Effectiveness and safety of eleven Chinese patent medicines combined with atorvastatin in the treatment of hyperlipidemia: a network meta-analysis of randomized controlled trials.

IF 3.9 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Frontiers in Endocrinology Pub Date : 2025-03-24 eCollection Date: 2025-01-01 DOI:10.3389/fendo.2025.1523553
Zeyang Shi, Wei Zheng, Zhijun Bu, Xian Zhou, Xuefeng Wang, Yike Song, Jialin Sun, Jian-Ping Liu, Zhao-Lan Liu
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引用次数: 0

Abstract

Background: Randomized controlled trials (RCTs) suggested that combining Chinese patent medicines with atorvastatin exhibited superior effectiveness in treating hyperlipidemia with reduced adverse reactions. However, the evidence regarding the clinical effectiveness and safety was not assessed to make informed decision in clinical practice.

Objective: To evaluate the clinical effectiveness and safety of combined Chinese patent medicines with atorvastatin.

Methods: Eight databases (CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, Web of Science, and Cochrane Library) were searched from inception to April 2024. The risk of bias (ROB) of the included RCTs was assessed using the ROB 2.0 tool recommended by the Cochrane Handbook. The surface under the cumulative ranking curve (SUCRA) probability values were used to rank the treatment measures, and the Confidence in Network Meta-Analysis (CINeMA) software was used to assess the grading of evidence.

Results: A total of 23 RCTs involving 2184 patients with hyperlipidemia were included. Hedan (tablets or capsules) combined with atorvastatin showed the highest clinical effectiveness with an RR of 1.58 (95% CI: [1.14, 2.12]) (SUCRA: 80.36%), the lowest post-treatment low-density lipoprotein cholesterol (LDL-C) level with an MD of -8.13(95% CI: [-9.70, -6.57]) (SUCRA: 3.37%), and the lowest post-treatment triglyceride (TG) level with an MD of -6.43(95% CI: [-7.71, -5.16]) (SUCRA: 0.33%). Dantian Jiangzhi Granules demonstrated the lowest post-treatment total cholesterol (TC) level with an MD of -2.22(95% CI: [-2.60, -1.83]) (SUCRA: 12.6%), while Xuezhikang Capsules displayed the highest post-treatment high-density lipoprotein cholesterol (HDL-C) level with an MD of 1.61(95% CI: [0.82, 2.39]) (SUCRA: 79.87%). However, it is important to note that most of the included studies showed "some concerns" regarding the risk of bias based on ROB 2.0. According to CINeMA, most confidence rating results were classified as "low".

Conclusion: Compared to atorvastatin alone, the combination of Chinese patent medicines with atorvastatin demonstrated superior effectiveness in treating hyperlipidemia. Among these, Hedan (tablets or capsules) exhibited the greatest overall benefit, significantly reducing TG and LDL-C levels. Dantian Jiangzhi Granules had the most pronounced effect in lowering TC, while Xuezhikang was most effective in improving HDL-C level. Although Xuezhikang is well-documented as lipid-lowering agent, the findings of this study suggest that hyperlipidemia treatment should be tailored to individual blood lipid profiles. Additionally, for drugs with limited evidence of efficacy and safety, larger randomized controlled trials and further pharmacological studies are necessary to valid these results.

Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42024573421.

11种中成药联合阿托伐他汀治疗高脂血症的有效性和安全性:随机对照试验的网络荟萃分析。
背景:随机对照试验(RCTs)提示中成药联合阿托伐他汀治疗高脂血症疗效显著,不良反应减少。然而,关于临床有效性和安全性的证据尚未进行评估,无法在临床实践中做出明智的决定。目的:评价中成药联合阿托伐他汀的临床疗效和安全性。方法:检索中国知网(CNKI)、万方、维普、中国医学信息网(SinoMed)、PubMed、Embase、Web of Science、Cochrane Library等8个数据库,检索时间为建库至2024年4月。纳入的随机对照试验的偏倚风险(ROB)采用Cochrane手册推荐的ROB 2.0工具进行评估。采用累积排序曲线下曲面(SUCRA)概率值对治疗措施进行排序,采用网络meta分析(CINeMA)软件评价证据的分级。结果:共纳入23项随机对照试验,涉及2184例高脂血症患者。和丹(片剂或胶囊)联合阿托伐他汀的临床疗效最高,RR为1.58 (95% CI: [1.14, 2.12]) (SUCRA: 80.36%),治疗后低密度脂蛋白胆固醇(LDL-C)水平最低,MD为-8.13(95% CI: [-9.70, -6.57]) (SUCRA: 3.37%),治疗后甘油三酯(TG)水平最低,MD为-6.43(95% CI: [-7.71, -5.16]) (SUCRA: 0.33%)。丹田降脂颗粒治疗后总胆固醇(TC)水平最低,MD为-2.22(95% CI: [-2.60, -1.83]) (SUCRA: 12.6%),血脂康胶囊治疗后高密度脂蛋白胆固醇(HDL-C)水平最高,MD为1.61(95% CI: [0.82, 2.39]) (SUCRA: 79.87%)。然而,值得注意的是,大多数纳入的研究都显示了对基于ROB 2.0的偏倚风险的“一些担忧”。根据CINeMA,大多数信心评级结果被归类为“低”。结论:中成药联合阿托伐他汀治疗高脂血症的疗效优于单用阿托伐他汀。其中,和丹(片剂或胶囊)表现出最大的总体效益,显著降低TG和LDL-C水平。丹田降脂颗粒降低TC的效果最显著,血脂康提高HDL-C的效果最显著。虽然血脂康作为降脂剂有充分的文献记载,但本研究的结果表明,高脂血症的治疗应根据个人的血脂状况量身定制。此外,对于有效性和安全性证据有限的药物,需要更大规模的随机对照试验和进一步的药理学研究来验证这些结果。系统综述注册:https://www.crd.york.ac.uk/prospero/,标识符CRD42024573421。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Frontiers in Endocrinology
Frontiers in Endocrinology Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
5.70
自引率
9.60%
发文量
3023
审稿时长
14 weeks
期刊介绍: Frontiers in Endocrinology is a field journal of the "Frontiers in" journal series. In today’s world, endocrinology is becoming increasingly important as it underlies many of the challenges societies face - from obesity and diabetes to reproduction, population control and aging. Endocrinology covers a broad field from basic molecular and cellular communication through to clinical care and some of the most crucial public health issues. The journal, thus, welcomes outstanding contributions in any domain of endocrinology. Frontiers in Endocrinology publishes articles on the most outstanding discoveries across a wide research spectrum of Endocrinology. The mission of Frontiers in Endocrinology is to bring all relevant Endocrinology areas together on a single platform.
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