用益生菌预防放射治疗诱导的肠病 (PREP):双盲随机化安慰剂受控试验
Yoon Young Jo1, Yeon Joo Kim2, Seung Hae Lee2
1Department of Radiation Oncology, Yeungnam University Medical Center, Daegu 42415, Republic of Korea.
这项研究发现,Bacillus licheniformis益生菌在接受盆腔放射治疗的患者中没有显著地预防辐射诱导肠道病变 (RIE). 与安慰剂相比,益生菌的使用在预防RIE方面没有显著差异.
科学领域:
- 胃肠病学 胃肠病学
- 在瘤学瘤学.
- 微生物学 微生物学
背景情况:
- 辐射诱导肠道病变 (RIE) 是盆腔放射治疗的常见副作用.
- 益生菌正在探索治疗癌症治疗的胃肠道副作用的潜在益处.
- 关于益生菌在预防RIE方面有效性的数据有限.
研究的目的:
- 评估Bacillus licheniformis在接受盆腔放射治疗的患者中预防急性辐射诱导肠道病变 (RIE) 的疗效.
- 在盆腔放射治疗期间评估Bacillus licheniformis的安全性和耐受性.
- 为了比较益生菌和安慰剂组之间的2级RIE发病率.
主要方法:
- 一项前性,随机,双盲,安慰剂控制,单中心研究.
- 接受盆腔放射治疗的234名患者 (≥40 Gy) 被随机分配给接受Bacillus licheniformis或安慰剂.
- 使用常用术语对不良事件的标准v5.0.0.对毒性进行了分级.
主要成果:
- 在益生菌组 (26%) 和安慰剂组 (22%) 之间,2级RIE发生率没有显著差异 (p = 0.493).
- 1级RIE在益生菌组的56%和安慰剂组的64%中观察到.
- 在两组中,药物坚持度都很好,没有显著差异.
结论:
- 与安慰剂相比,Bacillus licheniformis没有显示出对辐射诱导的肠病有显著的预防作用.
- 在这个患者群体中,Bacillus licheniformis的安全性概况与安慰剂相当.
- 可能需要进一步的研究来探索其他益生菌菌株或用于预防RIE的配方.
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