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 2 0例 ,开放组 10例 ,均按 5 0 0 mg 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 / 2 0 ) ,有效率 90 % ( 18/ 2 0 ) ,细菌清除率 10 0 % ( 18/ 18) ;对照组进口头孢他美酯分别为 85 % ( 17/2 0 ) ,90 % ( 18/ 2 0 ) ,10 0 % ( 16 / 16 ) ;试验组十开放组分别为 76 .7% ( 2 3/ 30 )、90 % ( 2 7/ 30 )、10 0 % ( 2 6 / 2 6 )。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 %。以上结果统计学处理差异无显著性 ( P>0 .0 5 )。结论 国产头孢他美酯是治疗呼吸道、泌尿道感染有效。

Objective This study was conducted to evaluate the efficacy and safety of domestic cefetamet pivoxil(CEMT) in a randomized controlled and open trial.Methods Twenty patients treated with domestic cefetamet pivoxil(testing group) were compared with another group of 20 patients treated by imported cefetamet pivoxil in the randomized controlled trial.The open group consisted of 10 patients.The dosage was 500mg twice daily orally for 7～14 days in all groups. Results In the domestic cefetamet pivoxil group,the cure rate was 75%(15/20),the effective rate 90%(18/20)and the bacterial clearance rate 100%(18/18).In the imported cefetamet pivoxil group,the corresponding rates were 85%(17/20),90%(18/20) and 100%(16/16)respectively.In the testing group plus opcn geroup,the rates werz 76.7%(23/30),90%(27/30) and 100% respectively.The adverse reaction rates of domestic cefetamet pivoxil and imported cefetamet pivoxil were 3.33% and 5% respectively.There were no statistically significant differences between domestic cefetamet pivoxil and imported one in overall results.Conclusion The above data demonstrate that domestic cefetamet pivoxil is an efficacious and safe antibiotic for treating respiratory and urinary tract bacterial infection.