• 제목/요약/키워드: Ambulatory blood pressure monitoring

검색결과 21건 처리시간 0.026초

Radial Electrical Impedance: A Potential Indicator for Noninvasive Cuffless Blood Pressure Measurement

  • Huynh, Toan Huu;Chung, Wan-Young
    • 센서학회지
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    • 제26권4호
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    • pp.239-244
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    • 2017
  • Noninvasive, cuffless, and continuous blood pressure (BP) monitoring is essential to prevent and control hypertension. A well-known existing method for this measurement is pulse transit time (PTT), which has been investigated by many researchers as a promising approach. However, the fundamental principle of the PTT method is based on the time interval taken by a pulse wave to propagate between the proximal and distal arterial sites. Consequently, this method needs an independent system with two devices placed at two different sites, which is a problem. Even though some studies attempted to synchronize the system, it is bulky and inconvenient by contemporary standards. To find a more sensitive method to be used in a BP measurement device, this study used radial electrical bioimpedance (REB) as a potential indicator for BP determination. Only one impedance plethysmography channel at the wrist is performed for demonstrating a ubiquitous BP wearable device. The experiment was evaluated on eight healthy subjects with the ambulatory BP monitor on the upper arm as a reference. The results demonstrated the potential of the proposed method by the correlation of estimated systolic (SBP) and diastolic (DBP) BP against the reference at $0.84{\pm}0.05$ and $0.83{\pm}0.05$, respectively. REB also tracked the DBP well with a root-mean-squared-error of $7.5{\pm}1.35mmHg$.

소아 및 청소년에서 24시간 활동 혈압 측정의 임상적 유용성 (Clinical Usefulness of Ambulatory Blood Pressure Monitoring in Children and Adolescents)

  • 황영주;박효정;양은애;조민현;고철우;양동헌;황현희
    • Childhood Kidney Diseases
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    • 제15권2호
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    • pp.154-162
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    • 2011
  • 목적 : 소아 청소년에서 고혈압의 유병률이 증가하면서 혈압의 측정에 대한 관심이 증가하고 있다. 활동 혈압 감시는 진성 고혈압과 백의 고혈압의 진단에 유용하다고 알려져 있어 우리나라 소아 청소년을 대상으로 활동 혈압 감시의 임상적 유용성을 알아보기 위해 본 연구를 시행하였다. 방법: 2002년 1월부터 2010년 2월까지 경북대학교병원 소아청소년과 및 내과를 방문하여 활동 혈압 감시를 시행한 6세부터 18세까지의 소아 및 청소년 51명을 대상으로 하였다. 외래에서 측정한 수시 혈압과 활동 혈압 감시 결과로 계산된 평균 혈압, 혈압 부하 및 야간 하강 정도를 환자들의 임상적 특징과 진단 별로 비교하였다. 결과:전체 51명의 환자 중 남자가 49명이었으며 평균연령은 $17.8{\pm}1.8$세였고 19명(37.3%)이 비만이었다. 활동 혈압 감시 시행 중 평균 유효 측정횟수는 37.8회, 유효 측정률은 94.3%이었다. 활동 혈압 감시 결과 진성 고혈압 환자가 37명(72.5%)이 었고 이 중 1명이 가면 고혈압이었다. 7명(14%)은 백의 고혈압으로 진단되었으며 나머지 7명은 수시혈압과 24시간 활동 혈압 모두 정상이었다. 백의 고혈압으로 진단된 7명 중 5명이 고혈압 전 단계였다. 진성 고혈압 환자에서 평균 수축기와 이완기 혈압 부하는 정상 혈압 소아에 비해 유의하게 높았고(P<0.001) 야간 강하는 10% 이하였으나 통계적 유의성은 없었다. 비만 환자에서 평균 수축기, 이완기 혈압 및 혈압 부하가 유의하게 높았다(P<0.001). 결론 : 본 연구에서 소아 청소년에서 활동 혈압 감시가 진성 고혈압 및 백의 고혈압을 진단하는데 유용하였으며 백의 고혈압을 가진 소아의 상당수가 고혈압 전 단계에 해당되어 향후 이들에 대한 지속적인 추적 관찰이 필요한 것으로 생각된다.

