Supervisor：Ministry of Education of the People's Republic of ChinaSponsor：Sichuan University Editor-in-chief：LI Youping Publishing period：
Monthly
ISSN：1672-2531CN：51–1656/R
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) (PTC=0.226, PLDL-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 (PTC=0.605, PLDL-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: 10.7507/1672-2531.20150147Copy
Copyright ? the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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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
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