1.Effect analysis of information-guided enteral nutrition-associated diarrhea treatment process in patients with chronic obstructive pulmonary disease undergoing continuous non-invasive assisted ventilation: a mixed cohort study of pre- and post-control
Xiaofei ZHU ; Jiao WANG ; Huibin PAN ; Zhuquan DAI ; Chaohui JI ; Chunmiao ZHONG ; Haiping HUANG
Chinese Critical Care Medicine 2024;36(1):62-66
Objective:To clarify the application effect of information-guided enteral nutrition-associated diarrhea (ENAD) management process in patients with chronic obstructive pulmonary disease (COPD) undergoing non-invasive assisted ventilation.Methods:A mixed cohort study of pre- and post-control was conducted. Thirty-nine patients with COPD who were admitted to the emergency intensive care unit (ICU) of Huzhou First People's Hospital from July 1, 2021 to July 31, 2022 were enrolled. Taking the completion of the software development of ENAD management software for critically ill patients on January 28, 2022 as the time node, 20 patients admitted from July 1, 2021 to January 28, 2022 were set as the control group, and 19 patients admitted from January 29 to July 31, 2022 were set as the observation group. The two groups of patients received the same enteral nutrition support treatment, and the control group implemented the conventional ENAD treatment process with enteral nutrition intolerance disposal process as the core. On the basis of the control group, the observation group implemented the information-guided ENAD treatment process, and the system software actively captured the information of ENAD patients and reminded the medical team to improve the patient's diarrhea-related examination and provide alternative treatment plans. The duration of antidiarrhea, feeding interruption rate, and energy and protein intake, blood biochemical indexes, incidence of abnormal blood electrolyte metabolism, daily continuous non-invasive assisted ventilation and endotracheal intubation after 7 days of targeted diarrhea intervention were compared between the two groups.Results:Except for the basal pulse rate, there were no significant differences in gender distribution, age, and vital signs, basic nutritional status, arterial blood gas analysis and blood biochemistry at admission between the two groups, indicating comparability between the two groups. When ENAD occurred, the patients in the observation group obtained earlier cessation of diarrhea than those in the control group [days: 3.00 (2.00, 3.25) vs. 4.00 (3.00, 5.00), P < 0.01], and the feeding interruption rate was significantly lower than that in the control group [10.53% (2/19) vs. 65.00% (13/20), P < 0.01]. After 7 days of diarrhea intervention, the energy intake of the observation group was significantly higher than that of the control group [kJ·kg -1·d -1: 66.28 (43.34, 70.36) vs. 47.88 (34.60, 52.32), P < 0.01], the levels of hemoglobin (Hb), albumin (Alb) and serum prealbumin (PAB) were significantly higher than those in the control group [Hb (g/L): 119.79±10.04 vs. 110.20±7.75, Alb (g/L): 36.00 (33.75, 37.25) vs. 31.00 (30.00, 33.00), PAB (mg/L): 155.79±25.78 vs. 140.95±14.97, all P < 0.05], the daily continuous non-invasive assisted ventilation duration was significantly shorter than that of the control group [hours: 14 (12, 16) vs. 16 (14, 18), P < 0.01], and the arterial partial pressure of carbon dioxide (PaCO 2) was significantly lower than that of the control group [mmHg (1 mmHg ≈ 0.133 kPa): 66.00 (62.00, 70.00) vs. 68.00 (67.50, 70.05), P < 0.05]. However, there were no significant differences in protein intake, incidence of abnormal electrolyte metabolism, and incidence of endotracheal intubation due to acute respiratory failure between the two groups. Conclusion:The information-guided ENAD treatment process can enable the COPD patients undergoing continuous non-invasive assisted ventilation who experience ENAD to receive earlier cessation of diarrhea, and improve the protein energy metabolism and respiratory function of the patients.
