Hou Liyan, Yang Jingjing, Zhang Xuan, Li Na, Li Sheng, Zhang Lei, Zhao Jie, Wang Qingshan
Dalian Medical University Library, Dalian Medical University, Dalian, China.
Department of Neurology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.
Front Pharmacol. 2023 Mar 28;14:1139514. doi: 10.3389/fphar.2023.1139514. eCollection 2023.
The aim of this study was to systematically review the efficacy and tolerability of perampanel (PER) when used as add-on treatment or monotherapy in patients with epilepsy aged 12 years and older in routine clinical practice. Electronic and clinical trials databases were searched for observational studies of PER published up to 1 March 2022. The outcomes of interest were responder rates, adverse effects (AEs), and withdrawal rates. Subgroup analyses were performed to explore the potential factors that might affect the efficacy and safety of PER usage. A total of 56 studies, which included 10,688 patients, were enrolled. The results showed that after 3, 6, and 12 months of PER treatment, the pooled 50% responder rates in patients with epilepsy were 50.0% (95% CI: 0.41-0.60), 44.0% (95% CI: 0.38-0.50), and 39.0% (95% CI: 0.31-0.48), respectively, and the pooled seizure-free rates were 24.0% (95% CI: 0.17-0.32), 21.0% (95% CI: 0.17-0.25), and 20.0% (95% CI: 0.16-0.24), respectively. Subgroup analyses revealed that the efficacy of PER could be affected by the way in which PER is administrated. Patients in the groups where PER was used as the first add-on, primary monotherapy, or combined with non-enzyme-inducing AEDs (non-EIAEDs) displayed a high 50% responder rate and seizure-free rate when compared with those in the late add-on, conversion therapy, or combined with the EIAEDs groups, respectively. Furthermore, the incidences of AEs at 3, 6, and 12 months of PER treatment were 46% (95% CI: 0.38-0.55), 52.0% (95% CI: 0.43-0.60), and 46.0% (95% CI: 0.40-0.52), respectively. The withdrawal rates due to AEs were 8.0% (95% CI: 0.06-0.11), 16.0% (95% CI: 0.13-0.20), and 16% (95% CI: 0.11-0.21) at 3, 6, and 12 months of PER treatment, respectively. Subgroup analyses showed a higher withdrawal rate in the rapid (30%, 95% CI: 0.22-0.38) than in the slow (12%, 95% CI: 0.06-0.18) titration group. Altogether, PER was effective and could be fairly tolerated in both short-term and long-term usage in patients with epilepsy in routine clinical practice. Furthermore, PER appeared to be more effective when PER was used as the first add-on, monotherapy, or concomitant with non-EIAEDs. : https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022384532.
本研究旨在系统评价在常规临床实践中，吡仑帕奈（PER）作为12岁及以上癫痫患者的附加治疗或单药治疗时的疗效和耐受性。检索电子数据库和临床试验数据库，查找截至2022年3月1日发表的关于PER的观察性研究。感兴趣的结局指标为缓解率、不良反应（AE）和撤药率。进行亚组分析以探索可能影响PER使用疗效和安全性的潜在因素。共纳入56项研究，涉及10,688例患者。结果显示，在接受PER治疗3、6和12个月后，癫痫患者的合并50%缓解率分别为50.0%（95%CI：0.41 - 0.60）、44.0%（95%CI：0.38 - 0.50）和39.0%（95%CI：0.31 - 0.48），合并无癫痫发作率分别为24.0%（95%CI：0.17 - 0.32）、21.0%（95%CI：0.17 - 0.25）和20.0%（95%CI：0.16 - 0.24）。亚组分析显示，PER的疗效可能受给药方式影响。与后期附加治疗、转换治疗或与酶诱导抗癫痫药物（EIAEDs）联合治疗组相比，PER作为首次附加治疗、一线单药治疗或与非酶诱导抗癫痫药物（non - EIAEDs）联合治疗组的患者50%缓解率和无癫痫发作率更高。此外，在PER治疗3、6和12个月时，AE的发生率分别为46%（95%CI：0.38 - 0.55）、52.0%（95%CI：0.43 - 0.60）和46.0%（95%CI：0.40 - 0.52）。在PER治疗3、6和12个月时，因AE导致的撤药率分别为8.0%（95%CI：0.06 - 0.11）、16.0%（95%CI：0.13 - 0.20）和16%（95%CI：0.11 - 0.21）。亚组分析显示，快速滴定组（30%，95%CI：0.22 - 0.38）的撤药率高于缓慢滴定组（12%，95%CI：0.06 - 0.18）。总之，在常规临床实践中，PER对癫痫患者的短期和长期使用均有效且耐受性良好。此外，当PER作为首次附加治疗、单药治疗或与non - EIAEDs联合使用时，似乎更有效。: https://www.crd.york.ac.uk/PROSPERO/，标识符CRD42022384532
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