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一项随机开放标签临床试验,比较静脉注射奎宁后口服马拉隆与静脉注射奎宁后口服奎宁治疗重症疟疾的疗效和安全性。

A randomized open label clinical trial to compare the efficacy and safety of intravenous quinine followed by oral malarone vs. intravenous quinine followed by oral quinine in the treatment of severe malaria.

作者信息

Esamai F, Tenge C N, Ayuo P O, Ong'or W Owino, Obala A, Jakait B

机构信息

Department of Child Health and Paediatrics, Faculty of Health Sciences, Moi University, Kenya.

出版信息

J Trop Pediatr. 2005 Feb;51(1):17-24. doi: 10.1093/tropej/fmh069. Epub 2004 Dec 15.

DOI:10.1093/tropej/fmh069
PMID:15601653
Abstract

The treatment of patients with severe malaria in sub-Saharan Africa has become a challenge to clinicians due to poor compliance to quinine and the increasing multidrug resistance to antimalarials by the P. falciparum parasite. The aim of this study was to compare the efficacy and safety profile of two truncated antimalarial regimens of intravenous quinine followed by oral Malarone (Malarone arm) with intravenous quinine followed by oral quinine (quinine arm) in the treatment of severe P. falciparum malaria. The outcome measures were parasite clearance time, fever clearance time, efficacy, and adverse events profile. Consecutive patients aged 1-60 years, with a diagnosis of severe malaria with positive blood smears for P. falciparum parasites and admitted to the Moi Teaching and Referral Hospital were randomized into the two study arms. Of the 360 patients studied 167 and 193 cases were randomized into the Malarone and quinine arms, respectively. Of the five (1.4 per cent) patients who died, three came from the quinine arm. The frequency of adverse reactions was higher in the oral quinine group (31.6 per cent) than in the Malarone group (25.7 per cent). The mean parasite clearance time was 120 h and 108 h for the quinine and Malarone arms of the study, respectively, and the mean fever clearance times were 84 h and 72 h for the quinine and Malarone arms, respectively (p=0.1). Truncated therapeutic regimen using malarone after intravenous quinine is safer and as effective as conventional intravenous quinine followed by oral quinine in the treatment of severe malaria. The P. falciparum recrudescence rate was lower with the use of Malarone than for quinine.

摘要

在撒哈拉以南非洲地区,由于患者对奎宁的依从性较差以及恶性疟原虫对抗疟药物的多重耐药性不断增加,重症疟疾患者的治疗已成为临床医生面临的一项挑战。本研究的目的是比较两种截短抗疟方案的疗效和安全性,一种是静脉注射奎宁后口服马拉隆(马拉隆组),另一种是静脉注射奎宁后口服奎宁(奎宁组),用于治疗重症恶性疟原虫疟疾。观察指标为寄生虫清除时间、发热清除时间、疗效和不良事件情况。年龄在1至60岁、诊断为重症疟疾且血涂片疟原虫阳性并入住莫伊教学与转诊医院的连续患者被随机分为两个研究组。在研究的360例患者中,分别有167例和193例被随机分到马拉隆组和奎宁组。在死亡的5例(1.4%)患者中,3例来自奎宁组。口服奎宁组的不良反应发生率(31.6%)高于马拉隆组(25.7%)。研究中奎宁组和马拉隆组的平均寄生虫清除时间分别为120小时和108小时,平均发热清除时间分别为84小时和72小时(p = 0.1)。静脉注射奎宁后使用马拉隆的截短治疗方案在治疗重症疟疾时更安全,且与传统的静脉注射奎宁后口服奎宁一样有效。使用马拉隆时恶性疟原虫的复发率低于奎宁。

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