沈阳市某二级甲等医院妇产科围手术期抗菌药物不良事件的调查分析

目的 探讨沈阳市某二级甲等医院妇产科围手术期患者使用抗菌药物的不良事件,以促进妇产科围手术期患者抗菌药物的合理应用.方法 采用分层随机抽样法,选取2010年6月至2011年6月于沈阳市某二级甲等医院妇产科手术期患者300例的临床病历资料为研究对象,提取其中抗菌药物的使用信息,分析抗菌药物不良事件的发生情况（本研究遵循的程序得到参与单位的医学伦理委员会批准,并与研究对象签署临床研究知情同意书）.结果 300例妇产科围手术期患者中,103例出现抗菌药物不良事件,发生率为34.33%.以头孢菌素类药物（53.32%,201/377）发生抗菌药物不良反应为主,不良反应的类型以消化道反应（28.12%,106/377）多见,Ⅰ类,Ⅱ类手术切口的抗菌药物合理应用较不合理应用的不良事件发生率明显低.结论 促进沈阳市某二级甲等医院妇产科围手术期患者抗菌药物的合理使用可明显降低抗菌不良事件的发生率.

A Cross-Section Study of Adverse Drug Event of Antibacterials Drugs for Patients With Preoperative Gynecological and Obstetric Surgery From a Second-Grade Class-A Hospital

Objective To study the adverse drug event of antibacterial drugs for patients with preoperative gynecological and obstetrical surgery in a second-grade class-A hospital. Methods A random sampling study was conducted on the use of antibacterial drugs in patients with preoperative gynecological and obstetrical surgery between June 2010 and June 2011. Their clinical data were retrospectively analyzed in the aspects of usage and adverse drug event of antibacterial drugs. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shenyang Women＇s and Children＇s Hospital. Informed consent was obtained from all participates. Results Out of 300 patients with preoperative gynecological and obstetrical surgery, 103 （34.33%） had adverse drug event report. The cases that caused by cephalosporins were accounted for the most （53. 32%, 201/377）, and damage to the digest system （28. 12% ,106/377） was the commonest type. Adverse event rate of rational use of antibacterial drugs was significantly lower than that of the irrational use of antibacterial. Conclusions Rational use of antibacterial for gynecologic and obstetric patients with surgical operation could significantly reduce the incidence of adverse drug event in this second-grade class-A hospital in Shenyang.