药品不良反应报告分析

Analysis of adverse drug reaction reports

目的 了解医院药品不良反应（ADR）发生的规律与特点,为预防ADR发生和临床合理用药提供参考.方法 收集解放军第一○○医院2012年1月至2013年12月上报的ADR报告183份,分别从ADR报告来源、ADR的类型、患者年龄及性别、给药途径、ADR涉及药品种类、ADR累及器官或系统及主要临床表现等方面进行统计、分析.结果 上报的183例药品不良反应报告中,药师上报比例最高,占53.6％ （98/183）;量变型异常不良反应71.6％ （131/183）多于质变型异常不良反应28.4％ （52/183）;发生ADR患者中,女性多于男性,但男女性别比例差异无统计学意义,65岁以上患者ADR发生率高于其他年龄段,占50.8％ （93/183）;涉及的药品共有124种,其中抗菌药物引发的比例最高,占38.8％ （71/183）,其次为中药制剂11.5％ （21/183）;静脉给药方式是导致ADR的主要给药途径,占55.7％（102/183）;ADR最常见的临床表现为皮肤及其附件损害,占34.4％ （63/183）,其次为消化系统18.0％（33/183）、全身系统11.5％ （21/183）.结论 临床应了解并重视ADR的监测和上报工作,完善相关报告分析制度,确保临床用药安全、有效、合理.

Objective To observe the characteristics of the adverse drug reactions （ADR） in order to provide a reference for prevention of the ADR and rational administration of the drugs. Methods Totally 183 ADR cases from January 2012 to December 2013 were collected and the ADR source, the type of ADR, age and sex, routes of administration, drug category, organs and systems involved and clinical manifestations were ana- lyzed. Results Of the 183 cases of ADR reports, the ADR reported by pharmacists took the highest proportion [ 53.6% （98/183） ] ; A-type of ADR was 71.6% （ 131/183）, higher than B-type ADR [ 28.4% （52/183） ] ; no significant gender difference was observed; the ADR incidence in patients aged over 65 years was the highest [50.8% （93/183）] ; the number of involved drug kinds was 124 with the highest proportion of anti -infection drugs [38.8% （71/183） ], followed by traditional Chinese medicine injections [ 11.5% （21/183） ] ; 55.7% （102/183） were intravenous administration; lesion of skin was the most common manifestation [ 34.4% （63/ 183 ） ], followed by lesion of digestive system [ 18.0% （ 33/183 ） ] and systemic damages [ 11.5 % （ 21/183 ） ]. Conclusion The ADR reporting and analyzing system should ensure clinical safe, effective and rational use of drugs.