青蒿琥酯/磺胺多辛-乙胺嘧啶与青蒿琥酯/阿莫地喹治疗喀麦隆山山坡附近儿童单纯性疟疾的疗效：一项随机对照试验。
Efficacy of Artesunate/Sulphadoxine-Pyrimethamine Artesunate/Amodiaquine in the Treatment of Uncomplicated Malaria in Children around the Slope of Mount Cameroon: A Randomized Controlled Trial.
作者信息
Apinjoh Tobias O, Anchang-Kimbi Judith K, Ajonina Marcelus U, Njonguo Esther T, Njua-Yafi Clarisse, Ngwai Andre N, Mugri Regina N, Achidi Eric A
机构信息
Department of Biochemistry and Molecular Biology, University of Buea, PO Box 63 Buea, Cameroon.
Department of Zoology and Animal Physiology, University of Buea, PO Box 63 Buea, Cameroon.
出版信息
Biomedicines. 2016 Feb 15;4(1):5. doi: 10.3390/biomedicines4010005.
BACKGROUND
The development and spread of antimalarial drug resistant parasites contributes to the global impact of the disease. efficacy assessments of treatments for malaria are essential for ensuring effective case management. Artemisinin-based combinations have been adopted as the first-line treatment for uncomplicated malaria in Cameroon since 2004.
METHODS
A total of 177 children aged six-months to 10 years with uncomplicated mono-infected falciparum malaria were randomized (1:1) to receive artesunate/sulphadoxine-pyrimethamine (AS/SP) or artesunate/amodiaquine (AS/AQ) pediatric tablets and followed up for 28 days according to the standard World Health Organization drug efficacy monitoring protocol. The primary and secondary endpoints were PCR uncorrected and corrected cure rates, as measured by adequate clinical and parasitological response (ACPR) on day 28.
RESULTS
The PCR corrected cure rate was high, overall (88.1%, 95% CI 83.1-93.1), 85.9% (95% CI 78.2-93.6), and 90.2% (95% CI 83.8-96.6) for AS/SP and AS/AQ, respectively. Twenty-one treatment failures were observed during follow-up, constituting one (4.6%), 14 (8.2%), and six (3.5%) early treatment failure (ETF), late clinical failure (LCF), and late parasitological failure (LPF), respectively. The drugs were well tolerated with no serious adverse events.
CONCLUSIONS
Both AS/SP and AS/AQ are highly effective and well-tolerated treatments for uncomplicated malaria around the slope of Mount Cameroon.
背景
抗疟药物耐药性寄生虫的发展和传播加剧了疟疾对全球的影响。疟疾治疗效果评估对于确保有效的病例管理至关重要。自2004年以来，以青蒿素为基础的联合用药已被用作喀麦隆单纯性疟疾的一线治疗药物。
方法
总共177名年龄在6个月至10岁之间的单纯性恶性疟原虫单感染疟疾儿童被随机分组（1:1），接受青蒿琥酯/磺胺多辛-乙胺嘧啶（AS/SP）或青蒿琥酯/阿莫地喹（AS/AQ）儿童片剂治疗，并根据世界卫生组织标准药物疗效监测方案进行28天的随访。主要和次要终点是第28天通过充分的临床和寄生虫学反应（ACPR）测量的PCR未校正治愈率和校正治愈率。
结果
总体而言，PCR校正治愈率很高，AS/SP和AS/AQ分别为88.1%（95%CI 83.1 - 93.1）、85.9%（95%CI 78.2 - 93.6）和90.2%（95%CI 83.8 - 96.6）。随访期间观察到21例治疗失败，分别构成1例（4.6%）早期治疗失败（ETF）、14例（8.2%）晚期临床失败（LCF）和6例（3.5%）晚期寄生虫学失败（LPF）。这些药物耐受性良好，未出现严重不良事件。
结论
AS/SP和AS/AQ都是喀麦隆山山坡周围单纯性疟疾的高效且耐受性良好的治疗药物。
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