ABSTRACT
BACKGROUND: Although various monoclonal antibodies have been used as add-on therapy for severe eosinophilic asthma (SEA), to the best of our knowledge, no direct head-to-head comparative study has evaluated their efficacy. OBJECTIVE: To compare the efficacy of reslizumab, mepolizumab, and dupilumab in patients with SEA. METHODS: This was a multicenter, prospective observational study in patients with SEA who had received 1 of these biologic agents for at least 6 months. Cox proportional hazard models were used to compare the risk of the first exacerbation event, adjusting for sputum or blood eosinophils and common asthma-related covariates. The annual exacerbation rate was analyzed using a negative binomial model, and a mixed-effect model was used to analyze changes in forced expiratory volume in 1 second and asthma control test score over time. RESULTS: A total of 141 patients with SEA were included in the analysis; 71 (50%) received dupilumab; 40 (28%) received reslizumab, and 30 (21%) received mepolizumab. During the 12-month follow-up, 27.5%, 43.3%, and 38.0% of patients in the reslizumab, mepolizumab, and dupilumab groups, respectively, experienced at least 1 exacerbation. However, after adjusting for confounding factors, the dupilumab and mepolizumab groups showed similar outcomes in time-to-first exacerbation, exacerbation rate, forced expiratory volume in 1 second, and asthma control test score to those of the reslizumab group. CONCLUSION: In patients with SEA, treatment with reslizumab, mepolizumab, and dupilumab resulted in comparable clinical outcomes within a 12-month period. TRIAL REGISTRATION: The cohort protocol was sanctioned by the Institutional Review Board of each study center (clinicaltrial.gov identifier NCT05164939).
Subject(s)
Anti-Asthmatic Agents , Asthma , Biological Products , Pulmonary Eosinophilia , Humans , Prospective Studies , Eosinophils , Antibodies, Monoclonal/therapeutic use , Pulmonary Eosinophilia/drug therapy , Biological Products/therapeutic use , Anti-Asthmatic Agents/therapeutic useABSTRACT
PURPOSE: This study aimed to advance the MetaLAB algorithm and verify its performance with multicenter data to effectively detect major adverse drug reactions (ADRs), including drug-induced liver injury. METHODS: Based on MetaLAB, we created an optimal scenario for detecting ADRs by considering demographic and clinical records. MetaLAB-HOI was developed to identify ADR signals using common model-based multicenter electronic health record (EHR) data from the clinical health outcomes of interest (HOI) template and design for drug-exposed and nonexposed groups. In this study, we calculated the odds ratio of 101 drugs for HOI in Konyang University Hospital, Seoul National University Hospital, Chungbuk National University Hospital, and Seoul National University Bundang Hospital. RESULTS: The overlapping drugs in four medical centers are amlodipine, aspirin, bisoprolol, carvedilol, clopidogrel, clozapine, digoxin, diltiazem, methotrexate, and rosuvastatin. We developed MetaLAB-HOI, an algorithm that can detect ADRs more efficiently using EHR. We compared the detection results of four medical centers, with drug-induced liver injuries as representative ADRs. CONCLUSIONS: MetaLAB-HOI's strength lies in fully utilizing the patient's clinical information, such as prescription, procedure, and laboratory results, to detect ADR signals. Considering changes in the patient's condition over time, we created an algorithm based on a scenario that accounted for each drug exposure and onset period supervised by specialists for HOI. We determined that when a template capable of detecting ADR based on clinical evidence is developed and manualized, it can be applied in medical centers for new drugs with insufficient data.
Subject(s)
Chemical and Drug Induced Liver Injury , Drug-Related Side Effects and Adverse Reactions , Humans , Adverse Drug Reaction Reporting Systems , Chemical and Drug Induced Liver Injury/diagnosis , Chemical and Drug Induced Liver Injury/epidemiology , Chemical and Drug Induced Liver Injury/etiology , Electronic Health Records , Hospitals, University , Outcome Assessment, Health Care , Multicenter Studies as TopicABSTRACT
This study aimed to investigate the effects of high-dose inhaled corticosteroids (ICS) on chronic cough patients with elevated fractional exhaled nitric oxide (FeNO) levels. In a prospective study, adults with chronic cough and FeNO ≥ 25 ppb, without any other apparent etiology, received fluticasone furoate (200 mcg) for three weeks. Outcomes were evaluated using FeNO levels, cough severity, and Leicester Cough Questionnaire (LCQ) before and after treatment. Of the fifty participants (average age: 58.4 years; 58% female), the treatment responder rate (≥ 1.3-point increase in LCQ) was 68%, with a significant improvement in cough and LCQ scores and FeNO levels post-treatment. However, improvements in cough did not significantly correlate with changes in FeNO levels. These findings support the guideline recommendations for a short-term ICS trial in adults with chronic cough and elevated FeNO levels, but the lack of correlations between FeNO levels and cough raises questions about their direct mechanistic link.
