-
1.
Effect of Intensive Lifestyle Intervention on Cardiovascular Risk Factors: Analysis From the Perspective of Long-Term Variability.
He, L, Liu, M, Zhuang, X, Guo, Y, Wang, P, Zhou, Z, Chen, Z, Peng, L, Liao, X
Journal of the American Heart Association. 2024;(3):e030132
Abstract
BACKGROUND An association between variability of cardiovascular risk factors and cardiovascular events has been reported. We examined whether intensive lifestyle intervention (ILI) for weight loss decreased variability of cardiovascular risk factors with a view to additional cardiometabolic benefits. METHODS AND RESULTS This study was a post hoc secondary analysis of the Look AHEAD (Action for Health in Diabetes) study. Cardiovascular risk factors were measured at 1-year intervals for 4 years in 4249 adults with overweight or obesity and type 2 diabetes who were randomly assigned to ILI or diabetes support and education. Long-term variability was defined as the SD of cardiovascular risk factors during 4-year follow-up. At multiple linear regression analysis, compared with the diabetes support and education group, the ILI group was associated with reduced variability of fasting blood glucose (β=-1.49 [95% CI, -2.39 to -0.59]), total cholesterol (β=-1.12 [95% CI, -1.75 to -0.48]), and low-density lipoprotein cholesterol (β=-1.04 [95% CI, -1.59 to -0.49]), as well as increased variability of systolic blood pressure (β=0.27 [95% CI, 0.00-0.54]). No significant effect of ILI was found on the variability of diastolic blood pressure (β=-0.08 [95% CI, -0.22 to 0.05]). CONCLUSIONS Among adults with overweight or obesity and type 2 diabetes, ILI may reduce long-term variability of fasting blood glucose, total cholesterol, and low-density lipoprotein cholesterol. Our results support that ILI should be recommended to individuals with diabetes as part of management of long-term glycemic and blood lipid control.
-
2.
The effectiveness of health education based on the 5Ts for teach-back on oral nutritional supplements compliance of post-discharge patients after surgery for gastric cancer: a randomized controlled trial.
Wang, J, Hu, H, Sun, J, Zhang, Q, Chen, Z, Wang, Q, Zhu, M, Yao, J, Yuan, H, Zhang, X
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2023;(3):157
-
-
Free full text
-
Abstract
OBJECTIVE This study aims to explore the 5Ts teach-back(5Ts) to improve oral nutritional supplements (ONS) compliance of discharged patients after gastric cancer surgery. SETTING AND METHODS Patients were recruited from the Bethune First Hospital of Jilin University. The patients were randomly assigned to 5Ts (n = 54) and routine health education (n = 54). Weekly ONS compliance was collected by "weekly ONS diary." ONS knowledge, health literacy, and health education satisfaction were collected at baseline and 5 weeks after discharge. Chi-square test, Mann-Whitney U test, and T test were used for data analysis. RESULTS At the end of the intervention, there were 41 and 40 patients in intervention and control group. 5Ts significantly improve ONS compliance, ONS knowledge level (P = 0.000), health literacy level (P = 0.011), and health education satisfaction (P = 0.009) of patients. At the end of follow-up, there were 30 and 27 patients in two groups, and no significant difference in ONS compliance (P = 0.728). CONCLUSION The 5Ts can significantly improve patients' ONS compliance and the effect of health education. TRIAL REGISTRATION NUMBER This prospective trial was registered in the Chinese Clinical Trial Registry at ChiCTR2000040986 ( http://www.chictr.org.cn ). PATIENT OR PUBLIC CONTRIBUTION Jia Wang and Haiyan Hu contributed to the performance of the study, analysis and interpretation the data, and drafted the manuscript; Jianan Sun and Qing Zhang contributed to the supervision of the study and interpreted the data; Zhiming Chen contributed to the analysis and interpretation the data; Qiuchen Wang contributed to the performance of the study and revised the manuscript; Mingyue Zhu contributed to interpretation the data; Jiannan Yao contributed to revise the manuscript; Hua Yuan and Xiuying Zhang contributed to the conception of the study, performed the study, interpreted the data, and significantly revised the manuscript. All authors screened the final version of the manuscript.
-
3.
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.
-
4.
A prognostic cuproptosis-related lncRNA predictive signature for bladder cancer patients.
