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 Shenzhen 518000, China.
People's Hospital of Yantian District Shenzhen 518085, China.
Zhongguo Zhong Yao Za Zhi. 2020 Jun;45(12):2966-2974. doi: 10.19540/j.cnki.cjcmm.20200211.502.
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.
系统评价脂必泰胶囊联合化学药物与单纯化学药物相比,在冠心病患者血脂调节中的疗效和安全性,为临床治疗提供循证参考。本研究检索了PubMed、EMbase、Cochrane图书馆、中国知网数据库(CNKI)、维普期刊数据库(VIP)和万方数据库(万方),以查找关于脂必泰胶囊联合他汀类药物(试验组)与单纯他汀类药物(对照组)治疗冠心病患者血脂调节疗效的随机对照试验(RCT)。检索时间限制为从建库至2019年10月。从随机对照试验中提取数据。采用Cochrane 5.1.0质量评价工具(血脂水平、炎症指标、中医证候评分及不良反应)进行质量评价后,使用RevMan 5.3统计软件进行Meta分析。共纳入11项RCT,涉及1538例患者。Meta分析结果显示,在降低总胆固醇方面(MD=-0.15,95%CI[-0.25,-0.05],P=0.004)、改善甘油三酯方面(MD=-0.16,95%CI[-0.23,-0.10],P<0.000 01)、降低低密度脂蛋白方面(MD=-0.08,95%CI[-0.15,-0.01],P=0.03)以及升高高密度脂蛋白方面(MD=0.06,95%CI[0.03,0.10],P=0.000 2),试验组均优于对照组。同时,试验组不良反应发生率较低(OR=0.40,95%CI[0.18,0.85],P=0.02)。结果表明,在冠心病治疗中,脂必泰胶囊联合他汀类药物在降低总胆固醇水平、甘油三酯水平、低密度脂蛋白水平及升高高密度脂蛋白水平方面的疗效优于单纯他汀类药物。试验组患者不良事件发生率较低,但异质性略高,结果稳定性较差。然而,由于纳入研究的样本量较小,部分试验设计不够完善,降低了本系统评价的推荐级别和证据强度。因此,需要高质量的多中心、大样本、随机、双盲随机对照试验以提供更可靠的依据。