目的 系统评价通心络胶囊联合阿托伐他汀治疗颈动脉粥样硬化的有效性和安全性。方法 通过网络检索中国学术期刊全文数据库(CNKI)、万方数据库(Wanfang Data)、维普中文科技期刊数据库(VIP)、PubMed、Embase、Cochrane Library、Web of Science,检索时间从建库至2023年8月31日,全面筛选通心络胶囊联合阿托伐他汀治疗颈动脉粥样硬化的临床随机对照试验(RCT),使用RevMan 5.4软件进行Meta分析。结果 共纳入16项RCTs,总病例数1 654例,治疗组832例、对照组822例。Meta分析结果显示:在阿托伐他汀治疗基础上加用通心络胶囊能降低总胆固醇(TC)[MD=-0.62,95%CI(-0.87,-0.37),P＜0.000 01]、三酰甘油(TG)[MD=-0.28,95%CI(-0.41,-0.15),P＜0.000 1]、低密度脂蛋白胆固醇(LDL-C)[MD=-0.38,95%CI(-0.56,-0.20),P＜0.000 1]和提高高密度脂蛋白胆固醇(HDL-C)水平[MD=0.22,95%CI(0.06,0.38),P=0.008],降低颈动脉内膜中层厚度(IMT)[MD=-0.21,95%CI(-0.27,-0.15),P＜0.000 01]和斑块Crouse积分[MD=-1.05,95%CI (-1.29,-0.80),P＜0.000 01],降低超敏C反应蛋白(hs-CRP)[MD=-0.44,95%CI(-0.57,-0.31),P＜0.000 01]和白细胞介素-6(IL-6)水平[MD=-3.96,95%CI(-6.25,-1.66),P=0.000 7],差异均有统计学意义。两组不良反应发生率[OR=1.48,95%CI(0.78,2.82),P=0.23]比较,差异无统计学意义。结论 通心络胶囊联合阿托伐他汀治疗颈动脉粥样硬化能改善血脂水平与炎症反应、减轻动脉粥样硬化程度,疗效和安全性均较好,建议临床进一步推广使用。

Objective Systematic evaluation of the efficacy and safety of Tongxinluo Capsule combined with atorvastatin in the treatment of carotid atherosclerosis.Methods A comprehensive screening of Tongxinluo Capsule combined with atorvastatin was performed by web searching the CNKI, Wanfang Data, VIP, PubMed, Embase, Cochrane Library, and Web of Science from the construction of the database to August 31, 2023, to comprehensively screen the literature of randomized controlled studies of Tongxinluo Capsule combined with atorvastatin in the treatment of carotid atherosclerosis in the literature of randomized controlled studies, and Meta-analysis was performed using RevMan 5.4 software.Results A total of 16 RCTs were included with 1 654 total cases, 832 in the treatment group and 822 in the control group. Meta-analysis showed that the addition of Tongxinluo Capsule to atorvastatin treatment lowered total cholesterol(TC) [MD =-0.62, 95%CI(-0.87,-0.37), P＜0.000 01], triglycerides(TG) [MD =-0.28, 95%CI(-0.41,-0.15), P＜0.000 1], low-density lipoprotein cholesterol(LDL-C) [MD =-0.38, 95%CI(-0.56,-0.20), P＜0.000 1] and increased high-density lipoprotein cholesterol(HDL-C) levels [MD=0.22, 95%CI(0.06, 0.38), P=0.008], lowered carotid intima-media thickness(IMT) [MD =-0.21, 95%CI(-0.27,-0.15), P＜0.000 01] and plaque Crouse's score [MD =-1.05,95%CI(-1.29,-0.80), P＜0.000 01], and lowered high-sensitivity C-reactive protein(hs-CRP) [MD =-0.44, 95%CI(-0.57,-0.31), P＜0.000 01] and interleukin-6(IL-6) levels [MD =-3.96, 95%CI(-6.25,-1.66), P=0.000 7], and the differences were statistically significant(P＜0.05). Adverse reactions were reported in seven studies, and a comparison of the incidence of adverse reactions [OR=1.48, 95%CI(0.78, 2.82), P=0.23] showed no statistically significant difference.Conclusion Tongxinluo Capsule combined with atorvastatin in the treatment of carotid atherosclerosis can improve the blood lipid level and inflammatory response,reduce the degree of atherosclerosis, with better efficacy and safety, and is recommended to be further promoted for clinical use.

R286.2，R969.3

国家自然科学基金资助项目(81573900); 中央高校基本科研业务费专项资金项目(2022-JYB-XJSJJ-073); 北京中医药大学新奥奖励基金项目(2019-XAJLJJ-019)