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 ; Male ; Female ; Anemia/etiology* ; 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

Objective:To analyze the result data of the first competition of medical-industrial integration innovation for transformation of the Pathological Equipment Branch of China Association of Medical Equipment,so as to explore the directions of medical-industrial integration and transformation innovation in the field of pathology.Methods:The data of the participated projects of the first competition of medical-industrial integration innovation for transformation in 2024,which was held by the Pathological Equipment Branch of China Association of Medical Equipment,were collected,and these data were divided into equipment category,and the category of reagents and consumables according to their declaration content.The data of the results of preliminary and final competition,award information,transformation number and other data of the two categories of participated projects were analyzed,and the scoring differences between the judges who were expert,and the judges from enterprise were compared.Results:This competition received 21 projects,which included 15 projects of equipment category,and 6 projects of the category of reagents and consumables.In 21 projects,there were 10 projects wined award,which included 7 projects of equipment category,and 3 projects of the category of reagents and consumables.There was not statistically significant difference in the results between equipment category and the category of reagents and consumables in preliminary and final competitions(P>0.05).There was not significant difference in the ratio between equipment category(46.7%)and the category of reagents and consumables(50%)(P>0.05).The results of preliminary and final competitions of the projects in equipment category were respectively(70.64±3.48)and(76.49±2.34),and the difference was significant(t=5.403,P<0.05).There was not significant difference in the category of reagents and consumables between preliminary and final competitions(P>0.05).In 15 projects of equipment category,6 projects obtained the intention of transformation from enterprises.In 6 projects of the category of reagents and consumables,3 projects obtained the intention of transformation from enterprises.The score of judges who were expert,and the score of judges from enterprise were respectively(68.90±4.76)and(71.90±4.38)for the results of preliminary competition,and the difference was significant(t=2.121,P<0.05).Conclusion:The competition of medical-industrial integration innovation for transformation has successfully built a bridge between pathological patent and enterprises,which can effectively promote the transformation of pathology-related patents,and promote a deep integration between medicine and engineering.It also can accelerate the application of innovational technique in pathological field,and the connection between product's development stage and related enterprises,and can construct a harmonious development environment for transformation and innovation of medical-industrial integration.

The aim of this updated guideline is to provide comprehensive recommendations for the management of gout in patients with common comorbidities, such as chronic kidney disease(CKD), cardiovascular disease(CVD), diabetes, osteoarthritis(OA), and gastrointestinal disorders. This guideline was developed by a multidisciplinary expert panel consisting of specialists in endocrinology, rheumatology, nephrology, cardiology, gastroenterology, and methodology. The development process adhered to standard methodologies, including PICO(population, intervention, comparator, and outcomes) question deconstruction, systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation(GRADE) for evidence and recommendation evaluation, Delphi voting, and expert consensus. The guideline presents 26 evidence-based recommendations addressing 7 clinical questions for patients with hyperuricemia and gout in the context of comorbidities. Key recommendations include the maintenance of strict serum urate targets, particularly for patients with CKD stage≥3, chronic gouty arthritis, and OA, in order to prevent disease progression. In patients with CVD or diabetes, intra-articular triamcinolone is preferred over systemic glucocorticoids. Prioritized anti-inflammatory treatments for patients with CKD, gastrointestinal diseases and OA are recommended. The guideline also introduces emerging therapies, such as interleukin-1 inhibitors and selective urate transport inhibitors, as potential treatment options for refractory cases. The update offers a comprehensive, patient-centered approach to managing gout, particularly in individuals with associated comorbidities. Multidisciplinary collaboration and emerging new treatments and evidence ensure the optimization of the recommendations.

