Abstract | OBJECTIVE: 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:
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Authors | L Guillevin, F Lhote, P Cohen, B Jarrousse, O Lortholary, T Généreau, A Léon, A Bussel |
Journal | Arthritis and rheumatism
(Arthritis Rheum)
Vol. 38
Issue 11
Pg. 1638-45
(Nov 1995)
ISSN: 0004-3591 [Print] United States |
PMID | 7488285
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenal Cortex Hormones
- Cyclophosphamide
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Topics |
- Adolescent
- Adrenal Cortex Hormones
(administration & dosage, adverse effects, therapeutic use)
- Adult
- Aged
- Churg-Strauss Syndrome
(drug therapy, therapy)
- Combined Modality Therapy
- Cyclophosphamide
(administration & dosage, therapeutic use)
- Drug Therapy, Combination
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Plasma Exchange
- Polyarteritis Nodosa
(drug therapy, therapy)
- Prospective Studies
- Treatment Outcome
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