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目的:了解温州地区药品不良反应(ADR)发生的规模、流行病学因素等情况。方法:收集2014年1~6月全市各县(市、区)中心上报的ADR病例报告进行统计分析,分析性别、年龄、ADR类型、药品剂型分布等情况。结果:半年度全市共发生ADR 3 612例,涉及220余家医疗机构;各年龄层均有发生,11~20岁构成比最低,31~40岁和41~50岁构成比最高;3 612例ADR报告中男1 628例,女1 977例;新的和严重ADR 1 133例,占31.36%,死亡病例5例;ADR报告中引起ADR的药品抗菌药(44.43%)和中药制剂(15.20%)所占比例最大;静脉滴注是最主要的给药途径(62.52%);ADR累及全身多个系统,以皮肤及附件损害(37.53%)和消化系统损害(21.63%)最常见。结论:抗菌药和中药制剂ADR高发,需进一步管理抗菌药使用,严格把握静脉给药指征,提高民众对静脉给药安全性的认识。
Objective: To understand the incidence of adverse drug reactions (ADR) in Wenzhou area scale, epidemiological factors and so on. Methods: The data of ADR cases reported by all counties (cities, districts) in China from January to June 2014 were collected for statistical analysis. The gender, age, ADR type and distribution of drug dosage forms were analyzed. Results: There were altogether 3 612 cases of ADR in the first half of the year, involving more than 220 medical institutions; all age groups occurred, with the lowest proportions of 11-20 years old, the highest proportions of 31-40 years old and 41-50 years old; 3 612 cases There were 1 628 males and 1 977 females in the ADR report; 133 new and serious cases of ADR (31.36%) and 5 deaths were reported; ADR drug-induced antimicrobial drugs (44.43%) and traditional Chinese medicine preparations (15.20% (62.52%). ADR involved multiple systems of the whole body, with skin and accessory lesions (37.53%) and digestive system damage (21.63%) the most common. Conclusion: The high ADR of antibacterial and traditional Chinese medicine preparations requires further management of the use of antimicrobial drugs, strict indications of intravenous administration, and raising public awareness of the safety of intravenous administration.