目的:系统评价保肝药对抗结核药肝损伤的预防作用.方法:计算机检索中国生物医学文献数据库(CBM)及中国期刊全文数据库(CNKI),纳入比较结核患者预防性保肝治疗的随机对照试验(RCT),对纳入研究的方法学质量进行评价,并应用RevMan 5.1软件进行统计分析.结果:共纳入13个RCT,合计2 310例患者.全部为中文文献,Jadad改良量表评分均为1～3分,为低质量文献.Meta分析结果表明,对结核初治患者,预防性保肝治疗组的肝损伤人数少于常规抗结核组,2组比较差异有统计学意义(P＜0.05)；未报道保肝药临床应用相关的严重不良反应.结论:基于纳入文献的Meta分析结果,认为对结核初治患者在抗结核治疗的同时加用保肝药,可减少肝损伤的发生.但由于纳入研究质量所限,降低了该系统评价结论的可靠性,尚需开展更多设计合理、执行严格的多中心、大样本RCT以进一步证实.%OBJECTIVE: To systematically evaluate the protective effect of hepatoprotective on liver injury induced by antitu-berculosis drugs. METHODS: We searched CBM and CNKI. RCTs on prophylactic liver-protecting treatment for tuberculosis patients were involved and compared, and the quality of included studies was evaluated and Meta-analysis was performed by Rev-Man5.1 software. RESULTS: 13 RCTs were included, involving 2 310 patients. All included studies were Chinese literatures with low quality and Jadad score of 1—3 points. Results of Meta-analysis indicated that the number of patients with initial treatment of tuberculosis who received prophylactic liver-protecting treatment additionally was less than that of conventional antituberculosis group. There were statistical differences(P＜0.05). Serious adverse drug reactions (ADRs) induced by hepatoprotective hadn' t been reported. CONCLUSION: According to the Meta-analysis' s result, hepatoprotective could greatly decrease the incidence of liver damage for patients with initial treatment for tuberculosis who receive antituberculosis treatment. However, the evidence is not reliable due to the general low methodological quality of RCTs. Further reasonably designed and strictly implemented, multiple-center and large-scale RCT should be carried out.
展开▼
