目的 探讨安替可胶囊联合TP方案（紫杉醇＋顺铂）治疗晚期食管鳞癌的临床疗效。方法 选取2019年1月—2022年1月河南省人民医院收治的100例术后复发转移、晚期转移无法手术治疗的晚期食管鳞癌患者，将所有患者随机分为对照组（50例）和治疗组（50例）。对照组第1天静脉滴注紫杉醇注射液135 mg/m²，第1～3天静脉滴注顺铂注射液75 mg/m²。治疗组于对照组基础上口服安替可胶囊，2粒/次，3次/d。3周为1个治疗周期，两组患者持续治疗3个周期。观察两组的临床疗效，比较两组肿瘤标志物[鳞状细胞癌抗原（SCC-Ag）、细胞角蛋白19片段（CYFRA21-1）、癌胚抗原（CEA）、糖类抗原125（CA125）]、细胞免疫功能淋巴细胞（CD3⁺、CD4⁺、CD8⁺、CD4⁺/CD8⁺）、生存质量（QLQ-C30评分、KPS评分）以及不良反应、随访1年的生存情况。结果 治疗后，治疗组客观缓解率（42.00%）、疾病控制率（74.00%）明显高于对照组（22.00%、52.00%），组间比较差异有显著性（P＜0.05）。治疗后，两组QLQ-C30评分、KPS评分均显著升高（P＜0.05），治疗组QLQ-C30评分、KPS评分显著高于对照组（P＜0.05）。治疗后，对照组CD3⁺、CD4⁺、CD4⁺/CD8⁺显著降低，CD8⁺显著升高（P＜0.05）；治疗组CD3⁺、CD4⁺、CD4⁺/CD8⁺明显高于对照组，CD8⁺低于对照组（P＜0.05）。治疗后，两组血清SCC-Ag、CYFRA21-1、CEA、CA125水平均显著降低（P＜0.05），治疗组血清SCC-Ag、CYFRA21-1、CEA、CA125水平显著低于对照组（P＜0.05）。治疗组不良反应发生率为28.00%，明显低于对照组不良反应发生率48.00%，组间比较差异有显著性（P＜0.05）。随访1年后，治疗组中位生存期、肿瘤无进展时间均明显长于对照组（P＜0.05）。结论 安替可胶囊联合TP方案治疗晚期食管鳞癌能增强治疗效果，提高生活质量，减轻免疫功能抑制，降低肿瘤标志物水平，有助于延长患者生存期。

Objective To investigate the clinical efficacy of Antike Capsules combined with TP chemotherapy regimen (paclitaxel + cisplatin) in treatment of advanced esophageal squamous cell carcinoma. Methods Patients (100 cases) with advanced esophageal squamous cell carcinoma patients with recurrence, metastasis, and advanced metastasis that cannot be treated surgically in Henan Provincial People’s Hospital from January 2019 to January 2022 were randomly divided into control and treatment groups, and each group had 50 cases. Patients in the control group were iv administered with Paclitaxel Injection at 135 mg/m²on the first day, and patients in the control group were iv administered with Cisplatin Injection at 75 mg/m²from first to third day. Patients in the treatment group were po administered with Antike Capsules on the basis of the control group, 2 grains/time, three times daily. Three weeks was one treatment course, and patients in two groups continued to be treated for three courses. After treatment, the clinical efficacies were evaluated, and tumor markers (SCC-Ag, CYFRA21-1, CEA, and CA125), cellular immune function [lymphocytes (CD3⁺, CD4⁺, CD8⁺, and CD4⁺/CD8⁺], quality of life (QLQ-C30 score and KPS score), 1-year follow-up survival and adverse reactions were compared between two groups. Results After treatment, the objective response rate (42.00%) and disease control rate (74.00%) of the treatment group were significantly higher than those of the control group (22.00%, 52.00%), with significant differences between two groups (P < 0.05). After treatment, QLQ-C30 score and KPS score of two groups were significantly increased (P < 0.05), and QLQ-C30 score and KPS score of the treatment group was significantly higher than those of the control group (P < 0.05). After treatment, CD3⁺, CD4⁺, CD4⁺/CD8⁺ in the control group were significantly reduced, while CD8⁺ in the control group was significantly increased (P <0.05). CD3⁺, CD4⁺, CD4⁺/CD8⁺ in the treatment group were significantly higher than those in the control group, while CD8⁺ in the treatment group was lower than that in the control group (P < 0.05). After treatment, the serum levels of SCC-Ag, CYFRA21-1, CEA, and CA125 in two groups were significantly reduced (P < 0.05), the serum levels of SCC-Ag, CYFRA21-1, CEA, and CA125 in the treatment group were significantly lower than those in the control group (P < 0.05). The incidence of adverse reactions in the treatment group was 28.00%, significantly lower than 48.00% in the control group, and there was a significant difference between two groups (P < 0.05). After 1 year of follow-up, the median survival time and tumor progression free time in the treatment group were significantly longer than those in the control group (P <0.05). Conclusion Antike Capsules combined with TP chemotherapy regimen in treatment of advanced esophageal squamous cell carcinoma can enhance the therapeutic effect, improve quality of life, alleviate immune suppression, reduce tumor marker levels, and help prolong patient survival period.

R979.1

河南省科技攻关项目(212102310693)