Ringwald P, Bickii J, Basco L K
Institut Français de Recherche Scientifique pour le Développement en Coopération (ORSTOM), Yaoundé, Cameroon.
Clin Infect Dis. 1998 Apr;26(4):946-53. doi: 10.1086/513942.
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.
咯萘啶是中国研制的一种新型抗疟药。在这项随机、非盲研究中，对喀麦隆88名患急性非复杂性恶性疟的儿童进行了研究，评估并比较了咯萘啶（n = 44）与非洲大部分地区标准一线抗疟药氯喹（n = 44）的安全性、耐受性及临床疗效。目标样本量的确定是为了在两组治疗组间检测出35%的体内抗药差异，检验效能为95%。在门诊对临床和寄生虫学反应进行了14天的监测。7名儿童（3名接受咯萘啶治疗，4名接受氯喹治疗）失访，被排除在分析之外。所有41名接受咯萘啶治疗的患者均治愈。40名接受氯喹治疗的儿童中有16名（40%）出现治疗失败。体外试验表明，从接受咯萘啶治疗的患者中获得的40株临床分离株中有23株在体外对氯喹耐药。与服用咯萘啶相关的副作用轻微且短暂。咯萘啶对有症状的喀麦隆儿童安全且耐受性良好，在氯喹耐药情况普遍的非洲，它具有很高的疗效。
