Psychological factors associated with exercise self-efficacy in the recipients of an implantable cardioverter defibrillator.

BACKGROUND: Insufficient exercise affects the health of patients who have implantable cardioverter defibrillators (ICD). The purpose of this study was to investigate the correlations between exercise self-efficacy (ESE) and its associated psychological factors in ICD recipients. METHODS: This cross-sectional study included individuals who had undergone ICD implantation at the cardiology department of a medical centre in Taiwan. A face-to-face survey was conducted. The survey questionnaire included questions regarding the participants' demographics, perceived health (PH), ICD shock-related anxiety (ICD-SRA), self-care self-efficacy (SSE), perceived exercise benefit (PE-benefit), perceived exercise barrier (PE-barrier), and ESE. Data were analysed using SPSS 20.0 Software. Stepwise multiple regression analyses were also performed to evaluate the predictive effects of the aforementioned factors on ESE. RESULTS: A total of 52 ICD recipients were enrolled. ESE was negatively correlated with ICD-SRA (r = -0.511; p < 0.01) and PE-barrier (r = -0.563; p < 0.01), but positively correlated with SSE (r = 0.339; p < 0.05) and PE-benefit (r = 0.464; p < 0.01). The stepwise multiple regression analysis revealed that PE-barrier, PE-benefit, and ICD-SRA effectively predicted ESE in the participants. CONCLUSIONS: ESE may be improved by overcoming PE-barrier, ICD-SRA and enhancing PE-benefit. Consequently, improving ESE may enhance the health benefits of exercise.

Association between colchicine use and the risk of dementia among patients with gout: A nationwide retrospective cohort study.

BACKGROUND: Recent findings suggest a link between gout and the development of dementia. Early treatment with colchicine is recommended as a first-line therapy for gout flares. Animal studies demonstrate that colchicine could induce cognitive impairment. This cohort study aimed to investigate the association between colchicine use and the risk of developing dementia. METHODS: In this nationwide cohort study, we performed comparative analysis on 6147 patients ≥40 years, with gout and colchicine new users against 6147 controls to assess subsequent dementia risk. The colchicine group and the control group (urate lowering therapy group) were matched on the bases of age, sex, index year, and comorbidities. All participants were followed for up to 14 years for a diagnosis of dementia considering medical records were retrospectively checked over this period. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Sensitivity analyses were performed to validate our findings. RESULTS: The adjusted hazard ratio (aHR) of dementia for colchicine users was 1.45 (95% CI = 1.05, 1.99) relative to comparison group after adjusting for sex, age, and comorbidities. Sensitivity analysis aiming to minimize underdiagnosed occult dementia at the time of index year yielded consistent positive association. In higher accumulative dose colchicine group (cumulative defined daily dose [cDDD] >30), the aHR of dementia risk for colchicine users was 1.42 (95% CI = 1.03, 1.97) compared with nonusers. For those duration of colchicine use >30 days, the aHR was 1.53 (95% CI = 1.01-2.32) compared to the nonuser group. CONCLUSIONS: A significant risk of dementia was observed in this study in patients with gout using colchicine at higher cDDD and for a longer period. Further research is needed to elucidate the relationship between colchicine, gout, and dementia.

Sex Differences and Positive Dose-Response Relationships between Serum Osteocalcin Levels and Low Muscle Strength.

