国产头孢他美酯治疗急性细菌感染临床研究

Clinical Study of Domestic Cefetamet Pivoxil in the Treatment of Acute Bacterial Infection

目的:通过随机对照和开放试验的方法评价国产头孢他美酯的临床疗效和安全性。方法:随机对照选用进口头孢他美酯作为对照组,每组各20例,开放组10例,均按500mg Bid给药,疗程7～14天。结果:国产头孢他美酯的临床治愈率75％(15/20),有效率90％(18/20),细菌清除率100％(18/18)。对照组分别为85％(17/20),90％(18/20),100％(16/16)。试验组+开放组分别为76.7％(23/30)、90％(27/30)、100％(26/26)。国产头孢他美酯和进口头孢他美酯不良反应发生率分别为3.33％和5％。以上结果经统计学处理差异无显著性(P>0.05)。结论:国产头孢他美酯是治疗呼吸道、泌尿道感染有效、安全的抗菌药物。

Objective:This study was conducted to evaluate efficacy and safety of domestic Cefetamet pivoxil(CEMT) in a randomized controlled and open trial. Methods: 20 patients were treated with domestic cefetamet pivoxil compared with imported cefetament pivoxil by randomized control. The doage was 500mg twice daily orally for 7～14days in all. Results: The results showed the cure rate of domestic cefetamet pivoxil was 75％(15/20), the effective rate was 90％(18/20)and the bacterial clearance rate was 100％(18/18), imported cefetamet pivoxil were 85％(17/20), 90％(18/20) and 100％(16/16), respectively.The testing group rind open group were 76.7％(23/30), 90％(27/30) and 100％ respectively. The adverse reaction rates of domestic eefetamet pivoxil and imported cefetamet pivoxil were 3.33％ and 5％ resepctively. There were no statistically significant difference between domestic cefetamet pivoxil and imported one in overall results. Conclusion: The study demonstrated domestic cefetamet pivoxil was an antibiotic of efficacy and safety in treating respiratory and urinary tract bacterial infection.