Thuan Phung Duc, Ca Nguyen Thuy Nha, Van Toi Pham, Nhien Nguyen Thanh Thuy, Thanh Ngo Viet, Anh Nguyen Duc, Phu Nguyen Hoan, Thai Cao Quang, Thai Le Hong, Hoa Nhu Thi, Dong Le Thanh, Loi Mai Anh, Son Do Hung, Khanh Tran Tinh Ngoc, Dolecek Christiane, Nhan Ho Thi, Wolbers Marcel, Thwaites Guy, Farrar Jeremy, White Nicholas J, Hien Tran Tinh
Am J Trop Med Hyg. 2016 Apr;94(4):879-885. doi: 10.4269/ajtmh.15-0740. Epub 2016 Feb 8.
A total of 128 Vietnamese patients with symptomatic Plasmodium vivax mono-infections were enrolled in a prospective, open-label, randomized trial to receive either chloroquine or dihydroartemisinin-piperaquine (DHA-PPQ). The proportions of patients with adequate clinical and parasitological responses were 47% in the chloroquine arm (31 of 65 patients) and 66% in the DHA-PPQ arm (42 of 63 patients) in the Kaplan-Meier intention-to-treat analysis (absolute difference 19%, 95% confidence interval = 0-37%), thus establishing non-inferiority of DHA-PPQ. Fever clearance time (median 24 versus 12 hours,P= 0.02), parasite clearance time (median 36 versus 18 hours,P< 0.001), and parasite clearance half-life (mean 3.98 versus 1.80 hours,P< 0.001) were all significantly shorter in the DHA-PPQ arm. All cases of recurrent parasitemia in the chloroquine arm occurred from day 33 onward, with corresponding whole blood chloroquine concentration lower than 100 ng/mL in all patients. Chloroquine thus remains efficacious for the treatment of P. vivax malaria in southern Vietnam, but DHA-PPQ provides more rapid symptomatic and parasitological recovery.
128例有症状的间日疟原虫单一感染的越南患者被纳入一项前瞻性、开放标签、随机试验，以接受氯喹或双氢青蒿素哌喹（DHA-PPQ）治疗。在Kaplan-Meier意向性分析中，氯喹治疗组（65例患者中的31例）临床和寄生虫学反应充分的患者比例为47%，DHA-PPQ治疗组（63例患者中的42例）为66%（绝对差异19%，95%置信区间=0-37%），从而确立了DHA-PPQ的非劣效性。DHA-PPQ治疗组的发热清除时间（中位数24小时对12小时，P=0.02）、寄生虫清除时间（中位数36小时对18小时，P<0.001）和寄生虫清除半衰期（平均值3.98小时对1.80小时，P<0.001）均显著缩短。氯喹治疗组所有复发性寄生虫血症病例均发生在第33天以后，所有患者相应的全血氯喹浓度均低于100 ng/mL。因此，氯喹对越南南部间日疟的治疗仍然有效，但DHA-PPQ能使症状和寄生虫学更快恢复。
