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. 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.

Key words: Tribendimidine, Hookworm, Ascaris lumbricoides, Trichuris trichiura, Efficacy, Safety