Randomized controlled clinical trial of domestic cefepime versus imported cefepime in the treatment of respiratory tract infections

Objective To evaluate the efficacy and safety of domestic cefepime in the treatment of the patients with respiratory tract infections. MethodsA randomized controlled, parallel, multicenter, single blind clinical trial was conducted. Patients were randomized into each group in the study. Trial group patients received domestic cefepime 2 g every 12 hours, and controlled group patients received imported cefepime 2 g every 12 hours by intravenous infusion. The duration was 7~14 days in both groups.ResultsOne hundred fifty-four cases in the FAS,77 patients in trial group received domestic cefepime,and 77 patients in control group received imported cefepime.One hundred twenty-nine cases in the PP, 63 patients in domestic cefepime group, and 66 patients in imported cefepime group. The overall cure rates of each group in FAS analysis were 53.25% and 55.84%, the overall efficacy rates were 79.22% and 76.62%. In PP analysis, the overall cure rates for the domestic cefepime were 65.08% and 65.15%, the overall efficacy rates for the imported cefepime were 96.83% and 89.39%, respectively. The bacterial eradication rates of each group in PP analysis were 92.16% and 93.22%, respectively. The adverse drug reaction was evaluated in 154 cases. The adverse drug reaction rates of trial and control groups were 10.39% and 7.79%, respectively. The results showed that there were no statistical differences between these two groups (P0.05).Conclusion Domestic cefepime was effective and safe as imported cefepime for the treatment of respiratory tract bacterial infections.