Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection
Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection
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DOI：
10.1056/nejm199705223362103
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发表时间：
1997-05-22
影响因子：
158.5
通讯作者：
Wohl, DA
中科院分区：
文献类型：
--
作者：
Jacobson, JM;Greenspan, JS;Wohl, DA
背景在晚期人类免疫缺陷病毒（HIV）感染的患者中，口腔和口咽部的阿弗他溃疡可以变得广泛和虚弱。初步报告表明，沙利度胺可能会促进口腔阿弗他溃疡的愈合。方法我们进行了一项双盲，随机，安慰剂对照研究沙利度胺作为治疗艾滋病病毒感染患者口腔阿弗他溃疡。患者接受为期四周的疗程，每天一次口服200 mg沙利度胺或安慰剂。每周对他们的溃疡状况、生活质量和毒性证据进行评估。测定血浆肿瘤坏死因子α结果沙利度胺组29例患者中有16例患者的血清TNF-α、可溶性TNF-α受体和HIV RNA水平均高于对照组。（55%）的患者在四周后口腔溃疡完全愈合，而安慰剂组的28名患者中只有2名完全愈合（7%;比值比，15;调整组序贯检验后的95%置信区间，1.8至499;未调整P < 0.001）。沙利度胺治疗后疼痛减轻，进食能力改善。沙利度胺的不良反应包括嗜睡和皮疹（各7例），29例患者中有6例因毒性而停止治疗。沙利度胺治疗增加了HIV RNA水平（中位数增加，0.42 log（10）拷贝/毫升;安慰剂增加，0.05; P = 0.04）。沙利度胺治疗有意想不到的增加，TNF-α和可溶性TNF-α receptors.Conclusions血浆浓度的沙利度胺是一种有效的治疗口腔和口咽部溃疡的HIV感染患者。(C)1997年，马萨诸塞州医学会。
Background In patients with advanced human immunodeficiency virus (HIV) infection, aphthous ulceration of the mouth and oropharynx can become extensive and debilitating. Preliminary reports suggest that thalidomide may promote the healing of oral aphthous ulcers.Methods We performed a double-blind, randomized, placebo-controlled study of thalidomide as therapy for oral aphthous ulcers in HIV-infected patients. The patients received a four-week course of either 200 mg of thalidomide or placebo orally once per day. They were evaluated weekly for the condition of the ulcers, their quality of life, and evidence of toxicity. Assays were performed for plasma tumor necrosis factor alpha (TNF-alpha), soluble TNF-alpha receptors, and HIV RNA.Results Sixteen of 29 patients in the thalidomide group (55 percent) had complete healing of their aphthous ulcers after four weeks, as compared with only 2 of 28 patients in the placebo group (7 percent; odds ratio, 15; 95 percent confidence interval after adjustment for group sequential testing, 1.8 to 499; unadjusted P < 0.001). Pain diminished and the ability to eat improved with thalidomide treatment. The adverse effects noted with thalidomide included somnolence and rash (7 patients each), and 6 of the 29 patients discontinued treatment because of toxicity. Thalidomide treatment increased HIV RNA levels (median increase, 0.42 log(10) copies per milliliter; increase with placebo, 0.05; P = 0.04). With thalidomide treatment there were unexpected increases in the plasma concentrations of TNF-alpha and soluble TNF-alpha receptors.Conclusions Thalidomide is an effective treatment for aphthous ulceration of the mouth and oropharynx in patients with HIV infection. (C) 1997, Massachusetts Medical Society.