Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial.

BACKGROUND/OBJECTIVE: Osteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients. METHODS: In this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L1-L4), total hip, and femoral neck. The secondary endpoints were safety assessment, the incidence of new vertebral fractures, and the trend of bone turnover markers (BTMs). RESULTS: A total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95% two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of - 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences [95% CIs] of 0.39 [- 1.34 to 2.11], 0.04 [- 1.61 to 1.69], and 0.41 [- 1.58 to 2.40], respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs. CONCLUSION: The efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03293108 ; Registration date: 2017-09-19.

Association between biomarkers of bone health and osteosarcopenia among Iranian older people: The Bushehr Elderly Health (BEH) program.

BACKGROUND: Osteosarcopenia is referred to as co-incidence of osteoporosis/osteopenia and sarcopenia which is defined as a geriatric syndrome with a significant prevalence that increases morbidity and mortality. There are some relevant factors that can show an increased risk of incidence of osteosarcopenia. AIM: We aimed to consider the association of bone turnover markers such as Osteocalcin (OC), C-terminal cross-linked telopeptide (CTX), Tartrate Resistant acid Phosphatase (TRAP), Bone Alkaline Phosphatase (BALP) and also other factors like vitamin D, calcium, phosphorous, and ALP with osteosarcopenia in elderly. METHODS: We carried out a cross-sectional study on a random sample including 400 elder participants of Bushehr Elderly Health (BEH) study, in Iran. Osteopenia/ osteoporosis was defined as a T-score ≤ -1.0 standard deviation below the mean values of a young healthy adult. We defined sarcopenia as low muscle strength (handgrip strength<26 kg for men and <18 kg for women) with reduced skeletal muscle mass [Skeletal muscle index (SMI) < 7.0 kg/m2 for male and <5.4 kg/m2 for female]. Osteosarcopenia was considered as the presence of both osteopenia/osteoporosis and sarcopenia. We estimated the age-standardized prevalence of osteosarcopenia for men and women, separately. We used multivariable logistic regression to address the factors associated with osteosarcopenia. RESULTS: The results showed that there was a statistically significant difference in OC), CTX, TRAP were between the osteosarcopenia (-) and osteosarcopenia (+) groups. No statistically significant difference was observed in BALP, vitamin D, calcium, phosphorous, and ALP between the compared groups. In the multivariable logistic regression model, OC and CTX were associated with increased likelihood of osteosarcopenia [adjusted OR= 1.023(1.002-1.045 for OC, 4.363(1.389-15.474 for CTX)]. Furthermore, TRAP increases the odds of osteosarcopenia in crude model [OR= 1.333 (1.070- 1.660)]. CONCLUSIONS: We observed the association between bone turnover markers particularly OC, CTX and osteosarcopenia. Given the rapid growth of the aging population, we should focus on geriatric diseases such as musculoskeletal disorders. Bone turnover markers maybe improve the early diagnosis, screening and assess the response to therapies in people with osteosarcopenia.

Predicting Risk Score for Mechanical Ventilation in Hospitalized Adult Patients Suffering from COVID-19.

BACKGROUND: COVID-19 has become a pandemic since December 2019, causing millions of deaths worldwide. It has a wide spectrum of severity, ranging from mild infection to severe illness requiring mechanical ventilation. In the middle of a pandemic, when medical resources (including mechanical ventilators) are scarce, there should be a scoring system to provide the clinicians with the information needed for clinical decision-making and resource allocation. OBJECTIVES: This study aimed to develop a scoring system based on the data obtained on admission, to predict the need for mechanical ventilation in COVID-19 patients. METHODS: This study included COVID-19 patients admitted to Sina Hospital, Tehran University of Medical Sciences from February 20 to May 29, 2020. Patients' data on admission were retrospectively recruited from Sina Hospital COVID-19 Registry (SHCo-19R). Multivariable logistic regression and receiver operating characteristic (ROC) curve analysis were performed to identify the predictive factors for mechanical ventilation. RESULTS: A total of 681 patients were included in the study; 74 patients (10.9%) needed mechanical ventilation during hospitalization, while 607 (89.1%) did not. Multivariate logistic analysis revealed that age (OR,1.049; 95% CI:1.008-1.091), history of diabetes mellitus (OR,3.216; 95% CI:1.134-9.120), respiratory rate (OR,1.051; 95% CI:1.005-1.100), oxygen saturation (OR,0.928; 95% CI:0.872-0.989), CRP (OR,1.013; 95% CI:1.001-1.024) and bicarbonate level (OR,0.886; 95% CI:0.790-0.995) were risk factors for mechanical ventilation during hospitalization. CONCLUSIONS: A risk score has been developed based on the available data within the first hours of hospital admission to predict the need for mechanical ventilation. This risk score should be further validated to determine its applicability in other populations.

