【3.4】第二次鉴定:治疗脊柱裂


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送交者: fuzzify 于 2009-11-27, 01:45:28:

回答: 最后一节:3.4。 由 JFF 于 2009-11-26, 19:54:44:

【3.4】第二次鉴定:治疗脊柱裂
The Second Evaluation: Treatment of Spina Bifida

平顶山的临床研究通过鉴定后,肖传国一面在武汉协和医院截瘫患者中推广,一面开始尝试把这种手术应用于另一类病人——脊柱裂患儿。
After he got the positive evaluation for his clinical study at Pingdingshan Hospital, Xiao Chuanguo started an attempt to apply this surgery technique to another type of patients – children suffering spina bifida, while he was continuing the operations for paralysis patients at [wuhan concord hospital?].

“这两类患者排尿困难的病因,基本上是一样的。”肖传国说,“我们最初先做了20个小孩。术后,每三个月随访一次。其中17人在一年内获得了自主排尿功能,成功率85%。2004年,卫生部对这项临床研究也进行了鉴定。”
“The medical causes for the urinary difficulties of these two types of patients are basically the same.” Xiao said, “We performed the surgery on 20 children at the beginning. After the surgery, we did one follow-up for every three months. 17 of them gained [autonomous urination] within a year, which means a success rate of 85%. In 2004, the Ministry of Health organized an evaluation on this clinical study as well.”

2004年8月,由鉴定专家同济医学院裘法祖、北京大学医学部韩济生等7位院士和一名教授组成的鉴定会,认定肖传国的成果对于解决先天性脊膜膨出患儿大小便失控“具有重要意义和突出的创新性”。
In August 2004, an expert panel, which consisted of seven academicians and one professor including Qiu Fazu from Tongji Medical School and Han Jisheng from the Medical Department of Beijing University, concluded that Xiao’s contribution to solving [uncontrollable urination of children born with spina bifida] was “important and outstandingly creative”.

记者采访了参加那次鉴定会的几位专家。据鞠躬院士回忆,成果原先也是准备被评为“国际领先”的,但大家讨论时提了很多问题,不过考虑到这是个创新,国内外都还没人开展,又有临床效果,最后还是给了个“国际先进”。
Our reporter interviewed several experts who participated in the evaluation. According to Academician Ju Gong, the experts initially wanted to give the highest evaluation of “world leading”. But many questions were brought up during the discussions. However, it was considered an invention, which nobody had done before either domestically or internationally, and it had some clinical effect. Eventually it was determined to be “world advanced”.

关于手术的成功率,一位参与那次鉴定的专家说,“肖传国的有些病例,参与鉴定的专家们也看了,排尿的膀胱压力曲线,还是被认可的;但是,提供给鉴定组的,只是部分资料,不是所有的病例资料都给大家看,他是有选择性的。他也找了七八个病人,排尿给大家看。他说早期做了20个病例,但专家们没看到 20个人的资料。”
As to the success rate, an expert of the panel said, “The panel experts reviewed some cases performed by Xiao. [the bladder pressure curve of urination was accepted], but he only provided partial information of his cases to the panel, instead of providing everything. He did it selectively. He also brought 7 or 8 patients in to demonstrate their urination to us. He said he performed 20 operations at the beginning, but the experts did not see any information of these 20 patients.”

这位专家提出,任何科研成果,必须是大、中型医院、多中心来进行试验,比如20家、30家来做一二百病例。而且要看远期疗效,光看近期疗效是不行的。
The expert also commented that any medical results must be tested by both large-sized and medium-sized hospitals, by multiple centers. For example, 100 to 200 cases should be done by 20 to 30 hospitals. Additionally, we need to see the long-term effectiveness, not only the short-term effectiveness.

他建议,让那些经过手术的患者,去其他一些有尿动力检验设备的、有尿动力学专家的医院检查,汇总这些病例,来给出一个客观的临床依据。
He further suggested those patients who underwent the operation should be examined by some other hospitals with urination dynamics measurement facilities and also urination dynamics experts. All those cases need to be analyzed and summarized to give an objective [clinical evidence].

在那份鉴定证书中,记者注意到,鉴定意见中还提到“这种患儿脊髓连续性并没中断,要建立人工反射弧支配膀胱必须牺牲一支正常体神经运动支及其功能,具有很大风险”。
In the evaluation report, the reporter noticed it also mentioned, “The spinal continuity of this type of children patients is not broken. [a healthy body neuromotor branch] and its functions must be sacrificed in order to construct an artificial reflex arc to control the bladder, which makes it a very big risk.”

对于手术的这个隐患,肖传国的解释是“在最初的20例手术中,确实有四五个小孩出现了些问题,你是拆东墙补西墙嘛,主要是对下肢有一点点影响,感觉腿有些软。但现在,我们已经解决了,(手术)只用1/3根神经,最多1/2,一年后它就能全部恢复。这已不是个问题了。”
About this hidden risk, Xiao provided an explanation, “There were indeed 4 or 5 children having some problems among the initial 20 cases. This is like “robbing Peter to pay Paul”. There is a very little side effect to lower limb, which may feel a little soft. But now we have solved it. Only a third of the nerve, at most a half, is used, and it will fully recover after a year. So this is not a problem any more.”

——这一描述与记者见到的郭资隆等患者的状况不相吻合。
This explanation does not agree with what the reporter observed -- the conditions of some patients including Guo Zilong,

“而且在手术知情同意书上,我们也是写清楚的。”肖传国补充说,“有一次在美国给一个家长介绍时,我说有这个问题。那个家长说,这个划得来啊!用小的损失换回了大小便的功能。”
“We also state it clearly on the surgery consent form.” Xiao added, “I once explained it to a patient’s parent when I was in the United States. The parent said it was worth it! This is to exchange a small loss for the urination function.”




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