Jian X U, Yuntao Liu, Zhihao Luo, Zhen Zhao, Dawei Wang, Qing Liu
Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, State Key Laboratory of Traditional Chinese Medicine Syndrome, the Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.
2 Guangdong Provincial Key Laboratory of Research on Emergency in Traditional Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510006, China.
J Tradit Chin Med. 2024 Dec;44(6):1082-1090. doi: 10.19852/j.cnki.jtcm.2024.06.001.
To synthesize the evidence from randomized controlled trials (RCTs) to assess the efficacy and safety of Chinese patent medicine (CPM) on atherosclerosis (AS) or with a high risk of atherosclerosis.
All RCTs in three databases (PubMed, EMBASE, and Cochrane Library) were included from the inception of the database to September 20, 2019. The methodological evaluation of the included trials was carried out using the Cochrane Collaboration Risk of Bias Tool. Meta-analysis was conducted using RevMan 5.3 software. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to evaluate the quality of evidence.
Eighteen RCTs were included, involving a total of 3885 patients with AS or with a high risk of AS. Most trials had favorable methodology. Meta-analysis suggested significant differences in clinical endpoint ( 1938, 0.53; 95% 0.40 to 0.69, 0.00001; = 0%); the change in carotid artery IMT ( 1723, -0.09, 95% -0.14 to -0.04, 0.001; = 40%); change in FMD ( 239, 0.87, 95% 0.52 to 1.21, 0.00001; = 0%); change in high sensitive C-reactive protein (hs-CRP) ( 1527, -1.89, 95% -3.36 to -0.42, 0.01; = 94%) and incidence of total adverse events ( 0.76, 95% 0.62 to 0.93, 0.009; = 40%) in favor of the experimental group. However, meta-analysis showed no significant differences in the change in low-density lipoprotein-C (LDL-C) ( 2419, -0.19, 95% -0.50 to 0.12, 0.22, = 94%) between the experimental and control groups.
CPM could have certain clinical efficacy in the treatment of AS. However, more double-blinded placebo-controlled RCTs are required in further evaluations to provide stronger evidence.
综合随机对照试验(RCT)的证据,评估中成药(CPM)对动脉粥样硬化(AS)或具有动脉粥样硬化高风险患者的疗效和安全性。
纳入三个数据库(PubMed、EMBASE和Cochrane图书馆)自建库起至2019年9月20日的所有RCT。采用Cochrane协作网偏倚风险工具对纳入试验进行方法学评价。使用RevMan 5.3软件进行荟萃分析。采用推荐分级的评估、制定与评价(GRADE)方法评估证据质量。
纳入18项RCT,共涉及3885例AS或具有AS高风险的患者。大多数试验方法良好。荟萃分析显示,在临床终点方面存在显著差异(1938,0.53;95%可信区间0.40至0.69,P = 0.00001;I² = 0%);颈动脉内膜中层厚度(IMT)变化(1723,-0.09,95%可信区间-0.14至-0.04,P = 0.001;I² = 40%);血流介导的舒张功能(FMD)变化(239,0.87,95%可信区间0.52至1.21,P = 0.00001;I² = 0%);高敏C反应蛋白(hs-CRP)变化(1527,-1.89,95%可信区间-3.36至-0.42,P = 0.01;I² = 94%)以及总不良事件发生率(0.76,95%可信区间0.62至0.93,P = 0.009;I² = 40%),均有利于试验组。然而,荟萃分析显示试验组与对照组在低密度脂蛋白胆固醇(LDL-C)变化方面无显著差异(2419,-0.19,95%可信区间-0.50至0.12,P = 0.22,I² = 94%)。
中成药在治疗动脉粥样硬化方面可能具有一定的临床疗效。然而,进一步评估需要更多双盲安慰剂对照的RCT以提供更有力的证据。