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Chinese Remedies & Clinics ,August 2002 ,Vol 2 ,No. 4 A randomised clinical trial on nimesulide2methotrexate combined therapy of adult2onset Still s disease
LIANG Liuqin , Xu Hanshi , ZHAN Zhongping , YE Yujing. Department of Rheumatology and clinical Immunlolgy , The First Affiliat2 ed Hospital , Zhongshan University , Guangzhou 510080 ,China Abstract
To explore the effect of a combined therapy of nimesulide and methotrexate in comparison with the corticosteroid therapy in adult2onset Still s disease (AOSD) . Methods
Sixty2eight consecutive patients of AOSD in the teaching hospital from 1996 to 2000 were randomly assigned to the combined therapy (35) or corticosteroid therapy (33) . The combined therapy comprised nimesulide 100 mg twice daily and methotrexate 10 mg weekly. Corticosteroid therapy was prednisone 015 mg per kg body weight. The corticosteroid dose was increased to prednisone 110 mg per kg body weight if the fever was not controlled with2 in 3 days. Methylprednisolone pulse with 500 mg daily for three days would be given ,and then pretydnisone 110 mg per kg body
weight and azathiopurine 50 mg twice daily be given if the patients did not respond to the corticosteroid therapy alone.Results
Twenty2four cases of the combined therapy group returned their temperature to normal within 24 hours (7413 %) ,but only 9 cases (2713 %) of the corticosteroid group did ( 2 = 31887 , P = 01000 1) . The combined group had 28 cases (8010 %) returning their temperature normal in the first week ,while the corticosteroid group had 19 cases (5716 %) ,having a significant difference ( 2 =21000 , P = 01045 5) . The combined therapy showed greater antipyretic potency than the corticosteroid therapy by a Kaplan2Meierestimate ,log2rank test ( 2 = 6110 , P = 01013 5) . The probability of fever relapse during the following up was 20 % in the com2bined therapy and 50 % in the corticosteroid therapy from the Kaplan Meier estimate ,log2rank test ( 2 = 4136 , P = 01036 8) .
There were significant differences between the two therapies in erythrocyte sedimentation rates ,C reactive protein ,leukocyte counts and serum ferritin levels at the points of 3 months and 6 months after treatment ,t test all P values < 01001. After a six2month ther2 apy 19 cases (5413 %) of the combined group could discontinue the medication ,but only 7 cases (2112 %) of the corticosteroid group did ( 2 = 4136 , P = 01005) . Side effects included 35 cases of hyperhidrosis in combined group ,18 cases in corticosteroidgroup ;2 cases of hepatic injury in combined group ,1 case in corticosteroid group ; and 2 cases of herpes zoster in corticosteroid group ,but none in the combined guoup . 2 patients in the combined therapy and 1 patient in the corticosteroid therapy had a tran2
sient increase in aminotransferase. Conclusion
The combination of nimesulide and methotrexate is an effective therapy in AOSD.
The research demonstrated that the combined therapy is better than and might replace the corticosteroid therapy.
Key words
Still s disease ,adult2onset ; Nimesulide ; Methotrexate ; Glucocorticoids Chinese Remedies & Clinics ,August 2002 ,Vol 2 ,No. 4 Chinese Remedies & Clinics ,August 2002 ,Vol 2 ,No. 4 Chinese Remedies & Clinics ,August 2002 ,Vol 2 ,No. 4 Masson C ,Le Loet X ,Liote F ,et al . Adult Still s disease. Part II. Man2 agement ,outcome ,and prognostic factors. Rev Rhum Engl Ed ,1995 ,62 Yamaguchi M ,Ohta A ,Tsunematsu T ,et al . Preliminary criteria for clas2 sification of adult Still s disease. J Rheumatol ,1992 ,19 (3) :42424301 Vignes S , Wechsler B ,Amoura Z ,et al . Intravenous immunoglobulin in adult Still s disease refractory to non2steroidal anti2inflammatory drugs.
Clin Exp Rheumatol ,1998 ,16 (3) :29522981 Jung J H ,Jun JB , Yoo DH ,et al . High toxicity of sulfasalazine in adult2 onset Still s disease. Clin Exp Rheumatol ,2000 ,18 (2) :24522481 Marchesoni A , Ceravolo GP ,Battafarano N ,et al . Cyclosporin A in the treatment of adult onset Still s disease. J Rheumatol ,1997 ,24 (8) :15822 Aydintug AO ,D Cruz D ,Cervera R ,et al . Low dose methotrexate treat2 ment in adult Still s disease. J Rheumatol ,1992 ,19 (3) :43124351 Fautrel B ,Borget C , Rozenberg S ,et al . Corticosteroid sparing effect of low dose methotrexate treatment in adult onset Still s disease. J Rheuma2 diseases. Rheum Dis Clin North Am ,1997 ,23 (4) :85528821 Ulukol B , Koksal Y , Cin S. Assessment of the efficacy and safety of paracetamol ,ibuprofen and nimesulide in children with upper respiratory tract infections. Eur J Clin Pharmacol ,1999 ,55 (9) :61526181


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