Pub Date : 2026-01-01Epub Date: 2025-06-19DOI: 10.1097/JCMA.0000000000001259
Jiao Zhang, Bin Shi, Da Li, Yan Du, Shujiang Gu, Haiying Yao, Dongxuan Zhang, Yuan Tao
Background: Mesalazine is a standard treatment for ulcerative colitis (UC). However, it is unclear whether the efficacy of mesalazine combined with traditional Chinese medicine (TCM) enemas is superior to that of mesalazine alone. Therefore, this study aimed to evaluate the clinical effectiveness of TCM enema hydrotherapy combined with mesalazine for active UC.
Methods: Patients with active UC were randomly assigned to two treatment groups: a combination of mesalazine and TCM enemas and mesalazine alone. Primary outcome measures included clinical effective and recurrence rate. Secondary outcomes included TCM symptom scores, levels of inflammatory markers (interleukin-8 [IL-8], tumor necrosis factor α [TNF-α], high-sensitivity C-reactive protein [hs-CRP]), colonoscopy scores (Baron score), and disease activity indices (Sutherland Disease Activity Index [DAI], modified Mayo score).
Results: A total of 80 patients were included in the study. Regarding the primary outcomes, the total effective rate in the combination group was 95%, which was significantly higher than the 75% observed in the mesalazine group ( p = 0.012). The recurrence rate was lower in the combined group (2.5%) than in the mesalazine group (17.5%), but this difference did not reach statistical significance ( p = 0.062). Regarding secondary outcomes, the combination group showed higher reductions in TCM symptom scores than the mesalazine group, particularly in the areas of bloody stool ( p < 0.001), diarrhea ( p < 0.001), and abdominal pain ( p = 0.044). The combination group also showed significantly lower inflammatory markers (IL-8, TNF-α, hs-CRP) and disease activity scores (Baron score, DAI, modified Mayo score) compared with the mesalazine group ( p < 0.05).
Conclusion: The combination treatment may be more effective than mesalazine. The combination of TCM enema and mesalazine led to significant clinical improvement with lower inflammatory responses and reduced recurrence rates in patients with active UC.
{"title":"Comparative study of Chinese herbal enema combined with mesalazine vs mesalazine alone in the treatment of ulcerative colitis: A randomized controlled trial.","authors":"Jiao Zhang, Bin Shi, Da Li, Yan Du, Shujiang Gu, Haiying Yao, Dongxuan Zhang, Yuan Tao","doi":"10.1097/JCMA.0000000000001259","DOIUrl":"10.1097/JCMA.0000000000001259","url":null,"abstract":"<p><strong>Background: </strong>Mesalazine is a standard treatment for ulcerative colitis (UC). However, it is unclear whether the efficacy of mesalazine combined with traditional Chinese medicine (TCM) enemas is superior to that of mesalazine alone. Therefore, this study aimed to evaluate the clinical effectiveness of TCM enema hydrotherapy combined with mesalazine for active UC.</p><p><strong>Methods: </strong>Patients with active UC were randomly assigned to two treatment groups: a combination of mesalazine and TCM enemas and mesalazine alone. Primary outcome measures included clinical effective and recurrence rate. Secondary outcomes included TCM symptom scores, levels of inflammatory markers (interleukin-8 [IL-8], tumor necrosis factor α [TNF-α], high-sensitivity C-reactive protein [hs-CRP]), colonoscopy scores (Baron score), and disease activity indices (Sutherland Disease Activity Index [DAI], modified Mayo score).</p><p><strong>Results: </strong>A total of 80 patients were included in the study. Regarding the primary outcomes, the total effective rate in the combination group was 95%, which was significantly higher than the 75% observed in the mesalazine group ( p = 0.012). The recurrence rate was lower in the combined group (2.5%) than in the mesalazine group (17.5%), but this difference did not reach statistical significance ( p = 0.062). Regarding secondary outcomes, the combination group showed higher reductions in TCM symptom scores than the mesalazine group, particularly in the areas of bloody stool ( p < 0.001), diarrhea ( p < 0.001), and abdominal pain ( p = 0.044). The combination group also showed significantly lower inflammatory markers (IL-8, TNF-α, hs-CRP) and disease activity scores (Baron score, DAI, modified Mayo score) compared with the mesalazine group ( p < 0.05).</p><p><strong>Conclusion: </strong>The combination treatment may be more effective than mesalazine. The combination of TCM enema and mesalazine led to significant clinical improvement with lower inflammatory responses and reduced recurrence rates in patients with active UC.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"61-68"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-07DOI: 10.1097/JCMA.0000000000001316
