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五种中成药治疗非酒精性脂肪性肝病的疗效比较:系统评价和贝叶斯网状 Meta 分析。

Comparative effectiveness of five Chinese patent medicines for non-alcoholic fatty liver disease: A systematic review and Bayesian network meta-analysis.

机构信息

Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China.

Department of Clinical Chinese Pharmacy, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China.

出版信息

Phytomedicine. 2024 Dec;135:156124. doi: 10.1016/j.phymed.2024.156124. Epub 2024 Oct 5.

DOI:10.1016/j.phymed.2024.156124
PMID:39388923
Abstract

BACKGROUND

Non-alcoholic fatty liver disease (NAFLD) is a metabolically stressed liver injury closely related to insulin resistance and genetic susceptibility and has become the leading chronic liver disease in China.

PURPOSE

To analyze the effectiveness of five Chinese patent medicines used alone or in combination with western medications (WM) for NAFLD using Bayesian network meta-analysis.

METHODS

Searches were conducted in Embase, Cochrane Library, PubMed, CNKI, Wanfang Database, VIP, and SinoMed for randomized controlled trials (RCTs) on Danning tablets, Huazhi Rougan granules, Dangfei Liganning capsules, Kezhi capsules, and Qianggan capsules, either alone or in combination with WM for NAFLD, up to January 10, 2024. This study was screened based on pre-designed inclusion and exclusion criteria, and the risk of bias was evaluated using the Cochrane ROB2 tool. The primary outcome was clinical efficacy rate, while secondary outcomes included levels of Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Triglycerides (TG), and Low-density lipoprotein cholesterol (LDL-C). These data will be analyzed using WinBUGS 1.4.3 and then visualized using Stata 14.0 software.

RESULTS

A total of 77 RCTs involving 7770 patients were included. The results indicated that Huazhi Rougan granules combined with WM (OR = 0.13, 95 % CI 0.05 ∼ 0.26) had a SUCRA probability value of 81.7 %, ranked first in clinical efficacy and significantly improved blood lipids levels including TG, High-density Lipoprotein Cholesterol (HDL-C), and LDL-C, Total cholesterol (TC). For the Chinese patent medicines alone, Danning tablets led with a 75.3 % clinical efficacy rate. Huazhi Rougan granules significantly increased levels of ALT (96.2 %) and AST (MD = -14.48, 95 % CI -23.38 ∼ -5.32). Dangfei Liganning capsules demonstrated significant efficacy in improving TG (73.1 %) and TC (83 %) levels.

CONCLUSION

In the treatment of NAFLD, the combination of Huazhi Rougan granules and WM demonstrated significant clinical effectiveness and improvement in blood lipid profiles. For different outcome indicators, Danning tablets used alone showed the highest clinical efficacy, while significant improvement in liver function indicators was best achieved with Huazhi Rugan granules used alone.

摘要

背景

非酒精性脂肪性肝病(NAFLD)是一种与胰岛素抵抗和遗传易感性密切相关的代谢应激性肝损伤,已成为中国主要的慢性肝病。

目的

采用贝叶斯网络荟萃分析比较单独使用或联合西药(WM)治疗非酒精性脂肪性肝病的 5 种中药的疗效。

方法

计算机检索 Embase、Cochrane 图书馆、PubMed、中国知网、万方数据库、维普数据库和中国生物医学文献数据库,检索时间截至 2024 年 1 月 10 日,收集丹宁片、化脂柔肝颗粒、当归六黄宁胶囊、壳脂胶囊和强肝胶囊单独或联合 WM 治疗非酒精性脂肪性肝病的随机对照试验(RCT)。根据预先设计的纳入和排除标准进行筛选,并使用 Cochrane ROB2 工具评价偏倚风险。主要结局为临床疗效率,次要结局包括丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、三酰甘油(TG)和低密度脂蛋白胆固醇(LDL-C)水平。采用 WinBUGS 1.4.3 分析数据,然后使用 Stata 14.0 软件进行可视化。

结果

共纳入 77 项 RCT,涉及 7770 例患者。结果表明,化脂柔肝颗粒联合 WM(OR=0.13,95%CI 0.050.26)的 SUCRA 概率值为 81.7%,在临床疗效方面排名第一,显著改善了 TG、高密度脂蛋白胆固醇(HDL-C)和 LDL-C、总胆固醇(TC)等血脂水平。对于单独使用的中药,丹宁片的临床疗效率为 75.3%。化脂柔肝颗粒可显著升高 ALT(96.2%)和 AST(MD=-14.48,95%CI-23.38-5.32)水平。当归六黄宁胶囊在改善 TG(73.1%)和 TC(83%)水平方面具有显著疗效。

结论

在治疗非酒精性脂肪性肝病时,化脂柔肝颗粒联合 WM 具有显著的临床疗效和改善血脂谱的作用。对于不同的结局指标,丹宁片单独使用的临床疗效最高,而单独使用化脂柔肝颗粒可显著改善肝功能指标。

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