姜黄素改善放射性口腔黏膜炎的疗效：一项初步的随机对照临床试验。
Efficacy of curcumin for amelioration of radiotherapy-induced oral mucositis: a preliminary randomized controlled clinical trial.
机构信息
Department of Pharmaceutics, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran.
Pharmaceutical Sciences Research Center, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran.
出版信息
BMC Cancer. 2023 Apr 17;23(1):354. doi: 10.1186/s12885-023-10730-8.
BACKGROUND
Oral mucositis (OM) is one of the main problems in almost all patients undergoing head and neck radiotherapy (RT). Owning to the antioxidant and anti-inflammatory properties of curcumin, the effect of both oral and topical formulations of curcumin was assessed on radiation-induced OM (ROM) in this study.
METHODS
The safety and efficacy of curcumin mouthwash 0.1% (w/v) and curcumin-nanocapsule were evaluated in ameliorating severity and pain/burning associated with OM during RT. The current randomized, placebo-controlled trial was conducted on 37 patients with head and neck cancers. Patients with grades 1 to 3 of ROM were randomized to receive one of the three interventions: curcumin mouthwash (0.1% w/v); Sinacurcumin soft gel containing 40 mg curcuminoids as nano-micelles (SinaCurcumin®40); or placebo mouthwash with a similar transparent appearance to curcumin mouthwash for 1 min three times daily during RT. Study evaluations were conducted at baseline and weekly thereafter for up to 3 weeks using the Numeric rating scale (NRS) and world health organization (WHO) scale.
RESULTS
Among the 45 patients randomized, 37 (mean (SD) age of 53.36 (15.99) years; 14 [37.8%] women) completed the treatment according to the protocol. Patients treated with either oral or topical curcumin showed a significantly reduced severity and burning related to OM during the first 3 weeks after administration (P-Value < 0.001) as compared with the placebo. At study termination, more than 33% of subjects utilizing curcumin mouthwash and 15% of patients utilizing curcumin-nanocapsule remained ulcer free while all of the placebo-receiving subjects had OM. The reduction of NRS and WHO scale between curcumin groups was comparable without significant differences.
CONCLUSION
Both curcumin mouthwash and nanocapsule were effective, safe, and well-tolerated in the treatment of radiation-induced OM. Higher doses of curcumin and larger sample sizes can be used for further investigation in future studies.
TRIAL REGISTRATION
https://irct.ir/ IRCT20190810044500N17 (13/08/2021).
背景
口腔黏膜炎（OM）是几乎所有接受头颈部放射治疗（RT）的患者的主要问题之一。由于姜黄素具有抗氧化和抗炎特性，因此评估了姜黄素的口服和局部制剂对放射诱导的 OM（ROM）的影响。
方法
在 RT 期间，使用 0.1%（w/v）姜黄素漱口水和姜黄素纳米胶囊来评估姜黄素漱口水改善 OM 严重程度和疼痛/烧灼感的安全性和有效性。本随机、安慰剂对照试验共纳入 37 例头颈部癌症患者。ROM 为 1 至 3 级的患者随机接受以下三种干预措施之一：0.1%（w/v）姜黄素漱口水；含有 40mg 姜黄素类的 Sinacurcumin 软凝胶（SinaCurcumin®40）；或 RT 期间每天使用三次、外观与姜黄素漱口水相似的安慰剂漱口水，每次 1 分钟。在基线和之后每周进行研究评估，使用数字评分量表（NRS）和世界卫生组织（WHO）量表进行评估。
结果
在随机分组的 45 例患者中，37 例（平均年龄 53.36±15.99 岁；14 例[37.8%]为女性）按方案完成了治疗。与安慰剂相比，接受口腔或局部姜黄素治疗的患者在给药后前 3 周 OM 的严重程度和烧灼感显著降低（P 值<0.001）。研究结束时，使用姜黄素漱口水的受试者中有超过 33%没有溃疡，而使用姜黄素纳米胶囊的患者中有 15%没有溃疡，而所有使用安慰剂的患者都有 OM。姜黄素组之间 NRS 和 WHO 量表的减少相当，无显著差异。
结论
姜黄素漱口水和纳米胶囊在治疗放射诱导的 OM 方面既有效又安全且耐受性良好。未来的研究可以使用更高剂量的姜黄素和更大的样本量进行进一步研究。
试验注册
https://irct.ir/IRCT20190810044500N17（2021 年 8 月 13 日）。
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