中药大规模临床试验及其管理与质量控制

doi:10.3736/jcim20070101

Abstract

Large-scale clinical trial is an important measure of clinical evaluation on drugs. This paperintroduces the concept and features of large-scale clinical trial, the possibility and necessity of large-scale clinical trial of traditional Chinese medicine, as well as its administration and quality control, with Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine (MISPS-TCM), a National Program Subject, as an example.

Key words: Chinese herbal drugs, clinical trials, administration, quality control

CLC Number:

R285.6

Hong-cai Shang, Jun-hua Zhang, Guo-hua Dai, Hong-bo Cao, Ming Ren, Yao-zu Xiang, Yang Wang, Bo-li Zhang, You-ping Li. Administration and quality control of large-scale clinical trials of traditional Chinese medicine. Journal of Chinese Integrative Medicine, 2007, 5(1): 1-4.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20070101

http://www.jcimjournal.com/EN/Y2007/V5/I1/1

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References 9

[1]	王文, 刘力生, 龚兰生 , 等. 我国大样本随机临床试验治疗心脑血管病的效价评估[J]. 中华心血管病杂志, 2003,31(1):24-28
	Wang W, Liu LS, Gong LS , et al. Assessment of cost-effectiveness of treatment for cardio-cerebrovascular diseases from large-sample randomized clinical trials in China[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 2003,31(1):24-28
[2]	刘建平 . 循证中医药临床研究方法学(第1版)[M]. 北京: 人民卫生出版社, 2006,( 第1版):7
	Liu JP. Clinical research methodology for evidence-based Chinese medicine(1st ed)[M]. Beijing: People's Medical Publishing House, 2006,( 1st ed):7
[3]	王杰松, 张俊虎, 胡慧渊 , 等. 三七总皂苷和复方丹参注射液治疗脑梗死的Meta分析[J]. 中国医院药学杂志, 2006,26(3):317-319
	Wang JS, Zhang JH, Hu HY , et al. Meta-analysis of notoginseng saponin and compound Salviae miltiorrhizae injection for treatment of cerebral infarction[J]. Zhongguo Yi Yuan Yao Xue Za Zhi, 2006,26(3):317-319
[4]	王丽平, 解越 . 针灸治疗卒中后吞咽困难的系统评价[J]. 中国针灸, 2006,26(2):141-146
	Wang LP, Xie Y . Systematic review on acupuncture and moxibustion for treatment of dysphagia after stroke[J]. Zhongguo Zhen Jiu, 2006,26(2):141-146
[5]	刘建平 , Manbeimer E, 施毅, 等. 中西医结合治疗SARS的系统评价与Meta-分析[J]. 中国中西医结合杂志, 2005,25(12):1082-1088
	Liu JP, Manheimer E, Shi Y , et al. Systematic review and meta-analysis on the integrative traditional Chinese and Western medicine in treating SARS[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2005,25(12):1082-1088
[6]	黄峻, 王文 . 脑血管疾病大型临床试验(第1版)[M]. 南京: 江苏科学技术出版社, 1998,( 第1版):1
	Huang J, Wang W . Large-scale clinical trials of cardio-cerebrovascular diseases(1st ed)[M]. Nanjing: Jiangsu Scientific and Technical Publishers, 1998,( 1st ed):1
[7]	王文, 刘力生 . 心血管药大样本临床试验的质量控制[J]. 中华心血管病杂志, 1999,27(2):153-154
	Wang W, Liu LS . Quality control of large-scale clinical trial for cardiovascular drugs[J]. Zhonghua Xin Xue Guan Bing Za Zhi, 1999,27(2):153-154
[8]	吴泰相, 李幼平, 李静 , 等. 中国临床试验注册和发表机制及实施说明[J]. 中西医结合学报, 2006,4(4):333-334
	Wu TX, Li YP, Li J , et al. Statement for Chinese clinical trial registration and publishing system[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(4):333-334
[9]	刘建平 . 中医药临床试验的方法学问题与挑战: 循证医学的观点[J]. 中西医结合学报, 2006,4(1):1-6
	Liu JP . Methodological quality assessment of clinical trials in traditional Chinese medicine: the principles of evidence-based medicine[J]. Zhong Xi Yi Jie He Xue Bao, 2006,4(1):1-6

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Administration and quality control of large-scale clinical trials of traditional Chinese medicine

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