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ID PMID Title PublicationDate abstract
21334947 Information on glucocorticoid therapy in the main studies of biological agents. 2011 Oct OBJECTIVE: To evaluate reported information on prednisone therapy in the main studies of biological agents used to treat rheumatoid arthritis (RA). METHODS: We reviewed 66 publications (including four abstracts), including 11 studies of infliximab, 19 of etanercept, eight of adalimumab, five of golimumab, four of certolizumab, four of rituximab, eight of abatacept, and seven of tocilizumab. RESULTS: Whether concomitant prednisone therapy was used, it was specified in only 56 (85%) of the 66 publications. Only 42 (64%) publications indicated that the prednisone dosage remained unchanged throughout the study. The maximum prednisone dosage allowed was specified in only 39 (59%) reports and was lower than 8 mg/day in only four (6%) studies. Data enabling determination of the mean daily prednisone dosage in prednisone-treated patients was available for only eight (12%) studies; the mean dosage ranged from 5.0 to 9 mg/day (mean, 7.1 ± 1.5). The percentage of patients receiving prednisone therapy was reported for only 41 (62%) studies. All the above-mentioned information was available in only two (3%) study reports. The percentage of patients on prednisone therapy ranged from 34% to 93% (mean, 58 ± 13%) overall and varied across biological agents as follows: abatacept, 74.4%; golimumab, 67.9%; infliximab, 60.6%; certolizumab, 57.5%; rituximab, 57.5%; etanercept, 54.4%; tocilizumab, 52.8%; and adalimumab, 50.4%. These percentages did not decline between 1997 and 2010. CONCLUSION: Study reports provide inadequate information on prednisone therapy during biological treatment for RA.
21442166 Subclinical atherosclerosis in gouty arthritis patients: a comparative study. 2012 Jun We evaluated the incidence of subclinical atherosclerosis and associated factors in our gouty arthritis patients. We included 55 gouty arthritis patients diagnosed at our center within the last 4 years. The control group included 41 patients with rheumatoid arthritis (RA) and 34 patients with asymptomatic hyperuricemia (AHU). Atherosclerotic risk factors were determined in all subjects. Carotid intima-media thickness (IMT) and the presence of plaques were evaluated by B-mode ultrasonography. The carotid IMT in gouty arthritis patients (0.730 ± 0.19) was significantly higher than in AHU subjects (0.616 ± 0.12) (P = 0.004) and tended to be higher than the RA group (0.669 ± 0.17) (P = 0.1). Atheromatous plaques were significantly more frequent in gouty arthritis patients (16 cases, 29.1%) than in RA patients (5 cases, 12.2%) and AHU subjects (3 cases, 8.8%) (P values, 0.05 and 0.023). Gout patients with plaques were older (P = 0.006) and tended to have tophi more frequently (P = 0.06). Logistic regression analysis showed that age (OR: 1.3, 95% CI: 1.02-1.54) and the presence of tophi (OR: 12.5, 95% CI: 1.2-140) were independent risk factors for the presence of plaques. Gouty arthritis bears a higher risk of atherosclerosis than both RA and AHU.
22806097 Chronic inflammation and lung fibrosis: pleotropic syndromes but limited distinct phenotyp 2012 Sep Experimental models of lung fibrosis have been disappointing in predicting therapeutic responses to a wide variety of interventions in clinical fibrosing lung diseases. There are multiple potential reasons, but this fundamentally calls into question the validity of the models and their fidelity to clinical syndromes. We propose that the clinical diseases associated with pulmonary fibrosis, although manifesting a broad array of widely different clinical presentations and features, result in essentially two distinct phenotypes of fibrosis that we will describe. The most common and problematic of these are not effectively modeled experimentally. In this review, we present several clinical entities as examples of the phenotypic distinctions. The first two represent the extremes: postinflammatory fibrosis observed in hypersensitivity pneumonitis (HP) and dysregulated matrix deposition as observed in idiopathic pulmonary fibrosis (IPF). We also present a third clinical entity, that of lung disease associated with rheumatoid arthritis (rheumatoid lung), representing a condition that can manifest as either phenotype, and offering a potential opportunity to explore the mechanisms underlying the pathogenesis of the two distinct fibrotic phenotypes.
