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OBJECTIVE: To assess safety of baricitinib in Japanese patients with rheumatoid arthritis in real-world clinical practice. METHODS: This all-case post-marketing surveillance study included patients initiating baricitinib for rheumatoid arthritis from September 2017 to April 2019. Treatment duration was recorded. Safety data were collected for up to 3 years from baricitinib initiation (up to 4 weeks post discontinuation in discontinuing patients). RESULTS: Safety analyses included 4720 patients; 2580 (54.7%) were ≥65 years old. Baricitinib persistence rate was 45.4% (3 year Kaplan-Meier analysis); the most common discontinuation reason was insufficient effectiveness (n = 1005, 21.3%). Serious adverse events occurred in 600 patients (incidence rate 10.42/100 patient-years; 95% confidence interval, 9.76-11.09). There were 39 deaths (incidence rate 0.43 [0.30-0.57]/100 patient-years). Incidence rate per 100 patient-years for adverse events of special interest were herpes zoster 4.68 (4.22-5.14), serious infection 3.05 (2.68-3.41), malignancy 1.09 (0.87-1.30), major adverse cardiovascular events 0.35 (0.23-0.48) and venous thromboembolism 0.25 (0.15-0.36). Incidence rates did not increase with prolonged exposure. CONCLUSIONS: No new safety concerns were identified during this 3 year post-marketing surveillance study of baricitinib in Japanese patients with rheumatoid arthritis. Patients and clinicians should be cognizant of herpes zoster and other serious infection risks during baricitinib treatment, especially in the first 6 months.
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PURPOSE: This study proposes a process for detecting slices with bone marrow edema (BME), a typical finding of axSpA, using MRI scans as the input. This process does not require manual input of ROIs and provides the results of the judgment of the presence or absence of BME on a slice and the location of edema as the rationale for the judgment. METHODS: First, the signal intensity of the MRI scans of the sacroiliac joint was normalized to reduce the variation in signal values between scans. Next, slices containing synovial joints were extracted using a slice selection network. Finally, the BME slice detection network determines the presence or absence of the BME in each slice and outputs the location of the BME. RESULTS: The proposed method was applied to 86 MRI scans collected from 15 hospitals in Japan. The results showed that the average absolute error of the slice selection process was 1.49 slices for the misalignment between the upper and lower slices of the synovial joint range. The accuracy, sensitivity, and specificity of the BME slice detection network were 0.905, 0.532, and 0.974, respectively. CONCLUSION: This paper proposes a process to detect the slice with BME and its location as the rationale of the judgment from an MRI scan and shows its effectiveness using 86 MRI scans. In the future, we plan to develop a process for detecting other findings such as bone erosion from MR scans, followed by the development of a diagnostic support system.
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This study aimed to investigate the predictive factors of transfer of glioblastoma multiforme (GBM) patients who underwent rehabilitation in acute care hospitals. We retrospectively identified 85 patients with GBM who underwent rehabilitation at our hospital. Multivariable logistic regression analysis showed that age and Barthel index (BI) at rehabilitation initiation significantly influenced the discharge destination. Cut-off values for these factors were 76 years of age and 30 BI points. These findings could help predict the discharge destination and the choice of rehabilitation strategies of newly diagnosed patients with GBM admitted to an acute care hospital.
