RESUMEN
Objectives: This study analyzed the safety of coronavirus disease 2019 (COVID-19) bivalent and monovalent booster vaccines, including the frequency of adverse events (AEs) such as myocarditis and pericarditis, in adolescents aged 12 to 17 years in the Republic of Korea. We aimed to share the safety profile of the COVID-19 bivalent vaccine booster doses. Methods: We analyzed the frequencies of AEs reported to the COVID-19 vaccination management system (CVMS) or self-reported through the text message survey (TMS). Diagnostic eligibility and causality with vaccines were compared using odds ratios (ORs) by vaccine type, and incidence rates per 100,000 person-days were calculated for confirmed cases of myocarditis and pericarditis following monovalent and bivalent booster doses. Results: In the CVMS, the AE reporting rate (per 100,000 doses) was lower after the bivalent booster (66.5) than after the monovalent booster (264.6). Among the AEs reported for both monovalent and bivalent vaccines, 98.2% were non-serious and 1.8% were serious. According to the TMS, both local and systemic AEs were reported less frequently after the bivalent vaccination than after the monovalent vaccination in adolescents aged 12 to 17 years (p<0.001). The incidence rates per 100,000 person-days for confirmed myocarditis/pericarditis following monovalent and bivalent booster doses were 0.03 and 0.05, respectively; this difference was not statistically significant (OR, 1.797; 95% confidence interval, 0.210-15.386). Conclusion: AEs in 12- to 17-year-olds following the bivalent booster were less frequent than those following the monovalent booster in the Republic of Korea, and no major safety issues were identified. However, the reporting rates for AEs were low.
RESUMEN
Two-dimensional magnetic materials are considered as promising candidates for developing next-generation spintronic devices by providing the possibility of scaling down to nanometers. However, a low Curie temperature is a crucial problem for practical applications, being intimately related to weak interlayer exchange coupling. Here, by using density functional theory calculations, we show that interlayer exchange coupling can be enhanced by intercalating 3d transition metals (Sc to Zn) into a bilayer of CrI3 and NiI2. It is found that intercalated Ni and Cr atoms exhibit strong antiferromagnetic coupling with the CrI3 and NiI2 host layers, respectively. This enhances the ferromagnetic interlayer exchange coupling between the host layers by many folds compared to pristine CrI3 and NiI2 bilayers. Moreover, both intercalated compounds show out-of-plane magnetic anisotropy with half metallic nature, which makes them ideal candidates for spintronics applications. Thereby our work provides a rational approach to raise the Curie temperature of non-metallic two-dimensional magnets by intercalation.
RESUMEN
Fecal calprotectin (FC) is commonly used to assess Crohn's disease (CD) activity. However, standardized cut-off values accounting for bowel resection history and disease location are lacking. In this study, we analyzed data from patients with CD who underwent magnetic resonance enterography, ileocolonoscopy, and FC measurements from January 2017 to December 2018. In 267 cases from 254 patients, the FC levels in the 'operated' patients were higher when the disease was active compared with those who were in the remission group (178 vs. 54.7 µg/g; p < 0.001), and similar findings were obtained for the 'non-operated' patients (449.5 vs. 40.95 µg/g; p < 0.001). The FC levels differed significantly according to the location of inflammation, with lower levels in the small bowel compared to those in the colon. The FC cut-off levels of 70.8 µg/g and 142.0 µg/g were considered optimal for predicting active disease for operated and non-operated patients, respectively. The corresponding FC cut-off levels of 70.8 µg/g and 65.0 µg/g were observed for patients with disease only in the small bowel. In conclusion, different FC cut-off values would be applicable to patients with CD based on their bowel resection history and disease location. Tight control with a lower FC target may benefit those with a history of bowel resection or small-bowel-only disease.
