Brasseur Philippe, Agnamey Patrice, Gaye Oumar, Vaillant Michel, Taylor Walter R J, Olliaro Piero L
UR 077, IRD, Dakar, Sénégal.
Malar J. 2007 Nov 15;6:150. doi: 10.1186/1475-2875-6-150.
There are no data on the long term use of an artemisinin combination treatment in moderate or high transmission areas of Africa.
Artesunate plus amodiaquine (AS+AQ) was used to treat slide-proven Plasmodium falciparum-infected patients of all ages in the Oussouye district, Casamance, Senegal, over a period of six years (2000 to 2005). Efficacy, by Kaplan Meier survival analysis (n = 966), and safety (adverse event rates, n = 752) were determined over 28 days. A weight-based dosing regimen was used for the loose tablets during 2000-2003 (n = 731) and a commercially available co-blister was used during 2004-2005 (n = 235). Annual crude (non PCR corrected) rates remained stable over the study period [range 88.5-96.7%; overall 94.6 (95% CI 92.9-95.9)]. Nine co-blister treated patients (0.9%) withdrew because of drug-related adverse events; seven had gastrointestinal complaints of whom two were hospitalized for vomiting. By Day 28, the mean total bilirubin (n = 72), AST (n = 94) and ALT (n = 95) values decreased. Three patients had Day 28 AST/ALT values > 40 < 200 IU/L. Changes in white cell counts were unremarkable (n = 87).
AS+AQ in combination was highly efficacious and well-tolerated in this area and justifies the decision to use it as first line treatment. Long-term monitoring of safety and efficacy should continue.
在非洲疟疾中度或高度传播地区，尚无关于青蒿素联合疗法长期使用的数据。
在六年期间（2000年至2005年），采用青蒿琥酯加阿莫地喹（AS+AQ）治疗塞内加尔卡萨芒斯大区乌苏耶区所有年龄经镜检确诊的恶性疟原虫感染患者。通过Kaplan Meier生存分析（n = 966）确定28天内的疗效，通过不良事件发生率（n = 752）确定安全性。2000 - 2003年期间（n = 731）对散装片剂采用基于体重的给药方案，2004 - 2005年期间（n = 235）使用市售复方泡罩包装。在研究期间，年度粗（未校正PCR）率保持稳定[范围88.5 - 96.7%；总体94.6（95% CI 92.9 - 95.9）]。9名接受复方泡罩包装治疗的患者（0.9%）因药物相关不良事件退出；7名有胃肠道不适，其中2名因呕吐住院。到第28天，平均总胆红素（n = 72）、AST（n = 94）和ALT（n = 95）值下降。3名患者第28天的AST/ALT值> 40 < 200 IU/L。白细胞计数变化不显著（n = 87）。
AS+AQ联合用药在该地区疗效高且耐受性良好，证明将其用作一线治疗的决定是合理的。应继续对安全性和疗效进行长期监测。
