Rash in multicenter trials of lamotrigine in mood disorders: clinical relevance and management.
Rash in multicenter trials of lamotrigine in mood disorders: clinical relevance and management.
复制标题
拉莫三嗪治疗情绪障碍的多中心试验中的皮疹：临床相关性和管理。
DOI：
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发表时间：
2002
影响因子：
5.3
通讯作者：
V. Kusumakar
中科院分区：
文献类型：
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作者：
J. Calabrese;J. Sullivan;C. Bowden;T. Suppes;J. Goldberg;G. Sachs;M. Shelton;F. Goodwin;M. Frye;V. Kusumakar
背景
情绪障碍患者中拉莫三嗪相关皮疹的发生率尚未得到很好的描述。这份报告的目的是确定拉莫三嗪在DSM-IV单相抑郁或双相情感障碍临床试验中的皮疹发生率。
方法
对1996年至2001年间的12项多中心研究的拉莫三嗪相关皮疹发生率进行了回顾性分析，其中包括1项开放研究、7项随机对照急性试验和4项随机对照维持试验。
结果
共有1955名患者在开放标签环境中接受拉莫三嗪治疗(随机前后的开放标签阶段和1项独立的开放标签研究)；1198名患者在对照环境中接受拉莫三汀治疗，1056名患者接受安慰剂治疗。在对照环境中，服用拉莫三嗪和服用安慰剂的患者的良性皮疹发生率分别为8.3%和6.4%。严重皮疹发生率拉莫三嗪为0%，安慰剂为0.1%(N=1)，对照组为0%。在开放标签设置中，拉莫三嗪的总皮疹发生率为13.1%(N=257)，严重皮疹的总发生率为0.1%(N=2)。1例轻度史蒂文斯-约翰逊综合征患者接受拉莫三嗪治疗后不需要住院治疗。在任何情况下都没有中毒性表皮坏死松解的病例。
结论
与拉莫三嗪相关的严重药疹很少见。虽然皮疹是一种潜在的危及生命的反应，但由于拉莫三嗪引起的严重皮疹的风险应该与未经治疗或治疗不足的双相抑郁相关的更常见的风险进行权衡。
BACKGROUND
The rate of lamotrigine-associated rash in patients with mood disorders has not been well characterized. The objective of this report was to determine rash rates in clinical trials of lamotrigine in DSM-IV unipolar depression or bipolar disorder.
METHOD
A retrospective analysis was conducted of rates of lamotrigine-related rash in 12 multicenter studies, including 1 open study, 7 randomized controlled acute trials, and 4 randomized controlled maintenance trials from 1996 to 2001.
RESULTS
A total of 1955 patients were treated with lamotrigine in open-label settings (open-label phases preceding or following randomization and 1 stand-alone open-label study); 1198 patients received lamotrigine in controlled settings, and 1056 patients received placebo. In controlled settings, rates of benign rash were 8.3% and 6.4% in lamotrigine- and placebo-treated patients, respectively. Rates of serious rash were 0% with lamotrigine, 0.1% (N = 1) with placebo, and 0% with comparators. In the open-label setting, the overall rate of rash for lamotrigine was 13.1% (N = 257) and of serious rash, 0.1% (N = 2). One mild case of Stevens-Johnson syndrome not requiring hospitalization occurred in a patient treated with lamotrigine. There were no cases of toxic epidermal necrolysis in any setting.
CONCLUSION
Serious drug eruptions associated with lamotrigine were rare. Although rash is a potentially life-threatening reaction, the risk of serious rash due to lamotrigine should be weighed against more common risks associated with untreated or undertreated bipolar depression.