替雷利珠单抗联合TP化疗方案治疗中晚期食管癌的随机对照研究

doi:magtech-2025-04-19-00001

摘要/Abstract

摘要： 目的：探究替雷利珠单抗联合紫杉醇+顺铂(TP)化疗方案治疗中晚期食管癌的有效性和安全性。方法：选取2021年1月至2023年1月收治的106例中晚期食管癌患者开展随机对照研究，应用随机数字表法分为对照组和研究组，各46例。对照组给予安慰剂注射液联合TP化疗方案，研究组给予替雷利珠单抗联合TP化疗方案。两组均治疗4个周期。比较两组临床疗效、治疗前后免疫功能(CD3+、CD4+、CD4+/CD8+)、血清肿瘤病情指标[癌胚抗原(CEA)、富半胱氨酸蛋白61(Cyr61)、醛酮还原酶1B10(AKR1B10)]、毒副反应及生存情况。结果：研究组疾病缓解率、疾病控制率均高于对照组(P<0.05)；治疗2个周期、4个周期，研究组CD3+、CD4+、CD4+/CD8+水平均高于对照组，血清CEA、Cyr61、AKR1B10水平低于对照组(P<0.05)；治疗期间，两组消化道症状、肝功能异常、骨髓抑制、皮疹、甲状腺功能减退等毒副反应发生率比较，无显著差异(P>0.05)；随访24个月，两组患者生存率比较无显著差异(P>0.05)。结论：替雷利珠单抗联合TP化疗方案能增强中晚期食管癌治疗效果，改善免疫功能，抑制病情进展，安全性较高。

关键词: font-size:medium, ">食管癌；TP化疗；替雷利珠单抗；免疫功能；富半胱氨酸蛋白61；毒副反应

Abstract: Objective： To explore the efficacy and safety of tislelizumab combined with paclitaxel + cisplatin (TP) chemotherapy regimen in the treatment of intermediate and advanced esophageal cancer. Methods： A prospective， randomized， double-blind study was conducted on 106 patients with intermediate and advanced esophageal cancer admitted to our Hospital from January 2021 to January 2023. The patients were randomly assigned to a control group and a study group using a random number table method， with 46 patients in each group. The control group was given a placebo injection combined with the TP chemotherapy regimen， while the study group was given tislelizumab combined with the TP chemotherapy regimen. Both groups underwent treatment for four cycles. The clinical efficacy， toxic and side effects and survival status were compared between the two groups， as well as the immune function (CD3+， CD4+， CD4+/CD8+)， serum tumor disease indicators [carcinoembryonic antigen (CEA)， cysteine-rich protein 61 (Cyr61)， aldehyde-ketone reductase 1B10 (AKR1B10)] before and after treatment. Results： The remission rate and control rate of disease in the study group were higher than those of the control group (P<0.05). After 2 and 4 cycles of treatment， the levels of CD3+， CD4+， and CD4+/CD8+ in the study group were higher than those in the control group， while the levels of serum CEA， Cyr61， and AKR1B10 were lower than those in the control group (P<0.05). During the treatment period， there was no significant difference in the incidence of toxic side effects such as digestive symptoms， abnormal liver function， bone marrow suppression， rash， and hypothyroidism between the two groups (P>0.05). After a follow-up of 24 months， there was no significant difference in survival rate between the two groups (P>0.05). Conclusion： The combination of tislelizumab and TP chemotherapy can enhance the therapeutic effect of intermediate and advanced esophageal cancer， ameliorate immune function， inhibit disease progression， and has high safety.

Key words: font-size:medium, ">Esophageal cancer； TP chemotherapy； Tislelizumab； Immune function； Cysteine-rich protein 61； Toxicity and side effects

中图分类号:

吴聪慧, 岳云霄, 刘会超. 替雷利珠单抗联合TP化疗方案治疗中晚期食管癌的随机对照研究[J]. 中国药物评价, 2025, 42(6): 477-477-481.

WU Conghui, YUE Yunxiao, LIU Huichao. A Prospective， Randomized， Double-blind Controlled Study on the Efficacy of Tislelizumab Combined with TP Chemotherapy Regimen in the#br# Treatment of Patients with Intermediate and Advanced Esophageal Cancer[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025, 42(6): 477-477-481.

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