Jiang, S, Zhang, J, Fan, Q, Li, Z, Dou, R, Lin, Z, Chen, Z, Xu, Y, Huang, Z, Lan, J, et al
Human cell. 2023;(2):798-811
Abstract
Cuproptosis is a novel form of cell death in tumours. However, the clinical impact and mechanism of cuproptosis in bladder cancer (BC) remain unclear. This study aimed to explore the functions of long noncoding RNAs (lncRNAs) related to cuproptosis in BC and develop a prognostic predictive model. RNA sequencing and clinicopathological data were derived from The Cancer Genome Atlas and randomly divided into training and validation groups. Cuproptosis-related lncRNAs were identified by Cox regression analysis and least absolute shrinkage and selection operator, and the patients were divided into high- and low-risk groups according to the median value of the signature-based risk score. We established a signature of 17 cuproptosis-associated lncRNAs in the training set. In both sets, patients with higher signature-based risk scores had a notably higher probability of death (P ≤ 0.001) and a shorter survival duration. Cox regression analyses confirmed the risk score as an independent predictor of BC prognosis in the entire set. The area under the curve (AUC) values for 1-, 3-, and 5-year survival were 0.767, 0.734, and 0.764, respectively, confirming that the signature could determine the prognosis of BC. A signature-based nomogram was developed, and its prediction accuracy was validated using calibration curves. Several drugs, including Gemcitabine, Oxaliplatin, Mitoxantrone, Camptothecin, Cytarabine and Irinotecan may benefit low-risk BC patients more. Finally, in vitro experiments confirmed that the cuproptosis-related lncRNAs are highly expressed in bladder cancer cells after cuproptosis induced by exogenous copper ions. In conclusion, a cuproptosis-related lncRNA signature independently predicted prognosis in BC, indicating a possible mechanism and clinical treatment approach.
-
5.
A 4-Week Straw Phonation in Water Exercise Program for Aging-Related Vocal Fold Atrophy.
Tsai, LY, Chan, RW, Shen, C, Chen, Z, Zhuang, P, Chiang, YN, Tai, SK, Xue, K
Journal of speech, language, and hearing research : JSLHR. 2023;(8):2581-2599
Abstract
PURPOSE This study evaluated the efficacy of a 4-week straw phonation in water (SPW) exercise program on aging-related vocal fold atrophy (VFA), with a secondary objective to examine the immediate effects of SPW exercises. METHOD Thirty-eight older adults aged 60 years and above formally diagnosed with aging-related VFA were randomly assigned into an experimental group undergoing SPW exercises with an 8-cm depth of straw submersion into water for 4 weeks plus vocal hygiene practice (n = 20), and a control group with only vocal hygiene practice (n = 18). Outcome measures included laryngeal endoscopic measures of glottal gap, auditory-perceptual ratings of voice quality, acoustic measures, aerodynamic measures, and standardized self-assessment questionnaire scores. An additional round of acoustic and aerodynamic assessment following 20 min of SPW exercises was conducted to examine the immediate effects. RESULTS Significant improvements in normalized glottal gap area, perceptual rating of breathiness, smoothed cepstral peak prominence, harmonics-to-noise ratio (HNR), mean oral airflow, subglottal pressure and laryngeal airway resistance at comfortable loudness, Voice-related Quality of Life scores, and Chinese Vocal Fatigue Index Factor 3 scores were observed in the experimental group relative to the control group. There were also significant immediate effects for HNR, mean oral airflow, subglottal pressure, and laryngeal airway resistance. CONCLUSIONS These findings suggested significant immediate improvements in vocal function following SPW exercises, with additional significant improvements in vocal function as well as significant improvements in quality of life following the 4-week SPW exercise program. Further studies with more long-term follow-up are recommended to better understand the efficacy of SPW exercises with deep levels of straw submersion into water as an effective clinical option for the management of hypofunctional dysphonia associated with aging-related VFA.
-
6.
Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study.
