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目的:通过药品不良反应(ADR)报告的统计分析,发掘警戒信号,提高药品不良反应监测工作质量,促进临床用药安全。方法:选取上海市宝山区2010年1-6月份上报的新的严重的ADR报告表405例,采用EXCEL电子表格和手工筛选方法,从多个维度进行统计分析。结果:405例ADR中,60岁以上患者192例(47.1%);引起ADR的药品主要是中药制剂156例(37.8%),抗微生品药140例(33.9%);用药途径中静脉注射239例(57.7%);ADR主要累及消化系统、皮肤和神经系统,分别占34.1%、22.3%和20.9%。结论:ADR的发生与诸多因素相关,包括患者年龄、药品种类和给药途径等,特别要重视中药制剂和抗微生物药品的不良反应监测,临床表现也呈现多元化,应加强ADR的监测,科学合理用药,确保用药的安全、有效。
OBJECTIVE: Through the statistical analysis of adverse drug reaction (ADR) reports, we can find the warning signal, improve the quality of adverse drug reaction monitoring and promote the safety of clinical medication. Methods: A total of 405 new cases of ADR were reported from January to June in 2010 in Baoshan District of Shanghai. Statistical analysis was conducted from multiple dimensions using EXCEL spreadsheet and manual screening method. Results: Among 405 cases of ADR, 192 cases (47.1%) were over 60 years old. The main drugs causing ADR were 156 cases (37.8%) of traditional Chinese medicine preparations and 140 cases (33.9%) of antimicrobial medicines. Intravenous injection 239 cases (57.7%). ADR mainly involved digestive system, skin and nervous system, accounting for 34.1%, 22.3% and 20.9% respectively. Conclusion: The incidence of ADR is related to many factors, including patient age, drug type and route of administration, with particular emphasis on the monitoring of adverse reactions of traditional Chinese medicine preparations and anti-microbial drugs. The clinical manifestations also showed diversification. The monitoring of ADR should be strengthened. The science Rational use of drugs to ensure the safety of drugs, effective.