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| 避孕药品不良反应报告质量评估及对策探讨 |
| Quality Evaluation and Countermeasure Discussion of Contraceptives Adverse Reaction Reports |
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| DOI： |
| 中文关键词: 避孕药品 药品不良反应 报告 质量评估 |
| 英文关键词:Contraceptive drugs Adverse reaction Report Quality evaluation |
| 基金项目:江苏省人口计生委指导性科技项目（编号：JSFPC2014010） |
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| 中文摘要: |
| 摘 要 目的：分析避孕药品不良反应报告的现状，评估报告质量，探索改进措施。方法：从本中心2010～2014年收集的1921例避孕药品不良反应报告表中抽取10%进行质量评分，并分析失分原因。结果：质量评估结果显示，新的和严重报告比例较低（6.65%）；报告主要来自计生机构（88.81%）；报告表质量在逐年提高（P＜0.000 1）。结论：报告表总体质量较高，亟待建立符合避孕药品不良反应报告及其数据库特点的科学、可操作的综合评估方法。 |
| 英文摘要: |
| ABSTRACT Objective:To analysis the status and quality of the adverse drug reaction reports of the State Contraceptives Adverse Reaction Surveillance Center (SCARS) ，and to explore the possible improvements. Methods:To choose the 10% sample from 1921 contraceptives adverse reaction (CAR) cases collected by SCARS from 2010 to 2014. Results:The quality evaluation results showed that the new and severe reports were in lower proportion (6.65%). And reports were mainly from family planning agencies (88.81%). Cochran Armitage test showed that the quality of the reports were increased year by year (P<0.000 1). Conclusion:Totally the quality of CAR reports were fine. And it was very necessary to establish scientific and operable comprehensive evaluation methods. |
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