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注射用头孢甲肟治疗急性下呼吸道细菌性感染的单盲随机平行对照研究

A Single-blind Parallelism Randomized Controlled Clincial Trial on Injective Cefmenoxime in the Treatment of Acute Lower Respiratory Tract Bacterial Infections
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摘要 目的评价国产注射用头孢甲肟治疗急性下呼吸道细菌性感染的临床疗效与安全性。方法采用随机、单盲平行对照试验设计,将入选的24例急性下呼吸道感染患者随机分为治疗组和对照组各12例,治疗组和对照组分别给予国产和进口注射用头孢甲肟,每次1.0 g,将注射用头孢甲肟加入0.9%氯化钠溶液100~250 mL静脉滴注,30m in^1 h滴完,b id,疗程7~10 d。观察两组临床疗效和安全性。结果治疗组与对照组总治愈率分别为100.0%与91.6%,有效率均为100.0%,细菌清除率分别为100.0%和91.6%。以上结果两组间比较均差异无显著性。治疗组与对照组不良反应发生率(分别为0和8.33%)亦差异无显著性。结论国产注射用头孢甲肟治疗急性下呼吸道细菌性感染疗效确切,安全性好。 Objective To evaluate the clinical efficacy and safety of an injectable cefmenoxime for the treatment of acute lower respiratory tract bacterial infections. Methods Single-blind and parallelism randomized clinical study was conducted to compare the efficacy and safty of home made cefmenoxime with Bestcal,imported cefmenoxime altogther ,24 patients were enrolled in the study , 12 were in cefmenoxime group (treatment group), other 12 were in Bestcall group as the contraol( in this group, one example was discontinued because of rash), the dose was 1 g , adder to 100 -250 mL Nacl Solution, iv drip for 30 min^-1 h ,bid, for a course of 7-10 d. Results at the end of treatment ,the cure rates and effective rates were 100.0% and 100.0% in cefmenoxime group , and 91.6% and 100.0% in Bestcall group respectively. The bacterial eradication rates were 100.0% and 91.6% in the two groups respectively. There were no statistically significant difference between the two groups. Adverse reaction rash observed in 8.33% (1/12) in the control group. Conclusion Home made injectable cefmenoxime is effective and safe for the treatment of scute moderate and severe bacterial infect .
出处 《医药导报》 CAS 2006年第11期1149-1152,共4页 Herald of Medicine
关键词 头孢甲肟 下呼吸道感染 细菌性 单盲平行随机对照 Cefmenoxime Bestcal acute bacterial infection Single-blind randomized parellelism clinical trial
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参考文献10

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