2.Relationship between illness perceptions and disability in HIV-infected people aged 50 and older in some areas of Sichuan Province
Chuanteng FENG ; Bin YU ; Bo YANG ; Yuling HUANG ; Jun YU ; Jun XIONG ; Kunming HE ; Huibin ZHOU ; Peng JIA ; Shujuan YANG
Chinese Journal of Epidemiology 2023;44(11):1697-1702
Objective:To explore the relationship between illness perceptions and disability, and the relative importance of association of illness perceptions items and disability in HIV-infected people aged ≥50 years in Sichuan Province.Methods:By using multi-stage cluster sampling, the baseline data of a cohort of HIV-infected people aged ≥50 years in 5 counties (district) in Sichuan were obtained from 2018 to 2021. The disability was evalauted with instrumental activities of daily living scale (IADL), and the illness perception was evaluated by using brief illness perception questionnaire. General additive model and general linear model were used to analyze the association between illness perceptions and IADL. Weighted sum quartile sum regression was used to find the dominant items on the association. Software R was used for statistical anlysis.Results:A total of 1 587 HIV-inbfected peoeple aged ≥50 years were included in this study. The prevalence of disability was 26.1% ( n=414). The median score of illness perception was 33. The illness perceptions had a negative effect on the IADL score ( β=-0.15, P<0.001) and the partial score of IADL declined when illness perception score was larger than 38 ( P<0.05). Personal control (32.98%) and consequence (22.50%) whose weight were higher than average (12.50%) were the dominant items on the association between the score of illness perception and IADL score. Conclusions:The prevalence of disability in HIV-infected people aged ≥50 years in Sichuan was high. It is necessary to intervent on personal control and consequence in HIV-infected people aged ≥50 years when their illness perception scores are high to prevent the incidence and development of disability.
3.Effective arterial elastance in evaluating the fluid challenge in septic shock patients
Ting YANG ; Huibin HUANG ; Li WENG ; Bin DU
Chinese Critical Care Medicine 2021;33(3):269-275
Objective:To explore the validity of the effective arterial elastance (Ea) before and after fluid challenge in evaluating the fluid challenge in septic shock patients.Methods:A retrospective study was conducted in the medical intensive care unit (MICU) of Peking Union Medical College Hospital from October 2016 to October 2020. 116 septic shock patients were enrolled. All patients received fluid challenge by 500 mL Gelatin or normal saline under invasive hemodynamic monitoring. Heart rate (HR), mean arterial pressure (MAP), cardiac output (CO) and other hemodynamic variables were collected at 10 minutes before and immediately after fluid challenge. An increase in CO greater than 10% after fluid challenge was defined as the positive preload responsiveness, as well as the definition of positive pressure responsiveness was an increase in MAP greater than 10%. Receiver operating characteristic curves (ROC curves) were established to evaluate the predictive abilities of baseline Ea and other arterial load indices in detecting the preload responders and pressure responders. The correlation of the baseline Ea with CO changes after fluid challenge as well as MAP changes were tested by Pearson correlation analysis. Patients with positive preload responsiveness were divided into two groups according to the pressure responsiveness. The changes in Ea and other arterial load indices were analyzed.Results:A total of 116 patients were finally analyzed. Sixty-three patients were preload responders and 53 patients were preload non-responders. There was no significant difference in demographics and baseline physical variables between the two groups. Ea in preload responders was higher than that in preload non-responders (mmHg/mL: 2.51±1.08 vs. 1.87±0.68, P < 0.01). ROC curve analysis showed that the baseline Ea could predict the preload responsiveness at an area under ROC curve (AUC) = 0.71 [95% confidence interval (95% CI) was 0.62-0.81, P < 0.001]. The cut-off value was 1.97 mmHg/mL with a sensitivity of 71.4% and a specificity of 60.4%. The baseline Ea did not present the predictive ability to detect the pressure responders and pressure non-responders (AUC = 0.52, 95% CI was 0.41-0.63, P = 0.73). Pearson correlation analysis showed that the changes in CO after fluid challenge was moderately correlated to the baseline Ea ( r = 0.47, P < 0.001), meanwhile a weak positive correlation between the changes in MAP and baseline Ea was found ( r = 0.20, P = 0.03). In preload responders, 27 (42.9%) of 63 patients were pressure responders and 36 (57.1%) patients were pressure non-responders. No statistical difference was found in the baseline Ea or other arterial load indices between the two groups. Fluid challenge decreased Ea both in pressure non-responders and pressure responders (mmHg/mL: 2.13±0.94 vs. 2.51±1.08, P < 0.01; 2.47±1.18 vs. 2.69±1.30, P < 0.05). Moreover, the changes in CO and changes in MAP were strongly correlated with the changes in Ea ( r values were -0.50 and 0.58, respectively, both P < 0.001). Conclusions:The Ea > 1.97 mmHg/mL before fluid challenge could predict fluid responsiveness in septic shock patients. The baseline Ea was not able to predict the subsequent changes in arterial pressure through fluid challenge. A significant decrease in Ea inducing by fluid administration explained why patients increased their CO without improving blood pressure.
