Adverse Drug Reaction of Compound Prescription of Huangyaozi (Dioscorea Bulbifera L.) in Clinical Trial and Its Management_Chinese Journal of Evidence-Based Medicine

Authors：

JIANG Meng , XIONG Ningning , LIU Shenlin , FU Weimin , YE Bo , CHEN Jing

National Base for Drug Clinical Trial; Affiliated Hospital of Nanjing University of Traditional Chinese Medicine; Nanjing 210029; China;

Corresponding author：

Keywords：

Huangyaozi （Dioscorea bulbifera L.）; Drug clinical trial; Adverse drug reaction

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In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.

Citation： JIANG Meng,XIONG Ningning,LIU Shenlin,FU Weimin,YE Bo,CHEN Jing. Adverse Drug Reaction of Compound Prescription of Huangyaozi (Dioscorea Bulbifera L.) in Clinical Trial and Its Management. Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 255-257. doi: Copy

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1. ［1］Xiong NN, Liu F, Jiang M, Fu WM, Bu QY, Wang XQ,Gao WM, Zou JD. Standard operating procedures for ethics committees in institution of clinical trial [ J ]. Chin. J Clin.Pharmacol. Ther, 2003 ;8(4) :477 -480.
2. 熊宁宁,刘芳,蒋萌,符为民,卜擎燕,汪秀琴,高维敏,邹建东临床试验机构伦理委员会标准操作规程[J]中国临床药理学与治疗学,2003;8(4):477～480.
3. ［2］Wang XQ, Xiong NN, Liu SL , Li QY, Liu F, Zou JD,Bu QY, Gao WM. Ethic review in clinical research: risk benefit analysis[J]. Chin. J Clin. Pharmacol. Ther, 2003;8(6) :718 -720.
4. 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.
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6. 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 2059～2061.
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10. 郑筱萸,任德权中药新药临床研究指导原则(试行)[M].第1版,北京:中国医药科技出版社,2002 20～21.

Chinese Journal of Evidence-Based Medicine

Adverse Drug Reaction of Compound Prescription of Huangyaozi (Dioscorea Bulbifera L.) in Clinical Trial and Its Management

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