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目的:探讨如何利用官方发布的权威信息资源如国家药品不良反应监测中心的《药品不良反应信息通报》来确定处方干预监测重点,以避免一些严重ADR的重复发生。方法:对2001—2013年间的58期《药品不良反应信息通报》所涉及的药品、发布频度、累及器官或系统、主要临床表现及引发原因等进行回顾性研究分析,以确定在处方干预中重点监测项目及采取避免一些严重ADR发生的措施。结果:2001—2013年国家药品不良反应监测中心共发布《药品不良反应信息通报》58期,涉及药品115种,其中化学药97种,占84.35%,涉及15个类别药品。中成药18种,占15.65%。在通报的化学药品中抗感染药所占比例最大,为30.93%。被通报药品中化学药和中成药的注射剂和口服制剂引发的ADR大致相当。ADR累及器官或系统及主要临床表现以皮肤及其附件受损或过敏、全身性损害、泌尿系统及肾功能受损、肝功能异常或损害等最多。引发ADR除药品原因、患者个体差异外,还与临床不合理用药如超适应证、用法用量不规范、禁忌证用药、药物配伍、儿童用药不规范问题等有密切关系。结论:药品不良反应除药品本身性质引起和患者个体差异外,许多是由于临床不规范用药造成的,应予以重视,通过《药品不良反应信息通报》等官方信息资源可以确定处方干预监测重点,将可避免的ADR发生率降低到最低,在这一过程中药师将最大程度地发挥专业作用。
OBJECTIVE: To explore how to use the official authority information resources such as the National Adverse Drug Reaction Monitoring Center to determine the focus of prescription intervention in order to avoid repeated occurrence of some serious ADR. Methods: A retrospective study was conducted on 58 drugs involved in ADRs in 2001-2013, such as the frequency of drug release, the organ or system involved, the main clinical manifestations, and the causes of the drug abuse. Focus on monitoring the project and take measures to avoid the occurrence of some serious ADR. Results: From 2001 to 2013, the National Center for Adverse Drug Reaction Monitoring released 58 information bulletins on adverse drug reactions involving 115 kinds of medicines, of which 97 were chemical medicines accounting for 84.35%, involving 15 categories of medicines. 18 kinds of proprietary Chinese medicines, accounting for 15.65%. Among the notified chemicals, anti-infectives accounted for the largest proportion of 30.93%. The notified ADRs caused by injections and oral preparations of chemical and proprietary Chinese medicines in pharmaceuticals were roughly equivalent. ADR involving organs or systems and the main clinical manifestations of skin and its accessories damaged or allergic, systemic damage, urinary and renal dysfunction, abnormal liver function or damage, etc. up. In addition to the causes of ADR caused by drugs, patients with individual differences, but also with unreasonable clinical use of drugs such as indications, the amount of non-standard usage, contraindications medication, drug compatibility, children’s medication is not standardized issues are closely related. Conclusion: In addition to the drug adverse reactions caused by the nature of the drug itself and the individual differences caused by patients, many of which are caused due to clinical non-standard medication, should be taken seriously, through “official information resources such as Adverse Drug Reaction” can determine the focus of prescription intervention monitoring will be The avoidable incidence of ADR is reduced to a minimum, and the pharmacist will have the maximum degree of professionalism in the process.