INTRODUCTION: Impaired handgrip strength is an indication for sarcopenia and frailty screening, and is associated with increased osteoporotic risks and all-cause mortality. Osteocalcin, secreted by osteoblasts, is a versatile factor that participates in bone turnover and muscle adaptation. The role of osteocalcin in muscle strength has mainly been discussed in animal models and requires more human data. The study aimed to investigate the association between the serum osteocalcin level and handgrip strength in middle-aged individuals and older adults with diabetes. METHODS: Adult participants (aged 40 and above, N = 237) with diabetes were enrolled in a medical center in northern Taiwan. Subjects were divided into normal, low muscle mass without dynapenia, dynapenia without low muscle mass, and groups of low muscle mass with dynapenia according to their handgrip strength and muscle mass measurements. Physical performance, including handgrip strength, repeated sit-to-stand tests, walking speed, and short physical performance batteries, was documented. Body composition was measured by bioelectrical impedance analysis. RESULTS: The median serum osteocalcin level was highest in the dynapenic group without low muscle mass (median [Q1, Q3], 14.1 [11.2, 16.3] ng/mL). Multivariate logistic regression showed that a higher serum osteocalcin level was associated with worse handgrip strength (OR: 3.89, 95% CI: 1.66-9.10) after adjusting for body mass index (adiposity), skeletal muscle mass index (muscle), and medication with dipeptidyl peptidase-4 inhibitor. Further sex stratification revealed a more significant association between serum osteocalcin level and impaired handgrip strength in women but not in men. The female groups showed increases in the risk of impaired handgrip strength: 4.84-fold in the osteocalcin T2 group (11.4 ≤ osteocalcin <15.0 ng/mL) and 4.54-fold in the osteocalcin T3 group (osteocalcin ≥15.0 ng/mL). Moreover, after adjusting for various confounders, 8.41-fold and 8.03-fold increases in the risk of impaired handgrip strength were observed in the osteocalcin T2 group (11.4≤ osteocalcin <15.0 ng/mL) and osteocalcin T3 group (osteocalcin ≥14.5 ng/mL), respectively. CONCLUSION: Higher serum osteocalcin is associated with increased risks of impaired handgrip strength and impaired physical performance. Dose-dependent associations were found especially in postmenopausal women but not in men.

Prediction of risk of ischemic heart disease in first-diagnosed systemic lupus erythematosus patients in taiwan: is air pollution exposure a risk factor?

BACKGROUND: Air pollution is a key public health factor with the capacity to induce diseases. The risk of ischemia heart disease (IHD) in those suffering from systemic lupus erythematosus (SLE) from air pollution exposure is ambiguous. This study aimed to: (1) determine the hazard ratio (HR) of IHD after the first-diagnosed SLE and (2) examine the effects of air pollution exposure on IHD in SLE for 12 years. METHODS: This is a retrospective cohort study. Taiwan's National Health Insurance Research Database and Taiwan Air Quality Monitoring data were used in the study. Cases first diagnosed with SLE in 2006 cases without IHD were recruited as the SLE group. We randomly selected an additional sex-matched non-SLE cohort, four times the size of the SLE cohort, as the control group. Air pollution indices by residence city per period were calculated as the exposure. Life tables and Cox proportional risk models of time-dependent covariance were used in the research. RESULTS: This study identified patients for the SLE group (n = 4,842) and the control group (n = 19,368) in 2006. By the end of 2018, the risk of IHD was significantly higher in the SLE group than in the control group, and risks peaked between the 6th and 9th year. The HR of incidence IHD in the SLE group was 2.42 times that of the control group. Significant correlations with risk of developing IHD were noted for sex, age, CO, NO2, PM10, and PM2.5, of which PM10 exposure had the highest risk of IHD incidence. CONCLUSIONS: Subjects with SLE were at a higher risk of IHD, especially those in the 6th to 9th year after SLE diagnosis. The advanced cardiac health examinations and health education plan should be recommended for SLE patients before the 6th year after SLE diagnosed.

Reduced risk of pneumonia and influenza infection after bariatric surgery: a retrospective cohort study among patients with nondiabetic obesity in Taiwan.

BACKGROUND: Bariatric surgery is associated with significant improvements in immunity in individuals with obesity, but the exact efficacy in reducing pneumonia and influenza infections is unclear. OBJECTIVE: To investigate the association between bariatric surgery and the risk of pneumonia and influenza infection. SETTING: Nondiabetic patients who underwent bariatric surgery and matched controls were identified from the National Health Insurance Research Database of Taiwan. METHODS: We identified 1648 nondiabetic patients who underwent bariatric surgery from the National Health Insurance Research Database of Taiwan in 2001-2009. These patients were matched by propensity score with 4881 nondiabetic patients with obesity who did not undergo bariatric surgery. We followed the surgical and control cohorts until death, any diagnosis of pneumonia or influenza, or December 31, 2012. The Cox proportional hazards regression model was used to calculate the relative risk of pneumonia and influenza infection in those who underwent bariatric surgery compared with those who did not. RESULTS: Overall, there was a .87-fold (95% CI, .78-.98) reduced risk of pneumonia and influenza infection in the surgical group versus the control group. Four years after bariatric surgery, a sustainable effect of the surgery was observed, and the risk of pneumonia and influenza infection was .83-fold reduced in the surgical group (95% CI, .73-.95). Individuals with obesity who underwent bariatric surgery had a reduced risk of pneumonia and influenza infection compared with matched control individuals. CONCLUSION: Individuals with obesity who underwent bariatric surgery had a reduced risk of pneumonia and influenza infection compared with matched control individuals.

