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系统评价和荟萃分析:巴氯芬治疗酒精使用障碍合并肝脏疾病患者的疗效和安全性。

Systematic review and meta-analysis: Efficacy and safety of baclofen in patients with alcohol use disorder co-morbid liver diseases.

机构信息

Division 3, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.

Division 3, Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China; Division 2, Department of Hepatology, The Fourth People's Hospital of Qinghai Province, 810000, China.

出版信息

J Psychiatr Res. 2023 Aug;164:477-484. doi: 10.1016/j.jpsychires.2023.06.042. Epub 2023 Jun 30.

DOI:10.1016/j.jpsychires.2023.06.042
PMID:37441998
Abstract

Baclofen is the only drug that has been investigated in randomized controlled studies for anti-craving in patients with alcohol use disorder (AUD) and liver disease. However, the results of its efficacy are controversial due to limited case numbers; therefore, a meta-analysis of all available studies is needed to verify efficacy and safety in this population. This systematic review and meta-analysis were conducted according to the Cochrane Collaboration Handbook (PROSPERO ID: CRD42021284439) clauses. PubMed, Embase, Medline, Cochrane, and Clinical Trials. Gov were searched for patients with AUD co-morbid liver diseases who used baclofen to maintain abstinence. The primary outcome was maintaining abstinence. Baclofen safety was evaluated by adverse reaction occurrence during treatment. A total of 322 patients with AUD co-morbid liver diseases (alcohol-related liver disease, hepatitis C, or cirrhosis) from five studies were included. The total abstinence rate was 53% (95% CI: 0.23-0.84). Specifically, the abstinence rate in patients with alcohol-related liver disease and cirrhosis was 63% and 55%, respectively. We further analyzed the two included randomized controlled studies to compare the efficacy between baclofen and a placebo. There was no significant difference in abstinence rates between baclofen and the placebo (RR: 1.42, 95% CI: 0.41-4.92). One serious adverse event was reported, and no cases of baclofen addiction were found. The abstinence rate in patients with AUD co-morbid liver diseases was 53%; however, the efficacy of baclofen for maintaining abstinence in this population still needs to be validated with further studies.

摘要

巴氯芬是唯一一种在随机对照研究中被用于治疗酒精使用障碍(AUD)合并肝病患者的渴求的药物。然而,由于病例数量有限,其疗效的结果存在争议;因此,需要对所有可用的研究进行荟萃分析,以验证该人群的疗效和安全性。这项系统评价和荟萃分析是根据 Cochrane 协作手册(PROSPERO ID:CRD42021284439)的条款进行的。检索了 PubMed、Embase、Medline、Cochrane 和 ClinicalTrials.gov 数据库,以纳入使用巴氯芬戒酒的 AUD 合并肝病患者。主要结局是维持戒酒。通过治疗期间不良反应的发生来评估巴氯芬的安全性。共有来自五项研究的 322 名 AUD 合并肝病(酒精性肝病、丙型肝炎或肝硬化)患者纳入本研究。总的戒酒率为 53%(95%CI:0.23-0.84)。具体而言,酒精性肝病和肝硬化患者的戒酒率分别为 63%和 55%。我们进一步分析了两项纳入的随机对照研究,以比较巴氯芬与安慰剂之间的疗效。巴氯芬与安慰剂的戒酒率无显著差异(RR:1.42,95%CI:0.41-4.92)。报告了 1 例严重不良事件,未发现巴氯芬成瘾病例。AUD 合并肝病患者的戒酒率为 53%;然而,巴氯芬在该人群中维持戒酒的疗效仍需要进一步研究来验证。

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