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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:随机对照试验的网状Meta分析

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

作者信息

Shi Zeyang, Zheng Wei, Bu Zhijun, Zhou Xian, Wang Xuefeng, Song Yike, Sun Jialin, Liu Jian-Ping, Liu Zhao-Lan

机构信息

Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.

Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

出版信息

Front Endocrinol (Lausanne). 2025 Mar 24;16:1523553. doi: 10.3389/fendo.2025.1523553. eCollection 2025.

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.

摘要

背景

随机对照试验(RCT)表明,中成药与阿托伐他汀联合使用在治疗高脂血症方面疗效更佳,且不良反应减少。然而,关于其临床有效性和安全性的证据尚未得到评估,无法在临床实践中做出明智的决策。

目的

评估中成药与阿托伐他汀联合使用的临床有效性和安全性。

方法

检索8个数据库(中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase、Web of Science和Cochrane图书馆),检索时间从建库至2024年4月。使用Cochrane手册推荐的ROB 2.0工具评估纳入RCT的偏倚风险。使用累积排序曲线下面积(SUCRA)概率值对治疗措施进行排序,并使用网络Meta分析置信度(CINeMA)软件评估证据等级。

结果

共纳入23项涉及2184例高脂血症患者的RCT。和丹(片剂或胶囊)联合阿托伐他汀显示出最高的临床有效性,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%),而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,需要注意的是,根据ROB 2.0,大多数纳入研究在偏倚风险方面显示出“一些担忧”。根据CINeMA,大多数置信度评级结果被归类为“低”。

结论

与单独使用阿托伐他汀相比,中成药与阿托伐他汀联合使用在治疗高脂血症方面显示出更好的疗效。其中,和丹(片剂或胶囊)总体获益最大,显著降低TG和LDL-C水平。丹田降脂颗粒在降低TC方面效果最显著,而血脂康在提高HDL-C水平方面最有效。尽管血脂康作为降脂药物已有充分的文献记载,但本研究结果表明,高脂血症治疗应根据个体血脂情况进行调整。此外,对于疗效和安全性证据有限的药物,需要进行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。

系统评价注册

https://www.crd.york.ac.uk/prospero/,标识符CRD42024573421。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50c1/11973096/2ab089dda64d/fendo-16-1523553-g001.jpg

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