scholarly journals AB0423 SAFETY AND TOLERABILITY OF RITUXIMAB IN THE TREATMENT OF SYSTEMIC SCLEROSIS: LONG-TERM FOLLOW-UP

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1239.3-1240
Author(s):  
L. Garzanova ◽  
L. P. Ananyeva ◽  
O. Koneva ◽  
O. Desinova ◽  
O. Ovsyannikova ◽  
...  

Background:Rituximab (RTX) has been used for the treatment of systemic sclerosis (SSc) for a long time, but data on tolerance and long-term adverse events (AE) are insufficient.Objectives:To assess the tolerability and safety of RTX in the patients (pts) with SSc in long-term prospective follow-up.Methods:Data on the safety and tolerability of RTX were evaluated in 149 SSc pts who received at least one RTX infusion in a long-term open-label prospective observational study. The mean age was 48±13,5 years (17-74), women - 122 (82%), diffuse cutaneous subset of the disease had 52%, limited-37% and overlap-11%. The mean disease duration was 6,4±5,8 years (0,5-30). The observation period was 12 years. All pts received prednisolone at a dose of 11,7±4,8mg/day, and 73 patients (49%) received immunosuppressants at inclusion. The indications for the appointment of RTX were ineffectiveness or impossibility of standard therapy and a severe course of the disease with high activity and unfavorable prognosis factors. AE were assessed and recorded by a physician at a hospital immediately after the infusion of RTX, then by patient reported outcome during the observation period. Severe AE were defined as those that required hospitalization for more than 24 hours, exacerbation of the disease requiring therapy, malignancies, life-threatening situations. All causes of death were considered, regardless of treatment.Results:The mean follow-up period after the first infusion of RTX was 5,6±2,6 years [834,4 patient-years (PY)]. Pts received a mean of 3,4 courses of RTX (1–10). The cumulative mean dose of RTX was 3,2±2,4 gr (0,5-11). AE were reported in 77 patients (52%), the overall frequency of AE was 9,3/100 PY (95% Confidence Interval (CI) 8-11). The highest frequency of all AE was observed in the first 2-6 months after the first infusion of RTX, however these were mainly mild AE (71%). There was a decrease of AE in the follow-up period (3,4/100 PY, 95% CI 2,4-4,9 – at the period from 3 to 10 course of RTX). The overall incidence of serious AE was 2,22/100 PY (95% CI 1,4–3,5). The specter of serious AE included: pneumonia in 7 pts, infusion reactions in 5, as well as in one case: cerebral ischemia, acute pancreatitis, allergic pneumonitis, lymphoma of pharynx, purulent arthritis, lower limb vein thrombosis, pulmonary embolism of small arteries. The most frequent AE were infections (n=53), with no serious opportunistic infections reported. The overall incidence of all infections was 6,4/100 PY (95% CI 4,9-8,3), serious infections – 1,32/100 PY (95% CI 0,7-2,4). The level of immunoglobulin G during follow-up period decreased from 12,9±4,9 to 10,1±3,4g/l (p=0,0001), but remained within normal limits. Infusion reactions occurred in 15 pts (1,8/100 PY, 95% CI 1-3). Other AE were observed in 9 pts (6%) (1,1/100 PY, 95% CI 0,53-2,12). Sixteen deaths were recorded – 10,7% or 1,91/100 PY, 95% CI 1,2-3,1. In most cases, pts died from the progression of the major organ failure. The causes of death were: progression of the interstitial lung disease (ILD) in 4 pts, heart failure associated with SSc cardiomyopathy (2), renal crisis (4), pulmonary arterial hypertension and ILD (2), pneumonia (2), sepsis after tooth extraction (1), acute pulmonary embolism (1).Conclusion:In our study, we considered the overall safety profile of RTX in SSc as favorable. It was similar to the AE profile in other autoimmune diseases treated with RTX. With an increase of the cumulative dose of RTX, there was no increase in AE. RTX could be considered as a relatively safe drug for the complex therapy of SSc when standard therapy is ineffective or impossible.Disclosure of Interests:None declared

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 681.1-681
Author(s):  
L. Garzanova ◽  
L. P. Ananyeva ◽  
O. Koneva ◽  
O. Desinova ◽  
O. Ovsyannikova ◽  
...  