21565963 High-resolution mapping of a complex disease, a model for rheumatoid arthritis, using hete 2011 Aug 1 Resolving the genetic basis of complex diseases like rheumatoid arthritis will require knowledge of the corresponding diseases in experimental animals to enable translational functional studies. Mapping of quantitative trait loci in mouse models of arthritis, such as collagen-induced arthritis (CIA), using F(2) crosses has been successful, but can resolve loci only to large chromosomal regions. Using an inbred-outbred cross design, we identified and fine-mapped CIA loci on a genome-wide scale. Heterogeneous stock mice were first intercrossed with an inbred strain, B10.Q, to introduce an arthritis permitting MHCII haplotype. Homozygous H2(q) mice were then selected to set up an F(3) generation with fixed major histocompatibility complex that was used for arthritis experiments. We identified 26 loci, 18 of which are novel, controlling arthritis traits such as incidence of disease, severity and time of onset and fine-mapped a number of previously mapped loci.
20805297 Effect of intra-articular corticosteroid injections and inflammation on periarticular and 2011 Jan OBJECTIVES: To explore the effect of intra-articular corticosteroid (IAST) injections on bone mineral density (BMD) in the hand and at the metacarpophalangeal (MCP) joints in early rheumatoid arthritis (RA). METHODS: In the first 3 months of the study, 19 patients with RA received methotrexate (MTX) alone and 21 received MTX and IAST injections into clinically inflamed joints. In the following 9 months, all patients received MTX+IAST. BMD was assessed at the hand and periarticular regions at MCP joints 2-5 at baseline, 3 and 12 months. RESULTS: In the first 3 months a numerically lower percentage rate of bone loss was seen in MTX+IAST-treated patients compared with MTX-treated patients. This observation was more pronounced at the MCP periarticular regions (eg, partial proximal phalanges: digit 2, -0.45% vs -2.69%, p=0.045; digit 3, -0.34% vs -3.32%, p=0.003; digit 4, -0.39% vs -2.57%, p=0.14; digit 5, -0.59% vs -2.70%, p=0.24) than for the whole hand (-1.53% vs -2.42%, p=0.32). In the 3-12-month period, only minor non-statistically significant differences were seen between the two groups. CONCLUSION: IAST given over 3 months protects against periarticular bone loss in inflamed finger joints in RA. These data emphasise the importance of suppressing inflammation in patients with active RA to maintain bone health.
22802109 Combined use of etanercept and MTX restores CD4⁺/CD8⁺ ratio and Tregs in spleen and th 2012 Nov OBJECTIVE: To further explore the mechanism of etanercept (ENT, rhTNFR:Fc) and methotrexate (MTX) in the combined treatment of rheumatoid arthritis (RA), we investigated whether thymic and splenic T-cell subsets and their related cytokines imbalance could be restored by ETN/MTX treatment. METHODS: The effect of ETN/MTX on collagen-induced arthritis (CIA) was evaluated by arthritis scores, joint and spleen histopathology, as well as indices of thymus and spleen. T lymphocytes proliferation was determined by [(3)H]-TdR incorporation. Levels of TNF-α, LT-α, IL-1β, RANKL, IL-10, IL-17, IFN-γ and IL-6 were detected by enzyme linked immunosorbent assay. The subsets of T lymphocytes including CD4(+), CD8(+), CD3(+)CD4(+), CD4(+)CD25(+), CD4(+)CD62L(+) and CD4(+)CD25(+)Foxp3(+) cells were quantified using flow cytometry. RESULTS: Combined administration of ETN/MTX significantly inhibited the proliferation of T lymphocytes, decreased serum IL-6, TNF-α, IL-1β, RANKL and macrophage supernatant IL-17, LT-α, increased serum IFN-γ and macrophage supernatant IL-10. Moreover, the combined administration could restore CD4(+)/CD8(+) ratio and Treg cells of CIA thymus and spleen. CONCLUSION: Taken together, our findings suggest that ENT/MTX may modify the abnormal T lymphocytes balance from central to peripheral lymphoid organs, which may partially, explained the mechanism of the combined administration.
