Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.</p><p><b>METHODS</b>A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (< 48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).</p><p><b>RESULTS</b>Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).</p><p><b>CONCLUSIONS</b>Etoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).</p>

Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis: a double blind, randomized, placebo-controlled and multicenter trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>A novel anti-rheumatic drug, T-614, has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis (RA). To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients.</p><p><b>METHODS</b>In a multicenter, randomized, double blind, placebo controlled study, 280 patients were randomly assigned to receive placebo (n = 95) or T-614 at 50 mg (n = 93) or 25 mg (n = 92) daily. Active disease was defined by 4 of the following 5 criteria: >or= 5 tender joints, >or= 3 swollen joints, morning stiffness lasting for >or= 60 minutes, and Westergren erythrocyte sedimentation rate (ESR) >or= 28 mm/h, the assessment of pain at the rest by patient as moderate or severe. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 24 was the American College of Rheumatology (ACR) response rate using the intent-to-treat population.</p><p><b>RESULTS</b>The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo (P < 0.0001), and the 50 mg/d dose compared to the 25 mg/d dose (P < 0.05) when using the ACR response analyses after 24 weeks. ESR and c-reactive protein (CRP) were significantly different in the treatment groups after 24 weeks. The incidence of adverse events (AEs) was not significantly higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, elevated serum alanine aminotransferase (sALT), skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups.</p><p><b>CONCLUSION</b>T-614, a new slow-acting drug, is effective in treatment of rheumatoid arthritis and is well tolerated.</p>

Treatment of rheumatoid arthritis with T-614:a multicenter,randomized,double blind,placebo-controlled trial / 中华风湿病学杂志

Objective To study the efficacy and safety of T-614 in treating rheumatoid arthritis(RA). Methods Two hundred and eighty patients with active RA were randomly allocated to 3 groups:T-614 50 mg each day,25 mg each day or placebo.Clinical and laboratory parameters were analyzed at baseline,2,4,6,12, 18 and 24 weeks.Results The ACR response rate was significantly higher in the T-614 treatment group com- pared with the placebo group during the first 6 weeks.After 24 weeks,25 mg/d,50 mg/d dosage group and the placebo group showed 39.1%,61.3% and 24.2% in ACR20,23.9%,31.2% and 7.4% in ACR50 respectively.A time-response in ACR response after 24 weeks was observed,with clear superiority of the 25 mg/d and 50 mg/d dosage groups compared to the placebo,and 50 mg/d dosage group compared to 25 mg/d dosage group(P

Expression and role of the inducible costimulator (ICOS) in patients with rheumatoid arthritis / 中华风湿病学杂志

Objective To assessed the expression of inducible costimulator(ICOS)on peripheral blood and joint fluid CD4,CDS,CD45RO T cells and B cells in rheumatoid arthritis(RA).Methods Expression of ICOS and ICOS/CD45RO on peripheral blood and joint fluid CD4~+CD8~+T cells and ICOS ligand(ICOSL)on CD19 B cells from RA patients and healthy volunteers were determind by three-color flow cytometry.Compar- ision with active and inactive RA,initial and relapsed RA had been done.Results Joint fluid CD4 and CD8 T cells expressing ICOS,ICOS/CD45RO were significantly increased than peripheral blood in RA patients and healthy subjects.Joint fluid B cells expressing ICOSL were significantly reduced than peripheral blood in RA patients.Meanwhile,peripheral blood B cells expressing ICOSL were significantly reduced in active RA than inactive RA patients.Conclusion Hyperexpression of ICOS and ICOS/CD45RO on joint fluid CD4 and CD8 T cells and lowexpression of ICOSL in B cells from RA patients,expecially in active RA may contribute to the local immunopathological roles and joint destructions in the pathogenesis of RA.

Clinical study on effect of Agkistrodon antithrombogenase in auxiliary treatment of rheumatoid arthritis / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the clinical effect of Agkistrodon antithrombogenase (AAT) in the treatment of rheumatoid arthritis (RA) and its possible mechanism.</p><p><b>METHODS</b>Besides the conventional non-steroid anti-inflammatory agents and disease-modifying anti-rheumatic drug, patients were treated supplementally with intravenous injection of AAT. The intracutaneous test showed allergic to AAT patients were treated with Salvia injection and taken as control group. Changes of related clinical indexes in the two groups were observed.</p><p><b>RESULTS</b>After 3 weeks treatment, condition of patients in both groups were improved clinically in joint swollen index, joint tenderness index, morning stiffness time, pain assessment (VAS) and health assessment questionnaire (HAQ) on daily life activity as well as ESR level (P < 0.05 or P < 0.01), with the VAS, HAQ and fibrinogen levels more significantly improved than those of control (P < 0.05 or P < 0.01), and the total effective rate higher in the AAT treated group than those in the control group (P < 0.05).</p><p><b>CONCLUSION</b>AAT has good effect on easing clinical symptoms of RA possibly through anti-inflammation and improving the microcirculation with less toxic and adverse reaction, so is worthy of recommendation.</p>

Methotrexate for hip involvement of ankylosing spondylitis:a clinical study / 中华风湿病学杂志

Objective To evaluate the efficacy and safety of methotrexate(MTX)on the hip involve ment in patients with ankylosing spondylitis(AS).Methods Among the AS patients with hip joint involvement admitted to the department from 1999—2002,50 patients were treated with sulfasalazine(SSZ)(control group, CG)and 48 MTX(observation group,OG).One kind of NSAIDs was taken by the patients in both groups as the basic therapy.The treatment was maintained in both groups after being discharged.Patients were followed-up for three years.The observation parameters included symptoms,signs,Bath AS disease activity index(BASDAI), Bath AS functional index(BASFI),hip joint function score,the CT staging of hip joint involvement,serum in- flammation markers,laboratory tests and side effects.The data were analyzed with SPSS10.0 statistics software. Results At the 1st,2nd and 3rd year,44,38 and 32 cases in the OG and 45,38 and 31 cases in the CG were followed up respectively.During the three-year follow-up period,the hip joint function score of the OG was significantly higher than that of the CG(P