Diagnostic Value of Anti-Nuclear Antibodies: Results From Korean University-Affiliated Hospitals.

BACKGROUND: Unnecessary and inappropriate laboratory testing accounts for a significant portion of waste in health care utilization. The aim of this study was to examine the diagnostic value of the anti-nuclear antibody (ANA) test by examining the rate of ANA associated rheumatic disease (AARD) diagnosis among ANA tested and ANA positive subjects and positive predictive value (PPV) of ANA test leading to AARD diagnosis in different ANA titers and different subsets of patients in 5 hospitals affiliated with a university. METHODS: We retrospectively extracted data from all subjects who were tested for ANA from year 2010 to 2019. Those who were first evaluated at or referred to rheumatology were further evaluated with extraction of data including ANA titer and ultimate diagnosis. PPVs for ANA test were evaluated after stratification according to clinically relevant key parameters, such as patient age (younger < 65 years vs. older), sex, and requesting department. RESULTS: From 2010 to 2019, A total of 94,153 patients were tested for ANA, of which 13,600 (14.4% of the total) were positive. AARD was diagnosed in only 0.69% among all ANA tested patients and 4.74% among ANA positive patients. The AARD diagnosis rate of ANA positive patients varied widely from 0.1% to 8.7% by requesting department. Using cutoff values above 1:320 yielded PPVs of 15.6 and 7.8% for all AARs and systemic lupus erythematosus. The PPV was significantly higher in young age (< 65 years) and in women, and when it was requested from internal medicine vs other departments. CONCLUSION: AARD was diagnosed in less than 1% of all ANA tested patients in university-affiliated hospitals. This result shows that careful consideration before ordering the screening ANA is needed to improve the utility of the test for providers and patients and to reduce health costs spurred by unnecessary testing and its consequences.

The prevalence of periarticular lesions detected on magnetic resonance imaging in middle-aged and elderly persons: a cross-sectional study.

BACKGROUND: Previous studies showed that among persons with radiographic knee OA, periarticular lesions were significantly more common among participants with knee pain than those without. However, data were derived mostly from persons with knee OA, and there were few normal participants without knee OA in the data analyses. The objectives of this study were to investigate the prevalence of periarticular lesions detected by magnetic resonance imaging (MRI), and to examine their prevalence according to the presence of knee pain and radiographic knee osteoarthritis (OA) in community residents in Korea. METHODS: Demographic and knee pain data were obtained by questionnaire from 358 participants of the population-based Hallym Aging Study who were recruited irrespective of the presence of knee OA or pain. Radiographic evaluations consisted of weight-bearing knee anteroposterior radiographs and 1.5-T MRI scans. Periarticular lesions included prepatellar or anserine bursitis, Baker's cyst, and tibiofibular cyst. The prevalence of each lesion in subjects with knee OA or knee pain compared to those without was examined by a chi-square test. RESULTS: The mean age of the subjects was 72 years and 50.6% were female. Radiographic knee OA was present in 34.5%. The most prevalent peri-articular lesion was Baker's cyst (27.9%), followed by tibiofibular cyst (9.5%). Anserine bursitis and tibulofibular cyst were more common in subjects with knee OA (17.5% vs 2.2% for anserine bursitis, 15.8% vs 6.1% for tibiofibular cyst in subjects with and without OA, respectively), while Baker's cyst and anserine bursitis were more common in subjects with knee pain (36.3% vs 21.8% for Baker's cyst, 14.4% vs 2.5% for anserine bursitis in subjects with and without knee pain, respectively). CONCLUSIONS: Periarticular lesions on MRI of the knee are common in middle-aged and elderly persons. Anserine bursitis and Baker's cysts are more common in subjects with knee pain compared to those without.

Detection of Anti-Type II Collagen Antibodies in Patients With Chronic Gouty Arthritis: Findings From a Pilot Study.

