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

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.