Hori M, Kono S, Hashimoto F
Jpn J Antibiot. 1978 Jul;31(7):389-94.
A clinical study of PC-904 was performed in children. The results were as follows; 1) Serum levels of PC-904 after single administration of 20 mg/kg were studied in patients by one-shot intravenous injection or drip infusion for 1 hour or 2 hours. The results obtained in this fundamental study led to the suggestion that the proper dosage in bacterial infections would be 50 approximately 100 mg/kg intravenously in 3 approximately 4 divided doses daily. 2) A clinical study of PC-904 was performed in 16 patients including acute pharyngitis and bronchitis (3 cases), acute bronchopneumonia (3 cases), pertussis pneumonia (1 case), lymphadenitis purulenta (2 cases), acute bronchopneumonia (3 cases), pertussis pneumonia (1 case), lymphadenitis purulenta (2 cases), abscess with chronic granuloma (2 cases) and urinary tract infection (5 cases). About 50 approximately 100 mg/kg of PC-904 were administered in 3 approximately 4 divided doses daily by one-shot intravenous injection. The clinical effects of 2 cases out of 16 were impossible to be evaluated, and thses cases were excluded from the clinical evaluation. Ten cases out of 14 showed excellent or good responses (efficacy rate: 71.4%). 3) The bacteriological examinations were performed and the causative or isolated organisms were determined in 11 cases. The responses were "disappeared" in 6 cases, "decreased" in 2 cases and "not disappeared" in 3 cases. 4) No side effects were observed. Abnormalities of laboratory findings were not also noticed.
对儿童进行了PC - 904的临床研究。结果如下：1）通过单次静脉注射或静脉滴注1小时或2小时，对单次给予20mg/kg后的患者血清PC - 904水平进行了研究。该基础研究的结果表明，细菌感染的合适剂量为每日静脉注射50至100mg/kg，分3至4次给药。2）对16例患者进行了PC - 904的临床研究，包括急性咽炎和支气管炎（3例）、急性支气管肺炎（3例）、百日咳肺炎（1例）、脓性淋巴结炎（2例）、急性支气管肺炎（3例）、百日咳肺炎（1例）、脓性淋巴结炎（2例）、慢性肉芽肿性脓肿（2例）和尿路感染（5例）。通过单次静脉注射，每日分3至4次给予约50至100mg/kg的PC - 904。16例中有2例的临床效果无法评估，这些病例被排除在临床评估之外。14例中有10例显示出优异或良好的反应（有效率：71.4%）。3）进行了细菌学检查，并在11例中确定了病原体或分离出的微生物。6例反应为“消失”，2例为“减少”，3例为“未消失”。4）未观察到副作用。实验室检查结果也未发现异常。
