基于即时检测的葡萄糖-6-磷酸脱氢酶定量检测，在巴西亚马孙地区采用tafenoquine 或伯氨喹进行根治性治疗间日疟原虫的可行性：一项真实世界的回顾性分析。
Operational feasibility of Plasmodium vivax radical cure with tafenoquine or primaquine following point-of-care, quantitative glucose-6-phosphate dehydrogenase testing in the Brazilian Amazon: a real-life retrospective analysis.
机构信息
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Brazil.
Centro de Pesquisa em Medicina Tropical de Rondônia, Porto Velho, Brazil.
出版信息
Lancet Glob Health. 2024 Mar;12(3):e467-e477. doi: 10.1016/S2214-109X(23)00542-9.
BACKGROUND
To achieve malaria elimination, Brazil must implement Plasmodium vivax radical cure. We aimed to investigate the operational feasibility of point-of-care, quantitative, glucose-6-phosphate dehydrogenase (G6PD) testing followed by chloroquine plus tafenoquine or primaquine.
METHODS
This non-interventional, observational study was done at 43 health facilities in Manaus (Amazonas State) and Porto Velho (Rondônia State), Brazil, implementing a new P vivax treatment algorithm incorporating point-of-care quantitative G6PD testing to identify G6PD status and single-dose tafenoquine (G6PD normal, aged ≥16 years, and not pregnant or breastfeeding) or primaquine (intermediate or normal G6PD, aged ≥6 months, not pregnant, or breastfeeding >1 month). Following training of health-care providers, we collated routine patient records from the malaria epidemiological surveillance system (SIVEP-Malaria) retrospectively for all consenting patients aged at least 6 months with parasitologically confirmed P vivax malaria mono-infection or P vivax plus P falciparum mixed infection, presenting between Sept 9, 2021, and Aug 31, 2022. The primary endpoint was the proportion of patients aged at least 16 years with P vivax mono-infection treated or not treated appropriately with tafenoquine in accordance with their G6PD status. The trial is registered with ClinicalTrials.gov, NCT05096702, and is completed.
FINDINGS
Of 6075 patients enrolled, 6026 (99·2%) had P vivax mono-infection, 2685 (44·6%) of whom were administered tafenoquine. G6PD status was identified in 2685 (100%) of 2685 patients treated with tafenoquine. The proportion of patients aged at least 16 years with P vivax mono-infection who were treated or not treated appropriately with tafenoquine in accordance with their G6PD status was 99·7% (95% CI 99·4-99·8; 4664/4680).
INTERPRETATION
Quantitative G6PD testing before tafenoquine administration was operationally feasible, with high adherence to the treatment algorithm, supporting deployment throughout the Brazilian health system.
FUNDING
Brazilian Ministry of Health, Municipal and State Health Secretariats; Fiocruz; Medicines for Malaria Venture; Bill & Melinda Gates Foundation; Newcrest Mining; and the UK Government.
TRANSLATION
For the Portuguese translation of the abstract see Supplementary Materials section.
背景
为实现消除疟疾目标，巴西必须实施间日疟根治。本研究旨在评估即时、定量检测葡萄糖-6-磷酸脱氢酶（G6PD）后采用氯喹联合泰诺福韦或伯氨喹治疗间日疟的可行性。
方法
本非干预性、观察性研究在巴西马瑙斯（亚马孙州）和波多韦柳（朗多尼亚州）的 43 个卫生机构开展，采用新的间日疟治疗方案，即即时定量 G6PD 检测以确定 G6PD 状态，对于 G6PD 正常、年龄≥16 岁、非妊娠或哺乳期的患者，给予泰诺福韦（G6PD 正常、年龄≥16 岁、非妊娠或哺乳期）或伯氨喹（G6PD 中间或正常、年龄≥6 个月、非妊娠或哺乳期＞1 个月）单剂治疗。在对卫生保健提供者进行培训后，我们从疟疾流行病学监测系统（SIVEP-Malária）回顾性收集所有年龄至少 6 个月且寄生虫学确诊的间日疟原虫单纯感染或间日疟原虫合并恶性疟原虫混合感染患者的常规病历记录，纳入时间为 2021 年 9 月 9 日至 2022 年 8 月 31 日期间就诊的患者。主要终点为按照 G6PD 状态，年龄至少 16 岁的间日疟原虫单纯感染者中，接受或未接受泰诺福韦恰当治疗的比例。该试验已在 ClinicalTrials.gov 注册，编号为 NCT05096702，现已完成。
结果
共纳入 6075 例患者，其中 6026 例（99.2%）为间日疟原虫单纯感染，其中 2685 例（44.6%）接受了泰诺福韦治疗。在接受泰诺福韦治疗的 2685 例患者中，有 2685 例（100%）明确了 G6PD 状态。按照 G6PD 状态，年龄至少 16 岁的间日疟原虫单纯感染者中，接受或未接受泰诺福韦恰当治疗的比例为 99.7%（95%CI 99.4-99.8；4664/4680）。
结论
泰诺福韦给药前进行定量 G6PD 检测具有操作性，治疗方案的依从性较高，支持在巴西卫生系统中推广应用。
资助
巴西卫生部、市和州卫生部门；Fiocruz；疟疾药物基金会；比尔及梅琳达·盖茨基金会；新力拓矿业公司；英国政府。
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