Therapeutics and Clinical Risk Management最新文献

{"title":"Predicting Sensory Block Level in Caudal Anesthesia Based on Sacral Canal Anatomical Parameters and Height: Development of an Ordinal Logistic Regression Model and Nomogram.","authors":"Zhengying Li, Haixuan Wu, Simin Zhang, Shuailong Yu, Ling Liu, Ning Liufu","doi":"10.2147/TCRM.S581371","DOIUrl":"10.2147/TCRM.S581371","url":null,"abstract":"<p><strong>Background: </strong>Caudal block in clinical practice relies on empirical drug administration without reliable prediction of anesthetic level, thereby limiting its application. This study aimed to develop a predictive model for sensory block level based on sacral canal anatomical factors and patient characteristics.</p><p><strong>Methods: </strong>A total of 132 patients undergoing elective anal surgery with caudal block were included. Ultrasound measured anatomical parameters (the width of the base of the sacrum (BSW), the anterior-posterior diameter of the sacral hiatus at its apex (SHAP), the anterior-posterior diameter of the sacral hiatus at the first segment inferior to the apex (SHFSIA-AP), the length of the sacral hiatus in the sagittal plane (SHLS) and demographic data (age, gender, height, weight) were collected. Sensory block level was categorized into five ordinal grades. Multivariable ordinal logistic regression identified independent predictors, with variance inflation factor (VIF) assessing multicollinearity and Brant test verifying proportional odds assumption. Model performance was evaluated via concordance index (C-index) and Lipsitz test, with internal validation performed using bootstrapping with 1000 resamples, and a nomogram was constructed.</p><p><strong>Results: </strong>Univariable analysis showed SHAP, SHLS, SHFSIA-AP, height, age, gender, and weight correlated with sensory block level (<i>P</i><0.05). Final independent predictors were SHAP, SHLS, and height. No multicollinearity (VIF<5) and valid proportional odds assumption (Brant test <i>P</i>=0.36) were confirmed. The model had good predictive performance (C-index=0.881, 95% CI [0.809-0.953]) and fit (Lipsitz test <i>P</i>=0.49), with the nomogram visualizing probabilities of each block level category.</p><p><strong>Conclusion: </strong>This study identified SHAP, SHLS, and height as predictors for caudal block sensory level. The nomogram enables individualized, precise drug administration, shifting the technique from experience-based to precision prediction.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"581371"},"PeriodicalIF":2.6,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13180391/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147975704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Staged Management of Bone Defects in Chronic Osteomyelitis and Nonunions Using Antibiotic-Loaded Calcium Sulphate-Hydroxyapatite: A Multicenter Retrospective Analysis of 101 Cases.","authors":"Jonas Armbruster, Nick Mattern, Felix Lamadé-Dootz, Eva Simone Steinhausen, Gregor Reiter, Marcel Dudda, Paul Alfred Grützner, Holger Freischmidt","doi":"10.2147/TCRM.S599996","DOIUrl":"10.2147/TCRM.S599996","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the clinical outcomes of an antibiotic-loaded calcium sulphate-hydroxyapatite biocomposite (ALB) used specifically in staged surgical protocols for chronic osteomyelitis and nonunions, including large bone defects resulting from the necessary debridement of necrotic bone.</p><p><strong>Patients and methods: </strong>This retrospective multicenter study analyzed 101 patients treated between 2013 and 2020. Inclusion criteria comprised adult patients with bone defects resulting from osteomyelitis, septic nonunion, or aseptic nonunion, treated with ALB (gentamicin or vancomycin) in a staged procedure. The primary outcome was treatment success, defined as infection eradication and stable bone consolidation without unplanned surgical revision. Secondary outcomes included revision rates, reinfection rates, and biomaterial-related side effects such as white drainage.</p><p><strong>Results: </strong>Treatment success was achieved in 30.7% of patients. The overall revision rate was 58.4%, and the reinfection rate was 45.5%. The mean defect size was 4.1 cm. Statistical analysis identified larger defect sizes and higher volumes of implanted ALB as significant risk factors for failure. \"White drainage\" was observed in 13.9% of patients and was significantly associated with the use of larger material volumes.</p><p><strong>Conclusion: </strong>The use of ALB in staged protocols for large bone defects is associated with high revision and reinfection rates. These findings identify the limits of the technique and sharpen its indication spectrum, standing alongside the favorable outcomes reported for single-stage procedures in smaller defects. In large defects, the resorption of the carrier may outpace bone ingrowth, leading to recurrence of infection. Consequently, the use of ALB in large defects cannot be recommended based on these data.