降脂通络软胶囊治疗高脂血症气滞血瘀型313例临床观察

A Clinical Observation on Jiangzhi Tongluo Soft Capsules for 313 Cases of Hyperlipidemia with Qi-Stagnation Blood-Stasis Pattern

目的评价降脂通络软胶囊治疗高脂血症(气滞血瘀证)的有效性与安全性。方法将高脂血症气滞血瘀证患者442例随机分为治疗组313例和对照组129例。治疗组给予降脂通络软胶囊和脂必妥片安慰剂口服,对照组给予脂必妥片和降脂通络软胶囊安慰剂口服,两组疗程均为6周。观察两组治疗前后血脂水平和载脂蛋白水平,并判断血脂疗效和中医证候疗效,同时观察不良反应。结果两组患者治疗后血脂水平及载脂蛋白水平均较治疗前均明显改善(P<0.05),并且治疗组在降低甘油三酯方面优于对照组(P<0.05)。治疗组血脂疗效总有效率为87.22%,中医证候疗效总有效率为91.37%,对照组分别为80.62%、82.95%,治疗组中医证候疗效优于对照组(P<0.01)。两组均无明显不良反应。结论降脂通络软胶囊治疗高脂血症(气滞血瘀证)安全有效,能显著降低血脂水平,提高中医证候疗效。

Objective To evaluate the efficacy and safety of Jiangzhi Tongluo Soft Capsules（lipid-lowering and network vessels-freeing soft capsules,JTSC） for hyperlipidemia with qi-stagnation blood-stasis pattern.Methods Totally 442 hyperlipidemia patients with qi-stagnation blood-stasis pattern were chosen and randomized into the treatment group（313 cases） and control group（129 cases）.The treatment group was given JTSC and Zhibituo placebo tablets.The control group was given JTSC placebo and Zhibituo tablets.Both groups were treated for 6 weeks.The lipid levels and apolipoprotein levels were observed in both groups before and after treatment.The lipid efficacy and TCM pattern efficacy was determined.The adverse reactions were observed.Results The lipid levels and apolipoprotein levels in both groups were significantly improved after treatment（P〈0.05）,especially triglycerides（TG） in the treatment group（P〈0.05）.The total lipid efficacy in the treatment group and control group was 87.22% and 80.62% respectively.The total TCM pattern efficacy in the treatment group and control group was 91.37% and 82.95% respectively,with a significant difference between groups（P〈0.01）.There was no obvious adverse reaction in both groups.Conclusion JTSC is effective for hyperlipidemia with qi-stagnation blood-stasis pattern and it can obviously decrease the lipid level and increase the TCM pattern efficacy.