温州地区2014年上半年药品不良反应报告统计分析

Statistic Analysis on Adverse Drug Reaction of Wenzhou Area in First Half of 2014

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 scale, rules, and epidemic disease factor of ADR in the district of Wenzhou city. Methods： Conducted statistical analysis by collecting case reports in all counties （cities, and districts） of whole city and analyzed gender, age, ADR type, and distribution of drug dosage. Results ：3 612 cases of ADR happened in the whole city within 6 months, involving more than 220 medical organizations; they happened in all age levels： people aging from 11 to 20 occupied 3.82%, which took account for the lowest proportion; people aging from 31 to 40 and from 41 to 50 occupied 15.67% and 15.06% respectively, which took account for the highest proportion, including 1 628 male cases and I 977 female cases; there were 1 133 cases of new and serious ADR, which occupied 31.36%, including 5 death cases;Of the 3 612 ADR cases, antibacterial drug （44. 43% ） ranked the first and followed by the Chinese medicine preparation （ 15.20% ） ; intravenous drip was the most dangerous drug deliver route; ADR involved multiple systems in body, a- mong which skin and appendix damage （37.53%） and alimentary system damage （21.63%） were the most common ones. Conclusian：ADR in antibacterial drug and Chinese medicine preparation happened frequently. We should take a further step to manage usage of antibiotics, strictly grasp the indication of intravenous administration, and improve the safety understanding of people on intravenous administration.