본태성 고혈압 환자의 자가간호증진을 위한 자기조절 프로그램 효과 -Orem이론과 Bandura이론의 합성과 검증- (An Effect of the Self-Regulation Program for Hypertensives -Synthesis & testing of Orem and Bandura's theory-)

  • 박영임;홍여신
    • 지역사회간호학회지
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    • 제5권2호
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    • pp.109-129
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    • 1994
  • Chronic health problems has become a major concern and challenge to the health care professionals today. Especially hypertension, one of the leading primary cause of death in Korea, is a typical chronic disease requiring adequate and continuous management. Though these hypertensives need to maintain desirable health practice by themselves for their life time, many previous studies indicated that most of the essential hypertensives have no specific symptoms and thus, reluctant to follow appropriate medical regimens causing the condition further aggravated and complicated. Self-care is an essential factor that keeps chronic patients in control of their health and wellness. Thus this study was conducted to identify the effect of the comprehensive self-regulation program as a nursing intervention on the promotion self-care performance and improvement in physical parameters of hypertensives. For this purpose, a one group quasi-experimental research with pre and post test design was used. The subjects of the study was consisted of thirty persons with mild or moderate essential hypertension from two companies in Cheong-ju city. The whole program was carried out from October, 1993 to February, 1994. The self-regulation program was consisted with group education on hypertension and self-care, self-regulation including the blood pressure self-monitoring and recording, recording of daily self-care activities, and encouraging and reinforcing self-efficacy through verbal persuation and enactive attainment. The subjects were asked to measure their own blood pressure by themselves twice per day and to record blood pressure and the daily self-care performance according to the instructions provided during the whole period of 9 weeks. The instruments used for data collection in this study were as follows : 1) Instruments used for measuring the knowledge about hypertension, multiple health locus of control, and perceived benifits and barriers were adapted from previous studies and modified by author to be fit for the subjects. 2) Self-efficacy scale and self-care performance record were developed by the author. 3) Physiological parameters included systolic / diastolic blood pressure, body weight, level of blood cholesterol, and 24hour ambulatory blood pressure. The post-experimental Cronbach's Alpha as the reliability test of scales were 0.703-0.897, an appropriate level of confidence. The effect of the program was analyzed by experimental stages ; the first week, the fifth week, and the ninth week since the experimental imput began. Data were analyzed by the SPSS PC+ program with paired t-test and t-test, repeated measure ANOVA, and pearson's correlation to de termine the effect of program. The results were as follows : 1) After the self-regulation program, scores on knowledge(t=-2.41, p=.011), perceived self-efficacy (F=5.60, p=.001), self-care performance(F=22.31, p=.0001) were significantly higher than those before the program. 2) After the program, both systolic and diastolic blood pressure were significantly lower than those before the program(F=10.89 -13.11, p=.0001). However in 24hour ambulatory blood pressure, systolic mean pressure was nearly significantly lower, but not in diastolic mean pressure. 3) After the program, the body weight was significant decresed(t=5.53, p=.0001), but the blood cholesterol level was not decreased significantly except in those cases with higher cholesterol level. 4) There were significant relationships between changes in self-care performance and diastolic pressure at 1st week (r=.3389, p=.033) and changes in self-care performance and systolic pressure at 9th week(r=.3651, p=.024). 5) There were significant relationship between perceived self-efficacy and self-care performance at 5th week(r=.5313, p=.001) and 9th week (r=.3026, p=.052). 6) After the program, internal health locus of control and perceived benefits did not show significant change, but perceived barriers was significantly lower than those before the program (t=3.57, p=.0001). From the above results, it can be concluded that 1) The self-regulation program is an effective nursing strategy to promote self-care performance of hypertensives and to lower the blood pressure. Thus this program can be recommended in the management of the hypertensives in workplaces and community settings. 2) The synthesis of Orem's self-care theory and Bandura's self-regulation & self-efficacy theory in this study was proved to enhance explanation and prediction of the change of self-care behavior. Thus the result of the study would contribute in development of the self-care theory and an expansion of practice-theory.