Background:Rituximab (RTX) is a new option in the treatment of systemic sclerosis (SSc) [1]. There is not enough data on changes in the level of autoantibodies and their clinical significance during RTM therapy. There are only a few reports on the higher efficiency of RTX in patients (pts) with SSc positive for anti-topoisomerase-1 antibodies (a-Topo-1), therefore the study of this issue might be interested.Objectives:To compare clinical parameters and B-lymphocytes (B-lymph) level in SSc pts depending on the presence or absence of a-Topo-1 during RTX therapy with prospective long-term follow-up.Methods:This study included 88 pts with SSc. The mean follow-up period was 26,3±10,7 months. The mean age was 47years (17-71), female-73 pts (83%), the diffuse cutaneous subset of the disease had 50 pts (57%). Symptoms of the interstitial lung disease (ILD) were observed in 70 pts (80%). The mean disease duration was 5,9±4,8 years. The cumulative mean dose of RTX was 2,9±1,1 grams. All patients received prednisone at a dose of 11,7±4,4 mg, immunosuppressants received 42% of them. There were 63 pts positive for a-Topo-1 and 25 pts - negative. The pts of the compared groups did not differ in the main demographic and clinical parameters, excepting lung involvement. In a-Topo-1 positive group 55 (87%) pts had ILD and only 15 (60%) – in a-Topo-1-negative group (p=0,02). The results at baseline and at the end of the follow up are presented in the form of mean values and changes in parameters (delta).Results:Considering the entire cohort, an improvement of almost all outcome parameters was found. When a-Topo-1 positive and a-Topo-1-negative pts were analyzed separately, we observed a significantly higher decrease in the activity score, depletion of B-lymph, an increase in forced vital capacity (FVC) and diffusion capacity for carbon monoxide (DLCO) in a-Topo-1 positive group of pts (table 1).Table 1.Changes of the main outcome parameters depending on the presence of a-Topo-1 on RTX therapy.Parametersa-Topo-1positive ptsa-Topo-1negative ptsPDelta Activity score (EScSG-AI)1,790,90,001Delta Rodnan skin score (mRSS)4,95,2NSDelta B-lymphocytes (absolute count)0,2120,1930,001Delta FVC*, %8,646,460,001Delta DLCO**, %2,860,0320,001*FVC - forced vital capacity % predicted, **DLCO - diffusion capacity for carbon monoxide % predictedThe a-Тopo-1 level decreased from 174,2±50,1 to 148,1±66,1 units/ml (p=0,0009). In this group, a-Тopo-1 became negative in 5 pts (7,9%). The disappearance of a-Topo-1 positivity was accompanied by a more pronounced decrease in mRSS (delta mRSS=7,4) and a higher depletion of B-lymph. There was a higher cumulative dose of RTX (4±1,4grams) in this 5 pts compared with the pts who sustained a-Topo-1 positivity. There was a moderate negative statistically significant correlation between the a-Topo-1 and the total dose of RTX (r=-0,298, p=0,017). A moderate negative statistically significant correlation was found between the a-Topo-1 and FVC (r=-0,322, p=0,009).Conclusion:In our study, the a-Topo-1 level significantly decreased during RTX therapy in Russian pts. The decrease in a-Topo-1 titers correlated with the total dose of RTX and was accompanied by a decrease in mRSS, disease activity index and an increase in FVC and DLCO. A higher efficacy of RTX in the a-Topo-1 positive group with prevalence of ILD was revealed, therefore a-Topo-1 positivity could be considered as a predictor of a better response to RTX therapy.References:[1]Jordan S, et al. Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group. Ann Rheum Dis.2015;74:1188–94.Doi:10.1136/annrheumdis-2013-204522.[2]Ebata S, Yoshizaki A, et.al. Rituximab therapy is more effective than cyclophosphamide therapy for Japanese patients with anti-topoisomerase I-positive systemic sclerosis-associated interstitial lung disease. J Dermatol.2019.Nov;46(11):1006-1013.doi:10.1111/1346-8138.15079.Disclosure of Interests:None declared


Author(s):  
A.P. Voznyuk ◽  
◽  
S.I. Anisimov ◽  
S.Y. Anisimova ◽  
L.L. Arutyunyan ◽  
...  