RESUMEN
BACKGROUND: Vaccines are vital for public health, but concerns about adverse effects, particularly myocarditis and pericarditis linked to COVID-19 vaccines-, persist. This study investigates the application of Brighton Collaboration case definition to national vaccine safety data related to post-COVID-19 vaccine myo/pericarditis, utilizing claims under the Korea National Vaccine Injury Compensation Program (NIVCP). METHODS: This study analyzed 190 medical records of individuals who claimed to have developed myo/pericarditis after receiving the COVID-19 vaccine, as reported to the NVICP between specified dates, categorizing cases based on the Brighton criteria for myocarditis or pericarditis. RESULTS: Between 2021-2022, NVICP received 190 cases meeting the Brighton criteria for myocarditis or pericarditis at levels 1, 2, or 3. Most cases fell into Level 2 (70%), followed by Level 1 (29%), and one at Level 3 (1%), with Level 1 cases showing a higher hospitalization rate (87.3%) and a notable proportion requiring admission to the Intensive Care Unit (25.5%). Chest pain and Troponin-I/T elevation were common findings in Level 1 cases, while Level 2 cases exhibited similar patterns but at a slightly lower frequency. Electrocardiogram and echocardiography findings differed between the two levels. CONCLUSION: The Brighton Collaboration case definition proved valuable for classifying and assessing AEFI data, enhancing our understanding of the potential relationship between myocarditis and the COVID-19 vaccine.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Miocarditis , Pericarditis , Humanos , Miocarditis/etiología , Pericarditis/etiología , República de Corea , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Masculino , Adolescente , Femenino , COVID-19/prevención & control , COVID-19/epidemiología , Hospitalización/estadística & datos numéricos , SARS-CoV-2/inmunologíaRESUMEN
In the present study, reduced toxicity (FluBu3) and myeloablative (BuCy) conditioning were compared in patients with AML who received first allogeneic HSCT in MRD-negative CR1. The study included 124 adult patients who underwent HSCT from an HLA-matched (8/8) sibling, unrelated, or 1-locus mismatched (7/8) unrelated donor (MMUD). The median age was 45 years and intermediate cytogenetics comprised majority (71.8%). The 2-year OS, RFS, CIR and NRM for BuCy (n = 78, 62.9%) and FluBu3 (n = 46, 37.1%) groups were 78.3% and 84.5% (p = 0.358), 78.0% and 76.3% (p = 0.806), 7.7% and 21.5% (p = 0.074) and 14.3% and 2.2% (p = 0.032), respectively. At the time of data cut-off, relapse and NRM were the main causes of HSCT failure in each of the FluBu3 and BuCy arms. Among patients, 75% of relapsed FluBu3 patients had high-risk features of either poor cytogenetics or FLT3-ITD mutation compared with 16.7% of BuCy patients. The majority of NRM in the BuCy group was due to GVHD (73%), half of whom received MMUD transplantation. To conclude, the FluBu3 reduced toxicity conditioning showed comparable post-transplant OS and RFS to BuCy and was associated with significantly reduced NRM that was offset by a trend towards higher risk of relapse even in MRD-negative CR1 population.
Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Leucemia Mieloide Aguda , Acondicionamiento Pretrasplante , Humanos , Acondicionamiento Pretrasplante/métodos , Leucemia Mieloide Aguda/terapia , Leucemia Mieloide Aguda/mortalidad , Persona de Mediana Edad , Trasplante de Células Madre Hematopoyéticas/métodos , Masculino , Femenino , Adulto , Neoplasia Residual , Trasplante Homólogo/métodos , Anciano , Adolescente , Adulto Joven , Agonistas Mieloablativos/uso terapéutico , AloinjertosRESUMEN
BACKGROUND/AIMS: The impact of vaccination on inflammatory bowel disease (IBD) patients is still unknown, and no studies have assessed the changes in patient-reported outcomes (PROs) after vaccination in patients with IBD. Therefore, in this study, we investigated the impact of vaccines on the PROs of patients with IBD. METHODS: We conducted a questionnaire survey of patients with IBD who visited outpatient clinics at 4 specialized IBD clinics of referral university hospitals from April 2022 to June 2022. A total of 309 IBD patients were included in the study. Patient information was collected from a questionnaire and their medical records, including laboratory findings, were reviewed retrospectively. Risk factors associated with an increase in PROs after COVID-19 vaccination were analyzed using logistic regression analyses. In addition, we assessed whether there were differences in variables by vaccine order using the linear mixed model. RESULTS: In multivariate analysis, young age ( < 40 years) and ulcerative colitis (UC) were found to be independent risk factors for aggravation of PROs in patients with IBD. In all patients, platelet count significantly increased with continued vaccination in multiple pairwise comparisons. In UC patients, PROs such as the short health scale, UC-abdominal signs and symptoms, and UC-bowel signs and symptoms were aggravated significantly with continued vaccination. There was no significant increase in the variables of patients with Crohn's disease. CONCLUSIONS: Therefore, there may be a need to counsel patients with IBD younger than 40 years of age, and patients with UC before they receive COVID-19 vaccinations.