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Neoplasias Encefálicas , Glioblastoma , Alta del Paciente , Humanos , Glioblastoma/terapia , Masculino , Femenino , Anciano , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Edad , Neoplasias Encefálicas/terapia , Anciano de 80 o más Años , AdultoRESUMEN
BACKGROUND: Mucoid degeneration of the anterior cruciate ligament is a pathological condition that may impair knee mechanics and contribute to the symptomatology of osteoarthritis. This study aimed to evaluate whether preoperative magnetic resonance imaging can predict anterior cruciate ligament degeneration, specifically mucoid degeneration, and to elucidate the histopathological characteristics of mucoid degeneration in knee osteoarthritis patients. METHODS: We evaluated a total of 95 knees of osteoarthritis patients (23 males, 72 females; mean age: 72.7 ± 7.5) scheduled for total knee arthroplasty. The relationship between preoperative magnetic resonance imaging findings and the histopathological evidence of anterior cruciate ligament mucoid degeneration was examined. Immunohistochemical analysis was employed for collagen types (COL-I, COL-II), chondrogenesis (SOX9), and vascularity (CD31). RESULTS: High signal intensity on magnetic resonance imaging showed a positive correlation with Alcian Blue staining areas (rs = 0.59, p < 0.01) and the swelling index (rs = 0.62, p < 0.01), indicating advanced mucoid degeneration. The absence of synovial lining around the anterior cruciate ligament was associated with more severe degeneration. In the histological evaluations, advanced degeneration was characterized by an increase in chondroid metaplasia and collagen disorientation. The Alcian Blue and SOX9 correlation was positive (rs = 0.69, p < 0.01), but negative with COL-I (rs = -0.38, p = 0.03) and vascularity (CD31) (rs = -0.60, p < 0.01). CONCLUSIONS: Preoperative magnetic resonance imaging is an effective tool in assessing the severity of anterior cruciate ligament degeneration; it influences surgical decisions. High signal intensity on magnetic resonance images denotes advanced mucoid degeneration. The absence of synovial lining around the anterior cruciate ligament is associated with more severe degeneration and may accelerate degenerative changes. Chondroid metaplasia and collagen disorientation mark advanced degeneration. Magnetic resonance imaging can be used to gauge the degree of anterior cruciate ligament degeneration in osteoarthritis.
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Subcutaneous anterior transposition of the ulnar nerve is a common surgical treatment for cubital tunnel syndrome. However, there are surgical failures associated with the new compressive sites at the edge of flexor carpi ulnaris (FCU) and resubluxation posterior to the medial epicondyle of the transposed nerve. To reduce the muscle volume at the edge of FCU, we approach the ulnar nerve by dividing the muscle belly of the FCU humeral heads. This procedure can reduce repeated traction forces on the transposed nerve at the edge of the FCU. To keep the transposed ulnar nerve anteriorly, we use a fat flap including the membranous superficial fascia. This flap can softly stabilize the ulnar nerve and act as a pliable cover to prevent perineural scarring or further constriction around the flap. Ninety-three elbows in 90 patients who had undergone this procedure for cubital tunnel syndrome were evaluated. According to Messina's criteria, the numbers of patients showing excellent, good, fair, and poor recovery were 41 (44%), 47 (51%), 5 (5%), and 0 (0%), respectively. Most patients experience resolution of symptoms and good functional outcomes. None of the patients suffered recurrence, infection, or nerve injury.
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Síndrome del Túnel Cubital , Nervio Cubital , Humanos , Síndrome del Túnel Cubital/cirugía , Nervio Cubital/cirugía , Masculino , Femenino , Persona de Mediana Edad , Adulto , Anciano , Colgajos Quirúrgicos , Prevención Secundaria , Recurrencia , Resultado del TratamientoAsunto(s)
Conservadores de la Densidad Ósea , Fracturas del Fémur , Curación de Fractura , Teriparatido , Humanos , Conservadores de la Densidad Ósea/uso terapéutico , Conservadores de la Densidad Ósea/farmacología , Teriparatido/uso terapéutico , Teriparatido/farmacología , Fracturas del Fémur/diagnóstico por imagen , Fracturas del Fémur/tratamiento farmacológico , Curación de Fractura/efectos de los fármacos , Curación de Fractura/fisiología , Fracturas Osteoporóticas/prevención & control , Fracturas Osteoporóticas/fisiopatología , Metaanálisis como AsuntoRESUMEN
OBJECTIVES: There are several surgical techniques for thoracic outlet syndrome (TOS). However, there have been no reports of endoscopically assisted transaxillary release of the anterior and middle scalene muscles (EATRS), leaving the first rib intact for TOS. We hypothesized that EATRS would achieve a good Quick Disability of the Arm, Shoulder and Hand score. This study aims to present our experience with a new technique for TOS using endoscopy. METHODS: We chose two surgeries depending on the patient's TOS condition. If the costoclavicular space was under 12 mm, we selected endoscopically assisted transaxillary first rib resection (EAFRR). If the costoclavicular space was over 12 mm, we selected EATRS. Between January 2021 and December 2022, 31 consecutive surgeries for TOS were performed in our institution. Twenty-five patients underwent EAFRR, and six (19%) underwent EATRS. Since July 2022, EAFRR has been performed under differential lung ventilation. RESULTS: Complete and almost complete relief was achieved in 24 patients (77%), and partial relief was conducted in seven patients (23%) at a mean of 19.7 months after surgery. The symptoms improved in all cases. Intraoperative pneumothorax did not occur, and no other complications were observed. Both EAFRR and EATRS were effective and safe surgeries for TOS. Operative time was significantly shorter in EATRS than in EAFRR. CONCLUSIONS: We first report EATRS surgery for TOS. EATRS is indicated for patients whose costoclavicular space is preserved before surgery. Good surgical results were obtained after surgery for this indication.