Purpose. To evaluate the efficacy and safety of femtolaser-assisted phacoemulsification in glaucomatous eyes in the long-term follow-up. Materials and methods. A retrospective analysis of the results of the surgical treatment of patients with combined cataract and glaucoma pathology was analyzed. The patients were divided into groups depending on the method of surgical intervention: 1) phacoemulsification with femtolaser support (26 eyes, 23 patients); 2) phacoemulsification (36 eyes, 30 patients); Results. Before surgery, there were no statistically significant differences in IOP and corneal hysteresis (СН) between groups 1 and 2. The mean values of IOP cc, IOP g and СН of group 1 before surgery were 22.7±6.1 mm Hg, 20.9±6.9 mm Hg, 8.5±1.6 mm Hg; 2 group – 22.9±8.7 mm Hg, 21.6±8.9 mm Hg, 8.9±1.6 mm Hg respectively. Average values of IOP cc, IOP g and CН 5 years after the surgical treatment in group 1 were 15.3±1.2 mm Hg, 14.4±3.4 mm Hg, 9.6±4.2 mm Hg; in group 2 – 18.0±4.2 mm Hg, 16.1±4.2 mm Hg, 8.8±2.2 mm Hg respectively. In both groups, stabilization of IOP and CH indices was noted, which remained throughout the entire observation period, which shows the normalization of the biomechanical properties of the corneoscleral membrane of the eye in the long-term postoperative period. Conclusion. Femtolaser accompaniment of phacoemulsification is an effective and safe method of cataract surgery for combined pathology. Key words: femtolaser, cataract, glaucoma, phacoemulsification.


2019 ◽  
Vol 2 ◽  
pp. 251581631882469 ◽  
Author(s):  
Sanjay Prakash ◽  
Chaturbhuj Rathore ◽  
Kaushik Rana ◽  
Hemant Joshi ◽  
Jay Patel ◽  
...  

Introduction: Till date, there is no prospective study in patients with hemicrania continua (HC). Methods: Patients fulfilling the international classification of headache disorders criteria for HC were evaluated prospectively. All patients were subjected to a detailed clinical interview, based on a structured questionnaire. Before starting indomethacin, all patients were instructed to fill a headache diary for at least 5 days. Gradual tapering of indomethacin was done at regular intervals. Results: We enrolled 41 patients over 4.5 years, 31 of whom met the criteria after confirming the indomethacin response. The mean age was 41 years, and 55% were female. The mean duration of headache was 43.6 months. All patients had continuous strictly unilateral pain with episodic exacerbations. At least one cranial autonomic feature was noted in 81% of patients. Twenty-five patients (81%) felt a sense of restlessness during exacerbations. The mean follow-up was 2.5 years. Three-fourths of patients noted a reduction in indomethacin dose after an average 2.5 of years follow-up. The mean reduction of the dose in the follow-up was statistically significant (172 mg vs. 110 mg, p < 0.001). All patients missed the drug for various reasons over the observation period. The headache reappeared within 48 h in 97% of patients. Conclusion: Misdiagnosis of HC is still very common. Patients may not volunteer about the background pain and will focus only on the exacerbations. HC rarely remits, but indomethacin requirements may decrease over time. Skipping of the effective drug leads to the immediate reappearance of pain.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1603.2-1603
Author(s):  
A. Petcu ◽  
M. M. Tamas ◽  
L. Muntean ◽  
S. P. Simon ◽  
I. Filipescu ◽  
...  