RESUMEN
BACKGROUND: Few clinical studies have addressed concavity restoration by natural remodeling after a Latarjet procedure. This study investigated the fibrous tissue and osseous remodeling of the reconstructed glenoid and concavity restoration after a Latarjet procedure using postoperative computed tomographic arthrography (CTA). METHODS: This retrospective study included 31 patients who underwent immediate postoperative computed tomographic (CT) scanning followed by CTA at 6 months postoperatively. We investigated whether fibrous tissue was newly created over the graft, whether the created fibrous tissue restored the congruity of the articular surface and the osseous remodeling of the graft to the glenoid level (whether the osseous portion of the graft was remodeled flush to the glenoid level) and the concavity of the glenoid using the radius of a best-fit circle on the articular surface, and the relationship between the amount of created fibrous tissue and the position of the graft. RESULTS: In all patients, the fibrous tissue on the graft yielded a smooth articular surface, as revealed by the CTA. The mean radius of the entire glenoid, including the transferred graft, was significantly smaller (p = 0.010) at 33.2 ± 8.5 mm than that of the glenoid posterior to the osseous step-off at 37.6 ± 9.4 mm, which is presumed to be the glenoid before the surgical procedure. Despite the congruity of the articular surfaces due to fibrous tissue seen in the CTA, 14 (45%) of 31 patients showed a subchondral osseous step-off on either the medial side or the lateral side in the immediate postoperative CT scans. However, through osseous remodeling, 8 of the 10 grafts with a lateral step-off and 2 of the 4 grafts with a medial step-off converted to a flush position. The position of the step-off was correlated with the thickness of the fibrous tissue, with a tendency for thicker tissue in cases of a step-off on the medial side (p = 0.014). CONCLUSIONS: Fibrous tissue formation plus remodeling of the transferred graft resulted in the restoration of a congruent concavity after a Latarjet procedure by compensating for initially non-flush positioning of the graft. However, due to the small sample size in our study, clinical outcomes could not be correlated with radiographic findings, and our recommendation is to continue placing the graft as anatomically as possible. LEVEL OF EVIDENCE: Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence.
Asunto(s)
Inestabilidad de la Articulación , Articulación del Hombro , Humanos , Articulación del Hombro/diagnóstico por imagen , Articulación del Hombro/cirugía , Estudios Retrospectivos , Inestabilidad de la Articulación/cirugía , Escápula/cirugía , Artroplastia/métodos , Trasplante Óseo/métodosRESUMEN
PURPOSE: To investigate the surgical outcomes of arthroscopic pull-out repair for medial meniscus root tear (MMRT) combined with the marrow stimulation procedures (MSP) for accompanying high-grade cartilage lesions. METHODS: Patients who underwent arthroscopic pull-out repair for MMRT between 2010 and 2019 were retrospectively reviewed. Patients who had at least 3 years of follow-up were included and classified into two groups according to whether MSP (microfracture or microdrilling) were performed on cartilage lesions in the medial tibiofemoral joint (group 1, patients with International Cartilage Repair Society [ICRS] grade 0-3a lesions and did not undergo MSP; group 2, patients with ICRS grade 3b-3d lesions and underwent MSP). Comparative analyses, including non-inferiority trials, were conducted between groups for subjective and objective outcomes. In addition, group 2 was further divided into two subgroups according to cartilage lesion size and compared with group 1 (group S, ≤ 2.0 cm2; group L, > 2.0 cm2). RESULTS: A total of 94 patients were included (group 1, 68 patients; group 2, 26 patients). There were no significant differences in clinical scores at postoperative 3 years and final follow-up between groups 1 and 2, but group 2 failed to satisfy the non-inferiority criteria compared to group 1 overall. In objective outcomes, group 2 did not meet the non-inferiority criteria for the rate of osteoarthritis progression compared to group 1, and it also showed a significantly higher proportion of high-grade osteoarthritis at final follow-up (P = 0.044) and a higher degree of osteoarthritis progression than group 1 (P = 0.03 for pre- to postoperative 3 years, and P = 0.006 for pre- to final follow-up). In additional evaluations comparing the subgroups of group 2 and group 1, group S showed relatively favourable results compared to group L in objective outcomes at final follow-up. CONCLUSION: Patients who underwent arthroscopic pull-out repair for MMRT combined with MSP for accompanying high-grade cartilage lesions showed suboptimal outcomes compared to those with no or low-grade lesions at mid-term follow-up. High-grade cartilage lesions ≤ 2.0 cm2 may be candidates for the surgical repair of MMRT if MSP are performed, but those with larger lesions may require alternative treatment strategies. LEVEL OF EVIDENCE: III.
