Background: In patients undergoing percutaneous coronary intervention (PCI) in the SMART-CHOICE trial, P2Y12 inhibitor monotherapy after three months of dual antiplatelet therapy (DAPT) achieved clinical outcomes comparable to those of 12 months of DAPT.Nonetheless, the effects of sex on these outcomes remain unknown. Methods: This open-label, non-inferiority, randomized study, conducted in 33 hospitals in South Korea, included 2,993 patients undergoing PCI with drug-eluting stents. Patients were randomly assigned to receive DAPT (aspirin plus a P2Y12 inhibitor) for three months then P2Y12 inhibitor alone for nine months, or DAPT for the entire 12 months. The primary endpoints were major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) 12 months after the index procedure. The bleeding endpoints were Bleeding Academic Research Consortium (BARC) bleeding types 2 to 5. Results: Of the patients, 795 (26.6%) were women, who were older and had a higher prevalence of hypertension, diabetes, and dyslipidemia than men. The sexes exhibited comparable primary endpoints (adjusted hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.55–1.55; P = 0.770) and bleeding endpoints (adjusted HR, 1.07; 95% CI, 0.63–1.81; P = 0.811). P2Y12 inhibitor monotherapy vs DAPT was associated with lower risk of BARC type 2 to 5 bleeding in women (adjusted HR, 0.40; 95% CI, 0.16–0.98; P = 0.045) but the difference was not statistically significant when using the Bonferroni correction. The primary endpoints were similar between treatment groups in both sexes. Conclusion In both sexes undergoing PCI, P2Y12 inhibitor monotherapy after three months of DAPT achieved similar risks of the primary endpoints and the bleeding events compared with prolonged DAPT. Therefore, the benefits of early aspirin withdrawal with ongoing P2Y12 inhibitors may be comparable in women and men.

Background: In this study, we prepared and evaluated an injectable poloxamer (P407) hydrogel formulation for intratympanic (IT) delivery of dexamethasone (DEX). Methods: DEX-loaded P407 hydrogels were characterized in terms of thermogelation, drug loading capacities, particle size, and drug release. The in vivo toxicity and drug absorption of the DEX-loaded P407 formulation after IT injection were evaluated using an animal model by performing histopathological analysis and drug concentration measurements. Results: The P407 hydrogel effectively solubilized hydrophobic DEX and demonstrated a sustained release compared to the hydrophilic DEX formulation. The in vivo study showed that the hydrogel formulation delivered considerable drug concentrations to the inner ear and displayed a favorable safety profile without apparent cytotoxicity or inflammation. Conclusion P407 hydrogel can be useful as an injectable inner ear delivery formulation for hydrophobic drugs due to their biocompatibility, drug-solubilizing capacity, thermogelation, and controlled release.

Although patellofemoral arthritis is a common and debilitating orthopedic disorder, its treatment varies and remains controversial. This review aims to provide an overview of the current understanding of the pathophysiology of patellofemoral arthritis, as well as its various diagnostic and treatment options.Current Concepts: The pathophysiology of patellofemoral arthritis includes lower limb malalignment, trochlear and/or patellar dysplasia, patellar instability, trauma, and obesity. The disorder is characterized by chronic anterior knee pain aggravated by flexion of the knee joint. A critical imaging study of the Merchant and lateral knee radiographs may show the progression of patellofemoral arthritis and dysplasia of the patellofemoral joints. Non-pharmacologic treatment options for patellofemoral arthritis include patient education, self-management, exercise, weight loss, taping, bracing, and orthotics. Pharmacologic agents (non-steroidal anti-inflammatory drugs, acetaminophen, oral narcotics, and duloxetine) and intra-articular injection therapies (glucocorticoids, hyaluronic acid, platelet-rich plasma, and other regenerative therapies) can be helpful for symptom relief in patients with patellofemoral arthritis. The surgical treatment can begin with lateral retinacular release to realign and decompress the patellofemoral joint. If failure in the improvement of symptoms is noted, a tibial tubercle osteotomy can be considered in young and active patients. While the early design and technique of patellofemoral arthroplasty were less than encouraging, more recent implant design and surgical techniques have demonstrated robust results.Discussion and Conclusion: Patellofemoral arthritis is a unique entity compared with tibiofemoral arthritis marked by distinct epidemiology, biomechanics, and risk factors and treatment options. It is essential to understand its pathophysiology and ensure proper treatment options.