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중풍환자 1기 고혈압에 청혈단(淸血丹)의 항고혈압 효과 (Antihypertensive effect of Chunghyul-dan(Qingxue-dan) on stage 1 hypertensive patients with stroke)

  • 김이동;이상호;김은주;김태훈;박영민;정동원;신원준;정우상;배형섭;윤상필
    • 대한한방내과학회지
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    • 제25권2호
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    • pp.195-201
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    • 2004
  • Background and Purpose : Hypertension is one of the modifiable risk factors for stroke. Lowering blood pressure is a primary or secondary preventative measure for stroke. This study aims to assess the efficacy of Chunghyul-dan(Qingxue-dan) in stage 1 hypertensive patients who have suffered a stroke by 24 hour ambulatory blood pressure monitoring(24ABPM). Subjects& Methods : We enrolled 40 hospitalized stroke patients with stage 1 hypertension and divided them into 2 groups by stratified randomization; group A took 1200mg of Chunghyul-dan(Qingxue-dan) at 8:00 a.m. for two weeks without changing herbal medicine, and group B was the control group. 28 patients were included in the final analysis(15 in group A. 13 in group B). Blood pressure is monitored from 8:00 am to 7:30 am every 30 minutes for 24 hours. Blood pressure was monitored two times at baseline and again two weeks later. We used 3 parameters for evaluating the efficacy of Chunghyul-dan(Qingxue-dan); The first parameter is change from baseline to two weeks later in blood pressure and pulse rate. The second parameter is the trough/peak ratio(TPR) and smoothness index(SI). The third parameter is antihypertensive rate by antihypertensive efficacy guideline. Results : There is no significant difference in the baseline assessment hetween the two groups. Systolic blood pressure $(141.37{\pm}8.96\;mmHg\;vs\;132.28{\pm}9.46\;mmHg)$ decreased after two weeks of 1200mg(P=0.03) intake of Chunghyul-dan(Qingxue-dan). Systolic TPR and SI was 0.87 and 1.04 in group A. Antihypertensive rate was higher in group A. Conclusion: These results suggest that 1200mg doses of Clunghyul-dan(Qingxue-dan) is an effective antihypertensive agent on stage 1 hypertension patients who have suffered a stroke.

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Frequency and Related Factors of Masked Hypertension at a Worksite in Korea

  • Kim, Sang-Kyu;Bae, Jun-Ho;Nah, Dung-Young;Lee, Dong-Wook;Hwang, Tae-Yoon;Lee, Kyeong-Soo
    • Journal of Preventive Medicine and Public Health
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    • 제44권3호
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    • pp.131-139
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    • 2011
  • Objectives: Masked hypertension is associated with metabolic risks and increased risk of cardiovascular disease. The purpose of this study was to identify the frequency of and risk factors of masked hypertension in Korean workers. Methods: The study was conducted among 121 employees at a hotel in Gyeongju, Korea, from December 2008 to February 2009. We measured blood pressure (BP) both in the clinic and using 24-hour ambulatory BP monitors for all subjects. Hypertension was defined independently by both methods, and subjects were classified into four groups: true normotension, masked hypertension, white coat hypertension, and sustained hypertension. Results: The frequency of masked hypertension in our study group was 25.6%. Compared with true normotension, the factors related to masked hypertension were male gender (odds ratio [OR], 10.7; 95% confidence interval [CI], 1.41 to 81.09), aging one year (OR, 0.88; 95% CI, 0.78 to 0.99), clinic BP 120-129 /80-84 mmHg (OR, 8.42; 95% CI, 1.51 to 46.82), clinic BP 130-139 / 85-89 mmHg (OR, 12.14; 95% CI, 1.80 to 81.85), smoking (OR, 5.51; 95% CI, 1.15 to 26.54), and increase of total cholesterol 1 mg / dL (OR, 1.05; 95% CI, 1.02 to 1.08). In males only, these factors were clinic BP 120-129/ 80-84 mmHg (OR, 15.07; 95% CI, 1.55 to 146.19), clinic BP 130-139/ 85-89 mmHg (OR, 17.16; 95% CI, 1.56 to 189.45), smoking (OR, 11.61; 95% CI, 1.52 to 88.62), and increase of total cholesterol 1 mg/dL (OR, 1.05; 95% CI, 1.01 to 1.09). Conclusions: The frequency of masked hypertension was high in our study sample. Detection and management of masked hypertension, a known strong predictor of cardiovascular risk, could improve prognosis for at-risk populations.