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Costillas , Síndrome del Desfiladero Torácico , Humanos , Síndrome del Desfiladero Torácico/cirugía , Femenino , Masculino , Costillas/cirugía , Adulto , Resultado del Tratamiento , Persona de Mediana Edad , Estudios Retrospectivos , Adulto Joven , Endoscopía/métodos , Descompresión Quirúrgica/métodos , Adolescente , Factores de TiempoRESUMEN
BACKGROUND: The incidence of developmental dysplasia of the hip (DDH) in Japanese newborns has reduced drastically following a primary prevention campaign initiated around 1972 to 1973; this perinatal education campaign promoted maintaining the hips of newborns in the naturally flexed-leg position. The purpose of the present study was to describe the life course epidemiology of hip osteoarthritis (OA) in adolescent and adult patients and to assess its association with exposure to the primary prevention campaign for DDH. METHODS: We included new patients with hip OA diagnosed from January 1, 2022, to December 31, 2022, at 12 core hospitals (8 special-function hospitals and 4 regional medical care support hospitals). The trend in the percentage of hips with a history of DDH treatment in childhood was estimated with use of a centered moving average using the birth year of the patient. We compared the prevalence of severe subluxation (Crowe type II, III, or IV) between patients with secondary hip OA due to hip dysplasia who were born in or before 1972 and those who were born in or after 1973. RESULTS: Overall, 1,095 patients (1,381 hips) were included. The mean age at the time of the survey was 63.5 years (range, 15 to 95 years). A total of 795 patients (1,019 hips; 73.8% of hips) were diagnosed with secondary OA due to hip dysplasia. Approximately 13% to 15% of hips among patients born from 1963 to 1972 had a history of DDH treatment in childhood; however, the percentage decreased among patients born in or after 1973. The prevalence of severe subluxation (Crowe type II, III, or IV) among patients born in or after 1973 was 2.4%, which was significantly less than that among patients born in or before 1972 (11.1%; odds ratio, 0.20; p < 0.001). CONCLUSIONS: As of 2022, secondary hip OA due to hip dysplasia is still responsible for most new cases of adolescent and adult hip OA seen in core hospitals in Japan. However, the perinatal education campaign initiated 50 years ago, which utilized a population approach and advocated for maintaining the hips of newborns in the naturally flexed-leg position, may have improved the environmental factors of DDH, as indicated by the apparently reduced need for treatment of DDH in childhood and the associated severe subluxation. This may result in a reduced need for challenging hip surgery later in life. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.
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Osteoartritis de la Cadera , Humanos , Japón/epidemiología , Osteoartritis de la Cadera/epidemiología , Osteoartritis de la Cadera/etiología , Estudios Transversales , Femenino , Masculino , Anciano , Adolescente , Persona de Mediana Edad , Adulto , Anciano de 80 o más Años , Adulto Joven , Prevalencia , Displasia del Desarrollo de la Cadera/epidemiología , Luxación Congénita de la Cadera/epidemiología , Luxación Congénita de la Cadera/terapia , IncidenciaRESUMEN
We experienced an atypical case of radial longitudinal deficiency that did not fit into any classifications, including Blauth. The patient had a bilateral hypoplastic thumb, in which the index and middle fingers were missing in the right hand. We performed surgeries in four stages: centralization of the right hand, opponensplasty of the right thumb, opponensplasty of the left thumb, and distraction lengthening of the right ulnar. Twenty-five years after the initial treatment, the patient was satisfied with the treatment and had no significant difficulty with activities of daily living.
