关于血脂异常:随机对照试验的系统评价
for dyslipidemia: A systematic review of randomized controlled trials.
作者信息
Dai Ning, Zhao Fang-Fang, Fang Min, Pu Feng-Lan, Kong Ling-Yao, Liu Jian-Ping
机构信息
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
出版信息
Front Pharmacol. 2022 Aug 26;13:917521. doi: 10.3389/fphar.2022.917521. eCollection 2022.
To evaluate the lipid-lowering effect and safety of (GP) used alone or as adjunctive therapy for dyslipidemia. Eight databases and three clinical trial registries were searched until January 2022. Randomized controlled trials (RCTs) assessing the effectiveness of GP for dyslipidemia were included. Trial quality was assessed using the Cochrane Risk of Bias Tool 2.0. Data were analyzed by RevMan 5.4 with effects estimated as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). Twenty-two RCTs involving 2,407 dyslipidemia participants were included. Regarding the risk of bias, 14 RCTs had some concerns, seven RCTs were high, and one trial was low. GP was comparable to n-3 fatty acids (RR 0.89, 95% CI 0.62-1.28) and red yeast rice (RR 0.33, 95% CI 0.1-1.12) on normalization of serum lipids. GP plus n-3 fatty acid was superior in normalization of triglycerides (TG) and total cholesterol (TC) than n-3 fatty acids (RR 1.34, 95% CI 1.01-1.77). GP was similar to lipid-lowering agents (statins, fibrates, and n-3 fatty acids) in regulating TG, TC, and high-density lipoprotein cholesterol (HDL-C). GP plus lipid-lowering agents were superior to lipid-lowering agents in TG (MD -0.65 mmol/L, 95% CI -1.03 to -0.28), LDL-C (MD -0.57 mmol/L, 95% CI -1.07 to -0.08), and HDL-C (MD 0.15 mmol/L, 95% CI 0.11-0.20). GP was inferior to red yeast rice in TC (MD 0.64 mmol/L, 95% CI 0.15-1.13), TG (MD 0.43 mmol/L, 95% CI 0.15-0.71), and HDL-C (MD -0.25 mmol/L, 95% CI -0.47 to -0.04). GP had fewer adverse events than lipid-lowering drugs. Very low certainty evidence showed that GP's effects on TC, TG, and HDL-C were comparable to that of lipid-lowering agents. Low certainty evidence showed that red yeast rice was superior to GP in TC, TG, and HDL-C. Low to moderate certainty evidence showed that the effects of GP plus lipid-lowering agents were superior to that of lipid-lowering agents on TG, LDL-C, and HDL-C. GP use for more than 8 weeks appears safe. https://inplasy.com/, identifier INPLASY202210135.
评估单独使用或作为血脂异常辅助治疗的(某种物质,原文未明确写出全称,暂用GP代替)的降脂效果和安全性。检索了八个数据库和三个临床试验注册库,检索截至2022年1月。纳入评估GP治疗血脂异常有效性的随机对照试验(RCT)。使用Cochrane偏倚风险工具2.0评估试验质量。采用RevMan 5.4分析数据,效应估计为风险比(RR)或均值差(MD),并给出95%置信区间(CI)。纳入了22项涉及2407名血脂异常参与者的RCT。关于偏倚风险,14项RCT存在一些问题,7项RCT风险较高,1项试验风险较低。在血脂正常化方面,GP与n-3脂肪酸(RR 0.89,95% CI 0.62 - 1.28)和红曲米(RR 0.33,95% CI 0.1 - 1.12)相当。GP加n-3脂肪酸在甘油三酯(TG)和总胆固醇(TC)正常化方面优于n-3脂肪酸(RR 1.34,95% CI 1.01 - 1.77)。在调节TG、TC和高密度脂蛋白胆固醇(HDL-C)方面,GP与降脂药物(他汀类、贝特类和n-3脂肪酸)相似。GP加降脂药物在TG(MD -0.65 mmol/L,95% CI -1.03至 -0.28)、低密度脂蛋白胆固醇(LDL-C)(MD -0.57 mmol/L,95% CI -1.07至 -0.08)和HDL-C(MD 0.15 mmol/L,95% CI 0.11 - 0.20)方面优于降脂药物。在TC(MD 0.64 mmol/L,95% CI 0.15 - 1.13)、TG(MD 0.43 mmol/L,95% CI 0.15 - 0.71)和HDL-C(MD -0.25 mmol/L,95% CI -0.47至 -0.04)方面,GP不如红曲米。GP的不良事件比降脂药物少。极低确定性证据表明,GP对TC、TG和HDL-C的影响与降脂药物相当。低确定性证据表明,红曲米在TC、TG和HDL-C方面优于GP。低至中度确定性证据表明,GP加降脂药物在TG、LDL-C和HDL-C方面的效果优于降脂药物。使用GP超过8周似乎是安全的。https://inplasy.com/,标识符INPLASY202210135 。