中国药物警戒 ›› 2021, Vol. 18 ›› Issue (12): 1171-1175.
DOI: 10.19803/j.1672-8629.2021.12.16

• 安全与合理用药 • 上一篇    下一篇

注射用五水头孢唑林钠不良反应前瞻性研究

李晋1,2, 郎罡, 魏理4, 覃正碧5, 孙银香6, 路晓钦7, 陈志高8, 李韵梅9, 黎美均2, 邓剑雄2,*   

  1. 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
  • 收稿日期:2021-03-10 出版日期:2021-12-15 发布日期:2021-12-16
  • 通讯作者: *邓剑雄,男,博士,副主任医师,药物警戒与大规模安全性研究。E-mail：dengjianxiong@gdyl.org
  • 作者简介:李晋,男,博士,主管药师,临床药学与药物安全性研究。Δ为并列第一作者。
  • 基金资助:
    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）

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

LI Jin1,2, LANG Gang, WEI Li4, QIN Zhengbi5, SUN Yinxiang6, LU Xiaoqin7, CHEN Zhigao8, LI Yunmei9, LI Meijun2, DENG Jianxiong2,*   

  1. 1Pharmacy Department, Guangzhou United Family Hospital, Guangzhou Guangdong 510335, China;
    2Guangdong Provincial Pharmacological Society, Guangzhou Guangdong, 510080, China;
    3China Resources Sanjiu Medical & Pharmaceutical CO., LTD., Shenzhen Guangdong 518049, China;
    4Department of Pharmacy, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou Guangdong 510120, China;
    5Department of Pharmacy, Affiliated Hospital of Hubei University for Nationalities, Enshi Hubei 445099, China;
    6Department of Pharmacy, Zhuhai People's Hospital, Zhuhai Guangdong 519070, China;
    7Department of Research and Education, Chongqing Ninth People's Hospital, Chongqing 400799, China;
    8Department of Pharmacy, Jiangyin Hospital Affiliated to Medical College of Southeast University, Jiangyin Jiangsu 214400, China;
    9Department of Pharmacy, Dongguan Hospital of Traditional Chinese Medicine, Dongguan Guangdong 523127, China
  • Received:2021-03-10 Online:2021-12-15 Published:2021-12-16

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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3 641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。

关键词: 五水头孢唑林钠, 不良反应, 前瞻性, 安全性研究

Abstract: 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 3 641 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.

Key words: cefazolin sodium pentahydrate, adverse drug reaction, prospective, safety study

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