Division of Infectious Diseases, Advanced Clinical Research Center, Institute of Medical Science, University of Tokyo, Tokyo, Japan.
Disease Control and Prevention Center, National Center for Global Health and Medicine, Tokyo, Japan.
Travel Med Infect Dis. 2015 May-Jun;13(3):235-40. doi: 10.1016/j.tmaid.2014.11.005. Epub 2014 Nov 20.
Recently, a dose of 30 mg (base) primaquine daily for 14 days is increasingly recommended for radical cure of Plasmodium vivax malaria. However, total primaquine doses, or those per body weight, are also recognized as important. In Japan, primaquine is not a licensed medicine, but has been used through the Research Group on Chemotherapy of Tropical Diseases for >3 decades.
Based on clinical records submitted to the Research Group, patients with P. vivax and Plasmodium ovale malaria treated with primaquine were analyzed to determine the efficacy and safety of the antimalarial drug.
Seventy-five P. vivax cases, including 3 in children, and 19 P. ovale cases were enrolled. Five of the P. vivax cases demonstrated at least one relapse despite primaquine therapy. Total primaquine doses per body weight were obtained in 4 of the 5 relapsed patients, presenting 9 malaria episodes totally, and most of the primaquine failures were caused with a total dose ≤ 3.5 mg/kg. Liver function disturbance was reported in 2 cases.
In order to optimize radical cure of P. vivax, the total primaquine dose per body weight should be considered, at least 3.5 mg/kg or even more if contracted in countries with significant drug resistance. Possibility of primaquine hepatotoxicity in chronic liver disease patients remains to be elucidated.
最近,推荐使用 30mg(碱式)伯氨喹每日 1 次,连服 14 天,作为根治间日疟的方法。然而,总剂量或体质量剂量也被认为是重要的。在日本,伯氨喹并非法定药物,但已通过热带病化学疗法研究组使用了>30 年。
基于提交给热带病化学疗法研究组的临床记录,对接受伯氨喹治疗的间日疟和卵形疟患者进行分析,以确定该抗疟药物的疗效和安全性。
共纳入 75 例间日疟病例(包括 3 例儿童病例)和 19 例卵形疟病例。尽管接受了伯氨喹治疗,仍有 5 例间日疟患者出现至少 1 次复发。在 5 例复发患者中,有 4 例获得了体质量总剂量,共出现 9 次疟疾病例,大多数伯氨喹失败是由于总剂量≤3.5mg/kg。有 2 例出现肝功能障碍。
为优化间日疟根治,应考虑体质量总剂量,在药物耐药性显著的国家,至少需要 3.5mg/kg,甚至更多。慢性肝病患者伯氨喹肝毒性的可能性仍需阐明。