Wilairatana P, Chanthavanich P, Singhasivanon P, Treeprasertsuk S, Krudsood S, Chalermrut K, Phisalaphong C, Kraisintu K, Looareesuwan S
Department of Clinical Tropical Medicine, Bangkok Hospital for Tropical Diseases, Faculty of Tropical Medicine, Thailand.
Int J Parasitol. 1998 Aug;28(8):1213-8. doi: 10.1016/s0020-7519(98)00101-5.
We compared the safety and efficacy of three formulations of dihydroartemisinin for the treatment of acute uncomplicated falciparum malaria in patients who received a total dose of 600 mg dihydroartemisinin over 5 days. The first group was treated by dihydroartemisinin produced and formulated in the People's Republic of China, the second group was treated by dihydroartemisinin produced in Vietnam but formulated by the Government Pharmaceutical Organization of Thailand and the third group was treated by dihydroartemisinin produced and formulated by the Government Pharmaceutical Organization of Thailand. All patients were admitted to hospital to evaluate safety and efficacy for a total of 28 days. By the third day of treatment, most patients were blood-smear negative for parasites and none had serious adverse effects. Minor symptoms such as nausea, dizziness and headache were similar in the three groups and disappeared after 3 days of treatment. One-hundred and thirty-three patients completed the 28-day follow-up period. The cure rates of groups I, II and III were 80%, 85% and 92%, respectively (P > 0.02). There were no significant differences in fever clearance or parasite clearance among the three groups. We conclude that the three formulations of dihydroartemisinin produced and formulated in different countries were safe and effective in treating uncomplicated falciparum malaria acquired in Thailand.
我们比较了三种双氢青蒿素制剂治疗急性非复杂性恶性疟的安全性和有效性,这些患者在5天内接受了总量为600毫克的双氢青蒿素治疗。第一组接受中华人民共和国生产和配制的双氢青蒿素治疗,第二组接受越南生产但由泰国政府制药组织配制的双氢青蒿素治疗,第三组接受泰国政府制药组织生产和配制的双氢青蒿素治疗。所有患者均入院评估安全性和有效性,为期共28天。到治疗第三天时,大多数患者的血涂片寄生虫检测呈阴性,且无一例出现严重不良反应。三组中恶心、头晕和头痛等轻微症状相似,且在治疗3天后消失。133名患者完成了28天的随访期。第一组、第二组和第三组的治愈率分别为80%、85%和92%(P>0.02)。三组之间在退热或寄生虫清除方面无显著差异。我们得出结论,在不同国家生产和配制的三种双氢青蒿素制剂在治疗在泰国感染的非复杂性恶性疟方面安全有效。