布拉氏酵母菌对妇科癌症盆腔放疗患者急性胃肠道毒性的影响：一项随机对照试验。
Impact of Saccharomyces boulardii on acute gastrointestinal toxicities in patients undergoing pelvic radiotherapy for gynecologic cancers: a randomized controlled trial.
作者信息
Muangwong Pooriwat, Tharavichitkul Ekkasit, Thiennimitr Parameth, Chitapanarux Imjai, Kittidachanan Kittikun, Chitapanarux Taned
机构信息
Division of Radiation Oncology, Department of Radiation, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Department of Microbiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
出版信息
Support Care Cancer. 2025 Jun 17;33(7):590. doi: 10.1007/s00520-025-09663-8.
PURPOSE
Acute gastrointestinal (GI) toxicities are common side effects of pelvic radiotherapy in gynecologic cancers. Although bacterial probiotics show promise, there is limited evidence for yeast-based probiotics such as Saccharomyces boulardii. This study aimed to evaluate the efficacy of S. boulardii in preventing acute radiation-induced GI toxicities in patients undergoing pelvic radiotherapy for cervical and endometrial cancers.
METHODS
A prospective, randomized, double-blind, controlled trial was conducted with 60 patients receiving definitive or postoperative pelvic radiotherapy. Patients were randomized to receive either S. boulardii (250 mg/day) or a placebo, starting one week before radiotherapy and continuing throughout treatment. Acute GI toxicities were assessed weekly using the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Stool consistency and inflammatory markers were also monitored. The primary outcome was the reduction in the severity of diarrhea and other GI symptoms.
RESULTS
S. boulardii significantly reduced the incidence of type 6 and 7 stool consistency at week 3 (p = 0.01). However, despite this transient improvement, the treatment group experienced a significantly higher incidence of diarrhea at week 4 compared to the control group (p = 0.03). Overall, no significant differences were found between the groups in terms of cumulative GI toxicities or anti-diarrheal medication use, with diarrhea remaining the most common acute GI toxicity in both groups.
CONCLUSION
No consistent effect of S. boulardii was observed across the measured outcomes, and its overall efficacy in preventing acute radiation-induced enteritis remains inconclusive. Further studies with larger sample sizes are warranted.
TRIAL REGISTRATION
The study was registered with the Thai Clinical Trials Registry (TCTR20210204013) on 04 February 2021.
目的
急性胃肠道毒性是妇科癌症盆腔放疗常见的副作用。尽管细菌益生菌显示出一定前景，但对于像布拉氏酵母菌这样的酵母益生菌，证据有限。本研究旨在评估布拉氏酵母菌在预防宫颈癌和子宫内膜癌盆腔放疗患者急性放射性胃肠道毒性方面的疗效。
方法
对60例接受根治性或术后盆腔放疗的患者进行了一项前瞻性、随机、双盲、对照试验。患者被随机分为接受布拉氏酵母菌（250毫克/天）或安慰剂组，从放疗前一周开始，持续整个治疗过程。每周使用不良事件通用术语标准（CTCAE）第5版评估急性胃肠道毒性。还监测了大便稠度和炎症标志物。主要结局是腹泻和其他胃肠道症状严重程度的降低。
结果
布拉氏酵母菌在第3周显著降低了6型和7型大便稠度的发生率（p = 0.01）。然而，尽管有这种短暂改善，但与对照组相比，治疗组在第4周腹泻发生率显著更高（p = 0.03）。总体而言，两组在累积胃肠道毒性或止泻药物使用方面未发现显著差异，腹泻仍是两组中最常见的急性胃肠道毒性。
结论
在所测量的结局中未观察到布拉氏酵母菌的一致效果，其在预防急性放射性肠炎方面的总体疗效仍不确定。有必要进行更大样本量的进一步研究。
试验注册
该研究于2021年2月4日在泰国临床试验注册中心（TCTR20210204013）注册。
Zotero 插件