注射用头孢哌酮钠他唑巴坦钠(6∶1)治疗中重度呼吸系统急性细菌性感染的多中心随机对照临床试验  

Injectable cefoperazone sodium and tazobactam sodium (6∶1) in the treatment of moderate to severe acute respiratory bacterial infections: a blind, randomized controlled, multi-center clinical trial

作　　者：陈峰[1] 俞海英[2] 莫碧文[1] 盛吉芳[2] 丁连明[3] 李翀[4] 尹琦[5] 刘文媛[6] 付秀华[7] CHEN Feng;YU Hai-ying;MO Bi-wen;SHENG Ji-fang;DING Lian-ming;LI Chong;YIN Qi;LIU Wen-yuan;FU Xiu-hua(Affiliated Hospital of Guilin Medical Unizersity,Guilin 541000,China;The First Afiliated Hospital ofof Zhejiang University,Hangzhou 310003,China;The 81st Group Army Hospital of the Chinese People'sLiberation Army(The 251st Hospital of the Chinese People's Liberation Army),Zhangjiakou 075000,China;The First People's Hospital of Changzhou,Changzhou 213003,China;Dongfang Hospital Affiliated toTongi University,Shanghai 200120,China;Sichuan Provincial People's Hospital,Chengdu 610072,China;The Affiliated Hospital of Inner Mongolia Medical University,Hohhot 10050,China)

机构地区：[1]桂林医学院附属医院,桂林541000 [2]浙江大学医学院附属第一医院,杭州310003 [3]中国人民解放军陆军第81集团军医院(中国人民解放军第二五一医院),张家口075000 [4]常州市第一人民医院,常州213003 [5]同济大学附属东方医院,上海200120 [6]四川省人民医院,成都610072 [7]内蒙古医学院附属医院,呼和浩特10050

出　　处：《中国新药杂志》2021年第23期2194-2202,共9页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项基金资助项目(2013ZX09301303)。

摘　　要：目的:评价注射用头孢哌酮钠他唑巴坦钠(6∶1)在呼吸系统感染受试人群中的有效性和安全性。方法:采用多中心、随机、盲法、阳性药物平行对照。共237例患者纳入试验,其中试验组179例,用头孢哌酮钠他唑巴坦钠(6∶1),对照组58例用注射用头孢哌酮钠他唑巴坦钠(4∶1)。筛选期统一接受注射用头孢哌酮钠单药治疗3 d,治疗期试验组给予试验药3.0 g,bid静脉滴注;对照组给予对照药2.0 g,tid静脉滴注。观察两组治疗前后症状、体征、实验室检查、胸部X线检查、痰细菌培养等的变化。结果:两组临床治愈率分别为87.65%和78.85%;细菌清除率分别为97.89%和97.06%;综合疗效分别为86.32%和73.53%;不良反应发生率为13.79%(24/174例)、14.29%(8/56例),主要表现为转氨酶升高、白细胞减少、嗜酸性粒细胞增多等,随访均恢复正常。结论:经过大规模Ш期临床试验证明,注射用头孢哌酮钠他唑巴坦钠(6∶1)用于治疗中、重度呼吸系统急性细菌性感染安全有效,为遏制耐药菌感染提供了可选的有效药物。Objective: To evaluate the efficacy and safety of injectable cefoperazone sodium and tazobactam sodium(6∶1) for the treatment of moderate to severe acute respiratory bacterial infections. Methods: Totally 237 patients with respiratory tract infections were enrolled in a randomized, double blind, multi-centerand, parallel controlled study, in which 179 in experimental group and 58 in control group[injectable cefoperazone sodium and tazobactam sodium(4∶1)]. During the screening period, cefoperazone sodium was uniformly injected for 3 d. During the treatment period, the experimental group was given the test drug 3.0 g by intravenous drip twice a day, and the control group was given 2.0 g of control drug by intravenous drip 3 times a day. The results of symptoms, signs, laboratory examination, chest X-ray examination and sputum bacterial culture were observed before and after treatment. Results: In experiment group and control group, the clinical cure rates were 87.65% and 78.85%, respectively. The bacterial clearance rates were 97.89% and 97.06%. Comprehensive efficacies were 86.32% and 73.53%. Incidences of adverse reaction were 13.79%(24/174 patients) in the test group and 14.29%(8/56 patients) in the control group. The main manifestations were elevated transaminase, leucopenia, eosinophilia and so on. All patients returned to normal after follow-up. Conclusion: Injectable cefoperazone sodium and tazobactam sodium(6∶1) is proved to be safe and effective in the treatment of moderate to severe acute bacterial infection of respiratory system after large-scale phase Ⅲ clinical trial, providing an effective drug for the control of drug-resistant bacterial infection.

关 键 词：注射用头孢哌酮钠他唑巴坦钠(6∶1) 耐药菌感染 呼吸系统 盲法 随机对照 多中心临床试验 

分 类 号：R978.1[医药卫生—药品]