title: The safety and effectiveness of a chloroform/methanol extract of Tripterygium wilfordii Hook F (T2) plus methotrexate in treating rheumatoid arthritis.
abstract: OBJECTIVE
  The objective of the study was to assess the safety and effectiveness of the chloroform/methanol extract of Tripterygium wilfordii Hook F (T2) plus methotrexate (MTX) in treating patients with rheumatoid arthritis (RA).
  
  
  METHODS
  One hundred sixty-six patients with RA, who started the combination therapy of T2 (20 mg b.i.d. or t.i.d.) and MTX (10-12.5 mg/wk), were enrolled, and these patients were followed up for at least 1 year. Demographics, disease severity, markers of disease activity before and after the combination therapy, and incidence of adverse events were evaluated.
  
  
  RESULTS
  The patients were predominantly female (n = 134, 81%) with a mean age of 58.0 (SD, 7.9) years (range, 39-79 years) and a mean disease duration of 55.0 (SD, 72.2) months (range, 0-456 months). A total of 161, 161, 146, and 85 patients had received at least 1, 3, 12, and 24 months of the combination of T2 and MTX, with a total of 4162 patient-months' exposure to the combination therapy. The combination therapy reduced tender and swollen joint counts, morning stiffness, inflammatory indices such as ESR and CRP, and improved disease activity as measured by the DAS28 significantly by 3 months as well as 12 months (P < 0.05). Most of the adverse events noted during this study were mild. Menstrual irregularity occurred in 72.7% (16/22) of premenopausal female. Only 10 (6.0%) and 8 (4.8%) subjects withdrew because of adverse events or lack of efficacy, respectively. Severe infections were very rare.
  
  
  CONCLUSIONS
  T2 plus MTX is an effective and relatively safe treatment for RA patients.
authors.affiliation: Dpartment of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
authors.forename: Wen
authors.initials: W
authors.lastname: Zhang
authors.forename: Qun
authors.initials: Q
authors.lastname: Shi
authors.forename: Li-Dan
authors.initials: LD
authors.lastname: Zhao
authors.forename: Yang
authors.initials: Y
authors.lastname: Li
authors.forename: Fu-Lin
authors.initials: FL
authors.lastname: Tang
authors.forename: Feng-Chun
authors.initials: FC
authors.lastname: Zhang
authors.forename: Xuan
authors.initials: X
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy*; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000378:metabolism; D002725:Chloroform; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D000432:Methanol; D008727:Methotrexate / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome; D029757:Tripterygium
chemical_list: D018501:Antirheumatic Agents; D010936:Plant Extracts; D002725:Chloroform; D002097:C-Reactive Protein; D000432:Methanol; D008727:Methotrexate