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The Effect of Post-Activation Potentiation Enhancement Alone or in Combination with Caffeine on Anaerobic Performance in Boxers: A Double-Blind, Randomized Crossover Study.
Zhang, Y, Diao, P, Wang, J, Li, S, Fan, Q, Han, Y, Liang, Y, Wang, Z, Del Coso, J
Nutrients. 2024;(2)
Abstract
Post-activation performance enhancement (PAPE) is a physiological phenomenon that refers to an acute excitation of the neuromuscular system following intense exercise that ends in enhanced physical performance in a subsequent bout of exercise. The scientific literature has primarily examined the effectiveness of PAPE alone or combined with caffeine (CAF) intake in all-out tests lasting ≤10 s, as the effect of PAPE is transitory. The aim of the present study was to determine the effect of a protocol to induce PAPE alone or in combination with caffeine intake on the 30 s Wingate Anaerobic Test in highly trained boxers. Twenty-five male and highly trained boxers (mean age: 20 ± 1 years) participated in a double-blind, randomized crossover study consisting of three different experimental conditions: (i) control (CON), with no substance intake and no PAPE protocol before the Wingate Anaerobic Test; (ii) PAPE + PLA, involving the intake of a placebo 60 min before and a PAPE protocol comprising a 10 s cycling sprint overloaded with 8.5% of the participants' body weight 10 min before the Wingate Anaerobic Test; and (iii) PAPE + CAF, involving the intake of 3 mg/kg of caffeine 60 min before and the same PAPE protocol used in the (ii) protocol before the Wingate Anaerobic Test. In all conditions, the participants performed the 30 s version of the Wingate Anaerobic Test with a load equivalent to 7.5% of their body weight, while the cycle ergometer setting was replicated. Immediately following the Wingate test, heart rate (HR), the rating of perceived exertion (RPE), and blood lactate concentration (Bla) were measured. In comparison to CON, PAPE + PLA enhanced mean power (p = 0.024; Effect size [ES] = 0.37) and total work (p = 0.022; ES = 0.38) during the Wingate test, accompanied by an increase in post-test blood lactate concentration (p < 0.01; ES = 0.83). In comparison to CON, PAPE + CAF enhanced mean power (p = 0.001; ES = 0.57), peak power (p = 0.013; ES = 0.57), total work (p = 0.001; ES = 0.53), post-test blood lactate concentration (p < 0.001; ES = 1.43) and participants' subjective perception of power (p = 0.041). There were no differences in any variable between PAPE + PLA and PAPE + CAF. In summary, a PAPE protocol that involves a 10 s all-out sprint 10 min before the Wingate Anaerobic Test was effective in enhancing Wingate mean power in highly trained boxers. The addition of 3 mg/kg of caffeine to the PAPE protocol produced an effect on mean power of a higher magnitude than PAPE alone, and it enhanced peak power along with participants' subjective perception of power. From a practical point of view, PAPE before exercise seems to be an effective approach for increasing Wingate performance in highly trained boxers, while the addition of caffeine can increase some benefits, especially peak power.
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Homoharringtonine-Based Induction Regimen Improved the Remission Rate and Survival Rate in Chinese Childhood AML: A Report From the CCLG-AML 2015 Protocol Study.
