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发表于 2002-5-30 22:11
| 乙肝危害世界3.5-4亿人口. 在中国中药常常在没有严格试药的情况下被拿来治疗乙肝, 或临床试验.
丹麦, 美国, 中国(四川第三军事医学院)合组对中药治疗乙肝进行了系统评估鉴定并发表在去年9月 "肝脏21" 期刊.
他们用随机盲选方法, 对比中药和安慰剂, 不间隔, 非特异治疗, 干扰素等的用药结果. 采用Jadad-scale 和 allocation concealment 方法鉴定. 电子, 人工手查纪录. 两个独立中介开包验证... .
在9组试药中(n=936), 只有一组试药符合试药标准, 可是有不对称作假漏洞现象. 药物比较发现几种草药(复合物), ("扶正解毒汤"有相对危险前提), 是可以使一些乙肝血清标志物减少... 也没有显示反作用.
但是光凭这还不能达到 "有效" "无害" 的标准. 因为这些临床试药质量太差(不合格, 作假), 文章论文太偏见, 执见(我的药一定是好的), 研究小组总结: "中药不适宜, 不能推荐给患者治疗乙肝". 小组还建议未来试药需要(无作弊的), 严格的试药制度, 质量, 随机选择, 双盲, 安慰剂控制等.
*译者按: 严格的, 高质量的, 随机选择的, 双盲的, 安慰剂控制的, (无作弊的)试药制度不是药物被承认与否的单一问题, 是一个卖药, 开药医生, 制药商最起码的德行之衡量标准. 最近还有朋友告知, 在中国, 医生, 药厂, 药物管理局职员合起来吃钱, 一起发大财的报道.
人心啊! 被狗给吃了.
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VIRAL HEPATITIS B-Chinese Medicinal Herbs for Chronic Hepatitis B: a Systematic Review
J. Liu(1), H. McIntosh(2), H. Lin(3)
(1) The Cochrane Hepato-Biliary Group, The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, H:S Rigshospitalet, Copenhagen, Denmark, (2) NHS Centre for Reviews and Dissemination, University of York, York, UK, (3) The Department of Epidemiology, Third Military Medical University, Chongqing, China
Aims/Background: Chronic hepatitis B is a serious health problem worldwide. Chinese medicinal herbs are widely used for treatment of chronic hepatitis B in China and many clinical trials have been conducted. This systematic review is to assess the efficacy and safety of Chinese medicinal herbs for chronic hepatitis B.
Methods: Randomised clinical trials comparing Chinese medicinal herbs versus placebo, no intervention, nonspecific treatment, or interferon treatment for chronic hepatitis B with ³3 months follow-up were included. No language and blinding limitations were applied. The electronic databases were searched, combined with handsearches on Chinese literature. Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment.
Results: Nine randomised trials (n=936) were included, with only one being of high quality. There was a funnel plot asymmetry (intercept 3.37, p=0.047). Compared to nonspecific treatment or placebo, the herbal compound Fuzheng Jiedu Tang showed an effect on clearance of serum HBsAg (relative risk 5.19, 95% CI 1.24-21.79), HBeAg (10.85, 3.56-33.06), and HBV DNA (8.50, 1.23-58.85). Polyporus umbellatus polysaccharide showed an effect on serum HBeAg (3.06, 1.13-8.29) and HBV DNA (4.14, 1.0-17.19); Phyllanthus amarus showed an effect on serum HBeAg (3.35, 1.49-7.56). Phyllanthus compound and kurorinone showed no significant difference on clearance of serum HBeAg and HBV DNA and on alanine aminotransferase normalisation compared to interferon. No serious adverse event was observed.
Conclusions: Chinese medicinal herbs are not recommended for chronic hepatitis B because of the publication bias and low quality of the trials. Rigorously designed, randomised, double-blind, placebo-controlled trials are needed. (Liver 21 , 280-286, 2001)
[ 此消息由 aloha 在 2002-05-30.09:12:10 编辑过 ] |
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