Need Assessment for Smartphone-Based Cardiac Telerehabilitation

  • Kim, Ji-Su;Yun, Doeun;Kim, Hyun Joo;Ryu, Ho-Youl;Oh, Jaewon;Kang, Seok-Min
    • Healthcare Informatics Research
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    • 제24권4호
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    • pp.283-291
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    • 2018
  • Objectives: To identify the current status of smartphone usage and to describe the needs for smartphone-based cardiac telerehabilitation of cardiac patients. Methods: In 2016, a questionnaire survey was conducted in a supervised ambulatory cardiac rehabilitation (CR) program in a university affiliated hospital with the participation of heart failure or heart transplantation patients who were smartphone users. The questionnaire included questions regarding smartphone usage, demands for smartphone-based disease education, and home health monitoring systems. Results were described and analyzed according to principal diagnosis. Results: Ninety-six patients (66% male; mean age, $5{\pm}11$ years), including 56 heart failure and 40 heart transplantation patients, completed the survey (completion rate, 95%). The median daily smartphone usage time was 120 minutes (interquartile range, 60-300), and the most frequently used smartphone function was text messaging (61.5%). Of the patients, 26% stated that they searched for health-related information using their smartphones more than 1 time per week. The major source of health-related information was Internet browsing (50.0%), and the least sought source was the hospital's website (3.1%). Patients with heart failure expressed significantly higher needs for disease education on treatment plan, home health monitoring of blood pressure, and body weight (${\chi}^2=5.79$, 6.27, 4.50, p < 0.05). Heart transplantation patients expressed a significant need for home health monitoring of body temperature (${\chi}^2=5.25$, p < 0.05). Conclusions: Heart failure and heart transplantation patients show high usage of and interest in mobile health technology. A smartphone-based cardiac telerehabilitation program should be developed based on high demand areas and modified to suit to each principal diagnosis.

사향소합원(麝香蘇合元)이 정상인의 뇌혈류역학에 미치는 영향 (Effects of Sahyangsohap-won on Cerebral Hemodynamics in Healthy Subjects)