Peng-Hui Wang, Brahmana Askandar Tjokroprawiro
{"title":"The impact of brain metastases on outcome in metastatic breast cancer and extensive-stage small cell lung cancer.","authors":"Peng-Hui Wang, Brahmana Askandar Tjokroprawiro","doi":"10.1097/JCMA.0000000000001316","DOIUrl":"10.1097/JCMA.0000000000001316","url":null,"abstract":"","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"3-4"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145461090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2024-12-23DOI: 10.1097/JCMA.0000000000001199
Suxin Zhang, Si Chen, Guochao Chai, Yaoyao Shi, Yang Bao, Shixiong Peng, Zifeng Cui, Jiamei Hao
Background: The surgical safety margin of the oral squamous cell carcinoma (OSCC) is not clear. We investigate the effect of nimotuzumab (N) combined with nab-paclitaxel, cisplatin, and fluorouracil (APF) neoadjuvant chemotherapy on the surgical margin.
Methods: This was a single-center retrospective study, included 18 to 75 ages diagnosed newly histologically confirmed OSCC patients at the Fourth Hospital of Hebei Medical University between September 2019 and December 2021. Patients were divided into neoadjuvant chemotherapy and surgery group (G1 group, N + APF), chemotherapy and surgery group (G2 group, APF alone), and surgery group (G3 group). Tissue samples of the tumor core zone (P0), adjacent (P1, 3-5 mm from tumor), distal adjacent (P2, 7-10 mm from tumor), and surgical margin (P3, 15 mm from tumor) were collected. The main indicators of pathological evaluation were pathologic complete response (pCR) and major pathologic response (MPR). Chi-square or Fisher test was used for the pathological response rate of qualitative data, and t test or analysis of variance (ANOVA) was used for protein expression changes of quantitative data. A threshold value of p < 0.05 indicated statistical significance.
Results: In the G1 (n = 15) and G2 (n = 20) groups, various degrees of degeneration and necrosis were observed in the tumor retraction area. Nine cases of MPR and four cases of pCR in the G1 group; eight cases of MPR and three cases of pCR in the G2 group. The expressions of p53, eIF4E, and EGFR in the samples of the three groups decreased from P0 to P2 ( p < 0.05). In the molecular tumor shrinkage area, the expression levels of p53, eIF4E, and EGFR in the shrinkage zone were lower than those in the negative margin.
Conclusion: There is no significant statistical difference between APF plus nimotuzumab or APF alone in the pathological remission rate. The surgical margin was defined to 1.5 cm clinical margin after tumor regression.
{"title":"Surgical margin assessment after neoadjuvant chemotherapy plus nimotuzumab in locally advanced oral squamous cell carcinoma.","authors":"Suxin Zhang, Si Chen, Guochao Chai, Yaoyao Shi, Yang Bao, Shixiong Peng, Zifeng Cui, Jiamei Hao","doi":"10.1097/JCMA.0000000000001199","DOIUrl":"10.1097/JCMA.0000000000001199","url":null,"abstract":"<p><strong>Background: </strong>The surgical safety margin of the oral squamous cell carcinoma (OSCC) is not clear. We investigate the effect of nimotuzumab (N) combined with nab-paclitaxel, cisplatin, and fluorouracil (APF) neoadjuvant chemotherapy on the surgical margin.</p><p><strong>Methods: </strong>This was a single-center retrospective study, included 18 to 75 ages diagnosed newly histologically confirmed OSCC patients at the Fourth Hospital of Hebei Medical University between September 2019 and December 2021. Patients were divided into neoadjuvant chemotherapy and surgery group (G1 group, N + APF), chemotherapy and surgery group (G2 group, APF alone), and surgery group (G3 group). Tissue samples of the tumor core zone (P0), adjacent (P1, 3-5 mm from tumor), distal adjacent (P2, 7-10 mm from tumor), and surgical margin (P3, 15 mm from tumor) were collected. The main indicators of pathological evaluation were pathologic complete response (pCR) and major pathologic response (MPR). Chi-square or Fisher test was used for the pathological response rate of qualitative data, and t test or analysis of variance (ANOVA) was used for protein expression changes of quantitative data. A threshold value of p < 0.05 indicated statistical significance.