w*****h 发帖数: 2120 | 1 送交者: 若明 于 2011-03-01 03:59:02
William Beaumont 医院有关接受肖氏手术的9例病人术后24个月的随访结果以前在会议
上报道过。
有关这项由NIH资助的多中心临床研究的最新进展发表在2010年12月1号的《Urology
Times》。同以前的报道比较可以得出以下几点新的结论:1. 术后24个月接受该手术的病人
仍然在改善中。2.新接受手术的4个病人结果比最初9个病人要好,恢复较快。3.最初接受手
术的9例病人中有2例失败,而失败的原因已经比较清楚。这2例病人都曾经接受过经子宫内的
修补手术。这样的手术通常会留下很多的瘢痕组织而给再次手术造成很大困难。基于这一结论,
凡是接受过经子宫内手术的病人不建议接受神经通路重建。
课题组正在对术后36个月的随访结果进行分析。虽然还没有完成,但已经看出36个月的
随访结果要好于24个月。
这个报道进一步证明肖氏手术的可行性而且经过改进和严格适应症可以进一步降低失败
率。
最后加一句:最初9例病人中2例失败,那成功率还是很高的。新手术的4例病人全部有
效。更重要的是失败的原因找到了,这样以后的手术成功率应该可以进一步提高。这可
以说明肖医生并没有夸大结果。
这里是原文:
http://www.modernmedicine.com/modernmedicine/Modern+Medicine+No
nerve-re-routing-possible-in-spina-bifida-
p/ArticleStandard/Article/detail/698880 |
x*********g 发帖数: 11508 | 2 支持肖医生移民美国,为美国人实行肖氏手术。等到把所有失败的原因都找清楚之后,
再引进到中国。 |
w*****h 发帖数: 2120 | 3 中国人自己原创的手术技术,需要先造福别国人,再从国外引进? |
x*********g 发帖数: 11508 | 4 是中国人自己原创的手术技术,需要先拿美国人当小白鼠,等技术成熟后再引进到中国
。呵呵。
【在 w*****h 的大作中提到】 : 中国人自己原创的手术技术,需要先造福别国人,再从国外引进?
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d**e 发帖数: 2420 | 5 哪里提到“美国卫生部更新记录肯定肖传国科研继续进行”?
美国有卫生部吗?似乎只看到美国卫生及公共服务部(HHS)
NIH是等同于美国卫生部吗?
嫌肖在中国害的人还不够多吗。 |
w*****h 发帖数: 2120 | 6 俺不介意当打脸党。
具体日期:
ClinicalTrials.gov processed this record on February 24, 2011
=============================================================
附件:美国卫生部更新记录,再次表明继续资助肖传国的手术科研。
(注:这是摘录。对全部详情感兴趣,可用地址连接去阅读原文全文)。
Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida
This study is not yet open for participant recruitment.
Verified by William Beaumont Hospitals, June 2010
First Received: March 23, 2010 Last Updated: June 4, 2010
ClinicalTrials.gov processed this record on February 24, 2011
[www.clinicaltrials.gov]
Sponsor: William Beaumont Hospitals.
Collaborator: National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK).
Information provided by: William Beaumont Hospitals.
ClinicalTrials.gov Identifier: NCT01096459 .
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.
Dr. Xiao, 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 with good results. 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. 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 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, in collaboration with Dr. Xiao, 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
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:
01. History of bladder cancer, augmentation, or radiation;
02. Anatomic outlet obstruction or urethral strictures;
03. History of untreated vesico-ureteric reflux grade 4 or higher
documented on screening video UDT;
04. Hydronephrosis grade 3 or higher;
05. Presence of an ileal conduit or supra-pubic catheter drainage;
06. Subjects with an artificial bladder sphincter;
07. Subjects who have had a sling procedure;
08. Subjects who have had the mitrofanoff procedure;
09. Bladder botox injections within last 12 months;
10. Spina Bifida subjects who underwent intrauterine closure of their
myelomeningocele;
11. Unable to ambulate independently with or without AFOs;
12. Subject is pregnant;
13. Contraindications to general anesthesia or surgery;
14. Inability to complete follow up visits for 2 years;
15. Inability to complete (or have parent complete) self administered
questionnaires;
16. Subject possesses any other characteristics that, per investigator's
judgment, deems them unsuitable (eg increases risk, impairs data
collection, etc) for the procedure/study.
【在 d**e 的大作中提到】 : 哪里提到“美国卫生部更新记录肯定肖传国科研继续进行”? : 美国有卫生部吗?似乎只看到美国卫生及公共服务部(HHS) : NIH是等同于美国卫生部吗? : 嫌肖在中国害的人还不够多吗。
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s*******n 发帖数: 10426 | 7 这个离临床推广差的远呢,也跟之前的review得出的结论近似,那就是这个方法还有待
进一步研究,而肖的手术在国内却进入了临床推广阶段,上千人就给他当了小白鼠了..
..
【在 w*****h 的大作中提到】 : 俺不介意当打脸党。 : 具体日期: : ClinicalTrials.gov processed this record on February 24, 2011 : ============================================================= : 附件:美国卫生部更新记录,再次表明继续资助肖传国的手术科研。 : (注:这是摘录。对全部详情感兴趣,可用地址连接去阅读原文全文)。 : Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida : This study is not yet open for participant recruitment. : Verified by William Beaumont Hospitals, June 2010 : First Received: March 23, 2010 Last Updated: June 4, 2010
|
w*****h 发帖数: 2120 | 8 国内有自己的临床推广流程,这只是该手术进一步在美国推广而已。
..