Prediction Accuracy Between Terminally Ill Patients' Survival Length and the Estimations Made From Different Medical Staff, a Prospective Cohort Study.

Background: Previous reports suggested the clinical predictions of survival (CPS) and prognostic scores had similar accuracy in patients with days to weeks of life. Objective: We aimed to evaluate and compare the accuracy of CPS by attending physicians, residents, and nurses in an acute palliative care unit at a medical center. Methods: This was a 1-year prospective cohort study. Survival prediction was made within 3 days after patients' admission and re-evaluated every week until patients' discharge or death. Associated factors of accurate survival predictions were also explored by multivariate logistic regression. Results: A total of 179 inpatients were recruited and 115 of them were included in this analysis. The mean age of participants was 72.9 years and the average length of actual survival was 11.5 ± 12.0 days. For patients with survival within 30 days, the medical staff tended to overestimate their life span. The predictions made by physicians and nurses showed much closer to actual survival length through repeated estimations. Patients with metastatic cancer (odds ratio: OR 2.77, 95% CI 1.23-6.22) or cognitive impairment (OR 2.39, 95% CI 1.12-5.11) had higher associations with accurate CPS. Poor performance status of ECOG (OR 1.82, 95% CI 1.09-3.02) and dysphagia (OR 2.01, 95% CI 1.07-3.77) were significant predictors for accurate CPS in patients with the survival of less than 2 weeks. Conclusions: The accuracy of CPS between different medical staff did not reveal significant differences in the study. The importance of re-evaluation for patients' survival length in clinical practice is worthy of attention.

Association between Statin Use and Diabetes Risk in Patients with Transient Ischemic Attack.

Statin therapy can effectively reduce recurrent transient ischemic attack (TIA) risk. However, studies have reported that statin use is associated with incidence of diabetes mellitus (DM). Whether statin therapy remains associated with higher DM risk in patients with TIA remains unknown. This study investigated whether statin treatment influences incident DM risk in patients with TIA. We conducted a retrospective cohort study using the Longitudinal Health Insurance Database 2000. Participants who were newly diagnosed with TIA (ICD-9-CM code 435) from 1 January 1997 to 31 December 2011 were recruited. The Kaplan-Meier method and Cox proportional risk model of time-dependent covariance were used. We enrolled 8342 patients with newly diagnosed TIA from 1 January 1997 to 31 December 2011. Of these, 1255 patients were classified as statin users and 7087 as nonusers. During the 14-year follow-up, the incidence of newly diagnosed DM was 0.545-fold lower in the statins group compared with nonusers (95% confidence interval [CI] = 0.457-0.650). According to cumulative defined daily doses (cDDDs), the adjusted hazard ratios for DM were 0.689, 0.594, and 0.463 when patients were treated with statins at cDDDs = 28-89, 90-180, and >180, respectively. In patients with TIA, statin use is associated with a lower incident DM risk compared with the nonuse of statins.

Upregulation of cluster of differentiation 36 mRNA expression in peripheral blood mononuclear cells correlates with frailty severity in older adults.