</p><p><strong>Results: </strong>In the G1 (n = 15) and G2 (n = 20) groups, various degrees of degeneration and necrosis were observed in the tumor retraction area. Nine cases of MPR and four cases of pCR in the G1 group; eight cases of MPR and three cases of pCR in the G2 group. The expressions of p53, eIF4E, and EGFR in the samples of the three groups decreased from P0 to P2 ( p < 0.05). In the molecular tumor shrinkage area, the expression levels of p53, eIF4E, and EGFR in the shrinkage zone were lower than those in the negative margin.</p><p><strong>Conclusion: </strong>There is no significant statistical difference between APF plus nimotuzumab or APF alone in the pathological remission rate. The surgical margin was defined to 1.5 cm clinical margin after tumor regression.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"90-96"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815551/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142879108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-12-08DOI: 10.1097/JCMA.0000000000001325
Yun Tien, Cheng-Ta Li
Treatment-resistant depression (TRD) and alcohol use disorder (AUD) frequently coexist, complicating clinical management and contributing to poor outcomes. Despite their distinct clinical presentations, converging neuroimaging evidence indicates shared neural circuit dysfunctions. This review synthesizes resting-state functional magnetic resonance imaging (fMRI) findings, highlighting disruptions within and between core intrinsic brain networks-the default mode network (DMN), salience network (SN), and central executive network (CEN)-as well as subcortical-limbic circuitry. Both TRD and AUD feature reduced anterior-posterior DMN connectivity (mPFC-PCC), impaired CEN function (particularly within the DLPFC), and aberrant SN connectivity (anterior insula, ACC). Altered limbic interactions involving the amygdala, hippocampus, and striatum further reflect common mechanisms of heightened reward sensitivity and emotional dysregulation. Conventional pharmacotherapies demonstrate limited efficacy, underscoring the need for novel approaches. Neuromodulation, particularly deep transcranial magnetic stimulation (dTMS), has emerged as a promising intervention targeting these shared circuit abnormalities. While current evidence remains preliminary, integrating neuroimaging biomarkers, multimodal methods, and longitudinal designs will be crucial for refining treatment precision. This review highlights the translational potential of circuit-based interventions, offering a framework for personalized neuromodulation strategies to improve outcomes in patients with TRD, AUD, and their frequent comorbidities.
{"title":"Shared neural network dysfunctions in treatment-resistant major depression and alcohol use disorder: Resting-state fMRI evidence and implications for neuromodulation.","authors":"Yun Tien, Cheng-Ta Li","doi":"10.1097/JCMA.0000000000001325","DOIUrl":"10.1097/JCMA.0000000000001325","url":null,"abstract":"<p><p>Treatment-resistant depression (TRD) and alcohol use disorder (AUD) frequently coexist, complicating clinical management and contributing to poor outcomes. Despite their distinct clinical presentations, converging neuroimaging evidence indicates shared neural circuit dysfunctions. This review synthesizes resting-state functional magnetic resonance imaging (fMRI) findings, highlighting disruptions within and between core intrinsic brain networks-the default mode network (DMN), salience network (SN), and central executive network (CEN)-as well as subcortical-limbic circuitry. Both TRD and AUD feature reduced anterior-posterior DMN connectivity (mPFC-PCC), impaired CEN function (particularly within the DLPFC), and aberrant SN connectivity (anterior insula, ACC). Altered limbic interactions involving the amygdala, hippocampus, and striatum further reflect common mechanisms of heightened reward sensitivity and emotional dysregulation. Conventional pharmacotherapies demonstrate limited efficacy, underscoring the need for novel approaches. Neuromodulation, particularly deep transcranial magnetic stimulation (dTMS), has emerged as a promising intervention targeting these shared circuit abnormalities. While current evidence remains preliminary, integrating neuroimaging biomarkers, multimodal methods, and longitudinal designs will be crucial for refining treatment precision. This review highlights the translational potential of circuit-based interventions, offering a framework for personalized neuromodulation strategies to improve outcomes in patients with TRD, AUD, and their frequent comorbidities.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"5-17"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145703459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-12-08DOI: 10.1097/JCMA.0000000000001326
