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脂康颗粒与辛伐他汀降脂作用的随机对照研究

[Randomized comparative study on the lipid lowering effects of Zhikang Granule and simvastatin].

作者信息

Zhao Fu-Hai, Liu Guo-Bing, Lu Shu-Zheng

机构信息

Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 Oct;30(10):1052-5.

Abstract

OBJECTIVE

To compare the lipid lowering effects of Zhikang Granule (ZKG) and simvastatin.

METHODS

Forty-five out-patients with hyperlipemia who met the entry criteria were enrolled and randomized into two groups in the ratio of 2: 1, 30 patients in the ZKG group and 15 patients in the simvastatin group. The lipid lowering effects and safety of treatment during the 24-week therapeutic period, as well as the influence of treatment on plasma high sensitivity C reactive protein (hs-CRP) level in patients were observed.

RESULTS

No significant difference between the two groups was observed in serum levels of total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C) and triglyceride (TG) at the 4th, 8th, 12th and 24th week (P > 0.05). However, as compared with baseline, significant reduction of TC and LDL-C in both groups was shown at all the observing time points (P < 0.01), while the changes in TG and HDL-C were insignificant (P > 0.05). The control rates of LDL-C and TC in the ZKG group and the simvastatin group were 86.7% (26/30) versus 100% (15/15) at the 4th week, 80.0% (24/30) versus 100% (15/15) at the 8th week, 53.3% (16/30) versus 60.0% (9/15) at the 12th week, and 90.0% (27/30) versus 93.3% (14/15) at the 24th week, respectively, all showed insignificant difference between groups. No statistical differences were found between groups in levels of plasma transaminase, creatinine, uric acid and hs-CRP (P > 0.05).

CONCLUSION

ZKG has a definite effect in lowering LDL-C and TC, and it is safe in long-term administration.

摘要

目的

比较脂康颗粒(ZKG)与辛伐他汀的降脂效果。

方法

将45例符合入选标准的门诊高脂血症患者按2∶1比例随机分为两组,脂康颗粒组30例,辛伐他汀组15例。观察24周治疗期内的降脂效果、治疗安全性以及治疗对患者血浆高敏C反应蛋白(hs-CRP)水平的影响。

结果

第4、8、12和24周时,两组患者血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)和甘油三酯(TG)水平比较,差异均无统计学意义(P>0.05)。但与基线相比,两组在各观察时间点TC和LDL-C均显著降低(P<0.01),而TG和HDL-C变化不明显(P>0.05)。第4周时脂康颗粒组和辛伐他汀组LDL-C及TC的控制率分别为86.7%(26/30)和100%(15/15),第8周时分别为80.0%(24/30)和100%(15/15),第12周时分别为53.3%(16/30)和60.0%(9/15),第24周时分别为90.0%(27/30)和93.3%(14/15),组间差异均无统计学意义。两组患者血浆转氨酶、肌酐、尿酸及hs-CRP水平比较,差异均无统计学意义(P>0.05)。

结论

脂康颗粒降低LDL-C和TC疗效确切,长期服用安全。

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