BACKGROUND: Aging-associated frailty has been connected to low-grade chronic inflammation and also to progressive monocytic activation. CD36 (cluster of differentiation 36, platelet glycoprotein 4 or fatty acid translocase) has been shown to induce the expression of pro-inflammatory cytokines and to activate macrophage connected inflammation. This study aims to examine whether the expression of CD36 is up-regulated among frail older adults. METHODS: The demographic data, Fried Frailty Index, metabolic and inflammatory parameters of our observational study were obtained from the comprehensive geriatric assessment programme of a hospital-based outpatient department. The mRNA isolated from the peripheral blood mononuclear cells (PBMCs) was used to determine the levels of CD36, tumour necrosis factor alpha (TNF-α), and CXC chemokine ligand-10 (CXCL10) mRNAs with real-time polymerase chain reaction (PCR). RESULTS: A total of 189 older adults (58% female) were included in the analysis, and the mean age was 77.19 ± 6.12 years. The numbers of participants who fitted in the groups of robust, pre-frail, and frail were 46, 106, and 37, respectively. Our data showed that CD36 mRNA expression levels in PBMCs were the highest in the frail group (1.25 ± 0.53 in robust, 2.13 ± 1.02 in pre-frail, and 2.78 ± 1.15 in frail group, P < 0.001). Further regression analyses revealed that CD36 mRNA levels were positively correlated with both the pre-frail and frailty status in the univariate analysis (both P's < 0.001). What might suggest something worthy of further investigation is that, with potential confounders being adjusted for, CD36 remained as an independent factor that positively correlated with the pre-frail and frailty status in the multivariable analysis (P < 0.001). CONCLUSIONS: CD36 mRNA levels in PBMCs in robust older adults are significantly lower than in pre-frail and in frail. Our findings suggest that CD36 mRNA levels in PBMCs may be considered a potential biomarker for frail severity.

Scabies Infestation and Risk of Acute Myocardial Infarction: A Population-Based Cohort Study.

BACKGROUND: Scabies is an infectious inflammatory skin disease. Cytokine-mediated inflammatory responses may be one of the pathological mechanisms underlying myocardial infarction. OBJECTIVE: We explore the association between scabies and subsequent acute myocardial infarction (AMI) and all-cause mortality; Methods: We conducted a nationwide population-based study using data from the National Health Insurance Research Database (NHIRD) in Taiwan. Patients with scabies (n = 30,184) and 120,739 controls without scabies were included. The primary outcomes were incidental AMI and all-cause mortality. Using Cox proportional-hazards regression analysis, we estimated the risk of acute myocardial infarction for the study cohort; Results: The mean age of the study cohort was 51.81 ± 19.89 years. The adjusted sub-distribution hazard ratios (aSHRs) of AMI were 1.214 (95% CI, 1.068-1.381) after adjusting for demographic characteristics, income, OPD utility frequency, days in hospital, co-morbidities, and medication. The adjusted hazard ratio (aHR) of all-cause mortality after adjusting for age, gender, income, OPD utility frequency, days in hospital, co-morbidities, co-medication, and urbanization was 1.612 (95% CI, 1.557-1.669). CONCLUSIONS: Our study showed that patients with scabies infestations were at higher risk for subsequent AMI and all-cause mortality.

The Chinese Inventory of Psychosocial Balance Short-Form Questionnaire for the Older Adults: Validity and Reliability Study.

BACKGROUND: Drawing from Erikson's theory, Domino and Affonso constructed the Inventory of Psychosocial Balance (IPB), a scale with satisfactory reliability and validity. However, the lack of a credible Chinese version of the scale may hinder research on ego development in Taiwan. The aim of the present study was to construct a short form Chinese IPB. In addition, factor analysis was employed to shorten the original 120-item scale to make it suitable for application in the older adults in the future. METHODS: The study involved three steps: The first step was to establish the 120-items of the Chinese Inventory of Psychosocial Balance (C-IPB), and we conducted translation, back-translation, expert validity, and reliability of pilot study for this step. Following the first step was to construct the short-form C-IPB (CIPB-SF) in the second step, and the CIPB-SF was developed via item analysis and factor analysis. Finally, we assessed the reliability and validity of the CIPB-SF via structural equation model in the third step. RESULTS: Three hundred eight older adults without cognitive disorder completed the IPB. The 40-item CIPB-SF was completed through item analysis and factor analysis. The internal consistency test of CIPB-SF and the eight stages were good (Cronbach's α = 0.81-0.89). The CIPB-SF had acceptable validity, except in the intimacy and identity stages, in which validity was only fair. Compared with the IPB, the CIPB-SF had good reliability and acceptable validity. However, because of its conciseness, the 40-item CIPB-SF was more suited for application among the Chinese elderly population because its application avoids physical overload. CONCLUSION: The CIPB-SF served as a concise scale for assessing ego development in our study. This scale can also serve as a useful tool for convenient screening in the future.

