摘要
目的评价降脂通络软胶囊联合阿托伐他汀钙片与单用阿托伐他汀钙片治疗混合型高脂血症的有效性和安全性。方法本研究采用随机、双盲、平行对照、多中心临床研究设计。采用随机数字表法将1 38例混合型高脂血症患者分为联合用药组与单用他汀组,每组69例,两组患者均给予阿托伐他汀钙片口服,20 mg/天。联合用药组在此基础上,予降脂通络软胶囊口服,1 00 mg/次,每天3次;单用他汀组予降脂通络软胶囊模拟剂口服治疗,1 00 mg/次,每天3次,疗程均为8周。分别于治疗前、治疗4、8周检测两组患者TG、TC、LDL-C、HDL-C水平,并对治疗安全性进行评价。结果与治疗前比较,治疗4、8周后联合用药组血清TG分别下降26.69%、33.29%(均P<0.01),单用他汀组TG分别下降25.70%、22.98%(均P<0.01)。治疗8周后,联合用药组TG下降值明显高于单用他汀组(P<0.05)。与治疗前比较,治疗4、8周后两组患者血清LDL-C、TC水平显著降低(均P<0.01),两组LDL-C、TC下降值及下降率比较,差异无统计学意义(P>0.05)。治疗8周后两组HDL-C均有升高趋势。两组治疗后均未出现肝酶和肌酸激酶明显升高。结论降脂通络软胶囊联合阿托伐他汀钙片治疗混合型高脂血症可明显降低患者血清TG水平,且安全性较好。
Objective To evaluate the efficacy and safety of using Jiangzhi Tongluo Soft Capsule（JTSC） combined with Atorvastatin Calcium Tablet（ACT） or ACT alone in treatment of combined hyperlipidemia.Methods A randomized,double blinded,parallel control,and multi-center clinical research design was adopted.Totally 138 combined hyperlipidemia patients were randomly assigned to the combined treatment group（A） and the atorvastatin treatment group（B） by random digit table,69 in each group.All patients took ACT20 mg per day.Patients in the A group took JTSC 100 mg each time,3 times per day.Those in the B group took JTSC simulated agent,100 mg each time,3 times per day.The treatment period for all was 8 weeks.Serum levels of triglyceride（TG）,total cholesterol（TC）,low density lipoprotein cholesterol（LDL-C）,and high density lipoprotein cholesterol（HDL-C） were observed before treatment,at week 4 and8 after treatment;and safety was assessed as well.Results At week 4 and 8 after treatment serum TG decreased by 26.69%and 33.29%respectively in the A group（both P〈0.01）,while it was decreased by25.7%and 22.98%respectively in the B group（both P〈0.01）.At week 8 decreased serum TG was obviously higher in the A group than in the B group（P〈0.05）.Compared with before treatment,serum levels of LDL-C and TC levels decreased significantly in the two groups（all P〈0.01）.There was no statistical difference in the drop-out value and the drop-out rate of serum LDL-C and TC levels（P〉0.05）.At week 8the serum HDL-C level showed an increasing tendency in the two groups.No obvious increase in peptase or creatase occurred in the two groups after treatment.Conclusion JTSC combined with ACT could lower the serum TG level of combined hyperlipidemia patients with safety.
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2014年第9期1059-1063,共5页
Chinese Journal of Integrated Traditional and Western Medicine
关键词
降脂通络软胶囊
阿托伐他汀钙片
混合型高脂血症
药物疗法
随机对照试验
Jiangzhi Tongluo Soft Capsule
Atorvastatin Calcium Tablet
combined hyperlipidemia
pharmacotherapy
randomized controlled trial
