Ojurongbe Olusola, Lawal Olubunmi A, Abiodun Oyindamola O, Okeniyi John A, Oyeniyi Ayobami J, Oyelami Oyeku A
Ladoke Akintola University of Technology, Osogbo, Nigeria.
J Infect Dev Ctries. 2013 Dec 15;7(12):975-82. doi: 10.3855/jidc.3058.
The development and spread of Plasmodium falciparum resistance to most commonly used antimalarials remain a major challenge in the control of malaria. Constant monitoring of drug efficacy is an important tool in establishing rational antimalarial drug policies.
A randomized comparative study was conducted at the Wesley Guild Hospital, Ilesa, Nigeria between February 2010 and September 2011 comparing the efficacy and safety of artemether-lumefantrine (Coartem) and fixed dose of artesunate plus amodiaquine (Larimal) in the treatment of uncomplicated P. falciparum malaria in children betweem 6 and 144 months of age. P. falciparum malaria parasitemia was assessed by microscopy and rapid diagnostic test. Drugs were administered according to age for three days under supervision. The primary efficacy endpoint was a day 28 PCR-corrected parasitological cure.
A total of 182 patients were enrolled in the two treatment groups, Coartem (n = 101) and Larimal (n = 81), and tested after 28 days. In the intention-to-treat population, Coartem (n = 101) and Larimal (n = 81) had a PCR-corrected cure rate of 98% and 100% respectively, while in the per-protocol population, Coartem (n = 89) and Larimal (n = 71) both had a PCR-corrected cure rate of 100% at day 28. Although parasite and fever clearance time was faster in the Larimal group, no significant difference was observed between the two drugs. No serious adverse effects were reported.
Five years after being introduced in Nigeria, both Coartem and Larimal have been shown to be safe and highly effective in the treatment of uncomplicated P. falciparum malaria in children.
恶性疟原虫对最常用抗疟药物产生耐药性并不断发展和传播，这仍然是疟疾控制中的一项重大挑战。持续监测药物疗效是制定合理抗疟药物政策的一项重要工具。
2010年2月至2011年9月期间，在尼日利亚伊莱萨的卫斯理公会医院开展了一项随机对照研究，比较蒿甲醚-本芴醇（科泰复）和固定剂量青蒿琥酯加阿莫地喹（Larimal）治疗6至144月龄儿童单纯性恶性疟原虫疟疾的疗效和安全性。通过显微镜检查和快速诊断检测评估恶性疟原虫疟疾的寄生虫血症。在监督下根据年龄给药三天。主要疗效终点为第28天经PCR校正的寄生虫学治愈。
两个治疗组共纳入182例患者，科泰复组（n = 101）和Larimal组（n = 81），并在28天后进行检测。在意向性治疗人群中，科泰复组（n = 101）和Larimal组（n = 81）的经PCR校正的治愈率分别为98%和100%，而在符合方案人群中，科泰复组（n = 89）和Larimal组（n = 71）在第28天的经PCR校正的治愈率均为100%。虽然Larimal组的寄生虫清除和退热时间更快，但两种药物之间未观察到显著差异。未报告严重不良反应。
在引入尼日利亚五年后，科泰复和Larimal均已证明在治疗儿童单纯性恶性疟原虫疟疾方面安全且高效。
