中药注射液治疗肺心病的系统评价再评价

Overview of systematic review of Chinese herbal injections for cor pulmonale

关键词:  中药注射液  肺心病  方法学质量  报告质量  证据质量  系统评价再评价

Key words:  Chinese herbal injection  cor pulmonale  methodological quality  reporting quality  grading of evidence  overview of systematic review

摘要:

[目的] 本研究对中药注射液治疗肺心病的系统评价/Meta 分析进行再评价，以期为临床应用中药注射液提供循证支持。[方法] 计算机检索中国知网（CNKI）、中国生物医学文献数据库（SinoMed）、Embase、The Cochrane Library等 8 个中英文数据库，检索年限为建库至 2023 年 3 月，搜集中药注射液治疗肺心病的系统评价/Meta 分析。分别使用AMSTAR-2、PRISMA 2020、GRADE 系统对纳入研究的方法学质量、报告质量及证据质量进行评价。[结果] 共纳入26 篇系统评价/Meta 分析，涉及 16 种中药注射液，29 个结局指标。AMSTAR-2 评价结果表明，纳入文献的方法学质量整体较低，无中、高质量文献，条目 2（前期方案）、3（研究类型选择原因）、4（文献检索）、8（研究特征描述）、10（资助来源）具有明显缺陷。PRISMA 2020 结果显示 8 个主题条目的报告完整度＜50%，分别为检索策略、方法综合、可信度评价、结果综合、证据可信度、注册与计划书、利益冲突和补充材料。GRADE 评估结果表明纳入研究中无高质量证据体，方法学质量低、结果不一致、存在发表偏倚是证据质量降级的主要因素。[结论] 基于现有证据，提示中药注射液治疗肺心病有效且基本安全，有助于纠正肺心病患者的缺氧状态、改善心室收缩和舒张功能、降低肺动脉压、改善血液流变学指标。但目前已发表系统评价/Meta 分析的方法学质量较低，文献报告存在一定缺陷，且证据质量等级不高，影响结果的可靠性。因此，未来需要更多高质量的临床研究和证据为中药注射液治疗肺心病的有效性和安全性提供循证支持。

Abstract:

[Objective] To This study re-evaluated the systematic review/Meta-analysis of traditional Chinese medicine（TCM） injection in the treatment of pulmonary heart disease，in order to provide evidence-based support for clinical application of TCM injection. [Methods] Eight Chinese and English databases，including CNKI，SinoMed，Embase and The Cochrane Library，were searched by computer from March 2023 to collect systematic reviews/meta-analyses of traditional Chinese medicine injection in the treatment of pulmonary heart disease. AMSTAR-2，PRISMA 2020 and GRADE systems were used to evaluate the methodological quality，reporting quality and evidence quality of the included studies. [Results] A total of 26 systematic reviews/Meta-analyses were included，involving 16 TCM injections and 29 outcome indicators. The results of AMSTAR-2 evaluation showed that the methodological quality of the included literatures was generally low，and there were no medium or high quality literatures. Items 2（preliminary scheme），3（reasons for the selection of research types），4（literature search），8（description of research characteristics），and 10（funding sources） had obvious defects. The results of PRISMA2020 showed that the reporting completeness of eight subject items was＜50%：search strategy，method synthesis，credibility evaluation，result synthesis，evidence credibility，registration and proposal，conflict of interest，and supplementary materials. GRADE evaluation results showed that there was no high-quality evidence in the included studies，and low methodological quality，inconsistent results，and publication bias were the main factors for evidence quality degradation. [Conclusion] Based on the existing evidence，it is suggested that Chinese medicine injection is effective and basically safe in the treatment of pulmonary heart disease，which can help to correct the hypoxia state，improve ventricular systolic and diastolic function，reduce pulmonary artery pressure and improve hemorheology indexes in patients with pulmonary heart disease. However，the methodological quality of the published systematic review/Meta-analysis is low，and there are some defects in the literature reports，and the quality of evidence is not high，which affects the reliability of the results. Therefore，more high-quality clinical studies and evidence are needed in the future to provide evidence-based support for the effectiveness and safety of TCM injection in the treatment of pulmonary heart disease.