Impact of Coronavirus Infectious Disease (COVID-19) pandemic on willingness of immunization-A community-based questionnaire study.

BACKGROUND: Coronavirus infectious disease 2019 (COVID-19) has had a great impact on global health, but with relatively few confirmed cases in Taiwan. People in Taiwan showed excellent cooperation with the government for disease prevention and faced social and behavioral changes during this period. This study aimed to investigate people's knowledge of COVID-19, attitudes and practices regarding vaccinations for influenza, pneumococcus and COVID-19. METHODS: We conducted a community-based, cross-sectional questionnaire survey from September 2020 to October 2020 among adults in northern Taiwan. The four-part questionnaire included questions on sociodemographic characteristics, knowledge, attitude, and practice toward COVID-19. RESULTS: Among a total of 410 respondents, 58.5% were categorized as having "good knowledge" responding to COVID-19. Among the total respondents, 86.6% were willing to receive influenza or pneumococcal vaccines, and 76% of them acted to receive COVID-19 immunization once the vaccine became available. Compared with the respondents with poor knowledge of COVID-19, those with good knowledge had a more positive attitude toward receiving influenza or pneumococcal immunization (OR 3.26, 95% CI = 1.74-6.12). CONCLUSIONS: Participants with good knowledge of COVID-19 had greater intent to receive immunization for influenza or pneumococcal vaccine. The promotion of correct knowledge of both COVID-19 and immunization preparations is necessary.

Diindeno[2,1-b:2',1'-h]biphenylenes: Syntheses, Structural Analyses, and Properties.

A series of diindeno[2,1-b:2',1'-h]biphenylenes with open-shell singlet ground states and interesting properties were prepared. The studied compounds consist of p-quinodimethane moieties, which suffer from geometric perturbation with bond angles of around 90°. The substituent effects on structural parameters, local aromaticity, and properties were systematically explored.

Predicting Ego Integrity Using Prior Ego Development Stages for Older Adults in the Community.

BACKGROUND: Erikson's ego development theory is the most accepted theory that involves eight stages of psychosocial development over an individual`s all lifespan. The result of development in prior stages will influence the later stages. The elderly were mainly characterized by the central developmental tasks: achieving ego integrity vs. despair. The harvest in the last stage will be related to the attitude of facing death in the elderly. METHODS: A cross-sectional study of elderly age from 65 to 90 years old (n = 292) was carried out and investigated via the Inventory of Psychosocial Balance. Pearson correlation and path analysis were performed in order to analyze the direct and indirect effect among the first seven stages with the eighth stage. RESULTS: We found that all the eight stages were significantly related to each other, and comparing to the previous seven stages, "the generativity stage" (r = 0.77) was the most relevant stage with "ego integrity". In all indirect and direct effects, the seventh stage had the greatest impact on the "ego integrity stage"; the direct effect was 0.89. CONCLUSIONS: Compared to the whole lifespan, adulthood possessed a higher influence on the elderly stage. We found that all the eight stages were significantly related to each other, and comparing the first seven stages, the "generativity stage" (r = 0.77) was the most relevant stage to "ego integrity". CONCLUSIONS: Compared to the whole lifespan, adulthood possessed a higher influence on the elderly stage.

Decreased swallowing function in the sarcopenic elderly without clinical dysphagia: a cross-sectional study.

