-
1.
[The dynamic monitoring of gastric residual volume by ultrasound was used to guide the early nutritional treatment of patients with severe mechanical ventilation to gradually achieve the standard].
Yang, H, Ma, J, Chen, J, Li, G, Ding, H
Zhonghua wei zhong bing ji jiu yi xue. 2024;(2):172-177
Abstract
OBJECTIVE To explore the application value of dynamic monitoring of gastric residual volume (GRV) in achieving different target energy in severe mechanical ventilation patients. METHODS A prospective randomized controlled study was conducted. Forty-two patients with mechanical ventilation admitted to the department of critical care medicine of General Hospital of Ningxia Medical University from July to December 2022 were enrolled. According to the random number table method, patients were divided into GRV guided enteral nutrition by traditional gastric juice pumpback method (control group, 22 patients) and GRV guided enteral nutrition by bedside ultrasound (test group, 20 patients). General data were collected from both groups, and clinical indicators such as hypersensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), neutrophil percentage (Neut%), procalcitonin (PCT), absolute lymphocytes (LYM), prealbumin (PA), and retinol-binding protein (RBP) were dynamically observed. Inflammation, infection, immunity, nutritional indicators, and the incidence of reflux/aspiration, ventilator-associated pneumonia (VAP) were compared between the two groups, and further compared the proportion of patients with respectively to reach the target energy 25%, 50%, and 70% on days 1, 3, and 5 of initiated enteral nutrition. RESULTS (1) There were no significant differences in gender, age, body mass index (BMI), duration of mechanical ventilation, and acute physiology and chronic health evaluation II (APACHE II), sequential organ failure assessment (SOFA), severe nutritional risk score (NUTRIC) at admission between the two groups, indicating comparability. (2) On day 1 of initiated enteral nutrition, there were no significant differences in infection, inflammation, immunity and nutrition indicators between the two groups. On day 3 of initiated enteral nutrition, the hs-CRP in the test group was lower than that control group, LYM and PA were higher than those control group [hs-CRP (mg/L): 129.60±75.18 vs. 185.20±63.74, LYM: 1.00±0.84 vs. 0.60±0.41, PA (mg/L): 27.30±3.66 vs. 22.30±2.55, all P < 0.05]. On day 5 of initiated enteral nutrition, the hs-CRP, Neut%, PCT in the test group were lower than those control group, LYM and PA were higher than those control group [hs-CRP (mg/L): 101.70±54.32 vs. 148.40±36.35, Neut%: (85.50±7.66)% vs. (92.90±6.01)%, PCT (μg/L): 0.7 (0.3, 2.7) vs. 3.6 (1.2, 7.5), LYM: 1.00±0.68 vs. 0.50±0.38, PA (mg/L): 27.10±4.57 vs. 20.80 ± 3.51, all P < 0.05]. There were no significantly differences in IL-6 and RBP between the two groups at different time points. (3) The proportion of 50% and 70% of achieved target energy in the test group on day 3, day 5 of initiated enteral nutrition were higher than those of the control group (70.0% vs. 36.4%, 70.0% vs. 36.4%, both P < 0.05). (4) The incidence of reflux/aspiration and VAP in the test group on day 5 of initiated enteral nutrition were significantly lower than those control group (incidence of reflux/aspiration: 5.0% vs. 28.6%, incidence of VAP: 10.0% vs. 36.4%, both P < 0.05). CONCLUSIONS Dynamic monitoring of GRV by bedside ultrasound can accurately improve the proportion of 50% of achieved target energy on day 3 and 75% on day 5 in severe mechanical ventilation patients, improve the patient's inflammation, immune and nutritional status, and can prevent the occurrence of reflux/aspiration and VAP.
-
2.
Lactobacillus plantarum 24-7 improves postoperative bloating and hard stools by modulating intestinal microbiota in patients with congenital heart disease: a randomized controlled trial.
