摘要
目的：以环内沙星注射剂为对照，采用随机对照、多中心、平行开放的试验设计，评价左氧氟沙星治疗敏感菌引起的临床感染的有效性和安全性。方法：左氧氟沙星注射剂用法用量为２００－３００ｍｇ，ｂｉｄ；环丙沙星注射剂的用法用量为２００－４００ｍｇ，ｂｉｄ。两组的疗程均为７－１４ｄ。左氧氟沙星组临床可评价病例为１０８例，细菌学疗效评价例数为９１例，药物不良反应评价例数为１０９例；环丙沙星组分别为１１０例，８８例和１１２例。结果：试验药组和对照组的临床有效率分别为９９．１％，９６．４％；细菌清除率分别为９２．４％，９３．３％；药物不良反应发生率分别为８．３％，８．９％。结论：左氧氟沙星注射剂是治疗临床感染的安全有效的药物。
OBJECTIVE: A randomized comparative open trial was conducted to evaluate the efficacy and safety of levofloxacin iv. compared to ciprofloxacin iv. METHODS:The dose of levofloxacin iv was 200-300mg, bid and the duration of treatment was 7-14days; the dose of ciprofloxacin iv. was 200-400mg, bid for 7-14 days. The total number of final clinical evaluated subjects was 218 including 108 subjects in levofloxacin iv treatment group (L group) and 110 subjects for ciprofloxacin iv. treatment group(C group). The bacterial evaluated subjects were 91 for L group and 88 for C group. RESULTS: show clinical efficacy rate and microbiologic eradication rate for L group were 99. 1% and 92.4%, respectively; Clinical efficacy rate and microbiologic eradication rate for C group was separately 96.4% and 93.3%. The incidence of adverse reaction including whole clinical reactions and laboratory abnormalities was 8.3% for L group and 8.9% for C group. CONCLUSION:It was concluded that levofloxacin had an excellent clinical efficacy and good safety profile in treating patients with bacterial infections.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2001年第5期323-328,共6页
The Chinese Journal of Clinical Pharmacology
