2019~2021年我院340例药品不良反应回顾性分析

Retrospective analysis of 340 cases of adverse drug reactions in our hospital from 2019 to 2021

目的 了解本院药品不良反应(ADR)发生的表现、程度,减少ADR的发生,指导临床合理用药。方法 回顾性分析本院向国家药品不良反应监测系统上报的340例ADR患者的临床资料。采用数据统计、分类,运用帕累托图等质量管理工具进行评价,分析ADR严重等级分布,患者年龄、性别分布情况,药品给药途径分布情况,引起ADR的药品种类及具体药品,ADR涉及的器官/系统分类及临床表现以及ADR的转归情况。结果 340例ADR患者中,一般不良反应244例(71.76%),严重不良反应24例(7.06%),新的不良反应72例(21.18%);男149例(43.82%),女191例(56.18%);其中>60岁患者最多,共141例(41.47%);11~20岁患者最少,共11例(3.24%);194例(57.94%)好转,142例(41.76%)痊愈,4例(1.18%)不详。引起ADR的给药途径包括静脉给药、口服给药、肌内注射、泵内注射、舌下给药、外用给药、皮下注射、阴道给药、吸入给药。帕累托图显示静脉给药和口服给药累计占比84.71%。根据帕累托法则,静脉给药和口服给药为导致ADR的主要给药途径。340例ADR患者的主要怀疑药品按照药理作用进行分类,其中抗感染药物发生102例(30.00%),中成药发生58例(17.06%),妇产科用药发生44例(12.94%),心脑血管系统药物发生38例(11.18%),其他类药物占比<10%。引起ADR次数前十名的药品中占据前三的分别为盐酸左氧氟沙星注射液(14.57%)、注射用头孢曲松钠(13.91%)、注射用阿奇霉素(13.25%)。根据帕累托法则,皮肤及其附件、消化系统、神经系统累计占比81.76%,是ADR涉及的主要器官/系统。结论 ADR以一般不良反应为主,女性发生几率略高于男性,年龄>60岁的老年患者为ADR高发人群,静脉给药是引起ADR最重要的给药途径,应重点关注抗感染药物和中成药物,注重个体化给药方案,加强监督管理,促进临床安全、合理用药。

Objective To understand the performance and extent of ADR occurrence in our hospital,so as to reduce the occurrence of adverse drug reactions(ADR) and guide the rational drug use.Methods The clinical data of 340 ADR patients reported by our hospital to the National Adverse Drug Reaction Monitoring System were analyzed retrospectively.Data statistics and classification,and quality management tools such as Pareto chart were used for evaluation.The distribution of ADR severity level,the distribution of patients’ age and gender,the distribution of drug administration routes,the types and specific drugs causing ADR,the classification of organs/systems involved in ADR,and the outcome of ADR were analyzed.Results Among 340 ADR patients,244 cases(71.76%) had general adverse reactions,24 cases(7.06%) had serious adverse reactions,and 72 cases(21.18%) had new adverse reactions;149 cases(43.82%) were males and 191 cases(56.18%) were females;the most patients were >60 years old,with a total of 141 cases(41.47%);the least patients were 11-20 years old,with a total of 11 cases(3.24%);194 cases(57.94%) improved,142 cases(41.76%) were cured,and 4 cases(1.18%) were unknown.The routes of administration that caused ADR included intravenous administration,oral administration,intramuscular injection,intra-pump injection,sublingual administration,topical administration,subcutaneous injection,vaginal administration,and inhalation administration.The Pareto chart showed that the cumulative percentage of intravenous and oral administration was 84.71%.According to Pareto’s law,intravenous and oral administration were the main routes of administration leading to ADR.The main suspected drugs of 340ADR patients were classified according to their pharmacological effects,among which 102 cases(30.00%) were induced by anti-infective drugs,58 cases(17.06%) by Chinese patent drug,44 cases(12.94%) by obstetric and gynecological drugs,38 cases(11.18%) by drugs of the cardiovascular system,and 60 years are the population with high incidence of ADR,and intravenous administration is the most important route of drug administration causing ADR.Attention should be payed to anti-infective drugs and Chinese patent drugs,individualized administration scheme,and strengthening supervision and management to promote safe and rational drug use.