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Pulgar , Humanos , Pulgar/anomalías , Pulgar/cirugía , Estudios de Seguimiento , Radio (Anatomía)/anomalías , Radio (Anatomía)/cirugía , Radio (Anatomía)/diagnóstico por imagen , Masculino , Deformidades Congénitas de la Mano/diagnóstico , Deformidades Congénitas de la Mano/cirugía , Resultado del Tratamiento , Femenino , Dedos/anomalías , Dedos/cirugíaRESUMEN
Background: Arthroscopic rotator cuff repair (ARCR) is a minimally invasive surgical technique. However, it is challenging to control postoperative pain. This study aimed to investigate the difference between a single-shot interscalene block and a combined continuous block for ARCR. Methods: Ninety-four patients who underwent ARCR were included in this study. In the preceding period, 43 patients received a single-shot interscalene block and continuous postoperative intravenous opioid infusion (Single group). In the posterior period, 51 patients received a single-shot interscalene block preoperatively and a continuous block postoperatively (Continuous group). Their mean age at surgery was 64.9 years (range, 43-83 years). The mean follow-up period was 25.4 months (range, 24-54 months). The numerical rating scale (NRS) of pain was evaluated immediately after the surgery, at rest, and at night for 1-4 days after the surgery. One day postoperatively, the amount of food taken was assessed from 0 % (no food intake) to 100 % (all food taken). The University of California at Los Angeles (UCLA) shoulder score, range of motion (ROM), and isometric shoulder strength were evaluated. Results: NRS at rest in the Continuous group on the day of surgery was 3.7 ± 2.5. This was significantly lower than in the Single group (5.2 ± 1.8) (P = 0.002). NRS at rest in the Continuous group on the second day after surgery was 3.0 ± 2.1, significantly lower than in the Single group (3.9 ± 1.8) (P = 0.04). The amount of food taken in the morning in the Continuous group was 61 % ± 37 %, which was significantly greater than in the Single group (35 % ± 41 %) (P = 0.004). The ROM of extension at 6 months postoperatively in the Continuous group was 47 ± 7°, which was significantly greater than in the Single group (43 ± 6°) (P = 0.02). The postoperative strength of the external rotator at 6 months in the Continuous group was 95 ± 33 N, significantly greater than in the Single group (78 ± 28 N) (P = 0.01). There was no significant difference in UCLA score at any time. Conclusion: The continuous interscalene block with ultrasound guidance in ARCR effectively relieved pain. The recovery of ROM for extension and the strength of the external rotator was better in the Continuous group.
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Purpose: The purpose of this study was to investigate the impact of patient sex on arm functional recovery after arthroscopic rotator cuff repair (ARCR). Methods: We retrospectively reviewed the clinical records of patients who underwent rehabilitation after ARCR at two affiliated hospitals between January 2014 and December 2019. Patient characteristics included age, sex, type of muscle tear, tear location, muscle strength, Japanese Orthopedic Association (JOA) score, and patient responses to the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. We used mixed-effects regression models with random intercepts to evaluate the QuickDASH scores, JOA scores, and muscle strength relative to the nonoperated side. Results: Of the 124 patients, 82 (66.1%) were 65-year-old men and 42 (33.9%) were 67-year-old women. The preoperative JOA scores (P = .03) and those at 6 months (P < .001) and 12 months (P = .04) after ARCR were significantly greater for men than for women. QuickDASH scores of men were significantly lower at 24 months (P = .02) and all other time points (P < .001) than those of women. The improvement in QuickDASH scores was significantly higher for women than for men (P < .01). The results of the multiple regression analysis showed that patient sex (95% confidence interval, 0.01-0.45; P < .05) had an impact on QuickDASH scores at 24 months after ARCR. Conclusion: In this study, patient sex was a significant factor affecting the recovery and QuickDASH scores of patients who underwent ARCR. Level of Evidence: Level IV, prognostic case series.
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OBJECTIVES: We evaluated the real-world safety/effectiveness of tofacitinib, an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), in patients with RA in Japan registered in a post-marketing surveillance study. METHODS: This interim analysis included data from July 2013 to December 2018. Adverse events (AEs), serious AEs (SAEs), Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)/Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4(ESR)] scores, and rates of SDAI/CDAI/DAS28-4(ESR)-defined remission and low disease activity were analysed using 6 months of data. Risk factors for serious infections were assessed by multivariable analyses. RESULTS: Safety and disease activity were evaluated in 6866 and 6649 patients, respectively. Overall, 32.73%/7.37% of patients reported AEs/SAEs. Clinically important AEs with tofacitinib included serious infections/infestations [3.13% of patients; incidence rate (IR; patients with events) 6.91/100 patient-years (PY)], herpes zoster (3.63%; IR 8.02/100 PY), and malignancies (0.68%; IR 1.45/100 PY). SDAI/CDAI/DAS28-4(ESR) scores and remission/low disease activity rates improved over 6 months. Male sex, older age, Steinbrocker's stage IV, history of infection, and diabetes mellitus at baseline were independent risk factors for serious infection. CONCLUSIONS: In patients with RA receiving tofacitinib in Japan, safety was consistent with the reported profile, and disease activity improved over 6 months. STUDY IDENTIFIER: NCT01932372.
