亚洲社会药学

• 论文 • 上一篇    下一篇

Analysis of 4,562 Cases of Adverse Drug Reaction/Event Caused by Cefoperazone Sodium and Sulbactam Sodium for Injection

Wei Fenfang, Zhang Zhongyi, Zheng Yongxia, Yang Yue*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 出版日期:2016-12-20 发布日期:2017-02-08

Analysis of 4,562 Cases of Adverse Drug Reaction/Event Caused by Cefoperazone Sodium and Sulbactam Sodium for Injection

Wei Fenfang, Zhang Zhongyi, Zheng Yongxia, Yang Yue*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • Online:2016-12-20 Published:2017-02-08
  • Contact: Yang Yue, professor. Major research area: regulatory affairs and drug policy, etc. Tel: 024-23986372, E-mail: yyue315@vip.126.com.

摘要: Objective To make a brief introduction of the marketing status of cefoperazone sodium and sulbactam sodium for injection at home and abroad and to find out risks of clinical drug use through analyzing two product instructions from Chinese and American medical enterprises and the adverse reaction reports from a provincial spontaneous reporting system (SRS). Methods Retrospective and descriptive methods were used to analyze 4,562 cases of adverse drug reaction/event (ADR/ADE) of cefoperazone sodium and sulbactam sodium for injection collected from January 1, 2004 to December 31, 2013. Results and Conclusion Adverse Drug Reaction Information Bulletin had a significant impact on the number of ADR reports in the SRS; 0–9 years old children were more prone to ADR; allergic shock was detected as the most severe ADR signal; irrational drug use was prominent; drug instructions from domestic producers was not specific enough. The use of ceftriaxone sodium for injection should be improved and the incidence of ADR/ADE should be reduced.

关键词: cefoperazone sodium and sulbactam sodium, adverse reaction, drug use risk

Abstract: Objective To make a brief introduction of the marketing status of cefoperazone sodium and sulbactam sodium for injection at home and abroad and to find out risks of clinical drug use through analyzing two product instructions from Chinese and American medical enterprises and the adverse reaction reports from a provincial spontaneous reporting system (SRS). Methods Retrospective and descriptive methods were used to analyze 4,562 cases of adverse drug reaction/event (ADR/ADE) of cefoperazone sodium and sulbactam sodium for injection collected from January 1, 2004 to December 31, 2013. Results and Conclusion Adverse Drug Reaction Information Bulletin had a significant impact on the number of ADR reports in the SRS; 0–9 years old children were more prone to ADR; allergic shock was detected as the most severe ADR signal; irrational drug use was prominent; drug instructions from domestic producers was not specific enough. The use of ceftriaxone sodium for injection should be improved and the incidence of ADR/ADE should be reduced.

Key words: cefoperazone sodium and sulbactam sodium, adverse reaction, drug use risk