为了系统地评估疗效,治疗药物难治性癫痫(DRE)的耐受性和保留性,并探讨影响疗效和保留率的独立因素。我们希望这将为临床医生提供使用PER治疗DRE患者的指南。
我们在河南省人民医院癫痫中心对接受PER作为附加治疗的DRE患者进行了一项单中心回顾性观察研究。中国,2020年3月2021年9月我们收集了这些患者的临床数据。观察期为6个月。观察终点是PER使用6个月时的药物反应和保留率。回归分析用于比较疗效和保留率的差异,分别。
获得72例DRE患者的临床数据(平均治疗持续时间:10.6个月)。6个月时,25%的患者(n=18)无癫痫发作;18.1%的患者(n=13)在添加PER后6个月保持无癫痫发作。22.2%的患者(n=16)有反应(其中一名患者因经济困难在增加PER后5个月退出)。6个月时PER的保留率为77.8%。不良反应往往以神经精神症状为主。多因素logistic回归分析显示,基线发作频率是否超过4次/月发作(OR=0.232,95CI:0.077-0.702,p=0.01)以及先前失败的ASM数量是否超过3次(OR=0.316;95CI:0.109-0.920,p=0.035)存在显着差异。这表明,基线癫痫发作频率越高,以前的ASM失败次数越多,无应答的风险就越高。因此,基线频率超过4次/月癫痫发作和3次以上以前的ASM失败是DRE患者增加PER治疗的独立影响因素.多因素COX回归显示,感染引起的DRE患者的保留率(OR=15.957,95%CI:3.692-68.972,P<0.001)低于其他非感染性病因引起的DRE患者。只有单一发作类型的DRE患者(OR=0.053,95%CI:0.006-0.476,P=0.009),和没有认知障碍的患者(OR=134.253,95%CI:5.623-3205.104,P=0.002)显示使用PER的持续时间更长。感染相关癫痫的病因,经历了多种类型的癫痫发作,认知功能障碍是DRE患者保留使用PER的独立影响因素。
我们的研究证明了PER对降低DRE患者癫痫发作频率的疗效,并发现疗效和保留率存在显着差异。分别。这为评估DRE患者使用PER的预期疗效和持续时间提供了基础。
To systematically evaluate the efficacy, tolerability and retention of perampanel (PER) for treating drug-refractory epilepsy (DRE), and to investigate the independent factors affecting efficacy and retention. We hope this will provide clinicians with guidelines for the use of PER to treat patients with DRE.
We conducted a single-center retrospective observational study of patients with DRE who received PER as add-on therapy at the Epilepsy Center of the People\'s Hospital of Henan Province,
China, between 2020 Mar. and 2021 Sep. We collected clinical data from these patients. The observation period was 6 months. The observation endpoint is the drug response and retention rate at 6 months of PER use. Regression analyses were used to compare the differences in efficacy and retention rates, respectively.
Clinical data were obtained for 72 patients with DRE (mean duration of treatment: 10.6 months). At 6 months, 25% of patients (n = 18) were seizure free; 18.1% of patients (n = 13) remained seizure free for 6 months after the addition of PER. 22.2% of patients (n = 16) had a response (One of the patients was withdrawn 5 months after adding PER due to financial difficulties). The retention rate of PER at 6 months was 77.8%. Adverse effects tended to be dominated by neuropsychiatric symptoms. Multifactorial logistic regression analysis showed significant differences in whether the baseline seizure frequency exceeded 4 seizures/month (OR = 0.232, 95%CI: 0.077-0.702, p = 0.01) and whether the number of previously failed ASMs exceeded 3 (OR = 0.316; 95%CI:0.109-0.920, p = 0.035). This indicates that the risk of experiencing a nonresponse is higher with a higher baseline seizure frequency as well as with a higher number of previous ASM failures. Therefore, a baseline frequency exceeding four seizures/month and more than three previous ASM failures were independent influencing factors for PER addition treatment for patients with DRE. Multifactorial COX regression showed that patients with DRE due to infection had a lower retention rate (OR = 15.957, 95% CI: 3.692-68.972, P < 0.001) than patients with DRE due to other noninfectious etiologies. Patients with DRE who only had a single seizure type (OR = 0.053, 95% CI:0.006-0.476, P = 0.009), and patients who did not have cognitive impairment (OR = 134.253, 95% CI:5.623-3205.104, P = 0.002) showed longer durations of PER use. Infection-related epilepsy etiology, experiencing multiple types of seizures, and with cognitive impairment were independent influencing factors on PER use retention in patients with DRE.
Our study demonstrated the efficacy of PER for reducing seizure frequency in patients with DRE and found significant differences in efficacy and retention rate, respectively. This provides a basis for assessing the expected efficacy and duration of use of PER for patients with DRE.