A Trial of Contraceptive Methods in Women with Systemic Lupus Erythematosus

作者：Jorge Sánchez‐Guerrero, América G. Uribe, Luisa Jiménez-Santana, Marilú Mestanza-Peralta, Pilar Lara-Reyes, Armando Humberto Seuc, Marı́a del Carmen Cravioto · 发表于：New England Journal of Medicine · 年份：2005 · DOI：10.1056/nejmoa050817 · 被引用次数：354 · 研究领域：Systemic Lupus Erythematosus Research、Pregnancy and Medication Impact、Rheumatoid Arthritis Research and Therapies

BACKGROUND: The effects of estrogen-containing contraceptives on disease activity in women with systemic lupus erythematosus have not been determined. METHODS: We conducted a single-blind clinical trial involving 162 women with systemic lupus erythematosus who were randomly assigned to combined oral contraceptives, a progestin-only pill, or a copper intrauterine device (IUD). Disease activity was assessed at 0, 1, 2, 3, 6, 9, and 12 months according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). The primary outcome was global disease activity, which we estimated by measuring the area under the SLEDAI curve. Secondary outcomes included the maximum SLEDAI score, change in SLEDAI score, incidence of lupus flares, median time to first flare, systemic lupus erythematosus treatment, and adverse events. The results were analyzed by the intention-to-treat method. RESULTS: At baseline, all demographic features and disease characteristics were similar in the three groups. The mean (+/-SD) SLEDAI score was 6.1+/-5.6 in the group assigned to combined oral contraceptives, 6.4+/-4.6 in the group assigned to the progestin-only pill, and 5.0+/-5.3 in the group assigned to the IUD (54 patients in each group) (P=0.36). Disease activity remained mild and stable in all groups throughout the trial. There were no significant differences among the groups during the trial in global or maximum disease activity, incidence or probability of flares, or medication use. The median ti...