进口阿莫西林-舒巴坦治疗社区获得性肺炎的多中心随机对照研究  

A multicenter,randomized controlled clinical trial of imported amoxicillin-sulbactam in the treatment of community-acquired pneumonia

作　　者：李群[1] 周新[1] 朱惠莉[2] 张婕[3] 李立[4] 王永兴 黄文杰[6] 许蒲生[7] 李航[8] 

机构地区：[1]上海交通大学附属第一人民医院呼吸科,上海200080 [2]复旦大学附属华东医院呼吸科,上海200040 [3]吉林大学第二医院呼吸科,长春130041 [4]吉林大学第三医院呼吸科,长春130031 [5]西安空军医院呼吸科,西安710054 [6]广州军区广州总医院呼吸科,广州510010 [7]广州医学院第二附属医院呼吸科,广州510260 [8]烟台毓璜顶医院呼吸科,烟台264000

出　　处：《世界临床药物》2010年第9期538-542,共5页World Clinical Drug

摘　　要：目的评价进口阿莫西林-舒巴坦(特福猛)治疗轻、中度社区获得性肺炎(CAP)的有效性和安全性。方法采用随机多中心研究设计。受试组接受特福猛治疗,轻度患者剂量为1.5g/12h;中度患者剂量为3.0g/12h;对照组接受注射用头孢呋辛钠(西力欣)治疗,轻度患者剂量为1.5g/12h;中度患者剂量为1.5g/8h。各组均为静脉滴注,疗程7～14d。结果共327例患者入选,可进行疗效分析的病例共316例。受试组痊愈率和有效率分别为32.9%和88.2%,相应的对照组分别为33.5%和89.0%,两组相比差异无统计学意义(P>0.05)。受试组和对照组细菌清除率分别为85.2%和85.5%,两组相比差异无统计学意义(P>0.05)。两组药物相关不良反应发生率分别为6.06%和4.93%,组间差异无统计学意义(P>0.05)。结论进口阿莫西林-舒巴坦对轻、中度CAP临床疗效较好,使用安全,有较高的临床应用价值。Objective To evaluate the efficacy and safety of imported amoxicillin/sulbactam in the treatment of mild to moderate community-acquired pneumonia （CAP）. Methods A multicenter, randomized controlled study was conducted. Amoxicillin/sulbactam （1.5 g/12 h for mild CAP and 3.0 g/12 h for moderate CAP） and cefuroxime （1.5 g/12 h for mild CAP and 1.5 g/8 h for moderate CAP） were used intravenously in trial group and control group respectively for 7-10 days. Results A totle of 327 patients were enrolled and 316 cases were clinical valuable. The cure rates and clinical effective rates were 32.9% and 88.2% in trail group, and 33.5% and 89.0% in control group. The pathogens eradication rates of trial group and control group were 85.2 % and 85.5%, respectively. The adverse drug reaction rates of trial group and control group were 6.06% and 4.93%, respectively. Conclusion Imported amoxicillin/sulbactam is an effective and safe antibacterial agent in the treatment of mild to moderate CAP.

关 键 词：阿莫西林-舒巴坦 头孢呋辛 社区获得性肺炎 治疗应用 

分 类 号：R978.11[医药卫生—药品] R563.1[医药卫生—药学]