1.Long-term safety and effectiveness of roxadustat in Chinese patients with chronic kidney disease-associated anemia: The ROXSTAR registry.
Xiaoying DU ; Yaomin WANG ; Haifeng YU ; Jurong YANG ; Weiming HE ; Zunsong WANG ; Dongwen ZHENG ; Xiaowei LI ; Shuijuan SHEN ; Dong SUN ; Weimin YU ; Detian LI ; Changyun QIAN ; Yiqing WU ; Shuting PAN ; Jianghua CHEN
Chinese Medical Journal 2025;138(12):1465-1476
BACKGROUND:
Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China.
METHODS:
This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion.
RESULTS:
The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon.
CONCLUSIONS:
Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings.
REGISTRATION
Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans
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Male
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Female
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Anemia/etiology*
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Middle Aged
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Renal Insufficiency, Chronic/complications*
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Glycine/adverse effects*
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Isoquinolines/adverse effects*
;
Aged
;
Prospective Studies
;
Adult
;
Hemoglobins/metabolism*
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Treatment Outcome
;
China
;
Registries
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East Asian People
2.Application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms: a scoping review
Xiaobo REN ; Changyun WEI ; Yiru WANG ; Yu LIU ; Yongling LIU ; Zirong TIAN
Chinese Journal of Modern Nursing 2025;31(34):4636-4642
Objective:To summarize the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms.Methods:Following the scoping review framework of Arksey and O'Malley, literature on the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms was electronically retrieved from databases including the Cochrane Library, Embase, PubMed, Web of Science, CINAHL, IEEE Xplore, China Biology Medicine disc, Wanfang Data, and China National Knowledge Infrastructure. The search period was from database establishment to August 5, 2025.Results:A total of 21 articles were included. Types of head and neck neoplasms included oropharyngeal cancer, nasopharyngeal cancer, oral cancer, tongue cancer, laryngeal cancer, hypopharyngeal cancer, and others. The application forms of digital health technologies involved virtual reality technology, telemedicine systems, interactive mobile health APPs/digital health platforms, and wearable devices. Interactive mobile health apps/digital health platforms were currently the most widely adopted form, with some applications integrating wearable devices for physiological data monitoring. The main components of the intervention included guiding swallowing training methods, training monitoring/supervision and feedback, swallowing function screening/assessment, and health education.Conclusions:The application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms is still in its early stages, but its advantages in enhancing rehabilitation accessibility and promoting patient adherence have already begun to emerge. Nevertheless, it also faces challenges such as limited user-friendliness, insufficient personalized feedback, and a lack of humanistic care. It is necessary to further explore and develop personalized, precision-oriented intelligent swallowing rehabilitation systems tailored to the specific needs of swallowing rehabilitation for head and neck cancer patients. High-quality clinical studies should be conducted to validate long-term efficacy, thereby providing intelligent solutions for clinical nursing practices in swallowing rehabilitation for these patients.
3.Application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms: a scoping review
Xiaobo REN ; Changyun WEI ; Yiru WANG ; Yu LIU ; Yongling LIU ; Zirong TIAN
Chinese Journal of Modern Nursing 2025;31(34):4636-4642
Objective:To summarize the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms.Methods:Following the scoping review framework of Arksey and O'Malley, literature on the application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms was electronically retrieved from databases including the Cochrane Library, Embase, PubMed, Web of Science, CINAHL, IEEE Xplore, China Biology Medicine disc, Wanfang Data, and China National Knowledge Infrastructure. The search period was from database establishment to August 5, 2025.Results:A total of 21 articles were included. Types of head and neck neoplasms included oropharyngeal cancer, nasopharyngeal cancer, oral cancer, tongue cancer, laryngeal cancer, hypopharyngeal cancer, and others. The application forms of digital health technologies involved virtual reality technology, telemedicine systems, interactive mobile health APPs/digital health platforms, and wearable devices. Interactive mobile health apps/digital health platforms were currently the most widely adopted form, with some applications integrating wearable devices for physiological data monitoring. The main components of the intervention included guiding swallowing training methods, training monitoring/supervision and feedback, swallowing function screening/assessment, and health education.Conclusions:The application of digital health technology in swallowing rehabilitation for patients with head and neck neoplasms is still in its early stages, but its advantages in enhancing rehabilitation accessibility and promoting patient adherence have already begun to emerge. Nevertheless, it also faces challenges such as limited user-friendliness, insufficient personalized feedback, and a lack of humanistic care. It is necessary to further explore and develop personalized, precision-oriented intelligent swallowing rehabilitation systems tailored to the specific needs of swallowing rehabilitation for head and neck cancer patients. High-quality clinical studies should be conducted to validate long-term efficacy, thereby providing intelligent solutions for clinical nursing practices in swallowing rehabilitation for these patients.
