三苯双脒肠溶片治疗899例儿童肠道线虫感染的临床观察

Clinical Observation on 899 Children Infected with Intestinal Nematodes and Treated with Tribendimidine Enteric Coated Tablets

目的评价三苯双脒肠溶片(200mg)治疗4～14岁儿童钩虫和蛔虫感染者的安全性和疗效。方法在海南、四川和贵州等3个临床试验中心进行三苯双脒肠溶片开放临床试验,受治者用改良加藤法(Kato-Katz)粪检确诊为钩虫、蛔虫感染,钩虫与蛔虫混合感染或合并鞭虫感染等,共收治4～14岁儿童899例,采用三苯双脒肠溶片200mg单剂口服治疗,观察不良反应,并于治疗后3～4周用相同方法作粪检评价治疗效果。结果三苯双脒肠溶片200mg对儿童钩虫感染的治愈率及有效率分别为82.0%(433/528)和99.2%(524/528);对蛔虫感染的治愈率及有效率分别为90.1%(576/639)和99.7%(637/639),而鞭虫感染治愈率仅为36.8%(112/304)。儿童顿服三苯双脒肠溶片200mg的不良反应轻微和短暂,总的不良反应率为1.6%(14/899),主要为头晕、恶心和呕吐等。血、尿常规,肝、肾功能和心电图检查未见明显影响。结论三苯双脒肠溶片200mg治疗儿童钩虫和蛔虫感染的疗效显著,不良反应率低。

Objective To evaluate the efficacy and safety of tribendimidine in treatment of children with hookworm and Ascaris lumbricoides infections. Methods An open and multi-center clinical trial was conducted in the provinces of Hainan, Sichuan and Guizhou. 899 children aged 4-14 years were enrolled in the study. Hookworm, A. lumbircoides or other helminth infections were diagnosed by improved Kato-Katz method. All the patients were treated orally with tribendimidine enteric coated tablet at a single dose of 200 mg. The efficacy was evaluated by stool examination 3--4 weeks post treatment. Results The cure rate and effective rate of the children with hookworm infection were 82.0%（433/528） and 99.2%（524/528）, respectively, while in children with A.lumbricoides infection, they were 95.0%（576/639） and 99.8% （637/639）, respectively. The efficacy of tribendimidine enteric coated tablet given to the children with Trichuris trichiura infection at a single dose of 200 mg was 36.8%（112/304）. The adverse effect induced by tribendimidine, such as dizziness, nausea and vomiting, was light and transient with an adverse effect rate of 1.6% （14/899）. No apparent impact was seen on the blood and urine routine examination, hepatic and renal function as well as ECG examination. Conclusion Tri- bendimidine given at a single dose of 200 mg exhibits lower adverse effect rate and potential efficacy in the treatment of children with hookworm and A.lumbricoides infections.