Treatment of progressive pulmonary sarcoidosis with cyclosporin A - A randomized controlled trial

被引:87
作者
Wyser, CP [1 ]
vanSchalkwyk, EM [1 ]
Alheit, B [1 ]
Bardin, PG [1 ]
Joubert, JR [1 ]
机构
[1] UNIV STELLENBOSCH, DEPT INTERNAL MED, PULM UNIT RES, ZA-7505 TYGERBERG, SOUTH AFRICA
关键词
D O I
10.1164/ajrccm.156.5.9506031
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Conventional treatment of sarcoidosis is often only partially effective. We examined the effect of cyclosporin A (CsA) combined with prednisone for the treatment of sarcoidosis. Thirty-seven patients with biopsy-proven sarcoidosis were treated with either prednisone 20 mg/d in a prospectively tapered regimen (P) or with combination therapy consisting of prednisone 20 mg/d in a prospectively tapered regimen and cyclosporin A, 5 to 7 mg/kg/d (P-CsA) for up to 18 mo in an open-label randomized controlled trial. Evaluation was done at baseline and at 3, 9, and 18 mo of the degree of dyspnea, pulmonary function, chest radiographs, bronchoalveolar lavage (BAL), and adverse events. Criteria for a good therapeutic response, improvement, treatment failure, and relapse were defined. Thirty-seven patients were treated for at least 9 mo and 18 for at least 18 mo. Six patients in remission were included in an intention-to-treat-analysis at 18 mo. The groups did not differ significantly with respect to therapeutic response from baseline. A significant (p < 0.05) improvement was observed in dyspnea until 9 mo (P) and 18 mo (P-CsA), and in lung function until 9 mo (P) and 3 mo (P-CsA). BAL results showed a significant decrease in lymphocyte counts at 9 mo for the P group only (p < 0.05). More side effects were observed in the P-CsA group than in the P group, including elevation of the mean serum creatinine concentration at 3 and 9 mo (p < 0.05), and a doubling of the number of infections in this group. Relapse after an initially good therapeutic response occurred in two of nine patients in the P group and five of seven patients in the P-CsA group (p < 0.07). Although CsA may have theoretical benefits in the treatment of sarcoidosis, our results do not support its use in this disease.
引用
收藏
页码:1371 / 1376
页数:6
相关论文
共 32 条
[1]  
[Anonymous], 1979, AM REV RESPIR DIS, V119, P831
[2]  
ATKINSON K, 1983, TRANSPLANT P, V15, P2430
[3]  
BOREL JF, 1977, IMMUNOLOGY, V32, P1017
[4]  
CARPENTER CB, 1994, HARRISONS PRINCIPLES, P1288
[5]   LOW-DOSE ALLOPURINOL PLUS AZATHIOPRINE CYCLOSPORINE PREDNISOLONE, A NOVEL IMMUNOSUPPRESSIVE REGIMEN [J].
CHOCAIR, P ;
DULEY, J ;
SIMMONDS, HA ;
CAMERON, JS ;
IANHEZ, L ;
ARAP, S ;
SABBAGA, E .
LANCET, 1993, 342 (8863) :83-84
[6]   THE ROENTGENOGRAPHIC STAGING OF SARCOIDOSIS - HISTORIC AND CONTEMPORARY PERSPECTIVES [J].
DEREMEE, RA .
CHEST, 1983, 83 (01) :128-133
[7]   CORTICOSTEROIDS IN SARCOIDOSIS - FRIEND OR FOE [J].
DUBOIS, RM .
EUROPEAN RESPIRATORY JOURNAL, 1994, 7 (07) :1203-1209
[8]  
FLEISS JL, 1981, STATISTICAL METHODS, P100
[9]   IMPORTANCE OF BETA, TYPE-II ERROR AND SAMPLE-SIZE IN DESIGN AND INTERPRETATION OF RANDOMIZED CONTROL TRIAL - SURVEY OF 71 NEGATIVE TRIALS [J].
FREIMAN, JA ;
CHALMERS, TC ;
SMITH, H ;
KUEBLER, RR .
NEW ENGLAND JOURNAL OF MEDICINE, 1978, 299 (13) :690-694
[10]  
GOLDMAN HI, 1959, AM REV TUBERC PULM, V79, P457