阿扎西奥普林剂量与提奥普林甲基转移酶活性用于中度至重度的亚托皮性湿疹:双盲随机对照试验
Simon J Meggitt1, Janine C Gray, Nick J Reynolds
1School of Clinical and Laboratory Sciences (Dermatological Sciences), University of Newcastle upon Tyne, UK. S.J.Meggitt@ncl.ac.uk
Lancet (London, England)
|March 15, 2006
概括
阿扎西奥普林单一治疗显著改善了成年人的中度至重度的亚托皮性湿疹. 这种治疗以 thiopurine 甲基转移酶 (TPMT) 活性为指导,为那些对局部皮质类固醇无反应的患者提供了安全有效的选择.
科学领域:
- 皮肤病学 皮肤病学
- 药物基因组学 药物基因组学
- 临床试验 临床试验
背景情况:
- 亚托皮性湿疹影响1-2%的成年人,导致显著的发病率.
- 对于对局部治疗无反应的中度至重度病例,需要全身疗法.
研究的目的:
- 评估阿扎西奥普林作为中度至重度亚托皮性湿疹的全身单疗法的安全性和有效性.
- 评估氨酸甲基转移酶 (TPMT) 多态性在确定阿扎西奥普林剂量和毒性的作用.
主要方法:
- 一个为期12周的,并行组,双盲,安慰剂对照试验,涉及63名成年患者.
- 患者接受了阿扎西奥普林或安慰剂,阿扎西奥普林的剂量根据TPMT酶活性进行调整.
- 临床反应使用六区域六标志性无皮炎 (SASSAD) 评分来衡量.
主要成果:
- 在12周后,阿扎西奥普林在疾病活动中显示出37%的改善,而安慰剂则为20%.
- 在,受影响区域,总体评估和生活质量方面观察到显著改善.
- 以TPMT为导向的剂量似乎可以降低毒性,同时保持有效性,在异合体患者中没有观察到骨髓毒性.
结论:
- 阿扎西奥普林单一治疗为适度至重度的对局部皮质类固醇耐药的亚托皮性湿疹提供了临床相关的改善.
- 这种方法可能有助于阐明阿扎西奥普林有效性,代谢物概况和炎症性疾病患者结果之间的关系.
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