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"599996"},"PeriodicalIF":2.6,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13165491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147933802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mesenchymal Stromal Cells in Knee Osteoarthritis: A Review of Nomenclature, Criteria, and Therapeutic Mechanisms.","authors":"Doo-Ho Lim, Chae-Chil Lee, Ki-Bong Park","doi":"10.2147/TCRM.S594869","DOIUrl":"10.2147/TCRM.S594869","url":null,"abstract":"<p><p>Cell-based therapies, particularly utilizing mesenchymal cells, have garnered significant global attention for treating knee osteoarthritis (OA). However, interpreting clinical outcomes remains challenging due to substantial heterogeneity in study designs, cell sources, and preparation methods. This narrative review aims to clarify the evolving nomenclature, outline defining criteria, and elucidate the fundamental mechanisms of these therapies. We highlight the critical scientific transition from \"mesenchymal stem cells\" to \"mesenchymal stromal cells\", an adjustment strongly supported by recent clinical approvals emphasizing immune recalibration over direct tissue regeneration. Currently, robust evidence indicates that mesenchymal stromal cells exert their therapeutic effects primarily through paracrine signaling and immunomodulation, predominantly orchestrated by exosomes, rather than through lineage-driven direct structural repair. Furthermore, we address the practical implications of cell processing-differentiating between minimal manipulation (e.g. cell concentrates) and in vitro expansion-and the stringent regulatory frameworks governing them. Ultimately, standardizing the mechanism-accurate \"stromal\" terminology and optimizing cell preparation protocols are essential steps for advancing the efficacy and reliability of regenerative treatments in knee OA.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"594869"},"PeriodicalIF":2.6,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13159940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147933775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Intravenous Esketamine or Magnesium Sulfate on Early Postoperative Negative Emotions and Pain in Patients Undergoing Endoscopic Sinus Surgery: A Randomized Controlled Trial.","authors":"Luyao Wang, Jie Zhou, Qian Liu, Kun Qian, Lei Wang, Chenglan Xie","doi":"10.2147/TCRM.S588126","DOIUrl":"10.2147/TCRM.S588126","url":null,"abstract":"<p><strong>Background: </strong>N-methyl-D-aspartate (NMDA) receptor antagonists are crucial for managing perioperative pain and psychological distress. Both esketamine and magnesium sulfate are NMDA receptor antagonists. This study compared their effects on early postoperative negative emotions and pain in patients undergoing endoscopic sinus surgery (ESS).</p><p><strong>Methods: </strong>This study involved 137 patients scheduled for ESS were randomly assigned to three groups: Group E (esketamine), Group M (magnesium sulfate), and Group C (saline control). Before induction, Group E received esketamine 0.25 mg/kg loading over 10 min then 0.25 mg/(kg·h) infusion until surgery end; Group M received magnesium sulfate 30 mg/kg loading over 10 min then 10 mg/(kg·h) infusion until surgery end; Group C received equal volume of normal saline. Hospital Anxiety and Depression Scale (HADS) and Self-rating Anxiety/Depression Scale (SAS/SDS) scores were assessed on postoperative days 1 and 2 (POD1, POD2). VAS scores, hemodynamics, intraoperative drug use, and adverse events were also evaluated.</p><p><strong>Results: </strong>On POD1, HADS, SAS, and SDS scores were significantly lower in Groups E and M than in Group C (<i>P</i>< 0.05). On POD2, these scores were lower in Group E than in Groups C and M(<i>P</i><0.05). VAS pain scores were significantly lower in Groups E and M at 2, 4, and 8 hours postoperatively (<i>P</i><0.001). Remifentanil consumption was lower in Groups E and M than in Group C (<i>P</i><0.05), nitroglycerin consumption was lower in Group M than in Group E (<i>P</i><0.05). Incidences of sore throat, rescue analgesia, postoperative respiratory depression, and PONV in Groups E and M were significantly lower than those in Group C (<i>P</i><0.05).</p><p><strong>Conclusion: </strong>Intravenous esketamine or magnesium sulfate effectively alleviated negative emotions and pain on POD1 in patients undergoing ESS.Esketamine demonstrated superior efficacy over magnesium sulfate on POD2.