[Clinical observation on 899 children infected with intestinal nematodes and treated with tribendimidine enteric coated tablets]

Abstract

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. lumbricoides 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 Tribendimidine 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.