Cysticercosis Unit, National Institute of Neurological Sciences, Lima, Peru; Department of Microbiology, School of Sciences, Cayetano Heredia Peruvian University, Lima, Peru; Center for Global Health - Tumbes, Cayetano Heredia Peruvian University, Lima, Peru; School of Public Health, Cayetano Heredia Peruvian University, Lima, Peru.
Epilepsia. 2014 Sep;55(9):1452-9. doi: 10.1111/epi.12739. Epub 2014 Aug 4.
Neurocysticercosis (NCC) is a major cause of seizures and epilepsy in endemic countries. Antiparasitic treatment of brain cysts leads to seizures due to the host's inflammatory reaction, requiring concomitant steroids. We hypothesized that increased steroid dosing will reduce treatment-associated seizures.
Open-label randomized trial comparing 6 mg/day dexamethasone for 10 days (conventional) with 8 mg/day for 28 days followed by a 2-week taper (enhanced) in patients with NCC receiving albendazole. Follow-up included active seizure surveillance and brain imaging. Study outcomes were seizure days and patients with seizures, both measured in days 11-42. Additional analyses compared days 1-10, 11-21, 22-32, 33-42, 43-60, and 61-180.
Thirty-two individuals were randomized into each study arm; two did not complete follow-up. From days 11 to 42, 59 partial and 6 generalized seizure days occurred in 20 individuals, nonsignificantly fewer in the enhanced arm (12 vs. 49, p = 0.114). The numbers of patients with seizures in this period showed similar nonsignificant differences. In the enhanced steroid arm there were significantly fewer days and individuals with seizures during antiparasitic treatment (days 1-10: 4 vs. 17, p = 0.004, and 1 vs. 10, p = 0.003, number needed to treat [NNT] 4.6, relative risk [RR] 0.1013, 95% confidence interval [CI] 0.01-0.74) and early after dexamethasone cessation (days 11-21: 6 vs. 27, p = 0.014, and 4 vs. 12, p = 0.021, NNT 4.0, RR 0.33, 95% CI 0.12-0.92) but not after day 21. There were no significant differences in antiparasitic efficacy or relevant adverse events.
Increased dexamethasone dosing results in fewer seizures for the first 21 days during and early after antiparasitic treatment for viable parenchymal NCC but not during the first 11-42 days, which was the primary predetermined time of analysis.
神经囊尾蚴病(NCC)是流行地区癫痫发作和癫痫的主要原因。针对脑囊虫的寄生虫治疗会因宿主的炎症反应而导致癫痫发作,需要同时使用类固醇。我们假设增加类固醇剂量将减少与治疗相关的癫痫发作。
本研究采用开放标签随机试验,比较了阿苯达唑治疗神经囊尾蚴病患者时,连续 10 天每天给予 6 毫克地塞米松(常规组)与连续 28 天每天给予 8 毫克地塞米松,随后 2 周逐渐停药(强化组)。随访包括主动癫痫监测和脑部成像。研究结局为第 11-42 天的癫痫发作天数和癫痫发作患者数,均在第 11-42 天进行测量。另外的分析比较了第 1-10 天、11-21 天、22-32 天、33-42 天、43-60 天和 61-180 天的天数。
32 名个体被随机分配到每个研究组;其中 2 名个体未完成随访。从第 11 天到第 42 天,20 名个体中出现了 59 次部分性和 6 次全身性癫痫发作,强化组明显较少(12 次 vs. 49 次,p=0.114)。在此期间,癫痫发作患者的数量也显示出相似的无显著性差异。在强化类固醇组中,寄生虫治疗期间(第 1-10 天:4 次 vs. 17 次,p=0.004,1 次 vs. 10 次,p=0.003,需要治疗的人数[NNT]为 4.6,相对风险[RR]为 0.1013,95%置信区间[CI]为 0.01-0.74)和地塞米松停药后早期(第 11-21 天:6 次 vs. 27 次,p=0.014,4 次 vs. 12 次,p=0.021,NNT 为 4.0,RR 为 0.33,95%CI 为 0.12-0.92)癫痫发作天数和患者数明显减少,但在第 21 天后无明显减少。寄生虫治疗的疗效或相关不良事件无显著差异。
在针对有活力的实质神经囊尾蚴病的寄生虫治疗期间和治疗后早期(第 1-21 天),增加地塞米松剂量可导致癫痫发作减少,但在第 11-42 天无明显减少,这是主要的预先确定的分析时间。