Kahn J B
Infectious Disease Research, Ortho-McNeil Pharmaceutical Inc, Raritan, NJ 08869-0602, USA.
Chemotherapy. 2001;47 Suppl 3:32-7; discussion 44-8. doi: 10.1159/000057842.
This paper reviews the safety data for levofloxacin utilizing reports from clinical and post-marketing surveillance trials. The side effect incidence rates are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were lower. Four clinical trials were reported. Levofloxacin achieved superior clinical and microbiological results compared to ceftriaxone/macrolide combination, and was better tolerated. Results comparing IV azithromycin plus ceftriaxone versus 500 mg levofloxacin in hospitalised CAP demonstrated that levofloxacin performed better, with more adverse events associated with the comparators (levofloxacin 5.3%, comparators 9.3%). High-dose levofloxacin (750 mg) was also evaluated and found to be well tolerated. Surveillance data reported low ADR rates for levofloxacin: nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhoea, dizziness, and vomiting 0.3%. Worldwide and US surveillance data confirmed that tendon rupture occurred in less than 4 per million prescriptions, taste perversion in less than 3 per million, convulsions in 2 per million, and photosensitivity, hepatitis, hepatic failure, QT prolongation, torsade de pointes or empyema all in less than 1 per million.
本文利用临床和上市后监测试验的报告回顾了左氧氟沙星的安全性数据。副作用发生率为：恶心1.3%，焦虑0.1%，失眠0.3%，头痛0.1%。未报告与左氧氟沙星相关的不良事件发生率高于1.3%，且大多数更低。报告了四项临床试验。与头孢曲松/大环内酯类药物联合使用相比，左氧氟沙星取得了更好的临床和微生物学结果，且耐受性更好。比较静脉注射阿奇霉素加头孢曲松与500毫克左氧氟沙星治疗住院社区获得性肺炎（CAP）的结果表明，左氧氟沙星表现更佳，对照药物相关的不良事件更多（左氧氟沙星5.3%，对照药物9.3%）。还评估了高剂量左氧氟沙星（750毫克），发现其耐受性良好。监测数据报告左氧氟沙星的不良反应发生率较低：恶心0.8%，皮疹0.5%，腹痛0.4%，腹泻、头晕和呕吐0.3%。全球和美国的监测数据证实，每百万张处方中肌腱断裂的发生率低于4例，味觉异常低于3例，惊厥低于2例，光敏反应、肝炎、肝衰竭、QT间期延长、尖端扭转型室速或脓胸均低于1例。
