Aung Pyae Linn, Soe Myat Thu, Soe Than Naing, Zhao Yan, Cao Yaming, Aung Poh Poh, Oo Thit Lwin, Lawpoolsri Saranath, Nguitragool Wang, Sattabongkot Jetsumon, Kaewkungwal Jaranit, Kyaw Myat Phone, Parker Daniel M, Cui Liwang
Myanmar Health Network Organization, Yangon, Myanmar.
Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Open Forum Infect Dis. 2025 Aug 5;12(8):ofaf465. doi: 10.1093/ofid/ofaf465. eCollection 2025 Aug.
poses a major challenge for malaria elimination, primarily because of relapse. Primaquine mass drug administration (PQ-MDA) has played a decisive role in eliminating vivax malaria in many temperate countries, but its efficacy in tropical/subtropical areas remains underexplored.
We conducted a cluster-randomized crossover trial to determine the effect of PQ-MDA on transmission in northern Myanmar, a subtropical area in the Greater Mekong subregion with perennial malaria transmission. Participants from two groups of villages (groups 1 and 2) were administered 0.25 mg/kg/day PQ base for 14 days as directly observed therapy. During PQ-MDA administration, each group alternated as the control while the other received the intervention, with the groups switching after 9 months. Clinical malaria incidence and prevalence were monitored to determine the efficacy.
PQ was administered in 541 participants in group 1 and 667 in group 2 during August-September 2019 and June-July 2020, respectively. In both groups, clinical incidence sharply declined to zero within a month of PQ-MDA and remained vivax-free for almost a year. During round 1 PQ-MDA, group 1 with MDA had a significant reduction in the prevalence of subclinical compared to group 2 as the control, with a model-adjusted odds ratio (aOR) of 0.46 [95% confidence interval (CI): 0.25-0.83]. During round 2, group 2 exhibited an even lower aOR of 0.15 (95% CI: 0.03-0.65) for subclinical infection.
PQ-MDA was effective in reducing both clinical and subclinical infections in a subtropical, low-endemicity setting.
This study was registered with ClinicalTrials.gov (NCT06392152).
这对疟疾消除构成了重大挑战,主要原因是复发。伯氨喹大规模药物管理(PQ-MDA)在许多温带国家消除间日疟方面发挥了决定性作用,但其在热带/亚热带地区的疗效仍未得到充分探索。
我们进行了一项整群随机交叉试验,以确定PQ-MDA对缅甸北部传播的影响,缅甸北部是大湄公河次区域的一个亚热带地区,常年有疟疾传播。来自两组村庄(第1组和第2组)的参与者作为直接观察治疗,接受14天每天0.25毫克/千克伯氨喹碱基的治疗。在PQ-MDA给药期间,每组交替作为对照组,而另一组接受干预,9个月后两组交换。监测临床疟疾发病率和患病率以确定疗效。
分别在2019年8月至9月和2020年6月至7月期间,第1组的541名参与者和第2组的667名参与者接受了伯氨喹治疗。在两组中,临床发病率在PQ-MDA给药后一个月内急剧降至零,并且几乎一年没有间日疟。在第一轮PQ-MDA期间,与作为对照组的第2组相比,接受MDA的第1组亚临床感染的患病率显著降低,模型调整后的优势比(aOR)为0.46 [95%置信区间(CI):0.25 - 0.83]。在第二轮期间,第2组亚临床感染的aOR甚至更低,为0.15(95% CI:0.03 - 0.65)。
在亚热带、低流行地区,PQ-MDA在减少临床和亚临床感染方面是有效的。
本研究已在ClinicalTrials.gov(NCT06392152)注册。