头孢托仑酯随机双盲对照治疗细菌性感染临床评价

Clinical evaluation of cefditoren pivoxil for treating bacteria infections in a randomized double blind trial

为评价头孢托仑酯（ＭＥ１２０７）治疗细菌性感染的有效性和安全性，采用随机双盲对照试验和开放试验方法共治疗８０例患者，其中ＭＥ１２０７（Ａ药）与头孢克肟（Ｂ药）随机双盲各治疗２０例（呼吸系统和泌尿系统各１０对），ＭＥ１２０７开放试验治疗４０例（呼吸系统２０例、泌尿系统１０例、皮肤软组织感染１０例）。每日４００ｍｇ，疗程７～１４ｄ。ＭＥ１２０７痊愈率和有效率在对照试验中为８０％和９５％，在开放试验中为７５％和９２．５％，总痊愈率为７６．７％，总有效率为９３．３％，细菌培养阳性率为１００％，细菌清除率在对照试验和开放试验中分别为９５％和９２．５％。纸片法药敏试验中ＭＥ１２０７敏感株百分率为１００％，与头孢哌酮相同，而优于头孢克肟和头孢克洛，明显优于阿莫西林（４８．８％）。ＭＥ１２０７６０例中６例出现不良反应，表现为消化道反应３例，转氨酶升高２例，凝血酶原时间延长１例。与对照药头孢克肟相比在痊愈率、有效率、细菌清除率及不良反应发生方面均无显著性差异（Ｐ＞０．０５）。ＭＥ１２０７在每日４００ｍｇ剂量下治疗轻、中度细菌感染安全、有效。

To evaluate the efficacy and safety of cefditoren pivoxil (ME1207), a new oral antibiotic of the third generation cephalosporins, a dose of 200 mg b.i.d. was administered to 20 patients (10 patients with respiratory tract infections; 10 patients with urinary tract infections) controlled with cefixime in a randomized double blind trial and to 40 patients (20 patients with respiratory tract infections; 10 patients with urinary tract infections; 10 patients with skin soft tissues infections) in an open trial. In the double blind group, the rates of clinical cure, efficacy and bacterial clearance of ME1207 were 80%, 95% and 95% respectively, and in the open trial group they were 75%, 92.5% and 92.5% respectively. We compared the in vitro activity of ME1207 with those of cefaperazone, cefixime, cefaclor and ampicillin. Results showed that 80 clinical isolates were all sensitive to ME1207. The activity of ME1207 was the same as that of cefoperazone and superior to those of cefixime, cefaclor and ampicillin. The adverse reaction rate of ME1207 was 10% (6/60), and there were no severe side effects observed during the trials.