Karbasforooshan Hedyieh, Rahimi Hossein, Arasteh Omid, Allahyari Abolghasem, Varmaghani Mehdi, Jannati Mahdi, Ghavami Vahid, Jaafari Mahmoodreza, Elyasi Sepideh
Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Internal Medicine, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
Iran J Pharm Res. 2024 Dec 16;23(1):e152364. doi: 10.5812/ijpr-152364. eCollection 2024 Jan-Dec.
Folinic acid, fluorouracil, and oxaliplatin (FOLFOX) and oxaliplatin and capecitabine (XELOX) are the most widely used chemotherapy regimens for treating metastatic colorectal carcinoma (CRC). These regimens are associated with various adverse reactions, including neuropathy and hand-foot syndrome (HFS). Silymarin, a flavonoid derived from , has a wide range of biological activities. It has been used to counteract chemotherapy side effects due to its antioxidant, anti-apoptotic, and anti-inflammatory properties.
The purpose of this study was to assess the preventive effect of nano-silymarin on neuropathy and HFS induced by the FOLFOX6 and XELOX regimens.
A randomized, triple-blinded, placebo-controlled clinical trial was conducted on 60 patients who were randomly assigned to receive 70 mg capsules containing 15% silymarin nano micelles twice a day after meals, starting from the first day of the first chemotherapy course and continuing for six courses of the XELOX or m-FOLFOX6 regimen. The severity of adverse effects was assessed after the third and sixth courses based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.
The median CTCAE scores for HFS and neuropathy were significantly lower in the nano-silymarin group at the end of the third course (P < 0.001). However, the difference remained significant only for HFS at the end of the sixth course (P = 0.022). Additionally, the scores increased significantly in both the placebo and nano-silymarin groups during the therapy (P < 0.05).
Nano-silymarin may be considered an adjuvant medication for the prevention of certain chemotherapy-induced adverse reactions. Further research with larger sample sizes and various doses of nano-silymarin is recommended for a more comprehensive evaluation.
亚叶酸、氟尿嘧啶和奥沙利铂（FOLFOX）以及奥沙利铂和卡培他滨（XELOX）是治疗转移性结直肠癌（CRC）最广泛使用的化疗方案。这些方案会引发各种不良反应，包括神经病变和手足综合征（HFS）。水飞蓟素是一种从[来源未明确]提取的类黄酮，具有广泛的生物活性。因其抗氧化、抗凋亡和抗炎特性，它已被用于对抗化疗副作用。
本研究旨在评估纳米水飞蓟素对FOLFOX6和XELOX方案诱导的神经病变和HFS的预防作用。
对60例患者进行了一项随机、三盲、安慰剂对照的临床试验，这些患者被随机分配，从第一个化疗疗程的第一天开始，每天饭后服用两次含15%水飞蓟素纳米胶束的70毫克胶囊，持续进行六个疗程的XELOX或m-FOLFOX6方案。根据美国国立癌症研究所不良事件通用术语标准（NCI-CTCAE）第5版，在第三个疗程和第六个疗程后评估不良反应的严重程度。
在第三个疗程结束时，纳米水飞蓟素组HFS和神经病变的CTCAE中位数评分显著较低（P < 0.001）。然而，在第六个疗程结束时，仅HFS的差异仍然显著（P = 0.022）。此外，在治疗期间，安慰剂组和纳米水飞蓟素组的评分均显著增加（P < 0.05）。
纳米水飞蓟素可被视为预防某些化疗引起的不良反应的辅助药物。建议进行更大样本量和不同剂量纳米水飞蓟素的进一步研究，以进行更全面的评估。