4.Application of the Simodont dental trainer in preclinical manual dexterity training
Weini XIN ; Jingna HUANG ; Bo ZOU ; Qingfeng XU ; Huibin MA ; Xi LIN ; Junqi LING
Chinese Journal of Medical Education Research 2021;20(10):1160-1164
Objective:To explore the application of the Simodont dental trainer in preclinical manual dexterity training for dental students of different grades, and to discuss its effect by quantitatively evaluating their practice results.Methods:The evaluation was conducted among 118 students in the Department of Stomatology, Shantou University Medical College from Batch 2015 to Batch 2018. Each student had five different manual dexterity modules for training. Each module had three levels of difficulty and was required to be completed in 30 minutes. The assessment index included Target, Leeway Bottom and Sides, Container Bottom and Sides, which was provided by the Simodont dental trainer. The operating time (in seconds), the displacement of the dental hand pieces and the dental mirrors (in meters) were simultaneously recorded. SPSS 25.0 was used for statistical analysis.Results:For the index Target, Leeway Bottom and Sides, Container Bottom and Sides, the results showed that there was a statistical difference between students who passed pre-clinical training and who did not take the professional course ( P < 0.001). For the index Target, differences were showed among students from different grades in all modules ( P < 0.001). Conclusion:The circle module, channel module, hollow-circle module and cross-module in the Simodont dental trainer have sensitivity to discriminate the manual dexterity of different levels of dental students. The further assessment of the discrimination of the manual dexterity is required for assume-block module. The Simodont dental trainer can quantitatively measure the manual dexterity of dental students, which is important for the quantitative evaluation of dental preclinical education.
5.MRtextureanalysisinthedifferentialdiagnosisofintracranialsolitaryfibroustumor/hemangiopericytomasandvascularmeningioma
Fei XIONG ; Chipeng WANG ; Wencai HUANG ; Huibin TAN ; Ying WANG ; Shun YAO
Journal of Practical Radiology 2019;35(4):523-526
Objective ToinvestigatethevalueofimagetextureanalysisbasedonconventionalMRimagesinthedifferentialdiagnosisof intracranialsolitaryfibroustumor/hemangiopericytoma(SFT/HPC)andvascularmeningiomas.Methods 12casesofSFT/HPCand 16casesofvascularmeningiomaconfirmedbypathologywerecollected.Variousdiscriminantanalysismethodsandimagetextureanalysis techniqueswereappliedtopre-operativeroutineMRIimagesofthebrain,andthebesttextureparameterswereselectedtoclassify cases,includinglineardiscriminantanalysis(LDA),nonlineardiscriminantanalysis(NDA),principalcomponentanalysis(PCA)and rawdataanalysis(RDA).Finally,thebestclassificationsequencetextureparameterswerechosenforstatisticalanalysis.Results The enhancedT1WIwasthebestclassificationsequence.ThePOE+ACC methodhadthelowestmisclassificationrate.Theabsolutegradient skewness,theautocorrelationofthecooccurrencematrix,andthevarianceofthehistograminthetexturefeaturesoftheSFT/HPC andvascularmeningiomasweredifferent(P<0.05).Conclusion ThatbasedontheconventionalMRimagetextureanalysiscanprovidemore quantitativeinformation,anew methodandideafortheidentificationofintracranialSFT/HPCandvascularmeningioma.