Asunto(s)
Cartílago Articular , Osteoartritis , Humanos , Meniscos Tibiales/cirugía , Estudios Retrospectivos , Médula Ósea/patología , Artroscopía/métodos , Osteoartritis/cirugía , Rotura/patología , Cartílago Articular/cirugía , Cartílago Articular/patología , Resultado del TratamientoRESUMEN
To explore the optimal mobilization for multiple myeloma (MM) patients, we conducted a prospective trial comparing single-dose etoposide (375 mg/m2 for one day) plus G-CSF versus G-CSF alone, followed by risk-adapted plerixafor. After randomization, 27 patients in the etoposide group and 29 patients in the G-CSF alone group received mobilizations. Six (22.2%) patients in the etoposide group and 15 (51.7%) patients in the G-CSF alone group received plerixafor based on a peripheral blood CD34+ cell count of < 15/mm3 (p = 0.045). The median count of CD34+ cells collected was significantly higher in the etoposide group (9.5 × 106/kg vs. 7.9 × 106/kg; p = 0.018), but the optimal collection rate (CD34+ cells ≥ 6 × 106/kg) was not significantly different between the two groups (96.3% vs. 82.8%; p = 0.195). The rate of CD34+ cells collected of ≥ 8.0 × 106/kg was significantly higher in the etoposide group (77.8% vs. 44.8%; p = 0.025). Although the rates of grade II-IV thrombocytopenia (63.0% vs. 31.0%; p = 0.031) and grade I-IV nausea (14.8% vs. 0%; p = 0.048) were significantly higher in the etoposide group, the rates of adverse events were low in both groups, with no neutropenic fever or septic shock. Thus, both single-dose etoposide plus G-CSF and G-CSF alone with risk-adapted plerixafor were effective and safe, but the former may be the better option for patients who are expected to receive two or more transplantations.
RESUMEN
INTRODUCTION: Carfilzomib plus dexamethasone (Kd) is widely used in patients with relapsed and/or refractory multiple myeloma (RRMM). However, the treatment outcomes of Kd, especially in trial-unfit patients, have not been extensively studied in the real-world setting. METHODS: We analyzed the outcomes of 152 RRMM patients who received Kd at our hospitals from April 2018 to March 2022. RESULTS: At the commencement of Kd, patients received a median of two (range 1-7) lines of prior anti-myeloma therapy. According to the ENDEAVOR study criteria, 93 (61.2%) and 59 (38.8%) patients were classified as the trial-fit and the trial-unfit group, respectively. The overall response (OR) rate for the entire cohort was 71.1% (95% CI 63.2-78.1%). Progression-free survival (PFS) and overall survival (OS) were 5.6 months (95% CI 3.9-6.9 months) and 24.0 months (95% CI 13.4-38.0 months), respectively. There was no significant difference in the OR rate between the trial-fit and the trial-unfit groups (76.3% vs. 62.7%; P = 0.105). However, the median PFS (3.6 months vs. 7.3 months; P < 0.001) and OS (15.0 vs. 36.8 months; P = 0.009) were significantly shorter in the trial-unfit group. On multivariate analysis, trial-fitness (unfit vs. fit) remained a significant covariate influencing the TRM (HR: 4.84, 95% CI 1.66-14.06; P = 0.004) and PFS (HR: 1.82, 95% CI 1.27-2.62; P = 0.001). CONCLUSION: Our data suggest that the treatment outcomes of Kd are acceptable in the real-world setting with significant differences between the trial-fit and the trial-unfit groups, although they are relatively inferior to those of a pivotal trial.
Asunto(s)
Mieloma Múltiple , Humanos , Catolicismo , Dexametasona , Resultado del Tratamiento , Protocolos de Quimioterapia Combinada AntineoplásicaRESUMEN
BACKGROUND: Bortezomib-melphalan-prednisone (VMP) and lenalidomide-dexamethasone (Rd) remain the standard treatments for transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). This study aimed to compare real-world benefits between the two regimens. We also were interested in exploring efficacy according to subsequent therapy following VMP or Rd. METHODS: A total of 559 NDMM patients treated with VMP (n = 443, 79.2%) or Rd (n = 116, 20.8%) was recruited retrospectively from a multicenter database. RESULTS: Rd provided more benefits than VMP-overall response rate: 92.2 vs. 81.8%, p = 0.018; median progression-free survival (PFS): 20.0 vs. 14.5 months, p <0.001; second PFS (PFS2): 43.9 vs. 36.9 months, p = 0.012; overall survival (OS): 100.1 vs. 85.0 months, p = 0.017. Multivariable analysis revealed significant benefits of Rd over VMP, with hazard ratios of 0.722, 0.627, and 0.586 for PFS, PFS2, and OS, respectively. In propensity score-matched cohorts with matched VMP (n = 201) and Rd (n = 67) arms to balance baseline characteristics, Rd still showed significantly better outcomes for PFS, PFS2, and OS than VMP. Following VMP failure, triplet therapy showed significant benefits for response and PFS2; after Rd failure, PFS2 with carfilzomib-dexamethasone was significantly better than bortezomib-based doublet treatment. CONCLUSION: These real-world findings may assist with better selection between VMP and Rd as well as subsequent therapy for NDMM.
