在体疗效的蒿甲醚-本芴醇和氯喹对间日疟原虫：在埃塞俄比亚中部的随机开放标签试验。
In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
机构信息
Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
出版信息
PLoS One. 2013 May 22;8(5):e63433. doi: 10.1371/journal.pone.0063433. Print 2013.
BACKGROUND
In vivo efficacy assessments of antimalarials are essential for ensuring effective case management. In Ethiopia, chloroquine (CQ) without primaquine is the first-line treatment for Plasmodium vivax in malarious areas, but artemether-lumefantrine (AL) is also commonly used.
METHODS AND FINDINGS
In 2009, we conducted a 42-day efficacy study of AL or CQ for P. vivax in Oromia Regional State, Ethiopia. Individuals with P. vivax monoinfection were enrolled. Primary endpoint was day 28 cure rate. In patients with recurrent parasitemia, drug level and genotyping using microsatellite markers were assessed. Using survival analysis, uncorrected patient cure rates at day 28 were 75.7% (95% confidence interval (CI) 66.8-82.5) for AL and 90.8% (95% CI 83.6-94.9) for CQ. During the 42 days of follow-up, 41.6% (47/113) of patients in the AL arm and 31.8% (34/107) in the CQ arm presented with recurrent P. vivax infection, with the median number of days to recurrence of 28 compared to 35 days in the AL and CQ arm, respectively. Using microsatellite markers to reclassify recurrent parasitemias with a different genotype as non-treatment failures, day 28 cure rates were genotype adjusted to 91.1% (95% CI 84.1-95.1) for AL and to 97.2% (91.6-99.1) for CQ. Three patients (2.8%) with recurrent parasitemia by day 28 in the CQ arm were noted to have drug levels above 100 ng/ml.
CONCLUSIONS
In the short term, both AL and CQ were effective and well-tolerated for P. vivax malaria, but high rates of recurrent parasitemia were noted with both drugs. CQ provided longer post-treatment prophylaxis than AL, resulting in delayed recurrence of parasitemia. Although the current policy of species-specific treatment can be maintained for Ethiopia, the co-administration of primaquine for treatment of P. vivax malaria needs to be urgently considered to prevent relapse infections.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01052584.
背景
抗疟药物的体内疗效评估对于确保有效的病例管理至关重要。在埃塞俄比亚，氯喹（CQ）加伯氨喹是疟疾流行地区治疗间日疟原虫的一线药物，但也常使用青蒿琥酯-咯萘啶（AL）。
方法和发现
2009 年，我们在埃塞俄比亚奥罗米亚地区进行了一项为期 42 天的 AL 或 CQ 治疗间日疟原虫的疗效研究。入组患者为间日疟原虫单感染患者。主要终点为第 28 天的治愈率。对出现复发寄生虫血症的患者，评估药物水平和微卫星标记物基因分型。采用生存分析，未经校正的第 28 天患者治愈率为 AL 组 75.7%（95%置信区间（CI）66.8-82.5），CQ 组 90.8%（95%CI 83.6-94.9）。在 42 天的随访期间，AL 组有 41.6%（47/113）的患者和 CQ 组有 31.8%（34/107）的患者出现间日疟原虫复发，复发的中位时间分别为 28 天和 35 天。使用微卫星标记物将不同基因型的复发寄生虫血症重新归类为非治疗失败，对第 28 天的治愈率进行基因分型校正，AL 组为 91.1%（95%CI 84.1-95.1），CQ 组为 97.2%（91.6-99.1）。在 CQ 组，有 3 名（2.8%）在第 28 天仍有寄生虫血症的患者药物水平高于 100ng/ml。
结论
在短期内，AL 和 CQ 对间日疟原虫均有效且耐受性良好，但两种药物均出现较高的寄生虫血症复发率。CQ 提供的治疗后预防时间长于 AL，导致寄生虫血症的复发延迟。尽管埃塞俄比亚目前可以维持针对特定物种的治疗政策，但急需考虑联合使用伯氨喹治疗间日疟原虫，以预防复发感染。
试验注册
ClinicalTrials.gov NCT01052584。
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