中药新药临床疗效评价中常见问题分析及对策  

Analysis on Common Problems in Clinical Evaluation of New Chinese Medicines and Countermeasures

作　　者：杜宝俊[1] 谢志敏[1] 

机构地区：[1]中国中医科学院西苑医院国家药晶临床研究机构,北京市100091

出　　处：《中医杂志》2009年第12期1075-1078,共4页Journal of Traditional Chinese Medicine

摘　　要：针对中药新药临床疗效评价中存在的技术问题进行了讨论,对于中药新药干预模式单一、治疗过程中针对证候变化缺少相应处理、证候辨证标准随意性大、对照药选择欠妥当、合并用药考虑不周等干扰临床疗效评价的问题提出改进意见,以提高中药新药临床疗效评价质量。The authors discuss the technical problems in clinical evaluation of newly-developed Chinese medicines. For improvement of evaluation quality, this paper puts forward some suggestions for solving the common problems such as unitary intervention pattern, lack of corresponding treatment for the changed syndrome, subjectivity in standards of syndrome-differentiated diagnosis, ill-chosen medicine in control group, and mismanagement of medicine combination.

关 键 词：中药新药 临床研究 疗效评价 药品临床试验管理规范(GCP) 

分 类 号：R285[医药卫生—中药学]