益脂平胶囊治疗高脂血症有效性及安全性的多中心、随机对照双盲研究

Effectiveness and Safety of Yizhiping Capsules on Hyperlipidemia: A Multi- center,Randomized Controlled Double-blind Trial

目的评价益脂平胶囊治疗高脂血症的有效性和安全性。方法采用多中心、双盲(试验者和受试者)、双模拟(药物和安慰剂)、平行对照研究方法,选择2011年1月—2013年5月于广东省第二中医院、福建省中医药研究院、桂林市中医医院、江门市五邑中医院、聊城市中医医院、清远市中医院、湛江市第二中医医院就诊的高脂血症患者626例,采用SAS 6.12 PROC PLAN程序,给定种子数、中心数,自动给出随机数字表,将患者随机分为试验组466例和对照组160例。对照组患者给予绞股蓝总甙胶囊联合模拟益脂平胶囊治疗,试验组患者给予模拟绞股蓝总甙胶囊联合益脂平胶囊治疗,两组患者均治疗12周。观察两组患者综合疗效、血脂控制达标率,治疗前后血脂指标〔总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)〕变化及不良反应情况。结果治疗组患者综合疗效优于对照组(u=2.101,P=0.036)。两组患者血脂控制达标率及治疗前后TC、TG、LDL-C及HDL-C水平比较,差异均无统计学意义(P>0.05)。两组患者均未出现与药物有关的不良反应。结论益脂平胶囊治疗高脂血症安全有效,且较绞股蓝总甙胶囊综合疗效佳。

Objective To evaluate the effectiveness and safety of yizhiping capsules on hyperlipidemia. Methods From January 2011 to May 2013, based on the principles of multi - center, randomized, double - blind （ tester and subjects）, double- dummy, parallel control, a total of 626 hyperlipidemia patients were selected in the Second Traditional Chinese Medicine Hospital of Guangdong Province, Traditional Chinese Medicine Institute of Fujian, Traditional Chinese Medicine Hospital of Guilin, Wuyi Traditional Chinese Medicine Hospital of Jiangmen, Traditional Chinese Medicine Hospital of Liaocbeng, Traditional Chinese Medicine Hospital of Qingyuan, the Second Traditional Chinese Medicine Hospital of Zhanjiang. By SAS 6. 12 PROC PLAN software, seed number, center number and random number table were made and the patients were randomly divided into control group （n = 160） and test group （n =466）. Patients of control group were given gynostemma total glucoside capsules and mimetic yizhiping capsules, while patients of test group were given yizhiping capsules and mimetic gynostemma total glucoside capsules, both groups treated for 12 weeks. Comprehensive therapeutic effect, blood lipid control rate, blood lipid parameter （ including TC, TG, LDL-C, HDL - C） before and after treatment , incidence of adverse reactions were compared between the two groups. Results The comprehensive therapeutic effect of test group was statistically significantly better than that of control group （ u = 2. 101, P = 0. 036）. No statistically significant differences of blood lipid control rate was found between the two groups （P 〉0. 05） ; neither of TC, TG, LDL-C, HDL - C before or after treatment between the two groups （P 〉 0. 05）. No one of the two groups occurred obvious adverse reactions during the treatment. Conclusion Yizhiping capsules is effective and safe in treating hyperlipidemia, which has significantly better comprehensive therapeutic effect than ynostemma total glucoside capsules.