Combination Therapy of Atorvastatin and JiangZhi Decoction for Primary Hyperlipidemia (Tan Zhuo Zu E Zheng): A Stratified Randomized Controlled Trial_Chinese Journal of Evidence-Based Medicine

Authors：

CHENTie-jun ,  JIANGZi-yan , WANGXiao-Long , WANGYing-Jie ,  SHENZhi-jie

Department of Cardiovascular, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China;

Corresponding author：

SHENZhi-jie, Email: 13817908883@163.com

Keywords：

Hyperlipidemia; JiangZhi Decoction; Atorvastatin; Drug interaction; Factorial design; Randomized controlled trial

DOI：

10.7507/1672-2531.20150147

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Object To observe the clinical efficacy and safety of the combination therapy of atorvastatin and JiangZhi Decoction (ZJD) for primary hyperlipidemia (Tan Zhuo Zu E Zheng) and to analyze the interactions of drugs in hypolipidemic effect. Methods A 2*2 factorial design, single-blind, stratified randomized controlled trial according to the level of lipid was conducted. Primary hyperlipidemia (Tan Zhuo Zu E Zheng) patients met the inclusion criteria were divided into 5 groups:ATV 10 mg group (group A), ATV 20 mg group (group B), ATV 10 mg+JZD group (group C), ATV 20 mg+JZD group (group D), JZD group (group E). After two weeks treatment, the efficacy and safety among the 5 groups were compared. Results A total of 92 patients were included, of which, 20 were in group A, 25 in group B, 21 in group C, 17 in group D, and 9 in group E. The results showed that:(1) There was no significant difference between group C and group B in the reduction of serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) (P_TC=0.226, P_LDL-C=0.818). (2) The results of 2*2 factorial analysis showed that, there was no significant interaction between TCM factor and western medicine factor (P_TC=0.605, P_LDL-C=0.843). (3) There were no significant differences in safety outcomes among 5 groups (all P values >0.05). Conclusion ATV 10 mg+JZD and ATV 20 mg have a similar efficacy in reducing TC and LDL-C. There is no obvious interaction between JZD and ATV in hypolipidemic effect, and the combination therapy of ATV and JZD is safe.

Citation： CHENTie-jun, JIANGZi-yan, WANGXiao-Long, WANGYing-Jie, SHENZhi-jie. Combination Therapy of Atorvastatin and JiangZhi Decoction for Primary Hyperlipidemia (Tan Zhuo Zu E Zheng): A Stratified Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2015, 15(8): 873-877. doi: 10.7507/1672-2531.20150147 Copy

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1. 中华医学会. 中国成人血脂异常防治指南. 中华心血管病杂志, 2007, 35(5):390-419.
2. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel Ⅲ). JAMA, 2001, 285(19):2486-2497.
3. Grundy SM, Cleeman JI, Merz CN, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel Ⅲ guidelines. Circulation, 2004, 110(2):227-239.
4. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults:a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol, 2014, 63(25 Pt B):2889-2934.
5. 王肖龙, 王英杰, 沈智杰, 等. CYP450介导的中药复方对阿托伐他汀体外代谢性增效研究. 中国医师协会中西结合医师大会, 2011.
6. 王肖龙, 王英杰, 毛玉昌, 等. 中药降脂方对肝细胞色素P450同工酶3A4的抑制作用. 上海中医药杂志, 2012, 46(4):76-79.
7. 张学智. 血脂异常中医诊疗标准(初稿). 中华中医药杂志, 2008, 23(8):716-719.
8. 郑筱萸. 中药新药临床研究指导原则(试行). 第1版. 北京:中国医药科技出版社, 2002:85-89.
9. 立普妥^®(阿托伐他汀钙)说明书.
10. Cholesterol Treatment Trialists' (CTT) Collaboration, Baigent C, Blackwell L, et al. Efficacy and safety of more intensive lowering of LDL cholesterol:a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet, 2010, 376(9753):1670-1681.
11. Newman C, Tsai J, Szarek M, et al. Comparative safety of atorvastatin 80 mg versus 10 mg derived from analysis of 49 completed trials in 14,236 patients. Am J Cardiol, 2006, 97(1):61-67.
12. Baigent C, keech A, Kearrny PM, et al. Efficacy and safety of cholesterol low erring treatment:prospective meta-analysis is of data from 90,056 participant 8 in 14 randomized trials of statins. Lancet, 2005, 366(9493):1267-1278.

Chinese Journal of Evidence-Based Medicine

Combination Therapy of Atorvastatin and JiangZhi Decoction for Primary Hyperlipidemia (Tan Zhuo Zu E Zheng): A Stratified Randomized Controlled Trial

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