Mirza Mehdi Ali, Aruna D, Irukulla Monica
Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.
Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India.
Cancer Treat Res Commun. 2022;31:100523. doi: 10.1016/j.ctarc.2022.100523. Epub 2022 Jan 25.
The natural flora of healthy mucosa offer protection to the host. The loss of this barrier during radiotherapy enhances insults from physical, chemical and microbial agents.
A randomized, double blind, placebo-controlled, parallel study on forty-six patients who underwent radiotherapy for head and neck cancers was undertaken. Patients were randomized either to standard treatment plus Bacillus clausii UBBC07 or standard treatment plus placebo. Bacillus clausii UBBC07 was given as an oral suspension of 2 billion spores twice every day for 30 days or until completion of total fractions of radiation. Grading of the mucositis was performed using CTCAE v.4.03 severity scale. The time taken for the appearance, resolution and severity of mucositis was evaluated.
There was a significant increase (p < 0.01) in median time for the onset of mucositis i.e., 10 days in test and 8 days in control groups respectively. The median time for remission was found to be 12 days in test and 14 days in the control group (p < 0.05). Grade IV mucositis was observed in no patients in test group and 2 patients in the control group (p < 0.05). No adverse events attributed to the Bacillus clausii were seen. Bacillus clausii UBBC07 therapy delayed the onset, decreased the time to remission and displayed strong impact on suppressing the occurrence of high-grade mucositis amongst the test group.
This study provides a positive trend that probiotics like Bacillus clausii UBBC07 spores could act as a tool to ameliorate oral mucositis.
健康黏膜的自然菌群为宿主提供保护。放疗期间这种屏障的丧失会增加物理、化学和微生物因素造成的损伤。
对46例接受头颈部癌症放疗的患者进行了一项随机、双盲、安慰剂对照的平行研究。患者被随机分为标准治疗加克劳氏芽孢杆菌UBBC07组或标准治疗加安慰剂组。克劳氏芽孢杆菌UBBC07以20亿孢子的口服混悬液形式，每天服用两次，共30天，或直至完成全部放疗剂量。使用CTCAE v.4.03严重程度量表对黏膜炎进行分级。评估黏膜炎出现、消退的时间及严重程度。
黏膜炎开始的中位时间有显著增加（p<0.01），即试验组为10天，对照组为8天。试验组缓解的中位时间为12天，对照组为14天（p<0.05）。试验组无患者出现IV级黏膜炎，对照组有2例（p<0.05）。未观察到归因于克劳氏芽孢杆菌的不良事件。克劳氏芽孢杆菌UBBC07治疗延迟了试验组黏膜炎的发生，缩短了缓解时间，并对抑制高级别黏膜炎的发生有显著作用。
本研究提供了一个积极的趋势，即像克劳氏芽孢杆菌UBBC07孢子这样的益生菌可以作为改善口腔黏膜炎的一种手段。
