Artemisinin-naphthoquine combination versus chloroquine-primaquine to treat vivax malaria: an open-label randomized and non-inferiority trial in Yunnan Province, China

Malaria Journal

Research

Jia-zhi Wang¹  Jian-Wei Xu²  Chun-fu Li²  Ren-hua Nie²  Heng-lin Yang²  Hui Liu² 

[1]Tengchong County Center for Disease Control and Prevention, Tengchong, China

[2]Yunan Institute of Parasitic Diseases, 665000, Puer, China

关键词: Plasmodium vivax;    Artemisinin-naphthoquine;    Efficacy;    Safety;   

DOI  :  10.1186/1475-2875-12-409

 received in 2013-07-03, accepted in 2013-10-30,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundPlasmodium vivax is the main malaria parasite in China, and China is now making efforts to eliminate malaria by 2020. Radical cure of vivax malaria is one of challenges for malaria elimination. The purpose is to evaluate the efficacy and safety of artemisinin-naphthoquine (ANQ) versus chloroquine-primaquine (CQ-PQ) in treatment of vivax malaria in Yunnan Province, China.MethodsAn open-label randomized and non-inferiority design, eligible patients with monoinfections of P. vivax were randomly assigned to receive either a total target dose of ANQ 24.5 mg/kg (naphthoquine 7 mg/kg and artemisinin 17.5 mg/kg), once a day for three days, or a total CQ dose of 24 mg base/kg, once a day for three days plus a PQ dose of 0.45 mg base/kg/day, once a day for eight days. Patients were followed up for one year. The difference in efficacy between ANQ and CQ-PQ was compared via Wilson’s test.ResultsBy day 42, the number of patients free of recurrence was 125 (98.4%; 95% Confidence interval, 94.4-99.8%) for ANQ arm and 123 (96.1%; 95%CI, 91.1-98.7%) for CQ-PQ, and non-significant (P = 0.4496). By day 365, the number was 101 (79.5%; 95%CI, 71.8-85.9%) for ANQ and 106 (82.8%; 95%CI, 75.1-88.9%) for CQ-PQ, and non-significant (P = 0.610). So the proportions of patients free of recurrence had no significant difference between ANQ and CQ-PQ groups by day 28, 42 and 365; compared with CQ-PQ, the side effect of ANQ was mild.ConclusionANQ is non-inferior to CQ-PQ in terms of patients free of recurrence, and safer than CQ-PQ.

【 授权许可】

Unknown   
© Liu et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.