[关键词]
[摘要]
目的 系统评价中药注射液防治蒽环类药物心脏毒性的作用,为中药注射液防治蒽环类药物心脏毒性的临床应用提供循证依据。方法 检索中国知网、万方、维普、PubMed、Cochrane Library和EMbase数据库,检索时限为建库至2020年8月31日,收集所有使用中药注射液防治蒽环类药物心脏毒性的临床研究,2名研究者严格按照纳入和排除标准独立进行文献筛选、数据提取,运用Cochrane系统评价手册的偏倚风险评估工具进行方法学质量评价,采用Rev Man5.3软件进行Meta分析。结果 共纳入19项研究,1705例患者,所纳入研究总体质量一般。Meta分析结果显示:中药注射液可减少蒽环类药物所致心电图出现异常情况[OR=0.22,95% CI(0.17,0.29),P<0.000 01],降低心脏毒性[OR=0.26,95% CI(0.16,0.43),P<0.000 01],提高左室射血分数(left ventricular ejection fraction,LVEF)[MD=5.72,95% CI(4.16,7.29),P<0.000 01],降低肌酸激酶同工酶(creatine kinase MB,CK-MB)水平[SMD=-1.13,95% CI(-2.21,-0.06),P=0.04]、肌钙蛋白I(cardiac troponin,cTnI)水平[SMD=-3.03,95% CI(-4.37,-1.69),P<0.000 01]和N端脑钠肽前体(N-terminal pro brain natriuretic peptide,NT-proBNP)水平[MD=-31.03,95% CI(-59.02,-3.03),P=0.03]。结论 中药注射液可有效防治蒽环类药物所致心脏毒性,但仍需要高质量的随机对照试验(randomized controlled trial,RCT)研究进一步验证。
[Key word]
[Abstract]
Obiective To systematically evaluate the efficacy of traditional Chinese medicine (TCM) injection in preventing and treating anthracycline-induced cardiotoxicity, provide evidence-based basis for clinical application of TCM injection in preventing and treating anthracycline-induced cardiotoxicity. Methods CNKI, Wanfang, VIP, Pubmed, Cochrane Library and EMbase database were retrieved with retrieval time from the establishment to August 31, 2020, all the clinical researches with TCM injection for prevention and treatment of anthracycline-induced cardiotoxicity were collected, two independent researchers were in strict accordance with the standard selection and data extraction of literature, with Cochrane manual bias risk assessment tools for system evaluation methodological quality assessment, Meta analysis was performed by using Rev Man5.3 software. Results A total of 19 studies with 1705 patients were included, and the overall quality of the included studies was moderate. Meta-analysis results showed that:TCM injection could reduce abnormal electrocardiograms caused by anthracyclines[OR=0.22, 95%CI (0.17, 0.29), P<0.000 01], reduce cardiotoxicity[OR=0.26, 95%CI (0.16, 0.43), P<0.000 01], increase LVEF[MD=5.72, 95%CI (4.16, 7.29), P<0.000 01], decrease CK-MB[SMD=-1.13, 95%CI (-2.21, -0.06). P=0.04], cTnI value[SMD=-3.03, 95%CI (-4.37, -1.69), P<0.000 01] and NT-proBNP[MD=-31.03, 95%CI (-59.02, -3.03), P=0.03]. Conclusion Traditional Chinese medicine injection can effectively prevent and cure the cardiotoxicity caused by anthracycline, but high quality RCT study is still needed for further validation.
[中图分类号]
R285.64
[基金项目]
国家重点研发中医药现代化研究项目(2019YFC1710000,2019YFC1710001,2019YFC1710002,2019YFC1710003);国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG003);河南省科技攻关计划(212102311079);河南省中医药科学研究专项课题(2018JDZX009)