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移植中的贝利穆巴:一种随机对照的试验性第二阶段药物
Gemma D Banham1, Shaun M Flint2, Nicholas Torpey3
1Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK; National Institute of Health Research (NIHR) Cambridge Biomedical Research Centre, Cambridge, UK.
Lancet (London, England)
|June 19, 2018
概括
在接受移植的患者中,贝利穆巴没有显著减少原始B细胞. 然而,与安慰剂相比,它在减少严重感染方面显示出潜在的益处,这表明它可能在改善移植结果方面发挥作用.
科学领域:
- 肝脏病学
- 免疫学
- 移植
背景情况:
- B细胞和抗体对移植的存活率产生负面影响.
- 调控性B细胞与移植耐受性有关.
- 针对性B淋巴细胞刺激剂 (BLyS) 可能提供一种新的免疫治疗方法.
研究的目的:
- 评估抗BLyS抗体belimumab在移植患者中的安全性和活性.
- 评估贝利穆马布对IgG新生代和调控性B细胞的影响.
- 确定贝利穆马布是否会影响B细胞度.
主要方法:
- 进行了一项双盲,随机,安慰剂控制的第二阶段试验.
- 接受移植的成年人接受了标准的免疫抑制药物加上贝利木马布或安慰剂.
- 同一主要终点是从基线到24周的安全性和原始B细胞的变化.
主要成果:
- 28名患者被随机分类;25名患者被纳入修改后的治疗意向群体.
- 两组间的不良反应相似;贝利木马布组的严重感染率较低 (8%对38%).
- 贝利穆巴没有显著减少原始B细胞 (调整后的平均差异为-34. 4细胞/μL).
结论:
- 在移植中,贝利可能是标准免疫抑制剂的有益补充.
- 没有观察到贝利穆马布感染风险的重大增加.
- 在移植患者中,贝利可能对体内免疫有潜在的益处.
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