CLINICAL TRIAL
ENGLISH ABSTRACT
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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[Field trials on the efficacy of albendazole composite against intestinal nematodiasis].

AIM: To study the anthelmintic effect of albendazole composite (containing 67 mg of albendazole and 83.3 mg base of pyrantel pamoate per tablet).

METHODS: A randomized controlled study was carried out to compare the efficacy of a single dose of 3 or 2 tablets of albendazole composite versus a single dose of 400 mg of albendazole or 10 mg base/kg of pyrantel pamoate for treatment of intestinal nematodiasis including 1,864 cases infected with hookworm, 1,568 cases infected with Ascaris, 1,785 cases infected with Tricuris trichiura and 373 children infected with Enterobius vermicularis.

RESULTS: In adults, the egg negative conversion rate of a single dose of 3 or 2 tablets of albendazole composite reached 65.0% and 52.7% for hookworm infection (P < 0.01), 100% and 100% for Ascaris infection, and 26.5% and 19.2% for Trichuris infection (P < 0.01), respectively. There were significantly better effect against hookworm with 3 tablets of albendazole composite than that with single albendazole or pyrantel pamoate (65.0% vs. 47.6% and 38.5%, P < 0.01). The effect of 2 tablets of albendazole composite against hookworm was also higher than that of single pyrantel pamoate (P < 0.01) and equal to single albendazole but the anthelmintic effect against Trichuris infection was lower than that of single albendazole (19.2% vs. 26.5%). In 2-6-year-old children, the effect of 1.5 tablets of albendazole composite against Enterobius vermicularis infection showed an egg negative conversion rate of 100% which was higher than that of single pyrantel pamoate (100% vs. 83.0%, P < 0.01). The worm collection data showed that the worm-expelling action of albendazole composite was much more rapid than that of albendazole. There were no adverse effects of albendazole composite on blood picture, liver or renal function and ECG. The side effect of both 3 and 2 tablets of albendazole composite was mild and transcient.

CONCLUSION: Albendazole composite exhibits a synergistic effect of both albendazole and pyrantel pamoate.

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