PDF(Pubmed)
Abstract：
BACKGROUND: Plasmodium vivax malaria, with the widest geographic distribution, can cause severe disease and death. Primaquine is the main licensed antimalarial drug that can kill hypnozoites. The dose-dependent acute haemolysis in individuals with glucose-6-phospate dehydrogenase (G6PD) deficiency is the main safety concern when using primaquine. The recommended treatment regimen for P. vivax malaria is chloroquine plus primaquine for 14 days (CQPQ14) in Myanmar. The study aimed to evaluate the therapeutic efficacy, safety and adherence for the regimen of artemisinin-naphthoquine plus primaquine for 3 days (ANPQ3) in patients with P. vivax infections compared to those with CQPQ14.
METHODS: The patients in the ANPQ3 group were given fixed-dose artemisinin-naphthoquine (a total 24.5 mg/kg bodyweight) plus a lower total primaquine dose (0.9 mg/kg bodyweight) for 3 days. The patients in the CQPQ14 group were given a total chloroquine dose of 30 mg/kg body weight for 3 days plus a total primaquine dose of 4.2 mg/kg bodyweight for 14 days. All patients were followed up for 365 days.
RESULTS: A total of 288 patients completed follow-up, 172 in the ANPQ3 group and 116 in the CQPQ14 group. The first recurrence patients were detected by day 58 in both groups. By day 182, 16 recurrences had been recorded: 12 (7.0%) patients in the ANPQ3 group and 4 (3.4%) in the CQPQ14 group. The difference in recurrence-free patients was 3.5 (-8.6 to 1.5) percentage points between ANPQ3 and CQPQ14 group (P = 0.2946). By day 365, the percentage of recurrence-free patients was not significant between the two groups (P = 0.2257). Mean fever and parasite clearance time of ANPQ3 group were shorter than those in CQPQ14 group (P ≤ 0.001). No severe adverse effect was observed in ANPQ3 group, but five (3.9%) patients had acute haemolysis in CQPQ14 group (P = 0.013). Medication percentage of ANPQ3 group was significantly higher than that of CQPQ14 group (P < 0.0001).
CONCLUSIONS: Both ANPQ3 and CQPQ14 promised clinical cure efficacy, and the radical cure efficacy was similar between the ANPQ3 and CQPQ14 group. ANPQ3 clears fever and parasites faster than CQPQ14. ANPQ3 is safer and shows better patient adherence to the regimen for treatment of P. vivax malaria along the China-Myanmar border.
BACKGROUND: ChiCTR-INR-17012523. Registered 31 August 2017, https://www.chictr.org.cn/showproj.html?proj=21352.
METHODS: The patients in the ANPQ3 group were given fixed-dose artemisinin-naphthoquine (a total 24.5 mg/kg bodyweight) plus a lower total primaquine dose (0.9 mg/kg bodyweight) for 3 days. The patients in the CQPQ14 group were given a total chloroquine dose of 30 mg/kg body weight for 3 days plus a total primaquine dose of 4.2 mg/kg bodyweight for 14 days. All patients were followed up for 365 days.
RESULTS: A total of 288 patients completed follow-up, 172 in the ANPQ3 group and 116 in the CQPQ14 group. The first recurrence patients were detected by day 58 in both groups. By day 182, 16 recurrences had been recorded: 12 (7.0%) patients in the ANPQ3 group and 4 (3.4%) in the CQPQ14 group. The difference in recurrence-free patients was 3.5 (-8.6 to 1.5) percentage points between ANPQ3 and CQPQ14 group (P = 0.2946). By day 365, the percentage of recurrence-free patients was not significant between the two groups (P = 0.2257). Mean fever and parasite clearance time of ANPQ3 group were shorter than those in CQPQ14 group (P ≤ 0.001). No severe adverse effect was observed in ANPQ3 group, but five (3.9%) patients had acute haemolysis in CQPQ14 group (P = 0.013). Medication percentage of ANPQ3 group was significantly higher than that of CQPQ14 group (P < 0.0001).
