Data Sheet 3_Traditional Chinese medicine injections with Tonifying Qi, equivalent effect of regulating energy metabolism, for acute myocardial infarction: a systematic review and meta-analysis of randomized clinical trials.pdf

BackgroundTraditional Chinese medicine injections for Tonifying Qi (TCMi-TQs), which exhibits comparable effect of regulating energy metabolism, is commonly used as an adjuvant treatment for acute myocardial infarction (AMI) in China.
ObjectiveA systematic review and meta-analysis was conducted to contrast the effectiveness and safety of four TCMi-TQs in AMI.
MethodsEight Databases were thoroughly searched before 31 July 2024, for randomized controlled trials (RCTs) focusing on the application of TCMi-TQs combined with conventional treatments (CT) to treat AMI. The primary outcomes were in-hospital mortality and long-term mortality. Secondary outcomes included malignant arrhythmia, left ventricular ejection fraction (LVEF), and adverse events. Stata17.0 and RevMan 5.4.1 software were employed for meta-analysis. The quality of evidence was evaluated using the GRADE approach.
ResultsA total of 113 RCTs involving 10,779 patients were included in the analysis, none of which described in-dependent testing of the purity or potency of the TCMi-TQ product used. 51/113 reported random sequence generation. All RCTs lack adequate description of allocation concealment. 112/113 failed to assess blinding. The meta-analysis results demonstrated that the combined application of TCMi-TQ + CT, compared with CT, significantly reduced in-hospital mortality in AMI patients [RR = 0.58, 95% CI (0.51, 0.67), P < 0.05], decreased the incidence of malignant arrhythmia [RR = 0.51, 95%CI(0.42, 0.63), P < 0.05], increased LVEF [MD = 6.52, 95%CI(5.54, 7.50), P < 0.05], and decreased the incidence of adverse events [RR = 0.70, 95%CI(0.60, 0.81), P < 0.05]. The GRADE evidence quality classification indicated that the evidence for in-hospital mortality, malignant arrhythmia, and adverse events was of moderate quality, while the evidence for LVEF was of low quality.
ConclusionTCMi-TQ demonstrates additional clinical value in reducing mortality, the risk of malignant arrhythmia, and adverse events in patients with AMI. However, further validation of these findings is warranted through high-quality clinical trials due to methodological weaknesses in randomization, blinding, allocation concealment, and insufficient assessment of the purity/potency of botanical drugs and the quantity of active metabolites.
Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD42024573818, identifier PROSPERO (CRD42024573818).

背景：益气类中药注射剂（Tonifying Qi Traditional Chinese Medicine Injections, TCMi-TQs）具备相似的能量代谢调节作用，在中国常被用作急性心肌梗死（acute myocardial infarction, AMI）的辅助治疗方案。
研究目的：本研究旨在系统评价并荟萃分析四种益气类中药注射剂在急性心肌梗死治疗中的有效性与安全性。
研究方法：本研究于2024年7月31日前全面检索8个数据库，筛选聚焦于益气类中药注射剂联合常规治疗（conventional treatments, CT）治疗急性心肌梗死的随机对照试验（randomized controlled trials, RCTs）。本研究的主要结局指标为住院死亡率与长期死亡率，次要结局指标包括恶性心律失常、左心室射血分数（left ventricular ejection fraction, LVEF）及不良事件。本研究采用Stata17.0与RevMan 5.4.1软件开展荟萃分析，并采用GRADE（Grading of Recommendations Assessment, Development and Evaluation）方法评价证据质量。
研究结果：本研究共纳入113项随机对照试验，涉及10779例患者，所有研究均未报告所用益气类中药注射剂产品的纯度与效力独立检测情况。其中113项研究中的51项报告了随机序列生成方法，所有研究均未充分描述分配隐藏方案，112项研究未实施盲法评价。荟萃分析结果显示，与单纯常规治疗相比，益气类中药注射剂联合常规治疗可显著降低急性心肌梗死患者的住院死亡率[相对危险度（Relative Risk, RR）=0.58，95%置信区间（Confidence Interval, CI）(0.51, 0.67)，P<0.05]，降低恶性心律失常发生率[RR=0.51，95%CI(0.42, 0.63)，P<0.05]，提升左心室射血分数[均数差（Mean Difference, MD）=6.52，95%CI(5.54, 7.50)，P<0.05]，并降低不良事件发生率[RR=0.70，95%CI(0.60, 0.81)，P<0.05]。GRADE证据质量分级结果显示，住院死亡率、恶性心律失常及不良事件的证据质量为中等，左心室射血分数的证据质量为低等。
研究结论：益气类中药注射剂可进一步为急性心肌梗死患者带来临床获益，降低其死亡率、恶性心律失常发生风险及不良事件发生率。但由于本研究纳入的研究在随机化、盲法、分配隐藏等方法学层面存在缺陷，且对植物药的纯度/效力及活性代谢物含量的评估不足，上述结论仍需通过高质量临床试验进一步验证。
系统评价注册：本系统评价已在PROSPERO平台注册，注册编号为CRD42024573818，注册链接：https://www.crd.york.ac.uk/PROSPERO/view/CRD42024573818。