BACKGROUND: Sarcopenia and dysphagia are prevalent health issues as the elderly population continues to grow. However, whether sarcopenia, defined by either reduced handgrip strength or gait speed, would lead to pathological effects on swallowing function is still a matter of debate. Studies focusing on subclinical changes in the swallowing function in the sarcopenic elderly are lacking. This study evaluates the swallowing function in the sarcopenic elderly without dysphagia. METHODS: A cross-sectional study was conducted including subjects recruited from the community. Ninety-four individuals aged 65 and older without dysphagia were divided into two groups: sarcopenia and nonsarcopenia. The swallowing assessment included tongue pressure measurement, hyoid displacement (HD), hyoid velocity (HV) measurement with submental ultrasonography, 100-ml water-swallowing test, and the 10-item Eating Assessment Tool (EAT-10). RESULTS: The average tongue pressure was 47.0 ± 13.7 and 48.6 ± 11.5 kPa in the sarcopenia and nonsarcopenia groups, respectively (p = 0.55), whereas the average HD during swallowing was 15.3 ± 4.4 and 13.0 ± 4.2 mm in the sarcopenia and nonsarcopenia groups, respectively (p < 0.05). The median of HV during swallowing was 19.5 (6.41-45.86) and 15.9 (3.7-39.7) mm/s in the sarcopenia and nonsarcopenia group (p < 0.05). The median of time needed for consuming 100 ml water was 12.43 (3.56-49.34) and 5.66 (2.07-19.13) seconds in the sarcopenia and nonsarcopenia groups, respectively (p < 0.05). The median of the EAT-10 score was 0 (0-2) and 0 (0-1) in the sarcopenia and nonsarcopenia groups, respectively (p < 0.05). CONCLUSIONS: In elderly individuals, swallowing function was significantly impaired with sarcopenia before clinical symptoms become clear. However, tongue muscles exhibited resistance to sarcopenia. We observed compensative strategies in patients with sarcopenia, such as reduced swallowing speed and increased hyoid bone movement.

Unstable blood sugar levels as triggers for the syndrome of acute bilateral basal ganglia lesions in diabetic uremia: Two Taiwanese patients with unusual neuroimaging findings.

The syndrome of acute bilateral basal ganglia lesions in diabetic uremia is uncommon and usually affects Asian patients. The underlying pathogenesis of this syndrome is not clear. We searched PUBMED using the keywords "bilateral basal ganglia", "diabetic", and "uremia", and found a total of 34 cases from 1998 to 2016. In most cases, blood sugar levels were normal. Here we report two Taiwanese cases presenting with dyskinesias. In one case the syndrome was triggered by hyperglycemia, and in the other by severe hypoglycemia. Their neuroimaging findings were unusual as compared with previously reported cases, presenting as mixed hypo- and hyperintensity on T1-weighted magnetic resonance imaging. We think these new finding would shed some light on the underlying pathophysiology of this syndrome. For treatment, it is advisable to keep glucose levels as stable as possible in diabetic uremic patients to prevent this syndrome. A rapid correction of hyper- or hypoglycemia after the onset may help recovery.

A novel XK gene mutation in a Taiwanese family with McLeod syndrome.

McLeod syndrome is one subtype of rare neuroacanthocytosis syndromes characterized by misshapen red blood cells and progressive degeneration of the basal ganglia. It is an X-linked recessive disorder with mutation in the XK gene of the Kell blood group system with multisystem involvements. Concerning the movement disorders, its dyskinesias are various and difficult to differentiate from those in Huntington's disease or other hyperkinetic movement disorders. In this report, we described a 62-year-old male patient presenting with insidious myalgia and muscle fatigue. Progressive motor restlessness and toes choreoathetosis were noted. Previously, he had chronic psychotic disorder with irregular treatment for 14 years. The laboratory tests revealed elevated creatine phosphokinase and acanthocytes (36.3%). The electrophysiological test demonstrated an axonal type polyneuropathy. The neuroimaging of brain showed striatal degeneration. Genetic analysis revealed a nonsense hemizygous mutation c.154C>T (p.Gln52X) at exon 1 of XK gene. The genetic counseling of his family revealed one elder brother carrying the same mutation and showing a similar but very mild syndrome. Several offspring were the asymptomatic carriers. We suggest that for a patient with multiple system disorders including dyskinetic movement disorders, psychiatric symptoms, polyneuropathy, and elevated CPK, a genetic test for XK gene mutation is highly indicated to confirm the McLeod syndrome and to guide the possible therapy.

