信迪利单抗联合沙利度胺治疗中晚期食管癌的临床研究

doi:10.3760/cma.j.cn441417-20240425-05021

摘要/Abstract

摘要：

目的　探讨信迪利单抗联合沙利度胺治疗中晚期食管癌的效果。方法　本研究为随机对照试验。按随机数字表法将2020年1月至2023年1月铜川市人民医院就诊的155例中晚期食管癌患者分为研究组（77例）和对照组（78例）。对照组男41例，女37例，年龄（60.41±8.21）岁，体重指数（22.86±1.24）kg/m²，肿瘤分期：Ⅱ期10例、Ⅲ期30例、Ⅳ期38例；研究组男44例，女33例，年龄（59.32±8.06）岁，体重指数（22.91±1.28）kg/m²，肿瘤分期：Ⅱ期8例、Ⅲ期27例、Ⅳ期42例。对照组在常规化疗基础上口服沙利度胺，200 mg/次，1次/d。研究组在对照组基础上静脉滴注信迪利单抗200 mg，每21 d给药一次。两组均以21 d为1个化疗周期，治疗4个周期后评价疗效，对比两组抗肿瘤疗效、肿瘤标志物水平、免疫功能、药物不良反应，随访1年生存情况。采用独立样本t检验、配对t检验、χ²检验、Log-rank检验进行统计学分析。结果　研究组的客观缓解率［33.77%（26/77）］、疾病控制率［85.71%（66/77）］高于对照组［19.23%（15/78）、71.79%（56/78）］，差异均有统计学意义（均P<0.05）。治疗后，研究组的癌胚抗原、鳞状细胞癌抗原、细胞角蛋白19片段抗原水平均低于对照组［（26.27±4.18）ng/L比（35.19±5.12）ng/L、（20.03±3.27）ng/L比（24.25±4.01）ng/L、（14.92±2.73）ng/L比（18.23±3.14）ng/L］，差异均有统计学意义（均P<0.05）。治疗后，研究组的辅助性T细胞1/辅助性T细胞2高于对照组［（6.37±0.98）%比（6.01±1.02）%］，辅助性T细胞17/调节性T细胞低于对照组［（1.02±0.15）%比（1.23±0.19）%］，差异均有统计学意义（均P<0.05）。两组总不良反应发生率对比差异无统计学意义（P>0.05）。随访1年，研究组和对照组分别存活48例和36例，研究组总生存优于对照组（P<0.05）。结论　信迪利单抗联合沙利度胺治疗中晚期食管癌可增强抗肿瘤疗效，改善患者免疫功能，安全可靠。

关键词:

信迪利单抗, 沙利度胺, 食管癌, 疗效, 安全性

Abstract:

Objective　To investigate the effect of Sintilimab combined with thalidomide in the treatment of advanced esophageal cancer. Methods　This study was a randomized controlled trial. According to the random number table method, 155 patients with advanced esophageal cancer treated in People's Hospital of Tongchuan from January 2020 to January 2023 were divided into a study group (77 cases) and a control group (78 cases). In the control group, there were 41 males and 37 females, aged (60.41±8.21) years, with a body mass index (BMI) of (22.86±1.24) kg/m², and the tumor stages were as follows: stage Ⅱ in 10 cases, stage Ⅲ in 30 cases, and stage Ⅳ in 38 cases. In the study group, there were 44 males and 33 females, aged (59.32±8.06) years, with a BMI of (22.91±1.28) kg/m², and the tumor stages were as follows: stage Ⅱ in 8 cases, stage Ⅲ in 27 cases, and stage Ⅳ in 42 cases. The control group was given thalidomide orally, 200 mg/time, once a day, on the basis of conventional chemotherapy. The study group was given 200 mg of Sintilimab intravenously every 21 days on the basis of the control group. With 21 days as one chemotherapy cycle, and the efficacy was evaluated in both groups after 4 cycles of treatment. The anti-tumor efficacy, levels of tumor markers, immune function, and adverse drug reactions of the two groups were compared, and the survival status was followed up for 1 year. Independent sample t test, paired t test, χ² test, and Log-rank test were used for statistical analysis. Results　The objective response rate [33.77% (26/77)] and disease control rate [85.71% (66/77)] of the study group were higher than those of the control group [19.23% (15/78) and 71.79% (56/78)], with statistically significant differences (both P<0.05). After treatment, the levels of carcinoembryonic antigen, squamous cell carcinoma antigen, and cytokeratin 19 fragment antigen in the study group were lower than those in the control group [(26.27±4.18) ng/L vs. (35.19±5.12) ng/L, (20.03±3.27) ng/L vs. (24.25±4.01) ng/L, (14.92±2.73) ng/L vs. (18.23±3.14) ng/L], with statistically significant differences (all P<0.05). After treatment, helper T cell 1/helper T cell 2 in the study group was higher than that in the control group [(6.37±0.98)% vs. (6.01±1.02)%], and helper T cell 17/regulatory T cells was lower than that in the control group [(1.02±0.15)% vs. (1.23±0.19)%], with statistically significant differences (both P<0.05). There was no statistically significant difference in the total incidence of adverse reactions between the two groups (P>0.05). After 1 year of follow-up, 48 and 36 patients survived in the study group and the control group, respectively, and the total survival of the study group was better than that of the control group (P<0.05). Conclusion　Sintilimab combined with thalidomide in the treatment of advanced esophageal cancer can enhance the anti-tumor effect, improve the patients' immune function, and is safe and reliable.

Key words:

Sintilimab, Thalidomide, Esophageal cancer, Curative effect, Security

宋群莉关微陈瑶莉.

信迪利单抗联合沙利度胺治疗中晚期食管癌的临床研究 [J]. 国际医药卫生导报, 2025, 31(5): 806-810.

Song Qunli, Guan Wei, Chen Yaoli.

Clinical study of Sintilimab combined with thalidomide in the treatment of advanced esophageal cancer [J]. International Medicine and Health Guidance News, 2025, 31(5): 806-810.

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