The comparative efficacy and tolerability of CGP 56697 (artemether plus lumefantrine) versus halofantrine in the treatment of uncomplicated falciparum malaria in travellers returning from the Tropics to The Netherlands and France
The comparative efficacy and tolerability of CGP 56697 (artemether plus lumefantrine) versus halofantrine in the treatment of uncomplicated falciparum malaria in travellers returning from the Tropics to The Netherlands and France
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DOI：
10.1016/s0924-8579(99)00070-9
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发表时间：
1999-07-01
影响因子：
10.8
通讯作者：
Mull, R
中科院分区：
文献类型：
--
作者：
van Agtmael, M;Bouchaud, O;Mull, R
CGP 56697(Riamet(TM))是一种新型口服抗疟疾药物，由蒿甲醚和鲁米芬(本氟美托)组成，它将快速、短效的蒿甲醚用于快速清除寄生虫与鲁米芬用于预期根治的长期作用结合在一起。在这项双盲对照试验中，CGP 56697的疗效和耐受性分别为4x4片48h和3x2片12h，1周后第2个疗程进行比较。患有急性、无并发症恶性疟原虫感染的患者(大多为非免疫性)被随机分配到CGP56697组(n=51)或氟喹诺酮组(n=52)。CGP 56697在寄生虫清除时间(中位数32对48 h，P<；0.001)和24小时寄生虫减少率(中位数99.7对89.6%，P<；0.001)方面优于对照组，而在退热方面(中位数24对32 h，P=0.835)无显著差异。然而，观察到CCP 56697的28天治愈率为82%，氟苯三胺为100%。服药6-12h后QTc值显著延长(-gt；30ms)，但服药56697后未见明显延长。CGP 56697是一种有效的、耐受性良好的治疗单纯性恶性疟疾的方法，但对于这种剂量方案，复发率高得令人无法接受(18%)。对于在国外感染疟疾的旅行者，我们建议在3天内服用6剂CGP56697。(C)1999年埃尔塞维尔科学公司和国际化疗学会。版权所有。
CGP 56697 (Riamet(TM)) is a new oral anti-malarial drug composed of artemether and lumefantrine (benflumetol) which combines the fast, short-acting artemether for rapid parasite clearance with the prolonged action of lumefantrine for intended radical cure. In this double-blind, comparative trial, the efficacy and tolerability of CGP 56697, given as a course of 4 x 4 tablets over 48 h, was compared to halofantrine, given as 3 x 2 tablets over 12 h with a second course 1 week later. Patients (mostly non-immune) with acute, uncomplicated Plasmodium falciparum infection were randomly assigned to either CGP 56697 (n = 51) or halofantrine (n = 52). CGP 56697 proved superior with respect to parasite clearance time (median 32 vs. 48 h, P < 0.001) and parasite reduction at 24 h (median 99.7 vs. 89.6%, P < 0.001) with a non-significant difference in resolution of fever (median 24 vs. 32 h, P = 0.835). However, a 28-day cure rate of 82% was observed for CCP 56697 and 100% for halofantrine. Significant QTc prolongations (> 30 ms) were seen 6-12 h after halofantrine intake but not after CGP 56697 intake. CGP 56697 is an effective, well-tolerated treatment for uncomplicated falciparum malaria but for this dosing regimen the recrudescence rate is unacceptably high (18%). For travellers contracting malaria abroad, we propose a six-dose regimen of CGP 56697 over 3 days. (C) 1999 Elsevier Science B.V. and International Society of Chemotherapy. All rights reserved.