Purpose The results of EBER in situ hybridization on the external quality assessment(EQA)organ-ized by the pathology Equipment Branch of the China Association of Medical Equipment were analyzed,for providing technical support for the standardization and normalization of the technology.Methods Paraffin-embedded sections of confirmed EBV-positive diffuse large B-cell lymphoma were selected as the evaluation specimens.Additionally,EBER in situ hybridization liquid cell controls were applied to the slides as evaluation references.A questionnaire was distrib-uted to collect staining information and methodologies from participating laboratories.Finally,the stained slides were collected and independently evaluated by pathology experts from the association according to predefined scoring criteria.Results A total of 38 pathology laboratories from 7 provinces and municipalities directly under the central government participated in the EQA,including 32 hospital pathology departments and 6 independent clinical laboratories.21 par-ticipants used manual staining,and others(17)used automated staining method by immunohistochemistry(IHC)stainers.The overall qualification rate of EBER in situ hybridization staining was 94.74％(36/38),and the excellent& good rate was 26.32％(10/38).The excellent & good rate of automated staining(41.12％,7/17)was significant-ly higher than that of manual staining(14.29％,3/21)(x2=4.852,P=0.028).The positive cell line control showed good consistency with the tissue control(Kappa=0.909,r=0.944).Conclusion The EBER in situ hybrid-ization technique in most of the pathology laboratories in the external quality assessment is qualified.There is a statisti-cally significant difference in the excellent & good rate between different staining methods.EBER in situ hybridization using automated IHC stainers is recommended as the preferred method.There is no difference in the performance of positive cell line control and tissue control.Some laboratories' staining techniques need to be improved.

Purpose The results of EBER in situ hybridization on the external quality assessment(EQA)organ-ized by the pathology Equipment Branch of the China Association of Medical Equipment were analyzed,for providing technical support for the standardization and normalization of the technology.Methods Paraffin-embedded sections of confirmed EBV-positive diffuse large B-cell lymphoma were selected as the evaluation specimens.Additionally,EBER in situ hybridization liquid cell controls were applied to the slides as evaluation references.A questionnaire was distrib-uted to collect staining information and methodologies from participating laboratories.Finally,the stained slides were collected and independently evaluated by pathology experts from the association according to predefined scoring criteria.Results A total of 38 pathology laboratories from 7 provinces and municipalities directly under the central government participated in the EQA,including 32 hospital pathology departments and 6 independent clinical laboratories.21 par-ticipants used manual staining,and others(17)used automated staining method by immunohistochemistry(IHC)stainers.The overall qualification rate of EBER in situ hybridization staining was 94.74％(36/38),and the excellent& good rate was 26.32％(10/38).The excellent & good rate of automated staining(41.12％,7/17)was significant-ly higher than that of manual staining(14.29％,3/21)(x2=4.852,P=0.028).The positive cell line control showed good consistency with the tissue control(Kappa=0.909,r=0.944).Conclusion The EBER in situ hybrid-ization technique in most of the pathology laboratories in the external quality assessment is qualified.There is a statisti-cally significant difference in the excellent & good rate between different staining methods.EBER in situ hybridization using automated IHC stainers is recommended as the preferred method.There is no difference in the performance of positive cell line control and tissue control.Some laboratories' staining techniques need to be improved.

Objective:To analyze the result data of the first competition of medical-industrial integration innovation for transformation of the Pathological Equipment Branch of China Association of Medical Equipment,so as to explore the directions of medical-industrial integration and transformation innovation in the field of pathology.Methods:The data of the participated projects of the first competition of medical-industrial integration innovation for transformation in 2024,which was held by the Pathological Equipment Branch of China Association of Medical Equipment,were collected,and these data were divided into equipment category,and the category of reagents and consumables according to their declaration content.The data of the results of preliminary and final competition,award information,transformation number and other data of the two categories of participated projects were analyzed,and the scoring differences between the judges who were expert,and the judges from enterprise were compared.Results:This competition received 21 projects,which included 15 projects of equipment category,and 6 projects of the category of reagents and consumables.In 21 projects,there were 10 projects wined award,which included 7 projects of equipment category,and 3 projects of the category of reagents and consumables.There was not statistically significant difference in the results between equipment category and the category of reagents and consumables in preliminary and final competitions(P>0.05).There was not significant difference in the ratio between equipment category(46.7%)and the category of reagents and consumables(50%)(P>0.05).The results of preliminary and final competitions of the projects in equipment category were respectively(70.64±3.48)and(76.49±2.34),and the difference was significant(t=5.403,P<0.05).There was not significant difference in the category of reagents and consumables between preliminary and final competitions(P>0.05).In 15 projects of equipment category,6 projects obtained the intention of transformation from enterprises.In 6 projects of the category of reagents and consumables,3 projects obtained the intention of transformation from enterprises.The score of judges who were expert,and the score of judges from enterprise were respectively(68.90±4.76)and(71.90±4.38)for the results of preliminary competition,and the difference was significant(t=2.121,P<0.05).Conclusion:The competition of medical-industrial integration innovation for transformation has successfully built a bridge between pathological patent and enterprises,which can effectively promote the transformation of pathology-related patents,and promote a deep integration between medicine and engineering.It also can accelerate the application of innovational technique in pathological field,and the connection between product's development stage and related enterprises,and can construct a harmonious development environment for transformation and innovation of medical-industrial integration.

