麝香保心丸治疗冠心病的有效性及安全性的系统评价再评价

Efficiency and safety of Shexiang baoxin pill for coronary heart disease:an overview of systematic reviews

目的目前研究表明麝香保心丸能预防和减轻心绞痛的发生,使冠状动脉粥样硬化性心脏病(冠心病)患者受益。多项关于麝香保心丸治疗冠心病的有效性及安全性的系统评价/Meta分析,但研究的方法学质量和证据质量尚缺乏系统性评估,难以指导临床决策。对麝香保心丸治疗冠心病的有效性及安全性的系统评价和Meta分析进行再评价。方法计算机系统检索中国知网、万方数据库、维普数据库、中国生物医学数据库、PubMed和the Cochrane Library数据库中麝香保心丸治疗冠心病的系统评价和Meta分析,检索时间自建库至2020年9月16日。根据纳入和排除标准由两位研究者对检索到文献进行筛选,数据提取和评价,如遇分歧,则与第三位研究者讨论解决。采用AMSTAR2量表评价纳入研究的方法学质量,GRADE证据等级评价工具对纳入研究的结局指标进行证据质量评价。结果检索到107篇文献,最终纳入17篇相关系统评价和Meta分析,包括85个结局指标,有12个研究报告不良反应,文献发表时间为2004年12月30日至2020年1月10日。方法学质量评价结果显示纳入的17项研究均为极低质量,GRADE评价结果显示定量分析的70个指标中中质量12个,低质量29个,极低质量29个。结论本研究纳入的17项麝香保心丸治疗冠心病的系统评价和Meta分析的方法学质量极低,结局指标的证据等级以低、极低质量为主,研究结论可信度不高,建议临床医生在参考麝香保心丸治疗冠心病的系统评价进行临床决策时,应结合临床具体情况谨慎判断。同时呼吁高质量、报告规范的系统评价以为临床决策提供优质的证据。

Objective The studies indicate that Shexiang baoxin pill has an effect on preventing and reducing the occurrence of angina pectoris,also been good for patients with coronary heart disease.There has been some systematic evaluation/meta-analysis on the efficacy and safety of Shexiang baoxin pill in patients with coronary heart disease.However,the methodological quality and evidence quality lack systematical evaluation,which makes it difficult for studies to guide clinical decisions.To overview meta-analysis as well as the systematic reviews(SRs)on the efficiency and safety of Shexiang baoxin pill for coronary heart disease.Method Databases(from the beginning until Sept.16,2020)of PubMed,the Cochrane Library,CNKI,Wanfang Data,VIP and CBM were systematically searched.All collected SRs/meta-analysis were screened by two researchers independently to identify studies meeting inclusion criteria.Data extraction,methodological quality evaluation and evidence quality were also conducted by two researchers independently.AMSTAR2 was applied to evaluate the methodological quality.The GRADE system was used to evaluate evidence quality.Results 107 SRs/meta-analysis were identified and 17 SRs/meta-analysis were included,published from December 30,2004 to January 10,2020.85 outcomes were reported and adverse reactions were reported in 12 SRs/meta-analysis.The methodological quality of all the 17 included SRs/meta-analysis was critically low.Qualities of evidence for 70 outcomes were graded as medium(20),low(29)and critically low(29).Conclusion The methodological quality of include 17 SRs/meta-analysis was critically low and qualities of evidence were mainly in low and critically low grade.The confidence in conclusions was not high.It is recommended that clinicians should combine systematic reviews and the specific situations in patients when using Shexiang baoxin pill for coronary heart disease to carefully make clinical decisions.High-quality and standardized reports are appealed to provide good-quality evidence for clinical decisions.