OBJECTIVE: We hypothesized that chronic gouty arthritis patients would develop an immune response to type II collagen that would be revealed by the presence of anti-type II collagen (CII) antibodies in serum, which may in turn be involved in progression to non-remitting arthritis. METHODS: Chronic gouty arthritis was defined as crystal-confirmed gout in patients with no pain-free intercritical period, with or without the presence of tophi, who did not have clinical features of other forms of chronic arthritis. Age-matched gout patients suffering acute gouty attacks who had definite intercritical periods were selected as a control group. Four RA patients who had active disease were enrolled as a positive control group. Anti-CII antibodies were quantified in patient sera via ELISA using a human IgG anti-CII antibody assay kit. Correlations between anti-CII levels and clinical parameters were sought. RESULTS: Fifteen chronic gouty arthritis patients were identified. The anti-CII level was significantly higher among subjects with chronic gout compared to controls, but did not significantly differ in control gout patients during acute attacks and in the intercritical periods. Five patients with chronic gouty arthritis had anti-CII antibody levels higher than 200 AU/mL, whereas only one control gout patient exhibited this feature. Two of four patients with active RA had anti-CII antibody levels higher than 200 U/mL.Patients with tophi had significantly higher anti-CII levels than those without, whereas patients showing radiographic erosion tended to have higher anti-CII levels than those without. CONCLUSION: Patients with chronic gouty arthritis had significantly higher levels of anti-CII antibodies than control gout patients. Such antibody production would be triggered by initiation of cartilage damage but may also play a role in perpetuation of inflammation.

Four-week effects of allopurinol and febuxostat treatments on blood pressure and serum creatinine level in gouty men.

The aim of this study was to observe the effects of uric acid lowering therapy (UALT), febuxostat and allopurinol, on blood pressure (BP) and serum creatinine level. Post-hoc data were derived from a phase-III, randomised, double-blind, 4-week trial of male gouty patients that compared the safety and efficacy of febuxostat and allopurinol in adults with gout. The subjects were randomly assigned to one of five groups, 35-37 in each group (febuxostat: 40, 80, 120 mg/d; allopurinol: 300 mg/d; control group: placebo). Blood pressure and serum creatinine level were measured at baseline and at weeks 2 and 4. Diastolic BP and creatinine level had decreased significantly in the UALT groups compared to the control group at week 4. Diastolic BP had decreased significantly in the allopurinol group and serum creatinine level had decreased significantly in the febuxostat groups at week 4. After adjusting for confounding variables, serum uric acid changes were found to be significantly correlated with changes in serum creatinine level but were not associated with changes in systolic or diastolic BP. UALT in gouty subjects significantly decreased diastolic BP and serum creatinine level. Changes in uric acid were significantly correlated with those in serum creatinine level, suggesting the feasibility of renal function improvement through UALT in gouty men.

A study on the estimation of area of origin of swing cast-off pattern.

In bloodstain pattern analysis (BPA), a field of forensic science, there has been active discussion on the estimation of the area of origin of impact spatter. However, there is no established methodology to quantitatively analyze the area of origin of a swing cast-off pattern. To quantitatively analyze the methodology of previous research on estimation of area of origin, a device for generating uniform swing cast-off patterns was produced. Using artificial blood, 10 swing cast-off patterns were generated on porous paper; in each, 10 blood drops were selected for the calculation of the impact angle. Hemospat software was used for individual bloodstain analysis, and an open source code was used for estimation of area of origin. Under the same conditions, an additional 10 swing cast-off patterns were generated, and quantitative analysis was performed using trigonometric functions and an adjustment formula that minimized errors in calculating the impact angle. The adjustment formula was corrected to calculate the impact angle for the bloodstains on the porous surface. As uncertainty decreases, the error increases, and the point at which both uncertainty and error can be minimized is calculated as 75%. The existing formula included the trajectory in the estimated likelihood range in 75% of samples. When the adjustment formula was applied, the accuracy was improved, with the trajectory included in the area with a 90% likelihood.

A case of bilateral hemarthrosis due to pseudoaneurysms in a patient on anticoagulation therapy.

Hemarthrosis can occur in patients with a predisposition to hemorrhage, such as hemophiliacs or patients on anticoagulation therapy. If hemarthrosis recurs after supportive treatment, however, other etiologies such as anatomical abnormalities should be considered. Spontaneous articular pseudoaneurysm associated with anticoagulation treatment has not been reported previously. We describe a patient on anticoagulation therapy with bilateral hemarthrosis due to pseudoaneurysms. After failing to respond to the correction of over-anticoagulation, magnetic resonance imaging led to the diagnosis of articular pseudoaneurysm. The patient was treated successfully by transarterial embolization.

