80842
document
Corticosteroids plus pulse cyclophosphamide and plasma exchanges versus corticosteroids plus pulse cyclophosphamide alone in the treatment of polyarteritis nodosa and Churg-Strauss syndrome patients with factors predicting poor prognosis . A prospective , randomized trial in sixty-two patients . OBJECTIVE To define the most effective treatment for severe polyarteritis nodosa ( PAN ) and Churg-Strauss syndrome ( CSS ) and to investigate the indication for plasma exchange treatment . METHODS We conducted a prospective , randomized , multicenter trial in which 62 patients were randomly assigned to receive either prednisone plus cyclophosphamide ( intravenous bolus ) ( group A ; n = 28 ) or prednisone plus cyclophosphamide ( intravenous bolus ) plus plasma exchanges ( group B ; n = 34 ) as first-line treatment for severe PAN or CSS . Factors predicting poor prognosis were renal symptoms , gastrointestinal tract involvement , cardiomyopathy , central nervous system involvement , weight loss > 10 % of body weight , and age > 50 years old . Patients with hepatitis B virus-related PAN were not included in this study . The end point of the study was control of the disease ( recovery or remission ) or death . RESULTS Clinical symptoms and laboratory findings did not differ significantly in the 2 groups . Initial control of the disease was similar in both groups . Relapse after initial control of the disease was observed in 7 patients ( 4 in group A and 3 in group B ) . The mean +/- SD followup period was 31.1 +/- 20 months for group A and 35.9 +/- 16.8 months for group B . At 5 years of followup , 38 patients ( 61.3 % ) were cured ( 16 in group A and 22 in group B ) , and 5 ( 8.1 % ) were in remission without treatment but had not yet completed the cure-defining period of 18 months ( 3 in group A and 2 in group B ) . Eight ( 12.9 % ) ( 2 in group A and 2 in group B ) were considered to be in clinical remission and required a maintenance regimen of low-dose corticosteroids . Eleven patients died during the study period ( 7 in group A [ 25 % ] , 4 in group B [ 11.8 % ] ) . Uncontrolled vasculitis was responsible for 4 deaths ( 2 in each group ) , and treatment side effects caused the death of 1 patient in group A . There was no significant difference between the 5-year cumulative survival rates of the 2 groups ( 75 % and 88 % , respectively ) . CONCLUSION Based on our data , combined treatment with prednisone , cyclophosphamide , and plasma exchanges is not superior to treatment with prednisone and cyclophosphamide alone , and plasma exchanges should not be systematically proposed for initial treatment of severe PAN or CSS .
80843
Intervention_Pharmacological
Corticosteroids plus pulse cyclophosphamide and plasma exchanges
80844
Intervention_Pharmacological
corticosteroids plus pulse cyclophosphamide alone
80845
Intervention_Pharmacological
prednisone plus cyclophosphamide ( intravenous bolus )
80846
Intervention_Pharmacological
prednisone plus cyclophosphamide ( intravenous bolus ) plus plasma exchanges
80847
Intervention_Pharmacological
prednisone , cyclophosphamide
80848
Intervention_Pharmacological
plasma exchanges
80849
Intervention_Pharmacological
prednisone
80850
Intervention_Pharmacological
cyclophosphamide
80851
Outcome_Physical
Relapse
80852
Outcome_Physical
mean +/- SD followup
80853
Outcome_Physical
cured
80854
Outcome_Physical
clinical remission
80855
Outcome_Other
maintenance regimen of low-dose corticosteroids
80856
Outcome_Mortality
died
80857
Outcome_Mortality
deaths
80858
Outcome_Adverse-effects
treatment side effects
80859
Outcome_Mortality
death
80860
Outcome_Mortality
5-year cumulative survival rates
80861
Participant_Condition
severe polyarteritis nodosa ( PAN ) and Churg-Strauss syndrome ( CSS )
80862
Participant_Sample-size
62 patients