Methylprednisolone In The Treatment Of Rheumatoid Arthritis Clinical Studies

Objective:1.To assess the clinical efficacy and safety of methylprednisolone(MP) in active rheumatoid arthritis(RA);2.To understand the change of RA disease activity after MP therapy.Methods:This was a 24-week,open-lable,clinical trial.30 patients of active RA were treated with 165～500 mg per day,3～4 times per week on the first,the second,the third week and followed up every 3 weeks.The primary end point was proportion of ACR20 responders.The secondary end point was proportion of ACR50,ACR70 responders.The efficacy and safety were assessed.Results:(1)At week 1,63.3%of patients of MP treatment reached the primary end point of ACR20.The percent of patients achieving the secondary end points of ACR50,ACR70 were 23.3%and 10%.The percent of patients achieving ACR20,ACR50 and ACR70 were 83.3%, 56.7%and 40%at week 2.The peak percent of patients achieving ACR20,ACR50 and ACR70 were observed at week 3,86.7%and 73.3%respectively.The rate of reaching ACR20 was significant higher at week 1,2,3 than week 0(P＜0.05～0.01).Improvements over base-line values for measures including patient's assessment of pain,physician's global assessment, PGA,HAQ,tender joint score,swollen joint score,ESR/CRP,were significantly decreased at week 1,2,3(P＜0.05～0.01).(2)There were no serious adverse reactions.The incidence of MP related adverse event was 20%.The intensity of all adverse events was rated as mild or moderate and transient during the whole study.(3)30 patients were followed up.46.67%patients felt that symptom aggravated then before at the first consultation.Two patients of the total(6.67%) relapsed.The percent of patients who relapsed within 2,3and 6 months were 16.67%,16.67%and 10%respectively.Conclusion:1.Treatment with MP resulted in rapid and significant improvement in patients with active RA;2.MP was safe and well tolerated,there were no serious adverse reactions;3.After MP treatment,the patients who relapsed were less.