Objective To evaluate the safety of Rongbisu capsule used for treating benign prostatic hyperplasia.
Methods A total of 218 patients (average age 63.73±7.50 years old) with phase Ⅰor Ⅱ benign prostatic hyperplasia were treated with oral Rongbisu capsule at a dose of 3 granules twice daily. The therapeutic course was 6 weeks and hepatic function was determined every 2 weeks.
Results The median value of ALT in 218 patients rose significantly after the patients took Rongbishu capsule for 6 weeks (P=0.001 7). There were 17 patients whose ALT level rose from normal to abnormal, the incidence was 7.80%. There were 3 patients whose hepatic function was seriously impaired (ALT＞200 IU/L).
Conclusions The essential component of Rongbishu capsule is edible tulip which has been recorded in the medical literature as being toxic. Airpotato yam of which the alias is also edible tulip is easily mistaken for edible tulip. Airpotato yam is the tuber of dioscorea bulbifera L. (family dioscoreaceae) which has confirmed hepatotoxcity. Our study result indicates that in order to insure the safety of Chinese crude drug, the origin of Chinese crude drug should be defined in the formulation according to the standard of Chinese drugs preparation. Pharmaceutical enterprises should strictly abide by the standards to identify the origin of Chinese crude drugs when approving the raw materials, especially for species which are poisonous and easily mistaken.
Citation：
LIU Shen lin,XIONG Ning ning,ZOU Jian dong,JIANG Meng,NING Ke qin,WANG Hong. Clinical Report on Hepatic Function Lesion Caused by Rongbishu Capsule for Treating Benign Prostatic Hyperplasia. Chinese Journal of Evidence-Based Medicine, 2005, 05(3): 229-231. doi:
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| 1. |
丁红, 赵杨, 于浩, 苏炳华, 陈峰. 多中心临床试验中实验室数据的定量分析方法[J]. 中国临床药理学与治疗学, 2004; 9(10): 1 193～1 196.
|
| 2. |
新编中药大辞典[M]. 新文丰出版公司, 中华民国70年. p. 692～695, 176～177, 224～225.
|
| 3. |
中华人民共和国药典[M]. 2000年版一部. p. 24.
|
| 4. |
江苏新医学院. 中药大辞典[M]. 第1版. 上海:上海科学技术出版社,1977. p. 3 285～3 286, 4 199～4 200.
|
| 5. |
汪秀琴, 熊宁宁, 刘沈林, 李七一, 蒋萌, 刘芳, 邹建东, 卜擎燕, 高维敏. 临床试验的伦理审查:风险与受益分析[J]. 中国临床药理学与治疗学, 2003; 8(6): 718～720.
|
| 6. |
Ding H, Zhao Y, Yu H, Su BH, Chen F. Quantitative analysis of laboratory data in multi center clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2004; 9(10): 1 193-1 196.
|
| 7. |
New Chinese Herb Dictionary[M]. Xin Wen Feng Publishing Company, The 70th anniversary of China Republic. p. 92-695, 176-177, 224-225.
|
| 8. |
Pharmacopoeia of the People’s Republic of China[M]. Part one. Version of the year 2000. p. 24.
|
| 9. |
Jiangsu New Medical College. Chinese Herb Dictionary[M]. 1st ed. Shanghai: Technology book concern of Shanghai, 1977. p. 3 286-3 286, 4 199-4 200.
|
| 10. |
Wang XQ, Xiong NN, Liu SL, Li QY, Jiang M, Liu F, Zou JD, Bo QY, Gao WM. Ethic Review in Clinical Research: Risk/Benefit Analysis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2003; 8(6): 718-720.
|
- 1. 丁红, 赵杨, 于浩, 苏炳华, 陈峰. 多中心临床试验中实验室数据的定量分析方法[J]. 中国临床药理学与治疗学, 2004; 9(10): 1 193～1 196.
- 2. 新编中药大辞典[M]. 新文丰出版公司, 中华民国70年. p. 692～695, 176～177, 224～225.
- 3. 中华人民共和国药典[M]. 2000年版一部. p. 24.
- 4. 江苏新医学院. 中药大辞典[M]. 第1版. 上海:上海科学技术出版社,1977. p. 3 285～3 286, 4 199～4 200.
- 5. 汪秀琴, 熊宁宁, 刘沈林, 李七一, 蒋萌, 刘芳, 邹建东, 卜擎燕, 高维敏. 临床试验的伦理审查:风险与受益分析[J]. 中国临床药理学与治疗学, 2003; 8(6): 718～720.
- 6. Ding H, Zhao Y, Yu H, Su BH, Chen F. Quantitative analysis of laboratory data in multi center clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2004; 9(10): 1 193-1 196.
- 7. New Chinese Herb Dictionary[M]. Xin Wen Feng Publishing Company, The 70th anniversary of China Republic. p. 92-695, 176-177, 224-225.
- 8. Pharmacopoeia of the People’s Republic of China[M]. Part one. Version of the year 2000. p. 24.
- 9. Jiangsu New Medical College. Chinese Herb Dictionary[M]. 1st ed. Shanghai: Technology book concern of Shanghai, 1977. p. 3 286-3 286, 4 199-4 200.
- 10. Wang XQ, Xiong NN, Liu SL, Li QY, Jiang M, Liu F, Zou JD, Bo QY, Gao WM. Ethic Review in Clinical Research: Risk/Benefit Analysis[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2003; 8(6): 718-720.
