Khoromana C O, Campbell C C, Wirima J J, Heymann D L
Am J Trop Med Hyg. 1986 May;35(3):465-71. doi: 10.4269/ajtmh.1986.35.465.
In 1984 the government of Malawi instituted a program to reduce malaria mortality and morbidity in children less than 5 years of age as a part of the Combatting Childhood Communicable Diseases (CCCD) program. To define the appropriate malaria therapy regimen, investigators used a quality assurance design in a simplified 7-day in vivo drug response study with follow-up observations on day 2 (D2), D3, and D7 after the initial day of the study (D0). The efficacy of oral chloroquine was assessed in 224 children who were enrolled at 6 sites, 2 in each of the 3 administrative regions of Malawi. Parasitological failure, defined as failure of parasitemia to decrease by 75% of the value by D3 or presence of any detectable parasitemia on D7, ranged from 41%-65% following administration of chloroquine 25 mg (base)/kg. However, only 8% of children who were parasitemic on D7 were febrile or judged to be ill. Considering these therapeutic results and the higher cost and limited availability of alternative therapies, chloroquine 25 mg/kg therapy was adopted as the primary therapy for malaria.
1984年,马拉维政府启动了一项计划,作为抗击儿童传染病(CCCD)计划的一部分,降低5岁以下儿童的疟疾死亡率和发病率。为确定合适的疟疾治疗方案,研究人员在一项简化的7天体内药物反应研究中采用了质量保证设计,并在研究首日(D0)后的第2天(D2)、第3天(D3)和第7天(D7)进行随访观察。在马拉维3个行政区各2个、共6个地点招募的224名儿童中评估了口服氯喹的疗效。寄生虫学失败定义为到D3时寄生虫血症未降低至初始值的75%或D7时存在任何可检测到的寄生虫血症,在给予25mg(碱)/kg氯喹后,发生率在41%-65%之间。然而,D7时仍有寄生虫血症的儿童中只有8%发热或被判定患病。考虑到这些治疗结果以及替代疗法成本更高且供应有限,采用25mg/kg氯喹疗法作为疟疾的主要治疗方法。