Objective To evaluate the efficacy and safety of safflower yellow pigment lyophilized power amp; dripping solution in the treatment of patients with angina, by using parenteral solution of Dan-shen root extraction as control, we designed the nonferiority clinical trial phase Ⅲ.
Method 784 patients with stable angina pectoris Ⅰ, Ⅱ, Ⅲ degree and occurred more than twice per week were selected. They were randomly, stratified and blindly assigned into 5 parallel groups including one control. They were treated by using safflower yellow pigment lyophilized power (SYPLP) 80 mg + 0.9% NS 250ml, intravenously guttae, daily (trial group 1); SYPLP 160 mg + 0.9% NS 250 ml, intravenously guttae, daily (trial group 2); safflower yellow pigment lyophilized dripping solution (SYPLDS) 200 ml (160 mg), intravenously guttae, daily (trial group 3); SYPLDS 100 ml (80 mg), intravenously guttae, daily (trial group 4) and parenteral solution of Dan-shen root extraction 20 ml + 0.9% NS 250 ml, intravenously guttae, daily (control group) respectively. Efficacy and safety were evaluated after 14 days of continuous treatment.
Results The angina efficacy (per-protocol population, PP): The notable effective rates of trial groups 1 to 4 and control group were 53.27%，69.44%，70.09%，55.09% and 26.00% respectively, and the effective rates were 88.79%，92.59%，93.46%，89.81% and 73.00% respectively。There was significant differences between trial group 1 and 2, trial group 3 and 4. All trial groups showed significant different effect when compared with control (P＜0.05). The effect of trial group 2 was better than those of trial group 1, and trial group 3 better than trial group 4, the four trial groups better than control group. The intention-to-treat (ITT) analysis result was almost the same to PP analysis, but trial group 3 showed no significant difference to trial group 4. In trial group 2, 3 and 4, each occurred one adverse effect, while the number was 10 in control group.
Conclusion SYPLP amp; SYPLDS have certain effect on angina. They are more effective than parenteral solution of Dan-shen root extraction. No toxic side effect has been found in clinic tests.
Citation：
ZHANG Qiong,CHEN Zhiyang,WU Linbin,WANG Shuchen,ZHENG Qingshan. Clinical Nonferiority Evaluation on the Efficacy and Safety of Safflower Yellow Pigment Lyophilized Power & Dripping Solution in the Treatment of Patients with Angina. Chinese Journal of Evidence-Based Medicine, 2005, 05(4): 276-285. doi:
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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- 1. 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.
- 2. 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.
- 3. 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. p. 69～73.
- 4. 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.
- 5. 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.
- 6. 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.
- 7. 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.
- 8. Zheng XY. The guide for clinical trials of new drugs[M]. 1st Edition. Beijing: Medical Press Science of Technology of China; 2002. p. 68-73.
- 9. 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.
- 10. 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.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. 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.
