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Objective:The aim of this study was to compare the efficacy and safety of iguratimod (IGU) or leflnomide (LEF) in combination with methotrexate (MTX) in patients with active rheumatoid arthritis (RA).Methods:This was a multicenter, randomized, double-blinded, double dummy and controlled clinical trial. Patients with moderate or high active RA were randomized in a 1∶1 ratio to receive IGU+MTX (Group A) or LEF+MTX (Group B) treatment. The efficacy and safety were assessed at week 12, 24 and 52, respectively. The primary endpoint was the American Colleague of Rheumatology 20 (ACR20) response rates at the 52th week. Pearson chi square test and two-way Analysis of Variance (ANOVA) were used to compare the improve- ment of ACR20 and DAS28 at 52 weeks. Pearson chi square test or Fisher exact probability test were used to compare the ACR 20 and ACR70 rate between the two groups after treatment. The measurement data of the two groups were compared by independent sample t-test or nonparametric test. Results:A total of 240 RA patients were enrolled in the present study. As a result, 84.1% and 81.0% of patients achieved ACR20 criteria at the 52th week in Group A and Group B, respectively ( χ2=0.35, P=0.56). And the ACR50/70 response rates, disease activity score 28 (DAS28), simplified disease activity index (SDAI) and the absolute decrease of DAS28 from baseline were not statistically different between the two groups at week 12, 24 and 52. The rates of adverse events were lower in Group A than those in Group B (60.0% vs 79.0%, P<0.01). The elevations of glutamic pyruvic transaminase/glutamic oxalacetic transaminase levels, concomitant use of hepatinica and white blood cell decrease were more common in Group B ( P<0.05). Conclusion:IGU in combination with MTX is an efficacious and safe treatment regimen, which is comparable in efficacy in control active RA but superior in safety to LEF combined with MTX.
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Objective To explore the role of health management in the treatment of rheumatoid arthritis combined with osteoporosis.Methods A total of 140 women with postmenopausal osteoporosis and rheumatoid arthritis were enrolled in this 12-month randomized controlled study and randomly assigned to receive drug therapy ( group A,n =70 ) or drug therapy + health management ( group B,n =70 ).Bone mineral density (BMD) of the forearm,lumbar spine and hip was measured by using dual-X-ray absorptiometry at baseline and 12 months after the intervention.The rates of fractures were calculated at 12months.Results BMD of the forearm,lumbar spine and hip of both groups were significantly increased at 12 months (group A:0.50 ± 0.13,0.78 ± 0.15 and 0.68 ± 0.14,respectively,all P ＜ 0.05; group B:0.54± 0.14,0.80 ± 0.12 and 0.73 ± 0.15,respectively,all P ＜ 0.05 ).The elevation of BMD and therapy compliance of group B were significantly higher than those of group A ( P ＜ 0.05 ),while the rate of fracture was relatively lower.Conclusions Health management can significantly improve patient compliance and medication efficacy.
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Objective To establish new classification criteria for early rheumatoid arthritis (E-RA) based on large samples of early inflammatory arthritis patients and to evaluate the value of this criteria in China.Methods Patients who had arthritic complaints with disease duration less than one year were enrolled.They were divided into RA group and non-RA group according to the clinical diagnosis by experienced rheumatologists.The clinical and laboratory parameters were analyzed and those with high sensitivity or specificity were selected as the new classification criteria.Statistical analysis was carried out by using t test,x2 test and Logistic regression.Results ① A total of 803 patients with early inflammatory arthritis were included in this study.Five hundreds and fourteen patients were diagnosed as early RA and 251 were diagnosed as other rheumatic diseases,and the diagnosis of 38 patients remained unestablished by the end of follow-up.② New E-RA classification criteria were established based on the parameters with high sensitivity and/or specificity.The sensitivity of the new E-RA criteria was 84.4％,which was higher than 1987 ACR criteria (58.0％),while the corresponding specificities were similar,which were 87.4％ and 93.6％ respectively.③ Compared with the complex scoring system of 2010 ACR/EULAR criteria,the E-RA criteria was more simple and practical.The diagnostic sensitivity and specificity of E-RA criteria were higher than those of 2010 ACR/EULAR criteria reported in the literatures.④ New classification criteria based on scoring system using Logistic regression analysis was established.The sensitivity of this criteria was 86.4％,which was higher than 1987 ACR criteria (58.0％).Conclusion The diagnostic value of the E-RA criteria developed in this study for early RA is better than 1987 ACR criteria,and is more simple than 2010 ACR/EULAR criteria.It may be used as a new classification criteria for early RA diagnosis.
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Objective To study the expressions of IGF-Ⅰ and TGF-?1 in lung tissue of rats with pulmonary fibrosis.Methods Sixty male Wistar rats were randomly divided into two groups: control group(n=20) and experimental group(n=40),and poured respectively by saline and bleomycin solutions,and killed on the 7th,14th,21th,28th day.Immunohistochemistry method was used to analyze the expressions of IGF-Ⅰ and TGF-?1 in lung tissue.Results After 4 weeks induction by bleomycin solutions,the lung tissue was obtained and stained by HE,the pathological changes were in accordance with pulmonary fibrosis.Pulmonary interstitial fibers were found by VG staining.So lung fibrosis models induced by bleomycin were set up successfully.The expressions of IGF-Ⅰ and TGF-?1 were increased during the progression of pulmonary fibrosis.Excellent differences of percentage of positive cells and expression level of IGF-Ⅰ and TGF-?1 were found between control group and experimental group(P
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Objective:To explore the role of Foxp3 expressing regulatory T cells in the initiation and development of rheumatoid arthritis(RA) and its correlation with clinical features of the disease.Methods:Total RNA isolated from PB in 25 RA treated patients, 25 RA untreated patients and 30 health volunteers was reversely transcribed into cDNA. The real-time-fluorescence quantitative PCR method was used to analyze the expression level of Foxp3 mRNA. The level of Anti-CCP antibody, CRP, ESR and RF of the patients were detected at the same time.Results:The level of Foxp3 mRNA from RA group was significantly lower than that of controls(P