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加替沙星注射液与左氧氟沙星注射液随机双盲对照临床研究
Randomized, Double-blind, Comparative Clinical Trial on Gatifloxacin Injection Versus Levofloxacin Injection
【作者】 郑莉;
【导师】 梁德荣;
【作者基本信息】 四川大学 , 内科学, 2003, 硕士
【摘要】 目的 评价加替沙星注射液治疗急性中、重度呼吸系统、泌尿系统感染的有效性和安全性。方法采用随机双盲对照试验设计,将纳入病例随机分配至试验组和对照组,分别予以加替沙星注射液和左氧氟沙星注射液200mg,静滴,每日两次,疗程7-14天。结果 1)有效性结果表明:试验组(n=36)与对照组(n=36)在疗程结束时的临床痊愈率和有效率分别为47.22%和86.11%与41.67%和80.56%。疗程结束后7天的痊愈率和有效率分别为48.57%和88.57%与48.45%和93.97%。疗程结束时,两组细菌清除率分别为96.77%与100.0%。疗程结束后7天,细菌清除率分别为93.33%与100.0%。以上结果两组比较差异均无统计学意义(P>0.05)。2)安全性结果表明:试验组(n科0)与对照组(n二38)的不良反应发生率分别为25%与21.05%,不良反应均为轻至中度。结论:加替沙星注射液临床疗效确切,可有效治疗急性中、重度呼吸道、泌尿道感染。
【Abstract】 Objective To evaluate the clinical efficacy and safety of gatifloxacin injection on moderate and severe acute respiratory and urinary infection. Method In the randomized, double-blind, comparative study, patients were randomly divided into two groups(test group and control group. Patients were respectively treated with Gatifloxacin injection and levofloxacin injection 200mg twice daily for 7-14 days. Results l)At the end of treatment ,clinical cure rate and efficacy rate of two groups were 47.22% and 86.11%, 41.67% and 80.56%. Seven days after treatment, clinical cure rate and efficacy rate of two groups were 48.57% and 88.57%, 48.48% and 93.94%. At the end of treatment ,eradication rates of two groups were 96.77% and100.0%. Seven days after treatment , eradication rates were 93.33% and 100.0%. The values of two groups has no significant differences (P>0.05). 2)Adverse drug reactions were slight to moderate. ADRs rates were 25% and 21.05%. Conclusion Gatifloxacin injection is effective for moderate and severe acute respiratory and urinary infection.
【Key words】 gatifloxacin; levofloxacin; randomized,double-blind,comparative study;
- 【网络出版投稿人】 四川大学 【网络出版年期】2004年 01期
- 【分类号】R969
- 【下载频次】99