Silber Steven A, Diro Ermias, Workneh Netsanet, Mekonnen Zeleke, Levecke Bruno, Steinmann Peter, Umulisa Irenee, Alemu Hailemaryam, Baeten Benny, Engelen Marc, Hu Peter, Friedman Andrew, Baseman Alan, Mrus Joseph
Janssen Research & Development LLC, Raritan, New Jersey.
University of Gondar, Gondar, Ethiopia.
Am J Trop Med Hyg. 2017 Dec;97(6):1851-1856. doi: 10.4269/ajtmh.17-0108. Epub 2017 Aug 31.
This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of a new chewable, rapidly-disintegrating mebendazole (MBZ) 500 mg tablet for and infection treatment. Pediatric patients (1-15 years; = 295; from Ethiopia and Rwanda) excreting and/or eggs were enrolled. The study had a screening phase (3 days), a double-blind treatment phase (DBP, 19 days), and an open-label phase (OLP, 7 days). Patients received MBZ or placebo on day 1 of DBP and open-label MBZ on day 19 ± 2 after stool sample collection. Cure rates (primary endpoint), defined as species-specific egg count of 0 at the end of DBP, were significantly higher in the MBZ group than placebo for (83.7% [72/86; 95% CI: 74.2%; 90.8%] versus 11.1% [9/81; 95% CI: 5.2%; 20.1%], < 0.001) and for (33.9% [42/124; 95% CI: 25.6%; 42.9%] versus 7.6% [9/119; 95% CI: 3.5%; 13.9%], < 0.001). Egg reduction rates (secondary endpoint) were significantly higher in the MBZ group than placebo for (97.9% [95% CI: 94.4; 99.9] versus 19.2% [95% CI: -5.9; 41.5]; < 0.001) and (59.7% [95% CI: 33.9; 78.8] versus 10.5% [95% CI: -16.8; 32.9]; = 0.003). Treatment-emergent adverse events (TEAEs) in MBZ group occurred in 6.3% (9/144) of patients during DBP and 2.5% (7/278) during OLP. No deaths, serious TEAEs, or TEAEs leading to discontinuations were reported. A 500 mg chewable MBZ tablet was more efficacious than placebo for the treatment of and infections in pediatric patients, and no safety concerns were identified.
这项随机、双盲、安慰剂对照研究评估了一种新型可咀嚼、速崩甲苯咪唑（MBZ）500毫克片剂用于治疗蛔虫和鞭虫感染的疗效和安全性。纳入了排出蛔虫卵和/或鞭虫卵的儿科患者（1至15岁；n = 295；来自埃塞俄比亚和卢旺达）。该研究有一个筛查阶段（3天）、一个双盲治疗阶段（DBP，19天）和一个开放标签阶段（OLP，7天）。患者在DBP的第1天接受MBZ或安慰剂，并在粪便样本采集后第19±2天接受开放标签的MBZ。治愈率（主要终点）定义为DBP结束时特定种类虫卵计数为0，在MBZ组中蛔虫感染的治愈率显著高于安慰剂组（83.7% [72/86；95% CI：74.2%；90.8%] 对11.1% [9/81；95% CI：5.2%；20.1%]，P < 0.001），鞭虫感染的治愈率也显著高于安慰剂组（33.9% [42/124；95% CI：25.6%；42.9%] 对7.6% [9/119；95% CI：3.5%；13.9%]，P < 0.001）。虫卵减少率（次要终点）在MBZ组中蛔虫感染显著高于安慰剂组（97.9% [95% CI：94.4；99.9] 对19.2% [95% CI： -5.9；41.5]；P < 0.001），鞭虫感染也显著高于安慰剂组（59.7% [95% CI：33.9；78.8] 对10.5% [95% CI： -16.8；32.9]；P = 0.003）。MBZ组治疗期间出现的不良事件（TEAE）在DBP期间发生在6.3%（9/144）的患者中，在OLP期间发生在2.5%（7/278）的患者中。未报告死亡、严重TEAE或导致停药的TEAE。一种500毫克可咀嚼MBZ片剂在治疗儿科患者蛔虫和鞭虫感染方面比安慰剂更有效，且未发现安全问题。