The aim of this updated guideline is to provide comprehensive recommendations for the management of gout in patients with common comorbidities, such as chronic kidney disease(CKD), cardiovascular disease(CVD), diabetes, osteoarthritis(OA), and gastrointestinal disorders. This guideline was developed by a multidisciplinary expert panel consisting of specialists in endocrinology, rheumatology, nephrology, cardiology, gastroenterology, and methodology. The development process adhered to standard methodologies, including PICO(population, intervention, comparator, and outcomes) question deconstruction, systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation(GRADE) for evidence and recommendation evaluation, Delphi voting, and expert consensus. The guideline presents 26 evidence-based recommendations addressing 7 clinical questions for patients with hyperuricemia and gout in the context of comorbidities. Key recommendations include the maintenance of strict serum urate targets, particularly for patients with CKD stage≥3, chronic gouty arthritis, and OA, in order to prevent disease progression. In patients with CVD or diabetes, intra-articular triamcinolone is preferred over systemic glucocorticoids. Prioritized anti-inflammatory treatments for patients with CKD, gastrointestinal diseases and OA are recommended. The guideline also introduces emerging therapies, such as interleukin-1 inhibitors and selective urate transport inhibitors, as potential treatment options for refractory cases. The update offers a comprehensive, patient-centered approach to managing gout, particularly in individuals with associated comorbidities. Multidisciplinary collaboration and emerging new treatments and evidence ensure the optimization of the recommendations.

Objective:By summarizing and analyzing the results of the inter-laboratory quality evaluation of hematoxylin-eosin(HE)staining organized by the Pathological Equipment Branch of Chinese Medical Equipment Association,to timely identify problems and summarize experience,and to improve the level of HE staining and the ability of inter-laboratory quality control management in medical institutions.Methods:The results of the national routine pathology HE staining inter-laboratory quality evaluation sponsored by the Pathology Equipment Branch of the China Medical Equipment Association in 2022 and 2023 were collected,and the grades,tissue types and evaluation results of the evaluation units participating in the inter-laboratory quality evaluation of HE staining were statistically analyzed.Results:In 2022,a total of 165 evaluation units participated in the inter-laboratory quality evaluation of HE staining with valid results,and 156 in 2023.HE stained tissue types included uterine tissue,gastrointestinal tissue,lung tissue,and breast tissue.The qualified rates of HE staining of the participating units in 2023 were 82.42％(136/165),which was higher than that of 90.38％(141/156)in 2022,the difference was statistically significant(x2=4.30,P＜0.05).There was no statistically significant difference in the staining pass rate of the tertiary hospitals participating in the evaluation in 2023 compared with that in 2022(P＞0.05).The qualified rates of secondary hospitals and non-public medical institutions were 100％and 92.37％,respectively,which were higher than those in 2022,the difference was statistically significant(x2=3.91,5.93,P＜0.05).The qualified rates of inter-laboratory quality evaluation of uterine tissue,gastrointestinal tissue,lung tissue and breast tissue evaluated in 2023 were 92.31％(144/156),91.03％(142/156),91.03％(142/156)and 91.67％(143/156),respectively,which were higher than those in 2022,the differences between uterine tissue and gastrointestinal tissue in two-year evaluation were statistically significant(x2=6.33,5.93,P＜0.05).There was no statistically significant difference in the two-year evaluation between lung tissue and breast tissue(P＞0.05).Conclusion:The continuous participation of medical institutions in the inter-laboratory quality evaluation activities of HE staining can improve the quality of routine pathological HE staining,improve the level of pathological technicians,and reduce the staining differences caused by different unit properties and specimen types.

