| 杨寅寅,胡宜佳,顾栩滈,等.长双歧杆菌BL21对宫颈癌放射治疗中急性放射性腹泻的预防作用:一项单臂Ⅱ期临床研究[J].中华放射医学与防护杂志,2025,45(2):101-107.Yang Yinyin,Hu Yijia,Gu Xuhao,et al.Preventive effects of Bifidobacterium longum subsp. longum BL21 on acute radiation-induced diarrhea during radiotherapy for cervical cancer: A single-arm, phase Ⅱ trial[J].Chin J Radiol Med Prot,2025,45(2):101-107 |
| 长双歧杆菌BL21对宫颈癌放射治疗中急性放射性腹泻的预防作用:一项单臂Ⅱ期临床研究 |
| Preventive effects of Bifidobacterium longum subsp. longum BL21 on acute radiation-induced diarrhea during radiotherapy for cervical cancer: A single-arm, phase Ⅱ trial |
| 投稿时间：2024-11-13 |
| DOI：10.3760/cma.j.cn112271-20241113-00436 |
| 中文关键词: 宫颈癌 放射性腹泻 长双歧杆菌BL21 肠道菌群 |
| 英文关键词:Cervical cancer Radiation-induced diarrhea (RID) Bifidobacterium longum subsp. longum BL21 Gut microbiota |
| 基金项目:江苏省卫生健康委员会科研项目-面上项目(M2021081);苏州市姑苏卫生人才计划人才科研项目(GSWS2021025);苏州大学临床医学教育家计划项目(MA12300123);苏州市放射肿瘤学临床医学中心(Szlcyxzx202103),肿瘤治疗学省医学重点学科建设单位(JSDW202236) |
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| 中文摘要: |
| 目的 评估益生菌长双歧杆菌BL21(BL21)预防宫颈癌放疗期间放射性腹泻(RID)的安全性与有效性, 以及患者肠道菌群的情况。方法 本研究是一项前瞻性单臂Ⅱ期临床研究, 自2023年4月至2023年11月, 入组在苏州大学附属第二医院放疗科接受根治性或辅助性放疗的宫颈癌患者, 自放疗第1天起1包/d口服BL21菌粉(每包含200亿CFU长双歧杆菌BL21)至放疗结束。通过不良事件的通用术语标准5.0版本判断放疗期间不良事件和RID的发生情况, 从而评估BL21预防RID的安全性和有效性;通过16SrRNA测序法分析放疗前后肠道菌群的变化。结果 共入组宫颈癌患者35例, 29例纳入最终分析。研究中没有观察到与BL21相关的严重不良事件。RID程度较轻, 有22例患者放疗期间未发生或仅出现1级RID。放疗后粪便样本中菌群α多样性降低(Chao1: P = 0.002, Shannon: P = 0.005), Clostridium属(LDA score = 3.98)的丰度较高。放疗后未发生RID和1级RID患者粪便样本中, 菌群α多样性较2级以上患者呈现更高的趋势(Chao1: P = 0.07, Shannon: P = 0.28), Gemmiger属(LDA score = 4.48)和Dorea属(LDA score = 3.83)的丰度较高。结论 宫颈癌放疗过程中使用BL21简单方便, 安全性高, 对预防RID有效, 值得进一步展开研究。 |
| 英文摘要: |
| Objective To evaluate the safety and efficacy of the probiotic Bifidobacterium longum subsp. longum BL21 (BL21) in preventing radiation-induced diarrhea (RID) in cervical cancer patients during radiotherapy (RT) and to investigate the intestinal microbiota in the patients. Methods This study was a prospective, single-arm, phase Ⅱ clinical trial, involving cervical cancer patients treated with radical and adjuvant RT. From the first day of RT, participants took one pack of BL21 powder (containing 20 billion colony-forming unit(CFU) of Bifidobacterium longum subsp. longum BL21) orally every day until the end of RT. The occurrence of adverse events and RID during RT were assessed as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0. In this way, the safety and efficacy of BL21 in preventing RID were evaluated. Additionally, the intestinal microbiota in fecal samples collected from the patients before and after RT were analyzed using 16S rRNA sequencing. Results A total of 35 cervical cancer patients were enrolled in this study, with 29 cases incorporated for the final analysis. No serious adverse event related to the administration of BL21 was observed. The patients exhibited slight RID, with the majority (22/29) developing no or grade 1 RID during RT. The microbiota in the fecal samples showed decreased alpha diversity after RT, as indicated by the Chao1 (P = 0.002) and Shannon (P = 0.005) indices. Furthermore, these samples exhibited a notably higher abundance of genus Clostridium (LDA score = 3.98). The fecal samples from patients with grade 1 RID or no RID post-RT exhibited higher alpha diversity than those from patients with grade 2 RID or above post-RT (Chao1: P = 0.07, Shannon: P = 0.28), as well as a high abundance of genera Gemmiger (LDA score = 4.48) and Dorea (LDA score = 3.83). Conclusions The administration of BL21 to cervical cancer patients during RT is simple, convenient, safe, and effective in preventing RID, thus warranting further investigation. |
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