三苯双脒肠溶片治疗899例儿童肠道线虫感染的临床观察

目的 评价三苯双脒肠溶片（200 mg）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200 mg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200 mg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200 mg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200 mg治疗儿童钩虫和蛔虫感染的疗效显著，不良反应率低。

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

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.