4.Association of Serum PTX3 Level with First-pass Effect and Prognosis of Mechanical Thrombectomy in Patients with Acute Ischemic Stroke of Large Vessel Occlusion
Yu HAO ; Chao LIU ; Yinguang CAO ; Changyun LI
Journal of Modern Laboratory Medicine 2024;39(4):110-115
Objective To investigate the relationship between pentraxin 3(PTX3)and first-pass effect of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke(AIS).Methods A total of 136 AIS patients with large vessel occlusion treated in Liaocheng People's Hospital from January to August 2023 were selected,and they were divided into first pass group(n=41)and non-first pass group(n=95)according to whether they achieved first-pass effect of mechanical thrombectomy.The clinical data of all patients were collected and the serum PTX3 levels were detected.All patients were followed up for 3 months,and the prognosis was evaluated according to the modified Rankin score.Multivariate Logistic regression was used to analyze the influencing factors of first-pass effect in AIS patients with large vessel occlusion.ROC analysis was used to analyze the predictive value of serum PTX3 for first-pass effect in AIS patients with large vessel occlusion.Results The rate of good prognosis in the first pass group was higher than that in the non-first pass group(56.10%vs 36.84%),and the difference was significant(x2=4.341,P=0.037).Compared with the non-first pass group,the age(59.38±5.12 years),the proportion of hypertension(43.90%),the National Institutes of Health Stroke Scale(NIHSS)score at admission(13.58±4.16 score)in the first pass group and serum PTX3 level(1.21±0.32 ng/L)in the first pass group were lower than those in the failed group(63.45±7.61 years,65.26%,15.75±5.13 score,1.71±0.41 ng/L),and the differences were significant(t/x2=3.129,5.395,2.389,6.944,all P<0.05).Multivariate Logistic regression analysis showed that younger age[OR(95%CI):0.859(0.752~0.982)],no hypertension[OR(95%CI):0.672(0.480~0.942)],decreased NIHSS score at admission[OR(95%CI):0.867(0.781~0.962)]and decreased serum PTX3 levels[OR(95%CI):0.558(0.326~0.954)]were the influencing factors of the first-pass effect of mechanical thrombectomy in AIS patients with large vessel occlusion(Waldx2=4.997,5.238,7.280,4.543,all P<0.05).After 3 months of follow-up,the serum PTX3 level of the good prognosis group was lower than that of the poor prognosis group(1.28±0.39 ng/L vs 1.65±0.43 ng/L),and the difference was significant(t=5.111,P<0.001).ROC analysis showed that serum PTX3 had a high predictive value for first-pass effect and poor prognosis in AIS patients with large vessel occlusion,with the areas under the curve(95%CI)of 0.785(0.703~0.866)and 0.734(0.651~0.806),respectively,and their optimal cut-off values were 1.38 ng/L and 1.56 ng/L,respectively.Conclusion The first-pass effect of mechanical thrombectomy in AIS patients with large vessel occlusion is beneficial to the short-term prognosis.The expression of serum PTX3 is closely related to the first-pass effect in AIS patients with large vessel occlusion,and this index could have a high predictive value for whether the patients can achieve the first-pass effect.
