A randomized, double-blind, comparative trial of a new oral combination of artemether and benflumetol (CGP 56697) with mefloquine in the treatment of acute Plasmodium falciparum malaria in Thailand

A randomized, double-blind, comparative trial of a new oral combination of artemether and benflumetol (CGP 56697) with mefloquine in the treatment of acute Plasmodium falciparum malaria in Thailand
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DOI:
10.4269/ajtmh.1999.60.238
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发表时间:
1999-02-01
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:
Looareesuwan, S;Wilairatana, P;Royce, C

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CGP 56697是一种新的蒿甲醚和本芴醇的口服固定组合,在一项双盲,随机试验中对252名成年患者进行了CGP 56697治疗,(4 × 4片,每片含20 mg蒿甲醚和120 mg本芴醇,在0、8、24和48小时给药)或与甲氟喹一起给药(初次诊断时3片250 mg,随后8小时时2片250 mg)。两组基线数据具有可比性。CGP 56697的28天治愈率低于甲氟喹(69.3%对82.4%; P = 0.002)。但CGP 56697在寄生虫清除时间(43小时对66小时; P < 0.001)、发热清除时间(32小时对54小时; P < 0.005)和配子体清除时间(152小时对331小时; P < 0.001)方面比甲氟喹更有效。这项研究表明,CGP 56697对泰国的多药耐药恶性疟原虫疟疾有效,但可能需要更高的剂量来改善罕见的治愈。
CGP 56697, a new oral fixed combination of artemether and benflumetol, was tested in a double-blinded, randomized trial in 252 adult patients treated either with CGP 56697 (4 x 4 tablets each containing 20 mg of artemether and 120 mg of benflumetol, given at 0, 8, 24, and 48 hr), or with mefloquine (three tablets of 250 mg at initial diagnosis, followed by two tablets of 250 mg at 8 hr). Baseline data of the two groups were comparable. The 28-day cure rate with CGP 56697 was lower than with mefloquine (69.3% versus 82.4%; P = 0.002). However, CGP 56697 was more effective than mefloquine in parasite clearance time (43 hr versus 66 hr; P < 0.001) fever clearance time (32 hr versus 54 hr; P < 0.005), and gametocyte clearance time (152 hr versus 331 hr; P < 0.001). This study revealed that CGP 56697 is effective against multidrug-resistant Plasmodium falciparum malaria in Thailand, but higher doses will probably be needed to improve the cure rare.