Evaluation of the comparative efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and artesunate-amodiaquine-chlorpheniramine (Artemoclo™) for the treatment of acute uncomplicated malaria in Nigerian children.
Evaluation of the comparative efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and artesunate-amodiaquine-chlorpheniramine (Artemoclo™) for the treatment of acute uncomplicated malaria in Nigerian children.
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DOI：
10.1159/000360578
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发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Ademowo OG
中科院分区：
文献类型：
--
作者：
Falade CO;Dada-Adegbola HO;Ogunkunle OO;Oguike MC;Nash O;Ademowo OG
评价蒿甲醚-苯芴醇（AL）、青蒿琥酯-阿莫地喹（ASAQ）和青蒿琥酯-阿莫地喹-氯苯那敏（AQC）治疗尼日利亚西南部儿童急性无并发症疟疾的疗效和安全性。160名6个月至14岁的急性无并发症疟疾儿童随机分为AL组（n = 53）、ASAQ组（n = 53）和AQC组（n = 54）。在第0-3天每天观察入组者，然后在第7、14、21、28和42天进行临床和寄生虫学评价。配对样本的基因组DNA在登记和复发的寄生虫血症时进行基因分型使用巢式PCR，以区分再感染和复发。作为安全性评价的一部分，在第0天、第7天和第28天对入组受试者子集进行了详细的血液学和生化评价。在160名儿童中，144名（90%）完成了研究。AL、ASAQ和AQC的平均发热清除时间和寄生虫清除时间相当（分别为p = 0.94和p = 0.122）。在第14天，AL和AQC的充分临床和寄生虫学应答（ACPR）为100%，ASAQ为90%（p = 0.39）。所有药物第28天和第42天的PCR未校正结果以及第42天的ACPR校正结果相似（分别为p = 0.62和p = 0.56）。AQC在第2天产生最佳寄生虫清除和血液学恢复（分别为p = 0.022和p = 0.018）。三种青蒿素类联合疗法对生化参数没有不利影响，而且耐受性良好。三种ACT有效且安全，但AQC在第2天的血液学恢复更好，在整个研究期间的治愈率更高。
To evaluate the comparative efficacy and safety of artemether-lumefantrine (AL), artesunate-amodiaquine (ASAQ) and artesunate-amodiaquine-chlorpheniramine (AQC) for the treatment of acute uncomplicated malaria among Southwest Nigerian children. One hundred and sixty children aged 6 months to 14 years with acute uncomplicated malaria were randomized to AL (n = 53), ASAQ (n = 53), or AQC (n = 54). Enrollees were seen daily on days 0-3 and then on days 7, 14, 21, 28 and 42 for clinical and parasitological evaluations. Paired samples of genomic DNA at enrolment and at the time of recurrent parasitaemia were genotyped using nested PCR to distinguish between reinfection and recrudescence. Detailed haematological and biochemical evaluations were carried out in a subset of enrollees on days 0, 7 and 28 as part of a safety evaluation. Of the 160 children, 144 (90%) completed the study. The mean fever clearance times and parasite clearance times for AL, ASAQ and AQC were comparable (p = 0.94 and p = 0.122, respectively). On day 14, the adequate clinical and parasitological response (ACPR) for AL and AQC was 100% and for ASAQ it was 90% (p = 0.39). The PCR-uncorrected results on days 28 and 42 and the ACPR-corrected results on day 42 were similar for all drugs (p = 0.62 and p = 0.56, respectively). AQC resulted in the best parasite clearance and haematological recovery on day 2 (p = 0.022 and p = 0.018, respectively). Biochemical parameters were not adversely affected by the three artemisinin-based combination therapies (ACTs) and these were well tolerated. The three ACTs were efficacious and safe, but AQC resulted in a better haematological recovery on day 2 and higher cure rates throughout the study period.
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影响因子：
3
作者：
Meremikwu, Martin;Alaribe, Ambrose;Ezedinachi, Emmanuel
通讯作者：
Ezedinachi, Emmanuel
DOI：
10.4269/ajtmh.2012.12-0058
发表时间：
2012-07-01
影响因子：
3.3
作者：
Maiga, Amelia W.;Fofana, Bakary;Djimde, Abdoulaye A.
通讯作者：
Djimde, Abdoulaye A.
DOI：
10.1016/s0035-9203(99)90120-7
发表时间：
1999-07-01
影响因子：
2.2
作者：
Snounou, G;Zhu, XP;Viriyakosol, S
通讯作者：
Viriyakosol, S
DOI：
10.4269/ajtmh.2011.11-0069
发表时间：
2011-11-01
影响因子：
3.3
作者：
Makanga, Michael;Bassat, Quique;Rosenthal, Philip J.
通讯作者：
Rosenthal, Philip J.
DOI：
10.1590/s0074-02762007005000038
发表时间：
2007-06-01
期刊：
Memórias do Instituto Oswaldo Cruz
影响因子：
--
作者：
Sowunmi, Akintunde;Gbotosho, Grace O;Oduola, Ayoade MJ
通讯作者：
Oduola, Ayoade MJ