Intermittent preventive treatment for malaria control administered at the time of routine vaccinations in Mozambican infants:: A randomized, placebo-controlled trial

Intermittent preventive treatment for malaria control administered at the time of routine vaccinations in Mozambican infants:: A randomized, placebo-controlled trial
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DOI:
10.1086/505431
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发表时间:
2006-08-01
影响因子:
6.4
通讯作者:
Menendez, Clara
Menendez, Clara
中科院分区:
医学2区
文献类型:
--
作者:
Macete, Eusebio;Aide, Pedro;Menendez, Clara

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背景迫切需要部署和开发新的控制工具,以减轻疟疾造成的无法忍受的负担。婴儿间歇性预防性治疗(IPTi)有可能成为疟疾控制的有效工具。我们在1503名莫桑比克儿童中进行了一项磺胺嘧啶-乙胺嘧啶(SP)治疗的随机、双盲、安慰剂对照试验。在3、4和9月龄时给予SP或安慰剂剂量。干预措施与通过扩大免疫计划(EPI)提供的常规疫苗接种一起实施。在婴儿5个月大时进行血液学和生化检查。在婴儿12个月和24个月大时,通过医院被动病例检测系统进行的发病率监测得到横断面调查的补充。IPTi耐受性良好,未记录与SP相关的不良事件。在出生后的第一年,间歇性SP治疗使临床疟疾发病率降低了22.2%(95%置信区间[CI],3.7% - 37.0%;),住院率降低了19%(95% CI,4.0%-31.0%;)。Pp. 020磅014尽管两组之间严重贫血(红细胞压积< 25%)的发生率没有显著差异(保护作用,12.7% [95%CI,-17.3%至35.1%];),但住院率明显降低P=.第一次和第二次给药后一个月内,36例患者因贫血入院。对计划免疫疫苗的血清学反应没有被干预所改变。IPTi与SP已被证明可适度降低莫桑比克婴儿的临床疟疾发病率,而没有证据表明在停止干预后出现反弹或与EPI疫苗发生相互作用。它作为莫桑比克疟疾控制战略的建议需要与负担得起的控制工具稀缺和儿童疟疾负担相平衡。
Background. There is an urgent need to deploy and develop new control tools that will reduce the intolerable burden of malaria. Intermittent preventive treatment in infants (IPTi) has the potential to become an effective tool for malaria control.Methods. We performed a randomized, double-blind, placebo-controlled trial of sulfadoxine-pyrimethamine (SP) treatment in 1503 Mozambican children. Doses of SP or placebo were given at 3, 4, and 9 months of age. The intervention was administered alongside routine vaccinations delivered through the Expanded Program on Immunization (EPI). Hematological and biochemical tests were done when infants were 5 months old. Morbidity monitoring through a hospital-based passive case-detection system was complemented by cross-sectional surveys when infants were 12 and 24 months old.Results. IPTi was well tolerated, and no adverse events associated with SP were documented. During the first year of life, intermittent SP treatment reduced the incidence of clinical malaria by 22.2% (95% confidence interval [CI], 3.7% - 37.0%;) and the rate of hospital admissions by 19% (95% CI, 4.0%-31.0%;). Pp. 020 Pp. 014 Although the incidence of severe anemia (packed cell volume of < 25%) did not differ significantly between the 2 groups (protective effect, 12.7% [95% CI, - 17.3% to 35.1%];), there was a significant reduction in hospital P=. 36 admissions for anemia during the month after dosing for both the first and second dose. The serological responses to EPI vaccines were not modified by the intervention.Conclusions. IPTi with SP has been shown to moderately reduce the incidence of clinical malaria in Mozambican infants without evidence of rebound after stopping the intervention or of interactions with EPI vaccines. Its recommendation as a malaria control strategy in Mozambique needs to be balanced against the scarcity of affordable control tools and the burden of malaria in children.