Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria in the setting of three different chemopreventive regimens.
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria in the setting of three different chemopreventive regimens.
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DOI：
10.1186/s12936-015-0583-9
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发表时间：
2015-02-05
期刊：
影响因子：
3
通讯作者：
Dorsey G
中科院分区：
文献类型：
--
作者：
Kapisi J;Bigira V;Clark T;Kinara S;Mwangwa F;Achan J;Kamya M;Soremekun S;Dorsey G
尽管使用了驱虫蚊帐，但非洲部分地区儿童的疟疾负担仍然很重。化学预防具有减轻疟疾负担的潜力；然而，关于化学预防背景下抗疟疾治疗的有效性和安全性的数据有限。600名4-5个月大的儿童在乌干达托罗罗登记，这是一个高传播强度的地区。参与者得到了ITN，照顾者指示无论何时他们生病都要把他们的孩子带到学习诊所。从6个月开始，579人被随机分为不进行化学预防、每月服用磺胺二甲胺(SP)、每日服用甲氧苄啶-磺胺甲恶唑(TS)或每月服用双氢青蒿素-哌喹(DP)。研究药物在家中无人监督下服用，直到24个月大。使用蒿甲醚-鲁米芬(AL)治疗无并发症的疟疾发作，并进行了28天的积极随访。分别使用Cox比例风险模型和广义估计方程比较了研究部门在84天内复发疟疾的累积风险和28天内不良事件的风险。在非化学预防、SP、TS和DP ARM中，分别治疗了1007、919、736和451例疟疾。只有19种治疗方法(0.6%)用于治疗重症疟疾。AL治疗的早期反应良好，第3天发热消退率为96.5%，寄生虫消退率为99.4%。然而，50%以上的AL治疗后在28天内出现反复寄生虫血症。与非化学预防组相比，单纯AL组治疗后84天内疟疾复发的累积风险在DP组显著降低(HR = 为0.77，95%CI为0.63~0.95，p = 0.01)，而SP组和TS组则无显著差异。与非化学预防组相比，没有一种化学预防方案与AL治疗疟疾后不良事件的风险增加有关。在这群生活在高传播环境中的幼儿中，严重疟疾的风险非常低。在化学预防的背景下，使用AL治疗无并发症的疟疾是安全有效的，在每月分配DP的儿童中对疟疾复发具有中等程度的保护。临床试验.gov NCT00948896。
The burden of malaria remains high for children in parts of Africa despite the use of insecticide-treated bed nets (ITNs). Chemoprevention has the potential of reducing the malaria burden; however, limited data exist on the efficacy and safety of anti-malarial therapy in the setting of chemoprevention. 600 children 4–5 months of age were enrolled in Tororo, Uganda, an area of high transmission intensity. Participants were given ITNs, and caregivers instructed to bring their child to a study clinic whenever they were ill. Starting at six months of age, 579 were randomized to no chemoprevention, monthly sulphadoxine-pyrimethamine (SP), daily trimethoprim-sulphamethoxazole (TS), or monthly dihydroartemisinin-piperaquine (DP). Study drugs were administered unsupervised at home until 24 months of age. Episodes of uncomplicated malaria were treated with artemether-lumefantrine (AL) with active follow-up for 28 days. The cumulative risk of recurrent malaria within 84 days and the risk of adverse events within 28 days were compared across study arms using a Cox proportional hazards model and generalized estimating equations, respectively. A total of 1007, 919, 736, and 451 episodes of malaria were treated in the no chemoprevention, SP, TS, and DP arms, respectively. Only 19 (0.6%) treatments were for severe malaria. Early response to therapy with AL was excellent with 96.5% fever clearance and 99.4% parasite clearance by day 3. However, over 50% of AL treatments were followed by recurrent parasitaemia within 28 days. Compared to the no chemoprevention arm, the cumulative risk of recurrent malaria within 84 days following treatment of uncomplicated malaria with AL was significantly lower in the DP arm (HR = 0.77, 95% CI 0.63-0.95, p = 0.01) but not the SP or TS arms. Compared to the no chemoprevention arm, none of the chemopreventive regimens were associated with an increased risk of adverse events following treatment of malaria with AL. The risk of severe malaria was very low in this cohort of young children living in a high transmission setting. In the setting of chemoprevention, treatment of uncomplicated malaria with AL was safe and efficacious, with moderate protection against recurrent malaria among children assigned monthly DP. ClinicalTrials.gov NCT00948896.
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影响因子：
3.7
作者：
Yeka, Adoke;Dorsey, Grant;Bukirwa, Hasifa
通讯作者：
Bukirwa, Hasifa
DOI：
10.1093/trstmh/trt103
发表时间：
2014-01-01
影响因子：
2.2
作者：
Tine, Roger C. K.;Ndour, Cheikh T.;Gaye, Oumar
通讯作者：
Gaye, Oumar
影响因子：
3
作者：
Osterbauer, Beth;Kapisi, James;Dorsey, Grant
通讯作者：
Dorsey, Grant
影响因子：
6.7
作者：
通讯作者：
--
影响因子：
3
作者：
Kilama M;Smith DL;Hutchinson R;Kigozi R;Yeka A;Lavoy G;Kamya MR;Staedke SG;Donnelly MJ;Drakeley C;Greenhouse B;Dorsey G;Lindsay SW
通讯作者：
Lindsay SW