Asunto(s)
Mieloma Múltiple , Humanos , Bortezomib , Prednisona , Melfalán , Lenalidomida , Estudios Retrospectivos , Protocolos de Quimioterapia Combinada Antineoplásica , Dexametasona , Sistema de Registros , Resultado del TratamientoRESUMEN
PURPOSE: Autologous hematopoietic stem cell transplantation (ASCT) has been introduced as a standard treatment for newly diagnosed multiple myeloma (NDMM) following novel agent-based induction chemotherapy. This study investigated whether pre-ASCT low muscle mass evaluated using the paraspinal muscle index (PMI) at the 12th thoracic vertebra (T12) level is a reliable prognostic marker in NDMM after chemotherapy. METHODS: A multi-center registry database was retrospectively analyzed. Between 2009 and 2020, 190 patients with chest computed tomography images underwent frontline ASCT following induction therapy. The PMI was defined as the value of the paraspinal muscle area at the T12 level divided by the square of the patient's height. The cut-off value indicating a low muscle mass was sex-specific, using the lowest quintiles. RESULTS: Of the 190 patients, 38 (20%) were in the low muscle mass group. The low muscle mass group had a lower 4-year overall survival (OS) rate than the non-low muscle mass group (68.5% vs. 81.2%; P = 0.074). The median progression-free survival (PFS) in the low muscle mass group was significantly shorter compared with the non-low muscle mass group (23.3 months vs. 29.2 months; P = 0.029). The cumulative incidence of transplant-related mortality (TRM) was significantly higher in the low muscle mass group than in the non-low muscle mass group (4-year probability of TRM incidence, 10.6% vs. 0.7%; P < 0.001). In contrast, no significant difference in the cumulative incidence of disease progression was found between the two groups. Multivariate analysis revealed that low muscle mass was associated with significant negative outcomes for OS [(hazard ratio (HR): 2.14; P = 0.047], PFS (HR: 1.78; P = 0.012), and TRM (HR: 12.05; P = 0.025). CONCLUSION: Paraspinal muscle mass may have a prognostic role in NDMM patients who undergo ASCT. Patients with low paraspinal muscle mass have lower survival outcomes compared to non-low muscle mass group.
Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Mieloma Múltiple , Masculino , Femenino , Humanos , Mieloma Múltiple/diagnóstico por imagen , Mieloma Múltiple/terapia , Pronóstico , Estudios Retrospectivos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Trasplante de Células Madre Hematopoyéticas/métodos , Trasplante Autólogo , MúsculosRESUMEN
Optimal first-line treatment that enables deeper and longer remission is crucially important for newly diagnosed multiple myeloma (NDMM). In this study, we developed the machine learning (ML) models predicting overall survival (OS) or response of the transplant-ineligible NDMM patients when treated by one of the two regimens-bortezomib plus melphalan plus prednisone (VMP) or lenalidomide plus dexamethasone (RD). Demographic and clinical characteristics obtained during diagnosis were used to train the ML models, which enabled treatment-specific risk stratification. Survival was superior when the patients were treated with the regimen to which they were low risk. The largest difference in OS was observed in the VMP-low risk & RD-high risk group, who recorded a hazard ratio of 0.15 (95% CI: 0.04-0.55) when treated with VMP vs. RD regimen. Retrospective analysis showed that the use of the ML models might have helped to improve the survival and/or response of up to 202 (39%) patients among the entire cohort (N = 514). In this manner, we believe that the ML models trained on clinical data available at diagnosis can assist the individualized selection of optimal first-line treatment for transplant-ineligible NDMM patients.
RESUMEN
Background: The goal of induction therapy for multiple myeloma (MM) is to achieve adequate disease control. Current guidelines favor triplet (bortezomib-lenalidomide-dexamethasone; VRd) or quadruplet regimens (daratumumab, bortezomib-thalidomide-dexamethasone; D-VTd). In the absence of a direct comparison between two treatment regimens, we conducted this study to compare the outcomes and safety of VRd and D-VTd. Methods: Newly diagnosed MM patients aged ï¼18 years who underwent induction therapy followed by autologous stem cell transplantation (ASCT) between November 2020 and December 2021 were identified. Finally, patients with VRd (N=37) and those with D-VTd (N=43) were enrolled. Results: After induction, 10.8% of the VRd group showed stringent complete remission (sCR), 21.6% showed complete response (CR), 35.1% showed very good partial response (VGPR), and 32.4% showed partial response (PR). Of the D-VTd group, 9.3% showed sCR, 34.9% CR, 48.8% VGPR, and 4.2% PR (VGPR or better: 67.6% in VRd vs. 93% in D-VTd, P=0.004). After ASCT, 68.6% of the VRd group showed CR or sCR, while 90.5% of the D-VTd group showed CR or sCR (P=0.016). VRd was associated with an increased incidence of skin rash (P=0.044). Other than rashes, there were no significant differences in terms of adverse events between the two groups. Conclusion: Our study supports the use of a front-line quadruplet induction regimen containing a CD38 monoclonal antibody for transplant-eligible patients with newly diagnosed MM.
