摘要
目的研究临床医师对中成药上市后再评价的认知度。方法采用自填式问卷调查,对临床医师的用药习惯、对联合用药的认识、中成药存在的问题(疗效、安全性)及中成药上市后再评价的认识等数据进行统计分析。结果发放调查问卷280份,回收合格问卷254份。临床医师使用中成药较多(47.6%);大多数认为中成药可以联合使用(90.1%);中成药存在疗效不佳(49.6%)与安全性的问题(28.3%);中成药说明书的问题主要是不良反应不明确(44.1%);中药注射剂存在的问题是制剂不过关(52.4%)以及说明书中无与西药相互作用的说明,使临床使用混乱(46.1%);上市后中成药再评价必要性已得到临床医师广泛认同(93.7%)。结论中成药再评价十分必要,重点在于临床安全性和有效性的研究;修订完善中成药说明书,加强中药注射剂的临床风险管理非常重要。
Objective It is to study the clinician recognition for reevaluation of post-marketing Chinese patent medicine.Methods Structured interviews were carried out to investigate clinicians for medication habits,cognition on drug combination,the existing issue of Chinese patent medicine（curative effect and safety） and recognition for reevaluation of post-marketing Chinese patent medicine.The statistical analysis on the data was carried out.Results 280 questionnaires were released and 254 qualified questionnaires were recovered.The quantity of Clinicians using Chinese patent medicine was most（47.6%）.Most Clinicians thought that Chinese patent medicine could be combined（90.1%）.Chinese patent medicine existed poor effects（49.6%） and safety problems（28.3%）.The main problem of the specification of Chinese patent medicine was not clear untoward reactions（44.1%）.The existed problems of traditional Chinese medicine injection were technology pharmaceutics fail（52.4%）,and less the elucidation of interaction with western medicine made clinical using confusion（46.1%）.The necessity of reevaluation of post-marketing Chinese patent medicine had widely recognized by clinicians（93.7%）.Conclusion The reevaluation of Chinese patent medicine is fully necessary.The key point is the study of safety and effectiveness.It is very important to amend and consummate the specification of Chinese patent medicine and strengthen the clinical risk management of traditional Chinese medicine injection.
出处
《现代中西医结合杂志》
CAS
2011年第8期911-913,共3页
Modern Journal of Integrated Traditional Chinese and Western Medicine
基金
科技部"重大新药创制"专项课题(2009ZX09502-030)
中国中医科学院自主选题项目(Z02101)
关键词
中成药
上市后再评价
认知度
Chinese patent medicine
reevaluation of post-marketing
recognition
