目的 观察替雷利珠单抗联合吡柔比星治疗肌层浸润性膀胱癌的临床疗效。方法 选自复旦大学附属中山医院青浦分院2021年5月—2024年5月收治的肌层浸润性膀胱癌患者90例进行回顾性研究，根据治疗方案的不同分为对照组和治疗组，每组各45例。对照组患者膀胱灌注注射用盐酸吡柔比星，30 mg溶解在50 mL 5%葡萄糖注射液中，1次/周，连续治疗9周。治疗组在对照组基础上静脉输注替雷利珠单抗注射液，第1次200 mg在60 min内输注完，患者耐受良好之后改为30 min内输注完，3周为1个疗程，治疗3个疗程。观察两组患者临床疗效，比较治疗前后两组患者T淋巴细胞免疫功能，肿瘤标志物癌胚抗原（CEA）、糖类抗原125（CA-125）、细胞角蛋白19片段抗原21-1（CY-211）和神经元特异性烯醇化酶（NSE）水平，及血清细胞因子碱性成纤维细胞生长因子（bFGF）、表皮生长因子（VEGF）及肿瘤坏死因子-α（TNF-α）水平。结果 治疗后，治疗组客观缓解率明显高于对照组（82.22% vs 62.22%，P＜0.05）。治疗后，两组CD4^＋/CD8^＋、CD3^＋、自然杀伤细胞（NK）水平显著升高（P＜0.05）；且治疗后，治疗组CD4^＋/CD8^＋、CD3^＋、NK水平均明显高于对照组（P＜0.05）。治疗后，两组患者CEA、CA-125、CY-211、NSE、bFGF、VEGF、TNF-α水平均明显降低（P＜0.05），且治疗后治疗组这些血清因子水平均明显低于对照组（P＜0.05）。结论 肌层浸润性膀胱癌患者经替雷利珠单抗联合吡柔比星膀胱灌注治疗效果更好，利于增强机体免疫功能，纠正异常血清细胞因子，降低肿瘤标志物水平，降低患者复发风险。

Objective To observe the clinical effect of tirelizumab combined with pirarubicin in treatment of muscular invasive bladder cancer. Methods The clinical data of patients (90 cases) with muscular invasive bladder cancer in Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University from May 2021 to May 2024 were analyzed retrospectively. They were randomly divided into control and treatment group based on different treatments, and each group had 45 cases. Patients in the control group were po administered with Pirarubicin Hydrochloride for injection to bladder for 9 weeks, 30 mg was dissolved in 50 mL of 5% glucose injection, once weekly. Patients in the treatment group were iv administered with Tislelizumab Injection on the basis of the control group, 200 mg was completed within 60 min for the first infusion, after the patient tolerated it well, the infusion was changed to 30 min. Three weeks was a course of treatment, and three courses of treatment were carried out. After treatment, the clinical evaluations were evaluated, and the T lymphocyte immune function, the levels of tumor markers CEA, CA-125, CY-211, and NSE, and the levels of serum bFGF, VEGF and TNF-α in two groups before and after treatment were compared. Results After treatment, the objective response rate in the treatment group was significantly higher than that in the control group (82.22% vs 62.22%, P < 0.05). After treatment, the levels of CD4⁺/CD8⁺, CD3⁺, and NK levels in both groups increased significantly (P < 0.05). After treatment, the levels of CD4⁺/CD8⁺, CD3⁺, and NK in treatment group were significantly higher than those in control group (P < 0.05). After treatment, the levels of CEA, CA-125, CY-211, NSE, bFGF, VEGF and TNF-α in both groups were significantly decreased (P < 0.05), and the levels of these serum factors in treatment group were significantly lower than those in control group after treatment (P < 0.05). Conclusion Intravesical infusion of terelizumab combined with pirarubicin in patients with muscular invasive bladder cancer has a better effect, which is conducive to enhancing the immune function, correcting abnormal serum cytokines, reducing tumor marker levels, and reducing the risk of recurrence.

R979.1

上海市青浦区卫生健康委员会科研项目（QWJ2022-06）