Thalidomide for treatment of patients with chronic graft-versus-host disease
Thalidomide for treatment of patients with chronic graft-versus-host disease
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DOI：
10.1182/blood.v96.12.3995.h8003995_3995_3996
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发表时间：
2000-12-01
期刊：
影响因子：
20.3
通讯作者：
Martin, PJ
中科院分区：
文献类型：
--
作者：
Koc, S;Leisenring, W;Martin, PJ
在一项随机、安慰剂对照、双盲试验中，沙利度胺或安慰剂与糖皮质激素和环孢霉素或他克莫司联合给药作为临床广泛性慢性移植物抗宿主病（cGVHD）的初始治疗。所有患者都有血小板减少症或直接从急性GVHD演变而来的cGVHD，作为预后不良的指标。研究药物（沙利度胺或安慰剂）最初以每天200 mg口服剂量给药，如果副作用可耐受，随后逐渐增加至800 mg/d。25例接受沙利度胺治疗的患者中有23例（92%）和26例接受安慰剂治疗的患者中有17例（65%）在cGVHD消退前停止了研究药物治疗（P = 0.02）。中性粒细胞增多症和神经系统症状是沙利度胺早期停药的最常见原因。沙利度胺治疗的持续时间太短，无法评估其控制cGVHD的疗效。(C)2000年，美国血液学会。
In a randomized, placebo-controlled, double-blind trial, thalidomide or placebo together with glucocorticoids and either cyclosporine or tacrolimus was administered as initial therapy for clinical extensive chronic graft-versus-host disease (cGVHD). All patients had thrombocytopenia or cGVHD that evolved directly from acute GVHD as an indicator of a poor prognosis. The study drug (thalidomide or placebo) was administered initially at a dose of 200 mg orally per day, followed by a gradual increase to 800 mg/d if side effects were tolerable. Treatment with the study drug was discontinued before resolution of cGVHD in 23 (92%) of the 25 patients who received thalidomide and in 17 (65%) of the 26 patients who received placebo (P = .02). Neutropenia and neurologic symptoms were the most frequent reasons for early discontinuation of treatment with thalidomide. The duration of treatment with thalidomide was too short to assess its efficacy in controlling cGVHD. (C) 2000 by The American Society of Hematology.