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*
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Aged
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Prospective Studies
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Adult
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Hemoglobins/metabolism*
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Treatment Outcome
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China
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Registries
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East Asian People
2.Associations between statins and all-cause mortality and cardiovascular events among peritoneal dialysis patients: A multi-center large-scale cohort study.
Shuang GAO ; Lei NAN ; Xinqiu LI ; Shaomei LI ; Huaying PEI ; Jinghong ZHAO ; Ying ZHANG ; Zibo XIONG ; Yumei LIAO ; Ying LI ; Qiongzhen LIN ; Wenbo HU ; Yulin LI ; Liping DUAN ; Zhaoxia ZHENG ; Gang FU ; Shanshan GUO ; Beiru ZHANG ; Rui YU ; Fuyun SUN ; Xiaoying MA ; Li HAO ; Guiling LIU ; Zhanzheng ZHAO ; Jing XIAO ; Yulan SHEN ; Yong ZHANG ; Xuanyi DU ; Tianrong JI ; Yingli YUE ; Shanshan CHEN ; Zhigang MA ; Yingping LI ; Li ZUO ; Huiping ZHAO ; Xianchao ZHANG ; Xuejian WANG ; Yirong LIU ; Xinying GAO ; Xiaoli CHEN ; Hongyi LI ; Shutong DU ; Cui ZHAO ; Zhonggao XU ; Li ZHANG ; Hongyu CHEN ; Li LI ; Lihua WANG ; Yan YAN ; Yingchun MA ; Yuanyuan WEI ; Jingwei ZHOU ; Yan LI ; Caili WANG ; Jie DONG
Chinese Medical Journal 2025;138(21):2856-2858
3.Development and application of regulatory T cells in corneal transplant rejection
Xin DU ; Ruijuan GUAN ; Zefeng KANG ; Ling LI ; Xin YAN ; Xiaoying ZHANG
International Eye Science 2024;24(8):1246-1249
Corneal transplantation is an effective treatment for corneal blindness, and it is the only hope for patients with corneal blindness. Cornea has no blood vessels and no lymphatic vessels, which is called immune privilege organ, so the success rate of corneal transplantation is significantly higher than that of other organ transplantation, but the rejection reaction after corneal transplantation is still the main reason for the failure of corneal transplantation. The directional movement of immune cells to lymphoid tissue and inflammatory sites is the mainly immune response after organ transplantation. And the regulatory T cells(Treg)play a key role in immune regulation, which can induce immune tolerance by regulating and inhibiting the activation of effector T cells and reduce the rejection reaction after corneal transplantation. In addition, this review also discussed the effectiveness of applying cordyceps sinensis extract FTY720 to enhance the function of Treg. Based on this, we briefly reviewed the sources, mechanism of action and treatment of Treg after corneal transplantation, so as to provide some reference for the subsequent clinical application transformation and basic research.
4.Recent advance in role of iron metabolism in vascular cognitive impairment
Xuehao JIAO ; Bingying DU ; Nuo WANG ; Xiaoying BI
Chinese Journal of Neuromedicine 2024;23(5):507-512
Iron is an essential trace element for brain development and cognitive function maintenance. Iron homeostasis disruption in the body, whether due to iron overload or deficiency, may lead to a series of adverse consequences to the brain. Vascular cognitive impairment is a neurodegenerative disease characterized by cognitive impairment such as mental decline and weak thinking, which seriously endangers people's health. At present, the relationship between iron metabolism and vascular cognitive impairment is receiving more and more attention. This paper summarizes the progress of iron metabolism and its role in vascular cognitive impairment, in order to provide new ideas and methods for prevention and treatment of vascular cognitive impairment.
5.Study on the Construction of a Question-Answer Corpus Dataset for Chinese Medical Knowledge Large Language Models
Tingyu LYU ; Xiaoying LI ; Ying ZHANG ; Yuyang LIU ; Jinhua DU ; Xinyi LI ; Yan LUO ; Xiaoli TANG ; Huiling REN ; Hui LIU ; Hao YIN
Journal of Medical Informatics 2024;45(5):20-25
Purpose/Significance To construct a Chinese medical knowledge Q&A corpus dataset as a standardized evaluation bench-mark for large language models(LLMs)in the medical domain,so as to improve the accuracy and efficiency of LLMs in handling Chinese medical questions.Method/Process Chinese medical paper knowledge,medical terminology explanations and supplementary questions are acquired from the Chinese medical licensing examination,and open-source Chinese medical Q&A datasets are encompassed in the developed Q&A datasets.Result/Conclusion The Chinese medical knowledge Q&A corpus datasets enrich the sources of existing datasets and promote the objective and comprehensive quantitative evaluation of large models in the medical field.In the near future,additional data such as electronic medical records and those from online health communities will be used to strengthen the support of artificial intelli-gence for the Healthy China strategy.
6.Analysis of vocal characteristics in hypopharyngeal cancer patients with vocal cord dysfunction.
