水飞蓟素对接受化疗的癌症患者的肝肾保护作用：一项随机、安慰剂对照试验。
The hepatorenal protective effects of silymarin in cancer patients receiving chemotherapy: a randomized, placebo-controlled trial.
机构信息
Internal Medicine Department, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Community and Family Medicine, School of Medicine, Isfahan University of Medical Sciences, P.O.BOX: 8177773095, Isfahan, Iran.
出版信息
BMC Complement Med Ther. 2024 Sep 4;24(1):329. doi: 10.1186/s12906-024-04627-7.
BACKGROUND
Breast cancer is one of the most common diseases globally that may have side effects on liver and renal function. Pharmacological treatments to reduce adverse liver and renal effects are still limited. It has been proposed that silymarin may possess hepatoprotective and anti-inflammatory properties. The present trial aims to assess the hepatorenal protective efficacy of silymarin supplementation in cancer patients receiving chemotherapy in an outpatient setting.
METHOD
This is a randomized, placebo-controlled clinical trial that recruited female breast cancer patients. Participants were randomly assigned to one placebo group and two intervention groups. The control group received 140 mg of placebo daily, while the two intervention groups received 140 mg silymarin daily. Follow-up assessments were conducted at baseline, 3 weeks, and 6 weeks. At the beginning of the study, the patients were subjected to a computed tomography (CT) scan, and the liver and renal parameters such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, Blood urea nitrogen (BUN) and Creatinine (Cr) were examined through laboratory tests.
RESULTS
Despite two deaths and three dropouts, 100 patients completed the study. Silymarin showed significant effects on liver enzymes in the levels of ALP and bilirubin (P < 0.05), with no significant impact on renal function in the levels of Blood urea nitrogen (BUN) and Creatinine (Cr) (P > 0.05). The medication was well-tolerated, with minimal reported side effects (P > 0.05).
DISCUSSION
The study suggests that silymarin may have hepato-renal protective potential in breast cancer patients and improve patient tolerance to chemotherapy. The data presented on the efficacy and safety of silymarin may provide stronger foundation for further trials and for a possible use in clinical practice.
TRIAL REGISTRATION INFORMATION
Registration Number: IRCT20201123049474N2, First Trial Registration: 16/08/2021, Access: https://www.irct.behdasht.gov.ir/trial/57641.
背景
乳腺癌是全球最常见的疾病之一，可能对肝肾功能有副作用。减少肝肾功能不良影响的药物治疗仍然有限。已经提出水飞蓟素可能具有保肝和抗炎作用。本试验旨在评估水飞蓟素补充剂在门诊接受化疗的癌症患者中的肝肾功能保护效果。
方法
这是一项随机、安慰剂对照的临床试验，招募了女性乳腺癌患者。参与者被随机分配到一个安慰剂组和两个干预组。对照组每天接受 140mg 安慰剂，而两个干预组每天接受 140mg 水飞蓟素。在基线、3 周和 6 周时进行随访评估。在研究开始时，患者接受了计算机断层扫描（CT）扫描，并通过实验室检查检查了肝和肾功能参数，如丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、碱性磷酸酶（ALP）、胆红素、血尿素氮（BUN）和肌酐（Cr）。
结果
尽管有两名患者死亡和三名患者退出，但仍有 100 名患者完成了研究。水飞蓟素对 ALP 和胆红素水平的肝酶有显著影响（P<0.05），对 BUN 和 Cr 水平的肾功能无显著影响（P>0.05）。药物耐受性良好，报告的副作用很少（P>0.05）。
讨论
该研究表明，水飞蓟素可能对乳腺癌患者具有肝肾功能保护潜力，并提高患者对化疗的耐受性。关于水飞蓟素的疗效和安全性的数据可能为进一步的试验提供更坚实的基础，并为在临床实践中的可能应用提供更强的依据。
试验注册信息
注册号：IRCT20201123049474N2，首次试验注册：2021 年 8 月 16 日，访问网址：https://www.irct.behdasht.gov.ir/trial/57641。
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