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两种青蒿琥酯直肠给药/甲氟喹口服联合用药方案治疗儿童单纯性恶性疟的有效性和药代动力学比较研究

Comparative study of the effectiveness and pharmacokinetics of two rectal artesunate/oral mefloquine combination regimens for the treatment of uncomplicated childhood falciparum malaria.

作者信息

Sirivichayakul Chukiat, Sabchareon Arunee, Pengsaa Krisana, Thaiarporn Itthipon, Chaivisuth Anong, Na-Bangchang Kesara, Wisetsing Pataraporn, Chanthavanich Pornthep, Pojjaroen-Anant Chanathep

机构信息

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, 420/6 Rachawithi Road, Bangkok 10400, Thailand.

出版信息

Ann Trop Paediatr. 2007 Mar;27(1):17-24. doi: 10.1179/146532807X170466.

DOI:10.1179/146532807X170466
PMID:17469728
Abstract

BACKGROUND

Rectal artesunate has been shown to be an effective treatment for falciparum malaria and is useful in patients who cannot take medicine orally or when parenteral medication is inconvenient. A combination with mefloquine can decrease the duration of treatment, increase compliance and delay development of resistance. There are no clear data on whether a higher dosage of rectal artesunate results in a better clinical response.

AIM

To assess two rectal artesunate/oral mefloquine regimens for treating uncomplicated multi-drug-resistant childhood falciparum malaria.

METHODS

Seventy children aged 1-14 years with uncomplicated falciparum malaria were randomly assigned to receive either 10 (range 8-12) or 20 (range 16-24) mg/kg/day rectal artesunate for 3 days followed by 25 mg/kg oral mefloquine. The study endpoints were fever clearance time, parasite clearance time and proportion of patients with recrudescence. Serum levels of artesunate and dihydro-artemisinin were measured after the first dose of rectal artesunate in 16 subjects.

RESULTS

Both regimens were safe and effective. The cure rate was 100% in the 53 patients who completed 28-day follow-up. All of the study endpoints were comparable between both treatment groups.

CONCLUSION

A regimen of rectal artesunate 10 mg/kg/day for 3 days followed by mefloquine 25 mg/kg is optimal for the treatment of uncomplicated falciparum malaria. There was no definite benefit from increasing the dosage of rectal artesunate from 10 to 20 mg/kg/day.

摘要

背景

直肠用青蒿琥酯已被证明是治疗恶性疟的有效方法,适用于无法口服药物或胃肠外用药不便的患者。与甲氟喹联用可缩短治疗时间、提高依从性并延缓耐药性的产生。目前尚无明确数据表明更高剂量的直肠用青蒿琥酯是否能带来更好的临床反应。

目的

评估两种直肠用青蒿琥酯/口服甲氟喹方案治疗儿童非复杂性多药耐药恶性疟的效果。

方法

70名1 - 14岁患非复杂性恶性疟的儿童被随机分配,接受10(8 - 12毫克/千克/天范围)或20(16 - 24毫克/千克/天范围)毫克/千克/天的直肠用青蒿琥酯治疗3天,随后口服25毫克/千克甲氟喹。研究终点为退热时间、寄生虫清除时间和复发患者比例。16名受试者在首次直肠用青蒿琥酯给药后测量了青蒿琥酯和双氢青蒿素的血清水平。

结果

两种方案均安全有效。完成28天随访的53名患者治愈率为100%。两个治疗组之间所有研究终点均具有可比性。

结论

直肠用青蒿琥酯10毫克/千克/天治疗3天,随后给予25毫克/千克甲氟喹的方案是治疗非复杂性恶性疟的最佳方案。将直肠用青蒿琥酯剂量从10毫克/千克/天增加到20毫克/千克/天并无明确益处。

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