| 中药新药防治儿童功能性便秘的临床研究技术要点 |
| |
| 引用本文： | 钟成梁,胡思源.中药新药防治儿童功能性便秘的临床研究技术要点[J].金属学报,2013,18(9):1025-1030. |
| |
| 作者姓名： | 钟成梁 胡思源 |
| |
| 作者单位： | 1.天津中医药大学第一附属医院,药物临床试验机构办公室,天津 300193;2.中国中医科学院·博士后流动站,北京 100700 |
| |
| 基金项目： | 科技部国家“十二五”重大新药创制资助项目(2011ZX09302-006-03) |
| |
| 摘 要： | 基于国内、外文献并结合作者的临床科研实践,在试验目的与试验设计、受试者的选择、治疗方案、试验流程、有效性评价、安全性评价、试验的质量控制和保证等方面,总结了中药新药防治儿童功能性便秘的临床研究技术要点,以期为本病的中药新药临床试验设计提供借鉴。
|
| 关 键 词： | 中药新药 儿童功能性便秘 临床评价 |
| 收稿时间： | 2013-01-11 |
| 修稿时间： | 2013-07-01 |
Key technologies elements of clinical study of TCM new drugs on children's functional constipation |
| |
| ZHONG Cheng-liang,HU Si-yuan.Key technologies elements of clinical study of TCM new drugs on children's functional constipation[J].Acta Metallurgica Sinica,2013,18(9):1025-1030. |
| |
| Authors: | ZHONG Cheng-liang HU Si-yuan |
| |
| Affiliation: | 1.Office of Drug Clinical Trial Institution,the First Affiliated Hospital of Tianjin University of TCM, Tianjin 300193,China;2.Post-Doctoral Program, China Academy of Chinese Medical Sciences, Beijing 100700,China |
| |
| Abstract: | The evidence of relevant systematic reviews and randomized controlled trials was assessed and graded, combined with the clinical study practice to identify eleven key elements as a focus for the clinical study of TCM New Drugs on children's functional constipation:the primary purpose and design of the study, the inclusion and exclusion criteria of the study,the treatment,the trail procedure,the effectiveness and safety evaluation, and quality control as well. In addition, six recommendations for the design of clinical study of TCM New Drugs on Children's Functional Constipation were provided. |
| |
| Keywords: | TCM New Drugs Children's functional constipation Clinical evaluation |
|
| 点击此处可从《金属学报》浏览原始摘要信息 |
|
点击此处可从《金属学报》下载全文 |
|
