目的 评估吡仑帕奈添加治疗≥12岁局灶性癫痫患者的有效性、耐受性及安全性。 方法 回顾性选择自2020年7月至2022年12月于广西医科大学第一附属医院神经内科接受吡仑帕奈添加治疗的119例≥12岁青少年及成人局灶性癫痫患者为研究对象，分别采集添加治疗第1~3个月、4~6个月、7~9个月和10~12个月阶段中患者每28天的癫痫发作频率、坚持用药情况及不良反应发生情况等，以评估吡仑帕奈添加治疗的有效性（癫痫发作频率较基线减少≥50%为总有效）、耐受性及安全性，同时依据吡仑帕奈添加治疗第4~6个月（短期）和10~12个月（长期）的有效性结果，将患者分为有效组与无效组，分析影响吡仑帕奈添加治疗短期及长期有效性的相关因素。 结果 吡仑帕奈添加治疗第1~3个月、4~6个月、7~9个月、10~12个月阶段中，患者每28天的癫痫发作频率较基线降低百分比分别为66.7%（24.3%，97.2%）、77.5%（48.6%，100.0%）、94.6%（50.0%，100.0%）、100.0%（70.9%，100.0%），总有效率分别为60.2%（59/98）、75.0%（57/76）、78.9%（45/57）、86.5%（32/37）。吡仑帕奈添加治疗第3、6、9和12个月末时，患者保留率分别为85.2%（98/115）、67.9%（76/112）、54.3%（57/105）、41.1%（37/90）。吡仑帕奈添加治疗期间，共有33例（27.7%）患者出现不良反应，主要症状为头晕，其次为精神症状。吡仑帕奈添加治疗第4~6个月和10~12个月阶段中，有效组与无效组患者间性别、添加吡仑帕奈治疗初始年龄、病程、病因、脑电图检查结果、影像学检查结果、联合抗癫痫发作药物的数量及种类、吡仑帕奈最大服用剂量等方面的差异均无统计学意义（P>0.05）。 结论 吡仑帕奈添加治疗≥12岁青少年及成人局灶性癫痫具有良好的有效性、耐受性及安全性。目前尚未发现影响吡仑帕奈添加治疗有效性的相关因素。 Objective To evaluate the clinical efficacy, tolerability and safety of adjunctive perampanel in focal epilepsy patients≥12 years old. Methods One hundred and nineteen focal epilepsy patients≥12 years old accepted adjunctive perampanel in Department of Neurology, First Affiliated Hospital of Guangxi Medical University from July 2020 to December 2022 were chosen. At 1-3 months, 4-6 months, 7-9 months and 10-12 months after adjunctive perampanel, seizure frequency changes every 28 d, medication retention rate and adverse reactions were recorded to evaluate the clinical efficacy (a reduction in seizure frequency≥50% from baseline was defined as overall valid treatment), tolerability and safety of adjunctive perampanel. According to efficacy results after adjunctive perampanel of 4-6 months (short-term) and 10-12 months (long-term), these patients were divided into valid group and invalid group and the influencing factors for short-term and long-term efficacy were analyzed. Results At 1-3, 4-6, 7-9, 10-12 months after adjunctive perampanel, reduction in seizure frequency every 28 d was 66.7% (24.3%, 97.2%), 77.5% (48.6%, 100%), 94.6% (50%, 100%), 100% (70.9%, 100%), enjoying overall valid rate of 60.2% (59/98), 75.0% (7/76), 78.9% (45/57), 86.5% (32/37). The retention rate at 3, 6, 9 and 12 months after adjunctive perampanel was 85.2% (98/115), 67.9% (76/112), 54.3% (57/105), 41.1% (37/90). Adverse reactions were reported in 33 patents (27.7%), mainly with dizziness and secondly with mental symptoms. After short-term and long-term adjunctive perampanel, no significant difference was noted in gender, initial age of adjunctive perampanel, course of disease, etiology, EEG results, imaging results, number and type of combined anti-seizure drugs, or maximum dose of pirampanel between the valid group and invalid group (P>0.05). Conclusion Perampanel has good efficacy, tolerability and safety in adolescents and adults≥12 years old with focal epilepsy no clear influencing factors for pirampanel valid treatment is found so far.
Abstract
Objective To evaluate the clinical efficacy, tolerability and safety of adjunctive perampanel in focal epilepsy patients≥12 years old. Methods One hundred and nineteen focal epilepsy patients≥12 years old accepted adjunctive perampanel in Department of Neurology, First Affiliated Hospital of Guangxi Medical University from July 2020 to December 2022 were chosen. At 1-3 months, 4-6 months, 7-9 months and 10-12 months after adjunctive perampanel, seizure frequency changes every 28 d, medication retention rate and adverse reactions were recorded to evaluate the clinical efficacy (a reduction in seizure frequency≥50% from baseline was defined as overall valid treatment), tolerability and safety of adjunctive perampanel. According to efficacy results after adjunctive perampanel of 4-6 months (short-term) and 10-12 months (long-term), these patients were divided into valid group and invalid group and the influencing factors for short-term and long-term efficacy were analyzed. Results At 1-3, 4-6, 7-9, 10-12 months after adjunctive perampanel, reduction in seizure frequency every 28 d was 66.7% (24.3%, 97.2%), 77.5% (48.6%, 100%), 94.6% (50%, 100%), 100% (70.9%, 100%), enjoying overall valid rate of 60.2% (59/98), 75.0% (7/76), 78.9% (45/57), 86.5% (32/37). The retention rate at 3, 6, 9 and 12 months after adjunctive perampanel was 85.2% (98/115), 67.9% (76/112), 54.3% (57/105), 41.1% (37/90). Adverse reactions were reported in 33 patents (27.7%), mainly with dizziness and secondly with mental symptoms. After short-term and long-term adjunctive perampanel, no significant difference was noted in gender, initial age of adjunctive perampanel, course of disease, etiology, EEG results, imaging results, number and type of combined anti-seizure drugs, or maximum dose of pirampanel between the valid group and invalid group (P>0.05). Conclusion Perampanel has good efficacy, tolerability and safety in adolescents and adults≥12 years old with focal epilepsy no clear influencing factors for pirampanel valid treatment is found so far.
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