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| 某三甲医院2013～2017年219例新的和严重的药品不良反应报告分析 |
| Analysis of 219 New or / and Severe Adverse Drug Reactions Occured in A Third Grade Hospital During 2013 to 2017 |
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| DOI： |
| 中文关键词: 药品不良反应，新的，严重的 报告 监测 安全用药 |
| 英文关键词:Drug adverse reactions, new, severe Report Monitoring Safe medication |
| 基金项目:上海交通大学医学院药学科研基金项目（编号：JDYX2017QN002） |
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| 中文摘要: |
| 摘 要 目的：了解新的和严重的药品不良反应(ADR)发生的规律及特点。方法：收集某三甲医院2013～2017年上报的219例新的和严重的ADR报告，从患者性别、年龄，涉及药品种类、剂型，ADR累及器官/系统及主要临床表现、关联性评价、转归等方面进行统计分析。结果：219例ADR中，新的ADR 191例，严重的ADR 20例，新的严重的ADR 8例。关联性评价结果：1.83%为肯定，75.34%为很可能，22.83%为可能。ADR患者男女比例为0.84 ∶〖KG-*2〗1，50～80岁所占比例为61.19%。药物剂型以口服药为主，占57.99%，而严重的ADR涉及药品以注射剂为主。引起新的ADR的药品以中成药（含中药注射剂）为主，共60例（31.41%)；引起严重的ADR的药品以抗微生物药物为主，共9例(32.14%)。严重的ADR主要临床表现为循环系统反应(39.29%)，以过敏性休克为主。95.89%的患者发生ADR后痊愈或好转。结论：应注重对于50～80岁人群进行ADR监测，并加强中成药（含中药注射剂）、抗微生物药物和抗肿瘤药物尤其是奥沙利铂的监测力度。 |
| 英文摘要: |
| ABSTRACT Objective: To discover the regularity and characteristics of new or / and adverse drug reactions (ADR). Methods:Two hundred and nineteen cases of new or / and severe ADRs onset in a Third Grade hospital during 2013 to 2017 were collected. The gender, age, type of drugs, drug formulation, involved organ and system, clinical symptoms, relevance evaluation, patient’s result and other aspects were summarized and analyzed. Results: Of the 219 ADRs, 191 were new, 20 were serious and 8 were new and serious. Drug related adverse reactions were positive in 1.83%, very likely in 75.34% and probable in 22.83%. The gender proportion (male : female) in those cases was 0.84 ∶〖KG-*2〗1. High risk age range was between 50 80 years (61.19%). The oral medicine mainly accounted for 57.99%, while injection dominated in severe ADRs. New ADRs mostly caused by Chinese patent medicines and Chinese traditional medicine injections with 60 cases (31.41%). Severe ADRs mostly caused by antibiotics with 9 cases (32.14%). Most clinical manifestations of severe ADRs were circulatory system (39.29%), mainly with anaphylactic shock. Around 95.89% of the patients recovered or improved after these adverse reactions. Conclusion:The population aged from 50 to 80 should be monitored. The Chinese patent medicines and Chinese traditional medicine injections, antibiotics, antineoplastic drugs especially oxaliplatin should be monitored intensively. |
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