6.Choice of assessment time after fluid challenge in patients with septic shock
Huibin HUANG ; Guangyun LIU ; Biao XU ; Ting YANG ; Bin DU
Chinese Critical Care Medicine 2019;31(4):407-412
Objective To explore the short-term hemodynamic change of fluid challenge (FC) with crystalloid or colloid and define fluid responsiveness at the optimal time in patients with septic shock. Methods A prospective observational study was conducted. Septic shock patients monitored with pulmonary catheters admitted to medical intensive care unit (ICU) of the Peking Union Medical College Hospital from July 2016 to December 2018 were enrolled. All included patients received FC and were divided into two groups according to the type of fluid used, i.e. crystalloid group (normal saline for 500 mL) and colloid group (4% succinyl gelatin for 500 mL). The choice of fluid type was decided by the attending physician. Hemodynamic variables were measured at baseline, and 0 (immediately), 10, 30, 45, 60, 90, 120 minutes after FC, included cardiac index (CI), heart rate (HR), mean artery pressure (MAP), central venous pressure (CVP) and pulmonary arterial wedge pressure (PAWP). Fluid responsiveness was defined as CI increased by more than 10% after FC. The data were analyzed by repeated measurements of variance between the two groups as well as responders and nonresponders. Results Forty patients were included, 20 cases each in colloid group and crystalloid group; of whom 26 were fluid responders with 12 of colloid group and 14 of crystalloid group. Of the 14 nonresponders, 8 were of colloid group and 6 of crystalloid group. ① Compared with before FC, CI (mL·s-1·m-2) was significantly increased in crystalloid and colloid groups after FC (71.7±16.7 vs. 65.0±16.7, 68.3±25.0 vs. 63.3±23.3, both P < 0.05). In the colloid group, volume expansion increased the CI to maximum (76.7±18.3) at 30 minutes after FC, at 120 minutes after FC, a significantly higher CI (70.0±16.7) was also observed (P < 0.05), an increased in CI≥10% was observed at 60 minutes after FC. In the crystalloid group, CI was increased to maximum at 10 minutes (73.3±28.3) and decreased to baseline at 60 minutes, an increased in CI≥10% was also observed at 10 minutes after FC. In addition, there was no significant difference in CI changes between colloidal group and crystalloid group at different time points after FC. ② CI did not change over time in nonresponders groups, whereas in responders CI increased parallelly to that in both crystalloid and colloid groups over time. However, an increased in CI≥10% was observed through the 120 minutes after FC in responders of colloid group compared with that of at 30 minutes after FC in crystalloid group. There was significant difference in CI changes between colloidal group and crystalloid group at 30, 45, 60, 90 minutes after FC (mL·s-1·m-2: 18.3±3.3 vs. 8.3±1.7, 18.3±3.3 vs. 5.0±1.7, 13.3±1.7 vs. 3.3±1.7, 11.7±3.3 vs. 3.3±1.7, all P <0.05). ③ The maximal values of CVP and PAWP were observed at the end of FC. In colloid group, both the two variables were notably higher than that before FC over 120 minutes compared with that of only at 10 minutes in crystalloid group. The MAP in colloid increased to maximum immediately at the end of FC and decreased to baseline at 45 minutes, however, the MAP in crystalloid group and HR of both groups showed no differences over 120 minutes. Conclusions Hemodynamic changes were significantly different between crystalloid and colloid after FC in patients with septic shock. Therefore, the timing of fluid responsiveness assessment should be different individually. The assessment time of colloid group may be prolonged to 30 minutes after FC while that of crystal group can be at 10 minute after FC.
7.Therapeutic effect of pulse high volume hemofiltration for treatment of patients with sepsis: a systemic review and Meta-analysis
Huibin HUANG ; Jianqin LIU ; Xiaoli CHEN ; Jiandong LIN
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2018;25(2):113-119
