加纳化物 (KAF156) 加上 lumefantrine 固体分散配方组合用于无并发的 Plasmodium falciparum 疟疾:一个开放式,多中心,并行组,随机,受控的,第二阶段试验
Bernhards Ogutu1, Adoke Yeka2, Sylvia Kusemererwa3
1Centre for Clinical Research, Kenya Medical Research Institute, Kisumu, Kenya.
The Lancet. Infectious diseases
|June 16, 2023
概括
这种新型抗疟疾药物组合药物 - - ganaplacide加 lumefantrine固体分散配方 (SDF) - - 在治疗无并发性Plasmodium falciparum疟疾时显示出高的疗效和耐受性. 对于成年人,青少年和儿童来说,最佳剂量是400毫克的加纳普拉西德加上960毫克的卢梅芬特林-SDF,每天服用一次,持续三天.
科学领域:
- 热带医学是一种热带医学.
- 药理学 药理学是指药理学的学科.
- 传染病 传染病 传染病
背景情况:
- 抗疟疾药物耐药性需要新的治疗方法.
- 评估 ganaplacide 加上 lumefantrine 固体分散配方 (SDF) 对于没有并发症的菌疟疾.
研究的目的:
- 确定加纳普拉西德加卢梅芬特林-SDF的有效和耐受剂量.
- 评估成年人,青少年和儿童的疗效.
主要方法:
- 第二阶段,开放标签,多中心,随机对照试验.
- 测试了各种 ganaplacide 加上 lumefantrine-SDF 疗法,以对抗 artemether-lumefantrine.
- 主要终点:在第29天通过PCR校正的足够的临床和寄生虫学反应.
主要成果:
- 所有经过测试的加纳化物-卢梅林-SDF疗法都满足了成人和青少年的主要终点.
- 3天的治疗方案 (400毫克甘酸+960毫克卢梅芬-SDF) 对所有年龄组来说都是最佳的.
- 副作用一般是轻微的,没有死亡.
结论:
- 加纳普拉西德加卢梅芬特林-SDF对没有并发症的P. falciparum疟疾有效且耐受良好.
- 建议使用3天的治疗方案进行进一步评估.
- 这种组合提供了一个有前途的新治疗方案.
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