21769486 Weak CD4+ T-cell responses to citrullinated vimentin in rheumatoid arthritis patients carr 2012 Jun Citrullinated vimentin (cVIM) is one of the antigens specifically targeted by anti-citrullinated protein antibodies (ACPA) in rheumatoid arthritis (RA) patients. The association between ACPA and certain HLA-DRB1 alleles, those coding for the shared epitope (SE), suggests that this response could be T-cell mediated. HLA-DR9 alleles, which do not code for the SE, have recently been associated with ACPA (+) RA. The objective of this work was to study CD4+ T cell responses to cVIM in RA patients and healthy controls carrying HLA-DR9 alleles. Fourteen RA patients and ten healthy controls previously genotyped for HLA-DRB1 were studied for the presence of serum anti-cVIM antibodies by Western blot and ELISA. Peripheral blood mononuclear cells were stimulated with native vimentin and cVIM, and CD4+ T cells proliferation was assessed by flow cytometry. Citrulline-specific CD4+ T cells proliferation was found not only in RA patients but also in healthy controls. Although most patients carrying HLA-DR9 alleles present anti-cVIM antibodies, HLA-DR9 alleles were associated with weaker cVIM-driven CD4+ T-cell responses among RA patients. These results suggest that HLA-DR9 alleles could exert a protective effect on the recognition of cVIM epitopes by CD4+ T cells. In this context, other citrullinated proteins may break T and B cell tolerance, with cVIM only acting as a cross-reactive target for ACPA.
21188454 Reduction in serum levels of substance P in patients with rheumatoid arthritis by etanerce 2011 Jun We determined the effects of etanercept on the serum concentrations of neuropeptides in RA patients. In a total of 11 patients who had been injected with etanercept, the serum levels of substance P, calcitonin gene-related peptide (CGRP), and gastrin-releasing peptide (GRP) were analyzed. Average levels of serum substance P were significantly reduced from 1.53 to 0.62 ng/ml after the injection of etanercept. In the CGRP and GRP analyses, these average levels dropped from 1.57 and 0.51 ng/ml to 0.44 and 0.04 ng/ml, respectively. Etanercept appears to decrease substance P levels with an improvement in disease activities.
22507362 Development and delivery of an exercise intervention for rheumatoid arthritis: strengtheni 2012 Jun This paper describes the development and implementation of a hand exercise intervention for rheumatoid arthritis (RA) as part of a large multi-centred randomised controlled trial in a U.K. National Health Service (NHS) setting. Participants are eligible if diagnosed with RA according to American College of Rheumatology criteria, have a history of disease activity, functional deficit or impairment in the hand and/or wrist, and have been on a stable medication regime for at least 3 months. The intervention development was informed by the current evidence base, published guidelines, clinician and expert opinion, and a pilot study. The exercise programme targets known, potentially modifiable physical impairments of the hand with 5 exercise sessions and a home exercise component over a 12 week period. The intervention will be provided to 240 participants along with usual care. A further 240 will receive usual care only as part of the control arm. Specific details of the treatments delivered are described. [ISRCTN no: 89936343].
