盐酸莫西沙星氯化钠注射液致不良反应危险因素研究

Analysis of Risk Factors of Adverse Reactions Induced by Moxifloxacin Hydrochloride and Sodium Chloride Injection

目的:研究盐酸莫西沙星氯化钠注射液致不良反应(ADR)的危险因素,为临床安全合理用药提供参考。方法:采用回顾性研究方法,收集2015年1月~2017年6月使用盐酸莫西沙星氯化钠注射液的全部住院患者资料,按照患者性别、年龄、过敏史、用药情况、ADR发生情况等进行调查,通过多因素Logistic分析进行危险因素分析。结果:378例患者中,共有47例发生ADR,发生率为12.43%。其中二重感染25例(6.61%),变态反应10例(2.65%),消化系统反应4例(1.06%)、神经系统反应4例(1.06%)、心血管系统反应3例(0.79%)及肝胆系统反应1例(0.26%)。多因素Logistic回归分析表明,盐酸莫西沙星氯化钠注射液使用疗程(OR=1.579,P=0.007)、合并慢性病(OR=4.188,P=0.043)和ALT(OR=1.080,P=0.030)是盐酸莫西沙星氯化钠注射液致不良反应的危险因素。结论:盐酸莫西沙星氯化钠注射液使用疗程长、合并慢性病、ALT水平异常是导致使用盐酸莫西沙星氯化钠注射液发生ADR可能的危险因素。注意对合并慢性病及ALT水平异常患者的监护、严格控制用药疗程,对减少ADR的发生,具有较为重要的临床意义。

Objective：To study the risk factors of adverse drug reaction （ADR） induced by moxifloxacin hydrochloride and sodium chloride injection, to provide some tips for the clinically safe and rational use of drugs. Methods： Data of 378 cases for all hospitalized patients used moxifloxacin hydrochloride and sodium chloride injection were retrospectively analyzed from January 2015 to June 2017. The gender, age, history of allergy, drug use, ADR of the patients were investigated. The risk factors were analyzed by multiple factors Logistic analysis. Results：In the 378 cases, 47 ADRs with inci- dence of 12.43% , among which 25 showed superinfection （6.61%）, 10 showed allergic reactions （2.65%） , 4 showed gastrointestinal reactions （ 1.06% ）, 4 showed nervous system reactions （ 1.06% ）, 3 showed cardiovascular system reac- tions （0.79%） and 1 showed hepatobiliary system reactions （0.26%）. Logistic regression analysis showed duration （ OR = 1. 579, P = 0. 007） , coexistent chronic diseases （ OR = 4. 188, P = 0. 043 ） and ALT （ OR = 1. 080, P = 0.030） were risk factors of ADR induced by moxifloxacin hydrochloride and sodium chloride injection. Conclusion ： Long duration, coexistent chronic diseases and abnormal level of ALT are the possible rick factors that caused ADR induced by moxifloxacin hydrochloride and sodium chloride injection. Close observation and controlling duration should be noticed to reduce the in- cidence of adverse reactions for coexistent chronic diseases and abnormal level of ALT medication.