The Risk Factors and Clinical Outcomes Associated with Acute Kidney Injury in Patients with COVID-19: Data from a Large Cohort in Iran.

INTRODUCTION: Kidney involvement, ranging from mild hematuria and proteinuria to acute kidney injury (AKI) in patients with coronavirus disease-2019 (COVID-19), is a recent finding with various incidence rates reported among hospitalized patients with COVID-19. Given the various AKI rates and their associated risk factors, lack of AKI recovery in the majority of patients hospitalized with COVID-19, and limited data regarding AKI in patients with COVID-19 in Iran, we aim to investigate the potential risk factors for AKI development and its incidence in patients hospitalized with COVID-19. METHODS: In this retrospective cohort study, we enrolled adult patients referred to the Sina Hospital, Iran, from February 20 to May 14, 2020, with either a positive PCR test or a highly susceptible chest computed tomography features consistent with COVID-19 diagnosis. AKI was defined according to the kidney disease improving global outcomes criteria, and patients were stratified based on their AKI staging. We evaluated the risk indicators associated with AKI during hospitalization besides in-hospital outcomes and recovery rate at the time of discharge. RESULTS: We evaluated 516 patients with a mean age of 57.6 ± 16.1 years and a male-to-female ratio of 1.69 who were admitted with the COVID-19 diagnosis. AKI development was observed among 194 (37.6%) patients, comprising 61.9% patients in stage 1, 18.0% in stage 2, and 20.1% in stage 3. Out of all patients, AKI occurred in 58 (11.2%) patients during the hospital course, and 136 (26.3%) patients arrived with AKI upon admission. AKI development was positively associated with all of the in-hospital outcomes, including intensive care unit admissions, need for invasive ventilation, acute respiratory distress syndrome (ARDS), acute cardiac injury, acute liver injury, multiorgan damage, and mortality. Patients with stage 3 AKI showed a significantly higher mortality rate, ARDS, and need for invasive ventilation than other stages. After multivariable analysis, male sex (odds ratio [OR]: 11.27), chronic kidney disease (CKD) (OR: 6.89), history of hypertension (OR: 1.69), disease severity (OR: 2.27), and high urea levels (OR: 1.04) on admission were independent risk indicators of AKI development. Among 117 (28.1%) patients who experienced AKI and survived, only 33 (28.2%) patients made a recovery from the AKI, and 84 (71.8%) patients did not exhibit full recovery at the time of discharge. DISCUSSION/CONCLUSION: We found that male sex, history of CKD, hypertension, disease severity, and high serum urea were independent risk factors associated with AKI in patients with COVID-19. Also, higher stages of AKI were associated with increased risk of mortality and in-hospital complications. Our results indicate a necessity for more precise care and monitoring for AKI during hospitalization in patients with COVID-19, and lack of AKI recovery at the time of discharge is a common complication in such patients.

Clinical Characteristics of COVID-19 Patients with Gastrointestinal Symptoms.

