Sabchareon A, Attanath P, Chanthavanich P, Phanuaksook P, Prarinyanupharb V, Poonpanich Y, Mookmanee D, Teja-Isavadharm P, Heppner D G, Brewer T G, Chongsuphajaisiddhi T
Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Am J Trop Med Hyg. 1998 Jan;58(1):11-6. doi: 10.4269/ajtmh.1998.58.11.
A randomized pilot study to compare the safety and efficacy of artesunate suppositories (15 mg/kg/day for three days) versus oral artesunate (6 mg/kg/day for three days), both in combination with mefloquine (25 mg/kg), was conducted in 52 Thai children with uncomplicated multidrug-resistant falciparum malaria. Forty-five patients (87%) had a full 28-day follow-up in the hospital to assess efficacy and exclude reinfection. Mean [range] times to fever clearance of the two groups were similar (42 hr [15-104] versus 42 hr [6-119]). Artesunate suppositories resulted in significantly longer times to achieve 50% and 90% reductions of the initial parasite counts (17 and 26 hr versus 9 and 15 hr; P < 0.05 and P < 0.001). Time [range] to parasite clearance was longer in the artesunate suppositories group (42 hr [14-93] versus 35 hr [16-69]), but the difference was not significant. The cure rates by days 28 were not significantly different, 92% for artesunate suppository-treated patients and 100% for oral artesunate-treated patients. Both drug regimens are safe and effective. Further studies are needed to characterize the pharmacokinetic properties and the optimum regimen of artesunate suppositories for the treatment of severe malaria.
一项随机试点研究在52名患有非复杂性多重耐药恶性疟的泰国儿童中开展，比较青蒿琥酯栓剂（15毫克/千克/天，连用三天）与口服青蒿琥酯（6毫克/千克/天，连用三天）联合甲氟喹（25毫克/千克）的安全性和疗效。45名患者（87%）在医院进行了为期28天的完整随访，以评估疗效并排除再次感染。两组的平均[范围]退热时间相似（42小时[15 - 104]对42小时[6 - 119]）。青蒿琥酯栓剂使初始寄生虫计数降低50%和90%所需的时间显著更长（17小时和26小时对9小时和15小时；P < 0.05和P < 0.001）。青蒿琥酯栓剂组的寄生虫清除时间[范围]更长（42小时[14 - 93]对35小时[16 - 69]），但差异不显著。到第28天的治愈率无显著差异，青蒿琥酯栓剂治疗的患者为92%，口服青蒿琥酯治疗的患者为100%。两种药物方案均安全有效。需要进一步研究来确定青蒿琥酯栓剂治疗重症疟疾的药代动力学特性和最佳方案。