Xiaohong LIU ; Guoyuan MU ; Nan CAO ; Na LI ; Minjuan YANG ; Yangjuan CHEN ; Xiaoying DU ; Xiaoyong REN ; Huanan LUO
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2024;38(11):1056-1065
Objective:To analyze the acoustic characteristics of patients with hypopharyngeal cancer accompanied by vocal cord dysfunction. Methods:A retrospective analysis was conducted on the data of patients with hypopharyngeal cancer who were initially treated at The Second Affiliated Hospital of Xi'an Jiaotong University from January 2018 to April 2024. Patients who had completed electronic laryngoscopy, stroboscopic laryngoscopy, and voice analysis were selected from the data. Among them, patients with hypopharyngeal cancer who had unilateral vocal cord activity disorders were selected as the experimental group, while patients with symmetrical bilateral vocal cord activity were assigned to the control group. Then the clinical characteristics, the vocal parameters, and the stroboscopic laryngoscopy results of patients with hypopharyngeal cancer in the experimental group and the control group were analyzed and compared. Results:Compared with that in the control group, the proportion of lesions located on the inner wall of the piriform fossa in the experimental group increased(83.3% vs 53.8%), and the difference was statistically significant(P<0.05). There was no significant difference in vocal parameters such as SPL, Jitter, Shimmer, MPT, DSI, F0, sound intensity, electroglottic value and VHI between the experimental group and the control group(P>0.05). However, the values of F0, Jitter, Shimmer and VHI in the experimental group were higher than those in the control group. In addition, in terms of the results of stroboscopic laryngoscopy, the proportion of glottic insufficiency(42.9% vs 18.8%) and asymmetric arytenoid cartilage(64.3% vs 0) in the experimental group was significantly higher than that in the control group(P<0.05). However, the mucosal waves of the vocal cords on the affected side did not weaken in patients in both the experimental group and the control group. In the experimental group of 18 patients with hypopharyngeal cancer who received induction chemotherapy(nituzumab+nedaplatin+5-fluorouracil), 13 of them had improved vocal cord activity(improvement rate of 72.2%). Conclusion:Hypopharyngeal cancer in the medial wall of the pyriform fossa is more prone to vocal cord dysfunction, but vocal cord dysfunction has little effect on the vocal parameters of patients with hypopharyngeal cancer.
Humans
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Hypopharyngeal Neoplasms
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Retrospective Studies
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Male
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Female
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Laryngoscopy
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Middle Aged
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Vocal Cord Dysfunction/etiology*
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Vocal Cords/physiopathology*
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Stroboscopy
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Voice Quality
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Aged
7.Construction of severe fever with thrombocytopenia syndrome virus recombinant pseudoviruses and effect of Gc glycosylation on viral infectivity
Xiaowen CHONG ; Zequn WANG ; Mengting CHEN ; Mengyu DU ; Xiaoying XU ; Youxiang MA ; Hongling WEN
Chinese Journal of Experimental and Clinical Virology 2023;37(6):583-591
Objective:To explore the relationship between severe fever with thrombocytopenia syndrome virus (SFTSV) Gc and its N-glycosylation site and viral infectivity, a recombinant pseudovirus containing SFTSV Gc glycosylation site mutant was constructed.Methods:The eukaryotic expression vectors pcDNA3.1(+ )-GC, PCDNA3.1(+ )-GC(N291Q), PCDNA3.1(+ )-GC(N352Q) and PCDNA3.1(+ )-GC (N374Q) were constructed by site-directed mutagenesis and homologous recombination. After their successful expression in 293T cells, we infected VSVΔG-Fluc*G pseudovirus, constructed four recombinant pseudoviruses and tested their effects on the cell force of infection.Results:Double digestion identification and sequence determination confirmed the successful construction of eukaryotic expression vectors pcDNA3.1 (+ )-Gc, pcDNA3.1 (+ )-Gc(N291Q), pcDNA3.1 (+ )-Gc(N352Q) and pcDNA3.1 (+ )-Gc(N374Q). Indirect immunofluorescence and Western Blotting result indicated the successful expression of all the four recombinant plasmids. SFTSV Gc recombinant pseudoviruses are specific for infecting Vero cells. Pseudovirus infection capacity was decreased significantly after the glycosylation site mutation, and the mutant strain with the glycosylation site at position 352 had the lowest level of infectivity ( P<0.001, P=0.001). Conclusions:The glycosylation site of SFTSV Gc may be associated with the infectious effect of the viral infection, and the amino acid mutation at position 352 has the greatest effect on the viral infectivity.
