Zhao Yunhan, Hu Haoxiang, Mao Jiesheng, He Jianghai, Zhang Yihan, Yang Xiaokai
Postgraduate Training Base Alliance of Wenzhou Medical University (Wenzhou People's Hospital), Wenzhou, China.
Front Pharmacol. 2025 May 14;16:1569602. doi: 10.3389/fphar.2025.1569602. eCollection 2025.
Baclofen, a centrally acting muscle relaxant, is widely utilized for the management of muscle spasms and alcohol use disorders associated with conditions. However, its neurological safety and tolerability in a large population remain limited. This study aimed to assess the neurological safety and potential risks of baclofen in the real world.
Data covering the period from the first quarter of 2004 to the third quarter of 2024 were collected from the Food and Drug Administration Adverse Event Reporting System (FAERS). Four disproportionality analysis methods were employed: the Reporting Odds Ratio, the Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and the Multi-item Gamma Poisson Shrinkage (MGPS). These methods were used to detect and evaluate adverse events Adverse drug events associated with baclofen. Additionally, the time to onset analysis was conducted.
A total of 432 neurological-related preferred terms (PTs) were identified. The number of PT that were positive for all four algorithms was 40, and the top 5 PT were Hypotonia, Encephalopathy, Coma, Unresponsive to stimuli, and Cerebrospinal fluid leakage. The top 5 PTs for ROR values are Intracranial hypotension [ROR 66.24 (55.45-79.13)], Cerebrospinal fluid leakage [ROR 51.34 (45.84-57.51)], Autonomic dysreflexia [ROR 47.4 (32.27-69.63)], Basal ganglion degeneration [ROR 33.03 (18.54-58.84)], Sciatic nerve palsy [ROR 21.6 (11.14-41.87)]. The median onset time for baclofen -related ADEs was 27 days. Most cases (n = 241, 55.5%) occurred within the first month of baclofen administration. In an analysis of severe vs. non-severe ADEs, the study found that the incidence of severe cases was higher than that of non-severe cases, with no gender-related differences observed.
This study identified clinically significant PTs using four different algorithms and performed gender subgroup analysis. The TTO analysis indicated that the onset of most ADEs occurred within 27 days. Furthermore, the frequency of severe ADEs was higher than that of non-severe ones. Clinicians should closely monitor for neurological adverse effects caused by baclofen, particularly severe ADEs, and consider individualized dosing strategies. Further research based on real-world data is needed to validate these findings.
巴氯芬是一种中枢性肌肉松弛剂，广泛用于治疗肌肉痉挛以及与某些病症相关的酒精使用障碍。然而，其在大量人群中的神经安全性和耐受性仍然有限。本研究旨在评估巴氯芬在现实世界中的神经安全性和潜在风险。
从美国食品药品监督管理局不良事件报告系统（FAERS）收集了2004年第一季度至2024年第三季度的数据。采用了四种不成比例分析方法：报告比值比、比例报告比值比、贝叶斯置信传播神经网络和多项目伽马泊松收缩法（MGPS）。这些方法用于检测和评估与巴氯芬相关的药物不良事件。此外，还进行了发病时间分析。
共识别出432个与神经相关的首选术语（PTs）。所有四种算法均呈阳性的PT数量为40个，排名前5的PT分别是肌张力减退、脑病、昏迷、对刺激无反应和脑脊液漏。报告比值比（ROR）值排名前5的PT分别是颅内低压[ROR 66.24（55.45 - 79.13）]、脑脊液漏[ROR 51.34（45.84 - 57.51）]、自主神经反射异常[ROR 47.4（32.27 - 69.63）]、基底神经节变性[ROR 33.03（18.54 - 58.84）]、坐骨神经麻痹[ROR 21.6（11.14 - 41.87）]。巴氯芬相关药物不良事件的中位发病时间为27天。大多数病例（n = 241，55.5%）发生在服用巴氯芬的第一个月内。在对严重与非严重药物不良事件的分析中，研究发现严重病例的发生率高于非严重病例，未观察到与性别相关的差异。
本研究使用四种不同算法识别出具有临床意义的PTs，并进行了性别亚组分析。发病时间分析表明，大多数药物不良事件在27天内发生。此外，严重药物不良事件的发生率高于非严重事件。临床医生应密切监测巴氯芬引起的神经不良反应，尤其是严重药物不良事件，并考虑个体化给药策略。需要基于现实世界数据的进一步研究来验证这些发现。
