依折麦布/辛伐他汀（10/10毫克）与高剂量他汀类药物治疗血脂异常患者的疗效比较：一项随机对照试验的荟萃分析

Efficacy of Ezetimibe/Simvastatin (10/10 mg) versus High Dose Statin in Dyslipidemia Patients: A Meta-Analysis of Randomized Controlled Trials.

作者信息

Yang Gaoming, Han Dengfeng, Ma Jianhua, Zhang Xiaoning

机构信息

Department of Neurology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, China.

Department of Neurology, Second Affiliated Hospital of Chengdu Medical College (China National Nuclear Corporation 416 Hospital), Chengdu, 610000, China.

出版信息

Iran J Public Health. 2019 Aug;48(8):1405-1417.

PMID:32292723

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7145912/

Abstract

BACKGROUND

The monotherapies of statin and ezetimibe had not successfully achieved their objectives in the management of lipid levels of dyslipidemia patients. We aimed to compare the effects of combined low-dose simvastatin and ezetimibe versus high-dose statin on the lipid-lowering treatment of dyslipidemia patients.

METHODS

We searched five databases published before May 2018, namely PubMed, EMBASE, Cochrane, Web of Science, and Clinicaltrials.gov. Completely published randomized controlled trials (RCTs) comparing the effect of high-dose statin (S) with ezetimibe/simvastatin (10/10 mg; E/S) on the management of dyslipidemia patients were included.

RESULTS

A total of ten RCTs met the inclusion criteria, including 1,624 patients (E/S:691, S:933). Six outcomes underwent pooled analysis, including weighted mean difference (WMD) from baseline in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), high sensitivity C-reactive protein (hs-CRP), triglyceride (TG), and non-high-density lipoprotein cholesterol (non-HDL-C). No significant gap was found between high-dose statin and ezetimibe/simvastatin (10/10 mg) in LDL-C (-1.55; 95% confidence interval [CI]: -4.42∼1.31, =0 .29), HDL-C (1.05; 95%CI: -0.21∼2.3, P=0 .1), TG (4.03; 95%CI: -4.53∼12.58, =0.36), and hs-CRP (0.14; 95%CI: -0.50∼0.78, =0.67). However, there was significant difference found between the two lipid-lowering treatments in TC (-0.45; 95%CI: -9.07∼-0.83, P=0.02) and non-HDL-C (-4.97; 95%CI -8.46∼-1.49, =0.005).

CONCLUSION

Ezetimibe co-administered with simvastatin (10 mg) and high-dose statin monotherapy may show similar effects in reducing LDL-C, TG, and hs-CRP levels and in increasing HDL-C levels. However, the results suggest that there was greater TC and non-HDL-C lowering through high-dose statin monotherapy as compared with ezetimibe/simvastatin co-administration.

摘要

背景

他汀类药物和依折麦布单药治疗在血脂异常患者血脂管理中未成功实现目标。我们旨在比较低剂量辛伐他汀与依折麦布联合用药与高剂量他汀类药物对血脂异常患者降脂治疗的效果。

方法

我们检索了2018年5月之前发表的五个数据库，即PubMed、EMBASE、Cochrane、科学网和Clinicaltrials.gov。纳入了比较高剂量他汀类药物（S）与依折麦布/辛伐他汀（10/10毫克；E/S）对血脂异常患者治疗效果的完全发表的随机对照试验（RCT）。

结果

共有10项RCT符合纳入标准，包括1624例患者（E/S组691例，S组933例）。对六项指标进行了汇总分析，包括总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、高敏C反应蛋白（hs-CRP）、甘油三酯（TG）和非高密度脂蛋白胆固醇（non-HDL-C）相对于基线的加权平均差（WMD）。高剂量他汀类药物与依折麦布/辛伐他汀（10/10毫克）在降低LDL-C（-1.55；95%置信区间[CI]：-4.42至1.31，P=0.29）、HDL-C（1.05；95%CI：-0.21至2.3，P=0.1）、TG（4.03；95%CI：-4.53至12.58，P=0.36）和hs-CRP（0.14；95%CI：-0.50至0.78，P=0.67）方面未发现显著差异。然而，两种降脂治疗在TC（-0.45；95%CI：-