title: Clinical analysis of chinese patients with rheumatoid arthritis treated with leflunomide and methotrexate combined with different dosages of glucocorticoid.
abstract: OBJECTIVE
  To analyze the safety of combined leflunomide (LEF), methotrexate (MTX), and glucocorticoid (GC) therapy, we investigated the adverse effects of such combination therapy in patients with early active rheumatoid arthritis (RA).
  
  
  METHODS
  Two hundred sixty-six patients with RA who were receiving LEF and MTX therapy were randomly assigned to 3 groups, as follows: group 1 received no GC, group 2 received 7.5 mg prednisone, and group 3 received 15 mg prednisone. Adverse effects were analyzed using the χ(2) test at week 4 or the Fisher exact test at week 12.
  
  
  RESULTS
  Patients in group 1 had a higher incidence of skin rash, oral ulcers, leukopenia, and liver damage than did those in groups 2 and 3 (all, P ≤ 0.05). However, the rates of osteoporosis, diabetes, hyperlipidemia, and hypertension in group 3 were statistically higher than in groups 1 and 2 (P ≤ 0.05).
  
  
  CONCLUSIONS
  In the treatment of RA, the incidence of skin rash, liver dysfunction, and oral ulcers may be decreased with combination therapy using LEF, MTX, and 7.5 mg prednisone, and blood pressure, blood glucose concentration, and bone density are not increased. Most important, 7.5 mg prednisone was synergistic with LEF and MTX, and such combination therapy could be a useful option as initial treatment of early active RA.
authors.affiliation: Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: Cong-Zhu
authors.initials: CZ
authors.lastname: Ding
authors.affiliation: Department of Pharmacy, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Yao
authors.affiliation: Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: Xue-Bing
authors.initials: XB
authors.lastname: Feng
authors.affiliation: Department of Pharmacy, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Fang
authors.affiliation: Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: Cheng
authors.initials: C
authors.lastname: Zhao
authors.affiliation: The First Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Wang
keywords: adverse reactions; glucocorticoid; leflunomide; methotrexate; rheumatoid arthritis