乳酸左氧氟沙星氯化钠注射液不良反应12例报告分析及安全性评价

12 cases of adverse reaction report of levofloxacin lactate and sodium chloride injection: analysis and safety assessment

目的对乳酸左氧氟沙星氯化钠注射液不良反应进行分析研究,做出安全性风险评价。方法对我市2014年收集的12例乳酸左氧氟沙星氯化钠注射液不良反应报告采用回顾性研究方式,用Excel电子表筛选方法,进行统计、分析。结果本资料12例报告中,50岁以上人群所占比例最大,有6例(占50%);男性患者发生药品不良反应的几率明显高于女性;药品不良反应临床表现为全身性损害、皮肤及其附件损害、胃肠道损害(各占33.3%,41.7%,25%);新的严重的药品不良反应2例(占16.7%);好转5例,痊愈7例,无死亡病例。结论乳酸左氧氟沙星氯化钠注射液使用风险在临床中可表现为各种不良反应,不当给药方法和联合用药对该药不良反应的发生可能具有相当大的影响。应严格掌握适应症,加强不良反应监测才能确保乳酸左氧氟沙星氯化钠注射液使用的安全性和有效性。

Objective To make preliminary analysis of adverse reaction caused by levofloxacin lactate and sodium chloride injection and assess the safety risk. Methods 12 cases of the adverse reaction collected in 2014 were retrospectively studied and analyzed,using screening method of excel electronic form. Results Of the 12 cases,the over 50＇s accounted for the largest proportion（ 6 cases,50%）. The incidence of adverse drug reaction in male patients was apparently higher than that of female patients. Adverse drug reactions were clinically manifested as systemic damages,damages of skin and appendages,and gastrointestinal damage（ accounting for 33. 3%,41. 7%,25% respectively）. Newly developed serious adverse drug reaction occurred in 2 cases（ 16. 7%）. 5 cases were improved and 7 were cured. There was no death case. Conclusion Risks from levofloxacin lactate and sodium chloride injection can be manifested as a variety of adverse reactions. Improper administration method and combined medication may contribute to the adverse reaction of the drug. Medication of levofloxacin lactate and sodium chloride injection should be strictly monitored to ensure the safety and effectiveness.