Lee Young-Shin, Lee Jung-Myung, Chung Hyemoon, Woo Jong-Shin, Lee Byung-Cheol, Kim Weon
Department of Internal Medicine, Division of Cardiology, Kyung Hee University Hospital, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea.
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea.
Life (Basel). 2022 Mar 11;12(3):408. doi: 10.3390/life12030408.
Da-Chai-Hu-Tang (DCHT) is a herbal extract that has been shown to reduce serum triglyceride (TG) levels in animal experiments as well as small clinical trials. This study aimed to evaluate the efficacy and safety of DCHT in high-risk, statin-treated patients with residual hypertriglyceridemia (hyperTG). This was a 12-week, randomized, active-controlled, open-label, single-center trial. Of these patients, 42 had high cardiovascular risks whose LDL cholesterol levels were controlled by statin treatment; however, with TG levels of 200 to 500 mg/dL they were randomly assigned 1:1 to the OMEGA3 or DCHT group. The primary endpoint was defined as the percentage change in TG at 12 weeks, and changes in other lipid profiles and endothelial cell function were included as secondary endpoints. Safety analyses were also conducted. In the OMEGA3 group, the average TG level decreased from 294.5 ± 72.0 to 210.0 ± 107.8 mg/dL ( = 0.004), and in the DCHT group, from 288.7 ± 59.1 to 227.5 ± 98.1 mg/dL ( = 0.001). The percentage change in TG was -27.6 ± 33.6 and -22.4 ± 24.1 ( = 0.58), respectively, and there was no significant difference between the two groups. There were no severe adverse events in either group. In high-risk, statin-treated patients with residual hyperTG, the administration of OMEGA3 or DCHT for 12 weeks resulted in a significant reduction in TG, and the effect of DCHT was not inferior to that of OMEGA3.
大柴胡汤（DCHT）是一种草药提取物，在动物实验以及小型临床试验中已显示出可降低血清甘油三酯（TG）水平。本研究旨在评估大柴胡汤在高危、接受他汀类药物治疗且仍有高甘油三酯血症（高TG）的患者中的疗效和安全性。这是一项为期12周的随机、活性对照、开放标签、单中心试验。在这些患者中，42例具有高心血管风险，其低密度脂蛋白胆固醇水平通过他汀类药物治疗得到控制；然而，他们的TG水平为200至500mg/dL，被随机1:1分配至OMEGA3或大柴胡汤组。主要终点定义为12周时TG的百分比变化，其他血脂谱和内皮细胞功能的变化作为次要终点。还进行了安全性分析。在OMEGA3组中，平均TG水平从294.5±72.0降至210.0±107.8mg/dL（P = 0.004），在大柴胡汤组中，从288.7±59.1降至227.5±98.1mg/dL（P = 0.001）。TG的百分比变化分别为-27.6±33.6和-22.4±24.1（P = 0.58），两组之间无显著差异。两组均未出现严重不良事件。在高危、接受他汀类药物治疗且仍有高TG的患者中，给予OMEGA3或大柴胡汤12周可使TG显著降低，且大柴胡汤的效果不劣于OMEGA3。
