三年来药品不良反应数据的统计与分析.docxVIP

159例药品不良反应监测系统反馈数据分析与评价 李烈巧 （陕西君碧莎制药有限公司 咸阳 721000 ） 摘要 目的 收集陕西君碧莎制药有限公司2013年～2015年间药品不良反应（ADR）国家药品不良反应监测系统监测报告159例，分析该监测数据，为临床合理用药提供参考依据。方法 采用回顾性研究和描述性统计方法，计算机录入数据处理。结果 159例ADR报告中累及系统排名依次为消化系统损害（59.75%）、全身性损害（20.75%）、皮肤及其附件损害（15.72%）、生殖系统损害（3.77%）；出现频次较高的ADR依次是腹痛、腹泻（54例）、恶心、呕吐（22例）、皮疹、瘙痒（22例）、头晕（10例）；涉及的药物中药口服制剂153例，外用制剂3例；在可疑药品中，百癣夏塔热片57例、皮肤病血毒片25例，调经促孕丸14例。结论 国家药品不良反应监测系统建立，为进一步保证患者用药安全，完善药品上市后的评价起到了重要作用；我公司的产品不良反应发生率小于0.01%， 十分罕见，产品安全性较高。 关键词 药品不良反应；监测系统；反馈数据；分析评价 Analysis and evaluation of feedback data in 159 cases of adverse drug reaction monitoring system Li Lieqiao (Shaanxi junbisha Pharmaceutical Co. Ltd. Xianyang 721000) Abstract objective to collect Shaanxi junbisha Pharmaceutical Co., Ltd. in 2013 to 2015 adverse drug reaction (ADR) national drug adverse reactions monitoring system monitoring report of 159 cases, analyzing the monitoring data, in order to provide the reference for the clinical rational drug use. Methods Retrospective study and descriptive statistical methods were used in the data processing of computer. Results of 159 cases of ADR reports involving the system ranking followed by digestive system damage (59.75), systemic damage (20.75%), skin and its appendages (15.72%) and reproductive system damage (3.77%), higher frequency of ADR followed by abdominal pain, diarrhea (54 cases), nausea and vomiting (22 cases), skin rash, itching (22 cases), dizziness (10 cases); relates to the Chinese medicinal oral preparation of 153 cases, 3 cases of topical preparations; in the suspected drug, BAIXIAN xiatare tablet 57 cases, 25 cases of skin blood poison tablets, promote menstruation pregnancy pill in 14 cases. Conclusion the establishment of the national adverse drug reaction monitoring system has played an important role in ensuring the safety of drug use and improving the evaluation of drug products. The incidence rate of adverse reactions in our company is less than 0.01%,Very rare, high product safety. Keywords： a