头孢克肟与阿莫西林/克拉维酸钾对小儿下呼吸道感染临床干预的随机对照研究

A Clinical Intervention Randomized Controlled Study of Cefixime and Amoxicillin/Clavulanic Potassium in Children with Acute Lower Respiratory Tract Infection

目的：评价头孢克肟颗粒与阿莫西林/克拉维酸钾干混悬剂治疗小儿下呼吸道感染的疗效与安全性。方法：筛选我院2012年4月至2013年4月确诊为细菌性下呼吸道感染的2~5岁患儿198例,其中急性支气管炎132例,急性肺炎66例。随机分为对照组和观察组各99例,对照组给予头孢克肟颗粒治疗,每次3 mg/kg,2次/日,冲服;观察组给予阿莫西林/克拉维酸钾干混悬剂（阿莫西林200 mg,克拉维酸28.5 mg）治疗,40 mg/kg,2次/日,冲服。10 d后比较两组患儿在临床干预前后疗效、细菌清除率和不良反应等相关指标。结果：治疗期间两组患儿均耐受良好,临床疗效显著,对照组总有效率84.8%,观察组总有效率81.8%,两组比较差异无统计学意义（P〉0.05）。细菌检测总阳性率61.1%,对照组治疗后细菌清除率为70.4%,观察组为71.2%,两组比较差异无统计学意义（P〉0.05）。主要不良反应有恶心呕吐、腹痛、腹泻,两组比较差异无统计学意义（P〉0.05）。结论：头孢克肟颗粒和阿莫西林/克拉维酸钾干混悬剂治疗小儿下呼吸道感染均安全、有效。

Objective： To evaluate therapeutic efficacy and safety of cefixime and amoxicillin/clavulanic potassium in children with acute lower respiratory tract infection. Methods： One hundred and ninty-eight children （acute bronchitis 132 cases and acute pneumonia 66 cases）from 2 to 5 years of age were randomly assigned into two groups. The control group received cefixime 3 mg/kg, bid, po. The observation group received amoxicillin/clavulanic potassium 40 mg/kg, bid, po. Children were evaluated before, during and after treatment for ten days. Results： The treatment response was favorable in both groups. The overall efficacy rate in the control group was 84.8% , while in the control group was 81.8% ; there was no significant difference between the two groups （P〉0.05）. The bacterial pathogen was identified in 61. 1% children. The bacterial eradication rate was 70.4% in the control group and 71. 2% in the observation group after treatment; there was no significant difference between the two groups （P〉0.05）. Conclusions： Cefixime and amoxieillin/elavulanic potassium are effective and safe in treating lower respiratory infection.