Yuan-Jen Tsai, Yi-Hsueh Liao
Extracellular vesicles (EVs) are membrane-bound vesicles released by various cell types and contain biologically active molecules that participate in key physiological and pathological processes. EVs play crucial roles in intercellular communication, immune regulation, tissue repair, and disease progression, particularly in cancer, neurodegenerative disorders, and cardiovascular conditions. Because of their structural stability and ability to evade immune detection, EVs are potential noninvasive biomarkers and therapeutic delivery vehicles. Advances in isolation and purification techniques have further supported their application in precision medicine, with research indicating EVs provide insight into disease mechanisms and therapeutic responses. EVs also facilitate the transfer of nucleic acids, proteins, and lipids between cells, thereby modulating gene expression and cellular activities. Their emerging role as biomarkers for diagnosis and outcome prediction, especially in cancer and neurodegenerative diseases, are areas of active investigation. Despite these promising applications, several challenges hinder clinical translation, including difficulties in distinguishing disease-derived EVs from normal EVs, the absence of standardized therapeutic protocols, the possibility of oncogenic cargo, high production costs, and variability in immune responses. Addressing these challenges by developing improved isolation techniques, standardized evaluation protocols, and cost-effective production strategies and continuing to conduct research is essential to fully realizing the diagnostic and therapeutic potential of EVs in precision medicine.
{"title":"Development of extracellular vesicles in diagnostics and therapeutics: From extracellular vesicles to precision medicine.","authors":"Yuan-Jen Tsai, Yi-Hsueh Liao","doi":"10.1097/JCMA.0000000000001326","DOIUrl":"10.1097/JCMA.0000000000001326","url":null,"abstract":"<p><p>Extracellular vesicles (EVs) are membrane-bound vesicles released by various cell types and contain biologically active molecules that participate in key physiological and pathological processes. EVs play crucial roles in intercellular communication, immune regulation, tissue repair, and disease progression, particularly in cancer, neurodegenerative disorders, and cardiovascular conditions. Because of their structural stability and ability to evade immune detection, EVs are potential noninvasive biomarkers and therapeutic delivery vehicles. Advances in isolation and purification techniques have further supported their application in precision medicine, with research indicating EVs provide insight into disease mechanisms and therapeutic responses. EVs also facilitate the transfer of nucleic acids, proteins, and lipids between cells, thereby modulating gene expression and cellular activities. Their emerging role as biomarkers for diagnosis and outcome prediction, especially in cancer and neurodegenerative diseases, are areas of active investigation. Despite these promising applications, several challenges hinder clinical translation, including difficulties in distinguishing disease-derived EVs from normal EVs, the absence of standardized therapeutic protocols, the possibility of oncogenic cargo, high production costs, and variability in immune responses. Addressing these challenges by developing improved isolation techniques, standardized evaluation protocols, and cost-effective production strategies and continuing to conduct research is essential to fully realizing the diagnostic and therapeutic potential of EVs in precision medicine.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"18-24"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145703465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-19DOI: 10.1097/JCMA.0000000000001319
Ko-Han Lin, Shu-Huei Shen, William Ji-Shien Huang, Tzu-Chun Wei, Yu-Ming Liu, Nan-Jing Peng, Skye Hsin-Hsien Yeh, Yuh-Feng Wang
Background: To evaluate the diagnostic performance and clinical utility of integrating 18F-PSMA-1007 PET, 11C-acetate PET, and multiparametric MRI (mpMRI) in a one-stop-shop PET/MRI protocol for intermediate- to high-risk prostate cancer staging.
Method: This prospective study enrolled 22 patients with biopsy-confirmed, intermediate- to high-risk prostate cancer. All underwent simultaneous 18F-PSMA-1007 PET/MRI, followed by 11C-acetate PET in a dual-tracer design. Lesion detection, concordance across modalities, and region-based sensitivity, specificity, PPV, and NPV were analyzed. The impact on clinical management was also assessed.
