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The first part of methylprednisolone in the treatment of refractory ankylosing spondylitis clinical research purposes: 1. Evaluation of methylprednisolone (MP), short-term treatment of refractory ankylosing spondylitis (AS), the clinical efficacy and safety sex; 2. understand the the MP short term treatment AS patient's condition changes. Methods: In this study, two centers open clinical study, patients are in line with the revised AS 1984 New York diagnostic criteria, and after traditional treatment, the disease is active period, ie BASDAI ≥ 4 and spinal pain score ≥ 4 and ESR ≥ 30mm / hour, CRP ≥ upper limit of normal 1.5 times the screening subjects 4 weeks unused DMARDs drug (e.g., sulfasalazine or methotrexate, etc.). Patients accept intravenous infusion MP250 to 500 mg / d, respectively, in the 1, 2, and 3 weeks (30 cycles), once every 3 to 4 days for a course of treatment, respectively, at weeks 0, 1, 2, 3, and after every 3 week follow-up assessment of patients up to 24 weeks. The primary efficacy endpoint was achieve ASAS20 the proportion of patients, secondary outcome measures to achieve clinically significant proportion of patients, compared to baseline BASDAI and BASFI BASMI, spinal pain, night pain, spinal inflammation, patient global assessment index tendon end index The overall joint swelling index, quality of life and health questionnaire SF-36 to improve the situation. Results: 1. Efficacy results of the assessment: the end of the 1st MP treatment, that is, 90.24% (n = 37) of patients reach ASAS20 reaction, 51.21% (n = 21) of patients achieved the BASDAI score improvement is greater than 50%; the MP treatment after three courses, achieve the ASAS20 patients accounted for 95.12% (39 cases), the BASDAI score improvement greater than 50% of patients accounted for 92.68% (38 cases), erythrocyte sedimentation rate, C-reactive protein and BASFI, BASMI and other clinical indicators improved significantly . Security assessment results: 10 patients with treatment-related side effects, side effects often occurs at 2-3 times MP treatment, skin acne patients; 3 patients lower limbs edema; patients during treatment appears cough, sputum; one patient had an upset stomach, gastroscopy showed no abnormal; the patients appear blurred eyes, were given symptomatic treatment or after discontinuation improved. Long-term follow-up results: after MP treatment to reach ASAS20 efficacy indicators 39 patients follow-up observation of relapse in patients with recurrence was defined as BASDAI score ≥ 80% of the baseline value. The results showed: 51.28% of the patients symptoms over the previous three weeks referral heavier, including 2 cases (5.13%) in patients with relapsed, 7.69%, 12.8% and 5.13% of the patients relapse within 2,3,6 months. Conclusion: 1.MP can quickly and significantly improve the AS patients with clinical signs and symptoms, and improve the function of the AS patients, the range and quality of life. After a course of treatment in patients with clinical symptoms improved ,3-4 treatment most obvious symptoms basic control. 2 short-term, intermittent treatment of the AS given small doses of MP appear related adverse reactions, adverse reactions appear in the first 2-3 months after treatment, given symptomatic treatment or discontinuation better. Disable MP treatment, a small number of patients relapse, recurrence have hip involvement, with the immunosuppressant onset, reducing the proportion of recurrence, the majority of patients with stable condition. The traditional treatment is poor or severe illness AS patients can choose the MP quickly relieve symptoms. Interleukin-6, the second part of a role in the pathogenesis of ankylosing spondylitis disease activity and treatment evaluation purposes: 1. Ability to explore the plasma IL-6 levels as AS disease activity and efficacy assessment indicators. 2. Explore the relevance of the IL-6 gene-174G / C polymorphism with AS and AS disease activity. Methods: 1. Assessment of 80 patients with AS disease activity in patients with clinical indicators: Bath AS Disease Activity Index (BASDAI) BathAS Functional Index (BASFI) BathAS measure index (BASMI), spinal pain, night pain, spinal inflammation, tendon index, the overall joint swelling index and quality of life, detected 80 cases of AS disease activity in patients with laboratory parameters: ESR, CRP, PLT; enzyme-linked immunosorbent assay (ELISA) to detect the 80 AS patients and 20 normal subjects serum IL-6 levels, differences in comparative case group and the normal control group, serum IL-6 levels, and clinical indicators of AS serum IL-6 levels and AS disease activity at baseline laboratory parameters related analysis; 3. 41 cases the AS of serum IL-6 levels before and after the detection of MP treatment, comparing patients before treatment, after plasma IL-6 levels change; 4 by polymerase chain reaction and restriction fragment length polymorphism (PCR-RFLP) methods to detect the IL-6 gene promoter region of the 80 patients with AS and 52 normal bit -174 single nucleotide polymorphisms (single-nucleotide polymorphism, SNP) G / C, and AS disease The activity indicators correlation analysis. Results: the average age of the case group and the normal control group were the case group 29 ± 10.4 and 28.1 ± 8.7, male 69 cases, male 45 cases in the control group, age, gender composition of the patient group compared with the control group no significant difference . Normal control group, serum IL-6 level was 0.91 ± 0.42 MP before and after treatment of 41 cases of patients with AS of serum IL-6 levels were 24.68 ± 34.64 and 9.78 ± 24.03, significantly decreased, but still higher than normal control group. Correlation analysis show baseline serum IL-6 levels and functional status in patients with BASFI, ESR and CRP significantly related; related physiological function and quality of life. The case group and the control group, the GG genotype and the frequency of the control group were 96.25% and 96.15% of the case group and the GC genotype frequency of the control group were 3.75% and 3.85%, the the cases group's GG and GC genotype frequency and G allele frequency compared to the control group was not statistically significant. Conclusions: AS patients with baseline serum IL-6 levels significantly higher than the normal control group, and patients with AS BASFI, ESR and CRP related; related physiological function and quality of life. IL-6 levels after treatment with the other efficacy variables improved significantly decreased. IL-6 gene-174G / C with ankylosing spondylitis correlation.
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