中药新药防治儿童功能性便秘的临床研究技术要点

中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (9): 1025-1030.

中药新药防治儿童功能性便秘的临床研究技术要点

钟成梁^1,2, 胡思源¹

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

收稿日期:2013-01-11 修回日期:2013-07-01 发布日期:2013-09-07
通讯作者: 胡思源,男,医学博士,教授、主任医师,博士生导师,研究方向:中药新药临床评价方法学研究。Tel: 022-27432275-2718 E-mail: husiyuan1963@sina.com
作者简介:钟成梁,男,博士,中国中医科学院博士后在站,主治医师,研究方向:中药新药临床评价方法学研究。E-mail: Clitripro@sina.com.cn
基金资助:
科技部国家“十二五”重大新药创制资助项目(2011ZX09302-006-03)

Key technologies elements of clinical study of TCM new drugs on children's functional constipation

ZHONG Cheng-liang^1,2, HU Si-yuan¹

¹Office of Drug Clinical Trial Institution,the First Affiliated Hospital of Tianjin University of TCM, Tianjin 300193,China;
²Post-Doctoral Program, China Academy of Chinese Medical Sciences, Beijing 100700,China

Received:2013-01-11 Revised:2013-07-01 Published:2013-09-07

摘要/Abstract

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

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.

Key words: TCM New Drugs, Children's functional constipation, Clinical evaluation

中图分类号:

R969

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]. 中国临床药理学与治疗学, 2013, 18(9): 1025-1030.

ZHONG Cheng-liang, HU Si-yuan. Key technologies elements of clinical study of TCM new drugs on children's functional constipation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(9): 1025-1030.

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