Sacko M, De Clercq D, Behnke J M, Gilbert F S, Dorny P, Vercruysse J
Institut National de Recherche en Sante Publique (INRSP), Service de Parasitologie, Bamako-Coura, Mali.
Trans R Soc Trop Med Hyg. 1999 Mar-Apr;93(2):195-203. doi: 10.1016/s0035-9203(99)90306-1.
A randomized, placebo-controlled trial of the efficacy of pyrantel (single dose 12.5 mg/kg bodyweight), mebendazole (single 500 mg dose) and albendazole (single 400 mg dose) in the treatment of hookworm infections (Necator americanus) was carried out in January 1998 in the Southern Region of Mali, West Africa, during the period of Ramadan (Islamic fast). Statistical analysis of the pre-intervention faecal egg counts showed that there was a significant pre-treatment chance bias, despite randomization of subjects into treatment groups, arising from the main effect of sex (heavier infections among males) and a sex x treatment interaction (the sex bias was not evident in the pyrantel-treatment group). The participants were re-examined 10 days after treatment, and after controlling for the drift in faecal egg counts in the placebo-treated subset, age, sex, fasting and intensity of infection, albendazole was clearly the most effective drug showing consistently efficacies in the range 92.1 to 99.7%, depending on the method of evaluation and the particular subset of the treatment group. Neither mebendazole nor pyrantel was as effective, with efficacies ranging from 60.9 to 89.8% and 4.8 to 89.7%, respectively. Fasting made no difference to drug efficacy. On the basis of our results the single 400 mg dose of albendazole is the treatment of choice for hookworm infections in this region of Mali. We emphasize the need for standardization of the methods used for trial designs, for calculation of summary data relating to drug efficacies and the accompanying statistical tests.
1998年1月,在西非马里南部地区斋月(伊斯兰教斋戒期)期间,开展了一项关于噻嘧啶(单剂量12.5毫克/千克体重)、甲苯达唑(单剂量500毫克)和阿苯达唑(单剂量400毫克)治疗钩虫感染(美洲板口线虫)疗效的随机、安慰剂对照试验。干预前粪便虫卵计数的统计分析表明,尽管将受试者随机分为治疗组,但由于性别主效应(男性感染较重)和性别×治疗交互作用(噻嘧啶治疗组中性别偏差不明显),治疗前存在显著的机会偏差。治疗10天后对参与者进行复查,在控制了安慰剂治疗亚组中粪便虫卵计数的漂移、年龄、性别、禁食和感染强度后,阿苯达唑显然是最有效的药物,根据评估方法和治疗组的特定亚组,其疗效始终在92.1%至99.7%之间。甲苯达唑和噻嘧啶都没有那么有效,疗效分别为60.9%至89.8%和4.8%至89.7%。禁食对药物疗效没有影响。根据我们的结果,单剂量400毫克的阿苯达唑是马里该地区钩虫感染的首选治疗药物。我们强调试验设计所使用的方法、药物疗效相关汇总数据的计算以及伴随的统计检验需要标准化。