Kobbe Robin, Kreuzberg Christina, Adjei Samuel, Thompson Benedicta, Langefeld Iris, Thompson Peter Apia, Abruquah Harry Hoffman, Kreuels Benno, Ayim Matilda, Busch Wibke, Marks Florian, Amoah Kwado, Opoku Ernest, Meyer Christian G, Adjei Ohene, May Jürgen
Infectious Disease Epidemiology Group, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.
Clin Infect Dis. 2007 Jul 1;45(1):16-25. doi: 10.1086/518575. Epub 2007 May 29.
Intermittent preventive antimalarial treatment in infants (IPTi) with sulfadoxine-pyrimethamine reduces falciparum malaria and anemia but has not been evaluated in areas with intense perennial malaria transmission. It is unknown whether an additional treatment in the second year of life prolongs protection.
A randomized, double-blinded, placebo-controlled trial with administration of sulfadoxine-pyrimethamine therapy at 3, 9, and 15 months of age was conducted with 1070 children in an area in Ghana where malaria is holoendemic. Participants were monitored for 21 months after recruitment through active follow-up visits and passive case detection. The primary end point was malaria incidence, and additional outcome measures were anemia, outpatient visits, hospital admissions, and mortality. Stratified analyses for 6-month periods after each treatment were performed.
Protective efficacy against malaria episodes was 20% (95% confidence interval [CI], 11%-29%). The frequency of malaria episodes was reduced after the first 2 sulfadoxine-pyrimethamine applications (protective efficacy, 23% [95% CI, 6%-36%] after the first dose and 17% [95% CI, 1%-30%] after the second dose). After the third treatment at month 15, however, no protection was achieved. Protection against the first or single anemia episode was only significant after the first IPTi dose (protective efficacy, 30%; 95% CI, 5%-49%). The number of anemia episodes increased after the last IPTi dose (protective efficacy, -24%; 95% CI, -50% to -2%).
In an area of intense perennial malaria transmission, sulfadoxine-pyrimethamine-based IPTi conferred considerably lower protection than reported in areas where the disease is moderately or seasonally endemic. Protective efficacy is age-dependent, and extension of IPTi into the second year of life does not provide any benefit.
使用周效磺胺-乙胺嘧啶对婴儿进行间歇性预防疟疾治疗（IPTi）可降低恶性疟和贫血的发生率，但尚未在常年疟疾传播强烈的地区进行评估。尚不清楚在生命的第二年进行额外治疗是否能延长保护期。
在加纳一个疟疾高度流行的地区，对1070名儿童进行了一项随机、双盲、安慰剂对照试验，在3、9和15月龄时给予周效磺胺-乙胺嘧啶治疗。招募后通过主动随访和被动病例检测对参与者进行21个月的监测。主要终点是疟疾发病率，其他结局指标包括贫血、门诊就诊、住院和死亡率。对每次治疗后6个月的时间段进行分层分析。
预防疟疾发作的保护效力为20%（95%置信区间[CI]，11%-29%）。在前两次周效磺胺-乙胺嘧啶应用后，疟疾发作频率降低（第一次给药后的保护效力为23%[95%CI，6%-36%]，第二次给药后的保护效力为17%[95%CI，1%-30%]）。然而，在15月龄进行第三次治疗后，未获得保护。仅在第一次IPTi剂量后，预防首次或单次贫血发作才具有显著意义（保护效力为30%；95%CI，5%-49%）。在最后一次IPTi剂量后，贫血发作次数增加（保护效力为-24%；95%CI，-50%至-2%）。
在常年疟疾传播强烈的地区，基于周效磺胺-乙胺嘧啶的IPTi提供的保护比在疾病中度或季节性流行地区报道的要低得多。保护效力与年龄有关，将IPTi延长至生命的第二年没有任何益处。
