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扶正化瘀制剂(/)联合富马酸替诺福韦二吡呋酯治疗乙型肝炎:一项系统评价和 Meta 分析。

Fuzheng Huayu preparation (/) combined with tenofovir disoproxil fumarate on hepatitis B: a systematic review and Meta-analysis.

机构信息

Department of Infectious Diseases, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.

出版信息

J Tradit Chin Med. 2023 Apr;43(2):221-230. doi: 10.19852/j.cnki.jtcm.20221108.005.

Abstract

OBJECTIVE

To systematically evaluate the effectiveness of Fuzheng Huayu preparation (/, FZHY) plus tenofovir disoproxil fumarate (TDF) on hepatitis B.

METHODS

Numerous databases - PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database, WanFang Database, China Science and Technology Journal Database, and China Biological Medicine Database - were searched to identify the randomized controlled trials published from the inception of the database to November 2021. Two researchers independently conducted literature screening, data extraction, and bias risk assessment. RevMan 5.4 software was used for Meta-analysis.

RESULTS

Eight studies involving 990 patients met the inclusion criteria in the current Meta-analysis. Levels of alanine transaminase, aspartate aminotransferase, total bilirubin, hyaluronic acid, type III procollagen, laminin, and type IV collagen after combination therapy were significantly lower than those after TDF therapy alone. However, albumin levels did not differ significantly between the two regimens. Subgroup analysis based on disease progression suggested that the combination therapy improved albumin levels in patients with chronic hepatitis B but not in patients with hepatitis B-related cirrhosis. Moreover, subgroup analysis based on treatment duration suggested that the albumin levels were increased and the type III procollagen levels were decreased with the > 24-week combination therapy but not with the ≤ 24-week combination therapy.

CONCLUSIONS

A combination regimen of TDF and FZHY is more effective in treating hepatitis B than TDF alone. The combination therapy can effectively alleviate hepatic fibrosis and improve liver function. However, more standardized, high-quality studies with larger sample sizes are warranted to validate the study results.

摘要

目的

系统评价扶正化瘀制剂(FZHY)联合替诺福韦酯(TDF)治疗乙型肝炎的疗效。

方法

检索PubMed、Embase、 Cochrane 图书馆、中国知网、万方数据库、中国科技期刊数据库和中国生物医学文献数据库,搜集建库至 2021 年 11 月发表的 FZHY 联合 TDF 治疗乙型肝炎的随机对照试验。由 2 位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.4 软件进行 Meta 分析。

结果

最终纳入 8 项研究共 990 例患者。Meta 分析结果显示,联合治疗后患者的丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、透明质酸、III 型前胶原、层粘连蛋白和 IV 型胶原水平均低于 TDF 单药治疗,而白蛋白水平差异无统计学意义。基于疾病进展的亚组分析显示,联合治疗可改善慢性乙型肝炎患者的白蛋白水平,但对乙型肝炎相关性肝硬化患者的白蛋白水平无明显影响。基于治疗持续时间的亚组分析显示,联合治疗>24 周可升高白蛋白水平、降低 III 型前胶原水平,而联合治疗≤24 周则无此作用。

结论

TDF 联合 FZHY 治疗乙型肝炎的疗效优于 TDF 单药治疗,可有效缓解肝纤维化,改善肝功能。但仍需要更多设计规范、质量更高、样本量更大的研究来验证本研究结果。

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Liver Fibrosis: Therapeutic Targets and Advances in Drug Therapy.肝纤维化:治疗靶点与药物治疗进展
Front Cell Dev Biol. 2021 Sep 21;9:730176. doi: 10.3389/fcell.2021.730176. eCollection 2021.
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Advances in treatment and prevention of hepatitis B.乙型肝炎治疗与预防的进展
World J Gastrointest Pharmacol Ther. 2021 Jul 5;12(4):56-78. doi: 10.4292/wjgpt.v12.i4.56.
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The PRISMA 2020 statement: An updated guideline for reporting systematic reviews.PRISMA 2020 声明:系统评价报告的更新指南。
PLoS Med. 2021 Mar 29;18(3):e1003583. doi: 10.1371/journal.pmed.1003583. eCollection 2021 Mar.
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The effect and mechanisms of Fuzheng Huayu formula against chronic liver diseases.扶正化瘀方防治慢性肝病的作用及机制。
Biomed Pharmacother. 2019 Jun;114:108846. doi: 10.1016/j.biopha.2019.108846. Epub 2019 Apr 7.

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