Qin, S, Chan, SL, Gu, S, Bai, Y, Ren, Z, Lin, X, Chen, Z, Jia, W, Jin, Y, Guo, Y, et al
Lancet (London, England). 2023;(10408):1133-1146
Abstract
BACKGROUND Immunotherapy with immune checkpoint inhibitors combined with an anti-angiogenic tyrosine-kinase inhibitor (TKI) has been shown to improve overall survival versus anti-angiogenic therapy alone in advanced solid tumours, but not in hepatocellular carcinoma. Therefore, a clinical study was conducted to compare the efficacy and safety of the anti-PD-1 antibody camrelizumab plus the VEGFR2-targeted TKI rivoceranib (also known as apatinib) versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. METHODS This randomised, open-label, international phase 3 trial (CARES-310) was done at 95 study sites across 13 countries and regions worldwide. Patients with unresectable or metastatic hepatocellular carcinoma who had not previously received any systemic treatment were randomly assigned (1:1) to receive either camrelizumab 200 mg intravenously every 2 weeks plus rivoceranib 250 mg orally once daily or sorafenib 400 mg orally twice daily. Randomisation was done via a centralised interactive response system. The primary endpoints were progression-free survival, as assessed by the blinded independent review committee per Response Evaluation Criteria in Solid Tumours version 1.1, and overall survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of the study drugs. We report the findings from the prespecified primary analysis for progression-free survival and interim analysis for overall survival. This study is registered with ClinicalTrials.gov (NCT03764293). FINDINGS Between June 28, 2019, and March 24, 2021, 543 patients were randomly assigned to the camrelizumab-rivoceranib (n=272) or sorafenib (n=271) group. At the primary analysis for progression-free survival (May 10, 2021), median follow-up was 7·8 months (IQR 4·1-10·6). Median progression-free survival was significantly improved with camrelizumab-rivoceranib versus sorafenib (5·6 months [95% CI 5·5-6·3] vs 3·7 months [2·8-3·7]; hazard ratio [HR] 0·52 [95% CI 0·41-0·65]; one-sided p<0·0001). At the interim analysis for overall survival (Feb 8, 2022), median follow-up was 14·5 months (IQR 9·1-18·7). Median overall survival was significantly extended with camrelizumab-rivoceranib versus sorafenib (22·1 months [95% CI 19·1-27·2] vs 15·2 months [13·0-18·5]; HR 0·62 [95% CI 0·49-0·80]; one-sided p<0·0001). The most common grade 3 or 4 treatment-related adverse events were hypertension (102 [38%] of 272 patients in the camrelizumab-rivoceranib group vs 40 [15%] of 269 patients in the sorafenib group), palmar-plantar erythrodysaesthesia syndrome (33 [12%] vs 41 [15%]), increased aspartate aminotransferase (45 [17%] vs 14 [5%]), and increased alanine aminotransferase (35 [13%] vs eight [3%]). Treatment-related serious adverse events were reported in 66 (24%) patients in the camrelizumab-rivoceranib group and 16 (6%) in the sorafenib group. Treatment-related death occurred in two patients: one patient in the camrelizumab-rivoceranib group (ie, multiple organ dysfunction syndrome) and one patient in the sorafenib group (ie, respiratory failure and circulatory collapse). INTERPRETATION Camrelizumab plus rivoceranib showed a statistically significant and clinically meaningful benefit in progression-free survival and overall survival compared with sorafenib for patients with unresectable hepatocellular carcinoma, presenting as a new and effective first-line treatment option for this population. FUNDING Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics.
-
7.
A Single-dose, Two-Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects.
Feng, S, Cai, L, Wang, X, Yu, Q, Cai, J, Hao, W, Chen, Z, Su, X, Du, C, Zou, Q, et al
Clinical pharmacology in drug development. 2023;(4):385-391
Abstract
Liraglutide, a glucagon-like peptide 1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The original liraglutide products are costly, which limits patient access to this therapeutic treatment. Herein, a biosimilar was developed that is highly similar to the reference drug in molecular structure and bioactivity, and is expected to have similar pharmacokinetic (PK) and safety profiles in clinical studies. This study aimed to primarily evaluate the bioequivalence of 2 liraglutide formulations and secondarily assess their safety in healthy Chinese subjects following a single-dose subcutaneous injection. Thirty-two healthy volunteers were recruited in this randomized, open-label, single-dose, 2-period crossover bioequivalence study (ChiCTR2100043348). The geometric mean ratios (GMRs) of the test drug to the reference drug (T/R) and corresponding 90% confidence intervals (CIs) for maximum concentration (Cmax ) and the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t ) were estimated using a mixed-effects model, and bioequivalence was determined to have been achieved if the 2-sided 90%CI fell within the predefined range of 80%-125%. PK parameters were comparable between T and R, with GMRs of T/R for Cmax and AUC0-t being 105.7% and 107.7%, respectively, the 90%CI of which met the acceptance criteria for bioequivalence. We also observed a similar and favorable safety profile in the T and R arms, with adverse events being predominantly mild in severity and of gastrointestinal origin. Our findings indicate that the test drug is safe and well tolerated, bioequivalent to the reference drug, and warrants further testing in a phase III clinical trial.
