Abstract | OBJECTIVE: DESIGN: Single-centre, randomised, open label, parallel group comparison of conventional treatment plus interferon-alpha, conventional treatment plus thymomodulin, and conventional treatment alone. PATIENTS: SETTING: Tertiary cardiac referral centre. MAIN OUTCOME MEASURES: Clinical evaluation, echocardiography, and Holter monitoring at baseline, 6 months, and 1 and 2 years. Radionuclide ventriculography at rest and during exercise after 2 years. Endomyocardial biopsy at baseline and after a year if the initial diagnosis was myocarditis. RESULTS: Left ventricular ejection fraction was improved in 21 (81%) of 26 patients after interferon-alpha or thymomodulin administration and in 8 (66%) of 12 conventionally treated patients (P < 0.05) at 2 year follow up. The maximum exercise time was significantly longer at 2-year follow up in patients treated with immunomodulators (mean (SEM) 5.1 (0.6) minutes for interferon-alpha and 5.0 (0.4) minutes for thymomodulin) than in conventionally treated patients (3.3 (0.4) minutes). Left ventricular ejection fraction during exercise (assessed by radionuclide ventriculography) improved in 9 of 12 patients treated with interferon-alpha, 10 of 12 patients treated with thymomodulin, and 3 of 9 conventionally treated patients at 2 year follow up. The electrocardiogram was normal in 21 (88%) of 24 patients after interferon-alpha or thymomodulin treatment and 2 (22%) of 9 conventionally treated patients. At 2 year follow up, 19 (73%) of 26 patients treated with immunomodulators and 4 (25%) of 12 conventionally treated patients had improved their functional class. CONCLUSIONS:
|
Authors | M Mirić, J Vasiljević, M Bojić, Z Popović, N Keserović, M Pesić |
Journal | Heart (British Cardiac Society)
(Heart)
Vol. 75
Issue 6
Pg. 596-601
(Jun 1996)
ISSN: 1355-6037 [Print] England |
PMID | 8697164
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Antibodies, Viral
- Interferon-alpha
- Thymus Extracts
- thymomodulin
|
Topics |
- Adult
- Antibodies, Viral
(blood)
- Cardiomyopathy, Dilated
(drug therapy, immunology, therapy)
- Combined Modality Therapy
- Enterovirus B, Human
(immunology)
- Female
- Follow-Up Studies
- Humans
- Interferon-alpha
(therapeutic use)
- Male
- Middle Aged
- Prognosis
- Prospective Studies
- Thymus Extracts
(therapeutic use)
|