CAJ | 학술논문

背景中药临床应用的安全性受到社会越来越广泛的关注，如何有效加强中药不良反应监测是卫生主管部门、制药企业及医疗机构无法回避的课题。目的剖析中药不良反应监测的现状，并探讨中药不良反应监测今后的发展方向。方法综合涉及中药不良反应监测的数据和文献报告，并以香雪抗病毒口服液不良反应/事件监测研究作为范例进行分析。结果中药不良反应监测有了明显进步，但中药注射制剂与口服制剂之间存在巨大反差，企业对于口服中药制剂临床用药的风险防范意识薄弱，缺乏主动性。结论中药口服制剂的不良反应监测应得到充分重视，而制药企业应加强产品的不良反应监测研究，切实提高社会卫生保障能力和水平。
배경중약림상응용적안전성수도사회월래월엄범적관주，여하유효가강중약불량반응감측시위생주관부문、제약기업급의료궤구무법회피적과제。목적부석중약불량반응감측적현상，병탐토중약불량반응감측금후적발전방향。방법종합섭급중약불량반응감측적수거화문헌보고，병이향설항병독구복액불량반응/사건감측연구작위범례진행분석。결과중약불량반응감측유료명현진보，단중약주사제제여구복제제지간존재거대반차，기업대우구복중약제제림상용약적풍험방범의식박약，결핍주동성。결론중약구복제제적불량반응감측응득도충분중시，이제약기업응가강산품적불량반응감측연구，절실제고사회위생보장능력화수평。
Background Since more and more concern is raised regarding clinical safety of TCM products,effective and enhanced monitoring on adverse reactions of TCM products has become an inevitable subject for health authorities,pharmaceutical companies and medical institutes.Objective To analyze current status and to explore the future of monitoring on adverse reactions of TCM products.Methods data and literature reports concerning adverse reactions monitoring of TCM products were reviewed and summarized,and an adverse reactions/events monitoring study as conducted by Guangzhou Xiangxue Pharmaceutical was analyzed as a paradigm. Results Significant progress has been made in the monitoring of adverse reactions to TCM products.There is,however,huge difference between injectable and oraly administered products in the monitoring.Pharmaceutical companies are hardly aware of the clinical risks with oraly administered TCM products and thus are not initiative.Conclusion Adequate attention should be given to the monitoring of adverse reactions to oraly administered TCM products,while pharmaceutical companies should strengthen adverse reactions monitoring study on their products,so as to substantialy improve protection for public health.