Kotb Raghda R, Afifi Ahmed M, El-Houseini Motawa E, Ezz-Elarab Mohamed, Basalious Emad B, Omran Mervat M, Abdellateif Mona S
Department of Zoology, Faculty of Science, Cairo University, Cairo, Egypt.
Medical Biochemistry and molecular biology, Cancer Biology Department, National Cancer Institute, Cairo University, Cairo, Egypt.
Discov Oncol. 2023 Sep 13;14(1):169. doi: 10.1007/s12672-023-00785-1.
This is a phase II clinical trial to investigate the immunotherapeutic effect of Curcumin, Piperine, and Taurine (CPT) combination in hepatocellular carcinoma (HCC).
Twenty-six HCC patients aged (50-80 years) were recruited for administration of a daily dose of 5 g of curcumin, 50 mg of piperine, and 500 mg of taurine divided into three doses for successive 3 months. The three components (CPT) were prepared in one capsule. Patients were assessed after each month (cycle) for the plasma levels of CD4, CD8, CD25, Interleukins-2 (IL-2), IL-6, IL-12, Interferon-gamma (IFN- γ), Lactate dehydrogenase (LDH), and Vascular endothelial growth factor (VEGF), FOXP3 mRNA, and miRNA 21.
There was a significant increase in the plasma levels of CD4 and CD8, while a significant decrease in the CD25 level after the second and third cycles compared to the baseline level [P < 0.001 for both]. Also, there was a significant increase in the plasma levels of IL-2, IL-12, and IFN-γ [ P = 0.001, P = 0.006, and P = 0.029; respectively], while there was a significant decrease in IL-6, VEGF-α, LDH, and Alpha-fetoprotein (AFP) after CPT administration compared to the baseline levels [P < 0.001, P < 0.001, P = 0.020, and P = 0.004; respectively]. The expression level of miRNA-21 was significantly decreased after CPT administration compared to the baseline level [5.5±0.88, 4.1±0.78, 3±0.75, and 2.5±0.76; respectively, P<0.001]. Though there was a noticeable decrease in the FOXP3 expression after each cycle, however, it didn't reach a significant level [5.3±0.8, 4.2±0.76, 3.2±0.67, and 2.5±0.79; respectively, P=0.184].
CPT could exhibit a potential immune-stimulating effect in HCC patients. The current trial had been registered at the National Hepatology and Tropical Medicine Research Institute (NHTMRI), with a registration number of NHTMRI-IRB 2-21 on 5th January 2021.
这是一项II期临床试验，旨在研究姜黄素、胡椒碱和牛磺酸（CPT）联合用药对肝细胞癌（HCC）的免疫治疗效果。
招募了26名年龄在50至80岁之间的HCC患者，给予每日剂量为5克姜黄素、50毫克胡椒碱和500毫克牛磺酸，分三次给药，连续服用3个月。三种成分（CPT）制成一粒胶囊。每月（周期）对患者进行评估，检测血浆中CD4、CD8、CD25、白细胞介素-2（IL-2）、IL-6、IL-12、干扰素-γ（IFN-γ）、乳酸脱氢酶（LDH）、血管内皮生长因子（VEGF）、FOXP3 mRNA和miRNA 21的水平。
与基线水平相比，第二和第三个周期后血浆中CD4和CD8水平显著升高，而CD25水平显著降低[两者P均<0.001]。此外，血浆中IL-2、IL-12和IFN-γ水平显著升高[分别为P = 0.001、P = 0.006和P = 0.029]，而CPT给药后IL-6、VEGF-α、LDH和甲胎蛋白（AFP）与基线水平相比显著降低[分别为P < 0.001、P < 0.001、P = 0.020和P = 0.004]。与基线水平相比，CPT给药后miRNA-21的表达水平显著降低[分别为5.5±0.88、4.1±0.78、3±0.75和2.5±0.76；P<0.001]。尽管每个周期后FOXP3表达均有明显下降，但未达到显著水平[分别为5.3±0.8、4.2±0.76、3.2±0.67和2.5±0.79；P = 0.184]。
CPT对HCC患者可能具有潜在的免疫刺激作用。本试验已在国家肝病和热带医学研究所（NHTMRI）注册，注册号为NHTMRI-IRB 2-21，注册日期为2021年1月5日。
