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穿心莲提取物对高甘油三酯血症患者甘油三酯水平的影响:一项随机对照试验。

Effect of Andrographis paniculata Extract on Triglyceride Levels of the Patients with Hypertriglyceridemia: A Randomized Controlled Trial.

作者信息

Phunikhom Kutcharin, Khampitak Kovit, Aromdee Chantana, Arkaravichien Tarinee, Sattayasai Jintana

出版信息

J Med Assoc Thai. 2015 Jul;98 Suppl 6:S41-7.

Abstract

BACKGROUND

Hypertriglyceridemia is one of the risk factors for cardiovascular disease, and reduction oftriglyceride (TG) level is recommended in clinical practice guidelines for the treatment. Recently, andrographolide, a main active compound of Andrographispaniculata has been shown to possess hypolipidemic effects in animals.

OBJECTIVE

To investigate the TG-lowering effects of A. paniculata extract (APE) in patients with hypertriglyceridemia (TG ≥ 150 mg/dL) using gemfibrozil treatment as the reference.

MATERIAL AND METHOD

A randomized controlled clinical trial was carried out in sixty subjects with hypertriglyceridemia. They were divided into three groups and treated with low dose of APE (APE-L, andrographolide 71.64-72.36 mg/day), high dose of APE (APE-H, andrographolide 119.64-120.36 mg/day), and gemfibrozil 300 mg/day. The treatments were conducted for 8 weeks. Guidance on lifestyle modifications was provided.

RESULTS

The primary endpoint was the mean difference ± SD (95% CI) in TG levels (baseline from the end of treatment), which were -3 ± 125.6 (-59.1, 58.5), 41.6 ± 86.3 (1.2, 82), and 57.1 ± 94.9 (12.7, 101.6) in the APE-L, APE-H, and gemfibrozil groups, respectively. APE-H 120 mg/day and gemfibrozil 300 mg/day caused a significant reduction of TG level (P = 0.0442 and 0.0145, respectively) when compared to the baseline. There was no notable difference in the safety or tolerability among the treatment groups.

CONCLUSION

In patients with modest hypertriglyceridemia with lifestyle intervention, APE-H reduced the TG level comparable to the effect of gemfibrozil 300 mg/day. APE treatment was as tolerable as gemfibrozil treatment. Hence, Andrographis paniculata might be used as an alternative medicine in treating hypertriglyceridemic patients.

摘要

背景

高甘油三酯血症是心血管疾病的危险因素之一,临床治疗指南建议降低甘油三酯(TG)水平。最近,穿心莲内酯,一种穿心莲的主要活性化合物,已被证明在动物中具有降血脂作用。

目的

以吉非贝齐治疗为对照,研究穿心莲提取物(APE)对高甘油三酯血症(TG≥150mg/dL)患者的降TG作用。

材料与方法

对60例高甘油三酯血症患者进行随机对照临床试验。他们被分为三组,分别接受低剂量APE(APE-L,穿心莲内酯71.64 - 72.36mg/天)、高剂量APE(APE-H,穿心莲内酯119.64 - 120.36mg/天)和吉非贝齐300mg/天治疗。治疗持续8周。提供生活方式改变的指导。

结果

主要终点是TG水平(治疗结束时与基线相比)的平均差值±标准差(95%可信区间),APE-L组、APE-H组和吉非贝齐组分别为-3±125.6(-59.1,58.5)、41.6±86.3(1.2,82)和57.1±94.9(12.7,101.6)。与基线相比,APE-H 120mg/天和吉非贝齐300mg/天导致TG水平显著降低(分别为P = 0.0442和0.0145)。各治疗组在安全性或耐受性方面无显著差异。

结论

在进行生活方式干预的轻度高甘油三酯血症患者中,APE-H降低TG水平的效果与300mg/天吉非贝齐相当。APE治疗与吉非贝齐治疗的耐受性相同。因此,穿心莲可能用作治疗高甘油三酯血症患者的替代药物。

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