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针刺对绝经后高血压前期或1期高血压女性的影响:一项前瞻性、比较性、干预性队列研究的研究方案

Effects of acupuncture in postmenopausal women with prehypertension or stage 1 hypertension: study protocol for a prospective, comparative, interventional cohort study.

作者信息

Seo Bok-Nam, Park Ji-Eun, Kim Young-Eun, Kang Kyung-Won, Seol In-Chan, Choi Sun-Mi

机构信息

Department of Mibyeong Research Center, Korea Institute of Oriental Medicine, Daejeon, Korea.

Hoseo University Institutional Review Board, Daejeon, Korea.

出版信息

Integr Med Res. 2018 Mar;7(1):95-102. doi: 10.1016/j.imr.2017.11.003. Epub 2018 Feb 9.

Abstract

BACKGROUND

Hypertension is a major cause of cardiovascular disease and associated mortality, and postmenopausal women are at a high risk of hypertension. We aim to investigate the hypotensive effect and safety of acupuncture, focusing on postmenopausal women with prehypertension and stage 1 hypertension. In addition, we aim to investigate whether the effect of acupuncture treatment differed, depending on Sasang Constitution and cold-heat pattern.

METHODS

This study is designed as an intervention cohort study. Two hundred postmenopausal women aged <65 years with prehypertension or stage 1 hypertension living in Daejeon city in Korea will be recruited, and randomly assigned to either an acupuncture or no-treatment control group. The intervention will consist of four sessions; one session will include acupuncture performed 10 times for 4 weeks. There will be a 20-week observation period after each session, and the total study duration will be 96 weeks. Acupuncture will be applied at the bilateral Fengchi (GB20), Quchi (LI11), Zusanli (ST36), and Sameumgyo (SP6) acupoints. The effect of acupuncture will be evaluated by comparing the change in systolic and diastolic blood pressure between the acupuncture and control groups every 4 weeks until the end of the study.

DISCUSSION

To evaluate the success of blood pressure management, long-term observation is required, but no long-term studies have been conducted to evaluate the effect of acupuncture on blood pressure in postmenopausal women. To our knowledge, this study will be the first long-term study to investigate this issue for more than 6-8 weeks.

摘要

背景

高血压是心血管疾病及相关死亡率的主要原因,绝经后女性患高血压的风险很高。我们旨在研究针灸的降压效果和安全性,重点关注患有高血压前期和1期高血压的绝经后女性。此外,我们旨在研究针灸治疗的效果是否因体质和寒热证型而异。

方法

本研究设计为干预队列研究。将招募200名年龄小于65岁、居住在韩国大田市、患有高血压前期或1期高血压的绝经后女性,并随机分配到针灸组或非治疗对照组。干预将包括四个疗程;一个疗程将包括连续4周每周进行10次针灸。每个疗程后将有20周的观察期,总研究时长为96周。针灸将应用于双侧风池(GB20)、曲池(LI11)、足三里(ST36)和三阴交(SP6)穴位。在研究结束前,每4周比较针灸组和对照组收缩压和舒张压的变化,以评估针灸的效果。

讨论

为评估血压管理的成效,需要进行长期观察,但尚未有长期研究来评估针灸对绝经后女性血压的影响。据我们所知,本研究将是首个针对该问题进行超过6 - 8周的长期研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a69/5883999/1a4b6e29f9a1/gr1.jpg

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