Results: 18F-PSMA-1007 PET showed superior detection of both nodal and distant metastases, with region-based sensitivity of 75.0%, specificity of 100.0%, and NPV of 92.0%. Discordant findings between PET and mpMRI occurred in 34.8% of cases, but integrated interpretation improved lesion characterization. PSMA PET alone identified clinically significant findings in 22.7% of patients. 11C-acetate did not detect any additional lesions and served as a supplementary tool. The combined PET/MRI workflow enhanced diagnostic confidence while reducing interpretive delay.
Conclusion: The integration of dual-tracer PET and mpMRI into a single PET/MRI session provides a feasible, efficient, and potentially impactful strategy for prostate cancer staging. This protocol supports biologically-informed, patient-specific decision-making and may serve as a model for future risk-adapted workflows.
{"title":"One-stop shop-integrating 18 F-PSMA-1007 and 11 C-acetate positron-emission tomography with multiparametric magnetic resonance imaging for prostate cancer: A prospective study.","authors":"Ko-Han Lin, Shu-Huei Shen, William Ji-Shien Huang, Tzu-Chun Wei, Yu-Ming Liu, Nan-Jing Peng, Skye Hsin-Hsien Yeh, Yuh-Feng Wang","doi":"10.1097/JCMA.0000000000001319","DOIUrl":"10.1097/JCMA.0000000000001319","url":null,"abstract":"<p><strong>Background: </strong>To evaluate the diagnostic performance and clinical utility of integrating 18F-PSMA-1007 PET, 11C-acetate PET, and multiparametric MRI (mpMRI) in a one-stop-shop PET/MRI protocol for intermediate- to high-risk prostate cancer staging.</p><p><strong>Method: </strong>This prospective study enrolled 22 patients with biopsy-confirmed, intermediate- to high-risk prostate cancer. All underwent simultaneous 18F-PSMA-1007 PET/MRI, followed by 11C-acetate PET in a dual-tracer design. Lesion detection, concordance across modalities, and region-based sensitivity, specificity, PPV, and NPV were analyzed. The impact on clinical management was also assessed.</p><p><strong>Results: </strong>18F-PSMA-1007 PET showed superior detection of both nodal and distant metastases, with region-based sensitivity of 75.0%, specificity of 100.0%, and NPV of 92.0%. Discordant findings between PET and mpMRI occurred in 34.8% of cases, but integrated interpretation improved lesion characterization. PSMA PET alone identified clinically significant findings in 22.7% of patients. 11C-acetate did not detect any additional lesions and served as a supplementary tool. The combined PET/MRI workflow enhanced diagnostic confidence while reducing interpretive delay.</p><p><strong>Conclusion: </strong>The integration of dual-tracer PET and mpMRI into a single PET/MRI session provides a feasible, efficient, and potentially impactful strategy for prostate cancer staging. This protocol supports biologically-informed, patient-specific decision-making and may serve as a model for future risk-adapted workflows.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"69-75"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815548/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145703477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Anemia is a common complication in patients with chronic kidney disease (CKD), for which recombinant human erythropoietin (rhEPO) is the standard treatment. UB-851 is a biosimilar rhEPO developed as an alternative to epoetin alfa (Eprex ® ). This study evaluated the clinical equivalence, safety, and immunogenicity of UB-851 compared with epoetin alfa in patients with anemia due to CKD receiving hemodialysis.
Methods: In this 52-week, multicenter, randomized, parallel-group, phase III trial, patients with anemic CKD undergoing maintenance hemodialysis were assigned to receive either UB-851 or epoetin alfa. Part I (weeks 1-24) included dose titration and hemoglobin (Hb) maintenance. Part II (weeks 25-52) focused on long-term safety and immunogenicity. The primary endpoint was the change in Hb levels from baseline to the efficacy evaluation period (weeks 21-24). The secondary endpoints included epoetin dose, adverse events (AEs), and anti-drug antibody formation.
Results: A total of 201 participants were randomized, and the mean change in Hb levels during the efficacy period was within the predefined equivalence margin (±0.6 g/dL) in both the intention-to-treat and per-protocol populations. Differences in weekly epoetin dose changes between the groups also fell within the predefined equivalence range (±45 IU/kg/wk). No significant differences were observed in the laboratory parameters, electrocardiograms, or vital signs. No anti-epoetin antibodies were detected in the UB-851 group. Regarding AEs, the UB-851 appears to be biosimilar to epoetin alfa.
