国产与进口盐酸头孢他美酯多中心临床评价

Multicenter clinical trial on domestic versus imported cafetamet pivoxil

用国产与进口盐酸头孢他美酯随机对照及开放治疗急性细菌性感染，对前者进行安全性及有效性评价。共完成１６８例（试验组及对照组各６０例，开放组４８例），剂量为５００ｍｇｂｉｄ，餐后１ｈ服用，疗程５～１４ｄ，淋菌性尿道炎疗程３ｄ。试验组、对照组与开放组不同感染病种患者的有效率分别为８６．６７％、９０．００％与８７．５０％，各组间无显著性差异（Ｐ＞０．０５），试验组加开放组共１０８例，总有效率为８７．０４％，３组细菌产β－内酰胺酶率分别为６７．９２％、７５．００％与７５．００％，清除率分别为９６．２３％、９６．１５％与９２．５０％，不良反应发生率分别为６．６７％、６．６７％及１０．４２％（Ｐ＞０．０５），差异无显著性（Ｐ＞０．０５）。１４５株细菌对国产头孢他美纸片的高敏率为９１．７２％，与进口品９０．３４％相似，两者的ＭＩＣ值亦相似。表明：国产盐酸头孢他美酯片抗菌谱广，抗菌活性强，对大部分细菌产生的β－内酰胺酶稳定，为一治疗轻、中度急性细菌性感染安全有效的口服药物。

The efficacy and safety of domestic versus imported cafetamet pivoxil were evaluated through multicenter randomized controlled and open clinical trials on patients with acute bacterial infections. Sixty enrolled in trial and control groups respectively, 48 in open group, and received cafetamet pivoxill 500mg bid for 5￣14 days (3 days for gonococcal urethritis). The efficacy rate in three groups were 86.67%, 90.00% and 87.50%; β lactamses producing rate of bacterial isolates were 67.92%, 75.00% and 75.00%; bacterial eradication rate were 96.23%, 96.15% and 92.50%; adverse events rate were 6.67%, 6.67% and 10.42%, respectively. There were no significant differences between relative rates ( P >0.05). The sensitivity rate of 145 isolates to domestic cafetamet was 91.72%, similar to that of imported one. So as the MIC values. The results suggested that domestic cafetamet pivoxil, with wide antibacterial spectrum, satisfactory activity, stablizition to β lactamses, is an effective and safe antibiotics in treatment of mild to moderate acute bacterial infections.