Li, J, Gao, J, Liu, A, Liu, W, Xiong, H, Liang, C, Fang, Y, Dai, Y, Shao, J, Yu, H, et al
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023;(31):4881-4892
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PURPOSE Homoharringtonine (HHT) is commonly used for the treatment of Chinese adult AML, and all-trans retinoic acid (ATRA) has been verified in acute promyelocytic leukemia (APL). However, the efficacy and safety of HHT-based induction therapy have not been confirmed for childhood AML, and ATRA-based treatment has not been evaluated among patients with non-APL AML. PATIENTS AND METHODS This open-label, multicenter, randomized Chinese Children's Leukemia Group-AML 2015 study was performed across 35 centers in China. Patients with newly diagnosed childhood AML were first randomly assigned to receive an HHT-based (H arm) or etoposide-based (E arm) induction regimen and then randomly allocated to receive cytarabine-based (AC arm) or ATRA-based (AT arm) maintenance therapy. The primary end points were the complete remission (CR) rate after induction therapy, and the secondary end points were the overall survival (OS) and event-free survival (EFS) at 3 years. RESULTS We enrolled 1,258 patients, of whom 1,253 were included in the intent-to-treat analysis. The overall CR rate was significantly higher in the H arm than in the E arm (79.9% v 73.9%, P = .014). According to the intention-to-treat analysis, the 3-year OS was 69.2% (95% CI, 65.1 to 72.9) in the H arm and 62.8% (95% CI, 58.7 to 66.6) in the E arm (P = .025); the 3-year EFS was 61.1% (95% CI, 56.8 to 65.0) in the H arm and 53.4% (95% CI, 49.2 to 57.3) in the E arm (P = .022). Among the per-protocol population, who received maintenance therapy, the 3-year EFS did not differ significantly across the four arms (H + AT arm: 70.7%, 95% CI, 61.1 to 78.3; H + AC arm: 74.8%, 95% CI, 67.0 to 81.0, P = .933; E + AC arm: 72.9%, 95% CI, 65.1 to 79.2, P = .789; E + AT arm: 66.2%, 95% CI, 56.8 to 74.0, P = .336). CONCLUSION HHT is an alternative combination regimen for childhood AML. The effects of ATRA-based maintenance are comparable with those of cytarabine-based maintenance therapy.
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Impact of COVID-19 in patients with heart failure with mildly reduced or preserved ejection fraction enrolled in the DELIVER trial.
Bhatt, AS, Kosiborod, MN, Claggett, BL, Miao, ZM, Vaduganathan, M, Lam, CSP, Hernandez, AF, Martinez, FA, Inzucchi, SE, Shah, SJ, et al
European journal of heart failure. 2023;(12):2177-2188
Abstract
AIM: COVID-19 may affect clinical risk in patients with heart failure. DELIVER began before and was conducted during the COVID-19 pandemic. This study aimed to evaluate the association between COVID-19 and clinical outcomes among DELIVER participants. METHODS AND RESULTS Participants with chronic heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) were randomized to dapagliflozin or placebo across 350 sites in 20 countries. COVID-19 was investigator-reported and the contribution of COVID-19 to death was centrally adjudicated. We assessed (i) the incidence of COVID-19, (ii) event rates before/during the pandemic, and (iii) risks of death after COVID-19 diagnosis compared to risks of death in participants without COVID-19. Further, we performed a sensitivity analysis assessing treatment effects of dapagliflozin vs. placebo censored at pandemic onset. Of 6263 participants, 589 (9.4%) developed COVID-19, of whom 307 (52%) required/prolonged hospitalization. A total of 155 deaths (15% of all deaths) were adjudicated as definitely/possibly COVID-19-related. COVID-19 cases and deaths did not differ by randomized assignment. Death rate in the 12 months following diagnosis was 56.1 (95% confidence interval [CI] 48.0-65.6) versus 6.4 (95% CI 6.0-6.8)/100 participant-years among trial participants with versus without COVID-19 (adjusted hazard ratio [aHR] 8.60, 95% CI 7.18-10.30). Risk was highest 0-3 months following diagnosis (153.5, 95% CI 130.3-180.8) and remained elevated at 3-6 months (12.6, 95% CI 6.6-24.3/100 participant-years). After excluding investigator-reported fatal COVID-19 events, all-cause death rates in the 12 months following diagnosis among COVID-19 survivors (n = 458) remained higher (aHR 2.46, 95% CI 1.83-3.33) than rates for all trial participants from randomization, with censoring of participants who developed COVID-19 at the time of diagnosis. Dapagliflozin reduced cardiovascular death/worsening HF events when censoring participants at COVID-19 diagnosis (HR 0.81, 95% CI 0.72-0.91) and pandemic onset (HR 0.72, 95% CI 0.58-0.89). There were no diabetic ketoacidosis or major hypoglycaemic events within 30 days of COVID-19. CONCLUSION DELIVER is one of the most extensive experiences with COVID-19 of any cardiovascular trial, with >75% of follow-up time occurring during the pandemic. COVID-19 was common, with >50% of cases leading to hospitalization or death. Treatment benefits of dapagliflozin persisted when censoring at COVID-19 diagnosis and pandemic onset. Patients surviving COVID-19 had a high early residual risk. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03619213.
