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通过随机双盲对照试验及开放试验评价ME1207治疗细菌性感染88例的临床疗效、细菌学效果及其安全性。结果显示,ME1207治疗呼吸道、泌尿道敏感菌感染临床有效率、细菌阴转率及细菌清除率与对照药头孢克肟无显著差异,开放试验进一步证实ME1207对呼吸道、泌尿道及皮肤软组织感染均有满意的临床疗效及细菌学效果。体外细菌药敏结果显示ME1207对各种产酶及非产酶的G+球菌、G杆菌均有强大抗菌活性,对各临床分离菌的MIC50为0.016~0.5mg/L,MIC90为0.031~1mg/L,显著低于各对照药,敏感菌百分率也显著高于头孢克肟、头孢克罗及阿莫西林。不良反应少,多较轻微。结果表明,ME1207是一广谱、耐酶、强效口服第三代头孢菌素,疗效确切、使用安全。
The clinical efficacy, bacteriological efficacy and safety of ME1207 in the treatment of 88 bacterial infections were evaluated by randomized double-blind controlled trials and open trials. The results show that, ME 1207 treatment of respiratory tract, urinary tract infection, clinical efficacy, bacterial negative conversion rate and bacterial clearance rate with the control drug cefixime no significant difference, open test further confirmed that ME 1207 on the respiratory tract, urinary tract and skin Soft tissue infections have satisfactory clinical efficacy and bacteriological effects. In vitro bacterial susceptibility results showed that ME1207 had strong antibacterial activity against various enzyme producing and non-producing G + cocci, G bacilli. MIC50 of each clinical isolates was 0.016 ~ 0.5mg / L, MIC90 0.031 ~ 1mg / L, significantly lower than the control drug, the percentage of sensitive bacteria was significantly higher than cefixime, cefaclor and amoxicillin. Adverse reactions, more minor. The results show that, ME 1207 is a broad-spectrum, enzyme-resistant, potent oral third generation cephalosporin, curative effect is exact, safe to use.