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在布基纳法索,合并配方的甲氟喹和青蒿琥酯在感染非复杂性恶性疟原虫的孕妇和非孕妇中的药代动力学。

Pharmacokinetics of co-formulated mefloquine and artesunate in pregnant and non-pregnant women with uncomplicated Plasmodium falciparum infection in Burkina Faso.

作者信息

Valea Innocent, Tinto Halidou, Traore-Coulibaly Maminata, Toe Laeticia C, Lindegardh Niklas, Tarning Joel, Van Geertruyden Jean-Pierre, D'Alessandro Umberto, Davies Geraint R, Ward Stephen A

机构信息

Unité de Recherche Paludisme et Maladies Tropicales Négligées, Centre Muraz, Bobo-Dioulasso, Burkina Faso Institut de Recherche en Sciences de la Santé, Unité de Recherche Clinique de Nanoro, Nanoro, Burkina Faso

Unité de Recherche Paludisme et Maladies Tropicales Négligées, Centre Muraz, Bobo-Dioulasso, Burkina Faso Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso.

出版信息

J Antimicrob Chemother. 2014 Sep;69(9):2499-507. doi: 10.1093/jac/dku154. Epub 2014 Jun 2.

Abstract

OBJECTIVES

Mefloquine/artesunate has recently been developed as a fixed-dose combination, providing a promising rescue/alternative treatment for malaria during pregnancy. However, limited data are available on the effect of pregnancy on its pharmacokinetic properties. This study was conducted to assess the pharmacokinetic properties of mefloquine/carboxymefloquine and artesunate/dihydroartemisinin in pregnant and non-pregnant women with uncomplicated malaria.

METHODS

Twenty-four women in their second and third trimesters of pregnancy and 24 paired non-pregnant women were enrolled. All patients were treated for uncomplicated Plasmodium falciparum malaria with a standard fixed-dose combination of oral mefloquine and artesunate one daily over 3 days. Frequent blood samples were collected before treatment and at scheduled times post-dose for the drug measurements and pharmacokinetic analyses. The study was registered at www.clinicaltrials.gov (identifier: NCT00701961).

RESULTS

The total median exposure to mefloquine and dihydroartemisinin was not significantly different between the pregnant and non-pregnant women (P>0.05). There was a trend of higher exposure to mefloquine in the pregnant women, but this difference did not reach statistical significance (656700 versus 542400 h × ng/mL; P=0.059). However, the total exposure to carboxymefloquine was 49% lower during pregnancy (735600 versus 1499000 h × ng/mL; P<0.001) and the total drug exposure to artesunate was 42% higher during pregnancy (89.0 versus 62.9 h × ng/mL; P=0.039) compared with non-pregnant controls.

CONCLUSIONS

The plasma levels of mefloquine and dihydroartemisinin appeared to be similar in both pregnant and non-pregnant women, but there were significant differences in carboxymefloquine and artesunate exposure. The data presented here do not warrant a dose adjustment in pregnant patients, but an extensive analysis of the data could provide a better understanding of these findings.

摘要

目的

甲氟喹/青蒿琥酯最近已被开发成一种固定剂量复方制剂,为孕期疟疾提供了一种有前景的挽救/替代治疗方案。然而,关于妊娠对其药代动力学特性影响的数据有限。本研究旨在评估甲氟喹/羧甲氟喹和青蒿琥酯/双氢青蒿素在患有非复杂性疟疾的孕妇和非孕妇中的药代动力学特性。

方法

招募了24名处于妊娠中晚期的女性和24名配对的非妊娠女性。所有患者均接受标准固定剂量复方口服甲氟喹和青蒿琥酯治疗,每日1次,持续3天,用于治疗非复杂性恶性疟原虫疟疾。在治疗前及给药后的预定时间采集多次血样,用于药物测定和药代动力学分析。该研究已在www.clinicaltrials.gov上注册(标识符:NCT00701961)。

结果

孕妇和非孕妇中甲氟喹和双氢青蒿素的总中位暴露量无显著差异(P>0.05)。孕妇中甲氟喹的暴露量有升高趋势,但这种差异未达到统计学意义(656700对542400 h×ng/mL;P=0.059)。然而,与非妊娠对照组相比,孕期羧甲氟喹的总暴露量降低了49%(735600对1499000 h×ng/mL;P<0.001),孕期青蒿琥酯的总药物暴露量升高了42%(89.0对62.9 h×ng/mL;P=0.039)。

结论

孕妇和非孕妇中甲氟喹和双氢青蒿素的血浆水平似乎相似,但羧甲氟喹和青蒿琥酯的暴露量存在显著差异。此处呈现的数据并不支持对孕妇进行剂量调整,但对这些数据进行广泛分析可能会更好地理解这些发现。

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