Are High Doses of Prednisone Necessary for Treatment of Interstitial Lung Disease in Systemic Sclerosis?

• Published in: Reumatología clinica (Barcelona) 2012-03, Vol.8 (2), p.58-62
• Main Authors: Pérez Campos, Dionisio, Estévez Del Toro, Miguel, Peña Casanovas, Aisa, González Rojas, Pedro Pablo, Morales Sánchez, Lisvenia, Gutiérrez Rojas, Ángela Rosa
• Format: Article
• Language: English
• Subjects: Ciclofosfamida; Cyclophosphamide; Dosis alta y baja de prednisona; Esclerosis sistémica; High and low doses of prednisone; Interstitial lung disease; Neumopatía intersticial; Systemic sclerosis
• ISSN: 2173-5743; 2173-5743
• DOI: 10.1016/j.reumae.2011.11.005

Interstitial lung disease (ILD) as part of systemic sclerosis (SS) is a leading cause of morbidity and mortality. To evaluate the use of intravenous pulse cyclophosphamide combined with low and high doses of prednisone in the treatment of ILD in SS is equally effective. An experimental, exploratory and randomized single-blind clinical trial was conducted at Hermanos Ameijeiras Clinical Surgical Hospital from September 2006 to December 2009, including 23 patients with SS and ILD. Two treatment schedules were evaluated and randomly assigned. Group A was composed of 13 patients with a monthly dose of cyclophosphamide (ev) for 6 months and a twice-monthly dose for the remaining 6 months, prednisone (1mg×kg×day) 4 weeks and then the dose was lowered to 5mg every 2 weeks up to 10mg. Group B: 10 patients with cyclophosphamide (ev), oral prednisone 10mg daily. There are significant differences at onset of CVF and the honeycomb pattern between both groups, where the high dose group was at a disadvantage. At the end of treatment the low dose group achieved improvement of radiologic lesions and the Warrick index, unlike the high dose group. The remaining variables experienced improvement in both groups without marked inequality. Similarly, slight adverse reactions were present in both groups. Two patients dropped out of the study. A combination of low dose steroids with cyclophosphamide is effective in interstitial lung disease treatment especially in active disease, and results did not show differences regarding the high dose group but the sample size and the evolutionary severity of high dose patients oblige other studies to verify these data. La neumopatía intersticial (NI) en el curso de la esclerosis sistémica (ES) constituye la causa principal de morbilidad y mortalidad. Evaluar si el uso de prednisona en altas o bajas dosis combinado con ciclofosfamida intravenosa (iv) resulta igualmente eficaz en el tratamiento de la NI en la ES. Se realizó un estudio explicativo experimental tipo ensayo clínico, aleatorizado y a simple ciego, donde se reclutó a 23 pacientes con ES y NI. Se evaluaron dos esquemas de tratamientos; grupo A: 13 pacientes con ciclofosfamida (iv) mensual durante 6 meses y bimensual durante los 6 meses restantes, prednisona (1mg×kg×día) 4 semanas y después se rebajó la dosis a 5mg cada 2 semanas hasta 10mg, y grupo B: 10 pacientes con ciclofosfamida (iv) y prednisona por vía oral 10mg diaria. Se muestran las diferencias significativas al inicio del