-
8.
Workplace-based primary prevention intervention reduces incidence of hypertension: a post hoc analysis of cluster randomized controlled study.
Hu, Z, Wang, X, Hong, C, Zheng, C, Zhang, L, Chen, Z, Zhou, H, Tian, Y, Cao, X, Cai, J, et al
BMC medicine. 2023;(1):214
Abstract
BACKGROUND A workplace-based primary prevention intervention be an effective approach to reducing the incidence of hypertension (HTN). However, few studies to date have addressed the effect among the Chinese working population. We assessed the effect of a workplace-based multicomponent prevention interventions program for cardiovascular disease on reducing the occurrence of HTN through encouraging employees to adopt a healthy lifestyle. METHODS In this post hoc analysis of cluster randomized controlled study, 60 workplaces across 20 urban regions in China were randomized to either the intervention group (n = 40) or control group (n = 20). All employees in each workplace were asked to complete a baseline survey after randomization for obtaining sociodemographic information, health status, lifestyle, etc. Employees in the intervention group were given a 2-year workplace-based primary prevention intervention program for improving their cardiovascular health, including (1) cardiovascular health education, (2) a reasonable diet, (3) tobacco cessation, (4) physical environment promotion, (5) physical activity, (6) stress management, and (7) health screening. The primary outcome was the incidence of HTN, and the secondary outcomes were improvements of blood pressure (BP) levels and lifestyle factors from baseline to 24 months. A mix effect model was used to assess the intervention effect at the end of the intervention in the two groups. RESULTS Overall, 24,396 participants (18,170 in the intervention group and 6,226 in the control group) were included (mean [standard deviation] age, 39.3 [9.1] years; 14,727 men [60.4%]). After 24 months of the intervention, the incidence of HTN was 8.0% in the intervention groups and 9.6% in the control groups [relative risk (RR) = 0.66, 95% CI, 0.58 ~ 0.76, P < 0.001]. The intervention effect was significant on systolic BP (SBP) level (β = - 0.7 mm Hg, 95% CI, - 1.06 ~ - 0.35; P < 0.001) and on diastolic BP (DBP) level (β = - 1.0 mm Hg, 95% CI, - 1.31 ~ - 0.76; P < 0.001). Moreover, greater improvements were reported in the rates of regular exercise [odd ratio (OR) = 1.39, 95% CI, 1.28 ~ 1.50; P < 0.001], excessive intake of fatty food (OR = 0.54, 95% CI, 0.50 ~ 0.59; P < 0.001), and restrictive use of salt (OR = 1.22, 95% CI, 1.09 ~ 1.36; P = 0.001) in intervention groups. People with a deteriorating lifestyle had higher rates of developing HTN than those with the same or improved lifestyle. Subgroup analysis showed that the intervention effect of BP on employees with educational attainment of high school above (SBP: β = - 1.38/ - 0.76 mm Hg, P < 0.05; DBP: β = - 2.26/ - 0.75 mm Hg, P < 0.001), manual labor workers and administrative worker (SBP: β = - 1.04/ - 1.66 mm Hg, P < 0.05; DBP: β = - 1.85/ - 0.40 mm Hg, P < 0.05), and employees from a workplace with an affiliated hospital (SBP: β = - 2.63 mm Hg, P < 0.001; DBP: β = - 1.93 mm Hg, P < 0.001) were significantly in the intervention group. CONCLUSIONS This post hoc analysis found that workplace-based primary prevention interventions program for cardiovascular disease were effective in promoting healthy lifestyle and reducing the incidence of HTN among employees. TRIAL REGISTRATION Chinese Clinical Trial Registry No. ChiCTR-ECS-14004641.
-
9.
Effects of Tai Chi Chuan on Cognitive Function in Adults 60 Years or Older With Type 2 Diabetes and Mild Cognitive Impairment in China: A Randomized Clinical Trial.