BACKGROUND: At present, there is no uniform standard for the treatment time of chemical reagents for surface treatment of glass fiber posts. Therefore, studying the effect of treatment time of glass fiber post surface treatment reagents on the bond strength between fiber posts and resin cements is of great significance. OBJECTIVE: To evaluate the effect of two chemical agents on the bonding strength of glass fiber post and resin cement after surface pretreatment of glass-fiber posts at different times. METHODS: Forty-eight glass fiber posts were randomly divided into eight groups according to different surface treatment methods, six in each group. Group A received no special treatment; group B was treated with silanization for 1 minute; group C1 underwent a 30% hydrogen peroxide surface treatment for 5 minutes prior to 1-minute silanization; group C2underwent a 30% hydrogen peroxide surface treatment for 10minutes prior to 1-minutesilanization; group C3 underwent a 30% hydrogen peroxide surface treatment for 15 minutes prior to 1-minute silanization; group D1 underwent a 35% phosphoric acid surface treatment for 30 seconds prior to 1-minute silanization; group D2 underwent a 35% phosphoric acid surface treatment for 60 seconds prior to 1-minute silanization; group D3 underwent a 35% phosphoric acid surface treatment for 90 seconds prior to 1-minute silanization. The surface morphology of the treated glass fiber posts was observed under scanning electron microscope. The glass fiber post was bonded to the resin cement to form a cylindrical resin block and cut into a thin sample. The sheet was placed on a universal testing machine for micro-extrusion experiments. The failure mode of the specimens was observed under a stereomicroscope. RESULTS AND CONCLUSION: (1) Scanning electron microscope: the surface of the fiber post had different degrees of matrix dissolution and fiber bundle exposure after hydrogen peroxide and phosphoric acid treatment, but did not destroy the integrity of the fiber bundle. (2) Micro-extrusion experiments: the order of the bonding strength was as follows: group C3 > group C2 > group C1 > group D2 > groupD3 > groupD1> group B > group A, and there was significant difference between groups (P< 0.05) except for groups A and B, groups C2 andC3, and groups D2and D3. (3) Stereo microscope: the failure mode in the groups A and B was almost destruction in adhesion. The other six groups showed destruction in adhesion, but the cohesive failure and mixed failure were increased, and the failure mode changed from destruction in adhesion into cohesive failure and mixed failure. (4) These results indicate that the optimal treatment time of 30% hydrogen peroxide is 10 minutes, and the optimal treatment time of 35% phosphoric acid is 60 seconds. 30% hydrogen peroxide solution treatment of fiber post surface for 10 minutes has great clinical application value.

Objective To investigate the efficacy of leflunomide combined with prednisone in the induction therapy of proliferative lupus nephritis (LN).Methods A prospective,multicenter,randomized controlled clinical trial was conducted in patients with biopsy-proved proliferative lupus nephritis recruited from 15 renal centers from 2013 to 2015.Patients were randomized to two groups.Oral leflunomide or intravenous cyclophosphamide was given to patients in each group.Both groups received a tapering course of oral prednisone therapy.All patients were followed up for 24 weeks.The blood biochemistry,urine index,clinical curative effect and adverse reaction were recorded and analyzed statistically.Results A total of 100 patients were enrolled in this clinical trial,including 48 patients in leflunomide group and 52 patients in cyclophosphamide group.After 24 weeks,the overall response rate was 79％ (95％ CI 67％-90％) in the leflunomide group and 69％ (95％ CI 56％-82％) in the cyclophosphamide group.23％ (95％CI 11％-35％) of patients in leflunomide group showed complete remission compared with 27％ (95％CI 24％-30％) in cyclophosphamide group (P=0.35).The levels of 24-hr urine protein excretion,SLEDAI and anti-dsDNA antibody titers were decreased in patients treated with leflunomide group after 24-weeks treatment.And the levels of serum albumin and complement 3 after treatment were significantly higher compared with these before treatment.There was also no significant difference in changes of 24-hr urine protein excretion,SLEDAI score,anti-dsDNA antibody titers,serum albumin and complement C3 levels after treatment between two groups.Incidence of adverse events did not differ between the leflunomide and cyclophosphamide group.Conclusions Leflunomide combined with prednisone showed same efficacy compared with cyclophosphamide as induction therapy for lupus nephritis.Leflunomide might be an useful medicine in the induction therapy of lupus nephritis.