Sánchez-Guerrero Jorge, Uribe América G, Jiménez-Santana Luisa, Mestanza-Peralta Marilú, Lara-Reyes Pilar, Seuc Armando H, Cravioto María-del-Carmen
Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
N Engl J Med. 2005 Dec 15;353(24):2539-49. doi: 10.1056/NEJMoa050817.
The effects of estrogen-containing contraceptives on disease activity in women with systemic lupus erythematosus have not been determined.
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.
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 time to the first flare was three months in all groups. Thromboses occurred in four patients (two in each of the two groups receiving hormones), and severe infections were more frequent in the IUD group. One patient receiving combined oral contraceptives died from amoxicillin-related severe neutropenia.
Global disease activity, maximum SLEDAI score, incidence of flares, time to first flare, and incidence of adverse events were similar among women with systemic lupus erythematosus, irrespective of the type of contraceptive they were using.
含雌激素避孕药对系统性红斑狼疮女性疾病活动的影响尚未确定。
我们进行了一项单盲临床试验，纳入162例系统性红斑狼疮女性，她们被随机分配至复方口服避孕药组、仅含孕激素避孕药组或铜宫内节育器（IUD）组。根据系统性红斑狼疮疾病活动指数（SLEDAI）在0、1、2、3、6、9和12个月时评估疾病活动。主要结局为整体疾病活动，通过测量SLEDAI曲线下面积进行估计。次要结局包括最高SLEDAI评分、SLEDAI评分变化、狼疮发作发生率、首次发作的中位时间、系统性红斑狼疮治疗情况及不良事件。结果采用意向性分析方法进行分析。
在基线时，三组的所有人口统计学特征和疾病特征相似。复方口服避孕药组的平均（±标准差）SLEDAI评分为6.1±5.6，仅含孕激素避孕药组为6.4±4.6，IUD组为5.0±5.3（每组54例患者）（P = 0.36）。在整个试验过程中，所有组的疾病活动均保持轻度且稳定。试验期间，三组在整体或最高疾病活动、发作发生率或概率、或药物使用方面无显著差异。所有组首次发作的中位时间均为3个月。4例患者发生血栓形成（接受激素的两组各2例），IUD组严重感染更为常见。1例接受复方口服避孕药的患者死于阿莫西林相关的严重中性粒细胞减少症。
系统性红斑狼疮女性无论使用何种类型的避孕药，其整体疾病活动、最高SLEDAI评分、发作发生率、首次发作时间及不良事件发生率均相似。