22797949 Risk of restless legs syndrome in low socioeconomic rheumatoid arthritis patients. 2013 Jul OBJECTIVES: Our aim was to determine the frequency of restless leg syndrome (RLS) in rheumatoid arthritis (RA) patients from a low socioeconomic area of Pakistan and compare results with a control group to evaluate the effect of variables on RLS patients. METHODS: A clinical observational study was carried out on 240 RA patients form low socioeconomic group. Controls (n = 210) were frequency-matched by age group to the RA patients. We evaluated the presence of RLS and collected information on characteristics believed to be correlated with RLS in the general population. Multiple logistic regression models were used to study the association between RLS and other risk factors such as age, smoking status, and obesity. RESULTS: Among all rheumatic patients seen at our rheumatology clinic, 70.8% were women. Our study shows that 20% of RA patients were suffering from RLS compared with 10% of the control group with other rheumatic diseases. Multivariate logistic regression adjusted for age, obesity, and smoking also showed that women with RA were more likely to have RLS than control patients. RLS was also significantly associated with increasing age, high body mass index, and smoking status. CONCLUSIONS: Approximately 20% of RA patients were suffering from RLS. Hence, there is need of increase awareness of RLS among rheumatologists to enhance early RLS diagnosis and appropriate management of this treatable condition.
21498553 Survival of cancer in patients with rheumatoid arthritis: a follow-up study in Sweden of p 2011 Aug OBJECTIVES: Patients diagnosed with RA have an increased risk of some cancers. However, limited data are available on the important issue of prognosis of RA patients with cancer. METHODS: RA patients were identified from the Swedish Hospital Discharge Register by linkage to the Cancer Registry. Follow-up of patients was started from the date of diagnosis of cancer through year 2006. Hazard ratios (HRs) were calculated in cancer patients with RA compared with subjects without RA. RESULTS: A total of 1,411,163 cancer patients were identified in the database, of whom 6309 had a previous hospitalization for RA. Compared with all cancer patients without RA, patients with RA had a worse prognosis, with an HR of 1.29 and 1.31 for cause-specific and overall survival, respectively. For specific cancer sites, skin and breast cancers and non-Hodgkin's lymphoma showed worst survival. Age stratification did not change the results. CONCLUSION: Cancer patients with a previous hospitalization for RA had a worse prognosis for all and many site-specific cancers compared with patients without RA, independent of age at diagnosis and tumour staging. Improvement of survival for cancer patients with RA may require a multidisciplinary approach to accommodate the comorbidity.
21605676 The l-Ser analog #290 promotes bone recovery in OP and RA mice. 2011 Sep We previously characterized the l-Ser analog #290, H(tBut)-l-Ser-O-Methyl·HCl, as a novel inhibitor of osteoclastogenesis which functions in both mouse and human cells. Here, we assessed the activity of #290 in animal models of osteoporosis and rheumatoid arthritis. Treatment of animals with #290 both prevented bone loss and led to the recovery of lost bone in osteoporotic mice. When inflammatory arthritis was induced in SKG mice, #290 treatment suppressed arthritis scores and significantly prevented the destruction of calcaneous bones. Additionally, #290 reciprocally modulated the mammalian target of rapamycin (mTOR) pathway in osteoclasts and osteoblasts in vitro, suggesting a dual effect on bone homeostasis. Our results demonstrate that #290 is a potential novel therapeutic tool for the treatment and/or study of diseases associated with bone destruction.
23161901 Methotrexate polyglutamation in relation to infliximab pharmacokinetics in rheumatoid arth 2013 Jun OBJECTIVE: The combination of methotrexate (MTX) with infliximab can modify infliximab pharmacokinetics and lower the incidence of antibodies against infliximab (ATIs). We hypothesised that the pharmacokinetic interaction between MTX and infliximab is related to activation of MTX to immunosuppressive MTX polyglutamates (MTXPGs). METHODS: Adult patients with rheumatoid arthritis receiving weekly MTX with infliximab for more than 3 months were enrolled in a cross-sectional study. Blood was collected at trough before the infusion of infliximab. Red blood cell (RBC) MTXPGs were measured using liquid chromatography, and circulating levels of infliximab were measured using a cell-based assay. ATIs were measured using enzyme immunoassays. Statistical analyses consisted of multiple regression and Wilcoxon tests. RESULTS: In the 61 patients enrolled in the study, ATIs were detected in 11 (18%). Regression analyses revealed that lower infliximab levels (median 3.3 µg/ml) were associated with the presence of ATIs and lower RBC MTXPG levels (median 28 nmol/l) (p<0.05). Logistic regression revealed that RBC MTXPG levels above 25 nmol/l were associated with a 4.7-fold lower likelihood of having ATIs (OR=4.7; 95% CI 1.1 to 20.8; p=0.02). None of the 12 patients with RBC MTXPG levels above 50 nmol/l tested positive for ATIs. CONCLUSIONS: These hypothesis-generating data indicate that MTXPGs are associated with infliximab pharmacokinetics and ATI formation.