Conclusion: UB-851 demonstrated clinical equivalence with epoetin alfa in maintaining Hb levels in patients with anemic CKD undergoing hemodialysis. The safety and immunogenicity profiles were comparable, supporting UB-851 as a biosimilar to epoetin alfa.
{"title":"Efficacy, safety, and immunogenicity of UB-851 versus ® in patients with renal anemia receiving hemodialysis: A randomized, double-masked, phase III trial.","authors":"Chien-Hsing Wu, Chih-Chung Shiao, Hsien-Yi Wang, Ya-Chung Tian, Yi-Wen Chiu, Wen-Hung Huang, Shin-Hung Tsai, Hua-Chang Fang, Chin-Chan Lee, Bang-Gee Hsu, Horng-Rong Chang, Chien-Yu Lin, Chee-Hong Chan, Wei-Jie Wang, Kuo-Ching Huang, Szu-Chia Chen, Chia-Liang Wang, Chung-Yu Huang, Der-Cherng Tarng","doi":"10.1097/JCMA.0000000000001327","DOIUrl":"10.1097/JCMA.0000000000001327","url":null,"abstract":"<p><strong>Background: </strong>Anemia is a common complication in patients with chronic kidney disease (CKD), for which recombinant human erythropoietin (rhEPO) is the standard treatment. UB-851 is a biosimilar rhEPO developed as an alternative to epoetin alfa (Eprex ® ). This study evaluated the clinical equivalence, safety, and immunogenicity of UB-851 compared with epoetin alfa in patients with anemia due to CKD receiving hemodialysis.</p><p><strong>Methods: </strong>In this 52-week, multicenter, randomized, parallel-group, phase III trial, patients with anemic CKD undergoing maintenance hemodialysis were assigned to receive either UB-851 or epoetin alfa. Part I (weeks 1-24) included dose titration and hemoglobin (Hb) maintenance. Part II (weeks 25-52) focused on long-term safety and immunogenicity. The primary endpoint was the change in Hb levels from baseline to the efficacy evaluation period (weeks 21-24). The secondary endpoints included epoetin dose, adverse events (AEs), and anti-drug antibody formation.</p><p><strong>Results: </strong>A total of 201 participants were randomized, and the mean change in Hb levels during the efficacy period was within the predefined equivalence margin (±0.6 g/dL) in both the intention-to-treat and per-protocol populations. Differences in weekly epoetin dose changes between the groups also fell within the predefined equivalence range (±45 IU/kg/wk). No significant differences were observed in the laboratory parameters, electrocardiograms, or vital signs. No anti-epoetin antibodies were detected in the UB-851 group. Regarding AEs, the UB-851 appears to be biosimilar to epoetin alfa.</p><p><strong>Conclusion: </strong>UB-851 demonstrated clinical equivalence with epoetin alfa in maintaining Hb levels in patients with anemic CKD undergoing hemodialysis. The safety and immunogenicity profiles were comparable, supporting UB-851 as a biosimilar to epoetin alfa.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"35-44"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815523/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145758590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Pathological subtrochanteric fractures pose challenges due to the high biomechanical demands of this region and the systemic complexity of metastatic disease. At present, the optimal fixation method remains controversial, particularly between intramedullary nailing (IMN) and dynamic hip screw (DHS) fixation. This study compared the mechanical, oncological, and functional outcomes of these two treatment strategies.
Methods: This retrospective study reviewed patients treated for metastatic subtrochanteric fractures at a single tertiary referral center between 2002 and 2018. Demographic, surgical, and tumor-related characteristics were assessed. Primary outcomes included implant breakage, mechanical failure, local tumor progression, distal canal seeding, and revision surgery. Functional outcomes were evaluated using the Musculoskeletal Tumor Society (MSTS) scoring system, and survival was analyzed using the Kaplan-Meier method.
