摘要
目的：评价上海市2003—2007年药品不良反应（adverse drug reaction，ADR）报告表的质量。方法：根据《药品不良反应／事件报告表规范分级标准》对ADR报告表质量进行评价，影响ADR报告表质量的危险因素进行多个自变量的logistic逐步回归分析。结果：2003年12月-2007年4月上海市ADR报告总数为32752份。2006年已经达到每百万人口650份ADR报告，来源于医师的占61．94％，严重ADR比例为3．1％。影响ADR报告表质量的危险因素及优势比（OR）、95％可信区间（CI）为：新的严重ADR（OR=2．19，95％CI：1．38～3．47）、新的一般ADR（OR=2．13，95％CI：1．51～3．00）、已知严重ADR（OR--5．32，95％CI：4．15～6．81）、生产企业（OR--35．74，95％CI：28．27～45．19）、军队医院（OR=21．05，95％CI：14．62～30．32）、监测机构（OR=6．16，95％CI：2．38～15．92）、个人（OR=11．17，95％CI：2．33～53．43）、其他（OR=2．22，95％CI：1．04～4．76）。结论：上海市ADR报告百万人13每年上报率已达世界卫生组织（WHO）要求的标准，但整体质量仍需提高，建议加强ADR的宣传培训，充分发挥医师、药师和护十的作用，改善ADR榍告存纬录入功能．
Objective： To evaluate the quality of adverse drug reaction （ADR） reports collected by Adverse Drug Reaction Monitoring Center of Shanghai from December 2003 to April 2007. Methods： The quality of ADR reports was evaluated according to ＂The Specification Ranking Standard of Adverse Drug Reactions/Events＂ issued by State Food and Drug Administration of China （SFDA）. The risk factors for the quality of ADR reports were analyzed by multiple independent variable stepwise logistic regression. Results： The total number of ADR reports collected by ADR Monitoring Center of Shanghai from December 2003 to April 2007 was 32 752. It reached 650 ADR reports per 1 million inhabitants in 2006, of which 3.1% were the serious ADRs and 61.94 % were reported by doctors. The risk factors, odds ratio（OR） and 95 % confidence interval（CI） of the quality of ADR reports were as follows： unexpected serious ADR：OR=2.19, 95%CI： 1.38-3.47; unexpected common ADR：OR 2.13, 95%CI： 1.51-3.00; known serious ADR： OR= 5.32, 95% CI： 4.15-6.81; pharmaceutical enterprises： OR= 35.74, 95%CI： 28.27-45.19; military hospitals：OR=21.05, 95%CI：14. 62-30. 32; monitoring agencies：OR=6.16, 95%CI：2.38- 15. 923 individuals：OR=11.17,95%CI： 2.33-53. 433 others：OR 2.22,95%CI： 1.04-4.76. Conclusion： The annualADRreporting rate per 1 million inhabitants in Shanghai meets the requirement of World Health Organization （WHO） standard. The quality, however, should be improved. It is essential to strengthen education of knowledge in ADR reporters, encourage doctors, pharmacists and nurses to report ADR, and improve the functions of the on-line ADR reporting system in order to decrease manual errors.
出处
《药学服务与研究》
CAS
CSCD
2008年第4期276-280,共5页
Pharmaceutical Care and Research
关键词
药物副反应报告系统
数据说明
统计
上海
adverse drug reaction reporting systems
data interpretation,statistical
Shanghai
