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目的评价注射用头孢西酮钠与注射用头孢唑林钠治疗急性细菌性呼吸道感染的有效性和安全性。方法符合入选标准的患者连续7~14 d随机静脉滴注头孢西酮(试验组)或头孢唑林(对照组)2.0 g,q12h。定期评价有效性和安全性。结果 11个研究中心共入选260例患者,头孢西酮组126例,头孢唑林组134例。符合方案集(PPS)中,头孢西酮组和头孢唑林组的痊愈率分别是95.5%和94.9%,2组比较差异无统计学意义(P>0.05)。细菌学符合方案集(BPPS)中,头孢西酮组和头孢唑林组的细菌清除率为100%和91.7%,综合疗效痊愈率分别为94.4%和91.7%,2组比较差异均无统计学意义(P>0.05)。头孢西酮组不良事件(AE)发生人数为10人(10/126),头孢唑林组为14人(14/134),其中头孢西酮和头孢唑林组分别有6和10人发生了与药物相关的轻度或中度AE。头孢唑林组1例发生与药物无关严重AF。结论注射用头孢西酮钠治疗社区获得性呼吸系统感染是安全有效的。
Objective To evaluate the efficacy and safety of cefoxitin sodium for injection and cefazolin sodium for the treatment of acute bacterial respiratory infection. Methods Patients who fulfilled the inclusion criteria were randomized to receive either cefoxitin (experimental group) or cefazolin (control group) 2.0 g q12 h consecutively for 7 to 14 days. Evaluate effectiveness and safety regularly. Results A total of 260 patients were enrolled in 11 research centers, 126 in the cefazedone group and 134 in the cefazolin group. In the PPS group, the cure rates of cefazedone group and cefazolin group were 95.5% and 94.9%, respectively. There was no significant difference between the two groups (P> 0.05). Bacteriological compliance program set (BPPS), the bacterial clearance rate of the cefazedone group and cefazolin group was 100% and 91.7%, the overall cure rate was 94.4% and 91.7%, respectively, there was no statistical difference between the two groups Significance (P> 0.05). The incidence of adverse events (AE) in the cefoxitin group was 10 (10/126) and in the cefazolin group 14 (14/134), with 6 and 10 cefazolin and cefazolin groups respectively Mild or moderate AE associated with the drug. One case of cefazolin group had no drug-related serious AF. Conclusions Cefoxitin sodium for injection is safe and effective in the treatment of community-acquired respiratory infections.