Background: and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer’s disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-tosevere AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB—social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name— were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

Background: The purpose of this study was to prepare data for the prevention and management of iron deficiency by analyzing the effects of taking iron supplements provided by blood centers for repeat blood donors. Methods: The high-risk groups with a potential iron deficiency were defined as three or more whole blood donations within the previous year and were provided with iron supplements for three months. Their hemoglobin and ferritin levels were checked up once a month for six months. The effectiveness of the iron supplements was evaluated by analyzing the changes in the initial and monthly hemoglobin and ferritin results. Results: At the time of recruitments, an average 50.4% (40.8% of men and 65.3% of women, respectively) of participants had ferritin levels of less than 15 ng/mL, the World Health Organization iron deficiency standard, but after three months iron supplementation, the results decreased to 10.9% (9.0% of men and 13.8% of women). The ferritin levels increased significantly after taking iron supplements for three months and showed significant increases in both men and women, particularly after two months (P＜0.05). Conclusion The dietary iron supplements containing low-dose iron were effective in preventing iron deficiency in repeat blood donors by increasing the ferritin levels.

Background: The purpose of this study was to prepare data for the prevention and management of iron deficiency by analyzing the effects of taking iron supplements provided by blood centers for repeat blood donors. Methods: The high-risk groups with a potential iron deficiency were defined as three or more whole blood donations within the previous year and were provided with iron supplements for three months. Their hemoglobin and ferritin levels were checked up once a month for six months. The effectiveness of the iron supplements was evaluated by analyzing the changes in the initial and monthly hemoglobin and ferritin results. Results: At the time of recruitments, an average 50.4% (40.8% of men and 65.3% of women, respectively) of participants had ferritin levels of less than 15 ng/mL, the World Health Organization iron deficiency standard, but after three months iron supplementation, the results decreased to 10.9% (9.0% of men and 13.8% of women). The ferritin levels increased significantly after taking iron supplements for three months and showed significant increases in both men and women, particularly after two months (P＜0.05). Conclusion The dietary iron supplements containing low-dose iron were effective in preventing iron deficiency in repeat blood donors by increasing the ferritin levels.

BACKGROUND/AIMS: The Crohn's and Colitis Knowledge (CCKNOW) score does not reflect updated knowledge relating to inflammatory bowel disease (IBD). The aim of this study was to develop, validate, and apply a novel tool to measure disease-related knowledge in IBD patients. METHODS: A questionnaire composed of 24 items regarding knowledge of IBD was developed: Inflammatory Bowel Disease Knowledge (IBD-KNOW). Discriminate ability of IBD-KNOW was validated in three occupational groups (14 doctors, 20 nurses, and 19 clerks). The CCKNOW and IBD-KNOW were administered to IBD patients. Factors affecting the level of IBD-related knowledge were analyzed. RESULTS: The median Inflammatory Bowel Disease Knowledge (IBD-KNOW) score was significantly different among the three groups for validation (22 doctors, 20 nurses, and five clerks; p < 0.001). The IBD-KNOW showed excellent internal consistency (Cronbach α = 0.952) and high correlation with CCKNOW (Spearman ρ = 0.827, p = 0.01). A total of 200 IBD patients (120 Crohn's disease, 80 ulcerative colitis) completed questionnaires. Multivariate analysis showed that a higher IBD-KNOW score than the median was associated with hospitalization history (odds ratio [OR], 2.625; p = 0.003), high education level (OR, 2.498; p = 0.012), and information acquired from patient organization (OR, 3.305, p = 0.035). CONCLUSIONS: The IBD-KNOW demonstrated excellent test characteristics. Hospitalization history, education level, and information acquired from patient organization play an important role in correct IBD-related knowledge.
Colitis ; Crohn Disease ; Education ; Hospitalization ; Humans ; Inflammatory Bowel Diseases* ; Multivariate Analysis ; Occupational Groups ; Ulcer

