背景:活血中药注射剂(TCMi-ABC),具有相当的抗凝血和抗血小板作用,在中国通常用作急性心肌梗死(AMI)的辅助治疗。
目的:本研究的目的是进行一项荟萃分析,以评估TCMi-ABC联合常规西药降低AMI相关死亡率的有效性和安全性。
方法:我们对PubMed进行了全面搜索,科克伦图书馆,EMBASE,WebofScience,CBM,万方数据,和CNKI数据库。随机对照试验(RCTs)研究TCMi-ABC(包括丹红注射液,丹参酮IIA磺酸钠注射液,丹参注射液,和葛根素注射液)用于治疗AMI。搜索包括从数据库开始到2022年12月发表的研究。两位作者独立筛选了RCT,提取的数据,并评估了偏差的风险。采用RevMan5.3和Stata17.0进行Meta分析。使用GRADE方法评估证据质量。
结果:共52个RCTs,涉及5,363例患者纳入分析,其中没有描述对所用TCMi-ABC产品的纯度或效力的独立测试。19/52报道了随机序列的产生。所有RCT都缺乏对分配隐藏的充分描述。51/52未能评估盲法。荟萃分析结果表明,TCMi-ABC联合应用,与单纯的常规西药治疗相比,显著降低AMI患者的住院死亡率[RR=0.41,95%CI(0.29,0.59),P<0.05],降低恶性心律失常的发生率[RR=0.40,95%CI(0.26,0.61),P<0.05],左心室射血分数(LVEF)增加[MD=5.53,95%CI(3.81,7.26),P<0.05]。两组不良事件发生率比较差异无统计学意义(P>0.05)。等级证据质量分类表明,院内死亡率的证据,恶性心律失常,不良事件质量中等,而LVEF的证据质量低。
结论:TCMi-ABC在降低AMI患者死亡率和恶性心律失常风险方面具有额外的临床价值。然而,由于随机化方法学上的弱点,有必要通过高质量的临床试验进一步验证这些发现,盲法,分配隐藏,以及对草药的纯度/效力和活性成分的克数的评估不足。
背景:[插入],标识符[INPLASY202170082]。
BACKGROUND: Traditional Chinese medicine injection for Activating Blood Circulation (TCMi-ABC), which exhibits comparable anticoagulant and antiplatelet effects, is commonly used as an adjuvant treatment for acute myocardial infarction (AMI) in China.
OBJECTIVE: The aim of this study was to conduct a meta-analysis to assess the efficacy and safety of TCMi-ABC in combination with conventional western medicine in reducing mortality associated with AMI.
METHODS: We conducted a comprehensive search of PubMed, Cochrane Library, EMBASE, Web of Science, CBM, WanFang Data, and CNKI databases. Randomized controlled trials (RCTs) investigating the use of TCMi-ABC (including Danhong injection, sodium tanshinone IIA sulfonate injection, salvia miltiorrhiza ligupyrazine injection, and puerarin injection) for the treatment of AMI were included. The search included studies published from the inception of the databases up to December 2022. Two authors independently screened RCTs, extracted data, and assessed the risk of bias. Meta-analysis was performed using RevMan 5.3 and Stata 17.0. The quality of evidence was evaluated using the GRADE approach.
RESULTS: A total of 52 RCTs involving 5363 patients were included in the analysis, none of which described independent testing of the purity or potency of the TCMi-ABC product used. 19/52 reported random sequence generation. All RCTs lack adequate description of allocation concealment. 51/52 failed to assess blinding. The meta-analysis results demonstrated that the combined application of TCMi-ABC, compared with conventional western medicine treatment alone, significantly reduced in-hospital mortality in AMI patients [RR= 0.41, 95% CI (0.29, 0.59), P < 0.05], decreased the incidence of malignant arrhythmia [RR= 0.40, 95% CI (0.26, 0.61), P < 0.05], and increased left ventricular ejection fraction (LVEF) [MD= 5.53, 95% CI (3.81, 7.26), P < 0.05]. There was no significant difference in the incidence of adverse events between the two groups (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.
CONCLUSIONS: TCMi-ABC demonstrates additional clinical value in reducing mortality and the risk of malignant arrhythmia 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 assessing for the purity/potency of herbs and the gram amount of active constituents.
BACKGROUND: [INPLASY], identifier [INPLASY202170082].