8.Overview of Chinese Neonatal Network: current and future
Siyuan JIANG ; Yun CAO ; Mingyan HEI ; Jianhua SUN ; Xiaoying LI ; Huayan ZHANG ; Xiaolu MA ; Hui WU ; Laishuan WANG ; Huiqing SUN ; Yuan SHI ; Wei ZHOU ; Chao CHEN ; Lizhong DU ; Wenhao ZHOU ; K. Shoo LEE
Chinese Pediatric Emergency Medicine 2023;30(11):809-815
The Chinese Neonatal Network(CHNN) was established in 2018 with the mission of establishing a national collaboration platform, conducting high-quality and collaborative research, and ultimately improving the quality of neonatal-perinatal care and health in China.At present, 112 hospitals across the country have joined CHNN.CHNN has established a national standardized cohort of very premature infants/very low birth weight infants with >10 000 enrollments each year, has been leading data-driven collaborative quality improvement initiatives, conducting multicenter clinical studies, and performing multi-level training programs.Guided by the principles of collaboration and sharing, data-driven, continuous improvement, and international integration, CHNN has become an important platform for clinical and research collaboration in neonatal medicine in China.
9.Tuina treatment for children and adults with functional dyspepsia:a meta-analysis and systematic review of randomized controlled trials
Zijing TAO ; Zeng CAO ; Qian LIU ; Xiaoying LUO ; Gezhi ZHANG ; Shuangshuang FANG ; Sijing DU ; Yang YANG ; Wei WEI
Journal of Acupuncture and Tuina Science 2023;21(5):413-426
Objective:To evaluate the efficacy and safety of Tuina(Chinese therapeutic massage)in the treatment of functional dyspepsia(FD)in children and adults. Methods:Related articles in PubMed,Excerpta Medica Database(EMBASE),Cochrane Library,Web of Science,China Biology Medicine Disc(CBM),Wanfang Academic Journal Full-text Database(Wanfang),China National Knowledge Infrastructure(CNKI),and Chongqing VIP Database(CQVIP)were collected.The retrieval time was from each database's start to March 2022.Two researchers independently screened the literature,extracted the data,and evaluated the risk of bias in the included studies.A meta-analysis was then performed using the RevMan 5.4 software. Results:A total of 19 clinical trials were included,9 of which encompassed studies on adults while 10 were on children with FD,comprising a total of 1961 patients.The findings of the meta-analysis showed that the effective rate of FD in children and adults treated with Tuina was significantly higher than that in the control group[risk ratio(RR)=1.15,95%confidence interval(CI)(1.09,1.21),P<0.001],[RR=1.13,95%CI(1.06,1.21),P<0.001].In addition,the effective rate of FD in children and adults treated with Tuina combined with other treatments was significantly higher than that in the control group[RR=1.14,95%CI(1.07,1.21),P<0.001],[RR=1.12,95%CI(1.02,1.24),P=0.02].In terms of single symptoms,Tuina improved epigastric burning sensation score in adults[standardized mean difference(SMD)=-0.41;95%CI(-0.79,-0.02);Z=2.08;P=0.04]compared with that of the Western medicine group.Compared with children treated with oral Chinese medications(CM)or Chinese patent medicine(CPM),children with FD demonstrated lower scores of epigastric pain[SMD=-0.38,95%CI(-0.56,-0.19);Z=3.96;P<0.001],postprandial fullness[SMD=-0.30,95%CI(-0.50,-0.10);Z=2.88;P=0.004],and early satiety[SMD=-0.26,95%CI(-0.47,-0.06);Z=2.54;P=0.01]after receiving Tuina combined with CM or CPM treatment.No adverse events were reported in the Tuina treatment group,and the follow-up indicated that the symptom scores in the Tuina group improved. Conclusion:Compared with the control group,both Tuina and Tuina combined with other treatments are shown to have better effective rates,lower incidence of adverse events,and better follow-up outcomes.The study results suggest that Tuina may be a clinically viable complementary therapy.However,due to limitations in the number and quality of the included studies,the above conclusions should be verified by further high-quality studies.
10.Effect of music therapy on post-stroke cognitive impairment
Yufan LIN ; Tianyuan WEI ; Xiaoying ZHANG ; Chaojinzi LI ; Jingjie HE ; Xiaoxia DU
Chinese Journal of Rehabilitation Theory and Practice 2023;29(6):714-719
ObjectiveTo observe the effect of music therapy on cognitive function, motor function, and activities of daily living (ADL) of patients with post-stroke cognitive impairment. MethodsFrom December, 2020 to July, 2022, 48 patients with post-stroke cognitive impairment in Beijing Bo'ai Hospital were enrolled and randomly divided into control group (n = 24) and experimental group (n = 24). Both groups received conventional medication, nursing, and conventional rehabilitation, while the experimental group received music therapy additionally, for eight weeks. Before and after intervention, the cognitive function was assessed by Loewenstein Occupational Therapy Cognitive Assessment (LOTCA), and motor function and ADL were assessed with Fugl-Meyer Assessment (FMA) and modified Barthel Index (MBI), respectively. ResultsSix cases in the control group dropped down. The increase in the scores of LOTCA and FMA was more in the experimental group than in the control group (t > 2.665, P < 0.05), however, no significant difference was found in the increase of MBI score between two groups. ConclusionMusic therapy could improve the cognitive function and motor function of patients with post-stroke cognitive impairment.

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