在国家疟疾控制规划在Côte科特迪瓦部署5年后对一线抗疟药物疗效的评估

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
A. Offianan, S. Assi, A. Coulibaly, L. T. N’Guessan, A. A. Ako, Florence Kadjo, Moïse K San, L. Penali
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引用次数: 6

摘要

通信:Andre T Offianan,科特迪瓦巴斯德研究所疟疾学系,科特迪瓦阿比让01邮政信箱490,电话+225 22 44 84 25传真+225 22 48 53 05电子邮件andre_offianan@yahoo.fr背景:青蒿素耐药性的出现使人们担心最有效的抗疟药物可能受到威胁。青蒿琥酯+阿莫地喹(ASAQ)和蒿甲醚甲芳啶(AL)分别是科特迪瓦治疗无并发症恶性疟疾的一线和二线药物。比较两种联合用药的疗效和安全性是制定循证药物治疗政策的必要依据。方法:在一项开放标签、非效性、随机对照临床试验中,6-59月龄儿童随机接受ASAQ或AL治疗,两种药物治疗方案均为3 d,随访28 d。主要终点是28天治愈率,定义为28天随访后聚合酶链反应(PCR)校正治愈率的患者比例。研究结果:共有251名在Ayame和Dabakala医院就诊并出现急性无并发症恶性疟疾症状的患者被随机分配到ASAQ组(128名)和AL组(123名)。意向治疗分析显示,第28天ASAQ和AL的有效率分别为94.5%和93.5%。在对PCR结果进行调整后,这两个比率分别为96.1%和96.8%。第28天,按方案分析显示,ASAQ和AL的有效率分别为98.4%和96.6%。经PCR检测再感染后,每种药物的再感染率均为100%,两种方案均耐受良好。结论:ASAQ和AL仍是科特迪瓦儿童收养后5年无并发症恶性疟疾的有效治疗方法。因此,科特迪瓦的ASAQ和AL的效果需要持续监测和评价。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Assessment of the efficacy of first-line antimalarial drugs after 5 years of deployment by the National Malaria Control Programme in Côte d'Ivoire
Correspondence: Andre T Offianan Malariology Department, Institut Pasteur de Cote d’Ivoire, PO Box 490, Abidjan 01, Cote d’Ivoire Tel +225 22 44 84 25 Fax +225 22 48 53 05 Email andre_offianan@yahoo.fr Background: The emergence of artemisinin resistance has raised concerns that the most potent antimalarial drug may be under threat. Artesunate + amodiaquine (ASAQ) and artemetherlumefantrine (AL) are respectively the firstand second-line treatments for uncomplicated falciparum malaria in Cote d’Ivoire. A comparison of the efficacy and safety of these two drug combinations was necessary to make evidence-based drug treatment policies. Methods: In an open-label, non inferiority, randomized, controlled clinical trial, children aged 6–59 months were randomized to receive ASAQ or AL. Both drug regimens were given for 3 days, and follow-up was for 28 days. The primary endpoint was the 28-day cure rates and was defined as proportion of patients with polymerase chain reaction (PCR)-corrected cure rate after 28 days of follow-up. Findings: A total of 251 patients who were attending the Ayame and Dabakala hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive ASAQ (128) and AL (123). The intention-to-treat analysis showed effectiveness rates of 94.5% and 93.5% for ASAQ and AL, respectively on day 28. After adjustment for PCR results, these rates were 96.1% and 96.8%, respectively. On day 28, the per-protocol analysis showed effectiveness rates of 98.4% and 96.6% for ASAQ and AL, respectively. After adjustment by PCR for reinfection, these rates were 100% for each drug, and both regimens were well tolerated. Conclusion: ASAQ and AL remain efficacious treatments of uncomplicated falciparum malaria in Ivorian children 5 years after adoption. The efficacy of ASAQ and AL in Cote d’Ivoire requires, therefore, continuous monitoring and evaluation.
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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