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

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。

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（P0.05）.However,as compared with baseline,significant reduction of TC and LDL-C in both groups was shown at all the observing time points（P0.01）,while the changes in TG and HDL-C were insignificant（P0.05）.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（P0.05）.Conclusion ZKG has a definite effect in lowering LDL-C and TC,and it is safe in long-term administration.