Genetic analysis of the purplish Washington clam (Saxidomus purpuratus Sowerby) of Korean coastal waters.

To investigate the genetic structure of the purplish Washington clam population, Saxidomus purpuratus Sowerby, in Korea. A portion of mitochondrial COI gene sequences (605 bp) for phylogenetic comparison was determined. Sequence analysis of 62 individuals collected from six regions revealed 13 haplotypes. Phylogenetic analysis using Phylogeny Inference Package (PHYLIP) subdivided the purplish Washington clam into two clades (termed clade A and B), weak supported groups (< 65 of bootstrap value). This haplotype subdivision was also in accordance with geographic separation; one each at Masan, Yeosu, Samcheonpo, Jubyeon and Geojedo, and the other at Sineju. Population genetic analysis subdivided these two population groups with a geographic distance (d = 0.431, p = 0.379). Furthermore, in the Sineju population, the maximum sequence divergence (2.67%) and minimum nucleotide diversity (0.0012426) were shown in which might be reflective of a relatively small population size and the geographical isolation of the population as compared with other populations. However, a very high migration rate (N(m) = 59.62-infinite) and a very low level of geographic distance (F(ST) = -0.076-0.055) were noted to exist among the South and East Sea populations, suggesting that individuals between populations should show a significantly active genetic mixing and migration regardless of geography. These findings allowed us to conclude that the purplish Washington clam populations occurring in the South and East Sea were formed with randomly dispersed individuals.

Characteristics of patients with rheumatoid arthritis in clinical remission: the many aspects of DAS28 remission.

OBJECTIVES: The aim of this study was to observe the clinical characteristics, including the extent of foot and ankle involvement, of Korean patients with rheumatoid arthritis (RA) in remission, defined as Disease Activity Score in 28 joints (DAS28) <2.6. METHODS: Data from a registry of RA patients who visited a rheumatology clinic of a university-affiliated hospital and who were regularly evaluated with DAS28, including the ankle and foot metatarsophalangeal (MTP) joints were enrolled. Patients who were treated with disease-modifying anti-rheumatic drugs for at least three months and who were in DAS28 remission were included in this study. RESULTS: Two hundred and thirteen episodes of DAS28 remission were observed in 147 patients. The mean DAS28 value at the time of remission was 1.84 (range, 0.14-2.59). The mean numbers of swollen joints and tender joints (of the 28 joints examined for DAS28) at the time of remission was 0.4 (range, 0-6) and 1.5 (range, 0-13), respectively. Overall, 11.7% and 38% of the patients in clinical remission had foot MTP/ankle swollen and tender joints, respectively. Additionally, 7% and 8.9%, respectively, of the patients in clinical remission had foot MTP/ankle swollen and tender joints without any involvement of the 28 joints included in the DAS28. CONCLUSIONS: Our results show that RA patients in DAS28 remission frequently have residual disease activity in the ankle and foot joints. Given that fore-foot disease activity can lead to joint damage and disability with respect to weight-bearing activities, these joints should be included in the clinical examination.

Prevalence of knee pain and its influence on quality of life and physical function in the Korean elderly population: a community based cross-sectional study.

To investigate the prevalence of knee pain and its influence on physical function and quality of life (QOL), we examined 504 community residents of Chuncheon, aged ≥ 50 yr. Demographic information was obtained by questionnaire, and radiographic evaluations consisted of weight-bearing semi-flexed knee anteroposterior radiographs. Self-reported QOL and function were assessed using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and Short Form 12 (SF-12). Performance-based lower extremity function was assessed using the tests consisting of standing balance, usual walk and chair stands. The prevalence of knee pain was 46.2% (32.2% in men and 58.0% in women) and increased with age in women. After adjustment of confounders including the presence of knee OA, the subjects with knee pain had significantly worse WOMAC function and SF-12 scores compared to subjects without knee pain. Among the subjects with knee pain, women had worse WOMAC and SF-12 scores than men. Subjects with knee pain had worse physical performance score compared to those without knee pain, especially among females. In conclusion, the prevalence of knee pain is high (32.2% in men and 58.0% in women) in this elderly community population in Korea. Independent of knee OA and other confounding factors, subjects with knee pain have more than 5-fold increase in the risk of belonging to the worst lower extremity function compared to subjects without knee pain.

