Department of Infectious Diseases, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China.
J Tradit Chin Med. 2023 Apr;43(2):221-230. doi: 10.19852/j.cnki.jtcm.20221108.005.
To systematically evaluate the effectiveness of Fuzheng Huayu preparation (/, FZHY) plus tenofovir disoproxil fumarate (TDF) on hepatitis B.
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.
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.
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.
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。
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。
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。
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。