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青蒿琥酯-咯萘啶治疗苏丹东部无并发症间日疟原虫疟疾的疗效。

Efficacy of artemether-lumefantrine as a treatment for uncomplicated Plasmodium vivax malaria in eastern Sudan.

机构信息

Faculty of Medicine, Kassala University, Kassala, Sudan.

出版信息

Malar J. 2012 Dec 5;11:404. doi: 10.1186/1475-2875-11-404.

Abstract

BACKGROUND

Artemisinin-based combination therapy (ACT) is the treatment of choice for uncomplicated Plasmodium falciparum malaria in most areas of the world, where malaria is endemic, including Sudan. However, few published data are available on the use of ACT for treatment of P. vivax malaria.

METHODS

This study was conducted at a health centre in Kassala, eastern Sudan, from October to December 2011. Patients with uncomplicated P. vivax malaria received artemether-lumefantrine (AL) tablets (containing 20mg artemether and 120 mg lumefantrine) and were monitored for 28 days.

RESULTS

Out of the 43 cases enrolled in this study, 38 completed the 28-day follow-up. Their mean age was 25.1 years (SD: 1.5). On day 3 following AL treatment, all of the patients were afebrile and aparasitaemic. By day 28, all 38 patients exhibited adequate clinical and parasitological responses to AL treatment. The cure rate was 100% and 88.4% for the per protocol analysis andfor the intention to treat analysis, respectively. Mild adverse effects (nausea, vomiting, abdominal pain, dizziness and/or rash) that resolved spontaneously were observed in four (10.5%) of the patients.

CONCLUSION

AL combination therapy was fully effective for treatment of P. vivax malaria in the study in eastern Sudan.

TRIAL REGISTRATION

Trial. Gov: NCT01625871.

摘要

背景

在包括苏丹在内的世界上大多数疟疾流行地区,青蒿素为基础的联合疗法(ACT)是治疗无并发症恶性疟的首选疗法。然而,关于 ACT 治疗间日疟的使用数据很少。

方法

本研究于 2011 年 10 月至 12 月在苏丹东部的卡萨拉卫生中心进行。患有无并发症间日疟的患者接受青蒿琥酯-咯萘啶(AL)片(含 20mg 青蒿琥酯和 120mg 咯萘啶)治疗,并监测 28 天。

结果

本研究共纳入 43 例患者,其中 38 例完成了 28 天随访。他们的平均年龄为 25.1 岁(标准差:1.5)。在 AL 治疗后第 3 天,所有患者均无发热且无寄生虫血症。到第 28 天,所有 38 例患者均对 AL 治疗有充分的临床和寄生虫学反应。按方案分析和意向治疗分析的治愈率分别为 100%和 88.4%。有 4 例(10.5%)患者出现轻度不良反应(恶心、呕吐、腹痛、头晕和/或皮疹),这些不良反应自行缓解。

结论

AL 联合疗法对苏丹东部研究中的间日疟治疗完全有效。

试验注册

Trial.gov:NCT01625871。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4bf/3519545/53e7e85dd4e8/1475-2875-11-404-1.jpg

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