Efficacy of oral pyronaridine for the treatment of acute uncomplicated falciparum malaria in African children
Efficacy of oral pyronaridine for the treatment of acute uncomplicated falciparum malaria in African children
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DOI：
10.1086/513942
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发表时间：
1998-04-01
影响因子：
11.8
通讯作者：
Basco, LK
中科院分区：
文献类型：
--
作者：
Ringwald, P;Bickii, J;Basco, LK
咯萘啶是我国中国研制的一种新的抗疟疾药物。在这项随机、非盲法研究中，对88名喀麦隆儿童急性无并发症恶性疟疾患者应用咯萘啶(n=44)和氯喹(n=44)的安全性、耐受性和临床疗效进行了评估，并与氯喹(非洲大部分地区的标准一线抗疟药)进行了比较。目标样本量被确定为检测两个处理组之间的体内耐药性差异35%，功率为95%。门诊监测了14天的临床和寄生虫学反应。7名儿童(3名接受咯萘啶治疗，4名接受氯喹治疗)失去随访，被排除在分析之外。应用咯萘啶治疗的41例患者全部治愈。在接受氯喹治疗的40名儿童中，有16名(40%)治疗失败。体外药敏试验表明，40株临床分离株中有23株对氯喹耐药。与服用咯萘啶相关的副作用很小，而且是短暂的。吡罗那利定是安全的，喀麦隆有症状的儿童耐受性良好，在非洲非常有效，因为那里对氯喹的抵抗力很强。
Pyronaridine is a new antimalarial agent developed in China. In this randomized, unblinded study, the safety, tolerance, and clinical efficacy of pyronaridine (n = 44) were evaluated and compared with those of chloroquine (n = 44), the standard first-line antimalarial drug in most of Africa, in 88 Cameroonian children with acute uncomplicated falciparum malaria. The target sample size was determined to detect a 35% difference in in vivo resistance between the two treatment groups, with 95% power. Clinical and parasitological responses were monitored for 14 days on an outpatient basis. Seven children (3 treated with pyronaridine and 4 treated with chloroquine) were lost to follow-up and were excluded from the analysis. All 41 patients treated with pyronaridine were cured. Treatment failure was observed in 16 (40%) of the 40 children treated with chloroquine. In vitro assays indicated that 23 of 40 clinical isolates obtained from patients treated with pyronaridine were resistant in vitro to chloroquine. Side effects associated with pyronaridine intake were minor and transient. Pyronaridine is safe and well tolerated by symptomatic Cameroonian children, and it is highly efficacious in Africa, where chloroquine resistance is well established.