Lewis P, Garaud J J, Parenti F
Department of Medical Research, Merrell Dow Research Institute, Egham, Surrey, UK.
J Antimicrob Chemother. 1988 Jan;21 Suppl A:61-7. doi: 10.1093/jac/21.suppl_a.61.
A multicentre open trial of teicoplanin in 81 centres in nine European countries included 1431 cases: 531 female, 900 male; mean age 49.4 years, range 1-93 years. These were hospitalized patients most of whom had infections caused by Staphylococcus aureus (816 isolates). Of a total of 1427 Gram-positive pathogens 280 (19.6%) were methicillin resistant. There were 536 skin and soft tissue infections, 263 septicaemias, 135 lower respiratory tract infections, 179 joint and bone infections and 83 endocarditides. More than a third of the infections were severe. Complicating medical factors were present in 69% of cases, including malignant disease in 14% and diabetes mellitus in 11%. Mean teicoplanin dose was 289 mg/day; mean duration of treatment was 14 days. A total of 471 patients received a high dose regimen, 400 mg teicoplanin daily for at least five days. Monotherapy with teicoplanin was used in 1037 cases and combination with other antibiotics in 394. Overall 91.7% of the 1333 evaluable cases were clinical cured or improved. The MIC of teicoplanin was less than or equal to 1 mg/l for 90% of Gram-positive isolates. Adverse events were reported in 189 cases (13.2%). The most common drug-related event was an allergic type skin reaction which occurred in 35 cases (2.4%). Transient hepatic dysfunction was reported in 28 patients (2.0%).
在欧洲九个国家的81个中心进行的替考拉宁多中心开放性试验纳入了1431例患者：女性531例，男性900例；平均年龄49.4岁，年龄范围为1至93岁。这些均为住院患者，其中大多数由金黄色葡萄球菌感染（816株分离菌）。在总共1427株革兰氏阳性病原体中，280株（19.6%）对甲氧西林耐药。有536例皮肤和软组织感染、263例败血症、135例下呼吸道感染、179例关节和骨感染以及83例心内膜炎。超过三分之一的感染为重症。69%的病例存在复杂的医学因素，包括14%的恶性疾病和11%的糖尿病。替考拉宁的平均剂量为289毫克/天；平均治疗持续时间为14天。共有471例患者接受高剂量方案，即每日400毫克替考拉宁，至少持续五天。1037例采用替考拉宁单药治疗，394例与其他抗生素联合使用。在1333例可评估病例中，总体临床治愈率或改善率为91.7%。90%的革兰氏阳性分离菌对替考拉宁的最低抑菌浓度小于或等于1毫克/升。报告了189例不良事件（13.2%）。最常见的药物相关事件是过敏性皮肤反应，发生35例（2.4%）。28例患者（2.0%）报告有短暂性肝功能障碍。
