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目的:综合评价肿瘤患者使用酪氨酸激酶抑制药(TKI)导致肝毒性的风险,为临床治疗提供循证参考。方法:计算机检索Pub Med、EMBase、Sino Med、Cochrane图书馆、中国期刊全文数据库、万方数据库,搜集TKI对比安慰剂治疗肿瘤的随机对照试验(RCT),筛选文献,提取资料,采用RevMan 5.2统计软件进行Meta分析。结果:共纳入13篇文献,合计3 931例受试者。Meta分析结果显示,TKI组丙氨酸氨基转氨酶(ALT)升高≥3级的发生率(OR=3.77,95%CI:2.08 6.83,P<0.0001),天门冬氨酸氨基转氨酶(AST)升高≥3级的发生率(OR=3.85,95%CI:2.55 5.82,P<0.000 1)显著高于对照组,而血清总胆红素(TB)升高≥3级的发生率(OR=1.89,95%CI:0.90 3.96,P=0.09)与对照组相比差异无统计学意义。结论:现有的证据表明肿瘤患者使用TKI发生肝毒性的风险显著升高,提示在临床用药过程中,需对患者肝功能进行定期检查及监护。
Objective: To evaluate the risk of hepatotoxicity induced by tyrosine kinase inhibitor (TKI) in cancer patients and provide evidence-based reference for clinical treatment. METHODS: Randomized controlled trials (RCTs) were performed in PubMed, EMBase, SinoMed, Cochrane Library, Chinese Journal Full-text Database, and Wanfang database. TCD was compared with placebo in the treatment of cancer. Screening literature and extracting data were performed using RevMan 5.2 Meta-analysis software. Results: A total of 13 articles were included for a total of 3 931 subjects. Meta-analysis showed that the incidence of ALT increased ≥3 in TKI group (OR = 3.77, 95% CI: 2.08 6.83, P <0.0001), aspartate aminotransferase (AST) (OR = 3.85, 95% CI: 2.55 5.82, P <0.0001) was significantly higher than that of the control group, and the incidence of ≥3 grade elevated serum total bilirubin (TB) (OR = 1.89, 95% CI: 0.90 3.96, P = 0.09) compared with the control group, no significant difference. Conclusion: The available evidence indicates that the risk of hepatotoxicity of tumor patients using TKI is significantly increased, suggesting that regular monitoring and monitoring of liver function should be performed during the course of clinical medication.