氯喹二氨嘧啶-氨苯砜-青蒿琥酯与氯喹二氨嘧啶-氨苯砜：一项在非洲患有无并发症恶性疟原虫疟疾的儿童、青少年和成年患者中进行的随机、双盲、III 期试验。

Chlorproguanil-dapsone-artesunate versus chlorproguanil-dapsone: a randomized, double-blind, phase III trial in African children, adolescents, and adults with uncomplicated Plasmodium falciparum malaria.

机构信息

Centre National de Recherche et de Formation sur le Paludisme, Ministère de la Santé, Ouagadougou, Burkina Faso.

出版信息

Am J Trop Med Hyg. 2009 Dec;81(6):969-78. doi: 10.4269/ajtmh.2009.09-0351.

DOI:10.4269/ajtmh.2009.09-0351

PMID:19996424

Abstract

This multi-center, randomized, parallel-group, double-blind, double-dummy study compared the efficacy and safety of chlorproguanil-dapsone-artesunate (CDA) and chlorproguanil-dapsone (CPG-DDS) in the treatment of falciparum malaria in Africa (Burkina Faso, Ghana, Mali, Nigeria). Six hundred patients (>or= 1 year of age) received CDA 2.0/2.5/4.0 mg/kg, and 292 CPG-DDS 2.0/2.5 mg/kg, once daily for 3 days. Day 28 parasitologic cure rate (polymerase chain reaction [PCR]-corrected, per-protocol population) was 89.1% (416/467) for CDA, non-inferior but also superior to CPG-DDS, 83.0% (176/212) (treatment difference 6.1%; 95% confidence interval [CI] 0.3, 11.9). Glucose-6-phosphate dehydrogenase (G6PD) genotype was available for 844/892 (95%) patients. Occurrences of a composite hemoglobin safety endpoint (hemoglobin drop >or= 40 g/L or >or= 40% versus baseline, hemoglobin < 50 g/L, or blood transfusion) were CDA 13/44 (30%), CPG-DDS 7/24 (29%) in G6PD-deficient patients versus CDA 4/448 (< 1%), CPG-DDS 6/221 (3%) in G6PD-normal patients. No deaths occurred. CDA was more efficacious than CPG-DDS. However, the hemolytic potential in G6PD-deficient patients does not support further development of CDA.

摘要

这项多中心、随机、平行分组、双盲、双模拟研究比较了氯喹-氨苯砜-青蒿琥酯（CDA）和氯喹-氨苯砜（CPG-DDS）在非洲（布基纳法索、加纳、马里、尼日利亚）治疗恶性疟原虫疟疾的疗效和安全性。600 名（年龄大于等于 1 岁）患者接受了 CDA 2.0/2.5/4.0 mg/kg，292 名患者接受了 CPG-DDS 2.0/2.5 mg/kg，每天一次，连续 3 天。第 28 天寄生虫学治愈率（聚合酶链反应[PCR]校正，按方案人群）为 CDA 89.1%（416/467），不劣效且优于 CPG-DDS，83.0%（176/212）（治疗差异 6.1%；95%置信区间[CI]0.3，11.9）。葡萄糖-6-磷酸脱氢酶（G6PD）基因型可用于 844/892（95%）患者。复合血红蛋白安全性终点（血红蛋白下降>40 g/L 或>40%与基线相比，血红蛋白<50 g/L 或输血）的发生率为 CDA 13/44（30%），CPG-DDS 7/24（29%）在 G6PD 缺乏患者中，而 CDA 4/448（<1%），CPG-DDS 6/221（3%）在 G6PD 正常患者中。无死亡病例发生。CDA 比 CPG-DDS 更有效。然而，G6PD 缺乏患者的溶血潜力不支持进一步开发 CDA。