BACKGROUND: We aimed to assess the gastrointestinal (GI) manifestations of patients with severe acute respiratory syndrome coronavirus 2 infection and determine factors predicting disease prognosis and severity among patients with GI symptoms. METHODS: In this retrospective study, we evaluated laboratory confirmed (by real-time polymerase chain reaction) inpatient cases of coronavirus-associated disease 2019 (COVID-19), referred to Sina hospital, a tertiary educational hospital of Tehran University of Medical Sciences, from March 10 to May 20, 2020. Demographic and clinical characteristics, laboratory data, outcomes and treatment data were extracted and analyzed using SPSS version 20. RESULTS: A total of 611 patients (234 women and 377 men) were included with 155 patients having GI symptoms. The most prevalent reported GI symptom was nausea/vomiting in 115 (18.8%) of patients. A total of 20 patients (3.2%) only had GI symptoms (without respiratory symptoms). There was no statistically significant difference in the clinical outcomes, disease severity, intensive care unit (ICU) admission and mortality between patients with and without GI symptoms. Aspartate Aminotransferase level was associated with 446% increased risk of disease severity (adjusted odds ratio: 5.46, 95% CI: 2.01 to 14.81) (P=0.040) among patients with GI symptoms. Additionally, we found that treatment with antibiotics in addition to mechanical ventilation was associated with increased survival among patients with GI symptoms (Pearson Chi square: 6.22; P value: 0.013). CONCLUSION: More attention should be paid to patients with only GI symptoms for early patient detection and isolation. Moreover, patients with GI manifestations are not exposed to higher rates of disease severity or mortality.

The effect of a garlic supplement on the pro-inflammatory adipocytokines, resistin and tumor necrosis factor-alpha, and on pain severity, in overweight or obese women with knee osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is a prevalent degenerative joint disease, which is associated with chronic and disabling pain. The adipocytokines, resistin and tumor necrosis factor-alpha (TNF-α), might play a role in OA pathogenesis and outcomes. PURPOSE: The aim of this study was, therefore, to assess the anti-inflammatory and analgesic effects of a garlic supplement on serum resistin and TNF-α concentrations and on pain severity in overweight or obese women with knee OA. STUDY DESIGN: Randomized, double-blind, placebo-controlled, parallel-design trial. METHODS: In this study, 80 post-menopausal overweight or obese women (25 ≤ BMI ≤ 40 kg/m2, age 50-75 years) with mild to moderate knee OA were enrolled. Patients were randomly divided into two groups to receive twice-daily either garlic tablets (total: 1000 mg) or placebo for 12 weeks. The primary outcome measures were fasting serum concentrations of resistin and TNF-α, and pain severity (assessed using 0-10 point visual analogue scale (VAS)). RESULTS: At week 12, resistin concentrations were significantly decreased in the garlic group (6.41 ±â€¯2.40 to 5.56 ±â€¯2.16 ng/ml; P = 0.008). Serum TNF-α levels did not change significantly within or between the two groups. Pain scores were significantly reduced in the garlic (6.8 ±â€¯2 to 5.3 ±â€¯2.3; P = 0.002), but not in the placebo (6.7 ±â€¯2.4 to 6.2 ±â€¯2.5; P = 0.674), group. Pain scores were also significantly lower in the garlic, compared with the placebo, group following supplementation (5.3 ±â€¯2.3 vs. 6.2 ±â€¯2.5; P = 0.043). CONCLUSIONS: The findings suggest that garlic supplementation for 12 weeks might reduce pain severity in overweight or obese women with knee OA, which may, at least in part, be mediated via a reduction in the pro-inflammatory adipocytokine, resistin.

Association of Serum Level of 25-Hydroxy Vitamin D Deficiency and Pulmonary Function in Healthy Individuals.

BACKGROUND: Besides the extensive regulatory role in growing number of biologic processes, vitamin D has been recently considered essential for lungs function as well as protective against exacerbation of chronic obstructive pulmonary diseases. We assessed the correlation between vitamin D serum levels with pulmonary function in healthy individuals. METHODS: In a cross-sectional study, healthy volunteer (n = 92) participants underwent the following laboratory procedures: a blood test, a 24-hour urine collection test, and the serum level of 25-hydroxy vitamin D before undergoing spirometry. Linear correlation coefficient was calculated to detect the association between serum level of 25-hydroxy vitamin D and pulmonary volumes. RESULTS: The mean age of participants was 39.95 ± 9.98 years. 48% of participants showed different levels of 25-hydroxy vitamin D deficiency. We recognized a consistent direct positive correlation between serum levels of 25-hydroxy vitamin D and lung function volumes. The coefficient for forced vital capacity, forced expiratory volume in 1 second, forced expiratory flow 25-75%, and forced expiratory volume in 1 second/forced vital capacity ratio were 0.610, 0.509, 0.454, and 0.551, respectively. CONCLUSIONS: Our findings suggest correlation between higher serum levels of 25-hydroxy vitamin D and improved pulmonary function. Accordingly, supplemental vitamin D might significantly improve treatment response.

