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目的评价三苯双脒肠溶片治疗肠道线虫感染者的安全性和疗效。方法在海南省屯昌县进行开放临床试验,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785例。4~14岁儿童感染者顿服三苯双脒200 mg;>14岁蛔虫感染者顿服三苯双脒300 mg,钩虫和蛔虫混合感染及钩虫或蛔虫合并其他肠道蠕虫感染顿服三苯双脒400 mg,观察不良反应,并于治疗后3~4周用相同方法粪检,评价治疗效果。结果总体钩虫感染治愈率及有效率分别为86.57%(606/700)和98.86%(692/700);蛔虫感染治愈率及有效率分别为82.84%(111/134)和98.51%(132/134);儿童钩虫感染治愈率及有效率分别为86.16%(249/289)和98.62%(285/289);儿童蛔虫感染治愈率及有效率分别为81.75%(103/126)和99.21%(125/126)。三苯双脒的不良反应轻微且短暂,不良反应出现率为2.42%(19/785),主要表现为头晕、恶心和呕吐,对血、尿常规、肝肾功能和心电图无明显影响,儿童未见不良反应。结论三苯双脒治疗钩虫、蛔虫感染者的疗效显著,不良反应率低。
Objective To evaluate the safety and efficacy of tribendimidine enteric-coated tablets in the treatment of intestinal nematode infections. Methods An open clinical trial was conducted in Tunchang County, Hainan Province. The subjects were diagnosed as hookworm, roundworm infection, mixed infection with hookworm and roundworm or with whipworm infection by using modified Kato-Katz fecal examination. A total of 785 cases were treated. Children aged 4 to 14 were served Dayton tribendinum 200 mg;> 14-year-old roundworm infected Dayton tribendimidine 300 mg, mixed infection of hookworms and roundworms and hookworms or roundworms combined with other intestinal worms infection Dayton tribenzene Ammonia 400 mg, observed adverse reactions, and 3 to 4 weeks after treatment with the same method of fecal evaluation of the therapeutic effect. Results The overall cure rate and effective rate of hookworm infection were 86.57% (606/700) and 98.86% (692/700), respectively. The cure rate and effective rate of Ascaris infection were 82.84% (111/134) and 98.51% (132/134) ). The cure rate and effective rate of hookworm infection in children were 86.16% (249/289) and 98.62% (285/289) respectively. The cure rate and effective rate of children with roundworm infection were 81.75% (103/126) and 99.21% (125 / 126). Adverse reactions of tribendimidine were mild and transient. The incidence rate of adverse reactions was 2.42% (19/785). The main symptoms were dizziness, nausea and vomiting. No significant effect on blood, urine, liver and kidney function and electrocardiogram, See adverse reactions. Conclusion Tribendimidine is effective in treating hookworm and roundworm infections with low rate of adverse reactions.