加载丹红注射液治疗不稳定型心绞痛的Meta分析和GRADE评价  

Adjuvant Danhong Injection (丹红注射液) for Unstable Angina: a Meta-analysis and GRADE Profile

作　　者：陈浩佳 曹雅雯 林姗姗 王贤良[1] CHEN Haojia;CAO Yawen;LIN Shanshan;WANG Xianliang(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin,300381)

机构地区：[1]天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津300381

出　　处：《中医杂志》2022年第4期332-340,共9页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局中成药治疗优势病种临床应用指南标准化项目(SATCM-2015-BZ402);2019国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG007);天津市卫生计生行业高层次人才选拔培养工程;教育部“创新团队发展计划”(IRT_16R54)。

摘　　要：目的系统评价西医常规加载丹红注射液治疗不稳定型心绞痛的有效性和安全性。方法计算机检索中国知网、维普数据库、万方数据知识服务平台、中国生物医学文献服务系统、MEDLINE、Cochrane Library、Embase中西医常规加载丹红注射液治疗不稳定型心绞痛的随机对照试验,文献发表时间为从各数据库建库至2020年10月31日。使用Cochrane Handbook 5.1.0中的偏倚风险评估工具评价文献质量,采用Review Manager 5.3对主要结局指标[6个月内心血管事件(MACE)发生率、心绞痛发作次数、心绞痛持续时间]、次要结局指标[超敏C反应蛋白(hs-CRP)]及安全性指标不良反应发生率进行Meta分析,应用GRADEprofiler 3.6评价证据质量。结果共纳入51项研究,涉及5293例研究对象,其中试验组2676例,对照组2617例。纳入研究的整体方法学质量较低。Meta分析结果显示,与西医常规相比,西医常规加载丹红注射液可降低MACE发生率[RR=0.21,95%CI(0.12,0.36),P<0.001],减少心绞痛发作次数0.67次/天[MD=-0.67,95%CI(-0.90,-0.44),P<0.001],缩短心绞痛持续时间1.53分钟/次[MD=-1.53,95%CI(-1.97,-1.10),P<0.001],降低hs-CRP水平1.24 mg/L[MD=-1.24,95%CI(-1.62,-0.86),P<0.001],不良反应发生率比较两者差异无统计学意义(P>0.05)。GRADE证据质量分级结果显示MACE发生率为中等质量证据,心绞痛发作次数、心绞痛持续时间、hs-CRP、不良反应发生率均为低质量证据。结论与西医常规治疗相比,加载丹红注射液可进一步改善不稳定型心绞痛患者的远期预后,减少不良心血管事件,改善患者心绞痛症状,提高整体生活质量,不良反应发生率两者无显著差异。Objective To systematically evaluate the effectiveness and safety of Danhong Injection(丹红注射液)combined with routine western medicine in the treatment of unstable angina.Methods Electronic databases including CNKI,VIP,WanFang Data,SinoMed,MEDLINE,Cochrane Library and Embase were searched from the inception dates to October 31 st,2020 for randomized controlled trials(RCTs)on Danhong Injection in combination with western medicine for unstable angina.Risk of bias tool in the Cochrane Handbook 5.1.0 was used to evaluate the quality of the literature.Review Manager 5.3 was used to perform the meta-analyses of the primary outcomes including major adverse cardiovascular events(MACE)within 6 months,the number of angina attacks,and duration of angina,secondary outcomes including high-sensitivity C-reactive protein(hs-CRP)and safety outcomes such as incidence of adverse reaction.GRADE profiler 3.6 was used to evaluate the certainty of evidence.Results Fifty-one RCTs were included,involving 5293 patients,with 2676 cases in the intervention group and 2617 cases in the control group.The overall methodological quality of the included studies was relatively low.The results of meta-analyses showed that Danhong Injection combined with routine western medicine had better effects in reducing the incidence of MACE within 6 months[risk ratio(RR)=0.21,95%confidence interval(CI)0.12,0.36,P<0.001],decreasing the number of angina attacks(MD=-0.67,95%CI-0.90,-0.44,P<0.001),shortening the duration of angina(MD=-1.53,95%CI-1.97,-1.10,P<0.001),and decreasing hs-CRP level(MD=-1.24,95%CI-1.62,-0.86,P<0.001)than western medicine alone,and there was no statistical difference in the incidence of adverse reactions between the two groups(P>0.05).The GRADE profile showed moderate evidence on incidence of MACE within 6 months,and low evidence on outcomes including the number of angina attacks,duration of angina,hs-CRP level and incidence of adverse reactions.Conclusion Compared to conventional western medicine,adjuvant Danhong Injection can f

关 键 词：丹红注射液 不稳定型心绞痛 META分析 GRADE评价 

分 类 号：R541.4[医药卫生—心血管疾病]