Thera Mahamadou A, Keita Falaye, Sissoko Mahamadou S, Traoré Oumar B, Coulibaly Drissa, Sacko Massambou, Lameyre Valerie, Ducret Jean Pascal, Doumbo Ogobara
Malaria Research and Training Centre, Department of Epidemiology of Parasitic Diseases (DEAP)/Faculty of Medicine, Pharmacy and Odonto-Stomatologie, University of Bamako, Bamako, Mali.
Malar J. 2007 May 22;6:68. doi: 10.1186/1475-2875-6-68.
The acceptability and efficacy of a new kit with a new formulation of quinine alkaloids designed for the intra-rectal administration in the treatment of non-per os malaria was assessed in the peripheral health care system of Mopti, Mali.
A single-arm trial was conducted from August 2003 to January 2004. An initial dose of diluted quinine alkaloids (20 mg/kg Quinimax) was administered by the intra-rectal route to children with presumptive non per-os malaria at six peripheral heath care centres. The children were then referred to two referral hospitals where standard inpatient care including intravenous route were routinely provided. A malaria thick smear was done at inclusion and a second malaria thick smear after arrival at the referral facility, where a more complete clinical examination and laboratory testing was done to confirm diagnosis. Confirmed cases of severe malaria or others diseases were treated according to national treatment guidelines. Cases of non per-os malaria received a second dose of intra rectal quinine alkaloids. Primary outcome was acceptability of the intra rectal route by children and their parents as well as the ease to handle the kit by health care workers.
The study included 134 children with a median age of 33 months and 53.7% were male. Most of the children (67%) and 92% of parents or guardians readily accepted the intra-rectal route; 84% of health care workers found the kit easy to use. At the peripheral health care centres, 32% of children had a coma score < or = 3 and this was reduced to 10% at the referral hospital, following one dose of intra-rectal quinine alkaloids (IRQA). The mean time to availability of oral route treatment was 1.8 +/- 1.1 days. Overall, 73% of cases were confirmed severe malaria and for those the case fatality rate was 7.2%.
IRQA was well accepted by children, their parents/guardians and by the health workers at peripheral health facilities in Mopti, Mali. There was also a quick recovery from deep coma and a reduced case fatality rate in severe malaria.
在马里莫普提的基层医疗保健系统中,对一种新配方的奎宁生物碱直肠给药新试剂盒在治疗无法口服药物的疟疾方面的可接受性和疗效进行了评估。
2003年8月至2004年1月进行了一项单臂试验。在六个基层医疗保健中心,通过直肠途径给疑似无法口服药物的疟疾患儿初始剂量的稀释奎宁生物碱(20mg/kg奎尼麦克斯)。然后将这些儿童转诊至两家转诊医院,在那里常规提供包括静脉途径在内的标准住院治疗。入组时进行疟原虫厚涂片检查,到达转诊机构后进行第二次疟原虫厚涂片检查,在转诊机构进行更全面的临床检查和实验室检测以确诊。确诊的重症疟疾或其他疾病病例根据国家治疗指南进行治疗。无法口服药物的疟疾病例接受第二剂直肠奎宁生物碱。主要结局是儿童及其父母对直肠给药途径的可接受性以及医护人员使用试剂盒的便利性。
该研究纳入了134名儿童,中位年龄为33个月,53.7%为男性。大多数儿童(67%)以及92%的父母或监护人欣然接受直肠给药途径;84%的医护人员认为该试剂盒易于使用。在基层医疗保健中心,32%的儿童昏迷评分≤3分,在接受一剂直肠奎宁生物碱(IRQA)后,转诊医院这一比例降至10%。口服治疗可用的平均时间为1.8±1.1天。总体而言,73%的病例确诊为重症疟疾,这些病例的病死率为7.2%。
在马里莫普提的基层卫生机构,儿童、其父母/监护人和医护人员对直肠奎宁生物碱的接受度良好。重症疟疾患者从深度昏迷中恢复迅速,病死率降低。