丹红注射液治疗急性脑梗死系统评价再评价

Reevaluation of systematic reviews on Danhong Injection in the treatment of acute cerebral infarction

关键词:  丹红注射液  急性脑梗死  系统评价  再评价  循证医学

Key words:  Danhong Injection  acute cerebral infarction  systematic review  overview of systematic review  evidence based medicine

摘要:

[目的] 对丹红注射液治疗急性脑梗死（ACI）的随机对照试验的系统评价/Meta分析进行方法学质量评价和临床疗效证据分级评估，旨在为临床决策及临床实践指南制定提供参考。[方法] 检索中文全文期刊数据库（CNKI）、万方数据库（Wanfang Data）、SinoMed、PubMed、EMbase、Cochrane Library 6个中英文数据库中丹红注射液治疗ACI的随机对照试验的系统评价，检索时间为从建库至2023年6月。使用AMSTAR2量表对纳入的系统评价进行方法学质量评价，并对系统评价的结局进行证据汇总。[结果] 纳入14篇丹红注射液治疗ACI的系统评价，结果显示丹红注射液治疗ACI患者，可提高临床有效率、神经功能缺损评分、日常生活活动能力，未见严重不良反应报告。对方法学质量评价显示，纳入的随机对照试验的系统评价质量低，所有系统评价均未报告关键条目2和关键条目7，纳入研究的偏倚风险评估方法使用不合理。所有系统评价均未报告非关键条目3、10、16，即对研究设计的选择予以解释、报告系统评价的基金资助信息、潜在利益冲突来源等。[结论] 目前已经发表的丹红注射液治疗ACI的系统评价结果显示，丹红注射液单用或联合应用可提高ACI患者临床有效率，改善神经缺损功能评分、日常生活能力，并且安全性较好。然而，由于原始研究和系统评价的整体质量偏低，影响了结果的可靠性，还需高质量的临床证据支持临床决策。

Abstract:

[Objective] To evaluate the systematic review/Meta methodology quality of randomized controlled trials of Danhong Injection in the treatment of acute cerebral infarction，and to ebaluate the methodological quality and the status of clinical evidence. [Methods] Systematic review of randomized controlled trials of Danhong Injection in the treatment of acute cerebral infarction were searched in The Chinese Fulltext Journal Database（CNKI），Wanfang Data，SinoMed，PubMed，EMbase and the Cochrane Library databases from inception to June 2023. The AMSTAR2 scale was used to evaluate the methodological quality of the included systematic reviews，and the results of the systematic reviews were summarized. [Results] Fourteen systematic reviews of Danhong Injection in the treatment of acute cerebral infarction were included. The results showed that Danhong Injection could improve the clinical effective rate，neurological deficit score and activities of daily living in patients with acute cerebral infarction，and no serious adverse reactions were reported. It was found that the quality of systematic reviews of the included randomized controlled trials was extremely low，all systematic reviews did not report key item 2 and key item 7，and the bias risk assessment method used in the included studies was unreasonable. All systematic reviews failed to report non-critical items 3，10，and 16，namely to explain the choice of study design，to report information on the funding of the systematic review，and to report sources of potential conflicts of interest. [Conclusion] The published systematic evaluation results of Danhong Injection in the treatment of acute cerebral infarction showed that Danhong Injection alone or in combination can improve the clinical effective rate，improve the neurological deficit function score and daily living ability of patients with acute cerebral infarction，and has good safety. However，due to the low overall quality of the original study and systematic review，the reliability of the results is affected，and high-quality clinical evidence is needed to support clinical decision-making.