中国中药杂志

2020, v.45(12) 2966-2974

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脂必泰胶囊联合他汀调节冠心病患者血脂水平的Meta分析
Meta-analysis of Zhibitai Capsules combined with statin in reducing blood lipid levels in patients with coronary heart disease

黎美欢;李颖;陈铭泰;林海丹;巫燕慧;张忠;
LI Mei-huan;LI Ying;CHEN Ming-tai;LIN Hai-dan;WU Yan-hui;ZHANG Zhong;Department of Cardiovascular Disease, Shenzhen Hospital of Traditional Chinese Medicine/Forth College of Clinical Medicine, Guangzhou University of Chinese Medicine;People′s Hospital of Yantian District;

摘要(Abstract):

为系统评价脂必泰胶囊联合他汀降低冠心病血脂水平的有效性及安全性,该研究采用计算机检索PubMed,EMbase,Cochrane图书馆、中国期刊全文数据库、维普中文期刊、万方数据,全面收集脂必泰联合他汀对比单用他汀对冠心病调脂治疗的随机对照试验(RCT),检索时限均为建库至2019年10月,对符合纳入标准的临床研究进行资料提取,并采用Cochrane 5.1.0质量评价工具进行质量评价后,采用RevMan 5.3统计软件进行Meta分析(血脂水平、中医证候积分、炎症指标、不良反应等)。共纳入11项RCT,合计1 538例患者。Meta分析结果显示,试验组患者在降低总胆固醇(MD=-0.15,95%CI[-0.25,-0.05],P=0.004)、甘油三酯(MD=-0.16,95%CI[-0.23,-0.10],P<0.000 01)、低密度脂蛋白水平(MD=-0.08,95%CI[-0.15,-0.01],P=0.03),升高高低密度脂蛋白(MD=0.06,95%CI[0.03,0.10],P=0.000 2)等方面均优于对照组,且不良反应发生率低(OR=0.40,95%CI[0.18,0.85],P=0.02)。该系统评价结果提示,对比常规西医治疗,脂必泰联合他汀用于冠心病调脂在降低总胆固醇、甘油三酯、低密度脂蛋白水平,升高高密度脂蛋白水平均较好,患者不良事件发生率低,但异质性稍高,结果稳定性欠佳。
To systematically review the efficacy and safety of Zhibitai Capsules combined with chemical drugs versus chemical drugs alone in regulating blood lipid of patients of coronary heart disease, so as to provide evidence-based reference for clinical treatment. In this study, PubMed, EMbase, Cochrane Library, China Knowledge Network Database(CNKI), Technology Journal Database(VIP) and WanFang Database(WanFang) were retrieved to find the randomized controlled trials(RCT) about therapeutic efficacy of Zhibitai Capsules combined with statins(experimental group)versus statins alone(control group)in the treatment of regulating blood lipid of patients with coronary heart disease. The retrieval time was restricted to be from the inception to October 2019. The data were extracted from the randomized controlled trials. Meta-analysis was conducted by RevMan 5.3 statistical software after quality evaluation by Cochrane 5.1.0 quality evaluation tool(blood lipid level, inflammation indicators, traditional Chinese medicine syndrome score and adverse reactions). A total of 11 RCT were included, involving 1 538 patients. The results of Meta-analysis showed that in terms of decrease of total cholesterol(MD=-0.15,95%CI[-0.25,-0.05],P=0.004), decrease of triglycerides improvement(MD=-0.16,95%CI[-0.23,-0.10],P<0.000 01), decrease of low-density lipoprotein(MD=-0.08,95%CI[-0.15,-0.01],P=0.03), and increase of high-density lipoprotein(MD=0.06,95%CI[0.03,0.10],P=0.000 2), experimental group was better than control group. At the same time, the incidence of adverse reactions were low in the experimental group(OR=0.40,95%CI[0.18,0.85],P=0.02). As a result, in treatment of coronary heart disease, the therapeutic efficacy of Zhibitai Capsules combined with statins is better than statins alone in lowering total cholesterol level, triglyceride level, low-density lipoprotein level, and increasing high-density lipoprotein level. Patients in the experimental group had a low incidence of adverse events, but the heterogeneity was slightly higher, and the result had a poor stability. However, due to the small sample size of studies included, some experimental designs were not perfect, which reduces the recommendation level and evidence intensity of this system evaluation. Therefore, high-quality multi-center, large-sample, randomized, double-blind randomized controlled trials are needed for providing more reliable basis.

关键词(KeyWords): 脂必泰胶囊;他汀;冠心病;血脂水平;Meta分析;系统评价
Zhibitai Capsules;statin;coronary heart disease;blood lipid level;Meta-analysis;systematic review

Abstract:

Keywords:

基金项目(Foundation): 深圳市医疗卫生三名工程项目(SZSM201612033)

作者(Author): 黎美欢;李颖;陈铭泰;林海丹;巫燕慧;张忠;
LI Mei-huan;LI Ying;CHEN Ming-tai;LIN Hai-dan;WU Yan-hui;ZHANG Zhong;Department of Cardiovascular Disease, Shenzhen Hospital of Traditional Chinese Medicine/Forth College of Clinical Medicine, Guangzhou University of Chinese Medicine;People′s Hospital of Yantian District;

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