Zhang Lin, Liu Liping, Zhao Leina, Yuan Xinmei, Wang Yun, Yang Jing
Department of Pharmacy, Dongying People's Hospital, Dongying Hospital Affiliated to Shandong Provincial Hospital Group, 257091 Dongying, Shandong, China.
Department of General Surgery, Qingdao Eighth People's Hospital, 266100 Qingdao, Shandong, China.
Arch Esp Urol. 2023 Sep;76(7):538-547. doi: 10.56434/j.arch.esp.urol.20237607.67.
This study aimed to investigate the effect of Bushen Yiqi Fuzheng decoction combined with sunitinib on the prognosis, clinical efficacy and immune function of patients with renal cell carcinoma (RCC) after surgery.
A total of 120 patients who experienced RCC after surgery were randomly divided into the observation and control groups in this prospective study, with 60 cases in each group. The therapeutic effect, improvement of clinical symptoms, changes of immune function-related indicators and adverse reactions during medication were recorded. The changes in immune cell population, midkine (MK), interleukin 35 (IL-35), hypoxia-inducible factor 2alpha (HIF-2α), matrix metalloproteinase-9 (MMP-9), tissue inhibitor of metalloproteinase-1 (TIMP-1), carcinoembryonic antigen (CEA), osteopontin (OPN), ferritin (FERR) and beta2-microglobulin (β2-MG) levels were measured. The Karnofsky performance status (KPS) score of patients was recorded.
The total effective rate of the observation group (95%) was better than that of the control group (85%, < 0.05). After treatment, the changes of immune function indexes in the control group were not obvious. The indexes related to immune function in the observation group significantly decreased. Significant differences were observed in the cluster of differentiation 3+ (CD3+), cluster of differentiation 4+ (CD4+), cluster of differentiation 8+ (CD8+) and CD4+/CD8+ between the two groups after treatment. The incidence of adverse reactions in the observation group was lower than that of the control group. The KPS of the observation group was higher than that of the control group. Before treatment, no differences were observed in the MK, IL-35, HIF-2α, CEA, OPN, FERR, β2-MG, MMP-9 and TIMP-1 levels between the two groups. After treatment, the levels of the above parameters were lower than those before treatment, especially in the observation group.
Bushen Yiqi Fuzheng decoction combined with sunitinib can significantly improve the clinical efficacy and postoperative immune function of RCC patients after surgery and down-regulate MMP-9 and TIMP-1 levels in the serum, which is beneficial to the prognosis of patients.
本研究旨在探讨补肾益气扶正汤联合舒尼替尼对肾细胞癌（RCC）患者术后预后、临床疗效及免疫功能的影响。
在这项前瞻性研究中，将120例RCC术后患者随机分为观察组和对照组，每组60例。记录治疗效果、临床症状改善情况、免疫功能相关指标变化及用药期间的不良反应。检测免疫细胞群体、中期因子（MK）、白细胞介素35（IL-35）、缺氧诱导因子2α（HIF-2α）、基质金属蛋白酶-9（MMP-9）、金属蛋白酶组织抑制剂-1（TIMP-1）、癌胚抗原（CEA）、骨桥蛋白（OPN）、铁蛋白（FERR）和β2-微球蛋白（β2-MG）水平的变化。记录患者的卡氏功能状态（KPS）评分。
观察组总有效率（95%）优于对照组（85%，P<0.05）。治疗后，对照组免疫功能指标变化不明显。观察组免疫功能相关指标显著下降。治疗后两组间分化簇3+（CD3+）、分化簇4+（CD4+）、分化簇8+（CD8+）及CD4+/CD8+差异有统计学意义。观察组不良反应发生率低于对照组。观察组KPS高于对照组。治疗前，两组间MK、IL-35、HIF-2α、CEA、OPN、FERR、β2-MG、MMP-9和TIMP-1水平无差异。治疗后，上述参数水平均低于治疗前，尤以观察组为著。
补肾益气扶正汤联合舒尼替尼可显著提高RCC患者术后临床疗效及免疫功能，下调血清MMP-9和TIMP-1水平，有利于患者预后。
