在巴西进行的一项关于甲氟喹以及奎宁加磺胺多辛-乙胺嘧啶治疗有症状恶性疟的开放性、随机、III期临床试验。

An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil.

作者信息

de Souza J M, Sheth U K, de Oliveira R M, Roulet H, de Souza S D

出版信息

Bull World Health Organ. 1985;63(3):603-9.

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2536431/

Abstract

The clinical and parasitological response of adult male patients to mefloquine and to a combination of quinine and sulfadoxine-pyrimethamine during the treatment of falciparum malaria was compared. These patients were from an area in Brazil where Plasmodium falciparum is showing increasing resistance to quinine and to sulfadoxine-pyrimethamine. The drugs were administered to 100 patients (50 in each group), based on a randomized study design.The rates of clearance of parasitaemia and fever were similar in both groups. However, the parasitological cure rate ("S" response) was 100% for mefloquine but only 92% for quinine plus sulfadoxine-pyrimethamine. Tolerance was good in both groups. The main side-effects (nausea, vomiting, abdominal pain, and dizziness) were mild, transient and required no specific treatment. Nausea and vomiting were more frequent in patients who received quinine plus sulfadoxine-pyrimethamine, while abdominal pain and loose stools or mild diarrhoea were more frequent in the mefloquine group. Tinnitus and hearing difficulty were observed following the administration of quinine plus sulfadoxine-pyrimethamine, but not after mefloquine treatment. Laboratory tests of various haematological and biochemical parameters were not adversely affected in either group after drug administration.It can be concluded that mefloquine, given in a single oral dose of 1000 mg, is highly effective, well tolerated, and safe for the treatment of falciparum malaria in adult males in Brazil.

摘要

比较了成年男性患者在治疗恶性疟期间对甲氟喹以及奎宁与磺胺多辛 - 乙胺嘧啶联合用药的临床和寄生虫学反应。这些患者来自巴西的一个地区，在该地区恶性疟原虫对奎宁和磺胺多辛 - 乙胺嘧啶的耐药性正在增加。根据随机研究设计，将药物给予100名患者（每组50名）。两组的疟原虫血症清除率和发热率相似。然而，甲氟喹的寄生虫学治愈率（“S”反应）为100%，而奎宁加磺胺多辛 - 乙胺嘧啶的治愈率仅为92%。两组的耐受性都很好。主要副作用（恶心、呕吐、腹痛和头晕）轻微、短暂，无需特殊治疗。接受奎宁加磺胺多辛 - 乙胺嘧啶的患者中恶心和呕吐更常见，而甲氟喹组中腹痛和稀便或轻度腹泻更常见。服用奎宁加磺胺多辛 - 乙胺嘧啶后观察到耳鸣和听力困难，但甲氟喹治疗后未出现。给药后两组的各种血液学和生化参数的实验室检查均未受到不利影响。可以得出结论，对于巴西成年男性恶性疟的治疗，单次口服1000 mg甲氟喹是高效、耐受性良好且安全的。