环丙沙星治疗细菌性感染的随机对照试验  

A RANDOMIZED CONTROLLED CLINICAL TRIAL OF CIPROFLOXACIN IN BACTERIAL INFECTIONS

作　　者：尹非[1] 赵彩云[1] 林佳佳[2] 迟淑静 赵明[3] 李家泰[1] 

机构地区：[1]北京医科大学临床药理研究所,北京100034 [2]北京市地坛医院,北京100011 [3]卫生部药品审评办公室,北京100050

出　　处：《中国临床药理学杂志》1992年第3期133-140,共8页The Chinese Journal of Clinical Pharmacology

摘　　要：环丙沙星是合成抗菌药喹诺酮类新产品,是已上市的同类产品中抗菌作用最强、抗菌谱最广的一个,临床用于各系统感染均有较好的疗效,无明显不良反应。本研究用国产环丙沙星口服200mg,每天3次或400mg,每天2次,疗程7—14天,治疗呼吸道、泌尿道、肠道及其它感染33例,取得了满意的临床疗效与细菌消除结果,临床痊愈显效率为96.97%,33例的病人治疗前细菌阳性率为81.82%,治疗结束后27例细菌阳性中26例细菌消除,细菌阴转率为96.30%,33例中分离出致病菌28株,治疗后27株消除,细菌清除率为96.43%,不良反应发生率为8.57%。环丙沙星与头孢氨苄随机对照治疗呼吸道感染及其它感染,与诺氟沙星随机对照治疗肠道、泌尿道感染的痊愈显效率、细菌阴转率、细菌清除率及不良反应发生率试验药与对照药比较均无显著性差异。Ciprofloxacin is the most active agent in comparison with other new broad-spec-trum quinolones. A randomized controlled clinical trial on oral ciprofloxacin compared with bothcephalexin and norfloxacin, was conducted. 33 patients were treated with ciprofloxacin 200mg threetimes daily or 400mg twice daily orally for 7-14 dyas. The dosage and therapeutic duration of controlswere as follows: cephalexin 1-2g three times daily for 10-14 days, norfloxacin 200mg three timesdaily or 400mg twice daily for 7-14 days. Ciprofloxacin was compared with cephalexin in 21 respira-tory tract infections, 2 skin and soft tissue infections. 11 patients received ciptofloxacin. 10 werecured or excellent, and 1 failed. Favorable bacteriological responses were seen for 6 of 7 organismswith ciprofloxacin. 10 of 12 were cured, and 2 failed. The bacteriological responses occurred in 7 of9 organisms by cephalexin. Ciprofloxacin was compared with norfloxacin of 20 urinary tract and 24intestinal infections. All of these patients were cured. 40 isolates were obtained and all were cleaned.There was no statistical difference between ciprofloxacin and controls. The overall clinical efficacyrate of ciprofloxacin was 96.97%, and bacterial clearance rate was 96.43%.

关 键 词：环丙沙星 临床 细菌病 

分 类 号：R969.4[医药卫生—药理学]