Yang, H, Lan, W, Luo, C, Huang, Q, Zhong, Z, Yang, J, Xiang, H, Chen, T, Tang, Y
Food & function. 2024;(4):2090-2102
Abstract
Gastrointestinal symptoms are a common postoperative complication in patients with congenital heart disease (CHD), affecting their postoperative recovery. Probiotic intervention may be a promising therapeutic approach to alleviate postoperative gastrointestinal symptoms. This study aimed to evaluate the potential of Lactobacillus plantarum 24-7 (L. plantarum 24-7) in mitigating postoperative gastrointestinal symptoms and promoting patient recovery. Adult CHD patients scheduled for surgical intervention were recruited. One hundred and twenty patients were randomized and received L. plantarum or placebo intervention twice daily for ten days. Gastrointestinal symptoms were assessed utilizing the Gastrointestinal Symptom Rating Scale (GSRS). Various postoperative variables were analyzed across both groups. Alterations in gut microbiota were evaluated through 16S rRNA sequencing. 112 patients completed the study, with 55 in the probiotic group and 57 in the placebo group. While the disparity in overall postoperative GSRS scores between the two groups did not reach statistical significance (P = 0.067), marked differences were observed in bloating (P = 0.004) and hard stool (P = 0.030) scores. Furthermore, individuals within the probiotic group exhibited lower postoperative neutrophil counts (P = 0.007) and concurrently higher lymphocyte counts (P = 0.001). Variations in the diversity and composition of postoperative gut microbiota were discerned between the probiotic and placebo groups. Remarkably, no probiotic-related adverse events were documented. Supplementation with L. plantarum was well-tolerated and demonstrated partial efficacy in ameliorating gastrointestinal symptoms in postoperative CHD patients. Modulating the gut microbiota may be a potential mechanism by which L. plantarum exerts clinical benefits.
-
3.
High-flow nasal cannula may prolong the length of hospital stay in patients with hypercapnic acute COPD exacerbation.
Xia, J, Yang, H, Zhan, Q, Fan, Y, Wang, C
Respiratory medicine. 2023;:107465
Abstract
BACKGROUND High-flow nasal cannula (HFNC) is increasingly used in patients with acute exacerbation of COPD (AECOPD). We aimed to confirm whether the baseline bicarbonate is an independent predictor of outcomes in patients with hypercapnic AECOPD receiving HFNC. METHODS This was a secondary analysis of a multicentre randomised trial that enrolled 330 patients with non-acidotic hypercapnic AECOPD supported by HFNC or conventional oxygen treatment (COT). We compared the length of stay (LOS) in hospital and the rate of non-invasive positive pressure ventilation (NPPV) use according to baseline bicarbonate levels using the log-rank test or Cox proportional hazard model. RESULTS In the high bicarbonate subgroup (n = 165, bicarbonate 35.0[33.3-37.9] mmol/L, partial pressure of arterial carbon dioxide [PaCO2] 56.8[52.0-62.8] mmHg), patients supported by HFNC had a remarkably prolonged LOS in hospital when compared to COT (HR 1.59[1.16-2.17], p = 0.004), whereas patients in the low bicarbonate subgroup (n = 165, bicarbonate 28.8[27.0-30.4] mmol/L, PaCO2 48.0[46.0-50.0] mmHg) had a comparable LOS in hospital regardless of respiratory support modalities. The rate of NPPV use in patients with high baseline bicarbonate level was significantly higher than that in patients with low baseline bicarbonate level (19.4 % vs. 3.0 %, p < 0.0001). Patients with high bicarbonate level in HFNC group had a lower rate of NPPV use compared to COT group (15.4 % vs. 23.0 %, p = 0.217). CONCLUSIONS Among patients with non-acidotic hypercapnic AECOPD with high baseline bicarbonate level, HFNC is significantly associated with a prolonged LOS in hospital, which may be due to the reduced escalation of NPPV treatment. TRIAL REGISTRATION clinicaltrials.gov (NCT03003559).
-
4.
Genetic and lifestyle factors for breast cancer risk assessment in Southeast China.
