药品不良反应流行病学智能分析系统的建立及应用

发布时间：2018-09-13 07:59

【摘要】：目的：探讨重庆市药品不良反应/事件（ADR/ADE）发生的特点与规律，为加强药品安全监测、指导临床合理用药提供参考和依据，同时为药品监管部门提供决策依据。方法：以重庆市药品不良反应监测中心收集的ADR/ADE数据资料作为数据源，基于商业智能技术，构建药品不良反应智能分析系统；应用智能分析系统，对重庆市2008～2012年药物所致的65900例ADR/ADE进行药物流行病学研究，再分别对2012年头孢菌素类药及2010年～2013年6月热毒宁注射液引发的ADR/ADE进行智能分析。结果：①开发了具有各种汇总、统计、查询、更新等功能的智能分析系统；②65900例ADR/ADE报告中，以60岁以上的老年患者发生率较高；静脉给药引发的ADR/ADE最多；ADR/ADE涉及的药品以抗微生物药最多，其次是中成药；ADR/ADE主要累及器官和临床表现为消化系统症状、皮肤及其附件损害及全身症状；医疗机构为上报主体；③3394例头孢菌素类药引发的ADR/ADE报告中，10岁以下的儿童发生率较高；19.27%是由头孢曲松引发的；严重的ADR/ADE(包括新的严重的)有119例，以过敏性休克最常见；④125例热毒宁注射液发生ADR/ADE的患者中，29例ADE（23.20%）为超适应证用药引起；男性81例（64.8%），女性44例（35.2%）；2岁以下婴幼儿发生率较高（48.0%）；89.6%的患者在用药30min内发生ADR/ADE；共发生ADR/ADE207例次，73.9%为药物性皮疹、瘙痒等皮肤及其附件损害，20.3%为新的ADR。结论：智能分析系统能够有效地提高ADR/ADE报告信息的利用率，多层次、多角度地挖掘潜在的有价值的信息，具有良好的应用前景；临床应重视抗微生物药与中成药ADR/ADE的监测工作，尤其是以头孢曲松为主的头孢菌素类药物，并密切关注热毒宁注射液在用药30min内的临床表现，规范临床用药，以减少ADR/ADE的发生，保证用药安全、有效。
[Abstract]:Objective: to explore the characteristics and regularity of adverse drug reactions / events (ADR/ADE) in Chongqing, to provide reference and basis for strengthening drug safety monitoring and guiding rational drug use in clinic, and to provide decision basis for drug supervision department. Methods: based on business intelligence technology, an intelligent analysis system of adverse drug reactions was constructed based on ADR/ADE data collected by Chongqing ADR Monitoring Center. 65900 cases of ADR/ADE caused by drugs in Chongqing from 2008 to 2012 were studied by pharmacoepidemiology. The ADR/ADE induced by cephalosporins in 2012 and Reduning injection from 2010 to June 2013 were analyzed intelligently. Results the intelligence analysis system with various functions such as collection, statistics, query, update and so on was developed by 1: 1. Among the 265 900 cases of ADR/ADE reports, the incidence of ADR/ADE was higher in the elderly patients over 60 years old, and the ADR/ADE caused by intravenous administration was the most. The main drugs involved in ADR/ADE were antimicrobial drugs, followed by the Chinese patent medicine ADR / ADE, which mainly involved organs and clinical manifestations as digestive system symptoms, skin and its appendages damage and systemic symptoms, medical institutions as the main reporting body; In 33394 cases of ADR/ADE caused by cephalosporins, the incidence of children under 10 years of age was 19.27%, severe ADR/ADE (including new severe) was 119 cases, and anaphylactic shock was the most common. Of the 4125 patients with ADR/ADE, 29 cases (23.20%) were caused by ADE, and 81 cases (64.8%) were males and 44 cases (35.2%) were females. The incidence of ADR/ADE; in children under 2 years of age (48.0%) was higher (48.0%) than that in 30min patients (89.6%). A total of 73.9% of the ADR/ADE207 cases were drug-induced rash, pruritus and other skin and adnexal lesions. 20.3% of the cases were new ADR.. Conclusion: the intelligent analysis system can effectively improve the utilization rate of ADR/ADE report information, excavate the potential valuable information from multiple levels and angles, and have a good application prospect. The monitoring of ADR/ADE of antimicrobial drugs and proprietary Chinese medicines should be paid more attention to in clinic. Especially ceftriaxone mainly cephalosporins, and pay close attention to the clinical manifestation of Reduning injection in 30min, standardize the clinical use, in order to reduce the occurrence of ADR/ADE, ensure the safety and effectiveness of drug use.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R969.3

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