  • 구본수;김성환;문상관;조기호;김영석;배형섭;이경섭;류순현
    • 대한한방내과학회지
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    • 제22권2호
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    • pp.199-205
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    • 2001
  • Background and Purpose : Transcranial doppler ultrasonography(TCD) is a noninvasive and nonradioactive technique for evaluation of the hemodynamics in large cerebral vessels. Sahyangsohap-won(SS) has been considered to be effective for the treatment of various disease, especially cerebrovascular, cardiovascular, and psychosomatoform disorders. But, there is no study about the effect of SS on the cerebral hemodynamics in humans. The aim of this study was to assess the effect of SS on the changes in cerebral hemodynamics and the dose-dependant effect by using TCD. Subjects and Methods : 30 healthy subjects were randomly divided into three group: group 1 took no drug, group 2 took SS one pill, and group 3 took SS 2 pills. Changes in the mean blood flow velocity(MBFV) and pulsatility index(PI) in the middle cerebral artery were evaluated by means of TCD. We obtained hypercapnia with breath-holding and evaluated cerebrovascular reactivity with the breath-holding index(BHI). Systolic blood pressure(SBP), diastolic blood pressure(DBP), and heart rate(HR) were measured by means of ambulatory blood pressure monitoring. In group 2 and group 3, the evaluations were performed during the baseline and were repeated at 20, 40, and 60 minutes after SS administration. In group 1, the evaluation was performed at corresponding time intervals. Results : In mean values of MSFV, PI, SSP, DBP, and HR, no stastically significant differences were found between the 3 groups. However, BHI values were significantly lower in groups 2 and 3 than in group 1 at 40 minutes after SS administration(P<0.05, group 1 vs group 2, group 1 vs group 3 by post-hoc analysis: Scheffe's test) but in dose-dependant effect, there was no difference between group 2 and group 3. Conclusion : These results suggest that SS can decrease vascular resistance in cerebral small arteries or arterioles and enhance their distensibility. Further studies on larger numbers of subjects are needed to confirm these effects and the dose-dependant effects.

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고혈압노인과 정상혈압노인 및 청년의 식후혈압 변화 비교 (Postprandial Blood Pressure in Hypertensive and Normotensive Elderly and Young Adult Subjects)

  • 손정태
    • 한국산학기술학회논문지
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    • 제13권12호
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    • pp.5849-5859
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    • 2012
  • 본 연구는 고혈압노인과 정상혈압노인 그리고 청년 간의 식후혈압 변화 양상의 차이를 파악하기 위하여 참여자들의 서면동의를 받아 조사하였다. 휴대용 혈압모니터(ABPM)를 사용하여 식전 30분부터 식후 90분까지 15분 간격으로 혈압을 측정하였다. 고혈압노인군(26명)은 수축기혈압이 식후 30분부터 식후 90분까지 지속적으로 하강하였고, 최대 $19.3{\pm}19.4mmHg$ 하강하여, 정상혈압노인군(25명: $-7.7{\pm}9.4mmHg$) 및 청년군(26명: $-1.3{\pm}4.1mmHg$)과 차이가 있었다. 고혈압노인군의 식후 이완기혈압은 최대 $25.0{\pm}15.1mmHg$ 하강하였고 정상혈압노인군($-6.1{\pm}6.0mmHg$)과 청년군($-5.7{\pm}5.0mmHg$) 과 차이가 있었다. 고혈압노인군과 정상혈압노인군에서는 맥박수의 변화가 없었고, 청년군에서는 식후 30분에 일시적으로 맥박수가 상승하였다(p=.014). PPH 발생률은 고혈압노인군 73.1%, 정상혈압노인 24% 이었고, 청년군은 PPH 발생자가 없었다(p=.001). 따라서 간호사는 고혈압노인의 식후저혈압을 확인하기 위한 식후혈압 측정을 실시해야 한다. 또한 식후 90분까지는 갑작스런 혈압하강과 관련된 합병증의 발생을 주의관찰하고 관리하도록 하여야 한다.

폐쇄성 수면 무호흡이 전신성 혈압, 심조율 및 요 Catecholamines 농도 변화에 미치는 영향 (The Influence of Obstructive Sleep Apnea on Systemic Blood Pressure, Cardiac Rhythm and the Changes of Urinary)