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"588126"},"PeriodicalIF":2.6,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13159737/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147933832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcome of Emergent ABO-Incompatible Liver Transplantation is Acceptable but at the Cost of Higher Diffuse Intrahepatic Biliary Stricture: A Single-Center, Retrospective Study.","authors":"Junfang Liu, Jiameng Qi, Ying Chen, Xin Duan, Xinyu Yu, Pingbo Jin, Yuntao Zhang, Wei Zhang","doi":"10.2147/TCRM.S567879","DOIUrl":"10.2147/TCRM.S567879","url":null,"abstract":"<p><strong>Objective: </strong>The efficacy and clinical outcomes of emergent rituximab-based desensitization therapy in ABO-incompatible liver transplantation (ABO-I LT) remain poorly characterized. In this study, we analyzed a single-center cohort of emergency ABO-I LT recipients to delineate key clinical features and identify independent predictors of post-transplant survival.</p><p><strong>Methods: </strong>Between January 1, 2015, and August 31, 2021, 1015 (90.2%) recipients received ABO-compatible (ABO-C) deceased donor liver transplantation (DDLT), and 110 (9.8%) received ABO-I DDLT with emergent rituximab-based desensitization.</p><p><strong>Results: </strong>The ABO-C and ABO-I DDLT groups were followed up for 49.6 and 43.6 months, respectively. Following 1:1 propensity score matching (n=110 per group), the ABO-I group exhibited lower survival rates compared to the ABO-C group at 1, 3, and 5 years (74.0%, 68.5%, and 65.5% vs 88.0%, 83.0%, and 80.7%; <i>P</i> = 0.024). Multivariate analysis identified age > 65 years, liver cancer pre-transplantation, intraoperative blood loss > 1000 mL, and diffuse intrahepatic biliary stricture (DIHBS) as independent risk factors for patient survival. Crucially, after excluding DIHBS, survival outcomes between the two groups were comparable (<i>P</i> = 0.336).</p><p><strong>Conclusion: </strong>Emergent ABO-I LT with an adjusted desensitization protocol is feasible but associated with inferior survival due to a higher incidence of DIHBS. This disparity underscores the need for refined strategies to mitigate DIHBS and improve ABO-I LT outcomes.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"567879"},"PeriodicalIF":2.6,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13157701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147875768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevention and Care of Pressure Ulcers in Long-Term Bedridden Adult and Older Adult Patients in the Community: A Systematic Review.","authors":"Liuren Meng, Samoraphop Banharak, Chakkarin Sommana, Khanisorn Ransinyo, Wuttipong Cheumnok, Junhong Tian","doi":"10.2147/TCRM.S592581","DOIUrl":"10.2147/TCRM.S592581","url":null,"abstract":"<p><p>Pressure injuries remain a significant and costly complication among long-term bedridden adult and older adult patients, leading to increased morbidity, complications, and a diminished quality of life. This review aimed to summarize interventions for the prevention and care of pressure ulcers among long-term bedridden adult and older adult patients in the community. Fourteen databases were searched from March 2013 to March 2024, yielding 16 studies for final analysis. Two interconnected core elements were identified: 1) multidimensional intervention pathways and 2) three targeted preventive measures. The pathways include face-to-face education/training, home visits, digital tools (WeChat/smartphone apps), multidisciplinary collaboration, and remote follow-up. The targeted measures-position management with pressure-relief techniques, skin integrity maintenance, and nutritional/fluid support-were associated with improvements in PU-related outcomes: combined repositioning and pressure-relief devices were associated with lower PU incidence, temperature-controlled skin care with zinc oxide was associated with reduced skin redness, high-protein diets and omega-3 supplements were associated with improved skin resilience and barrier function, and integrated protocols (Braden-stratified repositioning/app monitoring) may improve care efficiency. Limitations included heterogeneity in study designs and outcome measures, incomplete reporting of implementation details, and limited geographical representation, as most were conducted in China (14/16), with only one study each from Finland and India. The certainty of evidence ranged from very low to moderate across outcomes; therefore, the findings should be interpreted cautiously. This review highlights potentially adaptable strategies for community-based PU prevention and care. It underscores the need for standardized, long-term studies to enhance the generalizability and sustainability of intervention strategies. <b>Prospero Registration Number</b>: CRD42024524789.