Background:Systemic sclerosis (SSc) is associated with an increased risk of death compared to the general population. Survival in SSc patients has improved significantly over the last 20 years with a decrease in renal involvement as a cause of early death and an increase in death caused by cardiopulmonary involvement (1,2). Causes of death in SSc patients have not been described in a Romanian cohort so far.Objectives:To study the causes of death in patients with SSc prospectively followed-up from 2002 to 2018 in a single tertiary centre from Romania.Methods:The cohort consists of 197 patients who fulfill the American College of Rheumatology /EULAR 2013 criteria for SSc. We examined the data of patients who had died during follow up. Patients were reviewed at least twice a year and the cause of death was classified as SSc-related or nonSSc-related. SSc-related deaths were then attributed to the major organ involved. A univariate Cox proportional hazard (PH) regression was used to examine the association between each variable and mortality. Variables reported in the literature to associate with mortality were considered in the multiple Cox PH regression model.Results:Of 197 SSc patients (87.8% females), 47.7% had diffuse SSc and 52.2% had limited SSc. The mean age at diagnosis was 47 (SD 12) years and mean follow up duration was 6.75 years. There were 41 deaths (20.8%). Survival rate was substantially lower in men (P <0.003). The mean age at the time of death in those with diffuse SSc was lower compared to limited SSc (55.8 years vs 68.7 years). Sixty percent of deaths were SSc-related (pulmonary cause[n=11], cardiac cause[n=6], gastrointestinal involvement [GI, n=3], renal crisis [n=2] and others [n=4]). Deaths no related to SSc were associated with cancer and infections. Age at onset of Raynaud phenomenon [HR 1.05], male gender [HR 3.41], diffuse SSc [HR 0.48], presence of tendon friction rub [HR 4.54], digital ulceration [HR 3], esophagitis [HR 2.07] and cardiovascular involvement [HR 3.68], use of corticosteroids[HR 2.13] and cyclophosphamide [HR 2.02] were associated with poor prognosis in multivariate analysis.Conclusion:In our cohort the main causes of death were lung and cardiovascular involvement. Deaths occurred early after the onset of the disease and the survival rate was significantly reduced among men. Multivariate analysis showed that age at onset of Raynaud phenomenon, male gender, diffuse disease form, presence of tendon friction rub, digital ulceration, esophagitis and cardiovascular history, use of corticosteroids and cyclophosphamide were independently associated with mortality.References:[1]Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010 Oct;69(10):1809–15.[2]Rubio-Rivas M, Royo C, Simeon CP, Corbella X, Fonollosa V. Mortality and survival in systemic sclerosis: systematic review and meta-analysis. Semin Arthritis Rheum. 2014 Oct;44(2):208–19.Disclosure of Interests:None declared


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Siegmund Lang ◽  
Carsten Neumann ◽  
Christina Schwaiger ◽  
Andreas Voss ◽  
Volker Alt ◽  
...  

Abstract Background For the treatment of unstable thoraco-lumbar burst fractures, a combined posterior and anterior stabilization instead of a posterior-only instrumentation is recommend in the current literature due to the instability of the anterior column. Data on restoring the bi-segmental kyphotic endplate angle (BKA) with expandable vertebral body replacements (VBR) and on the mid- to long-term patient-reported outcome measures (PROM) is sparse. Methods A retrospective cohort study of patients with traumatic thoraco-lumbar spinal fractures treated with an expandable VBR implant (Obelisc™, Ulrich Medical, Germany) between 2001 and 2015 was conducted. Patient and treatment characteristics were evaluated retrospectively. Radiological data acquisition was completed pre- and postoperatively, 6 months and at least 2 years after the VBR surgery. The BKA was measured and fusion-rates were assessed. The SF-36, EQ-5D and ODI questionnaires were evaluated prospectively. Results Ninety-six patients (25 female, 71 male; age: 46.1 ± 12.8 years) were included in the study. An AO Type A4 fracture was seen in 80/96 cases (83.3%). Seventy-three fractures (76.0%) were located at the lumbar spine. Intraoperative reduction of the BKA in n = 96 patients was 10.5 ± 9.4° (p < 0.01). A loss of correction of 1.0 ± 2.8° at the first follow-up (t1) and of 2.4 ± 4.0° at the second follow-up (t2) was measured (each p < 0.05). The bony fusion rate was 97.9%. The total revision rate was 4.2%. Fifty-one patients (53.1% of included patients; age: 48.9 ± 12.4 years) completed the PROM questionnaires after 106.4 ± 44.3 months and therefore were assigned to the respondent group. The mean ODI score was 28.2 ± 18.3%, the mean EQ-5D VAS reached 60.7 ± 4.1 points. Stratified SF-36 results (ISS < and ≥ 16) were lower compared to a reference population. Conclusion The treatment of traumatic thoraco-lumbar fractures with an expandable VBR implant lead to a high rate of bony fusion. A significant correction of the BKA could be achieved and no clinically relevant loss of reduction occurred during the follow-up. Even though health related quality of life did not reach the normative population values, overall satisfactory results were reported.


