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乳酸司氟沙星注射剂多中心临床疗效观察

A multicenter randomized clinical study on the efficacy and safety of intravenous sparfloxacin lactate vs ofloxacin in the treatment of bacterial infections

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【作者】 黄文祥王其南贾蓓时德肖永红郑行萍

【Author】 Huang Wen -xiang, et al (Department of Infectious Diseases, College of Clinical Medicine,Chongqing Medical University)

【机构】 重庆医科大学临床学院感染科重庆医科大学临床学院感染科 重庆400016重庆400016重庆400016

【摘要】 目的:评价司氟沙星注射剂治疗细菌性感染的疗效和安全性。方法:采用随机对照开放试验,在三所医院临床观察本品治疗各种感染100例,其中60例与氧氟沙星作随机对照;司氟沙星200mg—300mg;氧氟沙星200mg,bid。结果:司氟沙星临床有效率、细菌清除率、细菌敏感率和不良反应发生率分别为83.3%、91.1%、93.9%、12%,氧氟沙星为81.7%、90%、91.4%、10%,两组疗效和安全性经统计学处理无显著性差异(P>0.05)。司氟沙星的主要副反应为胃肠道反应和皮疹,无光过敏反应发生。结论:司氟沙星抗菌谱广,抗菌活性强,每天用 200mg治疗敏感菌所致的中至重度感染有较好的临床疗效。

【Abstract】 Objective: To evaluate the clinical efficacy and safety of intravenous sparfloxacin lactate (SPLX) administration in the treatment of bacterial infections. Methods: A randomized open trial was conducted in 3 multicenter controlled trials. 160 patients were admitted into the study, including 60 cases in the control group (ofloxacin,OFLX).The dosage of SPLX was 200mg qd and that of OFLX was 200mg bid. Results-. In the SPLX group,88.3% of patients were clinically cured or improved compared with 81.7% of the patients in the OFLX group (P>0.05).The eradication rates of pathogens were 91.1% and 90% ,respectively (P>0.05). Bacterial eradication rates were similar in both treatment groups. Drug -related adverse events were reported in 12% of patients receiving SPLX and in 10% of patients administered of OFLX. Gastrointestinal and rash adverse events were the most common ones reported in each treatment group. There is no photosensitivity reaction in both groups. The results of in vitro activity of SPLX showed good activity against many Gram - negative organ- isms and were similar to those of OFLX. The activity against Gram- positive organisms was higher than that of OFLX. Conclusion : Intravenous treatment with 200mg SPLX qd is as effective as the treatment with 200mg OFLX bid in patients with acute and serious infectious diseases caused by sensitive pathogens.

  • 【文献出处】 重庆医科大学学报 ,Acta Universitatis Scientiae Medicinae , 编辑部邮箱 ,2001年03期
  • 【分类号】R969
  • 【下载频次】14
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