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
;
Female
;
Anemia/etiology*
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Middle Aged
;
Renal Insufficiency, Chronic/complications*
;
Glycine/adverse effects*
;
Isoquinolines/adverse effects*
;
Aged
;
Prospective Studies
;
Adult
;
Hemoglobins/metabolism*
;
Treatment Outcome
;
China
;
Registries
;
East Asian People
2.The value of BRAF V600E mutation detection and liquid-based thin-preparation cytology in preoperative diagnosis of papillary thyroid carcinoma
Yiqing PAN ; Jie ZHENG ; Qingquan FANG ; Lihong DING
Chinese Archives of Otolaryngology-Head and Neck Surgery 2025;32(4):210-214
OBJECTIVE To evaluate the value of BRAF V600E mutation detection combined with liquid-based thin-preparation cytologic test(LCT)in the preoperative diagnosis of papillary thyroid carcinoma(PTC)and the related pathological characteristics of BRAF V600E mutation.METHODS Clinical data of 428 patients with thyroid nodules who underwent surgery at the First Affiliated Hospital of Xiamen University from January 2023 to December 2023 were retrospectively analyzed.All patients underwent ultrasound-guided fine needle aspiration and liquid-based cytology diagnosis and BRAF V600E gene mutation detection simultaneously before surgery.RESULTS The results of BRAF V600E mutation were significantly correlated with the results of liquid-based cytology diagnosis in patients(P<0.01).The area under the curve(AUC value)of LCT was 0.88,and the AUC value of BRAF V600E was 0.84.The sensitivity and specificity of LCT for preoperative diagnosis of PTC were 0.80 and 0.96,respectively.The sensitivity and specificity of BRAF V600E for preoperative diagnosis of PTC were 0.72 and 0.96,respectively.The AUC value of LCT combined with BRAF V600E for the diagnosis of PTC was 0.93 while the sensitivity and specificity were 0.88 and 0.92,respectively.The combined diagnosis significantly improved the sensitivity and specificity of thyroid nodule disease diagnosis,with a statistically significant difference(Z=-5.50,-4.60,P<0.001).In addition,BRAF V600E mutation was associated with the age of patients,the maximum diameter of nodules,and whether the capsule was invaded,with significant statistical differences between groups(P<0.05),but was not associated with gender,whether the nodules were multifocal,whether lymph node metastasis occurred,or whether Hashimoto's thyroiditis was present.CONCLUSION The combination of FNA liquid-based thin-preparation cytologic test and BRAF V600E detection can significantly improve the preoperative diagnostic accuracy of PTC.
3.Application of employer branding in the recruitment and retention of pediatricians
Modern Hospital 2024;24(5):677-679
The National Health Commission's Implementation Plan for the Development of Women and Children in China(2021-2030),released in 2022,has set a clear goal that:by 2030,we should train 1.12 pediatrician practitioners and add up to 3.17 hospital beds for every 1 000 children.Achieving the goal on schedule presents a significant challenge for children's hospi-tals,particularly in terms of attracting and retaining pediatric medical professionals to ensure the health of children.This paper addresses this issue by applying the 4 Ps model of employer branding theory,drawing on the experience of pediatrician recruit-ment and retention in Tianjin.The exploration encompasses several key areas:the work demands of pediatricians,employer brand positioning,human resource offerings,and employer brand promotion.It aims to enhance the appeal of pediatric medical institutions to pediatricians,thereby achieving effective recruitment and retention of talent within these institutions.Furthermore,by reviewing theoretical literature at home and abroad,this paper also proposes systematic ideas and approaches to improving employer branding.The proposed employer branding strategy in the paper is designed to enhance the effectiveness of employer branding for pediatric medical institutions,enabling them to secure a competitive edge in the attraction and retention of talent.Additionally,the paper of-fers a guidance for similar medical institutions,contributing to the advancement and expansion of pediatric medical institutions.