Hand ◽  
2019 ◽  
pp. 155894471987343 ◽  
Author(s):  
Femke Nawijn ◽  
Svenna H. W. L. Verhiel ◽  
Jesse B. Jupiter ◽  
Neal C. Chen

Background: The aim of this study was to assess factors associated with long-term patient-reported functional, pain, and satisfaction scores in patients who underwent (Bowers) hemiresection interposition technique (HIT) arthroplasty of the distal radioulnar joint (DRUJ). The secondary aims were to determine the complication and reoperation rates. Methods: A retrospective study with long-term follow-up of patients undergoing HIT arthroplasty was performed. Demographic, disease, and treatment characteristics were collected for the 66 included patients. Thirty-one patients completed all surveys, which were the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH), our custom-made HIT arthroplasty questionnaire, Numeric Rating Scale (NRS) for pain, and NRS for satisfaction. The mean interval between surgery and follow-up by means of questionnaires was 8.6 ± 3.4 years. Results: The mean QuickDASH score was 31.0 ± 20.2. The mean score of the HIT arthroplasty questionnaire was 2 ± 2. The median NRS for pain was 1 (interquartile range [IQR], 0-3), and the median NRS for satisfaction was 9 (IQR, 8-10). The complication rate and reoperation rate were 14% and 8%, respectively. Conclusion: Overall, patients expressed satisfaction with HIT arthroplasty, despite a mean QuickDASH score of 31.0. In our cohort, patients with inflammatory arthritis had higher satisfaction and lower pain scores. Patients who had prior trauma, prior surgery, or DRUJ subluxation are generally less satisfied. Men, older patients, and posttraumatic patients had higher long-term pain scores; however, posterior interosseous nerve neurectomy is associated with improved pain scores. Our findings support the use of HIT arthroplasty in patients with inflammatory arthritis.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 164-164
Author(s):  
N. Cristina ◽  
L. Groseanu ◽  
F. Berghea ◽  
A. Balanescu ◽  
V. Bojinca ◽  
...  

