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青蒿琥酯-阿莫地喹与青蒿琥酯-甲氟喹治疗布基纳法索纳诺罗无并发症恶性疟的疗效比较:一项非劣效性随机试验。

Effectiveness of artesunate-amodiaquine vs. artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Nanoro, Burkina Faso: a non-inferiority randomised trial.

机构信息

Unité de Recherche sur le Paludisme et les Maladies Tropicales Négligées, Centre Muraz, Bobo-Dioulasso, Burkina Faso; Institut de Recherche en Sciences de la Santé, Direction Régionale, Bobo-Dioulasso, Burkina Faso; Clinical Research Unit of Nanoro, Nanoro, Burkina Faso.

出版信息

Trop Med Int Health. 2014 Apr;19(4):469-75. doi: 10.1111/tmi.12274. Epub 2014 Feb 5.

DOI:10.1111/tmi.12274
PMID:24494602
Abstract

OBJECTIVES

Artemisinin-based combination therapies (ACTs) are essential for the effective control of falciparum malaria in endemic countries. However, in most countries, such choice has been carried out without knowing their effectiveness when deployed in real-life conditions, that is, when treatment is not directly observed. We report here the results of a study assessing the effectiveness of the two ACTs currently recommended in Burkina Faso for the treatment of uncomplicated malaria, that is, artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ).

METHODS

Between September 2008 and January 2010, 340 children were randomised to one of the two study arms and followed up for 42 days. Treatment was administered according to routine practices, that is, the first dose was given by study nurses who explained to the parent/guardian how to administer the other doses at home during the following 2 days.

RESULTS

The results showed a significantly higher unadjusted adequate clinical and parasitological response in the ASAQ (58.4%) than in the AL arm (46.1%) at day 28 but these trends were similar after correction with PCR data (ASAQ (89.7%) and AL (89.8%)). New infections started to appear after day 14, first in the AL and then in the ASAQ arm but at day 42 day of follow-up we observed no difference in the occurrence of recrudescent infection.

CONCLUSION

Despite a lower cure rate than those reported in efficacy studies in which the treatment administration was directly observed, both AL and ASAQ can still be used for the treatment of uncomplicated malaria in Burkina Faso.

摘要

目的

在流行疟疾的国家,青蒿素类复方疗法(ACTs)是有效控制恶性疟的关键。然而,在大多数国家,这种疗法的选择都是在不了解其在实际情况下的疗效的情况下进行的,也就是说,在治疗未被直接观察的情况下。我们在此报告了一项评估在布基纳法索目前推荐用于治疗无并发症疟疾的两种 ACT(即青蒿琥酯- 本芴醇(AL)和青蒿琥酯- 阿莫地喹(ASAQ))的疗效的研究结果。

方法

2008 年 9 月至 2010 年 1 月,340 名儿童被随机分配到两个研究组,并随访 42 天。治疗按照常规做法进行,即由研究护士先给予首剂量,然后向家长/监护人解释如何在接下来的 2 天在家中给予其余剂量。

结果

结果显示,在第 28 天,ASAQ 组(58.4%)的未经调整的充分临床和寄生虫学反应显著高于 AL 组(46.1%),但这些趋势在使用 PCR 数据校正后相似(ASAQ(89.7%)和 AL(89.8%))。新的感染在第 14 天后开始出现,首先在 AL 组,然后在 ASAQ 组,但在第 42 天的随访中,我们观察到复发性感染的发生率没有差异。

结论

尽管治疗管理直接观察的疗效研究中报告的治愈率较低,但 AL 和 ASAQ 仍可用于治疗布基纳法索的无并发症疟疾。

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