60764
document
[ Treating rheumatoid arthritis patients of Shen deficiency and cold invading syndrome by bushen quhan zhiwang decoction combined methotrexate : an evaluation of clinical efficacy and safety ] . OBJECTIVE To evaluate the clinical efficacy and safety of bushen quhan zhiwang decoction ( BQZD ) combined methotrexate ( MTX ) in treating rheumatoid arthritis ( RA ) . METHODS A prospective , randomized controlled study was carried out . RA patients of Shen deficiency and cold invading syndrome in the treatment group ( 120 cases ) were treated with BQZD and MTX ( 10 mg/week ) , while those in the control group ( 120 cases ) were treated with MTX ( 10 mg/week ) alone . The therapeutic course for all was 24 weeks . The efficacy and safety indices were evaluated at the baseline and 24 weeks after treatment , including clinical signs and symptoms , condition assessment , Health Assessment Questionnaire ( HAQ ) , disease activity index 28 ( DAS28 ) , laboratory parameters of erythrocyte sedimentation rate ( ESR ) and C-reactive protein ( CRP ) , safety indicators , and Chinese medical syndrome integrals . RESULTS The total effective rate was 80 . 0 % in the treatment group , better than that of the control group ( 66.7 % ) , showing statistical difference ( P < 0.01 ) . In the two groups significant improvement of clinical signs and symptoms , ESR , CRP , visual analogue scale ( VAS ) by both physicians and patients , HAQ , DAS28 , and Chinese medical syndrome integrals after treatment were shown ( P < 0.01 ) . Better effects were obtained in the treatment group in lessening tender joint numbers and swollen joint numbers , VAS by both physicians and patients , DAS28 , and Chinese medical syndrome integrals ( P < 0.05 ) . Besides , adverse reactions occurred less in the treatment group than in the control group ( P < 0.05 ) . CONCLUSIONS BQZD had roles in relieving symptoms , improving joint functions , signs , ESR , and CRP . It was an effective herb for RA patients of Shen deficiency and cold invading syndrome . It could enhance the efficacy and reduce adverse reactions of MTX through synergistic effects with MTX .
60765
Intervention_Pharmacological
bushen quhan zhiwang decoction combined methotrexate
60766
Intervention_Pharmacological
bushen quhan zhiwang decoction ( BQZD ) combined methotrexate ( MTX )
60767
Intervention_Pharmacological
BQZD and MTX ( 10 mg/week )
60768
Intervention_Pharmacological
treated with MTX ( 10 mg/week ) alone
60769
Intervention_Pharmacological
BQZD
60770
Outcome_Physical
clinical signs and symptoms
60771
Outcome_Physical
condition assessment
60772
Outcome_Physical
Health Assessment Questionnaire ( HAQ )
60773
Outcome_Physical
disease activity index 28 ( DAS28 )
60774
Outcome_Physical
laboratory parameters of erythrocyte sedimentation rate ( ESR )
60775
Outcome_Physical
C-reactive protein ( CRP )
60776
Outcome_Physical
safety indicators
60777
Outcome_Physical
Chinese medical syndrome integrals
60778
Outcome_Physical
clinical signs and symptoms
60779
Outcome_Physical
ESR
60780
Outcome_Physical
CRP
60781
Outcome_Physical
visual analogue scale ( VAS )
60782
Outcome_Physical
HAQ
60783
Outcome_Physical
DAS28
60784
Outcome_Physical
tender joint numbers
60785
Outcome_Other
and
60786
Outcome_Physical
swollen joint numbers