论文部分内容阅读
众所周知,60年代初爆发了震惊世界的“反应停事件”(thalidomide incident),在原联邦德国等国家,孕妇因服用反应停(沙立度胺)而导致了成千上万例海豹肢畸胎(phocomelus)。为此,世界卫生组织于1968年制订了一项有10个国家参加的国际药物监测合作试验计划,在美国弗吉尼亚州的亚历山大城设立了WHO协作组,收集和交流药物不良反应报告,制定了药物不良反应报表,药物不良反应术语,药品目录,并发展了计算机报告管理系统。1970年世界卫生组织大会认为该合作试验计划
It is well-known that the thalidomide incident that shocked the world broke out in the early 1960s. In the former Federal Republic of Germany and other countries, pregnant women caused tens of thousands of cases of seal limb teratogenicity due to the taking of thalidomide (thalidomide) phocomelus). To this end, WHO established a pilot program of international drug monitoring cooperation involving 10 countries in 1968 and set up a WHO collaborative group in Alexandria, Virginia, USA to collect and exchange ADR reports and to develop a drug Adverse reaction statements, ADR terminology, drug list, and the development of a computer reporting management system. The 1970 World Health Assembly considered the cooperation pilot scheme