The effect of 12-week garlic supplementation on symptom relief in overweight or obese women with knee osteoarthritis.

AIMS: Chronic joint pain and stiffness, and functional disability, are the major debilitating features of osteoarthritis (OA). The aim of this study was to assess the effect of 12-week supplementation with a garlic supplement on knee osteoarthritis outcomes in overweight or obese women. METHODS: Seventy-six postmenopausal overweight or obese women (25≤BMI≤40 kg/m2 ) with medically diagnosed knee OA participated in this randomised double-blind, placebo-controlled, parallel-design trial. After randomisation into 2 groups, patients received a daily dose of either 1000 mg odourless garlic tablet, or placebo, for 12 weeks. The total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), as well as pain, stiffness and physical function subscales, were evaluated pre- and poststudy. Anthropometric parameters and body composition (using bioelectrical impedance analysis) were also assessed. RESULTS: Following 12-week supplementation in overweight or obese women with OA, stiffness (but not pain, function or WOMAC total score) was significantly lower in the garlic group compared with the placebo group (1.4 ± 1.6 vs 2.5 ± 1.9, P = .023). The changes in WOMAC parameters showed no statistically significant differences between the 2 groups. WOMAC total score (38.4 ± 15.9-30.6 ± 15.7, P = .004) and all the subscales, including pain (8.3 ± 3.7-7 ± 4.4, P = .026), stiffness (2.3 ± 1.6-1.4 ± 1.6, P = .013) and physical function (27.7 ± 11.9-22.2 ± 12.4, P = .001) improved significantly in the garlic group postintervention compared with pre-intervention; although pain subscale also decreased in the placebo group (9.6 ± 3.1-6.9 ± 3.7, P < .001). CONCLUSIONS: Although pre- to postintervention knee OA symptoms were improved in overweight or obese women receiving 12 weeks garlic supplement, there was no significant difference in WOMAC changes compared with the placebo group. Further clinical trials are required to investigate the therapeutic value of garlic ingredients, and the potential role of placebo effect, in the management of OA symptoms.

Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.

AIM: Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions. METHODS: We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis. RESULTS: Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences. CONCLUSIONS: It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis.

Relationship between bone density and abdominal visceral fat in premenopausal overweight and obese Iranian women aged 30-50 years.

AIM: The presence of a direct relationship between body mass index (BMI) and bone mineral density (BMD) is frequently reported. However, data on the relationship between visceral fat and bone density varies, with positive, negative or no relationship having been reported. This study aims to examine the relationship between abdominal visceral fat and BMD. METHODS: A cross sectional study was carried out on 95 premenopausal, overweight and obese women aged 30-50 years referred to Sina Hospital, Tehran, Iran in 2011-2012. Anthropometric indices and visceral fat levels were measured. RESULTS: Multiple linear regression analysis showed that proximal femur BMD (P = 0.856) and lumbar spine BMD (P = 0.558) were not significantly related to visceral fat level. However, BMI had a direct and significant positive relationship with proximal femur BMD (P = 0.001) and lumbar spine BMD (P = 0.031). Menarche age was negatively related to lumbar spine BMD (P = 0.003). CONCLUSIONS: In this study, after adjusting for fat-free mass, no significant relationship was found between MBD of the proximal femur and lumbar spine, and visceral fat level or visceral fat to total fat percentage ratio. Therefore, abdominal visceral fat may not affect BMD, independent of weight. It seems that the positive relationship between BMI and proximal femur and lumbar spine BMD is due to the mechanical effects of weight on bones.

Single Nucleotide Polymorphism rs 2476601 of PTPN22 Gene and Susceptibility to Rheumatoid Arthritis in Iranian Population.

