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中药益气化瘀方对代谢综合征高血压患者的影响:一项随机、安慰剂对照试验。

Effects of Chinese herbal medicine Yiqi Huaju Formula on hypertensive patients with metabolic syndrome: a randomized, placebo-controlled trial.

机构信息

Institute of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.

出版信息

J Integr Med. 2013 May;11(3):184-94. doi: 10.3736/jintegrmed2013031.

Abstract

BACKGROUND

Patients with hypertension coupled with metabolic syndrome (MetS) are among the high risk population in cardiovascular and cerebrovascular diseases. To reduce the prevalence of cardiovascular and cerebrovascular diseases, it is essential to appropriately control blood pressure together with other cardiovascular risk factors.

OBJECTIVE

The current study was designed to investigate the therapeutic effects on blood pressure, blood pressure variability and other cardiovascular risk factors by giving Yiqi Huaju Formula, a compound traditional Chinese herbal medicine, in addition to routine treatment to hypertensive patients coupled with MetS.

DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A total of 43 patients with hypertension coupled with MetS were recruited into this study. The enrolled patients were randomly divided into the Chinese herbal formula group (anti-hypertensive drugs plus Yiqi Huaju Formula, CHF) and the control group (anti-hypertensive drugs plus placebo). The CHF group enrolled 22 patients while the control group received 21 cases. Treatments were given for 12 weeks in both groups.

MAIN OUTCOME MEASURES

Parameters examined include 24-hour ambulatory blood pressure monitoring, body mass index, waist circumference, waist-to-hip ratio, homeostatic model assessment for insulin resistance (HOMA-IR), fasting glycosylated hemoglobin (HbA1c), fasting plasma glucose, 2-hour postprandial plasma glucose (PPG), fasting plasma insulin, serum lipid, etc.

RESULTS

Compared with the control group, the CHF group had significant improvement (P<0.01) in anthropometric parameters, FPG, HOMA-IR, blood pressure amplitude, blood pressure variability and blood pressure load.

CONCLUSION

This study showed that integrated traditional Chinese and Western medicine treatment can achieve better results in controlling blood pressure as well as other cardiovascular risk factors. The mechanism of controlling of blood pressure may be associated with the improvement of insulin sensitivity due to the Yiqi Huaju intervention. TRIAL REGISTRATION IDENTIFIER: ChiCTR-TRC-11001633.

摘要

背景

高血压合并代谢综合征(MetS)的患者是心血管和脑血管疾病的高危人群之一。为降低心血管和脑血管疾病的患病率,必须适当控制血压和其他心血管危险因素。

目的

本研究旨在探讨在常规治疗的基础上加用益气化瘀方(一种复方中药)对高血压合并 MetS 患者血压、血压变异性及其他心血管危险因素的治疗效果。

设计、地点、参与者和干预措施:共纳入 43 例高血压合并 MetS 患者,采用随机数字表法将其分为中药组(降压药加益气化瘀方,CHF 组)和对照组(降压药加安慰剂),每组 22 例和 21 例。两组均治疗 12 周。

主要观察指标

检测 24 h 动态血压监测、体质量指数、腰围、腰臀比、稳态模型评估的胰岛素抵抗指数(HOMA-IR)、空腹血糖(FPG)、空腹糖化血红蛋白(HbA1c)、餐后 2 h 血糖(PPG)、空腹血浆胰岛素、血脂等参数。

结果

与对照组相比,CHF 组的体质量指数、腰围、腰臀比、FPG、HOMA-IR、血压幅度、血压变异性和血压负荷等指标均显著改善(P<0.01)。

结论

本研究表明,中西医结合治疗在控制血压和其他心血管危险因素方面效果更好。其降压机制可能与益气化瘀方干预后胰岛素敏感性的提高有关。

临床试验注册

ChiCTR-TRC-11001633。

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