Biso Letizia, Spini Andrea, Petragnano Francesco, Maggio Roberto, Scarselli Marco, Carli Marco
Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
Curr Neuropharmacol. 2025;23(5):579-593. doi: 10.2174/1570159X22666240902100058.
Worldwide, three million deaths each year are reported due to the harmful use of alcohol. To date, only a few drugs have been approved for the treatment of Alcohol Use Disorder (AUD). This systematic review and meta-analysis aim to assess the long-term efficacy and safety of sodium oxybate (SMO) treatment in patients with AUD.
We followed the PRISMA statement guidelines and searched PubMed and ISI Web of Science to retrieve the studies of interest. In total, 13 studies on long-term (>12 weeks) SMO administration in patients with AUD were included in this systematic review, and 7 were included in the metaanalysis.
Overall, the abstinence rate after 12 weeks of treatment was similar in the SMO and placebo groups, while it was significantly in favour of SMO compared to Naltrexone (NTX). The completion rate was similar in all three conditions. Mean corpuscular volume (MCV) levels favoured SMO over NTX, while Alcohol Craving Scale (ACS) scores did not favour SMO. The incidence of adverse reactions varied widely between studies.
SMO in the chronic treatment of patients with AUD showed no superiority to placebo in our analysis of published RCTs, although many observational studies reported its beneficial effect in the long term. On the contrary, SMO was superior to NTX treatment on abstinence. The rate of study completion was similar in the three groups. Safety was not an issue in any of the studies included. Further studies are needed to better assess SMO efficacy and safety in the long term.
据报道，全球每年有300万人死于酒精的有害使用。迄今为止，仅有少数药物被批准用于治疗酒精使用障碍（AUD）。本系统评价和荟萃分析旨在评估γ-羟基丁酸钠（SMO）治疗AUD患者的长期疗效和安全性。
我们遵循PRISMA声明指南，检索了PubMed和ISI科学网以获取相关研究。本系统评价共纳入了13项关于对AUD患者进行长期（>12周）SMO给药的研究，荟萃分析纳入了7项研究。
总体而言，治疗12周后，SMO组和安慰剂组的戒酒率相似，而与纳曲酮（NTX）相比，SMO组的戒酒率明显更高。三种情况下的完成率相似。平均红细胞体积（MCV）水平显示SMO组优于NTX组，而酒精渴望量表（ACS）评分则不支持SMO组。各研究之间不良反应的发生率差异很大。
在我们对已发表的随机对照试验的分析中，SMO在AUD患者的长期治疗中并不比安慰剂更具优势，尽管许多观察性研究报告了其长期有益效果。相反，在戒酒方面，SMO优于NTX治疗。三组的研究完成率相似。纳入的任何一项研究中安全性都不是问题。需要进一步研究以更好地评估SMO的长期疗效和安全性。