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Effectiveness and safety of Xingbei Zhike granules in patients with postinfectious cough: A multicenter, randomized, double-blinded, placebo-controlled trial.
Chi, Y, Lin, L, Guo, X, Xiao, J, Fan, F, Yu, C, Xue, H, Li, S, Guo, D, Liu, L, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2023;:155103
Abstract
BACKGROUND Postinfectious cough (PIC) is a common symptom following a respiratory tract infection. Xingbei Zhike (XBZK) granules, a Chinese patent medicine, has been widely used for PIC in clinics. However, there is a lack of evidence on the effectiveness. PURPOSE To investigate whether treatment with XBZK granules is effective for PIC. STUDY DESIGN A multicenter, randomized, double-blinded, placebo-controlled trial. METHODS Eligible participants from fourteen hospitals were randomly assigned in 3:1 ratio to receive either XBZK granules or placebo for 14 days. The primary outcome was the area under the curve (AUC) of a visual analogue scale (VAS) for cough symptoms. Secondary outcomes included cough symptom score (CSS), time and probability of recovery from cough, traditional Chinese medicine (TCM) syndrome score, relief rates of individual symptoms, Leicester Cough Questionnaire (LCQ) score, and the use of reliever drug. RESULTS A total of 235 patients (176 in XBZK and 59 in placebo groups) were included in the analysis. The AUC for cough VAS scores was lower in the XBZK than placebo group (-8.10, 95 % CI -14.12 to -2.07, p = 0.009), indicating superiority. XBZK decreased CSS (-0.68 points, 95 % CI -1.13 to -0.22, p = 0.01), shortened time to cough recovery (-2 days, hazard ratio [HR] 1.48, 95 % CI 1.03 to 2.13, p = 0.02), enhanced the probability of cough recovery (risk ratio [RR] 1.66, 95 % CI 1.07 to 2.58, p = 0.03), lowered TCM syndrome score (-0.99 points, 95 % CI -1.58 to -0.40, p = 0.004), increased the rate of daytime (RR 1.84, 95 % CI 1.07 to 3.15, p = 0.02) and nighttime (RR 2.07, 95 % CI 1.29 to 3.35, p = 0.004) cough recovery, and reduced the viscosity of sputum (RR 2.92, 95 % CI 1.66 to 5.13, p < 0.001) compared to placebo. There were no significant differences in LCQ scores and taking reliever drugs between groups. No severe adverse events were reported in either group. CONCLUSIONS XBZK granules are a promising therapy against PIC, effective in lowering the overall severity of cough, shortening the time to cough recovery, and reducing the viscosity of sputum.
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Comparison of an online versus conventional multidisciplinary collaborative weight loss programme in type 2 diabetes mellitus: A randomized controlled trial.
Han, Y, Ye, X, Li, X, Yang, P, Wu, Y, Chen, L, Wu, H, He, W
International journal of nursing practice. 2023;(1):e13126
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AIM: The aim of this study was to examine the effect of an online multidisciplinary weight loss management programme. METHODS Between July 2016 and July 2017 this randomized controlled trial recruited patients in Nanjing, China who were living with type 2 diabetes mellitus and who were obese or overweight and randomized them to online versus conventional groups. All participants were managed by a multidisciplinary team. The experimental group was managed using the Why Wait WeChat Platform for Weight Reduction Management. RESULTS There were 55 and 52 participants in the online and conventional groups, respectively. The decreases in fasting blood glucose (-4.26 vs. -2.99 mmol/L), 2-h postprandial blood glucose (-4.48 vs. -2.68 mmol/L) and glycated haemoglobin (-22.11 vs. -6.21 mmol/mol) were more pronounced in the online compared to conventional group (all P < 0.05). After the intervention, self-management ability parameters, including diet control, foot care and total score, were improved in the online group compared with the conventional group, as well as all indexes of quality of life (all P < 0.05). CONCLUSION The online multidisciplinary weight loss management programme improved blood glucose in obese or overweight patients living with type 2 diabetes mellitus. Self-management ability parameters (including diet control, foot care and total score) and quality of life were improved in the online group compared with the conventional group.
