London School of Hygiene and Tropical Medicine, London, UK.
Infectious Diseases Research Collaboration, Kampala, Uganda.
BMC Med. 2020 Aug 10;18(1):207. doi: 10.1186/s12916-020-01675-x.
Intermittent preventive treatment of malaria during pregnancy (IPTp) with dihydroartemisinin-piperaquine (DP) significantly reduces the burden of malaria during pregnancy compared to sulfadoxine-pyrimethamine (SP), the current standard of care, but its impact on the incidence of malaria during infancy is unknown.
We conducted a double-blind randomized trial to compare the incidence of malaria during infancy among infants born to HIV-uninfected pregnant women who were randomized to monthly IPTp with either DP or SP. Infants were followed for all their medical care in a dedicated study clinic, and routine assessments were conducted every 4 weeks. At all visits, infants with fever and a positive thick blood smear were diagnosed and treated for malaria. The primary outcome was malaria incidence during the first 12 months of life. All analyses were done by modified intention to treat.
Of the 782 women enrolled, 687 were followed through delivery from December 9, 2016, to December 5, 2017, resulting in 678 live births: 339 born to mothers randomized to SP and 339 born to those randomized to DP. Of these, 581 infants (85.7%) were followed up to 12 months of age. Overall, the incidence of malaria was lower among infants born to mothers randomized to DP compared to SP, but the difference was not statistically significant (1.71 vs 1.98 episodes per person-year, incidence rate ratio (IRR) 0.87, 95% confidence interval (CI) 0.73-1.03, p = 0.11). Stratifying by infant sex, IPTp with DP was associated with a lower incidence of malaria among male infants (IRR 0.75, 95% CI 0.58-0.98, p = 0.03) but not female infants (IRR 0.99, 95% CI 0.79-1.24, p = 0.93).
Despite the superiority of DP for IPTp, there was no evidence of a difference in malaria incidence during infancy in infants born to mothers who received DP compared to those born to mothers who received SP. Only male infants appeared to benefit from IPTp-DP suggesting that IPTp-DP may provide additional benefits beyond birth. Further research is needed to further explore the benefits of DP versus SP for IPTp on the health outcomes of infants.
ClinicalTrials.gov, NCT02793622 . Registered on June 8, 2016.
与目前的标准护理药物磺胺多辛-乙胺嘧啶（SP）相比，孕妇间歇性预防治疗疟疾（IPTp）使用二氢青蒿素-哌喹（DP）可显著降低孕期疟疾负担，但它对婴儿期疟疾发病率的影响尚不清楚。
我们进行了一项双盲随机试验，比较了随机接受 DP 或 SP 每月 IPTp 的 HIV 阴性孕妇所生婴儿在婴儿期的疟疾发病率。婴儿在专门的研究诊所接受所有医疗护理，并每 4 周进行一次常规评估。在所有就诊时，发热且厚血涂片阳性的婴儿均被诊断和治疗疟疾。主要结局是婴儿出生后 12 个月内的疟疾发病率。所有分析均采用改良意向治疗。
在纳入的 782 名妇女中，有 687 名妇女从 2016 年 12 月 9 日至 2017 年 12 月 5 日分娩时进行了随访，共分娩了 678 名活产儿：339 名母亲随机分配到 SP 组，339 名母亲随机分配到 DP 组。其中，581 名婴儿（85.7%）随访至 12 个月龄。总的来说，与随机接受 SP 的婴儿相比，随机接受 DP 的婴儿疟疾发病率较低，但差异无统计学意义（1.71 与 1.98 例/人年，发病率比 0.87，95%置信区间 0.73-1.03，p=0.11）。按婴儿性别分层，DP 组的 IPTp 与男性婴儿的疟疾发病率较低相关（发病率比 0.75，95%置信区间 0.58-0.98，p=0.03），但与女性婴儿无关（发病率比 0.99，95%置信区间 0.79-1.24，p=0.93）。
尽管 DP 对 IPTp 具有优越性，但接受 DP 的母亲所生婴儿与接受 SP 的母亲所生婴儿的婴儿期疟疾发病率无差异。只有男性婴儿似乎从 IPTp-DP 中受益，这表明 IPTp-DP 可能除了分娩之外还提供额外的益处。需要进一步研究以进一步探索 DP 与 SP 对 IPTp 对婴儿健康结局的益处。
ClinicalTrials.gov，NCT02793622。于 2016 年 6 月 8 日注册。
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