Association of body composition with disease activity and disability in rheumatoid arthritis.

BACKGROUND/AIMS: To explore the associations between body composition and pain, disease activity, and disability in rheumatoid arthritis (RA). METHODS: The study enrolled 335 patients with RA and underwent body composition measurement with an InBody analyzer. The associations of body mass index (BMI), body fat mass, and skeletal muscle mass with disease activity score in 28 joints (DAS28), an index derived to measure the subjective component of DAS28 (DAS28-P), a pain visual analogue scale (VAS), and disability measured with the health assessment questionnaire (HAQ) were explored. Obesity was defined as BMI ≥ 25 kg/m2. RESULTS: The median (interquartile range) disease duration was 6 years (3.5 to 9) and the mean DAS28 score was 3.6 ± 1.1. The mean BMI was 23.6 ± 3.6 kg/m2 and 109 patients (32.5%) were obese. Compared with non-obese patients, obese patients had a higher C-reactive protein (1.68 mg/dL vs. < 0.1 mg/dL, p = 0.013), higher pain VAS score (40 vs. 35, p = 0.031), and higher DAS28-erythrocyte sedimentation rate score (3.75 ± 1.18 vs. 3.46 ± 1.11, p = 0.031). In multivariate regression analysis, the DAS28 score in females was positively associated with the current steroid dose, body fat mass, and HAQ score, while the HAQ score in females was associated with older age, DAS28, lower skeletal muscle mass, and higher body fat/skeletal muscle ratio. In the multivariate regression analysis, the DAS28-P score in females was positively associated with body fat/skeletal muscle ratio and HAQ. CONCLUSION: Body composition, such as the body fat mass and body fat/skeletal muscle ratio, is significantly associated with disease activity and disability in female RA patients.

Tibiofemoral osteoarthritis affects quality of life and function in elderly Koreans, with women more adversely affected than men.

BACKGROUND: The prevalence of knee osteoarthritis(OA) in East Asia is as common for men and even higher for women than that reported in the Caucasian population. Since both population aging and economic growth have taken place at a much faster pace in Asian countries, such as South Korea, one would expect knee OA to become a major public health problem. However, few studies have examined the influence of knee OA on the quality of life (QoL) and physical function in Asia. The aim of this cross-sectional study is to investigate the influence of knee osteoarthritis (OA) on the quality of life (QoL), function and lower extremity physical performance and the gender difference in its influence in elderly community residents in Korea. METHODS: Participants were from the population-based Hallym Aging Study (HAS). The mean age of the 504 study subjects was 70.2 years and 274 (54%) were women. Demographic information was obtained by questionnaire, and radiographic evaluations consisted of weight-bearing semi-flexed knee radiographs. Self-reported QoL and function were assessed using Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and Short Form 12-item (SF-12). Performance-based lower extremity function was assessed using the tests consisting of standing balance, usual walk and chair stands. The odds ratios(ORs) for belonging to the worst quartile of WOMAC and physical performance test were calculated by logistic regression analysis in radiographic knee OA compared to non-OA after adjustment of confounders. Scores for SF-12 items were analyzed using general linear models and means adjusted for age, BMI and OA severity were compared. RESULTS: Subjects with radiographic knee OA had significantly increased OR for belonging to the worst WOMAC quartile(for pain, 2.13,95% confidence interval[CI], 1.33-3.40, for stiffness, 2.94,95% CI,1.78-4.86, and for function, 2.97, 95% CI,1.83-4.81) and significantly worse SF-12 scores compared to non-OA after adjustment of age, BMI and sex. Women had worse WOMAC and SF-12 scores compared to men, regardless of the presence of radiographic knee OA after adjustment of age, BMI and OA severity. OA subjects had significantly worse performance score for usual walk and chair stands compared to non-OA subjects, but the ORs were no more significant after adjustment of sex. CONCLUSIONS: Knee OA negatively affects the QoL and physical function in both genders, but women are more adversely affected than men.