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Antirreumáticos , Artritis Reumatoide , Piperidinas , Pirimidinas , Humanos , Masculino , Japón , Pirroles/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Vigilancia de Productos Comercializados , Resultado del Tratamiento , Antirreumáticos/efectos adversosRESUMEN
BACKGROUND: This study examined the bidirectional and temporal-ordinal relationship between loneliness and back pain. METHODS: Data from 7,730 participants in waves 6 (2012-2013), 7 (2014-2015), and 8 (2016-2017) of the national English Longitudinal Study of Ageing were analyzed. Back pain was graded on a scale of 0-10 (0, no discomfort; 10, unbearable pain). Loneliness was measured using the Revised University of California Los Angeles Loneliness Scale. A targeted minimum loss-based estimator was used to examine the bidirectional longitudinal associations between back pain and loneliness. RESULTS: No loneliness in waves 6 and 7 (relative risk [RR]=0.76; 95% confidence interval [CI], 0.61-0.94), no loneliness in wave 6 but loneliness in wave 7 (RR=0.58; 95% CI, 0.50-0.68), and loneliness in wave 6 but not in wave 7 (RR=0.69; 95% CI, 0.57-0.86) were associated with significant risk reductions of back pain in wave 8 compared with the scenario of loneliness in waves 6 and 7. Mild back pain in wave 6 but moderate back pain (RR=0.55; 95% CI, 0.35-0.86) or severe back pain in wave 7 (RR=0.49; 95% CI, 0.34-0.72) showed a significant risk reduction of loneliness in wave 8 compared with severe back pain in waves 6 and 7. CONCLUSION: Loneliness may be a risk factor for back pain, and back pain may be a risk factor for loneliness. The results of this study will inform the development of more effective interventions for loneliness and back pain.
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Envejecimiento , Dolor de Espalda , Soledad , Humanos , Soledad/psicología , Masculino , Femenino , Estudios Longitudinales , Anciano , Dolor de Espalda/psicología , Dolor de Espalda/epidemiología , Envejecimiento/psicología , Inglaterra/epidemiología , Anciano de 80 o más Años , Persona de Mediana Edad , Factores de RiesgoRESUMEN
The use of biomaterials and implants for joint replacement, fracture fixation, spinal stabilization and other orthopedic indications has revolutionized patient care by reliably decreasing pain and improving function. These surgical procedures always invoke an acute inflammatory reaction initially, that in most cases, readily subsides. Occasionally, chronic inflammation around the implant develops and persists; this results in unremitting pain and compromises function. The etiology of chronic inflammation may be specific, such as with infection, or be unknown. The histological hallmarks of chronic inflammation include activated macrophages, fibroblasts, T cell subsets, and other cells of the innate immune system. The presence of cells of the adaptive immune system usually indicates allergic reactions to metallic haptens. A foreign body reaction is composed of activated macrophages, giant cells, fibroblasts, and other cells often distributed in a characteristic histological arrangement; this reaction is usually due to particulate debris and other byproducts from the biomaterials used in the implant. Both chronic inflammation and the foreign body response have adverse biological effects on the integration of the implant with the surrounding tissues. Strategies to mitigate chronic inflammation and the foreign body response will enhance the initial incorporation and longevity of the implant, and thereby, improve long-term pain relief and overall function for the patient. The seminal research performed in the laboratory of Dr. James Anderson and co-workers has provided an inspirational and driving force for our laboratory's work on the interactions and crosstalk among cells of the mesenchymal, immune, and vascular lineages, and orthopedic biomaterials. Dr. Anderson's delineation of the fundamental biologic processes and mechanisms underlying acute and chronic inflammation, the foreign body response, resolution, and eventual functional integration of implants in different organ systems has provided researchers with a strategic approach to the use of biomaterials to improve health in numerous clinical scenarios.