5.Study on flow field characteristics of dust airflow in vibrating screen and optimization of dust removal system
Shanshan WU ; Jinning YU ; Jingyun LI ; Chunhong HE ; Changyun ZHANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(9):696-699
In order to solve the problem of dust hazard of vibrating screen machine and difficult treatment in catalyst production process, computational fluid dynamics software Fluent was used to carry out numerical simulation calculation of the local exhaust dust removal system for the main dust dispersing points of the vibrating screen machine, including fine/coarse particles outlet and product outlet blowing and cleaning the dust points. The optimal design scheme and key technical parameters of local ventilation and dust removal system of vibrating screen machine were proposed. The results showed that the dust diffusion could be prevented by setting up an upper suction hood without air blowing, but the exhaust air volume needed to be calculated accurately. On the premise of purge, it is necessary to control the air volume to form a wind speed band of 8 m/s with a height of 15 cm at the feed port, so as to effectively remove the dust on the surface of solid particles of catalyst products and ensure that the catalyst products will not be blown away when falling into the feed barrel. The simulated design was applied to the vibrating sieve powder machine of a catalyst company, and the maximum dust concentration in the workplace was reduced from 45.80 mg/m 3 to 5.46mg/m 3, which effectively improved the working environment in the workplace.
6.Study on flow field characteristics of dust airflow in vibrating screen and optimization of dust removal system
Shanshan WU ; Jinning YU ; Jingyun LI ; Chunhong HE ; Changyun ZHANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(9):696-699
In order to solve the problem of dust hazard of vibrating screen machine and difficult treatment in catalyst production process, computational fluid dynamics software Fluent was used to carry out numerical simulation calculation of the local exhaust dust removal system for the main dust dispersing points of the vibrating screen machine, including fine/coarse particles outlet and product outlet blowing and cleaning the dust points. The optimal design scheme and key technical parameters of local ventilation and dust removal system of vibrating screen machine were proposed. The results showed that the dust diffusion could be prevented by setting up an upper suction hood without air blowing, but the exhaust air volume needed to be calculated accurately. On the premise of purge, it is necessary to control the air volume to form a wind speed band of 8 m/s with a height of 15 cm at the feed port, so as to effectively remove the dust on the surface of solid particles of catalyst products and ensure that the catalyst products will not be blown away when falling into the feed barrel. The simulated design was applied to the vibrating sieve powder machine of a catalyst company, and the maximum dust concentration in the workplace was reduced from 45.80 mg/m 3 to 5.46mg/m 3, which effectively improved the working environment in the workplace.
7.Association between PON2 gene polymorphisms and susceptibility to noise-induced hearing loss
Shanshan WU ; Jinning YU ; Jie JIAO ; Guoshun CHEN ; Changyun ZHANG ; Shanfa YU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):128-132
Objective:To investigate the relationship between SNP and noise-induced hearing loss (NIHL) susceptibility in occupational noise exposure population in China.Methods:From 6297 for a certain steel works in contact with noise, contact length of 3 years or more and workplace noise exposure intensity of 80 dB (A) , ears or high frequency (3 000, 4 000, 6 000 Hz) average of hearing acuity 40 dB (HL) , or high frequency loss in both ears, on the basis of single whisper frequency (500, 1, 000, 2 000 Hz) average threshold of 26 dB (HL) or object as case group. A case-control study was designed with 1:1 matching. Subjects with the same gender, the same type of work, age ±5 years old, and working age ±2 years after noise exposure were selected as the control group. Subjects with any whisper frequency (500, 1, 000, 2, 000 Hz) whose hearing threshold in any frequency band was ≤25 dB (A) and whose average high-frequency hearing threshold in pure tone hearing test was <35 dB (A) were selected as the control group. Four sites of PON2 gene were genotyped by medium-and high-throughput SNP genotyping. Univariate logistic regression was used to analyze the relationship between single SNP polymorphism and NIHL.Results:A total of 286 case-control pairs were included. Smoking was statistically significant difference between cases and controls ( P<0.001) . Conclusion:No statistical difference has been found between single SNP polymorphism and NIHL. At the level of greater than 92 dB of high noise exposure, rs7785846 (CT+TT) genotype is a risk factor for occupational noise deafness, and its OR is 2.74 (95% CI: 1.09-6.89) compared with wild homozygous type (CC) . Conclusion. The rs7785846 (CT+TT) genotype carriers of PON2 gene are more susceptible to hearing impairment when exposed to high noise intensity.