Subject(s)
Cough , Nitric Oxide , Humans , Cough/drug therapy , Female , Middle Aged , Male , Prospective Studies , Administration, Inhalation , Chronic Disease , Nitric Oxide/metabolism , Nitric Oxide/analysis , Aged , Treatment Outcome , Fractional Exhaled Nitric Oxide Testing , Androstadienes/administration & dosage , Adult , Severity of Illness Index , Surveys and Questionnaires , Exhalation , Adrenal Cortex Hormones/administration & dosage , Chronic CoughABSTRACT
BACKGROUND: The determinants linked to the short- and long-term improvement in lung function in patients with severe eosinophilic asthma (SEA) on biological treatment (BioT) remain elusive. OBJECTIVE: We sought to identify the predictors of early and late lung function improvement in patients with SEA after BioT. METHODS: 140 adult patients with SEA who received mepolizumab, dupilumab, or reslizumab were followed up for 6 months to evaluate improvement in forced expiratory volume in one second (FEV1). Logistic regression was used to determine the association between potential prognostic factors and improved lung function at 1 and 6 months of treatment. RESULTS: More than a third of patients with SEA using BioT showed early and sustained improvements in FEV1 after 1 month. A significant association was found between low baseline FEV1 and high blood eosinophil count and sustained FEV1 improvement after 1 month (0.54 [0.37-0.79] and 1.88 [1.28-2.97] odds ratios and 95% confidence interval, respectively). Meanwhile, among patients who did not experience FEV1 improvement after 1 month, 39% exhibited improvement at 6 months follow-up. A high ACT score measured at this visit was the most reliable predictor of late response after 6 months of treatment (OR and 95% CI 1.75 [1.09-2.98]). CONCLUSION: Factors predicting the efficacy of biological agents that improve lung function in SEA vary according to the stage of response.
Subject(s)
Anti-Asthmatic Agents , Asthma , Biological Products , Pulmonary Eosinophilia , Adult , Humans , Anti-Asthmatic Agents/therapeutic use , Biological Products/therapeutic use , Eosinophils , Pulmonary Eosinophilia/drug therapy , LungABSTRACT
PURPOSE: Codeine is a narcotic antitussive often considered for managing patients with refractory or unexplained chronic cough. This study aimed to evaluate the proportion and characteristics of patients who responded to codeine treatment in real-world practice. METHODS: Data from the Korean Chronic Cough Registry, a multicenter prospective cohort study, were analyzed. Physicians assessed the response to codeine based on the timing and degree of improvement after treatment initiation. Follow-up assessments included the Leicester Cough Questionnaire and cough severity visual analog scale at six months. In a subset of subjects, objective cough frequency was evaluated following the initiation of codeine treatment. RESULTS: Of 305 patients, 124 (40.7%) responded to treatments based on anatomic diagnostic protocols, while 181 (59.3%) remained unexplained or refractory to etiological treatments. Fifty-one subjects (16.7%) were classified as codeine treatment responders (those showing a rapid and clear response), 57 (18.7%) as partial responders, and 62 (20.3%) as non-responders. Codeine responders showed rapid improvement in objective cough frequency and severity scores within a week of the treatment. At 6 months, responders showed significantly improved scores in cough scores, compared to non-responders. Several baseline parameters were associated with a more favorable treatment response, including older age, non-productive cough, and the absence of heartburn. CONCLUSIONS: Approximately 60% of chronic cough patients in specialist clinics may require antitussive drugs. While codeine benefits some, only a limited proportion (about 20%) of patients may experience rapid and significant improvement. This underscores the urgent need for new antitussive drugs to address these unmet clinical needs.
