中药注射剂治疗心律失常的系统评价再评价

目的：对中药注射剂治疗心律失常的Meta分析或系统评价进行再评价。方法：计算机检索PubMed、EMbase、the Cochrane Library、知网、万方、维普、CBMdisc等中英文数据库，检索中药注射剂治疗心律失常的系统评价，时间为建库至2019年6月。2位评价者独立进行文献筛选以及资料提取工作，应用AMSTAR2量表以及GRADE评估工具进行评价。结果：最终纳入7篇Meta分析或系统评价，包含25个结局指标，涉及4种中药注射剂。AMSTAR2量表评价结果中"是否提供前期设计方案"、"是否提供排除文献清单"、"纳入标准中是否考虑发表文献，如灰色文献"、"是否说明相关利益冲突"4项为导致方法学质量降低的主要因素。GRADE评估工具的评价结局中，纳入系统评价的局限性以及发表偏倚为引起结局指标证据质量降低的原因。对纳入文献再进行Meta分析显示，中药注射剂治疗心律失常，可提高治疗总有效率Z=10.99，RR=1.45，95% CI （1.36，1.55），P<0.01]、血管再通率Z=2.29，OR=1.34，95% CI （1.04，1.72），P=0.02]，改善心率Z=21.52，MD=4.80，95% CI （10.12，12.15），P<0.01]，降低心律失常发生率Z=4.38，RR=0.53，95% CI （0.40，0.70），P<0.01]、病死率Z=5.94，RR=0.49，95% CI （0.39，0.62），P<0.01]。结论：中药注射剂在治疗心律失常中发挥重要作用，但现今关于中药注射剂治疗心律失常的Meta分析或系统评价的评价方法尚不规范，证据质量偏低，对此次评价结论可靠性产生了影响。

Traditional Chinese medicine injection for arrhythmology:a reevaluation on systematic review/Meta-analysis

OBJECTIVE To conduct a reevaluation study on Meta-analysis or systematic review of traditional Chinese medicine(TCM) injection in the treatment of arrhythmia.METHODS PubMed, EMbase, the Cochrane Library, CNKI, Wanfang Data, VIP and CBMdisc databases were searched by computer to search the systematic review of traditional Chinese medicine injections in the treatment of arrhythmia from inception to June 2019. Two reviewers independently performed literature screening and data extraction, and applied the AMSTAR2 scale as well as the GRADE assessment tool for evaluation.RESULTS Seven meta-analyses or systematic reviews were finally included, containing 25 outcome measures, involving four traditional Chinese medicine injections. Among the evaluation results of AMSTAR2 scale, ‘whether the preliminary design scheme is provided’, ‘whether the list of excluded literatures is provided’, ‘whether the published literatures are considered in the inclusion criteria, such as gray literatures’ and ‘whether the relevant conflict of interest is described’ are the main factors leading to the reduction of methodological quality. Among the evaluation outcomes of the GRADE assessment tool, the limitations of including systematic reviews as well as publication bias are responsible for the reduced quality of evidence for outcome measures. Meta-analysis of the included literatures showed that traditional Chinese medicine injections in the treatment of arrhythmia could improve the overall response rateZ=10.99, RR=1.45, 95% CI (1.36, 1.55), P<0.01], recanalization rateZ=2.29, OR=1.34, 95% CI (1.04, 1.72), P=0.02], improve heart rateZ=21.52, MD=4.80, 95% CI (10.12, 12.15), P<0.01], reduce the incidence of arrhythmiaZ=4.38, RR=0.53, 95% CI (0.40, 0.70), P<0.01], and mortalityZ=5.94, RR=0.49, 95% CI (0.39, 0.62), P<0.01].CONCLUSION Traditional Chinese medicine injections play an important role in the treatment of arrhythmia. However, the current Meta-analysis or systematic evaluation of traditional Chinese medicine injections for arrhythmia is not standardized, and the quality of evidence is low, which has an impact on the reliability of this evaluation conclusion.