保肝药物治疗药物性肝损伤系统评价的再评价
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篇名: 保肝药物治疗药物性肝损伤系统评价的再评价
TITLE:
摘要: 目的:评价保肝药物治疗药物性肝损伤(DILI)系统评价的方法学偏倚及其结论的可靠程度。方法:计算机检索Cochrane图书馆、PubMed、中国期刊全文数据库、中国生物医学文献数据库和万方数据库,查找保肝药物治疗DILI的系统评价。采用AMSTAR量表评价纳入DILI系统评价的方法学质量,并采用GRADE方法对纳入的结局指标进行证据质量分级。结果:共纳入7项系统评价,7项系统评价均比较了保肝药物组与对照组(空白对照或其他保肝药物等)治疗DILI的疗效,1项系统评价分析了保肝药物的安全性。谷胱甘肽组总有效率显著高于对照组(P<0.001);硫普罗宁和腺苷蛋氨酸在降低丙氨酸转氨酶和总胆红素水平方面显著优于对照组(P<0.001);与对照组相比硫普罗宁和水飞蓟素能显著降低天冬氨酸转氨酶水平(P<0.001);对比其他保肝药物,甘草酸二铵治疗DILI的不良反应发生率差异无统计学意义(P=0.13)。7项系统评价的AMSTAR平均分为4.43分,其中3项(42.86%)为低质量, 4项(57.14%)为中等质量。7项系统评价所包含的28个结局指标中,22个(78.57%)指标的证据质量为低或极低。结论:部分保肝药物能有效改善DILI患者的肝功能,疗效显著,短期安全性较好,但目前研究的方法学质量较差,结论的证据水平不高。因此,临床医师在用药决策时应慎用这类证据。
ABSTRACT: OBJECTIVE:To evaluate the methodological bias of liver-protective drugs in the treatment of drug-induced liver injury (DILI) and reliability of its conclusions. METHODS: Retrieved from Cochrane Library,PubMed, CJFD, CBM and Wanfang database, systematic reviews about the liver-protective drugs in the treatment of DILI were researched. AMSTAR scale evaluation was included for the methodological quality of systematic review, and the GRADE system was applied for evidence quality assessment of included outcomes. RESULTS:Totally 7 systematic reviews were enrolled, in which the efficacy differences of 7 reviews between liver-protective drugs group and control group (blank control or other  liver-protective drugs)in the treatment of DILI were compared, and safety of 1 systematic review was analyzed. The total effective rate of glutathione group was significantly superior to control group(P<0.001); in respect of reducing ALT and TBIL levels, tiopronin group and ademetionine group were superior to control group(P<0.001); tiopronin group and silymarin group were superior to controlgroup in reducing AST level(P<0.001); the incidence rate of ADR of diammonium glycyrrhizinate in the treatment of DILI had no significant difference from other liver-protective drugs(P=0.13). The average AMSTAR score of 7 systematic reviews was 4.43, of which 3 (42.86%) were low quality and 4 (57.14%) were medium quality. Among the 28 outcomes included in 7 systematic reviews, 78.57%(22)outcomes were graded as “low” or “very low” quality. CONCLUSIONS: Some liver-protective drugs makes an significant improvement in liver biochemical indicators for patients with DILI with good short-term safety.However,the methodological quality of systematic reviews is poor on the whole, as well as low quality of evidence.Thus, physicians should apply the evidence to make decision with caution.
期刊: 2016年第27卷第9期
作者: 胡琴,吴凡,刘维,邵宏
AUTHORS: HU Qin,WU Fan,LIU Wei,SHAO Hong
关键字: 保肝药物;药物性肝损伤;系统评价;GRADE分级;再评价
KEYWORDS: Liver-protective drugs; Drug-induced liver injury; Systematic review; Grade system; Reevaluation
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