  • 노대근;최영미;송정섭;박성학;문화식
    • Tuberculosis and Respiratory Diseases
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    • 제45권1호
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    • pp.153-168
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    • 1998
  • 연구배경: 폐쇄성 수면 무호흡 증후군 환자들에서 동반될 수 있는 전신성 고혈압과 심부정백을 포함한 심혈관계 기능 부전은 장기사망률을 증가시키는 중요한 요인으로 생각되고 있다. 그러나 이들 환자에서 심혈관계 기능부전이 발생하는 병태생리학적 기전에 관한 정설은 확립 되지 못한 실정이다. 방 법: 저자들은 폐쇄성 수면 무호흡 증후군 환자 29명과 대조군 25명을 대상으로 수면다원검사, 각성시와 수면 중 요 catecholamines 농도 측정, 24 시간 활동중 심전도 및 혈압 감시를 실시하여 자료를 비교 분석함으로써 폐쇄성 수면 무호흡이 전신성 혈압, 심조율 및 요 catecholamines 농도 변화에 미치는 영향을 이해하고자 하였다. 결 과: 1) 요 norepinephrine (UNE) 및 epinephrine(UEP) 농도는 페쇄성 수면 무호흡증후군환자와 대조군 모두에서 각성시에 비하여 수면중에 유의하게 감소하였다(P<0.01). 폐쇄성 수면 무호흡 증후군 환자들의 수면중 UNE 농도는 대조군에 비하여 유의하게 높았으나(P<0.05), 각성시 UNE 농도는 대조군과 유의한 차이가 없었다. 두군 모두에서 전신성 고혈압의 동반 여부와 각성시 및 수면중 UNE 및 UEP 농도 상호간의 관련성은 없었다. 2) 폐쇄성 수면 무호흡 증후군 환자들에서는 수면 중 혈압 하강이 없는 경우 (non-dipper) 가 통계적으로 유의하지는 않았으나 대조군에 비하여 많은 경향을 보였으며(P=0.089), 수면중 혈압 하강의 유무와 전신성 고혈압의 동반 여부와는 상호 관련성이 없었다. 3) 전체 연구 대상에서 각성시 및 수면중 평균 수축기 혈압은 무호흡지수, 무호흡-저호흡지수, 수면중 최저 산소포화도, 수면중 산소 탈포화정도와 상호 관련성이 있었으며, 수면중 UNE 농도는 무호흡지수, 무호흡-저호흡지수, 수면중 최저 산소포화도 및 산소 탈포화정도, 수면중 평균 수축기 혈압과 관련성이 있었다. 4) 무호흡지수가 20 이상인 14명의 폐쇄성 수면 무호흡 증후군 환자들에서 무호흡 시기 동안의 섬박동수는 무호흡이 시작되기 전에 비하여 감소하였고, 무호흡이 끝나고 호흡이 재개되는 시기에는 우호흡이 시작되기 전에 비하여 유의한 증가를 보였으며 (P<0.01), 이러한 변화는 무호흡의 기간이 길수록 더욱 현저하였다 (P<0.01). 무호흡 시기와 무호흡이 끝나고 호흡이 재개되는 시기의 심박동수 차이 (${\Delta}HR$) 는 무호흡 발생 전후의 동맥혈 산소포화도의 차이 (${\Delta}SaO_2$)와 매우 유의한 상관관계를 보였다 (r=0.223, P<0.001). 5) 심부정맥의 발생 빈도는 두군 사이에 유의한 차이가 없었으며, 대조군에서는 심실성 기외수축이 각성시에 비하여 수면중에 현저히 감소하였으나(P<0.05), 폐쇄성 수면 무호흡 증후군 환자들에서는 수면중에도 각성시와 차이가 없었다. 결 론: 폐쇄성 수면 무호흡 증후군 환자들은 수면중에 무호홉, 저산소증 및 각성의 주기가 반복됨으로써 교감신경계 활성도의 변화가 초래될 수 있으며, 반복되는 저산소증과 교감신경계 활성도 증가는 전신성 혈압 및 심기능의 변화를 포함한 여러 가지 심혈관계 기능부전의 발생에 영향을 미칠 것으로 생각된다.

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Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial

  • Jovanovski, Elena;Smircic-Duvnjak, Lea;Komishon, Allison;Au-Yeung, Fei (Rodney);Sievenpiper, John L.;Zurbau, Andreea;Jenkins, Alexandra L.;Sung, Mi-Kyung;Josse, Robert;Li, Dandan;Vuksan, Vladimir
    • Journal of Ginseng Research
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    • 제45권5호
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    • pp.546-554
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    • 2021
  • Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;