【在 s*******n 的大作中提到】 : 这个离临床推广差的远呢,也跟之前的review得出的结论近似,那就是这个方法还有待 : 进一步研究,而肖的手术在国内却进入了临床推广阶段,上千人就给他当了小白鼠了.. : ..
|
d**e 发帖数: 2420 | 9 还打脸,从头到底没见着什么美国卫生部?
【在 w*****h 的大作中提到】 : 俺不介意当打脸党。 : 具体日期: : ClinicalTrials.gov processed this record on February 24, 2011 : ============================================================= : 附件:美国卫生部更新记录,再次表明继续资助肖传国的手术科研。 : (注:这是摘录。对全部详情感兴趣,可用地址连接去阅读原文全文)。 : Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida : This study is not yet open for participant recruitment. : Verified by William Beaumont Hospitals, June 2010 : First Received: March 23, 2010 Last Updated: June 4, 2010
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d**e 发帖数: 2420 | 10 为什么得以临床推广,与肖传国的造假分不开。
【在 w*****h 的大作中提到】 : 国内有自己的临床推广流程,这只是该手术进一步在美国推广而已。 : : ..
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w*****h 发帖数: 2120 | 11 还真是被方舟子洗脑很彻底,造啥假了?
13个手术11个有效,还是比例太低?
【在 d**e 的大作中提到】 : 为什么得以临床推广,与肖传国的造假分不开。
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s*******n 发帖数: 10426 | 12 不要混淆临床推广和临床研究,临床研究的东西跟在R&D的产品一样,八字还没一撇呢。
中国能让这样一个本应该还在临床研究阶段的术式进入推广阶段就是一个大问题。至于
肖传国本身则是那个治愈率还是有效率的问题了,他宣称这个不成熟的方法治愈率多高
多高,其实他的有效率都没那么高,如果他那个方法真的成熟了,他根本也用不着跟方
舟子干架了,直接发篇nature science就让方闭嘴了,那可是1000多例的临床试验呀,
如果结果行的话,所有人都得立马闭嘴....
【在 w*****h 的大作中提到】 : 国内有自己的临床推广流程,这只是该手术进一步在美国推广而已。 : : ..
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w*****h 发帖数: 2120 | 13 你学生物的吧。 要不为啥啥都要扯不相干的nature/science
没发到nature/science上,临床医学手术就不靠谱了?
【在 s*******n 的大作中提到】 : 不要混淆临床推广和临床研究,临床研究的东西跟在R&D的产品一样,八字还没一撇呢。 : 中国能让这样一个本应该还在临床研究阶段的术式进入推广阶段就是一个大问题。至于 : 肖传国本身则是那个治愈率还是有效率的问题了,他宣称这个不成熟的方法治愈率多高 : 多高,其实他的有效率都没那么高,如果他那个方法真的成熟了,他根本也用不着跟方 : 舟子干架了,直接发篇nature science就让方闭嘴了,那可是1000多例的临床试验呀, : 如果结果行的话,所有人都得立马闭嘴....
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R********n 发帖数: 5904 | 14 好像在lancet上发过吧。
做医学的,lancet的地位比CNS高,lancet引用率也比CNS还高些。当然生物千老知道这
的不多。
【在 w*****h 的大作中提到】 : 你学生物的吧。 要不为啥啥都要扯不相干的nature/science : 没发到nature/science上,临床医学手术就不靠谱了?
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m*****e 发帖数: 10963 | 15 肖的可恶在于 这个鸡巴蛋到中国去吧中国人当小白鼠。。。 |
x*********g 发帖数: 11508 | 16 既然美国卫生部肯定了,那么肖应该可以在美国推广了,如果他能在美国找到1000例病
人实行他的手术,我们就不反对他在中国推广了。
这么简单的事情,用事实说话,不比这么争来争去的强吗? |
h*********n 发帖数: 5789 | 17 美国卫生部是个什么单位?
【在 x*********g 的大作中提到】 : 既然美国卫生部肯定了,那么肖应该可以在美国推广了,如果他能在美国找到1000例病 : 人实行他的手术,我们就不反对他在中国推广了。 : 这么简单的事情,用事实说话,不比这么争来争去的强吗?
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w*****h 发帖数: 2120 | 18 煮熟的鸭子就剩嘴硬,需要时间罢了。
美国临床试验的结果,验证并证明了肖自己声称的有效率是靠谱的。
【在 x*********g 的大作中提到】 : 既然美国卫生部肯定了,那么肖应该可以在美国推广了,如果他能在美国找到1000例病 : 人实行他的手术,我们就不反对他在中国推广了。 : 这么简单的事情,用事实说话,不比这么争来争去的强吗?
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s*******n 发帖数: 10426 | 19 汗,俺是学医的,以为你是学生物的...
【在 w*****h 的大作中提到】 : 你学生物的吧。 要不为啥啥都要扯不相干的nature/science : 没发到nature/science上,临床医学手术就不靠谱了?
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x*********g 发帖数: 11508 | 20 不知道啊。我是顺着楼主的报道说,让肖先在美国给美国人做手术,等到技术成熟以后
再引进到中国。
【在 h*********n 的大作中提到】 : 美国卫生部是个什么单位?
|