Bi Yufei, Shi Ke, Chen Jialiang, Wang Xianbo
Center of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Front Pharmacol. 2023 Mar 21;14:1159222. doi: 10.3389/fphar.2023.1159222. eCollection 2023.
To delineate the curative effect and safety of anti-fibrosis Chinese patent medicines (CPMs) combined with ursodeoxycholic acid (UDCA) for primary biliary cholangitis (PBC). A literature search was conducted using PubMed, Web of Science, Embase, Cochrane Library, Wanfang database, VIP database, China Biology Medicine Database, and Chinese National Knowledge Infrastructure from their inception until August 2022. Randomized controlled trials (RCTs) of the treatment of PBC with anti-fibrotic CPMs were collected. The eligibility of the publications was assessed using the Cochrane risk-of-bias tool. The evaluation indicators were the clinical efficacy rate, liver fibrosis, liver function, immune function, and symptom score. Meta-analysis and subgroup analysis were conducted to evaluate the effectiveness of anti-fibrosis CPMs. Risk ratio (RR) was used to assess dichotomous variables, and continuous variables with a 95% confidence interval were calculated using mean difference. Twenty-two RCTs including 1,725 patients were selected. The findings demonstrated that anti-fibrotic CPMs combined with UDCA improved the efficacy rate, liver function, liver fibrosis, immunological indicators, and clinical symptoms compared with UDCA alone (all < 0.05). This study demonstrates that the combination of anti-fibrotic CPMs and UDCA can improve both clinical symptoms and outcomes. Nevertheless, more high-quality RCTs are needed to assess the effectiveness of anti-fibrosis CPMs for PBC.
探讨抗纤维化中成药联合熊去氧胆酸（UDCA）治疗原发性胆汁性胆管炎（PBC）的疗效及安全性。使用PubMed、Web of Science、Embase、Cochrane图书馆、万方数据库、维普数据库、中国生物医学数据库和中国知网，对自建库至2022年8月的文献进行检索。收集抗纤维化中成药治疗PBC的随机对照试验（RCT）。采用Cochrane偏倚风险工具评估纳入文献的合格性。评价指标为临床有效率、肝纤维化、肝功能、免疫功能和症状评分。进行Meta分析和亚组分析以评估抗纤维化中成药的有效性。采用风险比（RR）评估二分变量，采用均数差计算95%置信区间的连续变量。共纳入22项RCT，涉及1725例患者。结果表明，与单用UDCA相比，抗纤维化中成药联合UDCA可提高有效率、改善肝功能、肝纤维化、免疫指标和临床症状（均P<0.05）。本研究表明，抗纤维化中成药与UDCA联合应用可改善临床症状和预后。然而，仍需要更多高质量的RCT来评估抗纤维化中成药治疗PBC的有效性。
