Chang Deh-Ming, Lan Joung-Liang, Lin Hsiao-Yi, Luo Shue-Fen
Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.
Arthritis Rheum. 2002 Nov;46(11):2924-7. doi: 10.1002/art.10615.
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).
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.
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 flares 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.
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.
评估每日剂量为200毫克的脱氢表雄酮（DHEA）对患有活动性系统性红斑狼疮（SLE）的成年女性的疗效和耐受性。
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毫克/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指标（SLAM）评分相对于基线的平均变化。次要终点包括首次发作时间、SLE疾病活动指数（SLEDAI）评分的变化以及第24周时医生和患者的整体评估评分。
两组的基线特征均衡良好。治疗组之间SLAM评分相对于基线的平均降低相似，且无统计学显著差异（DHEA组为-2.6±3.4，安慰剂组为-2.0±3.8，均值±标准差）。DHEA组发作患者数量减少了16%（接受DHEA治疗的患者中有18.3%发作，而接受安慰剂治疗的患者中有33.9%发作；基于首次发作时间，P = 0.044）。两组之间患者的整体评估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）。与接受安慰剂治疗的患者相比，接受DHEA治疗的患者中严重不良事件的数量显著更低（大多数严重不良事件与SLE发作相关；P = 0.010）。观察到了预期的激素效应，包括睾酮水平升高和痤疮发病率增加。在本研究期间未发现危及生命的反应或严重安全问题。
总体结果证实，DHEA治疗耐受性良好，显著减少了SLE发作次数，并改善了患者对疾病活动的整体评估。