RESUMEN
Background: Tofacitinib is a small molecule that inhibits Janus kinase and has been reported to be effective in Western patients with ulcerative colitis (UC). However, the real-life data on tofacitinib in Asian UC patients are limited. Objective: To investigate the real-life effectiveness and safety of tofacitinib induction and maintenance treatment in Korean patients with UC. Design: This was a retrospective study on patients with UC who received tofacitinib treatment at 12 hospitals in Korea between January 2018 and November 2020. Methods: Clinical remission at week 52, defined as a partial Mayo score of ⩽2 with a combined rectal bleeding subscore and stool frequency subscore of ⩽1, was used as the primary outcome. Adverse events (AEs), including herpes zoster and deep vein thrombosis, were also evaluated. Results: A total of 148 patients with UC were started on tofacitinib. Clinical remission rates of 60.6%, 54.9%, and 52.8% were reported at weeks 16, 24, and 52, respectively. Clinical response rates of 71.8%, 67.6%, and 59.9% were reported at weeks 16, 24, and 52, respectively. Endoscopic remission rates at weeks 16 and 52 were 52.4% and 30.8% based on the Mayo endoscopic subscore and 20.7% and 15.2% based on the UC endoscopic index of severity (UCEIS), respectively. A higher UCEIS at baseline was negatively associated with clinical response [adjusted odds ratio (aOR): 0.774, p = 0.029] and corticosteroid-free clinical response (aOR: 0.782, p = 0.035) at week 52. AEs occurred in 19 patients (12.8%) and serious AEs in 12 patients (8.1%). Herpes zoster occurred in four patients (2.7%). One patient (0.7%) suffered from deep vein thrombosis. Conclusions: Tofacitinib was an effective induction and maintenance treatment with an acceptable safety profile in Korean patients with UC. Plain language summary: Real-life effectiveness and safety of tofacitinib treatment in Korean patients with ulcerative colitis Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disorder of the colonic mucosa that usually presents with bloody diarrhea and abdominal pain. Tofacitinib is a small molecule that inhibits Janus kinase and has been reported to be effective in Western patients with UC. However, real-life data on the effectiveness of tofacitinib in Asian patients with UC are limited. To investigate the real-life effectiveness and safety of tofacitinib treatment in Korean patients with UC, we retrospectively analyzed the data of 148 patients with UC who received tofacitinib treatment at 12 hospitals in Korea between January 2018 and November 2020. Clinical remission (i.e. complete improvement of symptoms) was achieved in 60.6% and 52.8% of patients at weeks 16 and 52, respectively. Endoscopic remission was achieved in 52.4% and 30.8% of patients at weeks 16 and 52, respectively. A higher baseline score of the UC endoscopic index of severity, which is one of the endoscopic indices that evaluate the severity of inflammation of the colon, was negatively associated with clinical response (i.e. partial improvement of symptoms). Adverse events (AEs) including herpes zoster and deep vein thrombosis occurred in 19 patients (12.8%) and serious AEs occurred in 12 patients (8.1%). Our real-life study shows that tofacitinib is a clinically effective treatment for Korean patients with UC, and the incidence of AEs was also similar to those observed in other real-world studies.
