Zhou Huiwen, Chen Jiaping, Liu Hongxu, Li Xiang, Zong Huiqi, Zhang Shuwen, Shi Yuxin, Li Yunze
Department of Cardiology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.
Department of Cardiology, Linping Branch of Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.
Front Pharmacol. 2025 Mar 28;16:1511486. doi: 10.3389/fphar.2025.1511486. eCollection 2025.
Traditional 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.
A systematic review and meta-analysis was conducted to contrast the effectiveness and safety of four TCMi-TQs in AMI.
Eight 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.
A 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), < 0.05], decreased the incidence of malignant arrhythmia [RR = 0.51, 95%CI(0.42, 0.63), < 0.05], increased LVEF [MD = 6.52, 95%CI(5.54, 7.50), < 0.05], and decreased the incidence of adverse events [RR = 0.70, 95%CI(0.60, 0.81), < 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.
TCMi-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.
https://www.crd.york.ac.uk/PROSPERO/view/CRD42024573818, identifier PROSPERO (CRD42024573818).
益气类中药注射剂在调节能量代谢方面具有相似作用，在中国常用于急性心肌梗死（AMI）的辅助治疗。
进行一项系统评价和荟萃分析，以对比4种益气类中药注射剂治疗AMI的有效性和安全性。
在2024年7月31日前全面检索8个数据库，查找关于益气类中药注射剂联合常规治疗（CT）用于治疗AMI的随机对照试验（RCT）。主要结局为住院死亡率和长期死亡率。次要结局包括恶性心律失常、左心室射血分数（LVEF）和不良事件。采用Stata17.0和RevMan 5.4.1软件进行荟萃分析。使用GRADE方法评估证据质量。
分析共纳入113项RCT，涉及10779例患者，其中无一描述所使用的益气类中药注射剂产品的纯度或效价的独立检测情况。51/113项报告了随机序列生成。所有RCT均缺乏对分配隐藏的充分描述。112/113项未评估盲法。荟萃分析结果表明，与CT相比，益气类中药注射剂联合CT显著降低了AMI患者的住院死亡率[RR = 0.58，95%CI（0.51，0.67），P < 0.05]，降低了恶性心律失常的发生率[RR = 0.51，95%CI（0.42，0.63），P < 0.05]，提高了LVEF[MD = 6.52，95%CI（5.54，7.50），P < 0.05]，并降低了不良事件的发生率[RR =
