Bunnag D, Viravan C, Looareesuwan S, Karbwang J, Harinasuta T
Department of Clinical Tropical Medicine, Mahidol University, Bangkok, Thailand.
Southeast Asian J Trop Med Public Health. 1991 Dec;22(4):539-43.
A double blind randomised comparative trial of the efficacy of daily dose (200 mg as an initial dose followed by 100 mg daily for another 4 days) and twice daily dose (100 mg 12 hourly for 2 doses on the first day, followed by 50 mg 12 hourly for another 8 doses) regimens of oral artesunate at 600 mg was studied in 59 Thai patients with uncomplicated falciparum malaria. Fifty patients had a complete 28-day follow-up period. Both regimens produced similar efficacy with no difference in adverse effects. The patients with the daily artesunate regimen had mean fever and parasite clearance times of 20 and 40 hours, respectively. The cure rate was 72%. Eight patients had recrudescence during days 15 to 28 while 8 showed P. vivax in their peripheral blood between days 12 and 21. The patients with the twice daily regimen had mean fever and parasite clearance time of 28 and 40 hours, respectively. The cure rate was 76%. Six patients had recrudescence during days 15 and 27 while 7 showed P. vivax during days 12 and 23. We suggest that the duration of the treatment may be a more important factor determining the efficacy of artesunate rather than the frequency of the doses. Further studies based on pharmacokinetics are therefore needed to improve the cure rate to 100% to prevent the spread of P. falciparum, particularly in areas where there are high numbers of multi-drug resistant strains.
对59例泰国非复杂性恶性疟患者进行了一项双盲随机对照试验，比较了口服青蒿琥酯600mg每日剂量方案（初始剂量200mg，随后4天每日100mg）和每日两次剂量方案（第1天每12小时100mg共2剂，随后8剂每12小时50mg）的疗效。50例患者有完整的28天随访期。两种方案疗效相似，不良反应无差异。接受每日青蒿琥酯方案的患者平均发热和寄生虫清除时间分别为20小时和40小时。治愈率为72%。8例患者在第15至28天复发，8例在第12至21天外周血中出现间日疟原虫。接受每日两次方案的患者平均发热和寄生虫清除时间分别为28小时和40小时。治愈率为76%。6例患者在第15至27天复发，7例在第12至23天出现间日疟原虫。我们认为，治疗持续时间可能是决定青蒿琥酯疗效的更重要因素而非给药频率。因此，需要基于药代动力学进行进一步研究，以将治愈率提高到100%，防止恶性疟原虫传播，特别是在多药耐药菌株数量众多的地区。