22521305 Usefulness of risk scores to estimate the risk of cardiovascular disease in patients with 2012 Aug 1 Patients with rheumatoid arthritis (RA) have an excess burden of cardiovascular (CV) disease (CVD). CV risk scores for the general population may not accurately predict CV risk for patients with RA. A population-based inception cohort of patients who fulfilled 1987 American College of Rheumatology criteria for RA from 1988 to 2007 was followed until death, migration, or December 31, 2008. CV risk factors and CVD (myocardial infarction, CV death, angina, stroke, intermittent claudication, and heart failure) were ascertained by medical record review. Ten-year predicted CVD risk was calculated using the general Framingham and the Reynolds risk scores. Standardized incidence ratios were calculated to compare observed and predicted CVD risks. The study included 525 patients with RA aged ≥30 years without previous CVD. The mean follow-up period was 8.4 years, during which 84 patients developed CVD. The observed CVD risk was 2-fold higher than the Framingham risk score predicted in women and 65% higher in men, and the Reynolds risk score revealed similar deficits. Patients aged ≥75 years had observed CVD risk >3 times the Framingham-predicted risk. Patients with positive rheumatoid factor or persistently elevated erythrocyte sedimentation rates also experienced more CVD events than predicted. In conclusion, the Framingham and Reynolds risk scores substantially underestimated CVD risk in patients with RA of both genders, especially in older ages and in patients with positive rheumatoid factor. These data underscore the need for more accurate tools to predict CVD risk in patients with RA.
23244227 Cardiovascular diseases in patients with rheumatoid arthritis. 2013 OBJECTIVES: To study cardiovascular autopsy findings and the lifetime prevalence of cardiovascular diseases (CVDs) in patients with rheumatoid arthritis (RA). METHOD: In 369 RA patients and their reference cases without any rheumatic disease (non-RA), we studied CVDs recorded on autopsy reports at consecutive autopsies from 1952 to 1991. From autopsy referrals by clinicians, we recorded lifetime CVDs. In RA patients autopsied from 1973, we evaluated clinical data. RESULTS: From 1952 to 1991, RA patients had, compared with non-RA, myocardial infarction (MI; 26% vs. 41%) and cerebral infarction (14% vs. 28%) less frequently but cardiac amyloidosis (28% vs. 3%), pericarditis (27% vs. 8%), and diffuse myocardial abnormality (21% vs. 11%) more frequently reported at autopsy. Of RA patients autopsied from 1973, 40% had had a diagnosis of congestive heart failure (CHF) and coronary heart disease (CHD) during their lifetime. The RA patients with CHF had a higher mean erythrocyte sedimentation rate (ESR) than those without CHF. In RA patients, MI or myocardial abnormality at autopsy had no such correlation. In RA, male sex, ischaemic electrocardiogram changes, diabetes, hypertensive disease, and severe radiographic changes typical for RA were associated with MI detected at autopsy. No such associations emerged with respect to diffuse myocardial abnormality. When disorders potentially causing diffuse myocardial damage were excluded, RA patients had, on autopsy reports, compared to non-RA, diffuse myocardial abnormality more frequently (21% vs. 12%, p = 0.002). Cardiac amyloidosis showed no correlation to this. CONCLUSION: RA patients seem to have an increased risk for myocardial damage. The influence of inflammation on the myocardium in RA needs further studies.
