van Vugt M, Looareesuwan S, Wilairatana P, McGready R, Villegas L, Gathmann I, Mull R, Brockman A, White N J, Nosten F
Shoklo Malaria Research Unit, Mae Sod, Thailand.
Trans R Soc Trop Med Hyg. 2000 Sep-Oct;94(5):545-8. doi: 10.1016/s0035-9203(00)90082-8.
The efficacy and safety of the 6-dose regimen of artemether-lumefantrine were assessed in an open randomized trial in children and adults presenting with acute, uncomplicated Plasmodium falciparum malaria in Thailand between November 1997 and March 1998. 200 patients were enrolled in 2 centres: 150 received artemether-lumefantrine (i.e., a median total dose of 9.6 mg/kg [interquartile range 8.7-10.7] and 57.9 mg/kg of lumefantrine [52.4-64.0]) and 50 the standard combination of artesunate (12 mg/kg over 3 d) and mefloquine (25 mg/kg). All patients had rapid initial clinical and parasitological responses. The 28 d cure rates were high: 97.7% (95% confidence interval [95% CI] 93.5-99.5%) for artemether-lumefantrine and 100% (95% CI 92.5-100%) for artesunate-mefloquine. The 6-dose regimen of artemether-lumefantrine was better tolerated than, and as effective as, artesunate-mefloquine, the current standard treatment in this area of multidrug-resistant P. falciparum malaria.
1997年11月至1998年3月期间,在泰国对患有急性、非复杂性恶性疟原虫疟疾的儿童和成人开展了一项开放性随机试验,评估了蒿甲醚-本芴醇6剂疗法的疗效和安全性。在2个中心招募了200名患者:150名接受蒿甲醚-本芴醇治疗(即总剂量中位数为9.6 mg/kg[四分位间距8.7 - 10.7],本芴醇为57.9 mg/kg[52.4 - 64.0]),50名接受青蒿琥酯(3天内12 mg/kg)和甲氟喹(25 mg/kg)的标准联合治疗。所有患者最初均有快速的临床和寄生虫学反应。28天治愈率很高:蒿甲醚-本芴醇为97.7%(95%置信区间[95%CI]93.5 - 99.5%),青蒿琥酯-甲氟喹为100%(95%CI 92.5 - 100%)。蒿甲醚-本芴醇6剂疗法的耐受性优于青蒿琥酯-甲氟喹,且疗效与之相当,后者是该多药耐药恶性疟原虫疟疾领域目前的标准治疗方法。