The rs2476601 (R620W, C1858T) polymorphism in PTPN22 gene has been repeatedly reported to be associated with rheumatoid arthritis (RA). The rs 2476601 is widely suggested for predictive testing and risk assessment for RA. The aim of this study was to test the possible association of this SNP with RA in Iranian population. A total of 872 samples (405 confirmed RA patients and 467 healthy controls) were recruited in this study. Genomic DNA was extracted from whole blood and the genotyping was performed by polymerase chain reaction-restriction fragment length polymorphism (PCR- RFLP). Genotyping for a set of samples were re-confirmed by two other rounds of genotyping, using another PCR-RFLP experiment with different enzyme and DNA sequencing. All 872 samples were genotyped as homozygous CC in first round of genotyping. Genotyping was repeated for 30% of samples by another restriction enzyme and for 10% of samples by sequencing. Again all samples showed homozygous CC genotype. This study suggests that the rs2476601 polymorphism of PTPN22 gene is mono-morphic in Iranian population, containing only C allele. Considering that previous studies in other populations reported the T allele as the risk allele at this locus, the present study concluded that rs2476601 play no role in susceptibility to RA and other autoimmune diseases in Iranian population. This finding has significant future clinical implications in determining the strategy for risk assessment and predictive testing for such diseases in Iranian population.

Lack of association between single nucleotide polymorphism rs10818488 in TRAF1/C5 region and rheumatoid arthritis in iranian population.

The association of rs10818488 SNP located in TRAF1/C5 region with Rheumatoid Arthritis (RA), has been picked up by genome-wide association studies. Independent studies in different populations revealed inconsistent results. The aim of this study was to investigate the possible association of this SNP with RA in Iranian population. A total of 362 cases and 422 healthy controls were recruited in this study. Genomic DNA was extracted from whole blood and the genotyping was performed by PCR-RFLP (Polymerase Chain Reaction-Restriction Fragment Length Polymorphism). A set of genotypes was confirmed by sequencing. Genotype and allele frequencies were compared between the case and control groups. Analysis indicated a higher frequency of A allele in cases, although the difference was not statistically significant (Chi-square=2.8, p=0.09). Comparison of genotype frequencies, revealed higher frequencies of AA and AG genotypes in case group but statistically the difference was not significant (Chi-square=2.72, p=0.25). These findings suggest that the rs0818488 in TRAF1/C5 region is not associated with rheumatoid arthritis in Iranian population.

Estimating the prevalence and disease characteristics of rheumatoid arthritis in Tehran: A WHO -ILAR COPCORD Study (from Iran COPCORD study, Urban Study stage 1).

BACKGROUND: To estimate the prevalence and characteristics of Rheumatoid Arthritis (RA) in an urban area of Tehran. METHODS: A total of 50 clusters were randomly selected in Tehran and 10291 subjects completed the COPCORD Core Questionnaire during 2004 and 2005. Patients with rheumatic complaints were examined and diagnosed by subspecialty fellows in rheumatology. Laboratory and radiology tests were also performed if required. RESULTS: A total of 35 subjects (5 men and 30 women) were diagnosed with RA, with a prevalence of 0.33% (95% CI: 0.22-0.46). Our results demonstrated that RA was six times more common in women than men. The mean age (± SD) of patients was 52.3 (± 17.6) years. Morning stiffness > 1 hour was reported in 37.1% of patients. Rheumatic signs were commonly found in wrist (60%), knee (60%), metacarpophalangeal (48.6%) and proximal interphalangeals of hand (40%). Approximately 46% of patients had difficulty carrying out daily activities. CONCLUSION: According to our study, the prevalence of RA in Iran seems to be lower than western countries. However, the prevalence of RA in Iran seems to be approximately in the middle point comparing the APLAR region (from 0.7% in Australia (rural) to 0.12% in Thailand).

Ischemic toes after venous thromboembolism: a difficult differential diagnosis with good response to combination therapy-a case report.

The obliteration of the arterial vascular system of toes is considered as a potentially catastrophic event in clinical practices. In most instances, the cessation of arterial blood flow heralds a serious underlying pathology. A definite classification of some cases is somehow difficult and subject to diagnostic challenges. The aim of the present case study is to share and discuss potentially complex and multifactorial mechanisms of some acute vascular events. In this report, we deal with a 46-year-old man with a rather gradual-onset ischemia of his toe who responded favorably to a combination of pulsed glucocorticoid and anticoagulation within a week.

Symptoms of anxiety and depression: A comparison among patients with different chronic conditions.