4.Correlation analysis between complement C3,C4,CRP,ESR and disease activity in systemic lupus erythematosus
Jinghong WANG ; Lu PAN ; Bingru LU ; Shiyu ZHAO ; Shan DING ; Yiqing LIU
International Journal of Laboratory Medicine 2024;45(11):1327-1330,1337
Objective To investigate the correlation between complement C3,C4,C-reactive protein(CRP),erythrocyte sedimentation rate(ESR)and disease activity of systemic lupus erythematosus(SLE).Methods A total of 69 SLE patients admitted to the hospital from January to December 2021 were selected as the SLE group,and 70 healthy individuals were selected as the control group during the same period.The changes of serum related indicators were compared between the SLE group and the control group.According to systemic lupus erythematosus disease activity index(SLEDAI),SLE patients were divided into mild active group(27 cases)and moderate and severe active group(42 cases).The changes of related indicators were compared between the two groups.Spearman correlation analysis was used to analyze the correlation between SLEDAI score and serum related indicators.Receiver operating characteristic(ROC)curve was used to ana-lyze the validity of diagnosis of disease severity.Results Compared with the control group,the levels of serum complement C3 and C4 in the SLE group were decreased,and the levels of CRP and ESR were increased,the differences were statistically significant(P<0.05).Compared with the mild group,the levels of serum com-plement C3 and C4 in the moderate and severe group were decreased,and the levels of CRP and ESR were in-creased,and the differences were statistically significant(P<0.05).The SLEDAI score of SLE patients was positively correlated with serum CRP and ESR levels(P<0.05),and negatively correlated with serum com-plement C3 and C4 levels(P<0.05).The area under the curve(AUC)of CRP,ESR,complement C3 and C4 were 0.716,0.875,0.872 and 0.856,respectively,the sensitivity were 59.52%,85.71%,78.57%and 78.79%,respectively,and the specificity were 79.83%,81.67%,86.79%and 86.54%,respectively.Conclu-sion Serum complement C3,C4,CRP and ESR are correlated with the progression of SLE,and play auxiliary roles in the disease activity stage of SLE.
5.Comparison of the effects of placental growth factor and vascular endothelial growth factor on acute myocardial infarction
Wang LYU ; Hui PAN ; Yiqing WANG ; Weidong LI ; Yu ZOU ; Chong ZHANG ; Tao JIN
Chinese Journal of Thoracic and Cardiovascular Surgery 2013;29(12):747-751
Objective AMI is a prevalent global health condition.This study assessed the effects of PLGF and VEGF in a rat model of post-AMI.Methods Wistar rats underwent LAD ligation and injection of VEGF,PLGF,VEGF + PLGF,antiVEGFR1,anti-VEGFR2,anti-VEGFR1 + anti-VEGFR2,IgG2α,or saline,into the infarct border zone.We also set up a pseudo-operation group.Two weeks later,heart function was detected by hemodynamic and geometry,then the hearts were dis sected and HE stained.We assessed vW factor and α-SMA by immunohistochemistry and cardiomyocyte apoptosis rate by TUNEL.Results Rats in the VEGF + PLGF group performed significantly well in cardiac function,had weaker LV remodeling and less cardiomyocyte apoptosis.There were no obvious changes in VEGF group.The use of VEGFR1/VEGFR2 antibody didnt deteriorate the rat's cardiac function.More new-born arteries were seen in PLGF and VEGF + PLGF rats,and change wasnt found in other groups.Lastly,the most angiogenesis,the least left ventricular remodeling and the best heart function were observed in VEGF + PLGF group.Conclusion Earlier intervention with PLGF or VEGF + PLGF can improve heart function in rats with AMI; VEGF alone didnt improve heart function.VEGFR1/VEGFR2 antibody didnt aggravate the rat's heart function.This indicates that left ventricular and coronary remodeling may involve other factors.
6.Galectin-3 expression in normal and LPS-stimulated genital system of female mouse
Yanhong YU ; Shanpei PAN ; Qixuan XIE ; Yiqing GUAN ; Dan HUANG
Chinese Journal of Pathophysiology 2000;0(07):-
AIM:To study the expressions of galectin-3 and the possible anti-infectious function in genital tract of female mouse. METHODS:The expressions of galectin-3 mRNA in different reproductive tissues were analyzed by RT-PCR. The mouse model of genital tract infection was constructed by injection of LPS and Freunds adjuvant incomplete into the vaginal mucous. The expression pattern of galectin-3 protein was detected by immunohistochemistry. RESULTS:The expression of galectin-3 mRNA was detected in the uterus,vagina,oviduct and ovary of normal adult mouse. The galectin-3 protein was expressed in the genital tract mucous of epithelial cell surface and uterine gland. After stimulation with LPS,the expression of galectin-3 protein was significantly up-regulated compared to normal control and adjuvant control (P

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