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Severity assessment to guide empiric antibiotic therapy for cholangitis in children after Kasai portoenterostomy: a multicenter prospective randomized control trial in China.
Wang, P, Zhang, HY, Yang, J, Zhu, T, Wu, X, Yi, B, Sun, X, Wang, B, Wang, T, Tang, W, et al
International journal of surgery (London, England). 2023;(12):4009-4017
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BACKGROUND Cholangitis is common in patients with biliary atresia following Kasai portoenterostomy (KPE). The prompt use of empiric antibiotics is essential due to the lack of identified microorganisms. The authors aimed to validate a severity grading system to guide empiric antibiotic therapy in the management of post-KPE cholangitis. MATERIALS AND METHODS This multicenter, prospective, randomized, open-label study recruited patients with post-KPE cholangitis and was conducted from January 2018 to December 2019. On admission, patients were categorized into mild, moderate, and severe cholangitis according to the severity grading system. Patients in the mild cholangitis group were randomized to receive cefoperazone sodium tazobactam sodium (CSTS) or meropenem (MEPM). Patients with severe cholangitis were randomized to treatment with MEPM or a combination of MEPM plus immunoglobulin (MEPM+IVIG). Patients with moderate cholangitis received MEPM. RESULTS The primary endpoint was duration of fever (DOF). Secondary outcomes included blood culture, length of hospital stay, incidence of recurrent cholangitis, jaundice clearance rate, and native liver survival (NLS). For mild cholangitis, DOF, and length of hospital stay were similar between those treated with CSTS or MEPM (all P >0.05). In addition, no significant difference in recurrence rate, jaundice clearance rate, and NLS was observed between patients treated with CSTS and MEPM at 1-month, 3-month, and 6-month follow-up. In patients with moderate cholangitis, the DOF was 36.00 (interquartile range: 24.00-48.00) h. In severe cholangitis, compared with MEPM, MEPM+IVIG decreased DOF and improved liver function by reducing alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, and direct bilirubin at 1-month follow-up. However, recurrence rate, jaundice clearance rate, and NLS did not differ significantly between MEPM+IVIG and MEPM at 1-month, 3-month, and 6-month follow-up. CONCLUSIONS In patients with post-KPE cholangitis, MEPM is not superior to CSTS for the treatment of mild cholangitis. However, MEPM+IVIG treatment was associated with better short-term clinical outcomes in patients with severe cholangitis.
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A combined diagnostic model based on circulating tumor cell in patients with solitary pulmonary nodules.