Results: Ninety patients met the inclusion criteria, including 48 treated with IMN and 42 treated with DHS fixation. DHS fixation was associated with a higher rate of implant breakage (16.7% vs 2.1%; p = 0.023), but lower rates of local tumor progression (4.8% vs 22.9%; p = 0.017) and distal canal seeding (0% vs 18.8%; p = 0.003). Revision surgery (21.4% vs 14.6%; p = 0.422), perioperative complications, MSTS functional scores, and median survival (20.3 vs 20.1 months; p = 0.938) were comparable between groups.
Conclusion: Although IMN remains essential for many pathological subtrochanteric fractures, its association with higher rates of local progression and distal canal seeding underscores the importance of careful patient selection. In appropriately selected patients, particularly those with extensive bone loss, narrow medullary canals, or elevated hemodynamic or thromboembolic risk, DHS fixation may provide a less invasive and oncologically favorable alternative with comparable functional and survival outcomes.
背景:病理性转子下骨折由于该区域的高生物力学要求和转移性疾病的系统性复杂性而提出了挑战。目前,最佳的固定方法仍然存在争议,特别是髓内钉(IMN)和动态髋螺钉(DHS)固定之间。本研究比较了这两种治疗策略的机械、肿瘤和功能结果。方法:本回顾性研究回顾了2002年至2018年在单一三级转诊中心治疗转移性转子下骨折的患者。评估了人口统计学、外科和肿瘤相关特征。主要结果包括种植体断裂、机械故障、局部肿瘤进展、远端根管播种和翻修手术。使用肌肉骨骼肿瘤协会(MSTS)评分系统评估功能结果,使用Kaplan-Meier方法分析生存。结果:90例患者符合纳入标准,其中IMN治疗48例,DHS固定42例。DHS固定与较高的种植体断裂率相关(16.7%对2.1%,p = 0.023),但较低的局部肿瘤进展率(4.8%对22.9%,p = 0.017)和远端根管播种率(0%对18.8%,p = 0.003)。翻修手术(21.4% vs. 14.6%, p = 0.422)、围手术期并发症、MSTS功能评分和中位生存期(20.3 vs. 20.1个月,p = 0.938)组间具有可比性。结论:尽管IMN对于许多病理性转子下骨折仍然是必需的,但它与较高的局部进展率和远端椎管播种的关系强调了谨慎选择患者的重要性。在适当选择的患者中,特别是那些广泛骨质流失,髓管狭窄,或血液动力学或血栓栓塞风险升高的患者,DHS固定可能提供一种侵入性较小,肿瘤有利的替代方案,具有相当的功能和生存结果。
{"title":"Comparison of treatment options with long intramedullary nail and dynamic hip screws for metastatic subtrochanteric fracture: A cohort study.","authors":"Ke-Chin Chou, Kun-Han Lee, Chao-Ming Chen, Yu-Kuan Lin, Po-Kuei Wu, Cheng-Fong Chen, Wei-Ming Chen","doi":"10.1097/JCMA.0000000000001322","DOIUrl":"10.1097/JCMA.0000000000001322","url":null,"abstract":"<p><strong>Background: </strong>Pathological subtrochanteric fractures pose challenges due to the high biomechanical demands of this region and the systemic complexity of metastatic disease. At present, the optimal fixation method remains controversial, particularly between intramedullary nailing (IMN) and dynamic hip screw (DHS) fixation. This study compared the mechanical, oncological, and functional outcomes of these two treatment strategies.</p><p><strong>Methods: </strong>This retrospective study reviewed patients treated for metastatic subtrochanteric fractures at a single tertiary referral center between 2002 and 2018. Demographic, surgical, and tumor-related characteristics were assessed. Primary outcomes included implant breakage, mechanical failure, local tumor progression, distal canal seeding, and revision surgery. Functional outcomes were evaluated using the Musculoskeletal Tumor Society (MSTS) scoring system, and survival was analyzed using the Kaplan-Meier method.</p><p><strong>Results: </strong>Ninety patients met the inclusion criteria, including 48 treated with IMN and 42 treated with DHS fixation. DHS fixation was associated with a higher rate of implant breakage (16.7% vs 2.1%; p = 0.023), but lower rates of local tumor progression (4.8% vs 22.9%; p = 0.017) and distal canal seeding (0% vs 18.8%; p = 0.003). Revision surgery (21.4% vs 14.6%; p = 0.422), perioperative complications, MSTS functional scores, and median survival (20.3 vs 20.1 months; p = 0.938) were comparable between groups.</p><p><strong>Conclusion: </strong>Although IMN remains essential for many pathological subtrochanteric fractures, its association with higher rates of local progression and distal canal seeding underscores the importance of careful patient selection. In appropriately selected patients, particularly those with extensive bone loss, narrow medullary canals, or elevated hemodynamic or thromboembolic risk, DHS fixation may provide a less invasive and oncologically favorable alternative with comparable functional and survival outcomes.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"76-84"},"PeriodicalIF":2.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12815553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145703495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Talent cultivation is a crucial focus in medical education, and retaining young physicians for further training is a primary goal for major hospitals. This study aimed to identify factors related to postgraduate year (PGY) training that influence the retention rates of resident physicians.
