Obua C, Gustafsson L L, Aguttu C, Anokbonggo W W, Ogwal-Okeng J W, Chiria J, Hellgren U
Department of Pharmacology and Therapeutics, Makerere University, Kampala, Uganda.
Acta Trop. 2006 Nov;100(1-2):142-50. doi: 10.1016/j.actatropica.2006.10.007. Epub 2006 Nov 20.
Amodiaquine (AQ) is an affordable compound, chemically related to chloroquine (CQ) but often effective against CQ resistant Plasmodium falciparum. In Uganda, a pre-packed fixed-dose combination of CQ plus sulfadoxine/pyrimethamine (CQ+SP) called Homapak is used in the home based management of fever program (HBM). We performed a single blind randomized trial to determine the efficacy of AQ+SP in comparison with the fixed-dose CQ+SP (Homapak) in the treatment of uncomplicated falciparum malaria in Ugandan children aged 6 months to 5 years. The study was done in 2004 at Walkuba Health Center, a sub-urban area in Jinja district, Uganda. Primary outcome was the day 14 per protocol clinical and parasitological response according to the WHO. A total of 183 children were included (mean age 28 months) and 90% completed 28 days of follow up. The day 14 adequate clinical and parasitological response was 70.9% for CQ+SP and 97.4% for AQ+SP (p<0.001). In those given CQ+SP, treatment failure rates for the 6 months to 2 years age group were much higher (48.2%) than in the older children (18.2%, p=0.004). The day 28 PCR adjusted parasitological failure rates were also higher in the CQ+SP (31.3%) than in the AQ+SP group (13.1%) (p=0.003), with a higher gametocyte carriage among the CQ+SP group. We conclude that the efficacy of AQ+SP was significantly superior to the fixed-dose CQ+SP (Homapak), particularly among the youngest children. Thus, AQ could be used instead of CQ in combination with SP to improve the effectiveness against falciparum malaria in Uganda.
阿莫地喹（AQ）是一种价格低廉的化合物，在化学结构上与氯喹（CQ）相关，但通常对耐氯喹的恶性疟原虫有效。在乌干达，一种预先包装好的固定剂量复方制剂，即氯喹加磺胺多辛/乙胺嘧啶（CQ+SP），商品名为霍马帕克（Homapak），用于居家发热管理项目（HBM）。我们开展了一项单盲随机试验，以确定与固定剂量的CQ+SP（霍马帕克）相比，AQ+SP治疗6个月至5岁乌干达儿童非复杂性恶性疟的疗效。该研究于2004年在乌干达金贾区郊区的瓦尔库巴健康中心进行。主要结局指标是按照世界卫生组织标准，第14天根据方案的临床和寄生虫学反应。总共纳入了183名儿童（平均年龄28个月），90%的儿童完成了28天的随访。第14天，CQ+SP组的充分临床和寄生虫学反应率为70.9%，AQ+SP组为97.4%（p<0.001）。在接受CQ+SP治疗的儿童中，6个月至2岁年龄组的治疗失败率（48.2%）远高于年龄较大儿童（18.2%，p=0.004）。第28天，经聚合酶链反应（PCR）调整后的寄生虫学失败率在CQ+SP组（31.3%）也高于AQ+SP组（13.1%）（p=0.003），CQ+SP组的配子体携带率更高。我们得出结论，AQ+SP的疗效显著优于固定剂量的CQ+SP（霍马帕克），尤其是在最小的儿童中。因此，在乌干达，可用AQ代替CQ与SP联合使用，以提高对恶性疟的治疗效果。