Subject(s)
Antitussive Agents , Codeine , Humans , Codeine/therapeutic use , Antitussive Agents/therapeutic use , Prospective Studies , Chronic Cough , Cohort Studies , Cough/drug therapy , Cough/etiologyABSTRACT
BACKGROUND: The fatty infiltration and atrophy in the muscle after a rotator cuff (RC) tear are important in surgical decision-making and are linked to poor clinical outcomes after rotator cuff repair. An accurate and reliable quantitative method should be developed to assess the entire RC muscles. PURPOSE: To develop a fully automated approach based on a deep neural network to segment RC muscles from clinical magnetic resonance imaging (MRI) scans. MATERIAL AND METHODS: In total, 94 shoulder MRI scans (mean age = 62.3 years) were utilized for the training and internal validation datasets, while an additional 20 MRI scans (mean age = 62.6 years) were collected from another institution for external validation. An orthopedic surgeon and a radiologist manually segmented muscles and bones as reference masks. Segmentation performance was evaluated using the Dice score, sensitivities, precision, and percent difference in muscle volume (%). In addition, the segmentation performance was assessed based on sex, age, and the presence of a RC tendon tear. RESULTS: The average Dice score, sensitivities, precision, and percentage difference in muscle volume of the developed algorithm were 0.920, 0.933, 0.912, and 4.58%, respectively, in external validation. There was no difference in the prediction of shoulder muscles, with the exception of teres minor, where significant prediction errors were observed (0.831, 0.854, 0.835, and 10.88%, respectively). The segmentation performance of the algorithm was generally unaffected by age, sex, and the presence of RC tears. CONCLUSION: We developed a fully automated deep neural network for RC muscle and bone segmentation with excellent performance from clinical MRI scans.
ABSTRACT
PURPOSE: To evaluate the radiographic and clinical outcomes when rerouting a pathologic biceps during arthroscopic rotator cuff repair by comparing it with concomitant subpectoral biceps tenodesis (SPBT). METHODS: This retrospective, historical cohort study was conducted with patients who underwent an arthroscopic repair of a full-thickness rotator cuff tear, with intraoperative confirmation of biceps pathology including partial tears, subluxation, pulley lesions, or type II SLAP lesions. Until May 2018, such patients were treated with concomitant subpectoral tenodesis (group SPBT). Afterward, biceps rerouting (BR) was done regardless of biceps pathology (group BR) without biceps or SLAP repair. Radiographic parameters, including fatty degeneration, acromiohumeral distance, Sugaya classification, and retears, were evaluated using preoperative and 1-year postoperative magnetic resonance imaging results. Clinical evaluation with a minimum 2-year follow-up included pain visual analog scale, American Shoulder and Elbow Surgeons, Simple Shoulder Test, and Constant-Murley scores. Whether individual patients exceeded these scores' minimal clinically important difference also was determined. RESULTS: A total of 64 patients (group SPBT = 32; group BR = 32) were included in the final analysis. The duration of clinical follow-up was 36.2 ± 9.3 months in group SPBT and 29.4 ± 6.9 months in the BR group (P = .002). Compared with group SPBT, group BR demonstrated a significantly lower retear rate (SPBT vs BR: 34.4% vs 12.5%, P = .039). In the BR group, 8 of 32 (25%) patients demonstrated a postoperative LHBT tear. The 4 cuff retears in group BR only took place within these patients. Other postoperative radiographic and clinical outcomes were comparable between the groups. Within each group, significant postoperative improvements were demonstrated (P < .05 for all clinical scores). CONCLUSIONS: Even in the presence of a pathologic LHBT and/or a type II SLAP lesion, augmenting the rotator cuff repair with BR significantly reduced retear rates while achieving clinical scores comparable with SPBT in a minimum 2-year follow-up. LEVEL OF EVIDENCE: Level III, retrospective comparative study.
Subject(s)
Arthroscopy , Rotator Cuff Injuries , Tenodesis , Humans , Tenodesis/methods , Retrospective Studies , Rotator Cuff Injuries/surgery , Rotator Cuff Injuries/diagnostic imaging , Female , Middle Aged , Male , Arthroscopy/methods , Treatment Outcome , Aged , Muscle, Skeletal/surgery , Muscle, Skeletal/diagnostic imaging , Recurrence , Magnetic Resonance ImagingABSTRACT
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ABSTRACT
Omalizumab is effective in chronic spontaneous urticaria unresponsive to antihistamines. Of the licensed dosing schedules, Korean patients prefer a low dose, of 150 mg/month, for financial reasons. However, real-world experiences of low-dose omalizumab consumption have not been reported. The aim of this retrospective study was to assess the treatment outcomes and long-term clinical course of patients with chronic spontaneous urticaria who were treated with low-dose omalizumab. The study included 179 patients aged ≥ 20 years who were treated with omalizumab 150 mg/month for ≥ 12 weeks. Baseline disease activity was mild, moderate, and severe in 54.7%, 35.2%, and 10.1% of patients, respectively. A complete response was observed in 133 patients at 12 weeks, among whom 88 patients showed early responses within 4 weeks. Overall, 158 patients finally achieved a complete response. Multivariate analyses revealed that baseline disease activity is more likely to be mild in patients who experience early and final complete responses. The absence of atopic comorbidities correlated with an early response. Smoking was associated with a final complete response. This study shows that low-dose omalizumab provides favourable treatment outcomes in antihistamine-refractory chronic spontaneous urticaria. Disease severity, atopic comorbidity, and smoking may be predictive factors for studying the response to omalizumab.
