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一项关于甲氟喹、周效磺胺和乙胺嘧啶组合药物(Fansimef)治疗恶性疟的II/III期双盲剂量探索性临床试验。

A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria.

作者信息

de Souza J M, Sheth U K, Wernsdorfer W H, Trigg P I, Doberstyn E B

出版信息

Bull World Health Organ. 1987;65(3):357-61.

PMID:3311438
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2490994/
Abstract

Fansimef is a combination of 250 mg mefloquine (base), 500 mg sulfadoxine, and 25 mg pyrimethamine per tablet. One hundred and fifty adult male Brazilian patients at Belém (Pará), who had peripheral blood smears positive for Plasmodium falciparum, with or without clinical symptoms of falciparum malaria, were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. Of those receiving one tablet (48 patients), 81% were cured and 19% exhibited RI recrudescences. All the patients receiving two or three tablets of Fansimef (49 patients in each group) were cured. The rates of initial clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects included nausea, vomiting, dizziness, diarrhoea and abdominal pain, but these were mild and transient and required no specific treatment. The incidence of vomiting and nausea was highest in patients given the three-tablet dose. The results of various haematological, biochemical and urine analyses were not adversely altered by the administration of Fansimef.

摘要

每片 Fansimef 含有 250 毫克甲氟喹(碱基)、500 毫克周效磺胺和 25 毫克乙胺嘧啶。在贝伦(帕拉州),150 名外周血涂片恶性疟原虫呈阳性、有或无恶性疟临床症状的成年男性巴西患者,以双盲随机方式接受 1 片、2 片或 3 片 Fansimef 治疗。在接受 1 片药物治疗的患者(48 例)中,81% 治愈,19% 出现复发。所有接受 2 片或 3 片 Fansimef 治疗的患者(每组 49 例)均治愈。所有治疗组中疟原虫血症和发热的初始清除率相似。所有剂量水平的耐受性良好。主要副作用包括恶心、呕吐、头晕、腹泻和腹痛,但这些症状轻微且短暂,无需特殊治疗。接受 3 片剂量的患者中呕吐和恶心的发生率最高。进行的各种血液学、生化和尿液分析结果未因服用 Fansimef 而受到不利影响。

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1
A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria.一项关于甲氟喹、周效磺胺和乙胺嘧啶组合药物(Fansimef)治疗恶性疟的II/III期双盲剂量探索性临床试验。
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Efficacy of Pyrimethamine/Sulfadoxine versus Chloroquine for the Treatment of Uncomplicated Falciparum Malaria in Children Aged Under 5 Years.乙胺嘧啶/磺胺多辛与氯喹治疗5岁以下儿童单纯性恶性疟的疗效比较
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本文引用的文献

1
A double-blind comparative clinical trial of mefloquine and chloroquine in symptomatic falciparum malaria.甲氟喹和氯喹治疗有症状恶性疟的双盲对比临床试验
Bull World Health Organ. 1983;61(4):713-8.
2
A double-blind clinical trial of a combination of mefloquine, sulfadoxine and pyrimethamine in symptomatic falciparum malaria.甲氟喹、周效磺胺和乙胺嘧啶联合用药治疗有症状恶性疟的双盲临床试验。
Bull World Health Organ. 1985;63(2):339-43.
3
Single-dose therapy of falciparum malaria with mefloquine or pyrimethamine-sulfadoxine.用甲氟喹或乙胺嘧啶-磺胺多辛单剂量治疗恶性疟。
Bull World Health Organ. 1979;57(2):275-9.
4
Chemotherapeutic studies with mefloquine and selection of a mefloquine resistant strain of Plasmodium berghei.用甲氟喹进行化疗研究及伯氏疟原虫耐甲氟喹株的选育。
Indian J Med Res. 1979 Dec;70 Suppl:95-102.