Valecha Neena, Srivastava Bina, Dubhashi N G, Rao B H Krishnamoorthy, Kumar Ashwani, Ghosh S K, Singh Jai Prakash Narayan, Kiechel J R, Sharma Bhawna, Jullien V, Dash A P, Taylor W R J, Anvikar Anupkumar R
National Institute of Malaria Research, New Delhi, India.
J Vector Borne Dis. 2013 Dec;50(4):258-64.
BACKGROUND & OBJECTIVES: India has switched over to artemisinin-based combination therapy (ACT) for the treatment of acute uncomplicated Plasmodium falciparum malaria and the ACT used in the national programme is artesunate + sulphadoxine-pyrimethamine. Since the efficacy of ACT is dependent also on the partner drug, there is a need to evaluate and deploy multiple ACTs.
This multicentre, single-arm, open-label clinical trial was carried out to assess the efficacy, safety and population pharmacokinetics of a fixed dose combination (FDC) artesunate mefloquine (ASMQ) in P. falciparum infected, Indian adults at Panjim, Goa, and Mangalore, Karnataka between December 2007 and November 2008.
A total of 77 patients (males 74) were screened and enrolled: 42 at Goa and 35 at Mangalore with a median age of 25 yr (range 18-55 yr). One patient failed in treatment on D53, a PCR proven new infection, seven developed recurrent vivax parasitaemia and 11 did not have a parasitological endpoint. By per protocol analysis, the D63 cure rate was 58/59 (98.3; 95% C.I. 90.9-99.9%), and 58/58, with PCR correction. ASMQ was well-tolerated and no serious adverse events were reported.
INTERPRETATION & CONCLUSION: The study showed that the ASMQ FDC was efficacious and well-tolerated for the treatment of acute, uncomplicated P. falciparum malaria in highly endemic, chloroquine resistant areas of Goa and Mangalore. It is a viable option for India.
印度已转而采用以青蒿素为基础的联合疗法（ACT）治疗急性非复杂性恶性疟原虫疟疾，国家项目中使用的ACT是青蒿琥酯+磺胺多辛-乙胺嘧啶。由于ACT的疗效还取决于其配伍药物，因此有必要评估并应用多种ACT。
本多中心、单臂、开放标签临床试验旨在评估固定剂量复方（FDC）青蒿琥酯-甲氟喹（ASMQ）对2007年12月至2008年11月期间在果阿邦帕纳吉和卡纳塔克邦芒格洛尔感染恶性疟原虫的印度成年患者的疗效、安全性及群体药代动力学。
共筛选并纳入77例患者（男性74例）：果阿邦42例，芒格洛尔35例，中位年龄25岁（范围18 - 55岁）。1例患者在第53天治疗失败，经PCR证实为新感染；7例出现间日疟原虫血症复发；11例未达到寄生虫学终点。按符合方案分析，第63天的治愈率为58/59（98.3%；95%可信区间90.9 - 99.9%），经PCR校正后为58/58。ASMQ耐受性良好，未报告严重不良事件。
该研究表明，ASMQ FDC对果阿邦和芒格洛尔高度流行、氯喹耐药地区的急性非复杂性恶性疟原虫疟疾治疗有效且耐受性良好。对印度来说，它是一个可行的选择。