22994945 Consistency of assessments and willingness to pay for a reduction in morning symptoms over 2012 OBJECTIVES: To determine the variation in morning symptoms and in the corresponding monetary equivalents assigned to their reduction. METHODS: The sampled (n = 100) rheumatoid arthritis (RA) patients were interviewed twice by a trained interviewer using the same interview, 2 weeks apart. Patients assessed fatigue, pain, and severity of morning stiffness (MS) on waking up and after maximum improvement on a numeric rating scale (NRS). Patients estimated the duration of MS in minutes and reported the number of tender and swollen joints. Patients were also asked to estimate how much they would be willing to pay on a daily basis if pain, duration of MS, and severity of MS when waking up could be reduced by 25, 50, 75, and 100%. Weighted averages of the monetary assessments for symptom reduction were computed. RESULTS: On average, the NRS values at the first and second assessments were close to each other, except for fatigue and pain, which were significantly lower (p < 0.01) in the second assessment. There was limited within-patient variation, with the majority of symptom assessments within a range of ±10%. Weighted average willingness-to-pay (WTP) estimates were consistent across time points for reduction in pain and MS severity and duration. Changes in symptom assessments were reflected in the WTP estimates. CONCLUSIONS: The duration and severity of MS seemed to be more consistent over time than pain and fatigue. WTP estimates and their changes corresponded closely to changes in symptom assessments.
22460408 Neuropsychological assessment of cognitive disorders in patients with fibromyalgia, rheuma 2012 Mar INTRODUCTION: This study assesses the possible existence of cognitive disorder associated with chronic diseases [fibromyalgia (FM), rheumatoid arthritis (RA) and lupus (SLE)], and the influence of the variables age, educational level and psychiatric symptoms on those disorders. MATERIALS AND METHODS: The patients were referred by the Rheumatology Outpatient Clinic of the Hospital Universitário de Brasília (HUB), with ages ranging from 30 to 80 years, and were divided into the following three groups: FM, 13 patients; RA, 13 patients; and SLE, 11 patients. Their performance in the neuropsychological tests of memory, language, executive functions and neuropsychiatric inventory was assessed considering their type of chronic disease, educational level and age. In addition, the cutoff points of cognitive normality of population samples were compared with the patients' performances. RESULTS: The cognitive disorders were shown to be associated with the three diseases studied, but with significant differences between them. CONCLUSION: The variables studied (low educational level and advanced age) were associated with various degrees of impairment in the different cognitive functions in the three pathological groups. However, FM and SLE groups showed significantly higher means of the neuropsychiatric symptoms of anxiety, irritability and hallucinations than the RA group in the neuropsychiatric inventory.
22388646 Intensive treatment and treatment holiday of TNF-inhibitors in rheumatoid arthritis. 2012 May PURPOSE OF REVIEW: Biologics targeting tumor necrosis factor (TNF) has revolutionized the treatment of rheumatoid arthritis (RA) and clinical remission becomes a realistic treatment goal. After achieving remission, discontinuation of TNF inhibitors may become an important issue from viewing points of safety and economy. However, there is not well established firm evidence regarding biologic-free remission. We here document whether 'treatment holiday' of TNF inhibitors is possible in RA patients, after maintaining low disease activity by intensive treatment with TNF inhibitors. RECENT FINDINGS: From European studies such as BeSt and OPTIMA in patients with early RA and Japanese studies such as RRR and HONOR in patients with established RA, after reduction of disease activity to clinical remission or low disease activity in patients with RA by infliximab or adalimumab in combination with methotrexate, some patients could successfully remain in clinical remission without TNF inhibitors for 6 months or 1 year and without radiologic and functional progression of articular destruction. SUMMARY: After maintaining low disease activity by intensive treatment with TNF inhibitors, discontinuation of TNF inhibitors without disease flare, joint damage progression and functional impairment, treatment holiday, is possible in some RA patients.