Subject(s)
Chronic Urticaria , Hypersensitivity, Immediate , Omalizumab , Humans , Asian People , Chronic Urticaria/diagnosis , Chronic Urticaria/drug therapy , Omalizumab/therapeutic use , Retrospective Studies , SmokingABSTRACT
PURPOSE: The Korean Chronic Cough Registry study was initiated to characterize patients with chronic cough (CC) and investigate their outcomes in real-world clinical practice. This report aims to describe the baseline cohort profile and study protocols. METHODS: This multicenter, prospective observational cohort study included newly referred CC patients and those already being treated for refractory or unexplained chronic cough (RUCC). Cough status was assessed using a visual analog scale, the Leicester Cough Questionnaire (LCQ), and the Cough Hypersensitivity Questionnaire (CHQ). RESULTS: A total of 610 patients (66.9% women; median age 59.0 years) were recruited from 18 centers, with 176 being RUCC patients (28.9%). The median age at CC onset was 50.1 years, and 94.4% had adult-onset CC (≥ 19 years). The median cough duration was 4 years. Compared to newly referred CC patients, RUCC patients had a longer cough duration (6.0 years vs. 3.0 years) but had fewer symptoms and signs suggesting asthma, rhinosinusitis, or gastroesophageal acid reflux disease. Subjects with RUCC had lower LCQ scores (10.3 ± 3.3 vs. 11.6 ± 3.6; P < 0.001) and higher CHQ scores (9.1 ± 3.9 vs. 8.4 ± 4.1; P = 0.024). There were no marked differences in the characteristics of cough between refractory chronic cough and unexplained chronic cough. CONCLUSIONS: Chronic cough typically develops in adulthood, lasting for years. Cough severity and quality of life impairment indicate the presence of unmet clinical needs and insufficient cough control in real-world clinical practice. Longitudinal follow-up is warranted to investigate the natural history and treatment outcomes.
Subject(s)
Gastroesophageal Reflux , Hypersensitivity , Female , Humans , Male , Middle Aged , Chronic Disease , Cough/diagnosis , Cough/epidemiology , Cough/etiology , Gastroesophageal Reflux/complications , Gastroesophageal Reflux/diagnosis , Gastroesophageal Reflux/epidemiology , Prospective Studies , Quality of Life , Republic of Korea/epidemiologyABSTRACT
The current emergence of the coronavirus disease 2019 (COVID-19) pandemic and the possible side effects of COVID-19 mRNA vaccination remain worrisome. Few cases of vaccination-related side effects, such as vasculitis, have been reported. Eosinophilic granulomatosis with polyangiitis (EGPA), also known as Churg-Strauss syndrome, is a type of vasculitis characterized by the histological richness of eosinophils, asthma, polyneuropathy, sinusitis, and skin or lung involvement. Here, we report the first case of new onset EGPA following COVID-19 vaccination in Korea. A 71-year old woman developed a skin rash and presented with progressive weakness of the upper and lower extremities after the BNT162b2 vaccination (Pfizer-BioNTech). She was diagnosed with EGPA and her symptoms improved after systemic steroid and immunosuppressant therapy. Although it is very rare, clinicians should be aware that EGPA may occur after COVID-19 vaccination.
