Somo-Moyou R, Mittelholzer M L, Sorenson F, Haller L, Stürchler D
Institut de Recherche Médicale et d'Etudes des Plantes Médicales (IMPM), Centre de Recherche Médicale, Yaoundé, Cameroon.
Trop Med Parasitol. 1994 Sep;45(3):288-91.
The novel antimalarial Ro 42-1611 (arteflene) was evaluated for safety and efficacy in an open, non-comparative study of patients with mild malaria in the south of Cameroon. Thirty male patients aged 12 to 42 years, with an initial Plasmodium falciparum count of > 5000 (mean: 21,406) parasites/microliters and a body temperature of 37.7% to 39.8 degrees C, were selected to receive a single dose of arteflene, corresponding to 25 +/- 2.5 mg/kg bodyweight. Efficacy was assessed at 6, 9, 12, 24, 36, 48 and 72 hours, and at seven days by: reduction in parasitaemia and time to parasite clearance; resolution of fever and clinical cure (defined as the absence of signs and symptoms of malaria). Adverse events were reported at baseline and at each assessment point, and laboratory tests were carried out at 2 and 7 days. The mean number of parasites/microliter fell from 21,406 at baseline to 157 after 48 hours, at which point 80% of patients were completely free of parasites. Mean body temperature was reduced from 38.9 degrees C at baseline to 37.3 degrees C 12 hours after arteflene administration, and by this time 80% of patients had a normal temperature. Clinical cure rates were also high, with 70% of patients free of all signs and symptoms after 24 hours. However, by day 7, 6/30 (20%) presented with smears positive for P. falciparum. There were no adverse events considered to be related to treatment. A single dose of 25 mg/kg arteflene was found to be an effective and well-tolerated treatment for mild P. falciparum malaria.
在喀麦隆南部针对轻度疟疾患者开展的一项开放性、非对照研究中，对新型抗疟药物Ro 42-1611（阿托氟喹）的安全性和疗效进行了评估。选取了30名年龄在12至42岁之间的男性患者，他们最初的恶性疟原虫计数>5000（平均：21,406）个/微升，体温在37.7%至39.8摄氏度之间，接受单剂量的阿托氟喹，剂量相当于25±2.5毫克/千克体重。在6、9、12、24、36、48和72小时以及7天时评估疗效，评估指标包括：疟原虫血症的降低情况和疟原虫清除时间；发热的消退情况和临床治愈（定义为无疟疾体征和症状）。在基线和每个评估点报告不良事件，并在第2天和第7天进行实验室检查。疟原虫/微升的平均数从基线时的21,406降至48小时后的157，此时80%的患者疟原虫完全清除。平均体温从基线时的38.9摄氏度降至阿托氟喹给药后12小时的37.3摄氏度，此时80%的患者体温正常。临床治愈率也很高，24小时后70%的患者无所有体征和症状。然而，到第7天，30例中有6例（20%）恶性疟原虫涂片呈阳性。未发现被认为与治疗相关的不良事件。发现单剂量25毫克/千克的阿托氟喹是治疗轻度恶性疟原虫疟疾的一种有效且耐受性良好的疗法。