RESUMEN
BACKGROUND AND AIMS: Treatment strategies for small pancreatic neuroendocrine tumors (PNETs) <2 cm in size are still under debate. The feasibility and safety of EUS-guided ethanol ablation (EUS-EA) have been demonstrated. However, sample sizes in previous studies were small with no comparative studies on surgery. Therefore, we aimed to compare the safety and long-term outcomes of EUS-EA with those of surgery for the management of nonfunctioning small PNETs. METHODS: We retrospectively reviewed patients with PNETs who were managed by EUS-EA (from 2011 to 2018) and surgery (from 2000 to 2018) at Asan Medical Center. Propensity score matching (PSM) was performed to increase comparability. The primary outcome was early and late major adverse events (Clavien-Dindo grade ≥III) after treatment. Secondary outcomes were 10-year overall (OS) and disease-specific survival (DSS) rates, length of hospital stay, and development of endocrine pancreatic insufficiency. RESULTS: Of all patients, 97 and 188 patients were included in the EUS-EA and surgery groups, respectively. PSM created 89 matched pairs. EUS-EA was associated with a significantly lower rate of early major adverse events (0% vs 11.2%, P = .003). Late major adverse events occurred more frequently after surgery, with no significant difference between groups (3.4% vs 10.1%, P = .07). Both treatment modalities showed comparable 10-year OS and DSS rates. The length of hospital stay was significantly shorter in the EUS-EA group (4 days vs 14.1 days, P < .001), and endocrine pancreatic insufficiency was less common after EUS-EA than after surgery (33.3% vs 48.6%, P = .121). CONCLUSIONS: EUS-EA had fewer adverse events and a shorter hospital stay with similar OS and DSS rates compared with surgery, suggesting that EUS-EA may be a preferred alternative to surgical resection in selected patients with nonfunctioning small PNETs.
Asunto(s)
Tumores Neuroectodérmicos Primitivos , Tumores Neuroendocrinos , Neoplasias Pancreáticas , Humanos , Tumores Neuroendocrinos/cirugía , Estudios Retrospectivos , Puntaje de Propensión , Neoplasias Pancreáticas/cirugía , Neoplasias Pancreáticas/patología , Resultado del TratamientoRESUMEN
PURPOSE: The purpose of this study was to investigate the outcomes of conservative treatment for recurrent shoulder dislocation without subjective apprehension, despite the presence of a Bankart lesion or glenoid defect. METHODS: A retrospective analysis was performed for 92 patients with recurrent shoulder dislocation treated with conservative treatment due to negative apprehension between 2009 and 2018. The failure of the conservative treatment was defined as a dislocation or subluxation episode or subjective feeling of instability based on a positive apprehension. The Kaplan-Meier method was used to estimate failure rates over time, and a receiver operating characteristic (ROC) curve was constructed to determine a cut-off value for a glenoid defect. The clinical outcomes were compared between patients who completed conservative treatment without recurrence of instability (Group A) and those who failed and subsequently underwent surgical treatment (Group B) using shoulder functional scores and sports/recreation activity level. RESULTS: This retrospective study included 61 of 92 eligible patients with recurrent shoulder dislocation. Among the 61 patients, conservative treatment failed in 46 (75.4%) over the 2-year study period. The cut-off value for a glenoid defect was 14.4%. The association between glenoid defect size (≥ 14.4% or as a continuous variable) and survival was statistically significant (p = 0.039 and p < 0.001, respectively). The mean glenoid defect size in Group B increased from 14.6 ± 3.0% to 17.3 ± 3.1% (p < 0.001), and clinical outcomes for Group A were inferior to those for Group B at the 24-month follow-up. CONCLUSIONS: Conservative treatment for recurrent shoulder dislocation in patients without subjective apprehension showed a high failure rate during the study period, especially if the glenoid defect was ≥ 14.4% in size. Despite clinical improvement in patients who completed conservative treatment without recurrence, functional outcome scores and sport/recreation activity levels were better in the patients who underwent arthroscopic Bankart repair. Therefore, for recurrent anterior shoulder instability, even without subjective apprehension, surgical treatment is warranted over conservative treatment. LEVEL OF EVIDENCE: Level IV.
