摘要
目的评估左氧氟沙星500mg静脉注射液每日一次治疗细菌性感染的有效性与安全性。方法多中心、前瞻性、开放性Ⅳ期临床试验。对入选患者给予左氧氟沙星500mg静脉注射液，1次／d，疗程7～14d，观察临床疗效、细菌学疗效。结果本研究入选病例4888例，其中367例由于不良事件致中途停药或给药方案错误等原因不能进行临床疗效评价，符合方案的临床疗效可评价病例为4521例，安全性评价4888例。左氧氟沙星500mg静脉注射每日一次治疗细菌性感染的总有效率为90．8％（4103／4521）；治疗呼吸系统感染、泌尿系统感染、消化系统感染、妇科感染、血液病合并感染的有效率分别为90．2％（2884／3198）、92．3％（810／878）、91．9％（203／221）、94．5％（120／127）、88．7％（86／97）；细菌总清除率为80．3％（677／843）。常见不良反应主要为胃肠道反应（3．9％，193／4888）、注射局部刺激（1．7％，84／4888），程度轻微，停药后消失。结论左氧氟沙星500mg静脉注射液每日一次可有效控制多系统细菌性感染，且不良反应少。
Objective To evaluate the clinical efficiency and safety of intravenous levofloxacin in the treatment of bacterial infections at a dose of 500 mg once a day. Methods Randomized, prospective, multicenter, open-label study. Results The total effective rate of levofloxacin was 90. 8% （4103/4521）. The effective rates of levofloxacin in the treatment of bacterial infections of respiratory tract, urinary tract, digestive tract and gynecologic infections and infections complicated with hematological disease were 90. 2% （2884/3198）, 92. 3% （810/878）, 91.9% （203/221）, 94. 5% （120/127）, 88. 7% （86/97）, respectively. The bacterial eradication rate was 80. 3 % （677/843）. The most common adverse drug reactions were gastrointestinal disorders （3.9%, 193/4888 ） and local irritation（ 1.7% ,84/4888 ）, which were mild and disappeared after stopping administration. Conclusion Intravenous levofloxacin with a dose of 500 mg once a day is effective and safe in treating bacterial infections with low adverse reactions.
出处
《中华内科杂志》
CAS
CSCD
北大核心
2009年第6期492-496,共5页
Chinese Journal of Internal Medicine
关键词
氧氟沙星
细菌感染
临床试验
Ⅳ期
多中心研究
Ofloxacin
Bacterial infection
Clinical trial,phase Ⅳ
Multicenter study