Zou, S, Lin, Y, Yu, X, Eriksson, M, Lin, M, Fu, F, Yang, H
Cancer medicine. 2023;(14):15504-15514
Abstract
BACKGROUND Despite the rising incidence and mortality of breast cancer among women in China, there are currently few predictive models for breast cancer in the Chinese population and with low accuracy. This study aimed to identify major genetic and life-style risk factors in a Chinese population for potential application in risk assessment models. METHODS A case-control study in southeast China was conducted including 1321 breast cancer patients and 2045 controls during 2013-2016, in which the data were randomly divided into a training set and a test set on a 7:3 scale. The association between genetic and life-style factors and breast cancer was examined using logistic regression models. Using AUC curves, we also compared the performance of the logistic model to machine learning models, namely LASSO regression model and support vector machine (SVM), and the scores calculated from CKB, Gail and Tyrer-Cuzick models in the test set. RESULTS Among all factors considered, the best model was achieved when polygenetic risk score, lifestyle, and reproductive factors were considered jointly in the logistic regression model (AUC = 0.73; 95% CI: 0.70-0.77). The models created in this study performed better than those using scores calculated from the CKB, Gail, and Tyrer-Cuzick models. However, the logistic model and machine learning models did not significantly differ from one another. CONCLUSION In summary, we have found genetic and lifestyle risk predictors for breast cancer with moderate discrimination, which might provide reference for breast cancer screening in southeast China. Further population-based studies are needed to validate the model for future applications in personalized breast cancer screening programs.
-
5.
Multicenter Randomized Double-Blind Phase III Trial of Donafenib in Progressive Radioactive Iodine-Refractory Differentiated Thyroid Cancer.
Lin, Y, Qin, S, Yang, H, Shi, F, Yang, A, Han, X, Liu, B, Li, Z, Ji, Q, Tang, L, et al
Clinical cancer research : an official journal of the American Association for Cancer Research. 2023;(15):2791-2799
Abstract
PURPOSE The phase II/III study of donafenib was initiated when there was no available treatment indicated for Chinese patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). Donafenib, an oral tyrosine kinase inhibitor (TKI), showed good efficacy and tolerability in the phase II study. We aimed to further evaluate the antitumor activity and safety of donafenib in Chinese patients with RAIR-DTC. PATIENTS AND METHODS This multicenter, double-blind, placebo-controlled, phase III study enrolled 191 patients with progressive RAIR-DTC and randomized in a ratio of 2:1 to donafenib (300 mg twice daily, n = 128) or matched placebo (n = 63). An open-label donafenib treatment period was allowed upon disease progression. The primary endpoint was progression-free survival (PFS) assessed by the independent review committee. The second endpoints include objective response rate (ORR), disease control rate (DCR), safety, etc. RESULTS Donafenib demonstrated prolonged median PFS over placebo [12.9 vs. 6.4 months; hazard ratio (HR), 0.39; 95% confidence interval (CI), 0.25-0.61; P < 0.0001] in Chinese patients with RAIR-DTC. Improved ORR (23.3% vs. 1.7%; P = 0.0002) and DCR (93.3% vs. 79.3%; P = 0.0044) were observed in the donafenib group over placebo. For donafenib, the most common grade ≥ 3 treatment-related adverse events (AE) included hypertension (13.3%) and hand-foot syndrome (12.5%), 42.2% underwent dose reduction or interruption, and 6.3% experienced discontinuation. CONCLUSIONS Donafenib was well-tolerated and demonstrated clinical benefit in terms of improved PFS, ORR, and DCR in patients with RAIR-DTC. The results suggest that donafenib could be a new treatment option for patients with RAIR-DTC.
-
6.
Deaf Weight Wise: A novel randomized clinical trial with Deaf sign language users.
