从复黄片的临床研究谈谈中药临床试验的设计与质量控制

doi:10.3736/jcim20050307

Abstract

Objectives

To assess the efficacy of Fuhuang Tablets in treating internal hemorrhoid hemorrhage and discussing the design and quality control of clinical trials of traditional Chinese medicine.

Methods

According to two-center, randomized, blinded and controlled study, 144 patients with internal hemorrhoids were divided into 2 groups. Seventy-two patients were treated with Fuhuang Tablets (4 tablets t.i.d. per os) and the other 72 patients were treated with Zhining Tablets (4 tablets t.i.d. per os). Symptoms and signs of the patients were recorded and evaluated at the third and seventh day of treatment respectively.

Results

At the third day of treatment, the overall response rates of Fuhuang Tablets-treated group and Zhining Tablets-treated group were 58.57% and 27.78% respectively, with statistic difference between the two groups (P<0.05). At the seventh day of treatment, the overall response rates of Fuhuang Tablets-treated group and Zhining Tablets-treated group were 91.43% and 81.94% respectively, with no statistic difference between the two groups. The laboratory test results and life signs of the 144 patients were normal before and after the treatment.

Conclusion

Fuhuang Tablets are effective and safe in treating internal hemorrhoid hemorrhage.

Key words: Fuhuang Tablets, Clinical research, Research design, Quality control

CLC Number:

R954.73

Jin-gen Lu, Yi-bin Pan, Yong-qing Cao, Wei Yang, Xin-lin Zhang. Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study. Journal of Chinese Integrative Medicine, 2005, 3(3): 191-193.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20050307

http://www.jcimjournal.com/EN/Y2005/V3/I3/191

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Group	N	Recovery	Significant effect	Partial response	Nonresponse	Overall response rate (%)
Fuhuang Tablets-treated group
At the third treatment day	70	0 (0)	0 (0)	41 (58.57)	29 (41.43)	58.57
At the seventh treatment day	70	4 (5.71)	21 (30.00)	39 (55.71)	6 (8.57)	91.43
Zhining Tablets-treated group
At the third treatment day	72	0(0)	0(0)	20(27.78)	52(72.22)	27.78*
At the seventh treatment day	72	3(4.16)	12(16.67)	44(61.11)	13(18.06)*	81.94

Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study

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