Background:Two pivotal studies, RAPIDS-1 and RAPIDS-2 revealed that bosentan reduces the development of new digital ulcers (DUs) in patients with systemic sclerosis (SSc). However data regarding the long-term use of this dual endothelin antagonist receptor in the treatment of DUs is scarce.Objectives:The aim of the present study was to evaluate long term efficacy and safety profile of bosentan in patients with DUs related to SSc.Methods:A prospective observational case-control study, conducted between 2014 and 2020 enrolled 65 SSc patients with ≥1 active DUs at baseline, who received bosentan therapy. Demographic and clinical features, including DUs incidence and patients subjective perception of DU pain and/or Raynaud’s Phenomenon, were collected. Nailfold videocapillaroscopy was performed in all patients.Results:The study included 51 females and 14 males, with a mean age of 52.6 years, 30 with diffuse subset, most of them with late scleroderma pattern (46/65). Number of DUs at baseline was 4.55 (±2.8), median duration of treatment was 25.95 (±19.4) months. Microangiopathy evolution score (MES) was 5.1 (2.19), visual analog scale (VAS) for DU was 77.9, VAS for Raynaud was 73.4.Patients receiving bosentan had clinically significant reduction in the mean number of DU (p<0.001). The effect was most powerful for the first 6 months of treatment, but the improvement was sustained until 24 months’ follow-up, when the mean DU number reached a plateau that was kept until end of study. 6 month and 24 month evaluations also revealed significant decrease in the VAS for DU (p<0.05) and in the VAS for Raynaud (p<0.01). Statistically significant difference was noted between bosentan-treated and the control group with respect to the decrease in the mean number of digital ulcers. (p=0.005).There was a clear trend towards an improvement in MES score, between baseline and the next follow-up assessments (p=0.003). The difference was statistically significant when compared to control group, but only for the first 18 months of treatment (p<0.001).14 patients (28.75%) discontinued bosentan therapy for administrative reasons. The median time among patients who interrupted the treatment was 6.9 months. An accelerated development of new DU was described 6 months after (p=0.02). Following recommencement of bosentan, the mean number of DU has rapidly decreased (p=0.008). There was no significant difference between patients who temporarily discontinued bosentan for 6 or 12 months.Bosentan was stopped due to lack of efficacy in 2 cases and due to side effects in 7 cases: 4 elevated liver enzymes, 1 severe trombocytopenia, 1 dyspneea agravation and low blood pressure.Conclusion:The present data suggest that treatment with endothelin receptor antagonist bosentan was associated with a significant reduction in the mean number of DU in patients with SSc. The beneficial effect of bosentan persisted throughout the study but was most evident in the first 6 months of treatment. Statistical analysis showed a significant improvement of the microangiopathy evolution score from baseline to end of therapy. 14 patients had a high relapse rate due to potential rebound effect, 6 months after bosentan withdrawal.The drug was reintroduced succesfully for 10 (70%) patients with a significant decrease in the number of DU.References:[1]UK Scleroderma Study Group: digital vasculopathy in systemic sclerosis, Rheumatology, Volume 54, Issue 11, November 2015, Pages 2015[2]Groseanu L, Berghea F, Bojinca V, et al AB0779 Long term follow-up of a systemic sclerosis group treated with bosentan, Annals of the Rheumatic Diseases 2018;77:1523-1524.Disclosure of Interests:None declared


2019 ◽  
Vol 42 (6) ◽  
pp. 581-586 ◽  
Author(s):  
Christina L Hvaring ◽  
Kari Birkeland

Summary Objectives The decision to preserve or to extract a deciduous tooth without a successor hinges upon whether it can be expected to be stable over time. This study aimed to record the number and location of deciduous teeth and to examine the condition of deciduous canines and molars in a group of patients with severe hypodontia, both at baseline and at follow-up. Material and methods A total of 50 patients participated in a follow-up study. The average age was 13.9 years (range 7–25 years) at baseline and 25.6 years (range 18–38 years) at follow-up. Of the 50 subjects, 44 had at least one persisting deciduous tooth at follow-up and 42 had at least one deciduous canine or molar at baseline. The presence of persisting deciduous teeth was identified on panoramic radiographs. Deciduous canines and second molars were classified as good or poor based on infraocclusion, root resorption, and restorations. Results The mean number of persisting deciduous teeth per patient was 6.3 (range 1–16) at baseline and 2.6 (range 0–9) at follow-up. The tooth types with the highest tendency to remain were canines and second molars, and in particular canines in the mandible. Among the 42 participants with a deciduous canine or molar, 183 teeth were present at baseline, of which 112 were classified as good. At follow-up, 86 (77 per cent) of these were still present, with 65 (58 per cent) classified as good. The number of teeth classified as poor due to infraocclusion decreased much more from baseline to follow-up than those classified as poor due to root resorptions and restorations, indicating that infraoccluded teeth were lost during the observation period. Conclusions Preserving deciduous canines and molars in good condition is often a dependable choice. Early infraocclusion is detrimental to the prognosis and often leads to tooth loss. Teeth with short roots proved to be more stable over time.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0025
Author(s):  
Yeokgu Hwang ◽  
Kwang Hwan Park ◽  
Seung Hwan Han ◽  
Jin Woo Lee

