Garcia Hector H, Lescano Andres G, Gonzales Isidro, Bustos Javier A, Pretell E Javier, Horton John, Saavedra Herbert, Gonzalez Armando E, Gilman Robert H
Cysticercosis Unit, Department of Transmissible Diseases, Instituto Nacional de Ciencias Neurologicas Department of Microbiology, School of Sciences Center for Global Health.
School of Public Health, Universidad Peruana Cayetano Heredia, San Martín de Porres Department of Parasitology, US Naval Medical Research Unit No. 6.
Clin Infect Dis. 2016 Jun 1;62(11):1375-9. doi: 10.1093/cid/ciw134. Epub 2016 Mar 16.
The efficacy of current antiparasitic treatment for cerebral Taenia solium cysticercosis with either albendazole (ABZ) or praziquantel (PZQ) is suboptimal. A recent study demonstrated that combining these 2 antiparasitic drugs improves antiparasitic efficacy. We present here the parasiticidal efficacy data obtained during a previous phase II pharmacokinetic study that compared combined ABZ plus PZQ with ABZ alone.
The study was a randomized, double-blinded, placebo-controlled phase II evaluation of the pharmacokinetics of ABZ (15 mg/k/d, for 10 days) and PZQ (50 mg/k/d, for 10 days) in intraparenchymal brain cysticercosis. Patients received the usual concomitant medications, including an antiepileptic drug (phenytoin or carbamazepine), dexamethasone, and ranitidine. Randomization was stratified by antiepileptic drug. Patients underwent safety laboratory evaluations at days 4, 7, and 11, as well as magnetic resonance (MR) imaging at 6 months to assess parasiticidal efficacy.
Thirty-two patients were included, 16 in each arm. All of them completed antiparasitic treatment and underwent follow-up brain MR imaging. Cysticidal efficacy was strikingly higher in the combined ABZ-plus-PZQ group than in the ABZ-alone group (proportion of cysts resolved, 78 of 82 [95%] vs 23 of 77 [30%] [relative risk {RR}, 3.18; 95% confidence interval {CI}, 2.08-4.88; P < .001]; patients with complete cyst clearance, 12 of 16 [75%] vs 4 of 16 [25%] [RR, 3.00; 95% CI, 1.23-7.34; P = .005]).
The combination of ABZ plus PZQ is more effective in destroying viable brain cysticercosis cysts than ABZ alone.
NCT00441285.
目前使用阿苯达唑(ABZ)或吡喹酮(PZQ)治疗脑猪囊尾蚴病的抗寄生虫疗法疗效欠佳。最近一项研究表明,联合使用这两种抗寄生虫药物可提高抗寄生虫疗效。我们在此展示了在前一项II期药代动力学研究中获得的杀寄生虫疗效数据,该研究比较了ABZ联合PZQ与单用ABZ的效果。
该研究是一项随机、双盲、安慰剂对照的II期评估,旨在研究ABZ(15mg/kg/天,共10天)和PZQ(50mg/kg/天,共10天)在脑实质内脑囊尾蚴病中的药代动力学。患者接受常规的伴随用药,包括抗癫痫药物(苯妥英或卡马西平)、地塞米松和雷尼替丁。随机分组按抗癫痫药物进行分层。患者在第4、7和1天接受安全性实验室评估,并在6个月时接受磁共振(MR)成像以评估杀寄生虫疗效。
共纳入32例患者,每组16例。所有患者均完成抗寄生虫治疗并接受了脑部MR成像随访。ABZ联合PZQ组的杀囊尾蚴疗效显著高于单用ABZ组(囊肿消失比例,82个囊肿中有78个[95%] vs 77个囊肿中有23个[30%][相对危险度{RR},3.18;95%置信区间{CI},2.08 - 4.88;P <.001];囊肿完全清除的患者,16例中有12例[75%] vs 16例中有4例[25%][RR,3.00;95%CI,1.23 - 7.34;P =.005])。
ABZ联合PZQ在破坏存活的脑囊尾蚴囊肿方面比单用ABZ更有效。
NCT00441285。