Zhang Ni, Jiang Tingting, Li Yanping, Guo Pei, Liu Yumeng, Zhang Yu, Liu Yao
Department of Pharmacy, The Daping Hospital of Army Medical University, Chongqing, China.
Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College, Chongqing, China.
SAGE Open Med. 2025 Apr 28;13:20503121251331812. doi: 10.1177/20503121251331812. eCollection 2025.
Baclofen is a muscle relaxant that could carry the risk for neurological adverse events (nAEs). We aim to analyze the nAE profile of frequently used baclofen for its clinical application.
Our research is a disproportional analysis based on the FDA Adverse Event Reporting System (FAERS) database. We obtained adverse event reports of baclofen from January 2004 to June 2023 from the FAERS database. Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) were performed to find nAE associated with baclofen.
We extracted a total of 9305 nAE cases with baclofen as the primary suspect. The patients were mostly under 18 years old (45.49%), with markedly more males (43.72%) than females (36.52%). In all, 7275 (78.18%) reports were from the United States. There were 2023 of 9305 (21.74%) reports that occurred serious adverse events (SAE). The median onset time of reports with baclofen-related nAE was 10 days (interquartile range (IQR) 1-112). Intrathecal injection (75.78%) was more than oral (23.06%). We detected 119 significant signals, among which the higher frequencies were somnolence (ROR: 4.69, 95% CI (4.37, 5.03); IC: 2.17, IC025 (2.06)), tremor (ROR: 2.76, 95% CI (2.50, 3.04); IC: 1.43, IC025 (1.29)), lethargy (ROR: 6.37, 95% CI (5.71, 7.10); IC: 2.61, IC025 (2.45)), status epilepticus (ROR: 8.71, 95% CI (7.07, 10.73); IC: 2.98, IC025 (2.69)), generalized tonic-clonic seizure (ROR: 3.17, 95% CI (2.54,3.95); IC: 1.62, IC025 (1.30)], and cerebrospinal fluid leakage (ROR: 229.56, 95% CI (197.76, 266.47); IC: 6.61, IC025 (6.43)]. Unexpected significant nAE might also occur, such as intracranial hypotension (ROR: 428.52, 95% CI (355.18, 517.00); IC: 6.75, IC025 (6.56)], cognitive disorder (ROR: 2.65, 95% CI (2.21, 3.19); IC: 1.38, IC025 (1.11)], anterograde amnesia (ROR: 7.35, 95% CI (2.74, 19.72); IC: 1.69, IC025 (0.90)], metabolic encephalopathy (ROR: 14.77, 95% CI (10.40, 21.00); IC: 3.55, IC025 (2.93)], and myoclonus (ROR: 5.98, 95% CI (4.70, 7.59); IC: 2.46, IC025 (2.13)].
Given the wide use of baclofen, clinicians should be well-informed about important potential nAE. Although disproportional analysis is a refinement approach, it is still necessary to be vigilant about the nAE of baclofen. It is extremely crucial to early monitoring, especially in minors and the initial stage following the commencement of use.
巴氯芬是一种肌肉松弛剂，可能存在神经学不良事件（nAEs）风险。我们旨在分析常用巴氯芬的nAE特征，以用于其临床应用。
我们的研究是基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库的不成比例分析。我们从FAERS数据库中获取了2004年1月至2023年6月期间巴氯芬的不良事件报告。采用报告比值比（ROR）和贝叶斯置信传播神经网络（BCPNN）来找出与巴氯芬相关的nAE。
我们共提取了9305例以巴氯芬为主要怀疑对象的nAE病例。患者大多为18岁以下（45.49%），男性（43.72%）明显多于女性（36.52%）。总计7275份（78.18%）报告来自美国。9305份报告中有2023份（21.74%）发生了严重不良事件（SAE）。与巴氯芬相关nAE报告的中位发病时间为10天（四分位间距（IQR）1 - 112）。鞘内注射（75.78%）多于口服（23.06%）。我们检测到119个显著信号，其中频率较高的有嗜睡（ROR：4.69，95%CI（4.37，5.03）；IC：2.17，IC025（2.06））、震颤（ROR：2.76，95%CI（2.50，3.04）；IC：1.43，IC025（1.29））、嗜睡（ROR：6.37，95%CI（5.71，7.10）；IC：2.61，IC025（2.45））、癫痫持续状态（ROR：8.71，95%CI（7.07，10.73）；IC：2.98，IC025（2.69））、全身强直阵挛性发作（ROR：3.17，95%CI（2.54，3.95）；IC：1.62，IC025（1.30））以及脑脊液漏（ROR：229.56，95%CI（197.76，266.47）；IC：6.61，IC025（6.43））。还可能出现意外的显著nAE，如颅内低压（ROR：428.52，95%CI（355.18，517.00）；IC：6.75，IC025（6.56））、认知障碍（ROR：2.65，95%CI（2.21，3.19）；IC：1.38，IC025（1.11））、顺行性遗忘（ROR：7.35，95%CI（2.74，19.72）；IC：1.69，IC025（0.90））、代谢性脑病（ROR：14.77，95%CI（10.40，21.00）；IC：3.55，IC025（2.93））以及肌阵挛（ROR：5.98，95%CI（4.⑦59）；IC：2.46，IC025（2.13））。
鉴于巴氯芬的广泛使用，临床医生应充分了解重要的潜在nAE。尽管不成比例分析是一种精细的方法，但仍有必要对巴氯芬的nAE保持警惕。早期监测极其关键，尤其是在未成年人及开始使用后的初始阶段。