The prevalence of knee osteoarthritis in elderly community residents in Korea.

The purpose of this study was to estimate the prevalence of radiographic and symptomatic knee osteoarthritis (OA) among community residents and to elucidate the relevant risk factors. This prospective, population-based study was conducted on residents over 50 yr of age in Chuncheon. Subjects completed an interview based on a standardized questionnaire and clinical evaluation including standardized weight bearing semiflexed knee A-P radiographs. We defined a subject with the Kellgren and Lawrence grade >or=2 as having radiographic knee OA (ROA). Symptomatic knee OA (SOA) was defined by the presence of both ROA and knee pain. We obtained symptom information and radiographs from 504 subjects. The prevalence of ROA and SOA was 37.3% and 24.2%, respectively. The prevalence of both ROA and SOA was significantly higher among women than among men. Multivariate analysis revealed that the presence of hypertension, and a manual occupation were significantly associated with the presence of ROA and SOA. Lower level of education was significantly associated with the presence of ROA, and female sex with the presence of SOA. In conclusion, both ROA and SOA are common in the aged adult population of Korea, with preponderance for women.

Clinical and radiographic features of adult-onset ankylosing spondylitis in Korean patients: comparisons between males and females.

The objective of this study was to investigate clinical and radiographic features and gender differences in Korean patients with adult-onset ankylosing spondylitis. Multicenter cross-sectional studies were conducted in the rheumatology clinics of 13 Korean tertiary referral hospitals. All patients had a confirmed diagnosis of ankylosing spondylitis according to the modified New York criteria. Clinical, laboratory, and radiographic features were evaluated and disease activities were assessed using the Bath ankylosing spondylitis disease activity index. Five hundred and five patients were recruited. The male to female ratio was 6.1:1. Average age at symptom onset was 25.4+/-8.9 yr and average disease duration was 9.6+/-6.8 yr. Males manifested symptoms at a significantly earlier age. HLA-B27 was more frequently positive in males. Hips were more commonly affected in males, and knees in females. When spinal mobility was measured using tragus-to-wall distance and the modified Schober's test, females had significantly better results. Radiographic spinal changes, including bamboo spine and syndesmophytes, were more common in males after adjustment of confounding factors. In conclusion, we observed significant gender differences in radiographic spinal involvement as well as other clinical manifestations among Korea patients with adult-onset ankylosing spondylitis. These findings may influence the timing of the diagnosis and the choice of treatment.

Study on development of forensic blood substitute: Focusing on bloodstain pattern analysis.

Bloodstain pattern analysis, one of the areas of forensic science, is performed to analyze the physical characteristics of bloodstains, including their size, shape, and distribution, to reconstruct a crime scene. A bloodstain pattern analyst should obtain through experiments and education the capabilities to both understand the generation mechanisms of bloodstains and identify the characteristics of the bloodstains. Experiments and education about bloodstain pattern analysis are carried out by using human blood taken from subjects, animal blood (porcine or bovine) supplied from butcheries, and blood substitute products developed in other countries. However, these kinds of blood have many limitations in their application due to various problems. The blood substitute developed in the present study is more similar to human blood than other blood substitute products developed in other countries with regard to the physical properties, including viscosity, viscoelasticity, and surface tension, as well as the drip bloodstain patterns depending on the surface and coordinate characteristics of drip stains impact angle. The blood substitute developed in the present study is more practical, because the materials that are used in its preparation are readily available in the market and do not include chemicals that are harmful to the human body, and the blood substitute has luminol reaction functionality and pattern transfer bloodstain (bloodstain fingerprint, bloodstain footprint, etc.) dyeing functionality.

Adiposis Dolorosa Pain Management.

While current approaches to treatment focus on surgery, opiates, and other medications, health care providers may also consider ketamine infusion, electrostimulation, and perineural injections.

A modified von Bertalanffy growth model dependent on temperature and body size.

