Effects of prasterone on disease activity and symptoms in women with active systemic lupus erythematosus: Results of a multicenter randomized, double-blind, placebo-controlled trial

摘要: Objective To determine whether prasterone administration results in improvement or stabilization of systemic lupus erythematosus (SLE) disease activity and its symptoms. Methods Women with active SLE were treated 200 mg/day plus standard treatments placebo for up to 12 months this randomized, double-blind investigation conducted at 27 centers. Standard included prednisone (≤10 mg/day), antimalarials, immunosuppressive agents; dosages required be stable ≥6 weeks prior enrollment remain unchanged during protocol treatment. Responders patients who experienced no clinical deterioration had over the duration study 2 measures (the Disease Activity Index [SLEDAI] Systemic Lupus Measure) quality life (patient's global assessment Krupp Fatigue Severity Scale). Results A total 381 women enrolled. Among clinically baseline (SLEDAI score >2), 86 147 group (58.5%) demonstrated without deterioration, as compared 65 146 (44.5%) (P = 0.017). Acne hirsutism reported 33% 16%, respectively, 14% 2%, < 0.05 both comparisons). However, most cases acne mild did not require withdrawal from therapy. Myalgias oral stomatitis less frequently (22% 15%, respectively) than (36% 23%, Serum levels high-density lipoprotein cholesterol, triglycerides, C3 complement significantly decreased, while testosterone and, a lesser extent, estradiol increased group. Conclusion In adult SLE, dosage improved stabilized signs symptoms was generally well tolerated.