Barnett, S, Matthews, K, DeWindt, L, Sutter, E, Samuel-Hodge, C, Yang, H, Pearson, TA, ,
Obesity (Silver Spring, Md.). 2023;(4):965-976
-
-
Free full text
-
Abstract
OBJECTIVE The goal of this study was to address the absence of evidence-based weight-control programs developed for use with Deaf people. METHODS Community-based participatory research informed the design of the Deaf Weight Wise (DWW) trial and intervention. DWW focuses primarily on healthy lifestyle and weight through change in diet and exercise. The study enrolled 104 Deaf adults aged 40 to 70 years with BMI of 25 to 45 from community settings in Rochester, New York, and randomized participants to immediate intervention (n = 48) or 1-year delayed intervention (n = 56). The delayed intervention serves as a no-intervention comparison until the trial midpoint. The study collected data five times (every 6 months) from baseline to 24 months. All DWW intervention leaders and participants are Deaf people who use American Sign Language (ASL). RESULTS At 6 months, the difference in mean weight change for the immediate-intervention arm versus the delayed-intervention arm (no intervention yet) was -3.4 kg (multiplicity-adjusted p = 0.0424; 95% CI: -6.1 to -0.8 kg). Most (61.6%) in the immediate arm lost ≥5% of baseline weight versus 18.1% in the no-intervention-yet arm (p < 0.001). Participant engagement indicators include mean attendance of 11/16 sessions (69%), and 92% completed 24-month data collection. CONCLUSION DWW, a community-engaged, culturally appropriate, and language-accessible behavioral weight loss intervention, was successful with Deaf ASL users.
-
7.
Efficacy of Transcranial Direct Current Stimulation Combined with Conventional Swallowing Rehabilitation Training on Post-stroke Dysphagia.
Wang, L, Shi, A, Xue, H, Li, Q, Wang, J, Yang, H, Hong, H, Lu, Q, Cheng, J
Dysphagia. 2023;(6):1537-1545
-
-
Free full text
-
Abstract
To observe the clinical effects of transcranial direct current stimulation (tDCS) combined with conventional swallowing rehabilitation training on post-stroke dysphagia and explore its long-term efficacy. A total of 40 patients with dysphagia after the first stroke were randomly divided into a treatment group (n = 20) and a conventional group (n = 20). The treatment group received tDCS combined with conventional swallowing rehabilitation training, while the conventional group only received conventional swallowing rehabilitation training. The Standardized Swallowing Assessment (SSA) Scale and the Penetration-Aspiration Scale (PAS) were used to assess dysphagia before and after treatment, at the end of 10 treatments, and at the 3-month follow-up. The changes in infection indicators [the white blood cell (WBC), C-reactive protein (CRP) and procalcitonin (PCT)], the oxygenation indicator [arterial partial pressure of oxygen (PaO2)] and nutrition-related indicators [hemoglobin (Hb) and serum prealbumin (PAB)] were compared before and after treatment. The SSA and PAS scores were lower in both groups after treatment than before treatment, and the difference was statistically significant (P < 0.01). The SSA and PAS scores of the treatment group were lower than those of the conventional group before and after treatment and during follow-up, and the difference was statistically significant (P < 0.05, P < 0.01). A within-group comparison showed that WBC, CRP and PCT after treatment were lower than those before treatment, and the difference was statistically significant (P < 0.05). The PaO2, Hb and serum PAB were higher after treatment than before treatment, with a statistically significant difference (P < 0.05). The WBC, CRP and PCT of the tDCS group were lower than those of the conventional group, and PaO2, Hb and serum PAB were higher in the treatment group than in the conventional group, with a statistically significant difference (P < 0.01). The tDCS combined with conventional swallowing rehabilitation training can improve dysphagia with a better effect than conventional swallowing rehabilitation training and has a certain long-term efficacy. In addition, tDCS combined with conventional swallowing rehabilitation training can improve nutrition and oxygenation and reduce infection levels.
-
8.
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
-
-
Free full text
-
Abstract
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.
-
9.
Short-term and long-term effect of nutrition intervention in the Linxian Dysplasia Nutrition Intervention Trial and the reason for disappearance of the intervention effect: A cohort study.