Asunto(s)
Inestabilidad de la Articulación , Luxación del Hombro , Articulación del Hombro , Humanos , Luxación del Hombro/diagnóstico , Luxación del Hombro/cirugía , Articulación del Hombro/cirugía , Estudios Retrospectivos , Inestabilidad de la Articulación/cirugía , Inestabilidad de la Articulación/etiología , Tratamiento Conservador , Artroscopía/métodos , Examen Físico , RecurrenciaRESUMEN
Newly diagnosed multiple myeloma (NDMM) frequently results in renal impairment (RI), and its natural course has not been fully elucidated in the era of novel agents. We aimed to identify the dynamics of renal function after autologous stem cell transplantation (ASCT) following induction treatment using a novel agent in transplantation-eligible NDMM patients with RI (estimated glomerular filtration rate [eGFR] ≤50 mL/min/1.73 m2) at diagnosis. The factors associated with achieving a renal response based on the term renal benefit regardless of baseline eGFR were investigated as well. In a multicenter registry database including 1795 patients with plasma cell disorder, 140 transplantation-eligible NDMM patients who developed RI at the time of initiation of treatment for NDMM were identified. They received protocol-based treatment (PBT) consisting of induction treatment using proteasome inhibitors and/or immunomodulatory drugs followed by ASCT. MM and renal responses were evaluated using the International Myeloma Working Group response criteria. To evaluate the standardized improvement of renal function irrespective of baseline eGFR, renal benefit was defined as a sustained (for at least 3 months) increase in eGFR >15 mL/min/1.73 m2. The mean patient age was 54.7 ± 7.4 years. With a mean baseline eGFR of 24.8 ± 13.9, the renal complete response (renalCR) and renal benefit rates were 49.3% and 67.9%, respectively. In a multivariable analysis, the 3 factors significantly associated with reduced likelihood of achieving both renalCR and renal benefit were age ≥55 years, light chain type NDMM, and failure to improve eGFR by 5 mL/min/1.73 m2 with supportive care when measured 3 days prior to induction therapy and at the initiation of chemotherapy. Hypertension and advanced eGFR also were associated with poor renalCR achievement. The mean eGFR improved until the time of ASCT and then decreased gradually over time. The mean eGFR improved significantly until 4 months post-PBT compared with each eGFR at previous time points, but this significant improvement disappeared by 5 months post-PBT. In a subgroup of patients who developed RI after undergoing ASCT (n = 55), the eGFR increased temporarily at 1 month post-ASCT; however, this improvement reverted to baseline at 2 months post-ASCT. Among another subgroup of 27 patients who were dialysis-dependent at the time of initial treatment, 18 (66.7%) were no longer dialysis-dependent after a median of 60 days. The best renal response was acquired early during the PBT period, and ASCT did not have a robust impact on the renal outcome. Patients who failed to achieve a renal benefit should be provided with the best supportive care for chronic kidney disease, and this simplified criterion for evaluating the renal response needs to be validated in larger studies before it can be recommended. © 2022 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.
Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Mieloma Múltiple , Insuficiencia Renal , Humanos , Persona de Mediana Edad , Mieloma Múltiple/tratamiento farmacológico , Mieloma Múltiple/complicaciones , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Trasplante Autólogo/métodos , Diálisis Renal , Insuficiencia Renal/diagnóstico , Insuficiencia Renal/etiología , Insuficiencia Renal/terapia , Riñón/fisiologíaRESUMEN
There has been a rise in the incidence of inflammatory bowel disease (IBD) in developing countries, including South Korea. Consequently, the use of immunosuppressive agents such as immunomodulators or biologics has also increased. Due to immunosuppression, patients on these agents are at increased risk of various opportunistic infections during treatment, which may sometimes lead to serious adverse outcomes. Viral hepatitis, especially hepatitis B, is one of the infectious conditions that can be reactivated during immunosuppressive therapy, and adequate strategies for monitoring and prophylaxis are needed to prevent it. South Korea is one of the countries with intermediate endemicity for hepatitis A and B. Thus, taking adequate precautions against viral hepatitis could prevent new infections or reactivation of these conditions in patients with IBD on immunosuppressive therapy. In this review article, we have summarized the latest evidence on viral hepatitis in patients with IBD that would be of assistance in clinical practice.
Asunto(s)
Hepatitis B , Hepatitis Viral Humana , Enfermedades Inflamatorias del Intestino , Hepatitis B/complicaciones , Hepatitis Viral Humana/complicaciones , Hepatitis Viral Humana/diagnóstico , Humanos , Inmunosupresores/efectos adversos , Enfermedades Inflamatorias del Intestino/inducido químicamente , Enfermedades Inflamatorias del Intestino/complicaciones , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , República de CoreaRESUMEN
Background: The aim of this study was to evaluate clinical outcomes of sodium tetradecyl sulphate (STS) sclerotherapy for conservative treatment of lateral malleolar bursitis of the ankle. Methods: We reviewed data from 20 consecutive patients (20 ankles) who underwent STS sclerotherapy between August 2018 and June 2019. After aspiration of fluid from the lateral malleolar bursal sac, 2 mL (20 mg) STS was injected into the sac. Clinical outcomes and side effects and complications were evaluated at 2 weeks, 3 months, 1 year, and 2 years after sclerotherapy. Responses to treatment were assessed according to degree of fluctuation, shrinkage of the bursal sac, and soft-tissue swelling. The 36-item short form survey (SF-36) was completed for each patient before and after therapy. Results: Complete response was observed in 17 patients (85%), and partial response was observed in 3 patients (15%) after STS sclerotherapy. SF-36 physical component scores improved from 62.2 (interquartile range, 5.2) before therapy to 70.0 (interquartile range, 7.9) at last follow-up (p < 0.05). One patient (5%) experienced transient hyperpigmentation at the injection site. No major complications occurred. Conclusions: STS sclerotherapy was an effective and safe treatment for patients with lateral malleolar bursitis of the ankle.