注射用五水头孢唑林钠不良反应前瞻性研究  

A Prospective Study on Adverse Reactions of Cefazolin Sodium Pentahydrate for Injection

作　　者：李晋 郎罡 魏理[4] 覃正碧 孙银香 路晓钦[7] 陈志高[8] 李韵梅 黎美均 邓剑雄 LI Jin;LANG Gang;WEI Li;QIN Zhengbi;SUN Yinxiang;LU Xiaoqin;CHEN Zhigao;LI Yunmei;LI Meijun;DENG Jianxiong(Pharmacy Department,Guangzhou United Family Hospital,Guangzhou Guangdong 510335,China;Guangdong Provincial Pharmacological Society,Guangzhou Guangdong,510080,China;China Resources Sanjiu Medical&Pharmaceutical CO.,LTD.,Shenzhen Guangdong 518049,China;Department of Pharmacy,the First Affiliated Hospital of Guangzhou Medical University,Guangzhou Guangdong 510120,China;Department of Pharmacy,Affiliated Hospital of Hubei University for Nationalities,Enshi Hubei 445099,China;Department of Pharmacy,Zhuhai People’s Hospital,Zhuhai Guangdong 519070,China;Department of Research and Education,Chongqing Ninth People’s Hospital,Chongqing 400799,China;Department of Pharmacy,Jiangyin Hospital Affiliated to Medical College of Southeast University,Jiangyin Jiangsu 214400,China;Department of Pharmacy,Dongguan Hospital of Traditional Chinese Medicine,Dongguan Guangdong 523127,China)

机构地区：[1]广州和睦家医院药剂科,广东广州510335 [2]广东省药理学会,广东广州510080 [3]深圳华润九新药业,广东深圳518049 [4]广州医科大学附属第一医院药剂科,广东广州510120 [5]湖北民族学院附属民大医院药剂科,湖北恩施445099 [6]珠海市人民医院药剂科,广东珠海519070 [7]重庆市第九人民医院科教部,重庆400799 [8]东南大学医学院附属江阴医院药剂科,江苏江阴214400 [9]东莞市中医院药剂科,广东东莞523127

出　　处：《中国药物警戒》2021年第12期1171-1175,共5页Chinese Journal of Pharmacovigilance

基　　金：广东省药理学会专项研究基金(GDPHARS-X20170001);中国临床试验注册中心项目(ChiCTR1900023508)。

摘　　要：目的采用中国医院药物警戒系统(CHPS)对注射用五水头孢唑林钠的不良反应(ADR)进行前瞻性调研,评价注射用五水头孢唑林钠的安全性。方法通过CHPS收集6家三级医院2018年3月1日至2018年10月31日注射用五水头孢唑林钠有效住院病例共3641例,对其进行上市后安全性分析。结果数据显示注射用五水头孢唑林钠ADR发生率为4.35‰,无严重ADR,出现时间均为用药后24 h内;一般处理为停药,停药后部分病例接受治疗,处理后所有病例均治愈或好转。结论注射用五水头孢唑林钠ADR发生率(4.35‰)较无定型的注射用头孢唑林钠说明书中ADR发生率(1.1%)差异明显。可能因注射用五水头孢唑林钠的螯合结构,使原本不太稳定的头孢唑林分子组成的隧道式空腔保护分子中的含硫基团不易脱落且可避免接触胶塞,提高了稳定性,减少了分解产物,进而降低了ADR发生率。Objective To evaluate prospectively the adverse reactions of cefazolin sodium pentahydrate for injection and evaluate its safety by means of the Chinese Hospital Pharmacovigilance System(CHPS).Methods From March 1,2018 to October 31,2018,the data on 3641 valid hospitalized patients was collected prospectively via the CHPS from six tertiary hospitals,and the post-marketing safety analysis of cefazolin sodium for injection was performed.Results The rate of adverse drug reactions(ADR)was 4.35‰.There were no serious ADR,and most of the ADR occurred within 24 hours of the administration.The drug was discontinued after the occurrence of ADR.Some patients received treatment after the discontinuation of this drug.All the patients were cured or improved after treatment.Conclusion The incidence of ADR(4.35‰)of cefazolin sodium pentahydrate for injection is significantly different from that of ADR(1.1%)in the instructions for amorphous cefazolin sodium.Probably due to the chelating structure of unstable cefazolin sodium pentahydrate,the sulfur-containing groups in the tunnel-shaped cavity protective molecules composed of cefazolin molecules will not easily fall off and can avoid contact with rubber plugs,thus improving stability,decreaseing catabolites and reducing adverse reactions.

关 键 词：五水头孢唑林钠 不良反应 前瞻性 安全性研究 

分 类 号：R994.11[医药卫生—毒理学]