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

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。

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.