8.Association between PON2 gene polymorphisms and susceptibility to noise-induced hearing loss
Shanshan WU ; Jinning YU ; Jie JIAO ; Guoshun CHEN ; Changyun ZHANG ; Shanfa YU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2020;38(2):128-132
Objective:To investigate the relationship between SNP and noise-induced hearing loss (NIHL) susceptibility in occupational noise exposure population in China.Methods:From 6297 for a certain steel works in contact with noise, contact length of 3 years or more and workplace noise exposure intensity of 80 dB (A) , ears or high frequency (3 000, 4 000, 6 000 Hz) average of hearing acuity 40 dB (HL) , or high frequency loss in both ears, on the basis of single whisper frequency (500, 1, 000, 2 000 Hz) average threshold of 26 dB (HL) or object as case group. A case-control study was designed with 1:1 matching. Subjects with the same gender, the same type of work, age ±5 years old, and working age ±2 years after noise exposure were selected as the control group. Subjects with any whisper frequency (500, 1, 000, 2, 000 Hz) whose hearing threshold in any frequency band was ≤25 dB (A) and whose average high-frequency hearing threshold in pure tone hearing test was <35 dB (A) were selected as the control group. Four sites of PON2 gene were genotyped by medium-and high-throughput SNP genotyping. Univariate logistic regression was used to analyze the relationship between single SNP polymorphism and NIHL.Results:A total of 286 case-control pairs were included. Smoking was statistically significant difference between cases and controls ( P<0.001) . Conclusion:No statistical difference has been found between single SNP polymorphism and NIHL. At the level of greater than 92 dB of high noise exposure, rs7785846 (CT+TT) genotype is a risk factor for occupational noise deafness, and its OR is 2.74 (95% CI: 1.09-6.89) compared with wild homozygous type (CC) . Conclusion. The rs7785846 (CT+TT) genotype carriers of PON2 gene are more susceptible to hearing impairment when exposed to high noise intensity.
9.Effects of microRNA-204-3p and microRNA-205-5p on the cell proliferation, migration and invasion of head and neck squamous cell carcinoma
Changyun YU ; Yong LIU ; Hua CAO
Journal of International Oncology 2018;45(11):641-646
Objective To investigate the effects of microRNA-205-3p (miR-205-3p) and microRNA-205-5p (miR-205-5p) on the cell proliferation,migration and invasion of head and neck squamous cell carcinoma (HNSCC).Methods The miRNA expression data were obtained from The Cancer Genome Atlas,and were used to determine miR-205 expression in HNSCC and paracancerous tissues.Quantitative real-time fluorescent polymerase chain reaction (qRT-PCR) was used to detect the expressions of miR-205-3p and miR-205-5p in HNSCC cell lines 5-8F,6-10B,CNE2,Tu686 and mucosal tissues of nasopharynx.MiR-205-3p inhibitor,miR-205-5p inhibitor and miR-NC were transfected into Tu686 cells,and qRT-PCR was employed to evaluate the silence efficiency.In the following study,the cells were divided into four groups:miR-205-3p inhibitor and control,miR-205-5p inhibitor and control.Then the cell counting kit (CCK-8) assay,Transwell migration and invasion assays were carried out to examine the proliferation,migration and invasion abilities of the cells in the four groups.Results Compared with paracancerous tissues,the higher expression of miR-205 in HNSCC tissues was observed [M (QR):61 012 (51 448) vs.28 579 (35 959),Z =-6.420,P < 0.001)].The expression levels of miR-205-3p in HNSCC cell lines 5-8F,6-10B,CNE2,Tu686 and mucosal tissues of nasopharynx were 0.36 ± 0.07,0.20 ± 0.06,0.15 ± 0.04,0.25 ± 0.04 and 1.00 ±0.00 respectively,with a significant difference (F =162.71,P < 0.001).The expression levels of miR-205-5p in cell lines 5-8F,6-10B,CNE2,Tu686 and mucosal tissues of nasopharynx were 0.20 ±0.01,0.21 ±0.01,1.06 ±0.18,23.61 ±2.07 and 1.00 ±0.00 respectively,with a significant difference (F =371.81,P <0.001).Compared with 5-8F,6-10B,CNE2 cells,the expression