【摘要】 避孕药物和器具的效益与危险性和其它治疗药物或医疗器具一样,须要接受广泛的市场后监察,及时发现和淘汰对人体具有严重危害的产品。许多国家建立了全国性药物监察网络。自觉报告制度是一种费用低、效果好的市场后安全性监察实用方法。重点监察项目则在样本人群中深入调查研究药物或器具与不良反应事故的因果关系;医药刊物也是报道不良反应案例的另一个重要信息资源。从生殖健康前景看,开展药物警戒学研究,设立全国性监察体制,加强对节育技术合并症或不良反应的市场后监察,将是评价影响避孕药具使用和提高计划生育服务质量的重要措施。更多还原

【Abstract】 As any treatment drugs, the benefit-risk profile of contraceptive drugs and devices should be evaluated by wide post-marketing surveillance in order to find out and even to eliminate the products with serious adverse reactions from the market. Many countries have established a national drug monitoring network and a spontaneous report system which is the most cost-effective and the practical way for post-marketing safety evaluation. The key monitoring programs should develop a thorough investigation and study on causality between drugs and adverse reactions in a target population. Medical and pharmaceutical journals are other important .sources of offering information on serious adverse reactions/ events. From a reproductive health perspective to develop study of pharmacovigilance, to set up national contraceptive monitoring system and to strengthen post-marketing surveillance of contraceptive adverse reactions or complications will be critical measures for assessing the impact of contraceptive drugs and devices on the clients, and improving quality of family planning service.更多还原