摘要

BACKGROUND & AIMS:Basiliximab is a chimeric monoclonal antibody that binds CD25 and thereby inhibits interleukin (IL)-2-mediated proliferation of lymphocytes. IL-2 might contribute to the resistance of T cells to corticosteroids. We investigated the efficacy and safety of basiliximab as a corticosteroid-sensitizing agent in patients with corticosteroid-refractory ulcerative colitis (UC).
METHODS:We studied 149 patients with moderate to severe UC (Mayo score ≥6 and endoscopic subscore ≥2) despite treatment for at least 14 days with oral prednisone (40-50 mg/day). Subjects were randomly assigned to groups that were given 20 mg (n = 46) or 40 mg (n = 52) basiliximab or placebo (n = 51) at weeks 0, 2, and 4. All subjects received 30 mg/day prednisone through week 2; the dose was reduced by 5 mg each week to 20 mg/day, which was maintained until week 8. At week 8, we compared the rates of clinical remission (Mayo score ≤2, no subscore >1) for patients given basiliximab with the rate for patients given placebo.
RESULTS:Twenty-eight percent of patients given placebo, 29% of those given the 40-mg dose of basiliximab, and 26% of those given the 20-mg dose of basiliximab achieved clinical remission (P = 1.00 vs placebo for each dose). Basiliximab was generally well tolerated. Six subjects who received basiliximab had serious adverse events (6.1%) compared with 2 who received placebo (3.9%; P = .72). In subjects given basiliximab, incomplete saturation of CD25 (<50%) on peripheral T cells was associated with the presence of anti-basiliximab antibodies (odds ratio, 21; 95% confidence interval, 2.4-184).
CONCLUSIONS:Basiliximab does not increase the effect of corticosteroids in the induction of remission in outpatients with corticosteroid-resistant moderate to severe UC.

译文

背景与目的: 巴利昔单抗是一种嵌合单克隆抗体,能结合 CD25,从而抑制白细胞介素 (IL)-2 介导的淋巴细胞增殖。IL-2 可能有助于 T 细胞对皮质类固醇的抵抗。我们研究了巴利昔单抗作为皮质类固醇增敏剂在皮质类固醇难治性溃疡性结肠炎 (UC) 患者中的疗效和安全性。
方法: 我们研究了 149 例中重度 UC 患者 (Mayo 评分 ≥ 6 分,内镜评分 ≥ 2 分) 尽管口服泼尼松治疗至少 14 天 (40-50 毫克/天)。受试者被随机分配到在 0,2 周给予 20 毫克 (n = 46) 或 40 毫克 (n = 52) 巴利昔单抗或安慰剂 (n = 51) 的组中, 和 4。所有受试者在第二周每天服用 30 毫克泼尼松;剂量每周减少 5 毫克至 20 毫克/天,一直持续到第八周。在第 8 周,我们比较了服用巴利昔单抗的患者的临床缓解率 (Mayo 评分 ≤ 2,无子评分> 1) 和服用安慰剂的患者的缓解率。
结果: 29% 的患者服用安慰剂,的患者服用 40 毫克剂量的巴利昔单抗, 26% 服用 20 毫克巴利昔单抗的患者获得了临床缓解 (每剂量 P = 1.00 vs 安慰剂)。巴利昔单抗通常耐受性良好。6 名接受巴利昔单抗的受试者有严重的不良事件 (6.1%),而 2 名接受安慰剂的受试者 (3.9%; P =.72)。在被给予巴利昔单抗的受试者中,外周 T 细胞上的 25 (<50%) 的不完全饱和与抗巴利昔单抗抗体的存在有关 (比值比,21; 95% 置信区间, 2.4-184)。
结论: 巴利昔单抗不会增加皮质类固醇在皮质类固醇耐药的中重度 UC 门诊患者中诱导缓解的效果。

Basiliximab

儿科 受体拮抗剂 治疗药物
概述  :  

巴利昔单抗是一种白介素2受体拮抗剂,它可以彻底抑制细胞免疫反应中由白介素2介导的关键性信号通路,从而达到抗免疫排斥的作用。巴利昔单抗开发的早期主要应用在非实体器官移植领域。1998年,美国食品药品监督局首次通过了巴利昔单抗作为肾移植受者中预防急性排斥反应的药物应用于临床。此后,巴利昔单抗的应用拓展到了其他实体器官移植,例如肺移植、胰腺移植和心脏移植等。成分本品活性成份为巴利昔单抗。每瓶含巴利昔单抗20 毫克或10 毫克,配5 毫升注射用水1 支。辅料:无水磷酸氢二钠、氯化钠、磷酸二氢钾、蔗糖

basiliximab  

释    义   巴利昔单抗

例    句   To study the clinical efficacy of immunosuppressive regimen with early steroid withdrawalbased on basiliximab. 目的观察在应用巴利昔单抗的基础上,早期撤除激素的免疫抑制剂方案临床效果。

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