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纳米姜黄素对乳腺癌患者放疗引起的皮肤反应的影响:一项随机、三盲、安慰剂对照试验

Effect of Nano-Curcumin on Radiotherapy-Induced Skin Reaction in Breast Cancer Patients: A Randomized, Triple-Blind, Placebo-Controlled Trial.

作者信息

Talakesh Tamara, Tabatabaee Nasibeh, Atoof Fatemeh, Aliasgharzadeh Akbar, Sarvizade Mostafa, Farhood Bagher, Najafi Masoud

机构信息

Department of Medical Physics and Radiology, Faculty of Paramedical Sciences, Kashan University of Medical Sciences, Kashan, Iran.

The Advocate Center for Clinical Research, Ayatollah Yasrebi Hospital, Kashan, Iran.

出版信息

Curr Radiopharm. 2022;15(4):332-340. doi: 10.2174/1874471015666220623104316.

DOI:10.2174/1874471015666220623104316
PMID:35747962
Abstract

PURPOSE

Despite advances in medical technology, radiation-induced dermatitis occurs in 95% of cancer patients receiving radiation therapy. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The aim of this study was to determine the efficacy of nano-curcumin in alleviating the radiation-induced skin reactions (RISRs) in breast cancer patients.

METHODS

A randomized, triple-blinded, placebo-controlled clinical trial was performed on 42 patients with breast cancer. The patients were randomly allocated to receive radiotherapy plus placebo (control group) and radiotherapy plus 80 mg/day nano-curcumin capsules (treatment group) up to two weeks after the end of treatment. Then, the RISRs (graded by the radiation therapy oncology group (RTOG) scale) and pain level of the patients were evaluated at baseline and weekly. Finally, the results were analyzed by T-test and Pearson chi-square test.

RESULTS

According to the RTOG scale, 0%, 14.28%, and 85.71% of patients in the control group showed grades 0, 1, and 2 RISRs, respectively. In the treatment group, it was observed that 9.52%, 47.61%, and 42.85% of patients had grades 0, 1, and 2 RISRs, respectively. Compared to the control group, it was found that concomitant use of the nano-curcumin supplement did not significantly reduce the RISR severity during the first to sixth weeks (P > 0.05); however, there was a significant difference at week 7 (P = 0.01). Moreover, the patient-reported pain, as the secondary endpoint, was significantly reduced in the treatment group compared with the control group (P < 0.05).

CONCLUSIONS

In general, it was found that the administration of nano-curcumin could alleviate radiation- induced skin toxicity of breast cancer patients, but this effect was not significant.

摘要

目的

尽管医疗技术有所进步,但接受放射治疗的癌症患者中95%会发生放射性皮炎。目前,对于预防或控制放射性皮炎尚无标准且有效的治疗方法。本研究的目的是确定纳米姜黄素在减轻乳腺癌患者放射性皮肤反应(RISRs)方面的疗效。

方法

对42例乳腺癌患者进行了一项随机、三盲、安慰剂对照的临床试验。患者被随机分配接受放疗加安慰剂(对照组)和放疗加80毫克/天纳米姜黄素胶囊(治疗组),直至治疗结束后两周。然后,在基线和每周对患者的RISRs(根据放射肿瘤学组(RTOG)量表分级)和疼痛程度进行评估。最后,通过T检验和Pearson卡方检验分析结果。

结果

根据RTOG量表,对照组中分别有0%、14.28%和85.71%的患者表现为0级、1级和2级RISRs。在治疗组中,观察到分别有9.52%、47.61%和42.85%的患者为0级、1级和2级RISRs。与对照组相比,发现同时使用纳米姜黄素补充剂在第1至6周期间并未显著降低RISR严重程度(P>0.05);然而,在第7周存在显著差异(P = 0.01)。此外,作为次要终点的患者报告的疼痛在治疗组中与对照组相比显著降低(P<0.05)。

结论

总体而言,发现给予纳米姜黄素可减轻乳腺癌患者的放射性皮肤毒性,但这种效果并不显著。

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