Methods: This longitudinal cohort study used data from 803 participants who attended PGY interviews at a 3000-bed tertiary medical center between 2014 and 2021. Demographic and interview performance data were retrieved and categorized into three main groups: individual factors, training process factors, and broader environmental factors. Participants were stratified based on their resident retention after PGY training. The associations between interview performance, PGY training content, and the year of the PGY course with resident retention were analyzed.
Results: A total of 373 participants who completed PGY training were included in the analysis. Neither the interview oral exam results nor the document review results significantly influenced the resident retention rate. The internal medicine and pediatrics groups had higher retention rates (76.92%) compared to other training groups. A significant decline was observed in resident retention rates during the coronavirus disease 2019 (COVID-19) pandemic (2020 vs 2021 retention rates were 57.14% vs 25.0%, respectively). Placing greater emphasis on academic performance during medical school and on document review results correlated with increased retention rates.
Conclusion: PGY training content and broader environmental factors, such as the COVID-19 pandemic, were correlated with resident retention.
{"title":"Effect of training content and environmental factors on resident retention rates in postgraduate year programs.","authors":"Hsiao-Chin Shen, Pei-Chi Huang, Mei-Lien Pan, Ching-Wen Yang, Chia Chen Ma, Shin-Yu Tsai, Hsiao-Yun Yeh, Yi-Hsuan Lin, Ying-Ying Yang, Shuu-Jiun Wang","doi":"10.1097/JCMA.0000000000001306","DOIUrl":"10.1097/JCMA.0000000000001306","url":null,"abstract":"<p><strong>Background: </strong>Talent cultivation is a crucial focus in medical education, and retaining young physicians for further training is a primary goal for major hospitals. This study aimed to identify factors related to postgraduate year (PGY) training that influence the retention rates of resident physicians.</p><p><strong>Methods: </strong>This longitudinal cohort study used data from 803 participants who attended PGY interviews at a 3000-bed tertiary medical center between 2014 and 2021. Demographic and interview performance data were retrieved and categorized into three main groups: individual factors, training process factors, and broader environmental factors. Participants were stratified based on their resident retention after PGY training. The associations between interview performance, PGY training content, and the year of the PGY course with resident retention were analyzed.</p><p><strong>Results: </strong>A total of 373 participants who completed PGY training were included in the analysis. Neither the interview oral exam results nor the document review results significantly influenced the resident retention rate. The internal medicine and pediatrics groups had higher retention rates (76.92%) compared to other training groups. A significant decline was observed in resident retention rates during the coronavirus disease 2019 (COVID-19) pandemic (2020 vs 2021 retention rates were 57.14% vs 25.0%, respectively). Placing greater emphasis on academic performance during medical school and on document review results correlated with increased retention rates.</p><p><strong>Conclusion: </strong>PGY training content and broader environmental factors, such as the COVID-19 pandemic, were correlated with resident retention.</p>","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":" ","pages":"949-956"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12742713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145350935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-26DOI: 10.1097/01.JCMA.0001177672.68128.57
{"title":"Title Index.","authors":"","doi":"10.1097/01.JCMA.0001177672.68128.57","DOIUrl":"https://doi.org/10.1097/01.JCMA.0001177672.68128.57","url":null,"abstract":"","PeriodicalId":94115,"journal":{"name":"Journal of the Chinese Medical Association : JCMA","volume":"88 12","pages":"XIV-XVIII"},"PeriodicalIF":2.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145835635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}