title: [Treatment of Refractory Rheumatoid Arthritis by Huayu Tongbi Recipe Combined Methotrexate].
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of Huayu Tongbi Recipe (HTR) combined methotrexate (MTX) in treating refractory rheumatoid arthritis (RRA).
  
  
  METHODS
  Totally 167 RRA patients were assigned to the treatment group (73 cases) and the control group (94 cases) according to different therapeutic methods. Patients in the treatment group were treated with HTR combined MTX, while those in the control group were treated with leflunomide (LEF) combined MTX. Clinical signs and symptoms, RF, CRP, ESR, disease activity score 28 (DAS28), and safety indicators were compared between the two groups before treatment, at week 12 and 24 after treatment. The efficacy and safety indices were also evaluated.
  
  
  RESULTS
  At week 12 after treatment the total effective rate was 82.2% (60/73 cases) in the treatment group and 79.8% (75/94 cases) in the control group, showing no statistical difference between the two groups (chi2 = 0.15, P > 0.05). At week 24 after treatment the total effective rate was 78.1% (57/73 cases) in the treatment group and 755% (71/94 cases) in the control group, showing no statistical difference between the two groups (chi2 = 0.15, P > 0.05). There was statistical difference in the total effective rate between week 24 and week 12 in the control group (chi2 = 0.49, P < 0.05). Clinical signs and symptoms, RF, CRP, ESR, and DAS28 were significantly improved in the two groups after 12- and 24-week treatment (P < 0.01). There was no statistical difference in the improvement at week 12 after treatment between the two groups (P > 0.05). There was statistical difference in time of morning stiffness, tender joint numbers, swollen joint numbers, patient global assessment, RF, CRP, and DAS28 at week 24 after treatment between the two groups (P < 0.05). Besides, adverse reactions occurred less in the treatment group than in the control group (P < 0.01).
  
  
  CONCLUSIONS
  The efficacy of HTR combined MTX was equivalent to that of LEF (10 mg per day) combined MTX, but with more stable therapeutic effects and less adverse reactions.
authors.forename: Xiu-min
authors.initials: XM
authors.lastname: Chen
authors.forename: Run-yue
authors.initials: RY
authors.lastname: Huang
authors.forename: Jing-yao
authors.initials: JY
authors.lastname: Yan
authors.forename: Zhi-hong
authors.initials: ZH
authors.lastname: Liu
authors.forename: Yong-liang
authors.initials: YL
authors.lastname: Chu
authors.forename: Qing-chun
authors.initials: QC
authors.lastname: Huang
mesh_terms: D018501:Antirheumatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D018771:Arthralgia; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007555:Isoxazoles; D000077339:Leflunomide; D008727:Methotrexate / Q000494:pharmacology / Q000627:therapeutic use*; D008517:Phytotherapy; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D004365:Drugs, Chinese Herbal; D007555:Isoxazoles; D000077339:Leflunomide; D008727:Methotrexate