Chen, Y, Qin, J, Tao, L, Liu, Z, Huang, J, Liu, W, Xu, Y, Tang, Q, Liu, Y, Chen, Z, et al
JAMA network open. 2023;(4):e237004
-
-
Free full text
-
Abstract
IMPORTANCE Type 2 diabetes (T2D) is associated with the progression of cognitive dysfunction. Physical activity benefits cognition, but no evidence from randomized clinical trials has shown whether tai chi chuan has better long-term benefits than fitness walking in cognitive function for patients with T2D and mild cognitive impairment (MCI). OBJECTIVE To compare the effectiveness of tai chi chuan, a mind-body exercise, for improving cognitive function in older adults with T2D and MCI, with fitness walking. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial was conducted between June 1, 2020, and February 28, 2022, at 4 sites in China. Participants included 328 adults (aged ≥60 years) with a clinical diagnosis of T2D and MCI. INTERVENTIONS Participants were randomized in a 1:1:1 ratio to a tai chi chuan group, a fitness walking group, or a control group. The tai chi chuan group received 24-form simplified tai chi chuan. The fitness walking group received fitness walking training. Both exercise groups took the training for 60 min/session, 3 times/wk, for 24 weeks in a supervised setting. All 3 groups were provided with a 30-minute diabetes self-management education session, once every 4 weeks for 24 weeks. The participants were followed up for 36 weeks. MAIN OUTCOMES AND MEASURES The primary outcome was the global cognitive function measured at 36 weeks by the Montreal Cognitive Assessment (MoCA). Secondary outcomes included MoCA at 24 weeks and other cognitive subdomain measures and blood metabolic indices at 24 and 36 weeks. RESULTS A total of 328 participants (mean [SD] age, 67.55 [5.02] years; mean [SD] T2D duration, 10.48 [6.81] years; 167 [50.9%] women) were randomized to the tai chi chuan group (n = 107), fitness walking group (n = 110), or control group (n = 111) and included in the intention-to-treat analysis. At 36 weeks, the tai chi chuan group showed improved MoCA scores compared with the fitness walking group (mean [SD], 24.67 [2.72] vs 23.84 [3.17]; between-group mean difference, 0.84 [95% CI, 0.02-1.66]; P = .046) in the intention-to-treat analysis. The per-protocol analysis data set and subgroup analysis at 36 weeks showed similar results. Based on the generalized linear models, the treatment effects were similar in each group after adjusting for self-reported dietary calories and physical activity. There were 37 nonserious adverse events (tai chi chuan group, 8; fitness walking group, 13; control group, 16) unrelated to the study with no statistically significant difference among the 3 groups (P = .26). CONCLUSIONS AND RELEVANCE In this randomized clinical trial including older adults with T2D and MCI, tai chi chuan was more effective than fitness walking in improving global cognitive function. The findings support a long-term benefit, suggesting the potential clinical use of tai chi chuan as an exercise intervention to improve cognitive function for older adults with T2D and MCI. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04416841.
-
10.
A nomogram based on metabolic profiling to discriminate lung cancer among patients with lung nodules.
Li, C, Chen, Z, Zhao, H, Wang, C, Yu, S, Ma, H, Wang, Q, Du, X
The Journal of international medical research. 2023;(3):3000605231161204
Abstract
OBJECTIVE To develop a nomogram that discriminates lung cancer from benign lung nodules through metabolic profiling. METHODS This was a retrospective cohort study that recruited 848 participants who were randomized into training and validation sets at a 7:3 ratio. Clinical characteristics and metabolic profiles were retrieved. Variables in the training set with statistically significant differences were selected for further least absolute shrinkage and selection operator (LASSO) regression. The nomogram was built from 13 variables identified by stepwise regression analysis. Receiver operating characteristic, calibration curve, and decision curve analyses were conducted to evaluate the performance of the nomogram by internal validation. RESULTS Thirteen variables were selected through LASSO regression to build the nomogram: age, sex, ornithine, tyrosine, glutamine, valine, serine, asparagine, arginine, methylmalonylcarnitine, tetradecenoylcarnitine, 3-hydroxyisovaleryl carnitine/2-methyl-3-hydroxybutyrylcarnitine, and hydroxybutyrylcarnitine. The nomogram had good discrimination for the training set, with an area under the curve of 0.836 (95% confidence interval: 0.830-0.890). Moreover, the calibration curve with 1000 bootstrap resamples showed that the predicted value coincided well with the actual value. Decision curve analysis described a net benefit superior to baseline within the threshold probability range of 15% to 93%. CONCLUSIONS The nomogram constructed from metabolic profiling accurately predicted risk of lung cancer.