Category: Ankle Arthritis Introduction/Purpose: Total ankle arthroplasty (TAA) is increasingly recommended for patients with end-stage ankle osteoarthritis. However, there were few studies which had investigated long-term clinical outcomes with mobile baering system. We analyzed the patient reported results of 124 arthroplasties performed with one type of three-component total ankle prosthesis. This prospective cohort study analyzed long-term outcomes of total ankle arthroplasty with use of the Hintegra prosthesis at one center. Methods: Consecutive patients who received the hintegra prosthesis between September 2004 and December 2009 were enrolled at one large, university hospitals. Patients were annually evaluated clinically, and the patients reported survey with visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) scores, Foot and Ankle Outcome Score (FAOS) and revision rate. Kaplan-Meier survival result showed survival outcomes of TAA in long-term follow-up. Results: One hundred and twenty-four ankles underwent arthroplasty with the Hintegra prosthesis. The mean age of patient at operation time was 64.2 years old (range, 47 to 84 years old). The mean duration of follow-up for all living patients without revision (Eighty-six ankles) was 10.0 ± 1.3 years. The mean change from baseline to final follow-up was -6.7 ± 4.3 points for Visual analog scale, and 26.1 ± 10.3 points for the AOFAS score. . Seven (5.6%) of the ankles required metal component revision at a mean of 2.9 ± 1.8 years (range, 0.5 to 5.8 years). Ten (8%) of the prostheses underwent polyethylene bearing exchange, mostly due to asymmetric wear, at a mean of 2.8 ± 1.8 years (range, 0.1 to 9.1 years). Conclusion: Long term outcomes were good after ankle arthroplasty with the Hintegra prosthesis performed by experienced surgeons, and long-term outcomes demonstrated. The revision rate was substantially higher among the first fifty ankles than among subsequent ankles. Further study to elucidate possible reasons for osteolysis and subjective pain after TAA is warranted.


2019 ◽  
Vol 44 (5) ◽  
pp. 319-326 ◽  
Author(s):  
Wen-Cheng Chen ◽  
Ming-Shao Tsai ◽  
Yao-Te Tsai ◽  
Chia-Hsuan Lai ◽  
Chuan-Pin Lee ◽  
...  

AbstractWe explored the effects of various parameters on taste impairments (TIs) in head-and-neck (H&N) cancer patients receiving intensity-modulated radiotherapy (IMRT). From January 2014 to September 2017, 88 H&N cancer patients subjected to curative or postoperative IMRT were enrolled in this prospective study. All patients underwent at least 1 year of follow-up after IMRT. Quality-of-life assessments in terms of patient-reported gustatory function were measured using the taste-related questions of the European Organization for Research and Treatment of Cancer H&N35 questionnaires. At a median follow-up time of 27 months, 27 of 88 patients (30.7%) reported long-term TIs. In multivariate analyses, glossectomy most significantly predicted TIs (P = 0.04). The percentage of TIs (61.5%) was significantly (P = 0.03) higher in patients who underwent partial or total glossectomy than in patients who did not undergo surgery (28.0%) and those who underwent radical surgery without glossectomy (20.0%). When we excluded surgical patients from analyses, the mean radiation dose to the oral cavity was of borderline significance in terms of TI prediction (P = 0.05). Only 10.5% of patients suffered from TIs when the mean radiation dose was <5000 cGy compared with 38.7% when the mean dose was ≥5000 cGy. In conclusion, glossectomy is the major cause of long-term TIs in H&N cancer patients receiving IMRT. In patients who do not undergo glossectomy, reduction of the mean radiation dose to the oral cavity may reduce TIs after IMRT.


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