Wang, D, Li, P, Fei, X, Che, S, Li, J, Xuan, Y, Wang, J, Han, Y, Gu, W, Wang, Y
The journal of gene medicine. 2023;(9):e3529
Abstract
BACKGROUND Although many prediction models in diagnosis of solitary pulmonary nodules (SPNs) have been developed, few are widely used in clinical practice. It is therefore imperative to identify novel biomarkers and prediction models supporting early diagnosis of SPNs. This study combined folate receptor-positive circulating tumor cells (FR+ CTC) with serum tumor biomarkers, patient demographics and clinical characteristics to develop a prediction model. METHODS A total of 898 patients with a solitary pulmonary nodule who received FR+ CTC detection were randomly assigned to a training set and a validation set in a 2:1 ratio. Multivariate logistic regression was used to establish a diagnostic model to differentiate malignant and benign nodules. The receiver operating curve (ROC) and the area under the curve (AUC) were calculated to assess the diagnostic efficiency of the model. RESULTS The positive rate of FR+ CTC between patients with non-small cell lung cancer (NSCLC) and benign lung disease was significantly different in both the training and the validation dataset (p < 0.001). The FR+ CTC level was significantly higher in the NSCLC group compared with that of the benign group (p < 0.001). FR+ CTC (odds ratio, OR, 95% confidence interval, CI: 1.13, 1.07-1.19, p < 0.0001), age (OR, 95% CI: 1.06, 1.01-1.12, p = 0.03) and sex (OR, 95% CI: 1.07, 1.01-1.13, p = 0.01) were independent risk factors of NSCLC in patients with a solitary pulmonary nodule. The area under the curve (AUC) of FR+ CTC in diagnosing NSCLC was 0.650 (95% CI, 0.587-0.713) in the training set and 0.700 (95% CI, 0.603-0.796) in the validation set, respectively. The AUC of the combined model was 0.725 (95% CI, 0.659-0.791) in the training set and 0.828 (95% CI, 0.754-0.902) in the validation set, respectively. CONCLUSIONS We confirmed the value of FR+ CTC in diagnosing SPNs and developed a prediction model based on FR+ CTC, demographic characteristics, and serum biomarkers for differential diagnosis of solitary pulmonary nodules.
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Conditioning therapy with N-acetyl-L-cysteine, decitabine and modified BUCY regimen for myeloid malignancies patients prior to allogeneic hematopoietic stem cell transplantation.
Tang, Y, Zhang, Z, Liu, S, Yao, Y, Pan, T, Qi, J, Kang, H, Liu, Y, Cai, C, Zhou, M, et al
American journal of hematology. 2023;(6):881-889
Abstract
Conditioning therapy is an essential procedure prior to hematopoietic stem cell transplant (HSCT), imposing a great impact on the outcomes of recipients. We performed a prospective randomized controlled trial to assess the outcome of HSCT recipients with myeloid malignancies after receiving the conditioning therapy consisting of modified BUCY (mBUCY), N-acetyl-L-cysteine (NAC), and decitabine. Enrolled patients were randomly allocated to either Arm A (decitabine, day -12 to -10; NAC, day -9 to +30; mBUCY, day -9 to -2), or Arm B (mBUCY regimen followed by stem cells infusion). Seventy-six patients in Arm A and 78 patients in Arm B were finally evaluated. The results showed platelet recovery accelerate in Arm A, with more patients achieving a platelet count of ≥50 × 109 /L than Arm B at day +30 and +60 (p = .004 and .043, respectively). The cumulative incidence of relapse is 11.8% (95% CI 0.06-0.22) in Arm A, and 24.4% (95% CI 0.16-0.35) in Arm B (p = .048). The estimated 3-year overall survival rate was 86.4% (±4.4%) and 79.9% (±4.7%) in 2 arms, respectively (p = .155). EFS at 3 years was 79.2% (±4.9%) in Arm A and 60.0% (±5.9%) in Arm B (p = .007). Intracellular reactive oxygen species (ROS) level was found to be reversely correlated with platelet recovery, and fewer patients in Arm A displayed excessive ROS within hematopoietic progenitor cells compared to Arm B. In conclusion, the addition of decitabine and NAC to mBUCY is a feasible and promising conditioning therapy for myeloid malignancies patients.
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Antiplatelet effect of ginkgo diterpene lactone meglumine injection in acute ischemic stroke: A randomized, double-blind, placebo-controlled clinical trial.
