从曲马多能否列入国际管制透视监测信息作用

Reviewing of Tramadol for International Control Based on Drug Surveillance

目的分析世界卫生组织讨论能否将曲马多列入国际管制的技术报告,了解药品上市后监测数据所发挥的作用。方法通过检索美国FDA和世届卫生组织网站,找出审评曲马多的技术报告。结果在1992～2006年期间,世界卫生组织对曲马多进行了4次审评,基于各国提供的曲马多滥用情况及对公共健康和社会所造成的危害等监测数据,考虑多种因素,权衡利弊,最终没有将其列入国际管制。结论药品上市后的监测数据,是对研发时期实验数据的一个重要补充,在专家决策及实施药品管制中发挥着重要作用。

Objective To analyze WHO Expert Committee＇s report on reviewing of tramadol for International Control, find out drug surveillance＇s data is a key factor which determines whether or not to recommend international control of substances. Methods US FDA and WHO website were retrieved and review data sheet of tramadol conducted by WHO Expert Committee are researched. Results During 1992 and 2006, tramadol had been submitted to the Expert Committee four times to determine whether or not to recommend under international control. According to the data subjected by countries, Committee considered that, even after a recent major increase in the extent of its use because of its therapeutic usefulness, tramadol continues to show a low level of abuse. Hence, the Committee concluded that there was not sufficient evidence to recommend international control of tramadol. Conclusion Surveillance of post-marketing psychoactive substances plays role in placing the substances under control.