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"592581"},"PeriodicalIF":2.6,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13155244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147869541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Effects of Prone Position Ventilation Combined with Drug on Clinical Outcomes in Neonates with ARDS: A Single-Center Retrospective Cohort Study.","authors":"Chunyan Lin, Ting Huang, Huangyi Wu, Yanzhu Lin, Chunling Guo, Liduan Li","doi":"10.2147/TCRM.S578819","DOIUrl":"10.2147/TCRM.S578819","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the association of prone position ventilation combined with intravenous ambroxol versus conventional supine ventilation on clinical outcomes in neonates with acute respiratory distress syndrome (ARDS).</p><p><strong>Methods: </strong>Neonates with ARDS admitted to the Neonatal Intensive Care Unit (NICU) of the Second Affiliated Hospital of Fujian Medical University between January 2023 and December 2024 were included. A total of 80 neonates were allocated into two groups (n=40 each) based on a temporal shift in clinical practice: an Observation Group receiving prone positioning (target >16 hours/day) plus intravenous ambroxol (7.5 mg/kg twice daily for 5 days), and a Control Group receiving supine ventilation alone. Both groups received standard lung-protective ventilation and co-interventions per protocol. The primary outcome was ventilator-free days (VFDs) to day 28.</p><p><strong>Results: </strong>The primary outcome, VFDs, was significantly higher in the observation group (median [IQR]: 18 [15-21] days) than in the control group (14 [10-17] days; P=0.003). The observation group also had a shorter duration of mechanical ventilation (mean difference: 2.04 days; 95% CI: 1.55 to 2.53; P<0.001) and a shorter hospital length of stay (mean difference: 6.55 days; 95% CI: 5.61 to 7.49; P<0.001). Physiological parameters improved more favorably in the observation group, with a significant Group × Time interaction for the Oxygenation Index (P<0.001) and a lower peak inspiratory pressure at 72 hours (adjusted mean difference: -1.95 cmH₂O; 95% CI: -2.45 to -1.45; P<0.001). The overall incidence of major complications was lower in the observation group (12.5% vs. 47.5%; Relative Risk: 0.26; 95% CI: 0.11 to 0.62; P=0.001).</p><p><strong>Conclusion: </strong>In this cohort, the combination therapy was associated with significantly improved respiratory outcomes and a lower complication rate in neonates with ARDS, suggesting it may be a beneficial adjunctive strategy. These findings warrant validation in a prospective randomized trial.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"578819"},"PeriodicalIF":2.6,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13138317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147843219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"rs10010131A in <i>WFS1</i> is Associated with Elevated Serum Urea in Type 2 Diabetes Patients Treated with SGLT2 Inhibitors.","authors":"Khaled Naja, Asma A Elashi, Laila Hedaya, Najeha Rizwana Anwardeen, Mashael Al-Shafai, Manfredi Rizzo, Mohamed A Elrayess","doi":"10.2147/TCRM.S578286","DOIUrl":"10.2147/TCRM.S578286","url":null,"abstract":"<p><strong>Introduction: </strong>Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are effective agents for type 2 diabetes (T2D) management, yet interindividual variability in response mechanisms remains unclear. This study examined genetic interactions influencing clinical and biochemical outcomes among SGLT2i treated patients.</p><p><strong>Methods: </strong>Data from 13,808 Qatar Biobank participants were analyzed, including 207 propensity score-matched T2D patients stratified into three groups: SGLT2i-treated, metformin monotherapy, and drug-naïve. Significant clinical traits across groups were further assessed for genotype effects within SGLT2i treated patients.</p><p><strong>Results: </strong>Compared with both comparators, SGLT2i-treated individuals showed elevated serum urea (FDR < 0.05). Genetic analysis identified an association between the <i>WFS1</i> rs10010131 A allele and higher urea levels exclusively in SGLT2i treated patients (β = +0.63 mmol/L per A allele, 95% CI [0.14-1.11], p = 0.012). This variant showed strong linkage disequilibrium <i>(r²</i> = 0.95, D' = 0.99) with rs6446482 in <i>WFS1</i>. Kidney-specific eQTL data revealed reduced <i>WFS1</i> expression in A-allele carriers.</p><p><strong>Discussion: </strong>These findings suggest a novel pharmacogenetic interaction between WFS1 rs10010131 and urea regulation under SGLT2i therapy. The observed effect could likely reflect a genotype-related renal adaptive response rather than dysfunction, emphasizing the potential of pharmacogenomic profiling to enhance precision treatment for T2D.