血滞通治疗高甘油三酯血症的多中心随机双盲双模拟阳性药和安慰剂平行对照研究。
Effects of Xuezhitong in Patients with Hypertriglyceridemia: a Multicentre, Randomized, Double-Blind, Double Simulation, Positive Drug and Placebo Parallel Control Study.
机构信息
Beijing University of Chinese Medicine, Beijing, China.
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
出版信息
Cardiovasc Drugs Ther. 2020 Aug;34(4):525-534. doi: 10.1007/s10557-020-06965-3.
BACKGROUD
Xuezhitong (XZT) is an extract of Allium macrostemon Bunge that has lipid-lowering properties.
OBJECTIVE
To evaluate the effects of XZT on lipids in subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia.
METHODS
A total of 358 subjects with HTG were enrolled and randomly assigned to receive XZT (2700 mg daily), xuezhikang (XZK) (1200 mg daily) or placebo. The primary endpoint was the reduction or percent reduction in the TG level over 12 weeks of treatment.
RESULTS
At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167). Treatment with XZT capsules also demonstrated superior performance compared with the placebo with respect to the control of lipids (17.97% vs 5.00%), total cholesterol (TC) (14.18% vs 3.89%), low-density lipoprotein cholesterol (LDL-C) (17.98% vs 2.95%), and high-density lipoprotein cholesterol (HDL-C) (21.47% vs 2.16%). Daily use of XZT for 12 weeks resulted in statistically significant (65.22% vs 38.30%, 25.00%; P < 0.0167) and clinically meaningful increases in HDL-C levels by ≥4 mg/dl compared with XZK and placebo. XZT was safe and well tolerated; the safety and tolerability profiles were similar across treatment groups. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase.
CONCLUSIONS
XZT significantly reduced TG levels and was well tolerated. Longer-term studies in more diverse patient populations are needed to corroborate these findings.
CLINICAL TRIAL REGISTRATION
www.chictr.org.cn Identifier: ChiCTR1900025854.
背景
雪脂通（XZT）是一种从葱属植物薤白中提取的物质，具有降脂作用。
目的
评估薤白提取物（XZT）对无严重血脂异常的高甘油三酯血症（HTG）患者血脂的影响。
方法
共纳入 358 例 HTG 患者，随机分为 XZT 组（每日 2700mg）、血脂康组（XZK，每日 1200mg）和安慰剂组。主要终点为治疗 12 周后 TG 水平的降低或降低百分比。
结果
在 12 周随访时，两组的 TG 水平均有降低，但 XZT 和 XZK 组的降低幅度明显大于安慰剂组（30.77%，24.02% vs 11.59%，P<0.0167）；XZT 组 70.54%和 XZK 组 62.30%的患者 TG 水平降低至少 20%，而安慰剂组仅 41.67%（P<0.0167）。与安慰剂组相比，XZT 胶囊治疗在控制血脂（17.97% vs 5.00%）、总胆固醇（TC）（14.18% vs 3.89%）、低密度脂蛋白胆固醇（LDL-C）（17.98% vs 2.95%）和高密度脂蛋白胆固醇（HDL-C）（21.47% vs 2.16%）方面也表现出了更好的效果。XZT 组患者在 12 周的治疗期间，与 XZK 和安慰剂相比，HDL-C 水平分别升高了统计学显著（65.22% vs 38.30%，25.00%；P<0.0167）和临床显著（≥4mg/dl）的幅度。XZT 组的安全性和耐受性良好，各组的安全性和耐受性特征相似。无患者发生肌病或显著升高的肝转氨酶或肌酸激酶。
结论
XZT 可显著降低 TG 水平，且耐受性良好。需要进行更长时间、更多样化患者人群的研究，以证实这些发现。
临床试验注册
www.chictr.org.cn 标识符：ChiCTR1900025854。
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