目的 系統(tǒng)評價通心絡(luò)膠囊聯(lián)合阿托伐他汀治療頸動脈粥樣硬化的有效性和安全性。方法 通過網(wǎng)絡(luò)檢索中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(CNKI)、萬方數(shù)據(jù)庫(Wanfang Data)、維普中文科技期刊數(shù)據(jù)庫(VIP)、PubMed、Embase、Cochrane Library、Web of Science,檢索時間從建庫至2023年8月31日,全面篩選通心絡(luò)膠囊聯(lián)合阿托伐他汀治療頸動脈粥樣硬化的臨床隨機對照試驗(RCT),使用RevMan 5.4軟件進行Meta分析。結(jié)果 共納入16項RCTs,總病例數(shù)1 654例,治療組832例、對照組822例。Meta分析結(jié)果顯示:在阿托伐他汀治療基礎(chǔ)上加用通心絡(luò)膠囊能降低總膽固醇(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]、低密度脂蛋白膽固醇(LDL-C)[MD=-0.38,95%CI(-0.56,-0.20),P＜0.000 1]和提高高密度脂蛋白膽固醇(HDL-C)水平[MD=0.22,95%CI(0.06,0.38),P=0.008],降低頸動脈內(nèi)膜中層厚度(IMT)[MD=-0.21,95%CI(-0.27,-0.15),P＜0.000 01]和斑塊Crouse積分[MD=-1.05,95%CI (-1.29,-0.80),P＜0.000 01],降低超敏C反應(yīng)蛋白(hs-CRP)[MD=-0.44,95%CI(-0.57,-0.31),P＜0.000 01]和白細胞介素-6(IL-6)水平[MD=-3.96,95%CI(-6.25,-1.66),P=0.000 7],差異均有統(tǒng)計學(xué)意義。兩組不良反應(yīng)發(fā)生率[OR=1.48,95%CI(0.78,2.82),P=0.23]比較,差異無統(tǒng)計學(xué)意義。結(jié)論 通心絡(luò)膠囊聯(lián)合阿托伐他汀治療頸動脈粥樣硬化能改善血脂水平與炎癥反應(yīng)、減輕動脈粥樣硬化程度,療效和安全性均較好,建議臨床進一步推廣使用。

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

國家自然科學(xué)基金資助項目(81573900); 中央高校基本科研業(yè)務(wù)費專項資金項目(2022-JYB-XJSJJ-073); 北京中醫(yī)藥大學(xué)新奧獎勵基金項目(2019-XAJLJJ-019)