺ1178õĳɹΪ85%
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⣬ĹͬǰҲɾ1998ժҪ[2]ȣ2003[1]
߶Victor NittiWilliam C. de Groat2003[5]ȣ2005Ӣ
[4]Ellen ShapiroHerbert LeporФ1999
ŦԼѧչSCIٴĵڶNIHʽ𣬶Щߴ
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Ф2003[1]2005[4]2006[8]NIH
֮һáƪģФƪлһи
ڵĻ鱨[9]³ΪBeaumontҽԺٴ[10]
ҪοϣǷδıеĺųƳ85%ĳɹʳΪBeaumont
ҽԺNIHʽҪֲ֧[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
1995꿪ʼٴӦоƽ̱142535
ã6߷ԭ԰׻У5ָ״ܡƽ
317½296ϵͳȾ1
ԭʧܡ8޷ԭ԰׻У5ȫָ״
ܣ1ָֻƽ288321۹
1ʧȥá

(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
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1һָɿʣ𽥼(22+/-15) mlӯʧʧ
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ꡣ
עժҪδἰ6߷ͻǰʣṩ
ӢժҪдݣ(102+/-39) ml (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
Ф2007걨Ժʿ֤
֤
֣ݴѧоģ20061¿ʼӦФڷ
˹񾭣񾭷仡Ƽѡ輹Ĥµ
ԭ԰׻11786085ĻߴСѻָ
ش֤
2007228
֣ݴѧо
(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
˵ФϷ仡
ѧ 2009128
ͼ3Bͼ4B󸴲ѧͼȷرʾǿ
ѹФȴΪ仡İ򣬲ұ־༭ԡ֤Ǹѹ
ͼΣPabdѹͼΣPvesһиѹʱаѹױ
ѹPdelǳͣһֱΪ㡣Ҳиѹʱų
ġ
(Translation) Opinions on Xiaos 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.

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ŷڡФϷ仡ͨķ

ߣʸ

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http://www.china.com.cn/zhibo/2010-11/09/content_21298706.htm
˺:
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ҽưȫͬʱרǻҪȫƶҽ¼ٴо
ҽƾףӦðչҵйطɷ洦


http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3585/200903/39511.htm
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http://www.gov.cn/gzdt/2009-06/11/content_1337464.htm
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2010/11/10

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ŦԼʱ1When does a human life begin? The Catholic 
Church says that life begins at fertilization, when egg and sperm 
unite and that the embryo created from this union has the same rights 
due any person. Because embryos must be destroyed to generate 
embryonic stem cells, opponents of the research say it is morally 
unacceptable.

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