Liu Qin, Garner Paul, Wang Yang, Huang Binghua, Smith Helen
School of Public Health, Chongqing Medical University, No,1 Yixueyuan Road, Chongqing, PR China.
BMC Public Health. 2008 Oct 21;8:365. doi: 10.1186/1471-2458-8-365.
Drugs to protect the liver are frequently prescribed in some countries as part of treatment for tuberculosis. The biological rationale is not clear, they are expensive and may do harm. We conducted a systematic review to a) describe the ingredients of "liver protection drugs"; and b) compare the evidence base for the policy against international standards.
We searched international medical databases (MEDLINE, EMBASE, LILACS, CINAHL, Cochrane Central Register of Controlled Trials, and the specialised register of the Cochrane Infectious Diseases Group) and Chinese language databases (CNKI, VIP and WanFang) to April 2007. Our inclusion criteria were research papers that reported evaluating any liver protection drug or drugs for preventing liver damage in people taking anti-tuberculosis treatment. Two authors independently categorised and extracted data, and appraised the stated methods of evaluating their effectiveness.
Eighty five research articles met our inclusion criteria, carried out in China (77), India (2), Russia (4), Ukraine (2). These articles evaluated 30 distinct types of liver protection compounds categorised as herbal preparations, manufactured herbal products, combinations of vitamins and other non-herbal substances and manufactured pharmaceutical preparations. Critical appraisal of these articles showed that all were small, poorly conducted studies, measuring intermediate outcomes. Four trials that were described as randomised controlled trials were small, had short follow up, and did not meet international standards.
There is no reliable evidence to support prescription of drugs or herbs to prevent liver damage in people on tuberculosis treatment.
在一些国家,护肝药物经常作为结核病治疗的一部分被开具处方。其生物学原理尚不清楚,这些药物价格昂贵且可能有害。我们进行了一项系统综述,以:a)描述“护肝药物”的成分;b)将该政策的证据基础与国际标准进行比较。
我们检索了截至2007年4月的国际医学数据库(MEDLINE、EMBASE、LILACS、CINAHL、Cochrane对照试验中央注册库以及Cochrane传染病组的专业注册库)和中文数据库(CNKI、维普和万方)。我们的纳入标准是报告评估任何用于预防接受抗结核治疗的人群肝损伤的一种或多种护肝药物的研究论文。两位作者独立对数据进行分类和提取,并评估所陈述的评估其有效性的方法。
85篇研究文章符合我们的纳入标准,这些研究在中国(77篇)、印度(2篇)、俄罗斯(4篇)、乌克兰(2篇)开展。这些文章评估了30种不同类型的护肝化合物,分为草药制剂、制成的草药产品、维生素与其他非草药物质的组合以及制成的药物制剂。对这些文章的严格评价表明,所有研究都是规模小、开展不佳的研究,测量的是中间结果。被描述为随机对照试验的四项试验规模小、随访时间短,且未达到国际标准。
没有可靠证据支持为接受结核病治疗的人群开具预防肝损伤的药物或草药处方。