Subject(s)
COVID-19 Vaccines , COVID-19 , Churg-Strauss Syndrome , Granulomatosis with Polyangiitis , Aged , Female , Humans , BNT162 Vaccine , Churg-Strauss Syndrome/diagnosis , Churg-Strauss Syndrome/etiology , Churg-Strauss Syndrome/drug therapy , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Granulomatosis with Polyangiitis/diagnosis , Granulomatosis with Polyangiitis/therapyABSTRACT
BACKGROUND: Adverse drug reactions (ADRs) are escalating, and their socioeconomic burden is increasing. However, large-scale prospective studies investigating ADRs during hospitalization are rare in Korea. We prospectively investigated the incidence, characteristics, and economic burden of ADRs in hospitalized patients based on electronic medical records (EMRs). METHODS: Among patients admitted to three hospitals from October 2016 to October 2017, 5,000 patients were randomly selected and prospectively observed during hospitalization. Research nurses monitored and detected patients who had symptoms, signs, or laboratory findings suspicious for ADRs using an EMR-based detection protocol. Next, allergy and ADR specialists reviewed the medical records to determine the relationship between adverse reactions and drugs. Cases in which a causal relationship was certain, probable/likely, or possible were included in the ADR cases. Clinically meaningful ADR cases or those leading to prolonged hospitalization were defined as significant ADRs. RESULTS: ADRs occurred in 510 (10.2%) patients. The mean length of hospital stay was approximately 5 days longer in patients with ADRs. Opioids accounted for the highest percentage of total ADRs. Significant ADRs were observed in 148 (3.0%) patients. Antibiotics accounted for the highest percentage of significant ADRs. Drug hypersensitivity reactions (DHRs) occurred in 88 (1.8%) patients. Antibiotics accounted for the highest percentage of DHRs. The average medical expenses for one day of hospitalization per patient were highest in significant ADRs, followed by non-significant ADRs, and non-ADRs. CONCLUSION: ADRs in hospitalized patients are an important clinical issue, resulting in a substantial socioeconomic burden. EMR-based strategy could be a useful tool for ADR monitoring and early detection.
Subject(s)
Drug Hypersensitivity , Drug-Related Side Effects and Adverse Reactions , Humans , Prospective Studies , Financial Stress , Incidence , Drug-Related Side Effects and Adverse Reactions/epidemiology , Hospitalization , Anti-Bacterial Agents , Electronic Health Records , Republic of Korea/epidemiologyABSTRACT
OBJECTIVE: The lung function changes presenting before and after asthma treatment in obese people remain largely unknown. This study aimed to investigate the association between obesity and lung function changes before and after treatment in adults with asthma. METHODS: We enrolled 937 newly diagnosed asthma patients from Cohort for Reality and Evolution of Adult Asthma in Korea cohort in 2015-2017, who performed follow-up spirometry after three months of asthma treatment. The percentage changes (Δ) between the spirometry results before and after treatment were calculated. Patients were categorized into four body mass index (BMI) groups; underweight (<18.5), normal (18.5-22.9), overweight (23.0-24.9), and obese (≥25.0). Association between percent change of pulmonary function and BMI was analyzed according to sex and/or age (< 45 yrs, 45-65 yrs, ≥ 65 yrs), which were statistically corrected for age, sex, smoking status, and medication history. RESULTS: There was no consistent correlation between BMI and each lung function parameter. However, there were significant differences between BMI and ΔFEV1/FVC before and after 3 months of controller treatment. The obese asthmatics showed significantly lower ΔFEV1/FVC (6.0 ± 13.5%) than the underweight (12.6 ± 21.4%, P = 0.044) or normal weight (9.1 ± 14.6%, P = 0.031). Middle-aged women had higher BMI (24.11 ± 3.60 vs. 22.39 ± 3.52) and lower ΔFEV1/FVC (5.7 ± 11.9% vs. 8.9 ± 14.3%, P = 0.012) than young women. CONCLUSIONS: Obesity is negatively correlated with the ΔFEV1/FVC before and after controller treatment. Sex and age differentially contribute to lung function changes in response to asthma medications in adult asthmatics, showing a significant decrease in the ΔFEV1/FVC in middle-aged women.
Subject(s)
Asthma , Thinness , Adult , Asthma/drug therapy , Body Mass Index , Female , Forced Expiratory Volume , Humans , Lung , Middle Aged , Obesity/epidemiology , Vital Capacity/physiologyABSTRACT
BACKGROUND: Targeted therapies have broadened the available treatment options for patients with severe eosinophilic asthma (SEA). However, differences in the magnitude of treatment responses among patients indicate the presence of various underlying pathophysiological processes and patient subgroups. OBJECTIVES: We aimed to describe the characteristics of SEA and identify its patient subgroups. METHODS: Clinical data from the Cohort for Reality and Evolution of Adult Asthma in Korea were analyzed. Cluster analysis was performed among those with SEA using 5 variables, namely, prebronchodilator forced expiratory volume in 1 s, body mass index, age at symptom onset, smoking amount, and blood eosinophil counts. RESULTS: Patients with SEA showed prevalent sensitization to aeroallergens, decreased lung function, and poor asthma control status. Cluster analysis revealed 3 distinctive subgroups among patients with SEA. Cluster 1 (n = 177) consisted of patients reporting the lowest blood eosinophils (median, 346.8 cells/µL) and modest severe asthma with preserved lung function during the 12-month treatment period. Cluster 2 (n = 42) predominantly included smoking males with severe persistent airway obstruction and moderate eosinophilia (median, 451.8 cells/µL). Lastly, cluster 3 (n = 95) included patients with the most severe asthma, the highest eosinophil levels (median, 817.5 cells/µL), and good treatment response in terms of improved lung function and control status. CONCLUSIONS: Three subgroups were identified in SEA through the cluster analysis. The distinctive features of each cluster may help physicians predict patients who will respond to biologics with greater magnitude of clinical improvement. Further research regarding the underlying pathophysiology and clinical importance of each subgroup is warranted.
