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目的:了解西安地区药品不良反应(ADR)的发生规律及特点,为临床安全用药提供参考。方法:采用帕累托(Pareto)最优分析法对2013~2015年西安地区医疗机构发生的2 076例ADR报告进行整理,汇总患者年龄、药物品种、给药途径、药物剂型和临床表现等并进行分析。结果:2 076例ADR中,引发ADR的年龄段、药物种类、给药途径、药物剂型及累计的系统/器官及主要临床表现情况的主要因素分别为:0~10岁(16.81%)、51~60岁(16.81%)、61~70岁(13.34%)、71~80岁(12.24%)、21~30岁(11.27%)和41~50岁(10.31%)年龄段;抗感染药物(46.97%)、中药注射剂(14.40%)、中枢神经系统用药(9.34%)和维生素类、营养类药物、酶制剂及调节水、电解质和酸碱平衡药物(8.14%)四大类药物,其中抗感染药物中头孢菌素类的报告例数最多(35.79%);静脉给药(85.84%);注射剂(88.05%);皮肤及其附件损害(41.43%)、消化系统损害(14.92%)、全身性损害(13.49%)和神经系统损害(10.75%)相关的ADR例数较多。结论:根据西安地区ADR发生的规律和特点,应加强临床合理用药管理,有针对性加强重点品种、患者的用药监护与ADR检测,保障患者用药安全。
Objective: To understand the occurrence and characteristics of adverse drug reaction (ADR) in Xi’an and to provide reference for clinical safety medication. Methods: A total of 2 076 cases of ADR from medical institutions in Xi’an area from 2013 to 2015 were sorted out by Pareto optimal analysis. The patients’ ages, drug varieties, route of administration, drug dosage form and clinical manifestations were also summarized Analyze. Results: The main factors affecting the ADR age, drug type, route of administration, drug dosage form, cumulative system / organ and main clinical manifestations of 2 076 ADR were 0 to 10 years old (16.81%), 51 (16.81%), 61-70 (13.34%), 71-80 (12.24%), 21-30 (11.27%) and 41-50 (10.31% 46.97%), traditional Chinese medicine injection (14.40%), central nervous system medication (9.34%) and vitamins, nutrition drugs, enzymes and four kinds of drugs for regulating water, electrolytes and acid-base balance drugs The highest reported cases of cephalosporins in infected drugs (35.79%) were intravenous injection (85.84%), injection (88.05%), skin and its accessory damage (41.43%), digestive system damage The number of ADRs associated with sexual damage (13.49%) and nervous system damage (10.75%) is high. Conclusion: According to the regularity and characteristics of ADR in Xi’an, we should strengthen the management of clinical rational use of medicines, and strengthen the drug administration and ADR testing of key varieties and patients to ensure the safety of patients.