注射用头孢唑肟钠治疗细菌性感染的多中心随机对照临床研究

・临床研究・

注射用头孢唑肟钠治疗细菌性感染的多中心随机对照临床研究

施　毅1,　苏　欣1,　肖永营1,　宋　勇1,　邵海枫1,　赵蓓蕾1,　曹鄂洪1,　肖鑫武1,　王卫萍1,

吴大伟2,　姜淑娟3

摘要:　目的　评价国产注射用头孢唑肟钠治疗呼吸系统及泌尿系统细菌性感染的临床疗效和安全性。方法　采用多中心、随机、盲法、平行对照试验设计,选择呼吸系统和泌尿系统细菌性感染患者,试验组(A 组)应用国产注射用头孢唑肟钠,对照组(B 组)应用进口注射用头孢唑肟钠(商品名益保世灵),用法均为2.0g ,静脉滴注,每12小时1次;下呼吸道感染疗程为7～14d ,泌尿系统感染为5～14d 。结果　本研究共入选病例144例,其中下呼吸道感染和泌尿系统感染各72例。A 、B 两组基本临床特征差异无统计学意义,资料具有可比性。疗效分析显示,A 组与B 组的痊愈率分别为81.9%和63.9%,总有效率分别为98.6%和98.6%,两组差异无统计学意义(P >0.05)。A 、B 两组细菌清除率分别为100%和98.4%(P >0.05)。本研究两组不良反应发生率均较低(2.8%与2.8%,P >0.05),未见严重不良反应。结论　国产注射用头孢唑肟钠对临床常见致病菌引起的下呼吸道、泌尿系统感染,临床疗效较好而不良反应发生率低,有较高的临床应用价值。关键词:　头孢唑肟;　细菌性感染;　随机对照研究中图分类号:R978.11;R515 文献标识码:B 文章编号:100927708(2005)0620350205

A multicenter randomized controlled clinical trial of injectable ceftizoxime in the treatment of bacterial infections

S H I Yi ,　S U X i n ,　X I A O Yong 2y i ng ,　S O N G Yong ,　S H A O H ai 2f eng ,　Z H A O B ei 2lei ,　CA O E 2hong ,　X I A O X i n 2w u ,　W A N G W ei 2pi n g ,　W U D a 2w ei ,　J I A N G S hu 2j uan.(Dep artment of Res pi 2rolog y ,N anj i ng General Hos pital of N anj i ng M ilit ary Com m and ,PL A ,N anj i ng 210002,Chi na )

Abstract :　Objective To evaluate the efficacy and safety of domestic injectable ceftizoxime in the treatment of bacterial infec 2tions.Methods The trial was designed as a randomized ,double blind and multiple center study.Patients with respiratory or uri 2nary tract bacterial infections were randomized into treatment group (A )or control group (B ).Patients in the treatment group were treated with domestic injectable ceftizoxime 2.0g ,iv ,q12h ,and patients in control group were treated with injectable ceftizoxime (Epocelin )2.0g ,iv ,q12h ,for 7210d (lower respiratory tract infections )or 5214d (urinary tract infections ).R e 2sults A total of 144patients (72with respiratory tract infections ,72with urinary tract infections )were enrolled and completed the trial.There was no significant difference between the two groups in terms of basic clinical characteristics.The total clinical cure rate were 81.9%and 63.9%in A and B group respectively.The total clinical effective rate were both 98.6%in two groups.There was no significant difference (P >0.05)between the two groups in terms of clinical efficacy.There was also no significant difference (100.0%vs 98.4%)between two groups with regard to bacterial eradication rate.The incidence of ad 2verse reaction was 2.8%in the treatment group and 2.8%in control group (P >0.05).No severe adverse reaction was found.Conclusions Domestic injectable ceftizoxime is an effective and safe antibiotic for the treatment of lower respiratory tract and u 2rinary tract bacterial infections.

K ey w ords :　Ceftizoxime ;　Bacterial infection ;　Randomized controlled trial

　作者单位:1.南京军区南京总医院呼吸科　210002;

2.山东大学齐鲁医院;

3.山东省立医院。

　作者简介:施毅(19562),男,主任医师,教授,博士生导师,主要研

究领域为呼吸系疾病诊治。

　通讯作者:施毅。

头孢唑肟(ceftizoxime )是一种新型半合成第三代头孢菌素类抗生素,其杀菌机制是通过作用于转肽酶抑制敏感菌细胞壁的合成及作用于细胞质膜上

某些蛋白抑制细菌生长而产生杀菌作用。头孢唑肟

对革兰阴性和阳性需氧菌具有广谱抗菌作用,对质粒和染色体介导的β内酰胺酶稳定[1]。该药治疗呼吸系统、泌尿系统和消化系统细菌性感染疗效确切。经国家食品药品监督管理局批准,本研究于2003年9月—2004年9月,以进口注射用头孢唑肟(商品名:益保世灵,Epocelin )为对照,评价苏州二叶制药有限公司研制的化学品四类新药注射用头孢唑肟钠治疗细菌性感染的安全性和有效性。