头孢克洛和阿莫西林-克拉维酸治疗小儿急性细菌性下呼吸道感染的随机对照研究  

A prospective multi-center randomized parallel study on efficacy and safety of cefaclor vs.amoxicillin-clavulanate in children with acute bacterial infection of lower respiratory tract

作　　者：陆权[1] 陈慧中[2] 张灵恩[3] 秦铭[4] 杨亚静[5] 

机构地区：[1]上海交通大学附属儿童医院,200040 [2]首都儿科研究所附属儿童医院 [3]上海复旦大学附属儿科医院 [4]南京儿童医院 [5]成都市儿童医院

出　　处：《中国感染与化疗杂志》2006年第2期77-81,共5页Chinese Journal of Infection and Chemotherapy

摘　　要：目的 对比研究头孢克洛混悬剂和阿莫西林-克拉维酸（4：1）干糖浆治疗小儿急性细菌性下呼吸道感染的疗效及安全性。方法采用前瞻性、随机平行对照、单盲（研究者设盲）、多中心的研究方法，于2001年9月至2002年9月间将确诊急性细菌性下呼吸道感染患儿220例，随机分入口服头孢克洛混悬剂组110例和口服阿莫西林-克拉维酸（4：1）干糖浆组110例，疗程10d。观察临床疗效、细菌清除率和不良反应等。结果220例患儿，其中急性支气管炎135例（头孢克洛组65例，阿莫西林-克拉维酸组70例），急性肺炎85例（头孢克洛组45例，阿莫西林-克拉维酸组40例），两组均有良好治疗反应，各临床征象明显改善，头孢克洛组总有效率85．5％（95％CI78．9％～92．0％），阿莫西林-克拉维酸组82、7％（95％CI75．7％～89．8％），两组比较P=0．580。细菌总阳性率55．9％，前3位细菌为流感嗜血杆菌、肺炎链球菌和卡他莫拉菌，治疗后细菌清除率头孢克洛组70．7％，阿莫西林-克拉维酸组70．8％，Fisher精确检验P=1．000。服药顺应性头孢克洛组95．0％，阿莫西林-克拉维酸组90．8％，不良反应有恶心、呕吐（两组分别为1．8％，2．7％），腹痛（2．7％，3．6％），腹泻（6．4％，9．1％），组间差异均无显著性（P〉0．05）。结论头孢克洛混悬剂和阿莫西林-克拉维酸干糖浆治疗小儿急性细菌性下呼吸道感染依然有效和安全。Objective To evaluate the efficacy and safety of cefaclor Ready to Use （RTU） vs. anaoxicillin-clavulanate （4： 1） in treating acute bacterial infection of lower respiratory tract in children. Methods A multi-center prospective randomized controlled single-blind study was performed from September 2001 to September 2002 to compare cefaelor with amoxicillin-clavulanate in 220 patients with bacterial lower respiratory tract infections. One hundred and ten （110） children were treated with cefaclor （40 mg.kg^-1 . d^-1）, and the other 110 were treated with amoxicillin-clavulanate （45 mg. kg^-1 . d^-1 ）. These agents were given orally in two divided doses daily for 10 days. Patients were evaluated before, during and after therapy. Results Of the 220 patients, acute bronchitis was diagnosed in 135 patients （65 in cefaclor groups 70 in amoxieillin-clavulanate group）, acute pneumonia was identified in 85 patients （45 in cefaclor group; 40 in amoxicillin-clavulanate group）. The treatment response was favorable in both groups. The overall efficacy rates of cefaclor and amoxicillin-clavulanate were 85.5% （95% CI78. 9%-92. 0%） and 82. 7% （95% CI 75. 7%-89. 8%） respectively （P=0, 580）, The bacterial pathogen was identified in 55. 9% of the patients, The leading pathogens were H. influenzae, S, pneumoniae and M. catarrhalis. The bacterial eradication rate was 70.7% and 70. 8% respectively in the two treatment groups （P= 1. 000）. The compliance rate was high （95.0% vs. 90. 8%）. The adverse events in the two groups were mainly nausea and vomiting （1.8% vs. 2.7%）, abdominal pain （2.7% vs. 3.6%） and diarrhea （6.4% vs. 9. 1%）. All of these were mild and resolved during therapy. Conclusions Both cefaclor RTU and amoxicillin-clavulanate are still effective and safe in treating bacterial infections of lower respiratory tract infection in children.

关 键 词：抗生素 头孢克洛 阿莫西林-克拉维酸 下呼吸道感染 细菌性 小儿 随机对照 

分 类 号：R725.6[医药卫生—儿科]