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Background: This study aimed to investigate the prognosticator of the contralateral rotator cuff in patients who underwent arthroscopic rotator cuff repair (ARCR) for symptomatic rotator cuff tear (RCT). Methods: A total of 104 patients with a mean age of 64.7 years (range, 40-83 years) underwent ARCR and were checked for the presence of a contralateral RCT using preoperative ultrasonography. Preoperative demographic data, including patients' occupations and sports activities, were also evaluated. Results: The mean follow-up period for the operated shoulder was 25.0 months (range, 12-72 months). An RCT of the contralateral shoulder was observed in 40 of the 104 (38.5%) patients. Contralateral shoulder pain was observed in 16 (40%) and 15 (23.1%) patients in the RCT group preoperatively and the non-tear group, respectively. Of the 31 patients with shoulder pain, a poor prognosis was seen in 17 (54.8%). Statistical significance was observed between the active and sedentary groups in the RCT group, with eight patients (30.8%) in the active group and none in the sedentary group having a poor prognosis (P = .02). In contrast, in the non-tear group, a poor prognosis was observed in four patients (10.5%) in the active group, which was not significantly different compared to the five patients (19.2%) in the sedentary group (P = .33). Conclusions: For patients in the active group, RCTs are a risk factor for poor prognosis in the contralateral shoulder of ARCR.
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OBJECTIVES: Methotrexate (MTX) is associated with extensive side effects, including myelosuppression, interstitial pneumonia, and infection. It is, therefore, critical to establish whether its administration is required after achieving remission with tocilizumab (TCZ) and MTX combination therapy in patients with rheumatoid arthritis (RA). Therefore, the aim of this multicenter, observational, cohort study was to evaluate the feasibility of MTX discontinuation for the safety of these patients. METHODS: Patients with RA were administered TCZ, with or without MTX, for 3 years; those who received TCZ+MTX combination therapy were selected. After remission was achieved, MTX was discontinued without flare development in one group (discontinued [DISC] group, n = 33) and continued without flare development in another group (maintain [MAIN] group, n = 37). The clinical efficacy of TCZ+MTX therapy, patient background characteristics, and adverse events were compared between groups. RESULTS: The disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) at 3, 6, and 9 months was significantly lower in the DISC group (P < .05, P < .01, and P < .01, respectively). Further, the DAS28-ESR remission rate at 6 and 9 months and Boolean remission rate at 6 months were significantly higher in the DISC group (P < .01 for all). Disease duration was significantly longer in the DISC group (P < .05). Furthermore, the number of patients with stage 4 RA was significantly higher in the DISC group (P < .01). CONCLUSIONS: Once remission was achieved, MTX was discontinued in patients who responded favorably to TCZ+MTX therapy, despite the prolonged disease duration and stage progression.
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Antirreumáticos , Artritis Reumatoide , Humanos , Metotrexato/efectos adversos , Antirreumáticos/efectos adversos , Estudios de Cohortes , Estudios de Factibilidad , Quimioterapia Combinada , Artritis Reumatoide/tratamiento farmacológico , Resultado del TratamientoRESUMEN
OBJECTIVES: To assess the safety and effectiveness of baricitinib treatment for rheumatoid arthritis (RA) in real-world clinical practice. METHODS: This ongoing all-case post-marketing surveillance study (starting September 2017) includes all patients with RA treated with baricitinib in Japan. Safety and effectiveness (disease activity) were assessed for 24 weeks. RESULTS: Safety analyses to February 2021 included 4731 patients (initial baricitinib dose: 4 mg/day, n = 3058; 2 mg/day, n = 1661; other, n = 12); 1059 (22.38%) were ≥75 years and 3362 (71.06%) previously received biologic therapy. The overall observational period was 1863.14 patient-years; 1174 (24.82%) patients discontinued baricitinib before Week 24, mostly for lack of effectiveness (n = 478; 10.10%). Adverse events occurred in 1271 (26.87%) patients [serious: 203 (4.29%); death: 18 (0.38%)]. The incidence of herpes zoster, hepatic function disorder, and serious infection was 3.09%, 2.77%, and 1.90%, respectively. Malignancy occurred in 17 patients (0.36%) and major adverse cardiovascular events in seven patients (0.15%). Among patients with effectiveness data, at least 26.57% (Boolean) achieved remission at Week 24. CONCLUSIONS: This large nationwide surveillance study evaluated the safety and effectiveness of 24 weeks of baricitinib for RA in real-world clinical practice. Continued surveillance of long-term safety is ongoing.
