Objective To evaluate the efficacy and safety of Niuhuangjiangya tablets (NT) on mild to moderate primary hypertension (overabundant liver-fire) in comparison with Niuhuangjiangya pills (NP).
Method The double-dummy and randomized controlled method was adapted to assess 240 patients (overabundant liver-fire) who were divided into the treatment group (n =120, treated with NT 2 tablets, twice a day) and the control group (n =120, treated with NP 1 pill, twice a day).The duration of treatment for both groups was 4 weeks.
Results Blood pressure began to decline in the first week of treatment. After 4 weeks, the mean diastolic and systolic blood pressure dropped 7.51 and 12.16 mmHg, respectively, in the treatment group; 7.53 and 12.45 mmHg dropped respectively in the control group. For diastolic blood pressure, the total efficacy rates of the two groups were 50.8% and 54.9% (P gt;0.05), respectively. For TCM syndromes, the total efficacy rates of the two groups were 45.6% and 42.34% (P gt;0.05), respectively. The two drugs were equivalent by the equivalent test (P lt;0.05). No adverse effect was found in the study.
Conclusions Niuhuangjiangya tablets have confirmed that the effects on mild to moderate hypertension has few side effects. The efficacy of the two drugs is equivalent by the equivalence test. placebo=controlled trials are required.
Citation：
HUANG Jihan,ZHENG Qingshan,GAO Rui,TU Xiuhua,XU Fengqin,SUN Ruiyuan. Clinical Equivalence Evaluation on the Efficacy and Safety of Niuhuangjiangya Tablets and Pills in the Treatment of Patients with Primary Hypertension ( Overabundant Liver-Fire ). Chinese Journal of Evidence-Based Medicine, 2004, 04(4): 249-254. doi:
Copy
Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
| 1. |
［1］Zheng QS, Sun RY, Chen ZY. Sample size estimation and equivalence margin in noninferiority and equivalence trials [ J ].Chinese Journal New Drugs, 2003; 12 ( 5 ): 368-371.
|
| 2. |
郑青山,孙瑞元,陈志扬.新药临床试验样本估计的简捷算法和等效标准探讨[J].中国新药杂志,2003;12(5):368～371.
|
| 3. |
［2］Zheng QS, Sun RY, Chen ZY. Lowest sample size and its safety in clinical trials in China [ J ]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2003; 8 ( 3 ): 354-355.
|
| 4. |
郑青山,孙瑞元,陈志扬新药临床试验最低例数规定的安全性分析[J]中国临床药理学与治疗学,2003;8(3):354～355.
|
| 5. |
［3］Zheng XY. The guide for clinical trials of new drugs [ M ]. 1 st Edition. Beijing: Medical Press Science of Technology of Chiha, 2002:68-73.
|
| 6. |
郑筱萸.中药新药临床研究指导原则[M].第1版.北京:中国医药科技出版社,2002:68～73.
|
| 7. |
［4］Zheng QS, Sun RY, Chen ZY. Determination of equivalence of two drugs in clinical trial [ J ]. Chinese Journal of Clinical Pharmacology and Therapeutics ,2002; 7 ( 6 ): 559-561.
|
| 8. |
郑青山,孙瑞元,陈志扬.临床两组药物等效的判别方法及其辨析[J].中国临床药理学与治疗学,2002;7(6):559～561.
|
| 9. |
［5］Chen ZY, Zheng QS , Sun RY. Function of the DAS Software for pharmacological calculation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2002; 7 ( 6 ): 562-564.
|
| 10. |
陈志扬,郑青山,孙瑞元大型药理学计算软件DAS的功能介绍[J].中国临床药理学与治疗学,2002;7(6):562～564.
|
| 11. |
［6］Zheng QS, Sun RY. Common questions of rank data and the statistical treatments in pharmacodynamical statistics[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2002; 7 (5): 469-472.
|
| 12. |
郑青山,孙瑞元药效指标等级划分的常见问题及其数据处理[J].中国临床药理学与治疗学,2002;7(5):469～472.
|
- 1. ［1］Zheng QS, Sun RY, Chen ZY. Sample size estimation and equivalence margin in noninferiority and equivalence trials [ J ].Chinese Journal New Drugs, 2003; 12 ( 5 ): 368-371.
- 2. 郑青山,孙瑞元,陈志扬.新药临床试验样本估计的简捷算法和等效标准探讨[J].中国新药杂志,2003;12(5):368～371.
- 3. ［2］Zheng QS, Sun RY, Chen ZY. Lowest sample size and its safety in clinical trials in China [ J ]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2003; 8 ( 3 ): 354-355.
- 4. 郑青山,孙瑞元,陈志扬新药临床试验最低例数规定的安全性分析[J]中国临床药理学与治疗学,2003;8(3):354～355.
- 5. ［3］Zheng XY. The guide for clinical trials of new drugs [ M ]. 1 st Edition. Beijing: Medical Press Science of Technology of Chiha, 2002:68-73.
- 6. 郑筱萸.中药新药临床研究指导原则[M].第1版.北京:中国医药科技出版社,2002:68～73.
- 7. ［4］Zheng QS, Sun RY, Chen ZY. Determination of equivalence of two drugs in clinical trial [ J ]. Chinese Journal of Clinical Pharmacology and Therapeutics ,2002; 7 ( 6 ): 559-561.
- 8. 郑青山,孙瑞元,陈志扬.临床两组药物等效的判别方法及其辨析[J].中国临床药理学与治疗学,2002;7(6):559～561.
- 9. ［5］Chen ZY, Zheng QS , Sun RY. Function of the DAS Software for pharmacological calculation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2002; 7 ( 6 ): 562-564.
- 10. 陈志扬,郑青山,孙瑞元大型药理学计算软件DAS的功能介绍[J].中国临床药理学与治疗学,2002;7(6):562～564.
- 11. ［6］Zheng QS, Sun RY. Common questions of rank data and the statistical treatments in pharmacodynamical statistics[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2002; 7 (5): 469-472.
- 12. 郑青山,孙瑞元药效指标等级划分的常见问题及其数据处理[J].中国临床药理学与治疗学,2002;7(5):469～472.
