姜黄素作为辅助治疗改善骨髓瘤患者缓解情况：一项前瞻性随机临床试验。
Curcumin as adjuvant therapy to improve remission in myeloma patients: A pilot randomized clinical trial.
作者信息
Santosa Damai, Suharti Catharina, Riwanto Ignatius, Dharmana Edi, Pangarsa Eko Adhi, Setiawan Budi, Suyono Suyono, Tobing Mika Lumban, Suhartono Suhartono, Hadisapurto Soeharyo
机构信息
Division of Hematology-Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Diponegoro University/Dr. Kariadi General Hospital, Jawa Tengah, Indonesia.
Departmen of Surgery, Faculty of Medicine, Diponegoro University, Jawa Tengah, Indonesia.
出版信息
Caspian J Intern Med. 2022 Spring;13(2):375-384. doi: 10.22088/cjim.13.2.9.
BACKGROUND
The treatment for ineligible transplant multiple myeloma is melphalan prednisone. Curcumin has an anti-inflammatory and antiangiogenesis in cancer-directed to nuclear factor-kappa B (NF-kB) pathway. Interleukin 6 (IL-6), vascular endothelial growth factor (VEGF), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP), and lactate dehydrogenase (LDH) were also involved in the pathogenesis of myeloma. No clinical study has evaluated the efficacy of curcumin in myeloma patients. To evaluate the efficacy of curcumin as adjuvant into melphalan prednisone in myeloma patients.
METHODS
33 myeloma patients at Dr. Kariadi General Hospital, Semarang, Indonesia during 2016-2017 were randomly assigned single-blindedly into MPC (n=17) and control group (n=16). The MPC group was treated with melphalan 4 mg/m2, prednisone 40 mg/m2 for 7 days, and curcumin 8 gram daily for 28 days. The MP control group was treated with melphalan, prednisone, and placebo. The primary endpoint was the overall remission. Pre- and post-treatment was examined for NF-κB, VEGF, TNF-α, IL-6, LDH, and CRP levels All data analyses were per protocol.
RESULTS
There was a significant difference in overall remission between the MPC and MP control groups [75%vs 33.3%, x=6.89, P=0.009]. A significant decrease of NF-κB, VEGF, TNF-α levels were shown in the MPC group compared with the MP control group. There was a significant decrease in IL-6 levels in a subgroup analysis of the MPC group. TNF-α levels had a significant correlation with remission [OR=1.35; (95%CI=1.03-1.76); P=0.03].
CONCLUSION
Curcumin has an efficacy in improving overall remission and decreasing NF-κB, VEGF, TNF-α, and IL-6 levels in myeloma patients
背景
对于不符合移植条件的多发性骨髓瘤，治疗方法是美法仑泼尼松。姜黄素在针对核因子-κB（NF-κB）途径的癌症中具有抗炎和抗血管生成作用。白细胞介素6（IL-6）、血管内皮生长因子（VEGF）、肿瘤坏死因子-α（TNF-α）、C反应蛋白（CRP）和乳酸脱氢酶（LDH）也参与了骨髓瘤的发病机制。尚无临床研究评估姜黄素对骨髓瘤患者的疗效。本研究旨在评估姜黄素作为美法仑泼尼松辅助药物对骨髓瘤患者的疗效。
方法
2016年至2017年期间，印度尼西亚三宝垄卡里阿迪综合医院的33例骨髓瘤患者被单盲随机分为MPC组（n=17）和对照组（n=16）。MPC组患者接受美法仑4mg/m²、泼尼松40mg/m²治疗7天，以及姜黄素8克/天治疗28天。MP对照组接受美法仑、泼尼松和安慰剂治疗。主要终点是总体缓解率。在治疗前后检测NF-κB、VEGF、TNF-α、IL-6、LDH和CRP水平。所有数据分析均按照方案进行。
结果
MPC组和MP对照组的总体缓解率存在显著差异[75%对33.3%，χ=6.89，P=0.009]。与MP对照组相比，MPC组的NF-κB、VEGF、TNF-α水平显著降低。在MPC组的亚组分析中，IL-6水平显著降低。TNF-α水平与缓解率有显著相关性[OR=1.35；（95%CI=1.03-1.76）；P=0.03]。
结论
姜黄素对提高骨髓瘤患者的总体缓解率以及降低NF-κB、VEGF、TNF-α和IL-6水平有效。
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