Fish growth models are widely used in fisheries as well in aquacultures and ecology. Water temperature is one of the most important factors determining the growth of fish. In the present study, we propose a growth model that includes the effect of water temperature on the growth in the von Bertalanffy growth model. Our model was applied to fit the growth data of bullhead (Cottus gobio), brown trout (Salmo trutta L.), juvenile salmon (Salmo salar), and Araucanian herring (Strangomera bentincki). The model reproduces the growth patterns of each species and fits a set of appropriate parameter values for each species. Moreover, the model reflects the seasonal growth rates quite well.

Contribution of subjective Disease Activity Score 28 (DAS28) components to the response to treatment of rheumatoid arthritis.

We investigated the contributions made by the subjective components of the Disease Activity Score 28 (DAS28) to the treatment response of rheumatoid arthritis (RA). In addition, factors associated with poor response to treatment at 6 months, despite normalization of objective measures, were examined. A total of 426 newly diagnosed RA patients were included. The DAS28-P score (the subjective components of the DAS28 relative to the total components) was calculated as DAS28-P = 0.56 ∗ sqrt(TJC28) + 0.014 ∗ (VAS-GH) /0.56 ∗ sqrt(TJC28) + 0.28 ∗ sqrt(SJC28) + 0.7 ∗ In(erythrocyte sedimentation rate (ESR)) + 0.014 ∗ (VAS-GH). The European League Against Rheumatism (EULAR) response was assessed after 6 months of treatment. Of those who failed to attain good EULAR responses, those for whom the objective measures (the ESR, the C-reactive protein level, and swollen joints) were normalized were defined as having failed treatment because of subjective measures. The median (IQR) DAS28 score at baseline was 4.8 (4.04-5.49) and that after 6 months of treatment 3.21 (2.41-3.95). The DAS28-P score fell significantly from baseline to 6 months in good (0.43 versus 0.28, p < 0.001) and moderate responders (0.44 versus 0.4, p = 0.003), but not in non-responders (0.43 versus 0.45, p = 0.727). Younger age, a lower DAS28 score, and a lower DAS28-P score at baseline were related to a good EULAR response. Subjects who failed to respond because of subjective measures tended to have higher DAS28-P scores at baseline. We found that RA patients with high DAS28-P scores, reflecting subjective measures, were less likely to achieve good EULAR responses 6 months after treatment initiation and tended not to be classified as good responders despite normalization of objective measures.

Prevalence and Risk Factors for Lumbar Spondylosis and Its Association with Low Back Pain among Rural Korean Residents.

OBJECTIVE: The purpose of this study was to investigate the prevalence of and the relevant risk factors for lumbar spondylosis (LS) among middle-aged and elderly rural Korean residents and to explore the association between radiographic LS and lower back pain (LBP) in relation to age and gender. METHODS: This community-based, cross-sectional study evaluated 1512 subjects with available radiograph. The prevalence of LBP was obtained using a questionnaire and disability resulting from LBP was measured using a validated Korean version of the Oswestry disability index (ODI). In lumbar spine radiographs, vertebral levels from L1/2 to L4/5 were evaluated for the presence of osteophytes and joint-space narrowing (JSN), and Kellgren-Lawrence (KL) grading was applied. RESULTS: Of 4261 subjects aged 40-79 years, data from 1512 subjects were included. The prevalence of radiographic LS indicated by grade ≥2 osteophytes and JSN were 53.9 and 15.8%, respectively. Seventy-three percent of subjects had KL grade ≥2 spondylosis and LBP was present in 36.5% of subjects. Although LS was more common among males, the prevalence of LBP was higher among females. Age, male gender and history of hand or knee arthritis were risk factors for LS. LS was significantly associated with LBP mostly among females over 60 years old and correlated with the ODI after adjusting for age and gender. CONCLUSION: Our study among rural Korean residents revealed a high prevalence of LS and LBP. The association between LS and LBP was observed mostly among females and LS was significantly correlated with the severity of back pain.

Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial.

