Looareesuwan S, Wilairatana P, Vanijanonta S, Pitisuttithum P, Viravan C, Kraisintu K
Department of Clinical Tropical Medicine, Mahidol University, Bangkok, Thailand.
Ann Trop Med Parasitol. 1996 Feb;90(1):21-28. doi: 10.1080/00034983.1996.11813022.
A clinical trial of oral dihydroartemisinin for the treatment of acute, uncomplicated, falciparum malaria involved 53 adult patients in Thailand. Each received a total dose of 480 mg over 7 days (120 mg given immediately, followed by 60 mg/day) after being admitted to the Hospital for Tropical Diseases in Bangkok for 28 days. Most (92%) completed the 28-day follow-up but four patients left the hospital early, for reasons unrelated to their treatment. Most patients showed clinical improvement 1-3 days after starting treatment and none suffered from serious adverse reactions. The cure rate was 90% (44/49). The mean (S.D.) parasite-clearance time was 40.4 (14.1) h and the mean fever-clearance time was 37.0 (30.2) h. Seven patients had a brief increase in parasitaemia after initiation of treatment but subsequent counts declined dramatically. Five patients who failed treatment (RI response) were successfully treated with quinine plus tetracycline for 7 days. No RII or RIII responses were observed. These findings indicate that treatment with oral dihydroartemisinin is effective and well tolerated, and that dihydroartemisinin may be suitable as an alternative treatment for acute, uncomplicated, falciparum malaria. Comparisons with other conventional antimalarial drugs in a large, double-blind, randomized trial and studies of dihydroartemisinin in combination with other, long-acting antimalarials are needed.
一项关于口服双氢青蒿素治疗急性、非复杂性恶性疟的临床试验在泰国纳入了53名成年患者。每位患者在曼谷热带病医院住院28天期间,7天内共接受480毫克的总剂量(立即给予120毫克,随后每天60毫克)。大多数患者(92%)完成了28天的随访,但有4名患者提前出院,原因与治疗无关。大多数患者在开始治疗后1 - 3天显示出临床改善,且无一例出现严重不良反应。治愈率为90%(44/49)。平均(标准差)寄生虫清除时间为40.4(14.1)小时,平均退热时间为37.0(30.2)小时。7名患者在开始治疗后寄生虫血症短暂上升,但随后计数急剧下降。5名治疗失败(RI反应)的患者用奎宁加四环素成功治疗了7天。未观察到RII或RIII反应。这些发现表明,口服双氢青蒿素治疗有效且耐受性良好,双氢青蒿素可能适合作为急性、非复杂性恶性疟的替代治疗药物。需要在一项大型、双盲、随机试验中与其他传统抗疟药物进行比较,并对双氢青蒿素与其他长效抗疟药物联合使用进行研究。