An open label randomized comparison of mefloquine-artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand
An open label randomized comparison of mefloquine-artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand
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DOI：
10.1111/j.1365-3156.2006.01724.x
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发表时间：
2006-11-01
影响因子：
3.3
通讯作者：
Nosten, Francois
中科院分区：
文献类型：
--
作者：
Ashley, Elizabeth A.;Lwin, Khin Maung;Nosten, Francois
以固定组合形式提供药物对于青蒿素类联合疗法战略的成功至关重要。这可以防止一种药物在没有另一种药物保护的情况下被服用，从而减少恶性疟原虫抗药性菌株出现和传播的机会。较低的片剂负荷也有助于治疗依从性。甲氟喹加青蒿琥酯的一种新的固定复方制剂已经研制成功。这是比较与传统的方案，单独的片剂治疗简单的多药耐药恶性疟malignancy.Methods在泰国西北边境500成人和儿童与简单的恶性疟随机接受新的固定组合或单独的片剂。结果聚合酶链反应校正后第63天的治愈率固定复方制剂组为91.9%（95%CI 88.2-95.6），散片组为89.2%（85.0-93.4），两组比较差异有统计学意义（P = 0.3）。有一个较低的发生率在接受固定combination.Conclusions的甲氟喹和青蒿琥酯的新的固定组合是有效的，耐受性好，方便给药组的早期呕吐。
Background Delivering drugs in a fixed combination is essential to the success of the strategy of artemisinin-based combination therapy. This prevents one drug being taken without the protection of the other, reducing the chance of emergence and spread of drug resistant strains of Plasmodium falciparum. A lower tablet burden should also facilitate adherence to treatment. A new fixed combination of mefloquine plus artesunate has been developed. This was compared with the conventional regimen of separate tablets for the treatment of uncomplicated multidrug-resistant falciparum malaria.Methods On the north-western border of Thailand 500 adults and children with uncomplicated falciparum malaria were randomized to receive either the new fixed combination or separate tablets. They were followed up weekly for 63 days.Results The day 63 polymerase chain reaction-adjusted cure rates were 91.9% (95% CI 88.2-95.6) in the fixed combination group and 89.2% (85.0-93.4) in the loose tablets group (P = 0.3). There was a lower incidence of early vomiting in the group receiving the fixed combination.Conclusions This new fixed combination of mefloquine and artesunate was efficacious, well tolerated and convenient to administer.