中药注射剂应用现状及安全性问题与对策

Application status and safety countermeasures of traditional Chinese medicine injections

中药注射剂的研发是中医药现代化的积极探索和重要创新,在我国医疗健康事业中具有重要的临床价值和不可替代性。然而近年来,随着中药注射剂应用范围的扩大,不良事件的报道逐渐增多,安全性问题备受关注。其原因主要有药物因素和临床应用不合理等。前者包括历史原因和质量标准不统一,后者包括中西药合用、剂量使用不规范以及方证药证不对应。我们应当积极面对问题,从药厂、医生以及政府三方面入手,制定切实可行的有效的防范措施:一是严格把好药物制剂关;二是倡导方证对应的用药理念,最大程度减少不良反应发生;三是加强药品上市后再评价,强化市场监督管理。

The research and development of traditional Chinese medicine（TCM） injections is an important innovation of modernization of TCM,which has great clinical value and irreplaceability in medical enterprise of China.But reports of adverse events of TCM injections gradually increased in recent years and the security problems received much concern with the enlargement of its application range.The reasons include unreliable herb sources and unreasonable utilization,in which the former includes historical reasons and non-unified standard and the latter includes combined use of Chinese and Western medicine,misused dosage and formula not corresponding to syndromes.We should face the problems,and preventive measures should be worked out by pharmaceutical factory,doctors and government.The first one is strictly guarding the pharmaceutical preparation procedures with advanced pharmaceutical technology;the second one is advocating the idea of formula corresponding to syndromes to minimize the occurrence of adverse effects;and the last one is strengthening the postmarketing reevaluation and market supervising management.