法罗培南钠片治疗细菌性感染随机双盲对照临床探究.docVIP

法罗培南钠片治疗细菌性感染随机双盲对照临床探究 　 【摘要】; 目的 评价国产法罗培南钠片治疗细菌性感染的临床疗效与安全性。方法 采用多中心、双盲、随机对照试验设计，以头孢克洛为对照药，两组均口服，每次2片，tid，疗程5～10d。结果 本研究共纳入60例，法罗培南组和头孢克洛组各30例，其中法罗培南组及头孢克洛组纳入ITT分析均为30例，PP分析分别为28和30例。疗程结束时，呼吸系统PP人群中，法罗培南组与头孢克洛组治疗后总痊愈率和有效率分别为71.43%与47.67%和92.86%与93.33%，泌尿道PP人群中，法罗培南组与头孢克洛组总痊愈率和有效率分别为85.71%与73.33%和100%与93.33%。疗程结束时两组细菌清除率均分别为83.33%和79.17%，法罗培南组和头孢克洛组的不良反应发生率分别为10.71%和20%，主要表现为恶心、呕吐、头晕、皮疹、腹泻等。以上结果两组比较无统计学差异(Pgt;0.05)。结论 国产法罗培南钠片治疗呼吸道感染和泌尿道感染疗效确切，安全性较好。 毕业论文 【关键词】; 法罗培南钠片 头孢克洛 细菌性感染 随机双盲对照 毕业论文 ; A multicenter, randomized controlled clinical study on 毕业论文 ABSTRACT; Objective; To evaluate the clinical efficacy and safety of domestic faropenem in the treatment of bacterial infections.; Methods; We designed a multicenter, double?blind, randomized controlled clinical trial and used cefaclor as control. Both groups were given 2 tablets three times daily, orally for 5 to 10 days.; Results; A total of 60 patients were enrolled in the study. Two groups were both distributed 30 patients. There was 30 patients who enrolled in ITT (intention to treat analysis) and the group of faropenem was 28 and the group of cefaclor was 30 in PP(per protocol). The cure and effective rates were 71.43% vs 47.67% and 92.86% vs 93.33% in the per?protocol patients with respiratory infections, the cure and effective rates were 85.71% vs 73.33% and 100% vs 93.33% in the per?protocol patients with urinary infections; the bacterial eradication rate were 83.33% vs 79.17%; the adverse events rate were 10.71% vs 20%, the adverse events were nausea, vomit, dizziness, rash, diarrhea and so on. There were no significant differences between the two groups (Pgt;0.05).; Conclusions; Domestic faropenem is effective and safe for the treatment of bacterial infections. 毕业论文 ; KEY WORDS; Faropenem sodium tablets Cefaclor Bacterial infection Randomized controlled clinical study 毕业论文 法罗培南是青霉烯母核的2?位上接有一个四氢呋喃基团，化学结构较稳定，它对需氧和厌氧的革兰阳性菌、革兰阴性菌显示出广谱的抗菌活性，特别是对耐药的葡萄球菌、肠球菌等革兰阳性菌和拟杆菌等厌氧菌的活性都优于现有的口服抗菌药。法罗培南与青霉