A survey of adverse events in 11241 patients with chronic viral hepatitis treated with alfa interferon

被引:402
作者
Fattovich, G [1 ]
Giustina, G [1 ]
Favarato, S [1 ]
Ruol, A [1 ]
Macarri, G [1 ]
Orlandi, F [1 ]
Iaquinto, G [1 ]
Ambrosone, L [1 ]
Francavilla, A [1 ]
Pastore, G [1 ]
Santantonio, MT [1 ]
Romagno, D [1 ]
Bolondi, L [1 ]
Sofia, S [1 ]
Marchesini, A [1 ]
Pisi, E [1 ]
Mazzella, G [1 ]
Roda, E [1 ]
Attaro, L [1 ]
Chiodo, F [1 ]
Mori, F [1 ]
Verucchi, G [1 ]
Lanzini, A [1 ]
Salmi, A [1 ]
Calvi, B [1 ]
Bozzetti, F [1 ]
Radaeli, E [1 ]
Bernasconi, M [1 ]
Pilleri, G [1 ]
Bacca, D [1 ]
Romano, G [1 ]
Mastrapasqua, G [1 ]
Cozzolongo, R [1 ]
Cacopardo, B [1 ]
Nunnari, A [1 ]
Blasi, A [1 ]
Sala, LO [1 ]
Minoli, G [1 ]
Sangiovanni, A [1 ]
Spinzi, GC [1 ]
Colombo, A [1 ]
Camassa, M [1 ]
Riva, D [1 ]
Maggi, G [1 ]
Boccia, S [1 ]
Gualandi, G [1 ]
Nucci, A [1 ]
Pacini, F [1 ]
Marino, N [1 ]
Mazzotta, F [1 ]
机构
[1] UNIV PADUA,IST MED CLIN,MED CLIN 2A,I-35100 PADUA,ITALY
关键词
chronic viral hepatitis; interferon alfa; side effects;
D O I
10.1016/S0168-8278(96)80184-X
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Aims: The aim of this study was to assess the incidence of fatal, life-threatening side effects and the de novo appearance of non-hepatic morbidity during interferon alfa therapy for chronic viral hepatitis. The relationship of these adverse events to actual total dose and duration of interferon was also evaluated. Methods: We conducted a retrospective study at 73 Italian centers of 11 241 consecutive patients with chronic viral hepatitis who underwent interferon alfa treatment. Results: Five patients died during interferon therapy due to liver failure (n=4) or complications arising from sepsis. Life-threatening side effects were observed in eight patients: two cases where depression developed and led to a suicide attempt and six patients with bone marrow suppression (granulocytes (500/ mm(3) or platelets <25 000/mm(3)). These symptoms and signs completely disappeared after interferon withdrawal. During interferon treatment, 131 patients developed the following de novo non-hepatic disorders: symptomatic thyroid disease (n=71), impotence (n=5), systemic autoimmune disease (n=5), immune-mediated dermatologic disease (n=14), diabetes mellitus (n=10), cardiovascular disease (n=7), psychosis n=10), seizures (n=4), peripheral neuropathy (n=3) and hemolytic anemia (n=2). Most of these complications are reversible or can be ameliorated. Fatal or life-threatening side effects were not related to actual total dose or duration of interferon alfa, while the majority of patients with de novo non-hepatic morbidity received medium/high doses (>200 million units) of interferon alfa or were treated for periods longer than 16 weeks (68% and 80%, respectively). Conclusions: Treatment with interferon alfa may have fatal or life-threatening side effects, their incidence in this study being low (0.04% and 0.07%, respectively) and perhaps no different than in untreated patients with chronic viral hepatitis. Moreover ne novo non-hepatic morbidity occurred in 1.2% of patients, and the dose and duration of interferon therapy seem important in determining the frequency of this complication, The development of clinically-overt thyroid disease was most common.
引用
收藏
页码:38 / 47
页数:10
相关论文
共 23 条
  • [1] REVERSIBLE CARDIAC DYSFUNCTION ASSOCIATED WITH INTERFERON ALFA THERAPY IN AIDS PATIENTS WITH KAPOSIS SARCOMA
    DEYTON, LR
    WALKER, RE
    KOVACS, JA
    HERPIN, B
    PARKER, M
    MASUR, H
    FAUCI, AS
    LANE, HC
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1989, 321 (18) : 1246 - 1249
  • [2] DURAND JM, 1991, LANCET, V338, P1268
  • [3] DEVELOPMENT OF TYPE-1 DIABETES-MELLITUS DURING INTERFERON-ALFA THERAPY FOR CHRONIC HCV HEPATITIS
    FABRIS, P
    BETTERLE, C
    FLOREANI, A
    GREGGIO, NA
    DELAZZARI, F
    NACCARATO, R
    CHIARAMONTE, M
    [J]. LANCET, 1992, 340 (8818) : 548 - 548
  • [4] AUTOANTIBODIES DURING ALPHA-INTERFERON THERAPY FOR CHRONIC HEPATITIS-B
    FATTOVICH, G
    BETTERLE, C
    BROLLO, L
    PEDINI, B
    GIUSTINA, G
    REALDI, G
    ALBERTI, A
    RUOL, A
    [J]. JOURNAL OF MEDICAL VIROLOGY, 1991, 34 (02) : 132 - 135
  • [5] GARANCINI P, 1991, EUR J EPIDEMIOL, V7, P55
  • [6] FATAL HEPATIC DECOMPENSATION ASSOCIATED WITH INTERFERON ALFA
    JANSSEN, HLA
    BROUWER, JT
    NEVENS, F
    SANCHEZTAPIAS, JM
    CRAXI, A
    HADZIYANNIS, S
    [J]. BRITISH MEDICAL JOURNAL, 1993, 306 (6870) : 107 - 108
  • [7] SUICIDE ASSOCIATED WITH ALFA-INTERFERON THERAPY FOR CHRONIC VIRAL-HEPATITIS
    JANSSEN, HLA
    BROUWER, JT
    VANDERMAST, RC
    SCHALM, SW
    [J]. JOURNAL OF HEPATOLOGY, 1994, 21 (02) : 241 - 243
  • [8] SEIZURES ASSOCIATED WITH LOW-DOSE ALPHA-INTERFERON
    JANSSEN, HLA
    BERK, L
    VERMEULEN, M
    SCHALM, SW
    [J]. LANCET, 1990, 336 (8730) : 1580 - 1580
  • [9] KASSIANIDES C, 1988, VIRAL HEPATITIS LIVE, P840
  • [10] DEVELOPMENT OF THYROID-DISEASE DURING THERAPY OF CHRONIC VIRAL-HEPATITIS WITH INTERFERON ALFA
    LISKERMELMAN, M
    DIBISCEGLIE, AM
    USALA, SJ
    WEINTRAUB, B
    MURRAY, LM
    HOOFNAGLE, JH
    [J]. GASTROENTEROLOGY, 1992, 102 (06) : 2155 - 2160