Efficacy of methylene blue monotherapy in semi-immune adults with uncomplicated falciparum malaria: a controlled trial in Burkina Faso
Efficacy of methylene blue monotherapy in semi-immune adults with uncomplicated falciparum malaria: a controlled trial in Burkina Faso
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DOI：
10.1111/j.1365-3156.2010.02526.x
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发表时间：
2010-06-01
影响因子：
3.3
通讯作者：
Muller, Olaf
中科院分区：
文献类型：
--
作者：
Bountogo, Mamadou;Zoungrana, Augustin;Muller, Olaf
目的评价亚甲蓝（MB）单药治疗布基纳法索无并发症的半免疫成人恶性疟的疗效。方法在布基纳法索西北部努纳60例无并发症的半免疫成人恶性疟的开放标签对照II期研究中，MB单药治疗（390 mg，每日2次）分别连续给药7天（MB 7）、5天（MB 5）和3天（MB 3）。主要结果是充分的临床和寄生虫学反应（ACPR）在第28天following. Results的研究人群中，27/58（47%）和5/51（10%）患者仍然有寄生虫在第2天和第3天，分别导致9/58（16%）的早期治疗失败的后续行动。到第14天，未观察到复发，但到第28天，在4/19（MB 5）和2/20（MB 3）个体中观察到复发。按符合方案分析，第7、5和3组ACPR的PCR校正率分别为72%、58%和85%。自限性排尿困难是最常见的不良事件。结论MB对恶性疟原虫的血液阶段作用缓慢。单用甲基溴至少需要服用7天才能有效治疗恶性疟疾，但应与速效抗疟药联合使用。
OBJECTIVE To assess the efficacy of methylene blue (MB) monotherapy in semi-immune adults with uncomplicated malaria in Burkina Faso.METHODS In an open-label controlled phase II study with 60 semi-immune adults with uncomplicated falciparum malaria in Nouna, north-western Burkina Faso, MB monotherapy (390 mg twice daily) was given sequentially to groups of 20 adults for 7 days (MB7), 5 days (MB5) and 3 days (MB3), respectively. The primary outcome was the rate of adequate clinical and parasitological response (ACPR) on day 28 of follow-up.RESULTS Of the study population, 27/58 (47%) and 5/51 (10%) patients still had parasites on days 2 and 3, respectively, of follow-up resulting in 9/58 (16%) early treatment failures. By day 14, no recrudescence was observed but in 4/19 (MB5) and 2/20 (MB3) individuals by day 28. The PCR-corrected rate of ACPR was 72%, 58% and 85% in groups 7, 5 and 3, respectively, by per protocol analysis. Self-limiting dysuria was the most frequent adverse event.CONCLUSIONS MB acts slowly against the blood stages of P. falciparum. MB alone needs to be given for at least 7 days to be efficacious in the treatment of falciparum malaria but should be used in combination with a fast acting antimalarial.