云芝糖肽胶囊联合TC方案治疗中晚期食管癌的临床研究

Clinical study on Yunzhi Tangtai Capsules combined with TC regimen in treatment of esophageal cancer

目的探讨云芝糖肽胶囊联合TC方案(紫杉醇和卡铂)治疗食管癌的临床疗效。方法选取2017年7月-2018年7月在青岛大学附属医院治疗的食管癌患者88例,根据用药方案的差别分为对照组(44)例和治疗组(44)例。对照组静脉滴注紫杉醇注射液,175 mg/m2加入5%葡萄糖注射液500 mL,同时静脉滴注卡铂注射液,AUC等于5加入5%葡萄糖注射液500 mL,1次/4周,共治疗4次;治疗组在对照组基础上口服云芝糖肽胶囊,3粒/次,3次/d。两组患者均经过4个周期治疗。观察两组患者临床疗效,同时比较治疗前后两组患者血清癌胚抗原(CEA)、可溶型MHC-I类链相关蛋白A(s MICA)、细胞角蛋白19片段(CYFRA21-1)、核转录调节因子YY1抗体(YY1)、鳞状细胞癌抗原(SCC-Ag)、骨桥蛋白受体(CD44v)、血管内皮生长因子(VEGF)、基质金属蛋白酶-9(MMP-9)、骨桥蛋白(OPN)、CD3+、CD4+、CD4+/CD8+水平及QLQ-C30和SF-36量表评分。结果治疗后,对照组客观缓解率和临床获益率分别率为40.91%和61.36%,均分别显著低于治疗组的63.64%和70.45%,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者血清CEA、s MICA、CYFRA21-1、YY1、SCC-Ag、CD44v、VEGF、MMP-9、OPN水平均显著下降(P<0.05),且治疗组患者这些指标血清水平明显低于对照组(P<0.05)。治疗后,两组患者CD3+、CD4+、CD4+/CD8+水平显著升高(P<0.05),CD8+水平显著降低(P<0.05),且治疗组患者上述T淋巴细胞亚群水平水平明显好于对照组(P<0.05)。治疗后,两组患者QLQ-C30量表评分、SF-36量表评分均明显升高(P<0.05),且治疗组患者QLQ-C30和SF-36量表评分明显高于对照组(P<0.05)。结论云芝糖肽胶囊联合紫杉醇和卡铂治疗食管癌可有效改善患者症状,提高机体免疫能力,降低机体肿瘤标志物水平和侵袭细胞因子水平,有利于提高患者生活质量。

Objective To investigate the clinical efficacy of Yunzhi Tangtai Capsules combined with TC regimen in treatment of esophageal cancer. Methods Patients(88 cases) with esophageal cancer in the Affiliated Hospital of Qingdao University from July 2017 to July 2018 were divided into control(44 cases) and treatment(44 cases) groups based on different treatments. Patients in the control group were iv administered with Paclitaxel Injection, 175 mg/m2 added into 5% glucose injection 500 mL, and at the same time administered with Carboplatin Injection, 5 of AUC added into 5% glucose injection 500 mL, once every 4 weeks, they were treated for 4 times. Patients in the treatment group were po administered with Yunzhi Tangtai Capsules on the basis of the control group, 3 grains/time, three times daily. Patients in two groups were treated for 16 weeks. After treatment, the clinical efficacy was evaluated, and the serum levels of CEA, s MICA, CYFRA21-1, YY1 SCC-Ag, CD44 v, VEGF, MMP-9, OPN, and CD3+, CD4+ CD4+/CD8+, QLQ-C30 scores, and SF-36 scores in two groups before and after treatment were compared. Results After treatment, the objective reaction rate and clinical benefit rate in the control group were 40.91% and 61.36%, which were significantly lower than 63.64% and 70.45% in the treatment group, respectively, and there were differences between two groups(P < 0.05). After treatment, the serum levels of CEA, sMICA, CYFRA21-1, YY1, SCC-Ag CD44 v, VEGF, MMP-9 and OPN in two groups were significantly decreased(P < 0.05), and these indexes levels in the treatment group were significantly lower than those in the control group(P < 0.05). After treatment, the CD3+, CD4+, CD4+/CD8+ in two groups were significantly increased(P < 0.05), but CD8+ was significantly decreased(P < 0.05), and the levels of T lymphocyte subsets in the treatment group were significantly better than that in the control group(P < 0.05). After treatment, the QLQ-C30 scores, and SF-36 scores in two groups were significantly increased(P < 0.05), and these scores in the treatment group were significantly higher than those in the control group(P < 0.05). Conclusion Yunzhi Tangtai Capsules combined with TC regimen in treatment of esophageal cancer can effectively improve the symptoms, improve the immune capacity, reduce the level of tumor markers and invasive cytokines, and improve the quality of life.