目的 了解我院药品不良反应(ADR)发生的规律和特点,为临床合理用药提供参考。方法 收集广州市第一人民医院南沙医院2015年1月1日—2019年12月31日上报国家药品不良反应监测中心的224例ADR,统计分析发生ADR的患者性别、年龄、药品种类、剂型、给药途径、累及系统等情况。结果 224例ADR报告中,女性报告数(51.79%)高于男性(48.21%),50岁以上的病人报告数占48.6%,其中60岁以上属于高发年龄段(30.8%);抗感染药ADR报告数最多(43.3%),其次是心血管系统用药(12.95%),第三是中枢神经系统用药(12.50%);静脉给药ADR报告数最多(57.14%),其次是口服给药(40.18%),剂型因素中,最高为注射液(32.59%),其次为普通片剂(28.57%),第三位粉针剂(24.55%);ADR累及系统中,皮肤及附件损害最多(26.43%),其次是胃肠系统损害(20.70%)和中枢及外周神经系统损害(18.06%);上报来源以药师上报为主(72.77%),护士上报率为0。结论 临床应加强合理用药,尤其抗菌药物使用,减少静脉给药途径,重点关注50岁以上ADR高发人群,加强ADR监测医护宣教,提高ADR上报率和报告质量。

Objective To investigate the occurrence and distribution of adverse drug reaction ADR from 2015 to 2019 in our hospital and provide relevant information for clinical rational usage of medication. Methods 224 ADR reported to National Center were collected from Nansha hospital of Guangzhou First People's Hospital monitoring during 2015~2019.Those ADR were analyzed in terms of gender and age of patients,type of drugs, route of administration,dosage form,etc. Results Among 224 ADR reports,the occurrence rate of ADR in female(51.79%)was higher than male,patients over the age of 50 accounted for 48.6% and age over 60 were at high risk of ADR.The top three of medicine were anti-infectious agent(43.3%),cardiovascular medicine(12.95%)and central nervous system medication(12.50%). Intravenous administration and oral medication accounted for 57.14%,40.18% respectively.For the dosage form factor,the top three were injection (32.59%), ordinary tablet (28.57%) and powder-injection (24.55%).Major systems involved in ADR were lesion of skin and its appendages(26.43%),gastrointestinal system(20.70%),central and peripheral nervous systems(18.06%).Sources of ADR were mainly composed of pharmacist(72.77%)and the nurse reported 0. Conclusion Clinical rational drug use should be strengthen especially antibacterial agents. The intravenous route should be decreased.Patients over the age of 50 deserved special attention. It is necessary to enhance awareness and education of medical workers to improve the reported rate and quality of ADR.

目的 分析雷替曲塞致药品不良反应(ADR)的特点及相关因素影响,为临床用药提供参考依据。方法 以“雷替曲塞”、“不良反应”、“raltitrexed”等为检索词,在中国期刊网全文数据库(CNKI)、维普中文期刊数据库等检索近5年的文献,共纳入符合标准文献28篇进行整理,分析雷替曲塞所致ADR类型及在不同给药剂量、联合化疗或同步放疗及老年患者、特殊给药途径下ADR发生的特点。结果 雷替曲塞常见的ADR包括消化系统症状、中性粒细胞减少和转氨酶升高,而中性粒细胞减少和转氨酶升高对临床治疗影响较大。给药剂量对ADR影响较小,而联合放疗会增加骨髓抑制的风险;在两药联合化疗时,雷替曲塞与长春瑞滨联合致中性粒细胞减少的风险增加;雷替曲塞引起的转氨酶升高多为Ⅰ~Ⅱ级,高龄(≥70 a)、肝转移对转氨酶升高影响不大。结论 雷替曲塞在不同治疗方案中的ADR发生存在差异,临床应用时应注意监测,防范严重和罕见ADR的发生。

Objective To Summarize the literature on adverse drug reactions(ADR) of Raltitrexed,in order to provide reference for the rational use of the drug in clinic. Methods Raltitrexed and adverse reaction were both used as key words to retrieve articles in CNKI and VIP database, 28literatures which met the inclusion and exclusion criteria were collected and analyzed. The characteristics of ADR were analyzed indifferent dosage, combined chemotherapy or radiotherapy, elderly patients and using with special administration. Results The main adverse reactions of Raltitrexed in the treatment included digestive system symptoms, neutropenia and elevation of aminotransferase, and the latter two had a great influence on the clinical treatment.Combination with radiotherapy increased the risk of myelosuppression. Incidence of neutropenia in combination Raltitrexed with Vinorelbine was higher. Transaminase elevations were generally Ⅰ-Ⅱ grades. Age(≥70 a) and liver metastasis had little effected on transaminase increase. Conclusion There were differences in the occurrence of ADR in different therapeutic schemes. Attention should be paid to ADRs of Raltitrexed especially to monitoring and reporting rare and severe ADRs in clinic.

目的 分析我院药品不良反应的相关资料,促进临床合理用药。方法 采用回顾性分析,对我院180例不良反应报告,按照患者的年龄、性别、给药途径、引起不良反应的药品种类、累及器官或者具体临床表现等进行分析。结果 180例不良反应报告中,涉及8大类药品,静脉给药较其他给予途径更容易发生不良反应(81.6%),抗感染药物引起不良反应率最高(44.5%),药品不良反应主要涉及皮肤及其附件最高(41.6%),女性比男性更容易引起不良反应,30~50岁的人群特别是女性发生不良反应率明显高于其他年龄段。结论 临床必需重视合理用药监测,积极上报不良反应报告,降低不良反应发生率。