Chen, C, Lv, H, Shan, L, Long, X, Guo, C, Huo, Y, Lu, L, Zhou, Y, Liu, M, Wu, H, et al
Phytotherapy research : PTR. 2023;(5):1986-1996
Abstract
This study was designed to evaluate antiplatelet effect and therapeutic effect of ginkgo diterpene lactone meglumine injection (GDLI) in acute ischemic stroke (AIS) patients. In this randomized, double-blind, placebo-controlled trial, we randomly assigned 70 inpatients within 48 hr after the onset of AIS to combination therapy with GDLI and aspirin (GDLI at a dose of 25 mg/d for 14 days plus aspirin at a dose of 100 mg/d for 90 days) or to placebo plus aspirin in a ratio of 1:1. Platelet function, the National Institute of Health Stroke Scale (NIHSS), and the modified Rankin Scale (mRS) were evaluated. A good outcome was defined as NIHSS scores decrease ≥5 or mRS scores decrease ≥2. Results showed that arachidonic acid induced maximum platelet aggregation rate (AA-MAR) and mean platelet volume (MPV) of the GDLI-aspirin group were much lower than that of the aspirin group (p = 0.013 and p = 0.034, respectively) after the 14-day therapy. The combination of GDLI and aspirin was superior to aspirin alone, and had significant impact on the good outcome at day 90 (ORadj 7.21 [95%CI, 1.03-50.68], p = 0.047). In summary, GDLI has antiplatelet effect and can improve the prognosis of AIS patients.
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Application of food exchange portion method in home-based nutritional intervention for elderly patients with chronic heart failure.
Zhou, C, Wang, S, Sun, X, Han, Y, Zhang, L, Liu, M
BMC cardiovascular disorders. 2023;23(1):80
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Chronic heart failure (CHF) is the terminal stage of heart disease and in recent years, the prevalence of CHF has been increasing among the elderly. Studies have demonstrated that the incidence rate of malnutrition among elderly patients with stable CHF is relatively high. Thus, how to help elderly CHF patients based at home to effectively carry out nutritional self-management and prevent the occurrence of malnutrition, has become a major focus of medical research. The aim of this study was to test the effect of home-based nutritional intervention method on improving the nutritional status of elderly patients with CHF. This study is a randomised controlled trial that enrolled a total of 90 elderly patients with stable CHF. The patients were randomly divided into the experimental group and the control group. Results show that home-based food exchange nutritional interventions can effectively improve the malnutrition status as well as the cardiopulmonary function and exercise tolerance of elderly patients with CHF. Furthermore, after two months of intervention, the protein content and skeletal muscle mass were significantly higher in the experimental group than in the control group, while the reduction in body fat and body fat rate was also significantly higher in the former than in the latter. Authors conclude that the food exchange method is easy to grasp, operate and master, and is highly suitable for home-based elderly CHF patients.
Abstract
BACKGROUND The home treatment of elderly patients with chronic heart failure (CHF) is often accompanied by malnutrition, which increases the risk of re-hospitalisation and affects the prognosis. Therefore, how to effectively improve the nutritional self-management of patients is a current focus of medical research. This study aims to test the effect of home-based nutritional intervention method on improving the nutritional status of elderly patients with CHF. METHODS A total of 90 hospitalised elderly patients with CHF were randomly divided into the experimental group (n = 45) and the control group (n = 45). The patients in both groups were given standardised drug therapy and their nutritional status was evaluated using a body composition analyser prior to discharge (protein, body fat percentage, visceral fat area, skeletal muscle, upper arm muscle circumference, left lower limb and right lower limb muscle mass), with the cardiopulmonary function evaluated using a six-minute walk test and the metabolic equivalents method. The control group was given general nutrition education and routine dietary guidance from cardiac rehabilitation nurses, while the experimental group was given an individualised nutrition prescription by dietitians based on the evaluation results, according to which one-to-one food exchange dietary intervention training was given until the patients mastered the process. RESULTS The nutritional indexes at the end of the study were significantly higher in the experimental group than in the control group and were higher than those before the intervention (P < 0.05). The muscle circumference of the upper arm, the muscle mass of the left lower limb and the right lower limb had no statistical significance following the intervention compared to the control group and before the intervention (P > 0.05). The cardiopulmonary function indexes were significantly better in the experimental group at the end of the study than before the intervention and were better than those in the control group, with statistically significant differences (P < 0.05), while no significant changes were observed in the control group before and after the intervention (P > 0.05). CONCLUSION The home-based nutritional intervention method of food exchange portions can effectively improve the nutritional status of elderly patients with CHF, with the distribution of visceral fat more reasonable and the cardiopulmonary function and exercise endurance improved.