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赵福海,刘国兵,吕树铮,卢燕玲.脂康颗粒与辛伐他汀降脂治疗随机对照研究[J].,2010,30(10):1052-1055
脂康颗粒与辛伐他汀降脂治疗随机对照研究
Randomized Comparative Study on the Lipid Lowering Effects of Zhikang Granule and Simvastatin
  
DOI:
中文关键词:  脂康颗粒  辛伐他汀  达标率  安全性
英文关键词:Zhikang Granule  simvastatin  control rate  safety
基金项目:
Author NameAffiliation
ZHAO Fu-hai 中国中医科学院西苑医院 
LIU Guo-bing 长沙市第三人民医院 
LU Shu-zheng 首都医科大学北京安贞医院 
卢燕玲 首都医科大学北京安贞医院 
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中文摘要:
      目的对中药降脂制剂脂康颗粒与辛伐他汀在降脂治疗中的作用。方法门诊筛选符合入选标准的原发性血脂异常的患者,按照2:1的比例随机分为脂康颗粒组30例,辛伐他汀组15例。观察24周治疗期间两组的血脂达标率,对高敏C-反应蛋白(high sensitivity C reactive protein,hs-CRP)水平的影响,并进行安全性评价。结果治疗结束时,不同时间点(4、8、12、24周)总胆固醇(total cholesterol,TC)、低密度脂蛋白胆固醇(lowdensity lipoprotein cholesterol,LDL-C)、高密度脂蛋白胆固醇(high density lipoprotein choles-terol,HDL-C)和甘油三酯(triglyceride,TG)水平两组间比较,差异均无统计学意义(P>0.05);脂康颗粒组:4、8、12、24周TC、LDL-C水平与治疗前比较明显降低(P<0.01);TG、HDL-C水平治疗前后差异无统计学意义(P>0.05);辛伐他汀组:4、8、12、24周TC、LDL-C水平与比较明显降低(P<0.01),HDL-C(P=0.02);TG水平差异无统计学意义(P>0.05)。LDL-C和TC达标,脂康颗粒组与辛伐他汀组4周比较,分别为26例(86.7%)与15例(100%),24例(80%)与15例(100%);24周16例(53.3%)与9例(60.0%),27例(90.0%)与14例(93.3%),差异无统计学意义(P>0.05);转氨酶、血肌酐、血尿酸水平、hs-CRP,差异均无统计学意义(P>0.05)。结论脂康颗粒具有确切的降低TC和LDL-C的作用,较长期应用安全可靠。
英文摘要:
      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.
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