Subject(s)
Asthma , Pulmonary Eosinophilia , Adult , Asthma/complications , Asthma/diagnosis , Asthma/drug therapy , Eosinophils , Forced Expiratory Volume , Humans , Leukocyte Count , Male , Pulmonary Eosinophilia/drug therapyABSTRACT
BACKGROUND: Some reports have suggested that the clinical and economic burdens of asthma are associated with blood eosinophil levels. The association between clinical burden and blood eosinophil counts were evaluated in a Korean adult asthma cohort. METHODS: Clinical information including blood eosinophil counts that were not affected by systemic corticosteroids were extracted from the Cohort for Reality and Evolution of Adult Asthma in Korea database. Clinical burden was defined as 1) asthma control status, 2) medication demand and 3) acute exacerbation (AE) events during 1 consecutive year after enrollment. All patients were divided into atopic and non-atopic asthmatics. The associations between asthma outcomes and the blood eosinophil count were evaluated. RESULTS: In total, 302 patients (124 atopic and 178 non-atopic asthmatics) were enrolled. In all asthmatics, the risk of severe AE was higher in patients with blood eosinophil levels < 100 cells/µL than in patients with levels ≥ 100 cells/µL (odds ratio [OR], 5.406; 95% confidence interval [CI], 1.266-23.078; adjusted P = 0.023). Among atopic asthmatics, the risk of moderate AE was higher in patients with blood eosinophil levels ≥ 300 cells/µL than in patients with levels < 300 cells/µL (OR, 3.558; 95% CI, 1.083-11.686; adjusted P = 0.036). Among non-atopic asthmatics, the risk of medication of Global Initiative for Asthma (GINA) steps 4 or 5 was higher in patients with high blood eosinophil levels than in patients with low blood eosinophil levels at cutoffs of 100, 200, 300, 400, and 500 cells/µL. CONCLUSION: The baseline blood eosinophil count may predict the future clinical burden of asthma.
Subject(s)
Asthma , Eosinophils , Adult , Asthma/drug therapy , Cohort Studies , Databases, Factual , Humans , Leukocyte CountABSTRACT
BACKGROUND: Baseplate screws have been suggested to be a possible cause of suprascapular neuropathy after reverse total shoulder arthroplasty (RTSA). Three-dimensional analyses of screw penetration and confirmation of its clinical impacts are relevant. The study aims to investigate the association between screw penetration and the clinical outcomes. MATERIALS AND METHODS: Eighty-two patients who underwent RTSA for a massive rotator cuff tear, cuff tear arthropathy, or osteoarthritis with rotator cuff tear were retrospectively enrolled. They were followed up for a minimum of 12 months, and all underwent computed tomography at 1 year postoperatively. The lengths of the superior and posterior baseplate screws were documented. Postoperative computed tomography images were subjected to 3-dimensional analysis to determine whether superior or posterior screws penetrated the glenoid vault and the location to which they penetrated, and screw-to-nerve distances were measured to estimate risks of screw nerve violation and iatrogenic suprascapular neuropathy. Patients with any screw <5 mm from the suprascapular nerve were deemed to have a high risk. Clinical outcomes (functional scores, ranges of motion, and isometric strengths) of patients in the high- and lower-risk groups were compared. RESULTS: The mean lengths of the superior and posterior screws were 28 ± 4 mm and 18 ± 3 mm, respectively. Penetration was detected for 13% of superior screws and 64% of posterior screws. Sixty-three percent of penetrating superior screws and 5% of penetrating posterior screws were <5 mm from the suprascapular nerve, and therefore, 12% of patients who received RTSA were assessed to have a high risk of iatrogenic suprascapular neuropathy. However, no significant difference was detected in clinical outcomes between the high- and lower-risk patients after a mean follow-up period of 20 months. CONCLUSION: Twelve percent of patients who received RTSA were assessed to be at high risk of iatrogenic suprascapular neuropathy by baseplate screw penetration. However, the clinical outcomes of RTSA at a minimum follow-up of 1 year were similar in the high- and lower-risk groups.