Sample size estimation for repeated measures analysis in randomized clinical trials with missing data.

In designing longitudinal studies, researchers must determine the number of subjects to randomize based on the power to detect a clinically meaningful treatment difference and a proposed analysis plan. In this paper, we present formulas for sample size estimation and an assessment of statistical power for a two-treatment repeated measures design allowing for subject attrition. These formulas can be used for comparing two treatment groups across time in terms of linear contrasts. Subjects are assumed to drop out of the study at random so that the missing data do not alter the parameters of interest.

Evaluation of the comparative efficacy and tolerability of rofecoxib and naproxen in children and adolescents with juvenile rheumatoid arthritis: a 12-week randomized controlled clinical trial with a 52-week open-label extension.

OBJECTIVE: To compare the safety and efficacy of rofecoxib* to naproxen for the treatment of juvenile rheumatoid arthritis (JRA). METHODS: This was a 12-week, multicenter, randomized, double-blind, double-dummy, active comparator-controlled, non-inferiority study with a prespecified 52-week open-label active comparator-controlled extension. Children (ages 2-11 yrs) and adolescents (ages 12-17 yrs) received lower-dose (LD)-rofecoxib [0.3 mg/kg/day up to 12.5 mg/day (base study only)]; or higher-dose (HD)-rofecoxib (0.6 mg/kg/day up to 25 mg/day) or naproxen 15 mg/kg/day as oral suspensions. Adolescents received daily rofecoxib (LD) 12.5 (base study only) or (HD) 25 mg, or naproxen 15 mg/kg/day (maximum 1,000 mg/day) as tablets. The primary endpoint was the time-weighted average proportion of patients meeting the American College of Rheumatology Pediatric-30 (ACR Pedi 30) response criteria. A prespecified bound for the 95% confidence interval for the ratio of the percentage of ACR Pedi 30 responders was used to assess non-inferiority of treatment response between groups. Safety was assessed throughout the study. RESULTS: A total of 310 patients ages 2-17 years (181 (3/4) age 11) were randomized to receive LD-rofecoxib (N=109), HD-rofecoxib (N=100), or naproxen (N=101). The ACR Pedi 30 response rates following 12 weeks of treatment were 46.2%, 54.5%, and 55.1%, respectively. The relative rates of response compared to naproxen were 0.81 (95% CI 0.61, 1.07) and 0.98 (95% CI 0.76, 1.26) for LD- and HD-rofecoxib, respectively. Both rofecoxib doses were not inferior to naproxen. Patients (N=227) entering the extension received HD-rofecoxib or naproxen with efficacy maintained during the extension. All treatments were generally well tolerated throughout the study. CONCLUSION: Daily treatment of JRA patients with rofecoxib up to 12.5 or 25 mg was well tolerated, providing sustained clinical effectiveness comparable to naproxen 15 mg/kg. *On September 30, 2004, Merck & Co., Inc. announced the voluntary worldwide withdrawal of rofecoxib from the market.

Protein S deficiency associated with progressive loss of vision and intracranial venous sinus thrombosis.

We report a 27-year-old male who presented with headache and rapid visual impairment. He had been diagnosed with venous sinus thrombosis 3 months earlier, when he had diffuse headache, nausea and vomiting, which subsided after incomplete thrombolytic therapy. Warfarin was then prescribed without screening for coagulopathy. Ophthalmic examination revealed bilateral papilloedema, splinter hemorrhage and lipid exudates. Neuroradiological studies including magnetic resonance imaging and cerebral angiography revealed chronic partial thrombosis over superior sagittal sinus, left side transverse sinus, right side transverse and venous confluence with engorged cortical veins and secondary dural arteriovenous malformation (AVM) and reversed flow over bilateral superior orbital veins, and thrombolytic therapy was considered not feasible. Clot-assay protein S activity was decreased (25%, normal range: 65-140%). No underlying connective tissue diseases or other coagulopathies were noted. The patient's vision failed to respond to aggressive medical treatment, and he received lumboperitoneal shunt in another hospital. His vision was improved. For young patients with occlusive cerebrovascular disorder, extensive hematological investigation for coagulopathy is strongly recommended.