头孢丙烯和头孢克洛治疗呼吸道感染的对照研究

Comparative study on cefprozil and cefaclor in the treatment of respiratory tract infections

目的 研究头孢丙烯在治疗社区获得性呼吸道感染中有效性和应用价值。方法 2 0 0 0年 4～ 9月在北京、上海、武汉和大连 9家医院进行开放、对照、多中心临床试验 ,比较头孢丙烯和头孢克洛在治疗社区获得性轻、中度呼吸道感染的临床和细菌学效果及不良反应。结果 共 417例 (上呼吸道感染 2 2 7例 ,下呼吸道感染 190例 ) ,头孢丙烯组 2 2 2例 ,头孢克洛组 195例。两组病人的性别、年龄、发热程度、血白细胞 (WBC)与中性粒细胞、病原体种类和构成 ,均无明显差异 (P >0 0 5 )。治疗上呼吸道感染头孢丙烯组用药 5 0 0mg ,qd ;头孢克洛组用药 2 5 0mg ,tid。治疗下呼吸道感染 ,头孢丙烯 5 0 0mg ,bid ;头孢克洛组 5 0 0mg ,tid ,疗程均为 7～ 14d。头孢丙烯组总有效率 (痊愈 +有效 )在上、下呼吸道感染中分别为 94 7%和 92 2 % ,高于头孢克洛组的 91 5 %和 83 0 % ,但统计检验无显著差异 (P >0 0 5 )。治疗前共分离到病原菌 15 1株 (头孢丙烯组 86株 ,头孢克洛组 6 5株 ) ,头孢丙烯组细菌清除率 90 8% ,高于头孢克洛组的 85 5 % ,但统计检验也无显著差异。肺炎链球菌、溶血性链球菌、流感与副流感嗜血杆菌、金黄色葡萄球菌和肺炎克雷伯氏菌对头孢丙烯和头孢克洛的敏感性均较高 ,分别为 90 9%～ 10

Objective To study the efficacy and safety of cefprozil in tereatment of community acquired respiratory tract infections (CARTI). Method An open,comparative, multicenter clinical trial was performed in 9 hospitals in Beijing, Shanghai, Wuhan and Dalian from April 2000 to September 2000. The clinical and bacteriological efficacy and safety were compared between cefprozil and cefaclor in treating mild to moderate CARTI. Results A total of 417 patiens was enrolled: upper respiratory tract infections (URTI) 227, lower respiratory tract infections (LRTI) 190. Among them, 222 patients were assigned to cefprozil group while 195 patients to cefaclor group. Sex, age, fever, WBC and PMN, bacteria spectrum were similar between groups (P>0.05). The regimens were as follows: cefrozil 500mg qd for URTI or 500mg bid for LRTI, cefaclor 250mg tid for URTL or 500mg tid for LRTI. The duration was 7～14d for all patients. The clinical efficacy of cefprozil, in URTI and LRTI was 94.7% and 92.2%, higher than that of cefaclor (91.5% and 83.0%). Successful bacteriological eradication of the causative pathogen in both URTI and LRTI was 90.8% in cefprozil and 85.5% in cefaclor. However, statistic analysis did not show significant differences (P>0.05). Sensitivity testing showed that Streptococcus pneumoniae, beta-hemolytic Streptococci, Haemophilus influenzae and Parainfluenzae, Staphylococcus aureus and Klebsiella pneumoniae isolated in these CARTI were sensitive to cefprozil and cefaclor with the rate 90.9%～100.0% and 91.9%～100.0% respectively. Side effects in both groups were low with 5.9% for cefprozil and 4.6% for cefaclor (P>0.05). Liver and kidney function tests in following up patients showed normal in both cefprozil and cefaclor groups (292 and 295 patients respective) at the end of treatment. Conclusion Due to its good antibacteria activity and clinical efficacy, high bacteriological eradication and low side effect rates, cefprozil should become first line antimicrobial agent in treating mild to moderate CARTI.