Subject(s)
Arthroplasty, Replacement, Shoulder , Peripheral Nerve Injuries , Rotator Cuff Injuries , Shoulder Joint , Arthroplasty, Replacement, Shoulder/adverse effects , Arthroplasty, Replacement, Shoulder/methods , Bone Screws/adverse effects , Humans , Iatrogenic Disease , Peripheral Nerve Injuries/etiology , Retrospective Studies , Rotator Cuff Injuries/complications , Rotator Cuff Injuries/diagnostic imaging , Rotator Cuff Injuries/surgery , Shoulder Joint/diagnostic imaging , Shoulder Joint/innervation , Shoulder Joint/surgery , Treatment OutcomeABSTRACT
BACKGROUND: Most previous studies used aluminum hydroxide-absorbed allergen extracts in evaluating the potential therapeutic roles of intralymphatic allergen-specific immunotherapy (ILAIT). In this study, we evaluated the therapeutic efficacy and safety of ILAIT with L-tyrosine-adsorbed allergen extracts of Dermatophagoides farinae, D. pteronyssinus, cat, dog, or mixtures thereof, in patients with allergic rhinitis induced by these allergens. METHODS: In this randomized, double-blind, placebo-controlled trial, study subjects received three intralymphatic injections of L-tyrosine-adsorbed allergen extracts (active group) or saline (placebo group) at 4-week intervals. RESULTS: Although ILAIT reduced daily medication use and skin reactivity to HDM and cat allergens at 4 months after treatment, overall symptom score on a visual analog scale (VAS), sinonasal outcome test-20 (SNOT-20), rhinoconjunctivitis quality of life questionnaire (RQLQ), daily symptom score (dSS), daily medication score (dMS), daily symptom medication score (dSMS), nasal reactivity to HDM allergen, and basophil activity to HDM, cat, and dog allergens at 4 months and 1 year after treatment were similar between the treatment and control groups. Intralymphatic injection was more painful than a venous puncture, and pain at the injection site was the most frequent local adverse event (12.8%); dyspnea and wheezing were the most common systemic adverse events (5.3%). CONCLUSIONS: ILAIT with L-tyrosine-adsorbed allergen extracts does not exhibit profound therapeutic efficacy in allergic rhinitis and can provoke moderate-to-severe systemic reactions and cause pain at the injection site. TRIAL REGISTRATION: clinicaltrials.gov: NCT02665754; date of registration: 28 January 2016.
Subject(s)
Antigens, Dermatophagoides/administration & dosage , Desensitization, Immunologic/methods , Quality of Life , Rhinitis, Allergic/therapy , Tyrosine/pharmacology , Adult , Animals , Cats , Dogs , Double-Blind Method , Female , Follow-Up Studies , Humans , Injections, Intralymphatic/methods , Male , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Although inhaled corticosteroids (ICSs) are the recommended first-line therapy for asthma, determining whether to continue or discontinue ICS treatment in patients with mild asthma remains challenging for clinicians. Several studies have revealed that patients with mild-persistent asthma maintained a well-controlled state after ICS withdrawal. However, the long-term outcomes of ICS withdrawal have not yet been determined. OBJECTIVE: To determine the possible clinical outcomes of the discontinuation of ICS in patients with well-controlled mild asthma. METHODS: We investigated the clinical outcomes of discontinuing ICSs in patients with well-controlled mild asthma and compared the time to loss of control (LOC) between patients who stopped ICS treatment (ICS withdrawal group, IWG) and those who continued treatment for 3 years (continuous ICS group, CIG). RESULTS: A significant difference in the time to LOC was observed between the IWG and CIG (hazard ratio, 2.56; 95% confidence interval, 1.52-4.33; P < .001). Increasing fractional exhaled nitric oxide levels (P = 0.008) and sputum eosinophil counts (%) (P = 0.015) revealed a weak but significant association with LOC risk in the CIG. The sputum eosinophil counts (P = 0.039) and serum total immunoglobulin E levels (P = 0.014) were significantly higher in the LOC group than in the non-LOC group of the CIG. CONCLUSION: Our results suggest that the maintenance of ICS treatment may help keep patients' asthma under control. Furthermore, patients with LOC had significantly higher sputum eosinophil counts in the CIG than those in the non-LOC group. Therefore, continuous ICS use by patients with mild, well-controlled asthma could be associated with good clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: KCT0002234.