Codeine is widely prescribed in clinical settings for the relief of pain and non-productive coughs. Common adverse drug reactions to codeine include constipation, euphoria, nausea, and drowsiness. However, there have been few reports of serious adverse reactions after codeine ingestion in adults. Here, we present a case of severe anaphylaxis after oral ingestion of a therapeutic dose of codeine. A 30-year-old Korean woman complained of the sudden onset of dyspnea, urticaria, chest tightness, and dizziness 10 minutes after taking a 10-mg dose of codeine to treat a chronic cough following a viral infection. She had previously experienced episodes of asthma exacerbation following upper respiratory infections, and had non-atopic rhinitis and a food allergy to seafood. A skin prick test showed a positive response to 1-10 mg/mL of codeine extract, with a mean wheal size of 3.5 mm, while negative results were obtained in 3 healthy adult controls. A basophil histamine release test showed a notable dose-dependent increase in histamine following serial incubations with codeine phosphate, while there were minimal changes in the healthy controls. Following a CYP2D6 genotype analysis, the patient was found to have the CYP2D6*1/*10 allele, indicating she was an intermediate metabolizer. An open label oral challenge test was positive. To the best of our knowledge, this is the first report of a patient presenting with severe anaphylaxis after the ingestion of a therapeutic dose of codeine, which may be mediated by the direct release of histamine by basophils following exposure to codeine.
Adult ; Alleles ; Anaphylaxis* ; Asthma ; Basophil Degranulation Test ; Basophils ; Codeine* ; Constipation ; Cough ; Cytochrome P-450 CYP2D6 ; Dizziness ; Drug-Related Side Effects and Adverse Reactions ; Dyspnea ; Eating ; Euphoria ; Female ; Food Hypersensitivity ; Genotype ; Histamine ; Histamine Release ; Humans ; Nausea ; Respiratory Tract Infections ; Rhinitis ; Seafood ; Skin ; Sleep Stages ; Thorax ; Urticaria

PURPOSE: Procalcitonin (PCT), a precursor of calcitonin, has been described as a biomarker of bacterial infection and inflammation. This study was performed to evaluate the clinical usefulness of PCT levels and to reduce the unnecessary usage of antibiotics in children with lower respiratory tract infection (RTI). METHODS: Eighty-eight children, with lower RTI, under the age of 5 years, who were admitted to Chungnam National University Hospital, between May 2010 and December 2010, were enrolled. White blood cell counts, erythrocyte sedimentation rate, C-reactive protein, and PCT were measured. Blood and sputum cultures were performed to identify the causative bacteria and reverse transcription-polymerase chain reaction for the viruses. Clinical features were reviewed, retrospectively. RESULTS: The mean participant age was 1.9+/-1.5 years. The cut-off value for serum PCT levels, which was derived from the receiver-operator characteristic curve, was 0.11 ng/mL. In 29 patients (33.0%) with low PCT levels (<0.11 ng/mL), antibiotic therapy showed no benefit for clinical and laboratory findings. However, in 59 patients (67.1%) with high PCT levels (> or =0.11 ng/mL), hospitalization (P=0.005) and fever (P=0.054) exhibited a shorter duration, after antibiotic therapy. CONCLUSION: A single initial serum PCT levels (> or =0.11 ng/mL) may be clinically useful to give a guideline for antibiotic treatment in children with lower respiratory tract infection and to reduce the unnecessary usage of antibiotics.
Anti-Bacterial Agents ; Bacteria ; Bacterial Infections ; Blood Sedimentation ; C-Reactive Protein ; Calcitonin ; Child ; Fever ; Hospitalization ; Humans ; Inflammation ; Leukocyte Count ; Protein Precursors ; Respiratory System ; Respiratory Tract Infections ; Sputum

PURPOSE: To determine the correlation and agreement between perpheral venous and arterial values in emergency department patients. METHODS: The study was conducted at an urban teaching hospital emergency department with an annual volume of 80,000 patient visits. Prospective comparison of paired peripheral venous and arterial values were evaluated from October, 2009 to February, 2010. Peripheral venous and arterial samples were taken as simultaneously as possible when patients who were deemed by the attending doctor to require an peripheral arterial sample presented in the emergency department. Collected information included age, sex, vital signs, emergency department initial diagnosis, lactate, pH, base excess, bicarbonate, pO2, and pCO2. Statistical methods were Shapiro-Wilk test, Spearman rho test, linear regression analysis, and Bland-Altman plots. RESULTS: Among the 546 patients, 50 were excluded and 496 were included. The majority (59.5%) of patients were male. Correlation constant (rho) of pH and lactate were 0.907 and 0.901, respectively. Mean difference and CI (confidence interval) of pH were -0.04 and -1.34~1.56, respectively. Mean difference and CI of lactate were 0.11 mmol/L and -0.15~0.07 mmol/L, respectively. CONCLUSION: Moderate correlation and agreement between perpheral venous and arterial pH, lactate, base excess, and CO2 was evident. Especially, peripheral venous pH, lactate correlated very well and had reasonable agreement with peripheral arterial values to serve as substitutes.
Blood Gas Analysis ; Emergencies ; Hospitals, Teaching ; Humans ; Hydrogen-Ion Concentration ; Lactic Acid ; Linear Models ; Male ; Prospective Studies ; Statistics as Topic ; Vital Signs