of miR-205-3p in Tu686 cells was higher than those in 6-10B,CNE2 cells (P =0.195;P =0.020),and lower than that in 5-8F cells (P =0.023),and the expression of miR-205-5p in Tu686 cells was the highest (P < 0.001;P < 0.001;P < 0.001).The expressions of miR-205-3p and miR-205-5p in Tu686 cells were effectively downregulated by inhibitors,and the silence efficiencies were 87% and 83%,respectively.The absorbance (A) values of miR-205-3p inhibitor group on the first,second,third,fourth and fifth day were 0.26 ± 0.06,0.55 ± 0.11,1.52 ±0.13,1.91 ± 0.07,2.14 ± 0.24,and those of miR-NC group were 0.29 ± 0.07,0.78 ± 0.11,1.59 ±0.15,1.95 ±0.08,2.02 ±0.12.There were no significant differences between the two groups (t =0.506,P=0.639;t =2.459,P=0.070;t =0.573,P=0.597;t =0.655,P=0.548;t=-0.759,P=0.490).The cell proliferations of miR-205-5p inhibitor group on the first,second,third,fourth and fifth day were 0.30 ± 0.08,0.61 ± 0.08,0.85 ± 0.08,1.08 ± 0.12,1.16 ± 0.18,and those of miR-NC group were 0.41 ± 0.10,0.78 ± 0.14,1.33 ± 0.28,1.87 ± 0.09,2.08 ± 0.19.The cell proliferations of miR-205-5p inhibitor group on the third,fourth and fifth day were significantly lower than those of miR-NC group (t =3.665,P =0.017;t =12.223,P < 0.001;t =7.825,P < 0.001).Transwell migration assay demonstrated that downregnlation of miR-205-3p had no significant effect on migration abilities of Tu686 cells.The numbers of cell permeating septum of miR-205-3p inhibitor group and miR-NC group were 192.00 ± 28.49 and 188.40 ± 22.52,respectively.There was no significant difference between the two groups (t =-0.160,P =0.877).Downregulation of miR-205-5p significantly decreased the migration abilities of Tu686 cells.The numbers of cell permeating septum of miR-205-5p inhibitor group and miR-NC group were 109.40 ± 27.63 and 183.60 ± 31.63,respectively,and the difference was statistically significant (t =3.951,P =0.004).Transwell invasion assay showed that the numbers of cell permeating septum of miR-205-3p inhibitor group and miR-NC group were 93.40 ± 10.24 and 96.20 ± 16.56,respectively.There was no significant difference between the two groups (t =0.322,P =0.756).The numbers of cell permeating septum of miR-205-5p inhibitor group and miR-NC group were 53.00 ± 17.80 and 94.40 ± 14.38,respectively,and the difference was statistically significant (t =4.045,P =0.004).Conclusion Downregulation of miR-205-5p can inhibit the proliferation,migration and invasion abilities of Tu686 cells.However,downregulation of miR-205-3p has no significant effect on the proliferation,migration and invasion of Tu686 cells.
10.Electrochemical Behavior and Determination of Pyridoxine Hydrochloride at Graphene-Carbon Nanotubes/Poly(nicotinic acid) Modified Electrode
Fengyun HE ; Jing YU ; Huan LIU ; Xiaoyan GU ; Pengpeng TANG ; Hong ZHOU ; Changyun CHEN ; Guofei LU
Chinese Journal of Analytical Chemistry 2014;(7):1039-1043
Graphene ( GN) and multiwalled carbon nanotubes ( MWCNT) composites were coated on glassy carbon electrode ( GCE ) and then poly ( nicotinic acid ) ( PNA ) was electrodeposited on the modified electrode. The electrochemical behavior of pyridoxine hydrochloride ( VB6 ) was investigated at the modified electrode by cyclic voltammetry ( CV ) and differential pulse voltammetry ( DPV ) . Results showed the oxidation current of VB6 at the GN-MWCNT/PNA/GCE was obviously larger than that at GCE, PNA/GCE and GN/MWCNT/GCE. The oxidation process of VB6 was an irreversible diffusion-controlled process involving one electron and two protons. The liner range between the peak current intensity of DPV and the concentration of VB6 was 0 . 05-200 μmol/L with a detection limit of 0 . 02 μmol/L ( S/N=3 ) . The modified electrode showed a good reproducibility with a relative standard deviation of 3 . 1% ( n=8 ) . The proposed method was applied to the analysis of vitamin B6 in vitamin B6 tablets and compound vitamin B tablets with recoveries between 96 . 1%-104 . 5%.

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