| 王平.619例严重药品不良反应报告回顾性分析[J].安徽医药,2020,24(8):1693-1696. |
| 619例严重药品不良反应报告回顾性分析 |
| Retrospective analysis of 619 cases of serious adverse drug reactions |
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| DOI：10.3969/j.issn.1009?6469.2020.08.056 |
| 中文关键词: 药物毒性 药物副反应报告系统 处方不当 合理用药 |
| 英文关键词: Drug toxicity Adverse drug reaction reporting systems Inappropriate prescribing Rational drug use |
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| 中文摘要: |
| 目的对严重药品不良反应(SADR)发生的特点、规律和影响因素进行统计分析，为指导临床安全合理用药提供依据。方法利用 EXCEL数据透视表等功能，对淮南市 2015—2019年通过“国家药品不良反应监测系统”上报的 SADR监测数据进行统计分析。结果 2015—2019年累计收集上报 SADR报告 619例(1.8%)。其中女性 350例(56.5%)男性 268例(43.3%)； SADR高发年龄段为 61～70岁，为 166例(26.8%)；涉及药物剂型 24种，其中注射剂 SADR为 460例，构成比，最高(74.3%)；静脉滴注给药 SADR为 408例，构成比最高(65.9%)；涉及 283个品种规格，抗肿瘤药物 SADR为 159例，构成比最高(25.7%)，其中，注射用盐酸吉西他滨的 SADR报告最多，为 40例(6.5%)。结论 SADR累及系统?器官范围广，对病人健康和生命安全危害大，是提示影响公众用药安全的最重要信息。 SADR的发生与病人年龄、药物剂型、给药途径和用药品种等多种因素有关。合理用药是减少 SADR发生的关键因素之一。医疗机构应加强抗肿瘤药物、抗菌药物和静脉给药 SADR监测，注重实施风险预警。 |
| 英文摘要: |
| Objective To analyze the characteristics，regularity and influencing factors of serious adverse drug reactions(SADR)and to provide a basis for guiding clinical safe and rational drug use.Methods Using EXCEL data pivot table and other functions，，statistical analysis of SADR monitoring data reported by Huainan City from 2015 to 2019 through the "National Adverse Drug Re?action Monitoring System".Results From 2015 to 2019，619 cases(1.8%)of SADR reports were collected and reported.Among them，350 cases were female(56.5%)and 268 were male(43.3%)； the high incidence of SADR was 61 to 70 years old，and had 166 cases(26.8%)； 24 drug dosage forms were involved，of which 460 were SADR injections，the highest composition ratio was 74.3%；408 cases of SADR administered by intravenous infusion，the highest composition ratiowas 65.9%；283 varieties of specifica? tionswere involved，the antitumor drug SADR was 159 cases，the highest composition ratio was 25.7%，of which，the SADR of gem? citabine hydrochloride for injection was the most reported，with 40 cases(6.5%).Conclusions SADR involves a wide range of or? gans and organs，and poses a great harm to human health and life safety.It is the most important information that prompts the im?pact of public drug safety.The occurrence of SADR is related to a variety of factors such as the patient’s age，drug dosage form，ad? ministration route and medication variety.Reasonable medication is one of the key factors to reduce the occurrence of SADR.Medi?cal institutions should strictly follow the four principles of safety，effectiveness，economy，and appropriateness，so that it can be tak? en orally without intramuscular injection，intramuscular injection without infusion.Anti?tumor drugs，anti?infective drugs and intrave? nous SADR monitoring should be strengthened，focusing on collecting drug safety risk information such as SADR with pharmacovigi? lance significance，ADR monitoring technical institutions at all levels should strengthen mission training and risk warning，prompt? ing the public to use drugs safely，and minimizing the occurrence and harm of SADR. |
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