超短疗程、高剂量伯氨喹预防儿童单纯性疟疾后间日疟原虫感染：早期与延迟治疗的随机、开放标签、非劣效性试验。
Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment.
作者信息
Woon Sze-Ann, Moore Brioni R, Laman Moses, Tesine Paula, Lorry Lina, Kasian Bernadine, Yambo Phantica, Yadi Gumul, Pomat William, Batty Kevin T, Salman Sam, Robinson Leanne J, Davis Timothy M E, Manning Laurens
机构信息
Medical School, University of Western Australia, Crawley, Australia; Department of Infectious Diseases, Royal Perth Hospital, Perth, Australia.
Medical School, University of Western Australia, Crawley, Australia; Curtin Medical School, Curtin University, Bentley, Australia; Curtin Health Innovation Research Institute, Curtin University, Bentley, Australia; Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia.
出版信息
Int J Infect Dis. 2023 May;130:189-195. doi: 10.1016/j.ijid.2023.03.010. Epub 2023 Mar 9.
OBJECTIVES
We aimed to assess safety, tolerability, and Plasmodium vivax relapse rates of ultra-short course (3.5 days) high-dose (1 mg/kg twice daily) primaquine (PQ) for uncomplicated malaria because of any Plasmodium species in children randomized to early- or delayed treatment.
METHODS
Children aged 0.5 to 12 years with normal glucose-6-phosphate-dehydrogenase (G6PD) activity were enrolled. After artemether-lumefantrine (AL) treatment, children were randomized to receive PQ immediately after (early) or 21 days later (delayed). Primary and secondary endpoints were the appearance of any P. vivax parasitemia within 42 or 84 days, respectively. A non-inferiority margin of 15% was applied (ACTRN12620000855921).
RESULTS
A total of 219 children were recruited, 70% with Plasmodium falciparum and 24% with P. vivax. Abdominal pain (3.7% vs 20.9%, P <0.0001) and vomiting (0.9% vs 9.1%, P = 0.01) were more common in the early group. At day 42, P. vivax parasitemia was observed in 14 (13.2%) and 8 (7.8%) in the early and delayed groups, respectively (difference, -5.4%; 95% confidence interval -13.7 to 2.8). At day 84, P. vivax parasitemia was observed in 36 (34.3%) and 17 (17.5%; difference -16.8%, -28.6 to -6.1).
CONCLUSION
Ultra-short high-dose PQ was safe and tolerated without severe adverse events. Early treatment was non-inferior to delayed treatment in preventing P. vivax infection at day 42.
目的
我们旨在评估超短疗程（3.5天）高剂量（每日两次，每次1毫克/千克）伯氨喹（PQ）用于治疗因任何疟原虫种类引起的儿童单纯性疟疾的安全性、耐受性和间日疟复发率，这些儿童被随机分为早期治疗组或延迟治疗组。
方法
纳入葡萄糖-6-磷酸脱氢酶（G6PD）活性正常的0.5至12岁儿童。在接受蒿甲醚-本芴醇（AL）治疗后，儿童被随机分为在治疗后立即（早期）或21天后（延迟）接受PQ治疗。主要和次要终点分别是在42天或84天内出现任何间日疟原虫血症。采用15%的非劣效性界值（ACTRN12620000855921）。
结果
共招募了219名儿童，其中70%感染恶性疟原虫，24%感染间日疟原虫。早期治疗组腹痛（3.7%对20.9%，P<0.0001）和呕吐（0.9%对9.1%，P = 0.01）更为常见。在第42天，早期治疗组和延迟治疗组分别有14例（13.2%）和8例（7.8%）观察到间日疟原虫血症（差异为-5.4%；95%置信区间为-13.7至2.8）。在第84天，早期治疗组和延迟治疗组分别有36例（34.3%）和17例（17.5%；差异为-16.8%，-28.6至-6.1）观察到间日疟原虫血症。
结论
超短疗程高剂量PQ安全且耐受性良好，无严重不良事件。在预防第42天的间日疟感染方面，早期治疗不劣于延迟治疗。
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