Strachunskiĭ L S, Sudilovskaia N N, Melikhov O G
Ter Arkh. 1995;67(3):7-11.
An open non-comparative study of rovamycin (spiramycin produced by Rhone-Poulenc Rorer) for intravenous administration was performed to evaluate its clinical and bacteriological efficacy, safety and tolerance. Thirty patients (adults aged 16-65 years) with community-acquired pneumonia were involved into the study. Two patients were dropped out because of adverse events. Dosage regimen was 1,500,000 I.U. three times a day (intravenous infusion). The treatment was continued after partial recovery (3,000,000 I.U. per os). Spiramycin showed a high clinical efficacy. Approximately half of the patients (41.4-55.6%) had positive clinical trends by third day of spiramycin treatment. The overall clinical efficacy by the completion of the drug administration reached 90.0%. Bacteriological activity was observed in 93.4% of the patients treated. Adverse events were observed in 6 (20.0%) patients, including 2 dropouts. Serious side effects were not registered. As rovamycin showed high clinical efficacy and good safety the drug may be recommended for the treatment of adult pneumonia.
进行了一项关于静脉注射罗瓦霉素(罗纳普朗克-罗雷尔公司生产的螺旋霉素)的开放性非对照研究,以评估其临床和细菌学疗效、安全性及耐受性。30例(年龄在16至65岁之间的成年人)社区获得性肺炎患者参与了该研究。两名患者因不良事件退出研究。给药方案为每日三次,每次150万国际单位(静脉输注)。部分康复后继续治疗(口服300万国际单位)。螺旋霉素显示出较高的临床疗效。在螺旋霉素治疗的第三天,约一半患者(41.4%至55.6%)呈现出积极的临床趋势。给药结束时的总体临床疗效达到90.0%。接受治疗的患者中有93.4%观察到细菌学活性。6例(20.0%)患者观察到不良事件,其中包括2例退出者。未记录到严重副作用。由于罗瓦霉素显示出较高的临床疗效和良好的安全性,该药物可推荐用于治疗成人肺炎。