中药注射剂治疗不稳定性心绞痛系统评价再评价

Chinese Medicine Injections for Treatment of Unstable Angina Pectoris:A Re-evaluation of Systematic Review

目的对中药注射剂治疗不稳定性心绞痛的系统评价或Meta分析进行再评价。方法计算机检索建库至2021年5月期间CNKI、VIP、WanFang data、中国生物医学文献数据库(CBM)、Pubmed、The Cochrane Library、EMbase、Web of Science等中英文数据库中药注射剂治疗不稳定性心绞痛的系统评价或Meta分析。由2名研究员独立筛选和提取资料后,应用AMSTAR2量表、PRISMA声明和GRADE方法对纳入研究的方法学质量、报告质量和证据质量进行评价。结果最终纳入48篇系统评价或Meta分析,包含160个结局指标,涉及22种中药注射剂。纳入文献的AMSTAR2方法学质量评价整体偏低,得分较差的条目是2、3、7、10、12、13、14、16,提示在前期方案、研究设计选择原因、文献排除理由、资金来源、偏倚风险分析、异质性评价及利益冲突方面存在不足。纳入文献的PRISMA得分在13~24分之间,平均为19.6分,报告质量问题主要表现方案与注册、检索、其他分析、证据强度总结和资金来源方面。采用GRADE进行结局指标证据的评价,提示证据质量均较低,主要降级因素为局限性、发表偏倚、不准确性。结论在常规西药治疗的基础上加用中药注射剂治疗不稳定性心绞痛具有进一步获效的潜在可能;所评价文献存在整体评价方法不规范、报告缺乏、文章结构不统一以及原始文献证据质量低等不足;原始临床研究文献质量不高,信息缺乏和数据质量低是影响系统评价或Meta分析质量的重要原因。

Objective To re-evaluate the systematic review or meta-analysis of Chinese medicine injections for the treatment of unstable angina pectoris.Methods Systematic reviews or meta-analysis of Chinese medicine injections for the treatment of unstable angina pectoris were searched from China National Knowledge Infrastructure(CNKI),VIP Chinese Technology Periodical Database(VIP),WanFang Database,China Biology Medicine disc(CBMdisc),PubMed,Cochrane Library,EMbase,Web of Science,and other Chinese and English databases.After data were independently screened out and extracted by two investigators,the methodological quality,reporting quality,and evidence quality of the included studies were evaluated by AMSTAR2 scale,PRISMA statement,and GRADE method.Results Forty-eight systematic reviews or meta-analyses were included,including 160 outcome indicators,involving 22 Chinese medicine injections.The quality evaluation of AMSTAR2 scale in the included literature was generally low,with items 2,3,7,10,12,13,14,and 16 scoring poorly,indicating that there were certain deficiencies in the preliminary scheme,reasons for research design selection,reasons for literature exclusion,funding sources,analysis of risk of bias,heterogeneity evaluation,and conflict of interest.PRISMA statement of the included literature ranged from 13 to 24 points,with an average of 19.6 points.The quality problems of reports were mainly reflected in the aspects of scheme and registration,retrieval,other analysis,evidence strength summary,and funding sources.GRADE was used to evaluate the evidence of outcome indicators,indicating that the quality of the evidence was low,and the main factors for degradation were limitation,publication bias,and inaccuracy.Conclusion Adding Chinese medicine injections in the treatment of unstable angina pectoris on the basis of conventional western medicine has the potential to become further effective.However,the overall evaluation method is not standard,the report is lacking,the structure of the article is not unified,and the quality of the original evidence is low.Low quality of original clinical study literature,lack of information,and low data quality are the important reasons affecting the quality of systematic evaluation or meta-analysis.