Subject(s)
Adrenal Cortex Hormones/administration & dosage , Asthma/drug therapy , Eosinophils/drug effects , Sputum/cytology , Administration, Inhalation , Adult , Aged , Asthma/immunology , Asthma/physiopathology , Bronchodilator Agents/administration & dosage , Cell Count , Eosinophils/cytology , Exhalation , Female , Humans , Immunoglobulin E/blood , Male , Middle Aged , Nitric Oxide/metabolism , Republic of Korea , Respiratory Function TestsABSTRACT
PURPOSE: To evaluate the incidence of intraoperative anchor pullout during arthroscopic rotator cuff repair, to compare the outcomes of different methods of managing anchor pullout, and to introduce a new technique for anchor pullout. METHODS: 1076 patients who underwent arthroscopic rotator cuff repair using a single-row repair technique were included. In 483 patients, rotator cuff repair was performed using a screw-in type anchor, and in 593 patients, soft anchors were used. When intraoperative anchor pullout occurred, it was managed by buddy screwing, anchor insertion in a different location, cement augmentation, or by bar anchoring using a threaded Steinmann pin. Plain radiography and sonography were used to check anchor locations and healing. RESULTS: Fifty-two patients experienced anchor pullout intra- or postoperatively (48 and four patients, respectively). Anchor pullouts were more frequently observed for larger tears, women, older patients, and in patients with preoperative stiffness (limitations of both active and passive movements of the affected shoulder joint). For screw-in type anchors, pullout during surgery occurred in 16 patients (3.3%, 16/483), and all were managed using the buddy screwing technique. For soft anchor cases, pullout occurred in 32 patients (5.4%, 32/593) and was managed by anchor insertion in a different location (17 patients), cement augmentation (two patients), or bar anchoring using a threaded Steinmann pin (13 patients). Three patients managed by buddy screwing and two patients managed by anchor insertion in a different location had anchor failure after repair. Tendon healing at 6 months was observed in 12/16 patients treated by buddy screwing, 11/17 treated by anchor insertion in a different location, 2/2 treated by cement augmentation, and 12/13 treated by bar anchoring with a threaded Steinmann pin. CONCLUSION: Intraoperative anchor pullout during arthroscopic rotator cuff repair is an uncommon but cumbersome complication. There are some techniques already introduced to deal with this complication. In comparison, not one technique is overwhelmingly superior to others; however, our new technique which is bar anchoring with a threaded Steinmann pin could be another solution, since it could utilize primary anchor sites and results appear to be acceptable. Level of evidence III.
Subject(s)
Arthroscopy/methods , Rotator Cuff Injuries/surgery , Suture Anchors , Aged , Arthroscopy/adverse effects , Arthroscopy/instrumentation , Bone Cements , Female , Humans , Intraoperative Complications/surgery , Male , Middle Aged , Radiography , Rotator Cuff/diagnostic imaging , Rotator Cuff/surgery , Rotator Cuff Injuries/diagnostic imaging , Suture Techniques , UltrasonographyABSTRACT
BACKGROUND: There could be a gap between asthma management guidelines and current practice. We evaluated the awareness of and compliance with asthma management guidelines, and the internal and external barriers to compliance, for the first time in Korea. METHODS: From March to September of 2012, 364 physicians treating asthma patients at primary, secondary, and tertiary teaching hospitals were enrolled. They completed a questionnaire on the awareness of and compliance with asthma management guidelines, and the barriers and alternatives to their implementation. RESULTS: Of the 364 physicians, 79.1% were men and 56.9% were primary care physicians. The mean age was 40.5 ± 11.2 years. Most of them were aware of asthma management guidelines (89.3%). However, only a portion (11.0%) of them complied with the guidelines for asthma. Pulmonary function tests for diagnosis of asthma were performed by 20.1% of all physicians and 9.2% of primary care physicians, and by 9.9% of all physicians and 5.8% of primary care physicians for monitoring. Physicians stated that 'asthma monitoring' was the most difficult part of the guidelines, followed by 'environmental control and risk factors.' Only 39.6% (31.9% of the primary care physicians) prescribed an inhaled corticosteroid (ICS) as the first-line treatment for persistent asthma. The internal barriers were physician's preference for oral medications, difficulty in use even with inhaler training, and concern over ICS side effects. The external barriers were possible rejection of medical reimbursement by health insurance, refusal by the patient, cost, and a poor environment for teaching the patient how to use the inhaler. Alternatives proposed by physicians to implement asthma management guidelines were to improve medical reimbursement policies and the level of awareness of such guidelines. CONCLUSION: Compliance with the asthma management guidelines, including ICS prescription, is low despite the awareness of the guidelines. It is necessary to develop a strategy to overcome the internal and external barriers.