In 1983, we initiated a prospective clinical trial to compare the effect of combined colchicine/prednisone, D-penicillamine/prednisone, and D-penicil-lamine/colchicine/prednisone with prednisone alone in the treatment of IPF. The question of whether the combinations of steroids with colchicine or D-peni-cillamine offer additional beneficial effects when compared with prednisone alone was the subject of the present research.
Materials and Methods
Study Population
Fifty-six adult patients with clinical, radiologic, and functional features of interstitial lung disease and histologically proven diagnosis of IPF were enrolled in this prospective study. The patients were seen at the National Institute of Respiratory Diseases in Mexico City between 1983 and 1990, and the protocol was approved by the corresponding Scientific and Ethical Committees. Diagnosis of IPF was suspected in patients with progressive dyspnea, diffuse reticulonodular infiltrates on chest radiograph, bibasilar crackles, digital clubbing, decrease in FVC and Pa02, and no evidence of systemic disease or environmental exposure other online asthma inhalers. The morphologic diagnosis of IPF, which was based on typical microscopic findings, included patchy alveolar septal fibrosis and interstitial inflammation consisting mostly of mononuclear cells but also of neutrophils and eosinophils; a variable macrophage accumulation was observed in the alveolar spaces as was the cuboidalization of the alveolar epithelium. Biopsy specimens lacked granulomas, vasculitis, microorganisms, and inorganic material by polarized light microscopy. The lung samples were taken by open lung biopsy, usually 1 week after hospital admission. None of the patients had been treated with immunosuppressive drugs at the time of biopsy. Lung biopsy tissue was obtained from two different sites from the middle lobe of the right lung or from the inferior lobe of the left lung, fixed immediately with 10% formaldehyde, and handled in identical conditions.