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"578286"},"PeriodicalIF":2.6,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13135346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147821135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Camrelizumab Plus Apatinib in Advanced Unresectable Alveolar Soft Part Sarcoma and Undifferentiated Pleomorphic Sarcoma Patients: A Single-Center, Exploratory Case Series.","authors":"Huijing Tan, Huike Wang, Jianguo Zhou, Liming Jiang, Susheng Shi, Wenna Wang, Yihebali Chi","doi":"10.2147/TCRM.S586907","DOIUrl":"10.2147/TCRM.S586907","url":null,"abstract":"<p><strong>Background: </strong>Certain histologic subtypes of advanced soft tissue sarcomas, including alveolar soft part sarcoma (ASPS) and undifferentiated pleomorphic sarcoma (UPS), lack standardized therapeutic options following anthracycline-based first-line therapy. This study was to investigate the efficacy and safety of camrelizumab plus apatinib in advanced unresectable ASPS or UPS.</p><p><strong>Methods: </strong>In this single-center, exploratory case series, patients with ASPS or UPS received a combination of camrelizumab and apatinib. The primary endpoint was the objective response rate (ORR), while the exploratory endpoints included progression-free survival (PFS), overall survival (OS), and safety.</p><p><strong>Results: </strong>The median follow-up period was 24.0 months, with an ORR of 88.9% (8/9). In the ASPS subgroup (n=7), neither the median PFS (mPFS) nor median OS (mOS) was reached, while the ORR was 100.0% (7/7). In the UPS subgroup (n=2), the mPFS was 7.5 months and the mOS was 9.5 months, with the ORR of 50.0% (1/2). One patient with ASPS died from immune-mediated myocarditis; all other adverse events (AEs) were grade 1-2 and manageable with symptomatic treatment.</p><p><strong>Conclusion: </strong>The combination therapy of camrelizumab and apatinib may provide benefits in clinical outcomes for ASPS, while the outcomes in UPS appears more variable, warranting further study. Close monitoring for AEs, especially fatal complications such as immune-mediated myocarditis, is essential.</p><p><strong>Registration: </strong>ClinicalTrials.gov (identifier: NCT04447274), registration date: 23-Jun-2020.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"586907"},"PeriodicalIF":2.6,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13117838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147781758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pregnancy Outcomes Following Medical Therapy versus Levonorgestrel-Releasing Intrauterine System for Atypical Endometrial Hyperplasia.","authors":"Min Wang, Shaojie Zhao, Hua Yuan, Min Zhao, Chen Hang, Rong Yuan","doi":"10.2147/TCRM.S577040","DOIUrl":"10.2147/TCRM.S577040","url":null,"abstract":"<p><strong>Objective: </strong>To compare pregnancy outcomes between systemic progestin therapy and levonorgestrel-releasing intrauterine system (LNG-IUS) in patients with atypical endometrial hyperplasia (AEH) desiring fertility preservation.</p><p><strong>Methods: </strong>This single-center retrospective cohort study included AEH patients who underwent fertility-sparing treatment between January 2017 and December 2024. Patients received either systemic progestins (medroxyprogesterone acetate [MPA] 250-600 mg/day, megestrol acetate [MA] 160-320 mg/day, or dydrogesterone 20-40 mg/day) or LNG-IUS. Primary outcomes were clinical pregnancy rate and live birth rate. Secondary outcomes included time to pregnancy (TTP), conception mode, and disease recurrence rate. Propensity score matching (PSM) controlled for confounders including age, body mass index, polycystic ovary syndrome, and infertility duration.</p><p><strong>Results: </strong>Of 186 patients (121 medical therapy, 65 LNG-IUS), 58 per group were analyzed after PSM. Complete remission rates were 77.6% (45/58) versus 84.5% (49/58) (adjusted OR 1.52, 95% CI 0.71-3.26, p=0.28). Among patients achieving complete remission, clinical pregnancy rates were 51.1% (23/45) versus 67.3% (33/49) (adjusted OR 2.14, 95% CI 1.08-4.25, p=0.029). Live birth rates were 37.8% (17/45) versus 55.1% (27/49) (adjusted OR 2.28, 95% CI 1.13-4.62, p=0.022). Median TTP was 8.5 months (IQR 6-14) versus 6.0 months (IQR 4-10) (HR 1.64, 95% CI 1.12-2.41, p=0.011). Per-protocol analysis yielded consistent results.</p><p><strong>Conclusion: </strong>LNG-IUS treatment was associated with significantly higher clinical pregnancy rates, live birth rates, and shorter TTP compared to systemic progestin therapy. These findings support LNG-IUS as a preferred fertility-sparing option for AEH patients, particularly when expedited conception is desired. Results should be interpreted considering the retrospective design, heterogeneous dosing, and potential residual confounding.</p>","PeriodicalId":22977,"journal":{"name":"Therapeutics and Clinical Risk Management","volume":"22 ","pages":"577040"},"PeriodicalIF":2.6,"publicationDate":"2026-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13103487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147781841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}