CONCLUSIONS: Both ANPQ3 and CQPQ14 promised clinical cure efficacy, and the radical cure efficacy was similar between the ANPQ3 and CQPQ14 group. ANPQ3 clears fever and parasites faster than CQPQ14. ANPQ3 is safer and shows better patient adherence to the regimen for treatment of P. vivax malaria along the China-Myanmar border.
BACKGROUND: ChiCTR-INR-17012523. Registered 31 August 2017, https://www.chictr.org.cn/showproj.html?proj=21352.
摘要：
背景：间日疟原虫疟疾，地理分布最广，会导致严重的疾病和死亡。伯氨喹是主要的已批准的抗疟药，可以杀死被催生子。使用伯氨喹时，葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症个体的剂量依赖性急性溶血是主要的安全性问题。在缅甸，间日疟原虫疟疾的推荐治疗方案是氯喹加伯氨喹14天（CQPQ14）。该研究旨在评估治疗效果，与CQPQ14相比，间日疟原虫感染患者使用青蒿素-萘酚加伯氨喹治疗3天（ANPQ3）的安全性和依从性。
方法：ANPQ3组患者给予固定剂量的青蒿素-萘酚喹（总剂量为24.5mg/kg体重）加上较低的总伯氨喹剂量（0.9mg/kg体重），持续3天。CQPQ14组患者给予总氯喹剂量30mg/kg体重3天，总伯氨喹剂量4.2mg/kg体重14天。所有患者随访365天。
结果：共有288例患者完成随访，ANPQ3组中的172和CQPQ14组中的116。两组均在第58天检测到首次复发患者。到第182天，记录了16例复发：ANPQ3组12例（7.0%），CQPQ14组4例（3.4%）。ANPQ3组和CQPQ14组之间无复发患者的差异为3.5(-8.6～1.5)个百分点(P=0.2946)。到第365天，两组之间无复发患者的百分比并不显著（P=0.2257）。ANPQ3组的平均发热和寄生虫清除时间短于CQPQ14组(P≤0.001)。ANPQ3组无严重不良反应,但CQPQ14组中有5例(3.9%)患者出现急性溶血(P=0.013).ANPQ3组的用药百分比显著高于CQPQ14组(P<0.0001)。
结论：ANPQ3和CQPQ14均有望获得临床治愈疗效，ANPQ3和CQPQ14组的根治疗效相似。ANPQ3比CQPQ14更快地清除发烧和寄生虫。ANPQ3更安全，患者对中缅边境间日疟原虫疟疾治疗方案的依从性更高。
背景：ChiCTR-INR-17012523。2017年8月31日注册，https://www.chictr.org.cn/showproj.html?proj=21352。
方法：ANPQ3组患者给予固定剂量的青蒿素-萘酚喹（总剂量为24.5mg/kg体重）加上较低的总伯氨喹剂量（0.9mg/kg体重），持续3天。CQPQ14组患者给予总氯喹剂量30mg/kg体重3天，总伯氨喹剂量4.2mg/kg体重14天。所有患者随访365天。
结果：共有288例患者完成随访，ANPQ3组中的172和CQPQ14组中的116。两组均在第58天检测到首次复发患者。到第182天，记录了16例复发：ANPQ3组12例（7.0%），CQPQ14组4例（3.4%）。ANPQ3组和CQPQ14组之间无复发患者的差异为3.5(-8.6～1.5)个百分点(P=0.2946)。到第365天，两组之间无复发患者的百分比并不显著（P=0.2257）。ANPQ3组的平均发热和寄生虫清除时间短于CQPQ14组(P≤0.001)。ANPQ3组无严重不良反应,但CQPQ14组中有5例(3.9%)患者出现急性溶血(P=0.013).ANPQ3组的用药百分比显著高于CQPQ14组(P<0.0001)。
结论：ANPQ3和CQPQ14均有望获得临床治愈疗效，ANPQ3和CQPQ14组的根治疗效相似。ANPQ3比CQPQ14更快地清除发烧和寄生虫。ANPQ3更安全，患者对中缅边境间日疟原虫疟疾治疗方案的依从性更高。
背景：ChiCTR-INR-17012523。2017年8月31日注册，https://www.chictr.org.cn/showproj.html?proj=21352。
