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[摘要]
目的 系统评价异甘草酸镁治疗抗结核药物所致肝损害的疗效和安全性。方法 检索PubMed、EMbase、Cochrane图书馆、Medline、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库和维普数据库,收集国内外关于异甘草酸镁治疗抗结核药致肝损害的临床随机对照研究(RCTs),评价纳入研究的质量并提取数据,使用RevMan 5.3软件进行Meta-分析。结果 共纳入14篇RCTs,包括1 202名抗结核药致肝损害患者。Meta-分析结果显示:异甘草酸镁在治疗抗结核药致肝损害总有效率[RR=1.38,95% CI (1.24,1.54),P<0.000 01]、降低丙氨酸氨基转移酶(ALT)[MD=-25.98,95% CI (-34.68,-17.29),P<0.000 01]、天冬氨酸氨基转移酶(AST)[MD=-20.21,95% CI (-24.49,-15.93),P<0.000 01]、总胆红素(TB)[MD=-9.92,95% CI (-16.41,-3.43),P=0.003]、碱性磷酸酶(ALP)[MD=-13.91,95% CI (-26.03,-1.79),P=0.02]方面均优于对照组,差异有统计学意义,同时不良反应发生率低于对照组[RR=0.51,95% CI (0.27,0.96),P=0.04]。结论 异甘草酸镁治疗抗结核药致肝损害临床疗效较好,可显著降低患者血清ALT、AST、TB和ALP水平,同时具有较高安全性,但本研究纳入文献多为较低质量的小样本研究,尚需更多高质量、大样本的随机对照试验进一步支持。
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[Abstract]
Objective To evaluate the efficacy and safety of magnesium isoglycyrrhizinate in the treatment of liver injury caused by anti-tuberculosis drugs.Methods PubMed,EMbase,Cochrane Database,Medline,CNKI,the Chinese Biomedical Database (CBM),Wanfang Database and WIP Database were searched to collecte the randomized controlled trials (RCTs) on liver injury patients caused by anti-tuberculosis drugs treated with magnesium isoglycyrrhizin.After screening the literatures,the quality of the included studies and extracted data was evaluated by using the RevMan 5.3 software for meta-analysis.Results A total of 14 RCTs were selected,including 1 202 patients with liver injury caused by anti-tuberculosis drugs.The total effective rate[RR=1.38,95% CI (1.24,1.54),P< 0.000 01],the reduced ALT[MD=-25.98,95% CI (-34.68),-17.29),P< 0.000 01],AST[MD=-20.21,95% CI (-24.49,-15.93),P< 0.000 01],TB[MD=-9.92,95% CI (-16.41,-3.43),P=0.003],ALP[MD=-13.91,95% CI (-26.03,-1.79),P=0.02]were superior to the control group,the difference was statistically significant,and the incidence of adverse reactions was lower than that of the control group[RR=0.51,95% CI (0.27,0.96),P=0.04].Conclusion Magnesium glycyrrhizinate has a good clinical effect in the treatment of liver injury caused by anti-tuberculosis drugs,which can significantly reduce the serum levels of ALT,AST,TB and ALP,and has a higher safety.However,the less quantity of samples,more high-quality and large-sample RCTs are needed to further support.
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