OBJECTIVE: This study evaluated the efficacy and tolerability of tramadol 37.5-mg/acetaminophen 325-mg combination tablets (tramadoUAPAP) as add-on therapy in subjects with rheumatoid arthritis (RA) pain that was inadequately controlled by NSAIDs and disease-modifying antirheumatic drugs alone. METHODS: Subjects in this multicenter, double-blind trial were randomized in a 3:1 ratio to receive 1 tramadol/ APAP tablet TID or a matching placebo for 1 week. Stable doses of previous medications were continued during the study. The primary efficacy variable was the mean daily pain relief score over 1 week, measured on a 6-point scale (4 = complete; ' = a lot; 2 = some; 1 = a little; 0 = none; -1 = worse). Secondary outcomes included the mean daily pain intensity score, measured on a 100-mm visual analog scale (VAS) (from 0 mm = no pain to 100 mm = extreme pain); pain intensity and pain relief at day 7; subjects' and investigators' mean overall assessments of study drug, measured on a Likert scale (from 2 = very good to -2 = very poor); and subjects' assessments of 8 aspects of physical function (measured on the Health Assessment Questionnaire). RESULTS: Of 277 subjects randomized to treatment, 267 (201 tramadol/APAP, 66 placebo) were included in the intent-to-treat population. Mean (SD) daily pain relief scores at the end of 1 week were significantly greater in the tramadol/APAP group compared with the placebo group (1.04 [0.89] vs 0.78 [0.80], respectively; P = 0.037), and mean daily pain intensity scores at the end of 1 week were significantly lower (47.23 [19.96] vs 53.81 [16.59]; P = 0.018). Physical function at the end of 1 week did not differ significantly between tramadol/APAP and placebo. Two hundred seventy-two subjects (205 tramadol/APAP, 67 placebo) were evaluable for tolerability. One hundred thirty-three of these subjects had at least 1 adverse event. The incidence of adverse events was significantly higher in the tramadol/APAP group than in the placebo group (57.6% vs 22.4%; P < 0.001). Discontinuations due to adverse events occurred in 19.0% of the tramadol/APAP group and 3.0% of the placebo group (P = 0.001). Of 213 treatment-related adverse events in tramadol/APAP subjects, nausea (34.1%) was the most frequent, followed by dizziness (20.0%) and vomiting (15.6%). One serious adverse event--chest discomfort, nausea, and vomiting after taking study medication-occurred in a subject receiving tramadol/APAP The symptoms resolved 1 day after discontinuing tramadol/APAP. CONCLUSIONS: In this study, tramadol/APAP used as add-on therapy in subjects with symptomatic RA was associated with a significant improvement in pain relief and a significant reduction in pain intensity compared with placebo, with no improvement in physical function. Use of tramadol/APAP may be considered when analgesics are needed in addition to conventional NSAIDs and disease-modifying antirheumatic drugs in subjects with RA.

Comparison of the disease activity score using the erythrocyte sedimentation rate and C-reactive protein levels in Koreans with rheumatoid arthritis.

OBJECTIVE: The Disease Activity Score based on 28 joints (DAS28) has been widely used in clinical practice and research studies of rheumatoid arthritis (RA). The objective of this study was to evaluate the discordance in the DAS28 based on the erythrocyte sedimentation rate (ESR) versus C-reactive protein (CRP) levels in Korean patients with RA. METHODS: From August to December 2011, 540 patients with RA who visited two rheumatology clinics affiliated with Hallym University (Korea) and had at least one DAS28 evaluation were examined. RESULTS: The mean age of the included patients was 53 years, and 82% were female. The mean duration of disease was 32.9 ± 41.2 months. The mean DAS28-ESR was higher than the DAS28-CRP (3.65 vs. 3.44; P < 0.001). In the DAS28-ESR group, 126 patients (23.3%) satisfied the criteria for remission versus 134 (24.8%) in the DAS28-CRP group. High disease activity was determined in 80 (14.8%) patients in the DAS28-ESR group and in 43 (8.0%) in the DAS28-CRP group. A comparison of the two groups with respect to four DAS28 disease activity categories showed agreement in 344 patients (63.7%; κ = 0.45). In classifying patients as European League Against Rheumatism (EULAR) responders, agreement between the two methods was shown in 56 patients (71.8%; κ = 0.76). When disagreements between the two scores occurred, more patients had a better EULAR response based on the DAS28-ESR than on the DAS28-CRP (19.2% vs. 8.9%, respectively). CONCLUSION: The discordance between the ESR-based and CRP-based DAS28 could affect clinical treatment decisions for patients with RA.