Objective To systematically evaluate the therapeutic effect of pulse high volume hemofiltration (PHVHF) for treatment of patients with sepsis. Methods Databases such as PubMed in American National Medical Library, Holland medical abstract Embase, the Cochrane Library, China National Knowledge Internet (CNKI), China Biological Medical Literature Database (CBM), VIP, WanFang databases, etc. were searched by computer to retrieve randomized controlled trials (RCTs) on PHVHF for treatment of patients with sepsis, and the retrieval time ranged from the creation of database to March 25, 2017. Both groups of patients received conventional treatments, including antibiotics, fluid resuscitation, vasoactive agents as well as other organ function support treatments to maintain the basic vital signs stable. Patients in PHVHF group received PHVHF besides conventional treatment, while the patients in control group received conventional treatment or any other continuous renal replacement therapy (CRRT) mode with PHVHF excluded. The literatures accepted should at least include one of the following changes of outcome indicators, such as overall mortality, the levels of inflammatory mediators eliminated, acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ) score, service life of filter, amount of replacement fluids used. Two researchers independently screened literatures, extracted data, and assessed the methodological quality of included studies. Meta-analysis was conducted by using RevMan 5.3 software and the publication bias was evaluated by visually inspecting funnel plots. Results A total of 11 RCTs involving 410 patients met eligibility criteria, of which 204 patients in the PHVHF group and 206 patients in the control group. In the control group 5 RCTs used other CRRT modes, and 6 RCTs applied the conventional therapy. Meta-analyses showed that interleukin-6 [IL-6, standard mean difference (SMD) = -0.80, 95% confidence interval (95%CI) = -1.56 to -0.06, P = 0.04], tumor necrosis factor-α (TNF-α, SMD = -0.78, 95%CI = -1.33 to -0.23, P = 0.006), APACHE Ⅱ scores [mean difference (MD) = -3.80, 95%CI = -5.08 to -2.52, P < 0.000 01] were obviously lower than those in control group, but no significant statistical significance in mortality was seen between the two groups [relative risk (RR) = 0.72, 95%CI = 0.49 - 1.07, P = 0.10]. Further subgroup analyses suggested that compared with conventional treatment group, in PHVHF group mortality (RR = 0.40, 95%CI = 0.16 - 0.95, P = 0.04), IL-6 (SMD =-1.87, 95%CI = -3.58 to -0.16, P = 0.03), TNF-α (SMD = -1.32, 95%CI = -2.24 to -0.40, P = 0.005), and APACHE Ⅱscore (MD = -4.29, 95%CI = -6.02 to -2.56, P < 0.000 01) were significantly decreased; however, only a significantly decreased APACHE Ⅱ score (MD = -2.95, 95%CI = -4.56 to -1.35, P = 0.000 3) was observed in PHVHF group compared to that in subgroup of other CRRT modes. Conclusions Compared with using conventional therapy alone, using PHVHF combined with conventional therapy for treatment of patients with sepsis can more effectively improve their prognosis, and PHVHF can be the efficacious alternatives of other CRRT modes especially the HVHF. However, due to the limited quantity and quality of the included studies, further high-quality, multicenter, large-scale RCTs are needed to verify the above conclusion.
8.Approach to the patient with Kallmann syndrome
Peipei LI ; Rongmei LU ; Wei LIN ; Huibin HUANG ; Jixing LIANG ; Liantao LI ; Lixiang LIN ; Gang CHEN ; Junping WEN
Chinese Journal of Endocrinology and Metabolism 2018;34(1):72-76
Kallmann syndrome ( KS) is a rare disease and characteristic of an absence of puberty, infertility, and a defective sensation of smell (anosmia or hyposmia). Here, we analyze the features of a case of KS diagnosed clinically. In addition, the etiology, genetic features, clinical manifestations, diagnosis, and treatment of KS were reviewed.
9.Approach to the patient with Klinefelter syndrome combined with neuropsychological abnormality
Lidan SHI ; Liangchun CAI ; Rongmei LU ; Wei LIN ; Huibin HUANG ; Jixing LIANG ; Liantao LI ; Junping WEN ; Lixiang LIN ; Gang CHEN
Chinese Journal of Endocrinology and Metabolism 2018;34(4):330-335
Klinefelter syndrome(KS) is the most common sex chromosome disorder in males,which is caused by the presence of the extra X chromosome that maybe inherited from mother or father. Approximately 80% karyotype of the cases is 47,XXY. KS is characterized by small firm testes, hypergonadotropic hypogonadism, infertility,gynaecomastia, increased height. However, cognitive disabilities and psychiatric disorders are rarely diagnosed in KS because they lack screening in related aspects. At the present, the pathogenesis of cognitive disabilities and increased risk of psychiatric diseases in KS have not been delineated. In this article,we report two cases of KS,and review their clinical manifestations,diagnosis,and treatments.
