中药注射剂治疗心力衰竭系统评价再评价
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摘要
目的:对中药注射剂治疗心力衰竭的系统评价或Meta分析进行再评价。方法:计算机检索Pubmed、The Cochrane Library、EMbase、WanFang Data、VIP、CBM、CNKI等中英文数据库,检索中药注射剂治疗心力衰竭的系统评价。由2位评审员独立对纳入文献进行资料收集,并采用AMSTAR量表以及GRADE评估工具,对所纳入文献进行评价。应用Rveman 5.3软件对结局指标进行亚组分析,并进行间接比较。结果:最终纳入40篇系统评价或Meta分析文献,包含193个结局指标,涉及11种中药注射剂。AMSTAR量表评价结果中"是否提供前期设计方案""纳入标准中是否考虑发表文献""是否提供排除文献名单""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。间接比较显示人参注射液、益气复脉注射液以及参芪扶正注射液分别在心力衰竭患者临床疗效、LVEF和BNP的改善方面效果最佳。中药注射剂对于心力衰竭患者死亡率的影响,无统计学意义。结论:目前关于中药注射剂治疗心力衰竭的系统评价或Meta分析存在评价方法不规范、证据质量等不足,导致本次评价结论的可靠性降低。今后的研究应进行科学、合理的研究设计,从而为中药注射剂治疗心力衰竭提供更为可靠地循证证据。
Objective: To evaluate the systematic or Meta-analysis of traditional Chinese medicine injection in the treatment of heart failure. Methods: Pubmed, The Cochrane Library, EMbase, WanFang Data, VIP, CBM and CNKI were used to evaluate the curative effect and safety oftraditional Chinese medicine injection in thetreatment of heart failure.Two reviewers independently collected the data and used the AMSTAR scale and the GRADE assessment tool to evaluate the included studies. Rveman 5.3 software was used for sub-analysis of the outcome indicators and indirect comparison.Results: A total of 40 systematic reviews or Meta-analyzes were finally included and included 193 outcome measures, involving 11 Chinese traditional medicineinjections.The results of AMSTAR scale showed that "whether to provide pre-design", "whether to consider the inclusion of the standard published documents", "whether to provide a list of excluded documents" and "whether to explain the related conflict of interest" werefour factors leading to the decline in the quality of the included studies. Outcomes of the GRADE assessment tool showed that the limitations of systematic reviews and the publication bias were main factorsto reduce the quality of evidence. Indirect comparison showed that Ginseng Injection, Yiqi Fumai Injection and Shenqi Fuzheng Injection had the best effect on the improvement of clinical efficacy, LVEF and BNP in patients with heart failure. Chinese medicine injection for heart failure patients mortality had no statistically significant.Conclusion: At present, the systematic evaluation or Meta-analysis of traditional Chinese medicine injections for the treatment of heart failure has some problems, such as the non-standard evaluation method and the quality of evidence, leading to the decrease of the reliability of this evaluation conclusion. Future research should be conducted scientific and rational research and designin order to provide more reliable evidence-based evidence of traditional Chinese medicine injections for the treatment of heart failure.
Objective: To evaluate the systematic or Meta-analysis of traditional Chinese medicine injection in the treatment of heart failure. Methods: Pubmed, The Cochrane Library, EMbase, WanFang Data, VIP, CBM and CNKI were used to evaluate the curative effect and safety oftraditional Chinese medicine injection in thetreatment of heart failure.Two reviewers independently collected the data and used the AMSTAR scale and the GRADE assessment tool to evaluate the included studies. Rveman 5.3 software was used for sub-analysis of the outcome indicators and indirect comparison.Results: A total of 40 systematic reviews or Meta-analyzes were finally included and included 193 outcome measures, involving 11 Chinese traditional medicineinjections.The results of AMSTAR scale showed that "whether to provide pre-design", "whether to consider the inclusion of the standard published documents", "whether to provide a list of excluded documents" and "whether to explain the related conflict of interest" werefour factors leading to the decline in the quality of the included studies. Outcomes of the GRADE assessment tool showed that the limitations of systematic reviews and the publication bias were main factorsto reduce the quality of evidence. Indirect comparison showed that Ginseng Injection, Yiqi Fumai Injection and Shenqi Fuzheng Injection had the best effect on the improvement of clinical efficacy, LVEF and BNP in patients with heart failure. Chinese medicine injection for heart failure patients mortality had no statistically significant.Conclusion: At present, the systematic evaluation or Meta-analysis of traditional Chinese medicine injections for the treatment of heart failure has some problems, such as the non-standard evaluation method and the quality of evidence, leading to the decrease of the reliability of this evaluation conclusion. Future research should be conducted scientific and rational research and designin order to provide more reliable evidence-based evidence of traditional Chinese medicine injections for the treatment of heart failure.
引文
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[6] 宣建伟,陶立波,朱水清,等.真实世界中我国心力衰竭患者非直接医疗费用和患者生命质量研究[J].中国医疗险,2017(3):61-64.
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[15] 杨克虎,刘雅莉,袁金秋,等.发展和完善中的系统评价再评价[J].中国循证儿科杂志,2011,6(1):54-57.
[16] 熊俊,陈日新.系统评价/Meta分析方法学质量的评价工具AMSTAR[J].中国循证医学杂志,2011(9):1084.
[17] 王子君,姚亮,刘练,等.GRADE指南改编方法“ADOLOPMENT”介绍[J].中国循证医学杂志,2018,18(1):109-115.
[18] 陈昊,王艳,陈耀龙,等.从GRADE系统方法学看中医药临床证据体系的构建[J].中华中医药杂志,2017,32(1):25-28.
[19] 宾晓芳,郭志华.参附注射液治疗充血性心力衰竭的系统评价与Meta分析[J].贵阳中医学院学报,2010,32(5):76-79.
[20] 徐萍蓉,肖洒,李涛,等.参附注射液治疗老年患者心力衰竭的系统评价[J].华西医学,2013,28(12):1822-1826.
[21] 马敬,叶玮,郭建华,等.参附注射液治疗慢性心力衰竭的Meta分析[J].湖北科技学院学报(医学版),2017,31(4):283-288.
[22] 马睿,汤磊,陈尔真.参附注射液治疗心功能不全随机对照试验的系统评价[J].医药导报,2009,28(11):1472-1473.
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