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头孢妥仑酯是日本明治制果株式会社开发的新的酯型口服三代广谱头孢菌素，具有广谱抗菌活性，以头孢克肟为对照药，进行随机双盲双模拟多中心临床试验，目的是评价头孢妥仑酯治疗细菌性感染的安全有效性。给药方法随机双盲试验中，试验样品里、外包装仅标明“Ａ”与“Ｂ”，两药剂量均为２００ｍｇ，ｑ１２ｈ，疗程７～１４ｄ。头孢妥仑酯开放组２００ｍｇ，口服；ｑ１２ｈ，疗程７～１４ｄ。随机双盲试验中头孢妥仑酯组及头孢克肟组分别各有１００例可评价疗效，两组有效率分别为９４．０％及９２．０％。对各种致病菌感染的有效率分别为９４．０％及９２．０％，细菌清除率分别为９５．２及９９．０％。两组安全性评价分别为１０３例及１０７例，药物不良反应发生率分别为８．７％与６．５％。两组经统计学处理差异无显著性（Ｐ＞０．０５）。开放试验共治疗２００例感染患者，则用头孢妥仑酯治疗的全部３００例患者中，总有效率为９３．３％，细菌学有效率为９３．３％，细菌清除率为９４．８％。３１６例患者可评价药物不良反应，总的药物不良反应发生率为７．６％。细菌敏感试验结果表明，头孢妥仑酯与头孢克肟对金黄色葡萄球菌的敏感率分别为９４．８％和１２．１％（Ｐ＜０．００１）。ＭＩＣ９?
Cefditoren pivoxil is a new ester type oral third-generation broad-spectrum cephalosporin developed by Meiji Confectionery Co., Ltd. Japan. It has broad-spectrum antimicrobial activity. With cefixime as a reference drug, double-blind double-dummy randomized multicenter clinical trial, The purpose is to evaluate the safety and efficacy of cefditoren in the treatment of bacterial infections. Methods of administration Randomized double-blind trial, the test sample, the outer package only marked “A” and “B”, the two doses were 200mg, q12h, treatment 7 ~ 14d. Cefditoren pivoxyl open group 200mg, orally; q12h, course of treatment 7 ~ 14d. Randomized double-blind trial of cefditoren ester group and cefixime group were 100 cases of evaluable efficacy, the two groups were 94.0% and 92.0%, respectively. The effective rates of various pathogenic bacteria infections were 94.0% and 92.0% respectively, and the bacterial clearance rates were 95.2% and 99.0% respectively. Safety evaluation of the two groups were 103 cases and 107 cases, the incidence of adverse drug reactions were 8.7% and 6.5%. No statistically significant difference was found between the two groups (P> 0.05). In an open trial of 200 infected patients, the total effective rate was 93.3% for all 300 patients treated with cefditoren well, with a bacteriological efficacy of 93.3% and a bacterial clearance of 94.8% . 316 patients can be evaluated adverse drug reactions, the overall incidence of adverse drug reactions was 7.6%. The results of the bacterial susceptibility test showed that the sensitivity rates of cefditoren pivoxil and cefixime to Staphylococcus aureus were 94.8% and 12.1%, respectively (P <0.001). MIC9?