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【摘要】：目的 通过自身免疫性肝炎二线药物相关文献的系统性回顾及Meta分析探讨药物的有效性和安全性。方法 计算机检索PubMed、EMBASE、Cochrane Library、Web of Science、中国知网、中国生物医学文献数据库、万方数据库及维普数据库等公开发表的关于自身免疫性肝炎二线药物治疗的研究文献，时间截至2019年12月31日。对纳入的文献采用纽卡斯尔-渥太华量表进行文献质量评价，提取相关数据，采用Meta-Analyst统计软件进行Meta分析。结果 纳入22篇文献，共计636例患者。Meta分析结果显示，吗替麦考酚酯（MMF）、他克莫司（TAC）、环孢素（CsA）及布地奈德（BUD）的汇总应答率分别为56.1%、76.0%、62.7%、57.3%，汇总的不良反应发生率分别为22.5%、47.4%、48.4%、33.0%。将应用MMF的患者按照一线治疗不耐受和一线治疗无应答进行分组比较，相对危险度为1.965，95%可信区间为1.181~3.269，异质性检验I2=0.665，P=0.014。结论 对于成人自身免疫性肝炎患者的二线药物治疗选择，结合应答率及不良反应发生率，MMF和TAC均是较好的选择，而对一线治疗无应答的患者，TAC可能是更优的选择。
【Abstract】：Objective To investigate the clinical effect and safety of second-line drugs in the treatment of adult patients with autoimmune hepatitis (AIH) through a Meta-analysis of related articles. Methods PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, CBM, Wanfang Data, and VIP were searched for the articles on second-line drugs for AIH published up to December 31, 2019. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of articles, related data were extracted, and Meta-Analyst software was used to perform the Meta-analysis. Results A total of 22 articles were included, with 636 patients in total. The Meta-analysis showed that mycophenolate mofetil (MMF), tacrolimus (TAC), cyclosporine, and budesonide had a pooled response rate of 56.1%, 76.0%, 62.7%, and 57.3%, respectively, and their pooled incidence rates of adverse events were 22.5%, 47.4%, 48.4%, and 33.0%, respectively. The patients treated with MMF were divided into groups based on intolerance or no response to the first-line treatment, and a comparative analysis of these groups showed a relative risk of 1.965 (95% confidence interval: 1.181-3.269, I2=0.665, P=0.014). Conclusion Selection of second-line drugs for adult AIH patients should consider response rate and incidence rate of adverse reactions. Both MMF and tacrolimus are good second-line drugs, and TAC may be a better choice for patients with no response to first-line treatment.
【关键字】：肝炎，自身免疫性； 药物疗法； Meta分析(主题)
【Key words】：hepatitis，autoimmune； drug therapy； Meta-analysis as topic
【引证本文】：QIAN L, YING L. Selection of second-line drugs for adult autoimmune hepatitis: A Meta-analysis［J］. J Clin Hepatol, 2020, 36(9): 2015-2020. (in Chinese)
钱乐， 应力. 成人自身免疫性肝炎二线药物治疗选择的Meta分析［J］. 临床肝胆病杂志, 2020, 36(9): 2015-2020.