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在老挝人民民主共和国,氯喹加周效磺胺-乙胺嘧啶与青蒿琥酯加甲氟喹以及蒿甲醚-本芴醇治疗非复杂性恶性疟的随机对照研究

Randomized comparison of chloroquine plus sulfadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic.

作者信息

Mayxay Mayfong, Khanthavong Maniphone, Lindegårdh Niklas, Keola Siamphay, Barends Marion, Pongvongsa Tiengkham, Yapom Ratsuda, Annerberg Anna, Phompida Samlane, Phetsouvanh Rattanaxay, White Nicholas J, Newton Paul N

机构信息

Wellcome Trust-Mahosot Hospital, Oxford Tropical Medicine Research Collaboration, Vientiane, Lao PDR.

出版信息

Clin Infect Dis. 2004 Oct 15;39(8):1139-47. doi: 10.1086/424512. Epub 2004 Sep 27.

Abstract

BACKGROUND

Recent clinical trials in the Lao People's Democratic Republic have demonstrated that chloroquine and sulfadoxine-pyrimethamine, which are national malaria treatment policy, are no longer effective in the treatment of uncomplicated Plasmodium falciparum malaria.

METHODS

A randomized comparison of 3 oral antimalarial combinations--chloroquine plus sulfadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine--with 42-day follow-up period, was conducted among 330 patients with acute uncomplicated falciparum malaria in southern Laos.

RESULTS

The 42-day cure rates, as determined by intention-to-treat analysis and adjusted for reinfection, were 100%, 97%, and 93% for the groups receiving artesunate plus mefloquine, artemether-lumefantrine, and chloroquine plus sulfadoxine-pyrimethamine, respectively. Of 8 patients receiving chloroquine plus sulfadoxine-pyrimethamine who experienced treatment failure, 6 had early treatment failure. The mean parasite clearance time was significantly longer in patients treated with chloroquine plus sulfadoxine-pyrimethamine (2.9 days; 95% confidence interval [CI], 2.8-3.0 days) than in those treated with artesunate plus mefloquine (2.07 days; 95% CI, 2.0-2.1 days; P<.001) and artemether-lumefantrine (2.08 days; 95% CI, 2.0-2.1 days; P<.001). Cure rates with artemether-lumefantrine were high despite low mean daily dietary fat intake (13.8 g; 95% CI, 12.5-15.1 g) and day 7 plasma lumefantrine concentrations (0.47 mu g/mL; 95% CI, 0.38-0.56 mu g/mL).

CONCLUSION

Oral artesunate plus mefloquine and artemether-lumefantrine are highly effective for the treatment of uncomplicated falciparum malaria in Laos.

摘要

背景

老挝人民民主共和国最近的临床试验表明,作为国家疟疾治疗政策的氯喹和磺胺多辛-乙胺嘧啶,对单纯性恶性疟原虫疟疾的治疗已不再有效。

方法

在老挝南部330例急性单纯性恶性疟患者中,对3种口服抗疟药物组合进行了随机比较——氯喹加磺胺多辛-乙胺嘧啶、青蒿琥酯加甲氟喹、蒿甲醚-本芴醇,并进行了42天的随访。

结果

在意向性分析确定并针对再感染进行调整后,接受青蒿琥酯加甲氟喹、蒿甲醚-本芴醇、氯喹加磺胺多辛-乙胺嘧啶治疗的组,其42天治愈率分别为100%、97%和93%。在接受氯喹加磺胺多辛-乙胺嘧啶治疗而出现治疗失败的8例患者中,6例出现早期治疗失败。接受氯喹加磺胺多辛-乙胺嘧啶治疗的患者,其平均疟原虫清除时间(2.9天;95%可信区间[CI],2.8 - 3.0天)显著长于接受青蒿琥酯加甲氟喹治疗的患者(2.07天;95%CI,2.0 - 2.1天;P<0.001)和接受蒿甲醚-本芴醇治疗的患者(2.08天;95%CI,2.0 - 2.1天;P<0.001)。尽管平均每日膳食脂肪摄入量较低(13.8克;95%CI,12.5 - 15.1克)且第7天血浆本芴醇浓度较低(0.47μg/mL;95%CI,0.38 - 0.56μg/mL),蒿甲醚-本芴醇的治愈率仍很高。

结论

口服青蒿琥酯加甲氟喹和蒿甲醚-本芴醇对老挝单纯性恶性疟的治疗非常有效。

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