Combined oral contraceptives in women with systemic lupus erythematosus
Combined oral contraceptives in women with systemic lupus erythematosus
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DOI：
10.1056/nejmoa051135
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发表时间：
2005-12-15
影响因子：
158.5
通讯作者：
Buyon, JP
中科院分区：
文献类型：
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作者：
Petri, M;Kim, MY;Buyon, JP
背景：由于担心潜在的副作用，很少为患有系统性红斑狼疮的女性开口服避孕药。在这项双盲、随机、非劣效性试验中，我们前瞻性评估了口服避孕药对患有系统性红斑狼疮的绝经前女性狼疮活动性的影响。方法：美国 15 个地点共有 183 名患有非活动性 (76%) 或稳定活动性 (24%) 系统性红斑狼疮的女性被随机分配接受口服避孕药（三相乙炔雌二醇剂量为 35 微克加炔诺酮剂量为 0.5 至 1 毫克，共 12 个周期，每个周期 28 天；91 名女性）或安慰剂（92 名女性），并在第 1、2、3、6、9 和 12 个月进行评估。如果受试者有中度或高水平的抗心磷脂抗体、狼疮，则被排除在外结果：主要终点是严重狼疮发作，在接受口服避孕药的 91 名受试者中，有 7 名（7.7%）发生，而在接受安慰剂的 92 名受试者中，有 7 名（7.6%）发生了主要终点。 12 个月的严重复发率相似：口服避孕药组为 0.084，安慰剂组为 0.087（P=0.95；这一差异的单侧 95% 置信区间上限为 0.069，在预先设定的 9% 非劣效范围内）。接受口服避孕药的受试者的轻度或中度发作率为每人每年 1.40 次，接受安慰剂的受试者为每人每年 1.44 次（相对风险为 0.98；P=0.86）。在随机接受口服避孕药的一组中，有 1 例深静脉血栓形成和 1 例移植物凝结；安慰剂组中，有 1 例深静脉血栓形成、1 例眼部血栓形成、1 例血栓性浅静脉炎和 1 例死亡（试验停止后）。 结论：我们的研究表明，口服避孕药不会增加病情稳定的系统性红斑狼疮女性患者病情恶化的风险。
BACKGROUND:Oral contraceptives are rarely prescribed for women with systemic lupus erythematosus, because of concern about potential negative side effects. In this double-blind, randomized, noninferiority trial, we prospectively evaluated the effect of oral contraceptives on lupus activity in premenopausal women with systemic lupus erythematosus.METHODS:A total of 183 women with inactive (76 percent) or stable active (24 percent) systemic lupus erythematosus at 15 U.S. sites were randomly assigned to receive either oral contraceptives (triphasic ethinyl estradiol at a dose of 35 microg plus norethindrone at a dose of 0.5 to 1 mg for 12 cycles of 28 days each; 91 women) or placebo (92 women) and were evaluated at months 1, 2, 3, 6, 9, and 12. Subjects were excluded if they had moderate or high levels of anticardiolipin antibodies, lupus anticoagulant, or a history of thrombosis.RESULTS:The primary end point, a severe lupus flare, occurred in 7 of 91 subjects receiving oral contraceptives (7.7 percent) as compared with 7 of 92 subjects receiving placebo (7.6 percent). The 12-month rates of severe flare were similar: 0.084 for the group receiving oral contraceptives and 0.087 for the placebo group (P=0.95; upper limit of the one-sided 95 percent confidence interval for this difference, 0.069, which is within the prespecified 9 percent margin for noninferiority). Rates of mild or moderate flares were 1.40 flares per person-year for subjects receiving oral contraceptives and 1.44 flares per person-year for subjects receiving placebo (relative risk, 0.98; P=0.86). In the group that was randomized to receive oral contraceptives, there was one deep venous thrombosis and one clotted graft; in the placebo group, there was one deep venous thrombosis, one ocular thrombosis, one superficial thrombophlebitis, and one death (after cessation of the trial).CONCLUSIONS:Our study indicates that oral contraceptives do not increase the risk of flare among women with systemic lupus erythematosus whose disease is stable.