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Therapeutic and prophylactic effect of intermittent preventive anti-malarial treatment in infants (IPTi) from Ghana and Gabon

机译:间歇性加纳和加蓬婴儿的预防性抗疟疾治疗(IPTi)的治疗和预防作用

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Background Intermittent preventive treatment in infants (IPTi) with sulphadoxine-pyrimethamine (SP) reduces the incidence of malaria episodes in young children. The exact mechanism by which the protective effect is mediated needs to be defined. This study aimed to investigate therapeutic, prophylactic, and possible exceeding effects of SP-based IPTi in two clinical trials. Methods Protective efficacies from two IPTi trials performed in Kumasi, Ghana, and Lambaréné, Gabon, were assessed for overlapping time series of 61 days. For six-months periods after each of three IPTi doses a multivariate Poisson regression model with the respective cohort as co-variate was generated and effect modification of protective efficacy with time strata was evaluated by log-likelihood tests. Results Protective efficacies were not significantly different between the two study cohorts. Study-cohort corrected protective efficacy was highest for the first 61 days after each IPTi application and decreased continuously. For the first 61 days after IPTi-1, IPTi-2, and IPTi-3 the protective efficacy was 71%, 44%, and 43%, respectively. A reduction of the malaria incidence rate was detectable for the first 60, 30 and 40 days after IPTi-1, IPTi-2 and IPTi-3 drug application, respectively. After IPTi-3 a higher risk for malaria could be seen after day 60. This effect was mainly based on the overwhelming influence of the Kumasi cohort. Conclusion The results suggest that SP-based IPTi mainly works through a therapeutic and prophylactic effect over 30 to 60 days after drug application and that a sustained effect beyond post-treatment prophylaxis might be very low. Trial registration Data analysis from clinical trials NCT ID # 00206739 (Kumasi Trial) and NCT ID # 00167843 (Lambaréné Trial), http://www.clinicaltrials.gov webcite.
机译:背景技术磺胺多辛-乙胺嘧啶(SP)对婴儿(IPTi)的间歇性预防性治疗可降低幼儿疟疾发作的发生率。需要确定介导保护作用的确切机制。这项研究的目的是在两项临床试验中研究基于SP的IPTi的治疗,预防和可能超过的疗效。方法在加纳的库马西和加蓬的兰巴嫩进行了两次IPTi试验的保护效果,评估了61天的重叠时间序列。在三个IPTi剂量中的每个剂量后六个月的时间里,生成了一个以相应队列作为协变量的多元Poisson回归模型,并通过对数似然测试评估了防护效果随时间分层的效果变化。结果两个研究组之间的保护效果没有显着差异。经过研究队列校正的防护功效在每次IPTi施用后的头61天内最高,并且持续下降。在IPTi-1,IPTi-2和IPTi-3之后的前61天内,防护效力分别为71%,44%和43%。在分别施用IPTi-1,IPTi-2和IPTi-3后的60天,30天和40天,可检测到疟疾发病率降低。在IPTi-3之后,在第60天后可能会出现更高的疟疾风险。这种影响主要是基于Kumasi人群的压倒性影响。结论结果表明,基于SP的IPTi在药物应用后的30至60天内主要通过治疗和预防作用发挥作用,并且在预防后的持续作用可能非常低。试验注册来自临床试验NCT ID#00206739(Kumasi试验)和NCT ID#00167843(Lambaréné试验)的数据分析,http://www.clinicaltrials.gov网站。

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