10.Predictive value of central venous-to-arterial carbon dioxide partial pressure difference for fluid responsiveness in septic shock patients: a prospective clinical study
Guangyun LIU ; Huibin HUANG ; Hanyu QIN ; Bin DU
Chinese Critical Care Medicine 2018;30(5):449-455
Objective To evaluate the accuracy of central venous-to-arterial carbon dioxide partial pressure difference (Pcv-aCO2) before and after rapid rehydration test (fluid challenge) in predicting the fluid responsiveness in patients with septic shock. Methods A prospective observation was conducted. Forty septic shock patients admitted to medical intensive care unit (ICU) of Peking Union Medical College Hospital from October 2015 to June 2017 were enrolled. All of the patients received fluid challenge in the presence of invasive hemodynamic monitoring. Heart rate (HR), blood pressure, cardiac index (CI), Pcv-aCO2 and other physiological variables were recorded at 10 minutes before and immediately after fluid challenge. Fluid responsiveness was defined as an increase in CI greater than 10% after fluid challenge, whereas fluid non-responsiveness was defined as no increase or increase in CI less than 10%. The correlation between Pcv-aCO2 and CI was explored by Pearson correlation analysis. Receiver operating characteristic (ROC) curves were established to evaluate the discriminatory abilities of baseline and the changes after fluid challenge in Pcv-aCO2 and other physiological variables to define the fluid responsiveness. The patients were separated into two groups according to the initial value of Pcv-aCO2. The cut-off value of 6 mmHg (1 mmHg = 0.133 kPa) was chosen according to previous studies. The discriminatory abilities of baseline and the change in Pcv-aCO2(ΔPcv-aCO2) were assessed in each group. Results A total of 40 patients were finally included in this study. Twenty-two patients responded to the fluid challenge (responders). Eighteen patients were fluid non-responders. There was no significant difference in baseline physiological variable between the two groups. Fluid challenge could increase CI and blood pressure significantly, decrease HR notably and had no effect on Pcv-aCO2 in fluid responders. In non-responders, blood pressure was increased significantly and CI, HR, Pcv-aCO2 showed no change after fluid challenge. Pcv-aCO2 was comparable in responders and non-responders. In 40 patients, CI and Pcv-aCO2 was inversely correlated before fluid challenge (r = -0.391, P = 0.012) and the correlation between them weakened after fluid challenge (r = -0.301, P = 0.059). There was no significant correlation between the changes in CI and Pcv-aCO2 after fluid challenge (r = -0.164, P = 0.312). The baseline Pcv-aCO2 and ΔPcv-aCO2 could not discriminate between responders and non-responders, with the area under ROC curve (AUC) of 0.50 [95% confidence interval (95%CI) =0.32-0.69] and 0.51 (95%CI = 0.33-0.70), respectively. HR and blood pressure before fluid challenge and their changes after fluid challenge showed very poor discriminative performances. Before fluid challenge, 16 patients had a Pcv-aCO2 > 6 mmHg. Their mean CI was significantly lower and Pcv-aCO2 was significantly higher than that in 24 patients whose Pcv-aCO2 ≤6 mmHg [n = 24; CI (mL·s-1·m-2): 48.3±11.7 vs. 65.0±18.3, P < 0.01; Pcv-aCO2 (mmHg): 8.4±1.9 vs. 2.9±2.8, P < 0.01]. Pcv-aCO2was decreased significantly after fluid challenge in patients with an initial Pcv-aCO2 > 6 mmHg and their ΔPcv-aCO2 was notably different as compared with the patients whose baseline Pcv-aCO2≤6 mmHg (mmHg: -3.8±3.4 vs. 0.9±2.9, P < 0.01). 68.8% (11/16) patients responded to the fluid challenge in patients with an initial Pcv-aCO2 > 6 mmHg. The AUC of the baseline Pcv-aCO2 and ΔPcv-aCO2 to define fluid responsiveness was 0.85 (95%CI = 0.66-1.00) and 0.84 (95%CI = 0.63-1.00), respectively, and the positive predictive value was 1 when the cut-off value was 8.0 mmHg and -4.2 mmHg, respectively. 45.8% (11/24) patients responded to the fluid challenge in patients whose baseline Pcv-aCO2≤6 mmHg. There was no predictive value of baseline Pcv-aCO2 and ΔPcv-aCO2 on fluid responsiveness. Conclusion Pcv-aCO2 and its change cannot serve as a surrogate of the change in cardiac output to define the response to fluid challenge in septic shock patients whose baseline Pcv-aCO2≤6 mmHg, while the predictive values of baseline Pcv-aCO2and the change in Pcv-aCO2 are presented in patients with the initial value of Pcv-aCO2 > 6 mmHg. Clinical Trial Registration Clinical Trials, NCT01941472.

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