破伤风抗毒素临床应用及安全性研究进展

摘要/Abstract

摘要： 目的了解破伤风抗毒素 (tetanus antitoxin, TAT)的临床应用现状及其安全性研究进展 ,为开展上市后安全性评估提供参考。方法检索国内外研究 TAT临床应用安全性相关的文献 ,对其进行归类分析研究。结果目前 TAT在临床上主要应用于破伤风被动免疫和破伤风治疗 ;大量安全性研究显示 ,其皮试阳性率较高 ,主要与患者体质、药物因素、操作因素及其他原因造成假阳性过高有关。其不良反应主要有过敏性休克、血清病及其他类型不良反应。结论 TAT仍是国内为外伤患者预防破伤风的首选注射药物 ,建议在临床应用中应重视过敏 ,注意观察 ,并尽快制定适合我国的破伤风预防指南和规范 ,促进合理用药。

关键词: 破伤风抗毒素, 临床应用, 安全性

Abstract: Objective To understand the progress of the clinical utilization status and safety of tetanus antitoxin (TAT), and to provide references for post-marketing safety evaluation. Methods Domestic and foreign literatures on the clinical application and safety of TAT were reviewed for further analysis and comparison. Results Now TAT has been mainly used for passive immunity and tetanus therapeutics in clinic. Intensive safety studies showed that higher false-positive rate of its skin test mainly related to patient’s physique, medicine factor, infusion operation factor, and so on. Its main adverse effects included anaphylactic shock, erum sickness, and other kinds of adverse reactions. Conclusion TAT is still the first choice against tetanus of trauma patients in China, the paper suggests that medical workers must put emphasis on anaphylaxis and close observation, along with our country should expeditiously enact a specific against tetanus guidelines and standards of Chinese style, and promoting rational drug use.

Key words: tetanus antitoxin, clinical application, security

中图分类号:

R994.11

余超,徐玉茗,徐瑾,万凯化,袁兴东,李穗,周鹃. 破伤风抗毒素临床应用及安全性研究进展[J]. 中国药物警戒, 2016, 13(1): 36-41.

YU Chao, XU Yu-ming, XU Jin, WAN Kai-hua, YUAN Xing-dong, LI Sui, ZHOU Juan . Progress of Clinical Application and Safety of Tetanus Antitoxin [J]. Chinese Journal of Pharmacovigilance, 2016, 13(1): 36-41.

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