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Antirreumáticos , Artritis Reumatoide , Humanos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Pueblos del Este de Asia , Vigilancia de Productos Comercializados , Resultado del Tratamiento , AncianoRESUMEN
BACKGROUND: Knowledge regarding the normal alignment of the lower limb is important when considering alignment for total knee arthroplasty. However, few studies have explored the lower limb alignment of healthy Japanese subjects. METHODS: Between July and October 2020, we performed whole leg standing radiography of 120 legs of 60 healthy adult Japanese volunteers aged <50 years in the closed-leg stance. The measurement parameters were hip knee ankle angle (positive for varus), percentage of constitutional varus (hip knee ankle angle ≥ 3°), mechanical axis deviation ratio, mechanical lateral distal femoral angle, medial proximal tibial angle, joint line convergence angle (positive for lateral opening), and tibial joint line angle (positive for medial inclination). RESULTS: The mean measured values for all volunteers, men and women, were as follows: hip knee ankle angle (°), 2.3, 2.6, and 2.0; mechanical axis deviation ratio, 35.8, 35.6, and 36.9; mechanical lateral distal femoral angle (°), 86.7, 87.0, and 86.7; medial proximal tibial angle (°), 85.6, 85.0, and 86.2; joint line convergence angle (°), 0.6, 0.3, and 0.8; and tibial joint line angle (°), -1.0, -0.7, -1.4, respectively. The percentage of constitutional varus was 35.8% overall, 35.8% in men and 35.3% in women. Only the medial proximal tibial angle was smaller in men than that in women (p = 0.003). CONCLUSIONS: The mechanical lateral distal femoral and medial proximal tibial angles were smaller, hip knee ankle angle was larger, and percentage of constitutional varus was higher in Japanese subjects than those reported for subjects in other countries. Our findings improve the understanding of Japanese-specific alignments when considering alignment for lower limb surgery, especially, total knee arthroplasty.
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Pueblos del Este de Asia , Osteoartritis de la Rodilla , Masculino , Adulto , Humanos , Femenino , Estudios Retrospectivos , Extremidad Inferior/diagnóstico por imagen , Articulación de la Rodilla/diagnóstico por imagen , Articulación de la Rodilla/cirugía , Tibia/diagnóstico por imagen , Tibia/cirugía , Osteoartritis de la Rodilla/cirugíaRESUMEN
BACKGROUND: Hip fracture is among the most common injuries in elderly people. We aimed to investigate the decennial trends in hip fractures in patients ≥65 years of age. METHODS: A questionnaire was distributed to all hospitals with a Department of Orthopaedic Surgery in Yamagata Prefecture to collect data on hip fractures occurring in 1996, 2006 and 2016. RESULTS: The response rate was 100%. The total numbers of hip fractures in 1996, 2006 and 2016 were 665, 1169 and 1,728, respectively (crude incidence: 258, 373 and 494 per 100,000 person-year, respectively). Injuries frequently occurred in the early morning and daytime morning in 1996. In contrast, they frequently occurred in activity times (e.g., morning and afternoon) in 2006 and 2016. Among the patients, 80-90% were injured by simple falls, and 70-80% were injured indoors. The incidence of trochanteric fractures was approximately 1.8-1.9 times greater than incidence of neck fractures in all years. Especially, trochanteric fractures in females of ≥90 years of age markedly increased. The rate of surgical treatment was the same in 1996 and 2006, but was lower in 2016. In 1996, the percentage of independent walkers at discharge and 1 year later was almost the same. In 2006 and 2016, the rate of independent walkers was low at discharge, but increased 1 year later. The rate of discharge to home decreased gradually. The combined percentage of patients discharged to home and to rehabilitation institutions in 2006 and the percentage of patients who entered the regional referral clinical pathway in 2016 were both approximately 70%, with no marked changes observed. CONCLUSIONS: Hip fractures, especially trochanteric fractures in super-aged females, increased. Discharge to home decreased, and the use of the regional referral clinical pathway was widespread. Ambulation ability was reduced at discharge, but improved after 1 year.