Fan, JH, Sun, WY, Yang, H, Wang, XK, Abnet, CC, Qiao, YL
Cancer. 2023;(15):2360-2372
Abstract
BACKGROUND The objective of this study was to determine the short-term and long-term effects of a nutrition intervention in using 37 years of follow-up data. METHODS The Linxian Dysplasia Population Nutrition Intervention Trial was a randomized, double-blind, placebo-controlled trial with 7 years of intervention and 30 years of follow-up. The Cox proportional hazard model was used for analyses. Subgroup analyses were conducted in age and sex subgroups, and the 30 years of follow-up were divided into two 15-year early and late periods. RESULTS The results at 37 years did not indicate any effects on mortality from cancers or other diseases. In the first 15 years, the intervention decreased the overall risk of gastric cancer deaths in all participants (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.58-1.00) and in the subgroup participants younger than 55 years (HR, 0.64; 95% CI, 0.43-0.96). In addition, in the group younger than 55 years (HR, 0.58; 95% CI, 0.35-0.96), the intervention decreased the risk of death from other diseases; and, in the group aged 55 years and older (HR, 0.75; 95% CI, 0.58-0.98), the intervention reduced the risk of death from heart disease. There were no significant results in the later 15 years, which indicated the disappearance of the intervention effect. Comparing demographic characteristics between those who died during the two periods, the participants who died later included more women, had a higher education level, had a lower smoking rate, were younger, and also more had a mild degree of esophageal dysplasia, representing a better lifestyle and health condition. CONCLUSIONS Long-term follow-up indicated no effect of nutrition on deaths in a population with esophageal squamous dysplasia, further supporting the significance of continuous nutritional intervention for cancer protection. The pattern of protective effect of a nutrition intervention on gastric cancer in patients with esophageal squamous dysplasia was similar to that in the general population. Participants who died in the later period had more protective factors than those who died in the earlier period, contributing to the obvious effect of the intervention in early stage disease.
-
10.
Modeling Tumor Growth Using Partly Conditional Survival Models: A Case Study in Colorectal Cancer.
Flynn, JR, Curry, M, Zhao, B, Yang, H, Dercle, L, Fojo, AT, Connors, DE, Schwartz, LH, Gönen, M, Moskowitz, CS
JCO clinical cancer informatics. 2023;:e2200203
-
-
Free full text
-
Abstract
PURPOSE There are multiple approaches to modeling the relationship between longitudinal tumor measurements obtained from serial imaging and overall survival. Many require strong assumptions that are untestable and debatable. We illustrate how to apply a novel, more flexible approach, the partly conditional (PC) survival model, using images acquired during a phase III, randomized clinical trial in colorectal cancer as an example. METHODS PC survival approaches were used to model longitudinal volumetric computed tomography data of 1,025 patients in the completed VELOUR trial, which evaluated adding aflibercept to infusional fluorouracil, leucovorin, and irinotecan for treating metastatic colorectal cancer. PC survival modeling is a semiparametric approach to estimating associations of longitudinal measurements with time-to-event outcomes. Overall survival was our outcome. Covariates included baseline tumor burden, change in tumor burden from baseline to each follow-up time, and treatment. Both unstratified and time-stratified models were investigated. RESULTS Without making assumptions about the distribution of the tumor growth process, we characterized associations between the change in tumor burden and survival. This change was significantly associated with survival (hazard ratio [HR], 1.04; 95% CI, 1.02 to 1.05; P < .001), suggesting that aflibercept works at least in part by altering the tumor growth trajectory. We also found baseline tumor size prognostic for survival even when accounting for the change in tumor burden over time (HR, 1.02; 95% CI, 1.01 to 1.02; P < .001). CONCLUSION The PC modeling approach offers flexible characterization of associations between longitudinal covariates, such as serially assessed tumor burden, and survival time. It can be applied to a variety of data of this nature and used as clinical trials are ongoing to incorporate new disease assessment information as it is accumulated, as indicated by an example from colorectal cancer.