Stivanello Elisa, Cavailler Philippe, Cassano Francesco, Omar Sabah Ahmed, Kariuki Daniel, Mwangi Jonathan, Piola Patrice, Guthmann Jean-Paul
Médecins Sans Frontières, Geneva, Switzerland.
Trop Med Int Health. 2004 Sep;9(9):975-80. doi: 10.1111/j.1365-3156.2004.01290.x.
To provide advice on the rational use of antimalarial drugs, Médecins Sans Frontières conducted a randomized, an open label efficacy study in Kajo Keji, an area of high transmission of malaria in southern Sudan. The efficacy of chloroquine (CQ), sulphadoxine-pyrimethamine (SP) and amodiaquine (AQ) were measured in a 28-day in vivo study, with results corrected by PCR genotyping. Of 2010 children screened, 115 children aged 6-59 months with uncomplicated Plasmodium falciparum malaria were randomized into each group to receive a supervised course of treatment. Of these, 114, 103 and 111 were analysed in the CQ, SP and AQ groups, respectively. The overall parasitological failure rates at day 28 were 93.9% [95% confidence interval (CI) 87.3-97.3] for CQ, 69.9% (95% CI 60.0-78.3) for SP, and 25.2% (95% CI 17.7-34.5) for AQ. These results provide important missing data on antimalarial drug efficacy in southern Sudan. They indicate that none of the drugs could be used in monotherapy and suggest that even in combination with artemisinin, cure rates might not be efficacious enough. We recommend a combination of artemether and lumefantrine as first-line treatment for uncomplicated P. falciparum malaria cases in Kajo Keji county.
为了就抗疟药物的合理使用提供建议,无国界医生组织在苏丹南部疟疾高传播地区卡乔凯吉开展了一项随机、开放标签的疗效研究。在一项为期28天的体内研究中测定了氯喹(CQ)、周效磺胺 - 乙胺嘧啶(SP)和氨酚喹(AQ)的疗效,结果通过聚合酶链反应(PCR)基因分型进行校正。在筛查的2010名儿童中,115名年龄在6至59个月、患有非复杂性恶性疟原虫疟疾的儿童被随机分为每组接受一个有监督的疗程治疗。其中,CQ组、SP组和AQ组分别有114名、103名和111名儿童接受分析。第28天的总体寄生虫学失败率,CQ组为93.9%[95%置信区间(CI)87.3 - 97.3],SP组为69.9%(95%CI 60.0 - 78.3),AQ组为25.2%(95%CI 17.7 - 34.5)。这些结果提供了苏丹南部抗疟药物疗效方面重要的缺失数据。它们表明这些药物都不能用于单一疗法,并提示即使与青蒿素联合使用,治愈率可能也不够有效。我们建议将蒿甲醚和本芴醇联合作为卡乔凯吉县非复杂性恶性疟原虫疟疾病例的一线治疗方案。