Efficacy and safety of CGP 56697 (artemether and benflumetol) compared with chloroquine to treat acute falciparum malaria in Tanzanian children aged 1-5 years

Efficacy and safety of CGP 56697 (artemether and benflumetol) compared with chloroquine to treat acute falciparum malaria in Tanzanian children aged 1-5 years
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DOI:
10.1046/j.1365-3156.1998.00250.x
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发表时间:
1998-06-01
影响因子:
3.3
通讯作者:
Royce, C
Royce, C
中科院分区:
医学4区
文献类型:
--
作者:
Hatz, C;Abdulla, S;Royce, C

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一项随机、开放的试验涉及 260 名患有急性恶性疟原虫疟疾的坦桑尼亚 1-5 岁儿童,旨在评估联合抗疟药 CGP 56697(蒿甲醚和苯氟美醇)的疗效,并将其与 Kilombero 地区用于疟疾治疗的标准药物氯喹进行比较。在最初 48 小时内接受过救援药物或同时出现阴性幻灯片的儿童被排除在外。 CGP 56697 的 7 天寄生虫学可爱率仅为 94% (95% CI 88-97.5),氯喹为 35.4% (95% CI 25.9-45.8)。使用相同的定义,CGP 56697 的 14 天寄生虫学治愈率为 86.4% (95% CI 78.5-92.2);氯喹为 10.3% (95% CI 5.1-18.1)。 CGP 56697 比氯喹更有效地抑制配子体。两种药物均未出现重大不良事件。 CGP 56697 在坦桑尼亚这一地区对恶性疟原虫非常有效。该研究有助于讨论治疗策略,特别是在疟疾传播率高且氯喹耐药性非常高的地区,氯喹是否仍然可以发挥其作为一线药物的作用。
A randomized, open trial involving 260 Tanzanian children, aged 1-5 years, with acute Plasmodium falciparum malaria was conducted to evaluate the efficacy of the combination antimalarial CGP 56697 (artemether and benflumetol), and to compare it with chloroquine the standard drug used for malaria treatment in the Kilombero area. Children who had received rescue medication within the first 48 h or had a negative slide at the same time were excluded. Seven-day parasitological cute rates Mere 94% (95% CI 88-97.5) for CGP 56697 and 35.4% (95% CI 25.9-45.8) for chloroquine. Using the same definition, the 14-day parasitological cure rates were 86.4% (95% CI 78.5-92.2) for CGP 56697; and 10.3% (95% CI 5.1-18.1) for chloroquine. Gametocytes were more effectively suppressed by CGP 56697 than by chloroquine. There were no major adverse events with either drug. CGP 56697 is highly efficacious against P. falciparum in this area of Tanzania. The study contributes to the discussion on treatment strategies, particularly whether chloroquine may still fulfil its role as first-line drug in an area of high malaria transmission and very high levels of chloroquine resistance.