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青蒿琥酯加磺胺多辛-乙胺嘧啶与单用磺胺多辛-乙胺嘧啶治疗秘鲁非复杂性恶性疟的疗效和耐受性

Efficacy and tolerability of artesunate plus sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine alone for the treatment of uncomplicated Plasmodium falciparum malaria in Peru.

作者信息

Marquiño Wilmer, Ylquimiche Laura, Hermenegildo Ygor, Palacios Ana Maria, Falconí Eduardo, Cabezas César, Arróspide Nancy, Gutierrez Sonia, Ruebush Trenton K

机构信息

Instituto Nacional de Salud, Lima, Peru; Dirección Sub-Regional de Salud Piura II, Ministerio de Salud, Sullana, Peru.

出版信息

Am J Trop Med Hyg. 2005 May;72(5):568-72.

Abstract

To assist the Peruvian Ministry of Health in modifying the malaria treatment policy for their north Pacific coastal region, we conducted an in vivo efficacy trial of sulfadoxine-pyrimethamine (SP) and SP plus artesunate (SP-AS) for the treatment for uncomplicated Plasmodium falciparum infections. A total of 197 patients were randomized to therapy with either SP (25 mg/kg of the sulfadoxine component in a single dose on day 0) or a combination of SP plus AS (4 mg/kg on days 0, 1, and 2) and were followed for 28 days for symptoms and recurrence of parasitemia. No statistically significant differences between the two groups were observed on enrollment with respect to age, sex, history of malaria, or geometric mean parasite density. A total of 185 subjects completed the 28-day follow-up. Of the 91 subjects treated with SP alone, two had recurrences of parasitemia on day 7 and one on day 21. Of the 94 subjects treated with SP-AS, one had a recurrence of parasitemia on day 21. Fever and asexual parasite density decreased significantly more rapidly and the proportion of patients with gametocytemia on days 3-28 was significantly lower in subjects treated with combination therapy than in those who received SP alone. No severe adverse drug reactions were observed; however, self-limited rash and pruritus were significantly more common and an exacerbation of nausea, vomiting, and abdominal pain were observed significantly more frequently among patients who had received SP-AS. These results have contributed to a National Malaria Control Program decision to change to SP-AS combination therapy as the first-line treatment for uncomplicated P. falciparum malaria in northern coastal Peru in November 2001, making Peru the first country in the Americas to recommend this combination therapy.

摘要

为协助秘鲁卫生部修改其北太平洋沿海地区的疟疾治疗政策,我们开展了一项关于磺胺多辛-乙胺嘧啶(SP)及SP加青蒿琥酯(SP-AS)治疗非复杂性恶性疟原虫感染的体内疗效试验。共有197名患者被随机分配接受SP治疗(第0天单剂量给予25mg/kg磺胺多辛成分)或SP加AS联合治疗(第0、1、2天给予4mg/kg),并随访28天观察症状及寄生虫血症复发情况。两组患者在入组时的年龄、性别、疟疾史或几何平均寄生虫密度方面未观察到统计学显著差异。共有185名受试者完成了28天的随访。在仅接受SP治疗的91名受试者中,2人在第7天出现寄生虫血症复发,1人在第21天复发。在接受SP-AS治疗的94名受试者中,1人在第21天出现寄生虫血症复发。联合治疗组受试者的发热和无性寄生虫密度下降明显更快,且在第3至28天配子体血症患者的比例显著低于仅接受SP治疗的患者。未观察到严重药物不良反应;然而,自限性皮疹和瘙痒在接受SP-AS治疗的患者中明显更常见,恶心、呕吐和腹痛加重的情况也明显更频繁。这些结果促使国家疟疾控制项目决定在2001年11月将SP-AS联合治疗改为秘鲁北部沿海地区非复杂性恶性疟的一线治疗方法,使秘鲁成为美洲第一个推荐这种联合治疗的国家。

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