摘要
目的：分析武汉市2012年新的和严重的药品不良反应（ADR）的特点及规律，提高ADR的监测和临床合理用药的水平，及时、有效地控制药品风险，保障公众用药安全。方法：对2012年武汉市16个区自愿上报的新的和严重的ADR报告，进行分类统计和分析。结果：新的和严重的ADR报告共有887例，占报告总数的10．75％；41～60岁人群ADR发生率最高，占35．51％；可疑药品中静脉滴注给药为引起严重的和新的ADR的主途径；引起新的和严重的ADR的药物以抗感染药为主；新的严重的ADR表现以全身性损害最为常见，其次是皮肤及其附件损害。引起严重的和新的ADR病例的前10位药品的剂型大部分为注射剂，前者病例报告最多的药品是克林霉素，后者病例报告最多的药品是头孢曲松钠。结论：应该加强对药品生产企业的新的和严重的ADR的上报工作，建立并落实ADR救济制度；医疗机构重点监测抗感染药物的ADR报告，加强疑似预防接种异常反应的监测，保障公众用药安全。
OBJECTIVE To analyze the characteristics and rules of the new and serious adverse drug reaction （ADR） in Wu ban city in 2012, for improving the level of ADR monitoring and clinical rational drug use, timely and effectively controlling of drug risks, and protecting public safety. METHODS All of the new and serious ADR reports collected from 16 districts of Wuhan city were classified and statistically analyzed. RESULTS The new and serious ADR reports reached to 887 cases in 2012, accounting for 10. 75G of the total number of the reports; the highest ADR incidence was found in the population with the age of 41-60 years old, accounting for 35.51 G; suspicious drugs intravenous infusion may be the main reason of the serious and new ADR; new and serious ADR mainly caused by anti-infective drugs; systemic damage was the most common manifesta- tion of the new and serious ADR, followed by skin and its appendages damage; the top 10 drugs causing the severe and the new ADR cases were relevant to injection type drugs, the most frequently reported drugs resulting severe ADR cases was clindamycin, and the new ADR cases mainly related to ceftriaxone sodium. CONCLUSION The works of reporting of the new and seri- ous ADR in pharmaceutical production enterprise should be strengthened. The ADR relief system also should be established. Medical institutions should focus on monitoring the ADR reports of anti infective drugs, particularly suspected abnormal reac- tion to vaccination monitoring, to protect the public safety in drug using.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2014年第4期326-331,336,共7页
Chinese Journal of Hospital Pharmacy
关键词
药品不良反应
新的和严重
药品不良反应
监测
adverse drug reaction
new and serious
adverse drug reactions
monitoring
