头孢妥仑酯与头孢克肟双盲双模拟随机对照治疗细菌性感染多中心临床试验  

A DOUBLE-BLIND DOUBLE-DUMMY RANDOMIZED CONTROLLED MULTICENTER CLINICAL STUDY ON CEFDITOREN PIVOXIL VERSUS CEFIXIME IN THE TREATMENT OF BACTERIAL INFECTIONS

作　　者：李家泰[1,2,3,4] 侯芳[1,2,3,4] 赵彩云 陆红[1,2,3,4] 陈亦芳 郝凤兰 刘富光[1,2,3,4] 王选锭[1,2,3,4] 卞如濂 胡文芝[1,2,3,4] 李立津 刘德梦[1,2,3,4] 张慧琳 梁德荣[1,2,3,4] 裘雁秋 

机构地区：[1]北京医科大学第一医院临床药理研究所 [2]浙江医科大学临床药理研究所 [3]天津医科大学附属第二医院 [4]华西医科大学附属第一医院

出　　处：《中国临床药理学杂志》1999年第1期1-8,共8页The Chinese Journal of Clinical Pharmacology

摘　　要：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(ME1207) is a third-generation oral cephalosporins with a broad spectrum of antibacterial activity. A double-blind double-dummy randomized controlled multicenter clinical study of cefditoren pivoxil was conducted compared with cefixime. The objective of the study is to evaluate the safety and efficacy of Cefditoren pivoxil in the treatment of bacterial infections. A total of 400 patients was enrolled in the study. 100 patients received cefditoren pivoxil 200mg every 12 hours orally and 100 patients received cefixime 200mg every 12 hours orally were assessable for clinical efficacy. The duration was 7～14 days in both groups. The result showed that the overall efficacy rates were 94.0% for the cefditoren pivoxil group and 92.0% for the cefixime group, whereas the bacterial efficacy rates were 94.0% and 92.0%, respectively. 204 strains were isolated from the patients in the randomized controlled group, the bacterial clearance rates were 95.2% and 99.0%, respectively. The adverse drug reaction was evaluated in 103 cases of cefditoren pivoxil group and 107 cases of cefixime group. The adverse drug reaction rates were 8.7% and 6.5%, respectively. In the open group, 200 patients with bacterial infections received cefditoren pivoxil 200mg every 12 hours orally. For the total 300 patients treated by cefditoren pivoxil,the overall efficacy rate was 93.3%, the bacterial efficacy rate was 93.3% .308 strains were isolated from the 300 cases, bacterial clearance rates were 94.8%. The adverse drug reaction was evaluated in 316 cases and the adverse drug reaction rate was 7.6%. The results showed that cefditoren pivoxil was effective and safe for the treatment of bacterial infections.There were no statistical differences between the two groups(P>0.05).The disk diffusion test showed that the susceptible rates against staphylococcus aureus were 94.8% and 12.1%, respectitively(P<0.001). Against staphycoccus aureus, cefditoren was more activi (MIC90: 0.5 mg·L-1) than cefixime ( MIC90: 32 mg·L-1).

关 键 词：头孢妥仑酯 头孢克肟 细菌性感染 双盲试验 

分 类 号：R515.05[医药卫生—内科学] R978.11[医药卫生—临床医学]