甲氟喹在泰国耐氯喹恶性疟患儿中的III期临床试验。
A phase-III clinical trial of mefloquine in children with chloroquine-resistant falciparum malaria in Thailand.
作者信息
Chongsuphajaisiddhi T, Sabchareon A, Chantavanich P, Singhasivanon V, Attanath P, Wernsdorfer W H, Sheth U K
出版信息
Bull World Health Organ. 1987;65(2):223-6.
Mefloquine is a highly effective drug for the treatment of falciparum malaria among adults, but studies of its effects on children are lacking. An open, noncomparative trial of mefloquine was therefore carried out among 84 children aged 5-12 years who were patients at the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand. The drug was administered as a single dose of 18-29 mg base per kg body weight. Eighty-two of the 84 children completed a 42-day period of post-treatment observation. The drug was well tolerated also by 11 children with glucose-6-phosphate dehydrogenase deficiency, and all the children in the study cleared their parasitaemia initially (average clearance time, 65 hours). Furthermore, the clinical-chemical parameters measured exhibited no drug-related changes during the study. The radical cure rate of nearly 98% and high tolerance indicate that mefloquine can be used effectively and safely for the treatment of children aged 5-12 years who are suffering from uncomplicated falciparum malaria.
甲氟喹是治疗成人恶性疟的一种高效药物，但缺乏其对儿童影响的研究。因此，在泰国曼谷玛希隆大学热带病医院的84名5至12岁儿童患者中开展了一项甲氟喹开放、非对照试验。药物按每公斤体重18至29毫克碱基的单剂量给药。84名儿童中有82名完成了42天的治疗后观察期。11名葡萄糖-6-磷酸脱氢酶缺乏的儿童对该药物也有良好耐受性，研究中的所有儿童最初均清除了寄生虫血症（平均清除时间为65小时）。此外，研究期间所测临床化学参数未显示出与药物相关的变化。近98%的根治率和高耐受性表明，甲氟喹可有效且安全地用于治疗患有非复杂性恶性疟的5至12岁儿童。
Zotero 插件