【摘要】 目的　对甲磺酸加替沙星临床耐受性试验中不良事件进行综合性的分析和评价。方法　通过甲磺酸加替沙星 期临床试验观察分析其不良反应。结果　在本次试验中共发现 6例不良反应 ,这些不良反应均为轻度一过性、可耐受 ,未见其他有临床意义的症状、体征及实验室检查改变 ,这部分受试者未作任何特殊治疗和处理 ,停药后 1周内全部自行恢复正常。结论　甲磺酸加替沙星是安全性较高的新型广谱氟喹诺酮类抗菌药物 ,但也要关注其不良反应 ,如轻度肝功能改变和过敏反应等。更多还原

【Abstract】 OBJECTIVE To analyze and evaluate the adverse events of gatifloxacin methanesulfonate in the clinical trial of tolerance. METHODS Gatifloxacin methanesulfonate was studied in the phaseⅠclinical trial to observe and analyze the adverse events. RESULTS Six adverse events were discovered in the trial, which were light, transient and resistible. Other vital signs, clinical symptoms and laboratory tests were in the normal range.Without any treatments,the ADRs disappeared in a week after drug withdrawal. CONCLUSIONS Gatifloxacin methanesulfonate is a new drug of fluoroquinolones (FQNs) which is broad-spectrum and safe in clinical treatments. But we shouldn′t ignore the adverse reactions of it, such as: changes in liver function, allergic reaction, etc.更多还原