Dehydroepiandrosterone treatment of women with mild-to-moderate systemic lupus erythematosus - A multicenter randomized, double-blind, placebo-controlled trial
Dehydroepiandrosterone treatment of women with mild-to-moderate systemic lupus erythematosus - A multicenter randomized, double-blind, placebo-controlled trial
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DOI：
10.1002/art.10615
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发表时间：
2002-11-01
影响因子：
--
通讯作者：
Luo, SF
中科院分区：
文献类型：
--
作者：
Chang, DM;Lan, JL;Luo, SF
Objective.评价脱氢表雄酮（DHEA）200 mg/d治疗成年女性活动性系统性红斑狼疮（SLE）的疗效和耐受性。在一项多中心、随机、双盲、安慰剂对照试验中，120名患有活动性SLE的成年女性接受口服DHEA（200 mg/天; n = 61）或安慰剂（n = 59）治疗24周。主要终点是治疗24周时系统性狼疮活动度测量（SLAM）评分较基线的平均变化。次要终点包括首次发作时间、SLE疾病活动指数（SLEDAI）评分的变化以及24周时医生和患者的总体评估评分。两组的基线特征平衡良好。SLAM评分较基线的平均降低相似，治疗组间无统计学显著差异（DHEA-2. 6 +/-3. 4 vs安慰剂-2. 0 +/-3. 8，平均值（+/- SD））。DHEA组中野兔患者数量减少16%（DHEA治疗患者为18.3%，安慰剂治疗患者为33.9%; P = 0.044，基于至首次发作的时间）。两组患者总体评估的平均变化具有统计学显著性（DHEA组为-5.5，安慰剂组为5.4; P = 0.005）。DHEA治疗组发生严重不良事件的患者数量显著低于安慰剂治疗组（P = 0.010），其中大部分与SLE发作相关。观察到预期的激素效应，包括睾酮水平升高和痤疮发病率升高。本研究期间未发现危及生命的反应或严重安全性问题。总体结果证实DHEA治疗耐受性良好，显著减少SLE发作次数，并改善患者对疾病活动的总体评估。
Objective. To evaluate the efficacy and tolerability of dehydroepiandrosterone (DHEA) at a dosage of 200 mg/day in adult women with active systemic lupus erythematosus (SLE).Methods. In a multicenter randomized, double-blind, placebo-controlled trial, 120 adult women with active SLE received oral DHEA (200 mg/day; n = 61) or placebo (n = 59) for 24 weeks. The primary end point was the mean change from baseline in the Systemic Lupus Activity Measure (SLAM) score at 24 weeks of therapy. Secondary end points included time to first flare, change in SLE Disease Activity Index (SLEDAI) score, and physician's and patient's global assessment scores at week 24.Results. The two groups were well balanced for baseline characteristics. Mean reductions in SLAM scores from baseline were similar and were not statistically significantly different between treatment groups (DHEA -2.6 +/- 3.4 versus placebo -2.0 +/- 3.8, mean (+/- SD). The number of patients with Hares was decreased by 16% in the DHEA group (18.3% of DHEA-treated patients versus 33.9% of placebo-treated patients; P = 0.044, based on time to first flare). The mean change in the patient's global assessment was statistically significant between the two groups (DHEA -5.5 versus placebo 5.4; P = 0.005). The number of patients with serious adverse events, most of which were related to SLE flare, was significantly lower in DHEA-treated patients compared with placebo-treated patients (P = 0.010). Expected hormonal effects, including increased testosterone levels and increased incidence of acne, were observed. No life-threatening reactions or serious safety issues were identified during this study.Conclusion. The overall results confirm that DHEA treatment was well-tolerated, significantly reduced the number of SLE flares, and improved patient's global assessment of disease activity.