摘要
临床试验受试者用药依从性可直接影响药物疗效终点指标的真实性。文章以多囊卵巢综合征临床试验为例,阐述如何提高受试者克罗米芬用药依从性问题。通过核查发现20(3+15+2)例受试者"违反方案",另也存在研究者指导服药错误或发药错误等情况。针对上述问题产生原因总结经验,建议今后临床试验在以下方面加大对用药依从性的重视程度:(1)提高现场监察及远程监查的及时性;(2)规范化培训研究助手;(3)对受试者进行健康宣教等。
Medication adherence will directly affect the validity of primary endpoint indicator. This article discussed how to improve the medication adherence of clomiphene citrate based on PCOSact. We found that 20 （3＋15＋2） cases were ＂protocol violation＂ and there were cases in which researchers made mistakes while distributing medicine and guiding patients how to take medicine. Focusing on these problems we sumed up experience and emphasized the importance of medication compliance through the following aspects： （1） Improvement of insite supervision and remote monitoring; （2） Standardization training for research assistants; （3） Health education for subjects.
出处
《中国循证医学杂志》
CSCD
2016年第12期1485-1488,共4页
Chinese Journal of Evidence-based Medicine
基金
2011年国家重大科技专项-国家公益性行业专项:多囊卵巢综合征不同生育阶段中医防治方案及转化应用研究(编号:201107005)
世界中医药学会联合会合作项目(编号:WFCMS-2016-001)
关键词
用药依从性核查
克罗米芬
服药方案优化
规范化培训
Verification of medication compliance
Clomiphene citrate
Protocol optimization
Standardized training
