降脂通络软胶囊联合西药治疗混合型高脂血症临床研究

目的：观察降脂通络软胶囊联合西药治疗混合型高脂血症气滞血瘀证的临床疗效。方法：选取62例混合型高脂血症气滞血瘀证患者，按照随机数字表法分为中成药组和对照组，每组31例。对照组给予西药治疗，中成药组在对照组基础上给予降脂通络软胶囊治疗，2组均治疗8周。比较2组临床疗效，治疗前后血脂指标[高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）、总胆固醇（TC）、甘油三酯（TG） ]、血液流变学指标（纤维蛋白原、血浆比黏度、全血比黏度、血细胞比容、全血还原黏度）、血管内皮功能指标[血管内皮素-1（ET-1）、降钙素基因相关肽（CGRP）、一氧化氮（NO） ]水平，以及不良反应发生率。结果：治疗后，中成药组总有效率96.77%，高于对照组74.19%（P＜0.05）。2组TC、TG、LDL-C水平均较治疗前降低（P＜0.05），HDL-C水平均较治疗前升高（P＜0.05）；中成药组TC、TG、LDL-C水平均低于对照组（P＜0.05），HDL-C水平高于对照组（P＜0.05）。2组纤维蛋白原、血浆比黏度、全血比黏度、血细胞比容、全血还原黏度均较治疗前降低（P＜0.05），中成药组上述5项血液流变学指标水平均低于对照组（P＜0.05）。2组ET-1水平均较治疗前降低（P＜0.05），CGRP、NO水平均较治疗前升高（P＜0.05）；中成药组ET-1水平低于对照组（P＜0.05），CGRP、NO水平均高于对照组（P＜0.05）。治疗期间，中成药组不良反应发生率6.45%，与对照组12.90%比较，差异无统计学意义（P＞0.05）。结论：降脂通络软胶囊联合西药治疗混合型高脂血症气滞血瘀证可提高临床疗效，调节血脂水平，改善血液流变学及血管内皮功能，安全性好。

Clinical Study on Jiangzhi Tongluo Soft Capsules Combined with Western Medicinefor Mixed Hyperlipidemia

Abstract： Objective： To observe the clinical effect of Jiangzhi Tongluo Soft Capsules combined withwestern medicine on mixed hyperlipidemia with qi stagnation and blood stasis syndrome. Methods：A totalof 62 cases of patients with mixed hyperlipidemia with qi stagnation and blood stasis syndrome wereselected and divided into the Chinese patent medicine group and the control group according to the randomnumber table method，with 31 cases in each group. The control group was treated with western medicine，and the Chinese patent medicine group was additionally treated with Jiangzhi Tongluo Soft Capsules basedon the treatment of the control group. Both groups were treated for 8 weeks. The levels of blood lipidindexes [high-density lipoprotein cholesterol (HDL-C)，low-density lipoprotein cholesterol (LDL-C)，totalcholesterol (TC)，and triglyceride (TG)]，hemorheology indexes (fibrinogen，plasma comparative viscosity，whole blood comparative viscosity，hematocrit，and whole blood reduction viscosity)，vascular endothelial function indexes [endothelin-1 (ET-1)，calcitonin gene-related peptide (CGRP)，and nitric oxide (NO)] andthe incidence of adverse reactions before and after treatment，as well as the clinical effects were comparedbetween the two groups. Results： After treatment， the total effective rate was 96.77% in the Chinesepatent medicine group，higher than that of 74.19% in the control group (P＜0.05). The levels of TC，TG andLDL-C in the two groups were decreased when compared with those before treatment (P＜0.05)，and thelevels of HDL-C were increased when compared with those before treatment (P＜0.05). The levels of TC，TG and LDL-C in the Chinese patent medicine group were lower than those in the control group (P＜0.05)，and the level of HDL-C was higher than that in the control group (P＜0.05). The levels of fibrinogen，plasmacomparative viscosity，whole blood comparative viscosity，hematocrit and whole blood reduction viscosityin the two groups were decreased when compared with those before treatment (P＜0.05)，and the abovefive hemorheological indexes in the Chinese patent medicine group were lower than those in the controlgroup (P＜0.05). The levels of ET-1 in the two groups were decreased when compared with those beforetreatment (P＜0.05)， and the levels of CGRP and NO were increased when compared with those beforetreatment (P＜0.05). The level of ET-1 in the Chinese patent medicine group was lower than that in thecontrol group (P＜0.05)，and the levels of CGRP and NO were higher than those in the control group (P＜0.05). During the treatment，the incidence of adverse reactions was 6.45% in the Chinese patent medicinegroup and 12.90% in the control group， there being no significant difference (P＞0.05). Conclusion：Jiangzhi Tongluo Soft Capsules combined with western medicine for mixed hyperlipidemia with qistagnation and blood stasis syndrome can enhance clinical effect，regulate blood lipid levels，and improvehemorheology and vascular endothelial function，with good safety.