BACKGROUND: Although patients with chronic diseases are at high-risk for symptoms of anxiety and depression, few studies have compared patients with different chronic conditions in this regard. This study aimed to compare patients with different chronic medical conditions in terms of anxiety and depression symptoms after controlling for the effects of socio-demographic and clinical data. METHODS: This cross-sectional study enrolled 2234 adults, either healthy (n = 362) or patients with chronic medical conditions (n = 1872). Participants were recruited from the outpatient clinic of Baqiyatallah Hospital, Tehran, Iran. Patients had one of the following five medical conditions: coronary artery disease (n = 675), renal transplantation (n = 383), chronic hemodialysis (n = 68), rheumatoid conditions (rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus and ankylosing spondylitis) (n = 666) and viral hepatitis (n = 80). Independent factors included socio-demographic data, pain disability, and somatic comorbidities (Ifudu index). Outcomes included symptoms of anxiety and depression through Hospital Anxiety and Depression Scale (HADS). Two multinomial regression models were used to determine the predictors of anxiety and depression symptoms. RESULTS: After controlling the effect of age, sex, educational level, comorbidities, disability and pain, rheumatoid arthritis and hepatitis were predictors of higher anxiety symptoms, while coronary artery disease and chronic hemodialysis were predictors of depression symptoms. CONCLUSIONS: Although all chronic conditions may require psychological consideration; be that as it may, different chronic diseases are dissimilar in terms of their mental health need. Anxiety for rheumatoid arthritis and hepatitis as well as depression for coronary artery disease and chronic hemodialysis is more important.

Health-related quality of life and disease activity in rheumatoid arthritis.

BACKGROUND: The present study sought to 1) investigate the degrees of correlations between different disease activity scores (DASs) and health-related quality of life (HRQoL), and 2) determine if DASs correlate with either physical or mental HRQoL. METHODS: Eighty patients with rheumatoid arthritis (RA) were assessed for different DASs, measured with erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), namely DAS4-ESR, DAS-3 ESR, DAS4-CRP, DAS3-CRP, DAS4-28 ESR, DAS3-28 ESR, DAS4-28 CRP, and DAS3-28 CRP, and Simplified Disease Activity Indexes namely SDAI-ESR, and SDAI-CRP. Physical and mental HRQoL were measured using the SF-36. The Pearson correlation test was employed to examine the correlations between HRQoL and different DAS indices. PASS 2000 (Power Analysis and Sample Size) software was utilized to find significant differences between the correlations. RESULTS: SF-36 total score showed a significant inverse correlation with the DAS4-ESR, DAS-3 ESR, DAS4-CRP, DAS3-CRP, DAS4-28 ESR, DAS3-28 ESR, DAS4-28 CRP, and DAS3-28 CRP, with correlation coefficients of -0.320, -0.314, -0.330, -0.323, -0.327, -0.318, -0.360 and -0.348, respectively (P < 0.01 for all). The correlation coefficients between different DAS indices and the HRQoL score were not significantly different. In addition, all DASs showed significant correlations with physical HRQoL, but not with mental HRQoL. CONCLUSIONS: Among patients with RA, disease severity indices are associated with physical, but not mental HRQoL. However this study failed to show any differences between various DASs in their clinical use.

Effect of conjugated linoleic acids, vitamin E and their combination on the clinical outcome of Iranian adults with active rheumatoid arthritis.