22692649 Clinical results of alendronate monotherapy and combined therapy with menatetrenone (VitKâ 2013 May OBJECTIVES: We aimed to evaluate the clinical efficacy of monotherapy with alendronate and combined therapy with alendronate and menatetrenone (vitamin K2 [VitK2]) in postmenopausal rheumatoid arthritis (RA) patients with osteoporosis or osteopenia. METHODS: Sixty-two postmenopausal RA patients with untreated osteoporosis or osteopenia (lumbar spine bone density ≤80 % of young adult mean [YAM]) were enrolled: 39 had abnormal serum undercarboxylated osteocalcin (ucOC) levels (>4.5 ng/mL) and received combined therapy with alendronate (35 mg/week) and VitK2 (45 mg/day) (ALN + K group); 23 had normal ucOC levels (≤4.5 ng/mL) and received alendronate monotherapy (35 mg/week) (ALN group). The clinical results for the 57 patients in both groups were evaluated after 1-year treatment. RESULTS: The mean baseline/follow-up (FU) lumbar spine bone density (%YAM) values were 73.0/76.8 % (P < 0.01) in the ALN + K group and 77.0/80.3 % (P < 0.01) in the ALN group; a significant increase was shown in both groups. Mean proximal femoral bone density values at baseline/FU were 71.4/73.8 (P < 0.01) in the ALN + K group and 71.4/71.6 % (not significant; NS) in the ALN group; a significant increase was shown in the ALN + K group only. Serum ucOC levels were normalized in the ALN + K group at FU. At FU, bone metabolism markers [bone-specific alkaline phosphatase (BAP) and N-terminal cross-linked telopeptides of type I collagen] were decreased in both groups. One patient in the ALN + K group and three in the ALN group suffered new fractures. CONCLUSIONS: Combined therapy with alendronate and VitK2 decreases bone metabolism marker levels and serum ucOC levels, and increases lumbar spine and femoral neck bone density in postmenopausal RA patients with abnormal ucOC levels and osteoporosis or osteopenia.
22574592 [Clinical study of Biqi Capsule combined with methotrexate for treatment of rheumatoid art 2012 Feb OBJECTIVE: To observe the clinical effects of Biqi Capsule (BQC) combined with methotrexate (MTX) for treatment of rheumatoid arthritis (RA), and to study an effective protocol of RA treated by integrative medicine. METHODS: One hundred and thirty-eight patients with RA were randomly assigned to Group I (44 cases, treated by BQC), Group II (46 cases, treated by MTX), and Group III (48 cases, treated by BQC combined with MTX). The therapeutic course for each group was 12 weeks. The degree of joint pain, the tender joint number, the tender joint index, the swollen joint number, the swollen joint index, the two-hand grip, the morning stiffness time, and related laboratory indices were observed in each group before and after treatment. The adverse reactions were recorded. RESULTS: Compared with before treatment, there was statistical difference in the degree of joint pain, the tender joint number, the tender joint index, the swollen joint number, the swollen joint index, the two-hand grip, the morning stiffness time, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and rheumatoid factor (RF) in the 3 groups (P < 0.05, P < 0.01). Besides, better results were obtained in Group III (P < 0.01). As for the inter-group therapeutic efficacy, better results were obtained in Group III (P < 0.01). The gastrointestinal discomfort was the only adverse reaction in the 3 groups. No treatment was given due to its milder symptoms without any effects on the treatment. CONCLUSIONS: BQC showed favorable effects on treating RA with no obvious adverse reaction. BQC combined with MTX showed better clinical efficacy than use of BQC or MTX alone. It could reduce the adverse reactions of MTX. BQC combined with MTX could reduce the toxic reactions and enhance the therapeutic effects, indicating it was an effective treatment program for RA.