BACKGROUND: Despite beneficial effects of conjugated linoleic acids (CLAs) in animal studies, there is little information on their effects on human inflammatory and autoimmune diseases. AIM: To investigate the effects of CLAs as an adjuvant therapy on the clinical manifestations of rheumatoid arthritis (RA) in adults with an active disease. METHODS: In a randomized, double-blind placebo-controlled trial, 87 patients with active RA were divided into four groups receiving one of the following daily supplements for 3 months: group C: CLAs 2.5 g equivalent to 2 g mixture of cis 9-trans 11 and trans 10-cis12 CLAs at a rate of 50/50; group E: vitamin E: 400 mg; group CE: CLAs and vitamin E at above doses; group P: placebo. Serum alpha-tocopherol was determined by high-performance liquid chromatography. Clinical data was determined by physician examination and filling the questionnaire by interview. Complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-Reactive protein (CRP) and rheumatoid factor (RF) were measured in each patient. DAS28 (diseases activity score) was also determined. RESULTS: A 3-month supplementation resulted significant reduction in DAS28, pain and morning stiffness in the groups C and CE compared with group P (P < 0.05). Compared with the baseline, ESR levels decreased significantly in the groups C (P < or = 0.05), E (P < or = 0.05) and CE (P < or = 0.001). Group CE had significantly lower ESR levels than group P (P v 0.05). CRP dropped non-significantly in all four groups (P > 0.1). The reduction of white blood cell count was significant in group CE compared with other groups (P < 0.05). Decrease in platelet count was non-significant in groups CE, C, and E. Changes in RF, body mass index, red blood cell count and hemoglobin were not significant in four groups, while RF decreased non-significantly in groups CE and E. In comparison with the baseline, alpha-tocopherol increased significantly in groups C (P < or = 0.05), E (P < or = 0.01) and CE (P < or = 0.001) and in groups E and CE compared with group P. CONCLUSION: CLA supplementation resulted in significant improvement in clinical manifestation among RA patients and may be useful in their treatments.

Clinical characteristics of Buerger's disease in Iran.

OBJECTIVE: To determine the clinical course of Buerger's disease as observed in two vascular surgery centers located in the capital of Iran. STUDY DESIGN: Case series. PLACE AND DURATION OF STUDY: Sina and Imam Hospitals, Tehran, Iran, during the years 1997 to 2002. METHODOLOGY: The records of all the patients admitted with Buerger's disease diagnosed on the basis of Shionoya's clinical criteria were studied. Their clinical characteristics, treatment offered and short-term follow-up results are described as frequencies and percentages. RESULTS: A total of 116 patients, aged 41.1+/-11.3 years, were enrolled. All patients were males; 99% of them were smokers with an average of 22.9 pack-years of tobacco use. Lower-extremity was affected in 102 (87.9%) patients, upper-extremity in 3 (2.6%) patients and both in 11 (9.5%). The most frequent reasons for being referred to hospital were ischemic ulcers (90.5%), claudication (87.9%), paresthesia (75.9%), rest pain (66.4%), gangrene (60.3%), Raynaud's phenomenon (23.3%) and thrombophlebitis (9.5%). Diagnostic arteriography, vascular bypass surgery and sympathectomy were performed in 60%, 24% and 83% of the patients, respectively. Sixty-eight patients (58.6%) had one of the following amputations: toe 36 (52.9%), transmetatarsal 3 (4.4%), below knee 25 (36.8%), finger 3 (4.4%) and above knee one (1.5%) patient. CONCLUSION: Since the studied hospitals are the referral centers for vascular surgery in Iran admitting patients with severe symptoms; therefore, a higher number of complications and amputations was found in the present study. Upper extremity involvement as well as the occurrence of thrombophlebitis and Raynaud's phenomenon was rather infrequent among the studied cases.

Prevalence of amyloid deposition in long standing rheumatoid arthritis in Iranian patients by abdominal subcutaneous fat biopsy and assessment of clinical and laboratory characteristics.

BACKGROUND: The study was aimed at determining the prevalence of secondary amyloidosis in a group of Iranian patients with Rheumatoid Arthritis (RA), and the assessment of its correlation with the clinical and laboratory findings and data. METHOD: A total number of 220 patients (167 female and 53 male) with a minimum five-year history of RA were selected. Congo red staining method was used for staining the specimens obtained by abdominal subcutaneous fat biopsy (ASFB) method. All of the specimens were examined for apple-green birefringence under polarized light microscope. Clinical and laboratory characteristics of the patients were assessed. Chi-square test and unpaired student's t-test were run for intergroup comparisons. RESULTS: Amyloid deposition test yielded positive results in 15 out of the 220 cases (6.8%) examined by the ASFB technique. Thirteen patients were found to have minimal amyloid deposits. Of all the clinically significant cases, 8 (53%) presented with proteinuria, and 7 cases (46.6%) had severe constipation. CONCLUSION: The prevalence of fat amyloid deposits in Iranian patients with RA is low. In up to half of the study group the deposits were subclinical. Follow up studies are required to determine whether this subclinical amyloidosis can develop into full-blown clinically significant amyloidosis.