| 替雷利珠单抗静脉注射联合吡柔比星膀胱灌注治疗非肌层浸润性膀胱癌的疗效及安全性 |
| 投稿时间：2025-01-16 修订日期：2025-02-10 点此下载全文 |
| 引用本文：罗裕春,谢碧翠,庞甄,凌峰,黄军成,刘宏伟.替雷利珠单抗静脉注射联合吡柔比星膀胱灌注治疗非肌层浸润性膀胱癌的疗效及安全性[J].医学研究杂志,2025,54(7):135-139, 174 |
| DOI：
10.11969/j.issn.1673-548X.2025.07.024 |
| 摘要点击次数: 3 |
| 全文下载次数: 3 |
|
| 基金项目:广东省湛江市科技攻关计划项目(2023B01205) |
|
| 中文摘要:目的 探讨替雷利珠单抗静脉注射联合吡柔比星膀胱灌注治疗非肌层浸润性膀胱癌(non-muscle invasive bladder cancer, NMIBC)的疗效和安全性。方法 本研究为随机对照试验,纳入广东省农垦中心医院泌尿外科2021年1月1日～2022年12月31日收治的80例行经尿道膀胱肿瘤电切术(transurethral resection of bladder tumor, TURBT)的NMIBC患者,随机分为试验组(替雷利珠单抗静脉注射联合吡柔比星膀胱灌注治疗,n=40)和对照组(单用吡柔比星膀胱灌注治疗,n=40)。观察主要疗效指标包括无进展生存期(progression-free survival, PFS)、复发率和进展率；安全性通过治疗相关不良事件(treatment-related adverse event, AE)的类型和发生率进行评估。结果 试验组的中位PFS优于对照组(16个月 vs 9个月,P=0.034)。1年和2年复发率试验组低于对照组(7.5% vs 15.0%,P=0.034；12.5% vs 22.5%,P=0.019)。试验组影像学进展率低于对照组(7.5% vs 20.0%,P=0.019)。两组均未出现治疗相关死亡事件,试验组疲劳发生率高于对照组(25.0% vs 10.0%,P=0.048),但其他不良事件差异无统计学意义,且均为轻至中度(1～2级),可通过对症治疗缓解。结论 替雷利珠单抗静脉注射联合吡柔比星膀胱灌注治疗可显著延长NMIBC患者的PFS,降低复发率,抑制肿瘤进展,且具有良好的安全性和耐受性。 |
| 中文关键词:非肌层浸润性膀胱癌 替雷利珠单抗 吡柔比星 疗效 安全性 |
| |
| Efficacy and Safety of Tislelizumab Intravenous Injection Combined with Pirarubicin Intravesical Instillation in the Treatment of Non-Muscle-Invasive Bladder Cancer. |
|
|
| Abstract:Objective To evaluate the efficacy and safety of tislelizumab intravenous injection combined with pirarubicin intravesical instillation in the treatment of non-muscle-invasive bladder cancer (NMIBC). Methods This study is a randomized controlled trial, including 80 patients with NMIBC who underwent transurethral resection of bladder tumor (TURBT) at the urology department of Central Hospital of Guangdong Nongken from January 1,2021, to December 31,2022. The patients were randomly assigned to either the experimental group (treated with tislelizumab intravenous injection combined with pirarubicin intravesical instillation, n=40) or the control group (treated with pirarubicin intravesical instillation alone, n=40). The primary efficacy endpoints included progression-free survival (PFS), recurrence rate, and radiological progression rate. Safety was assessed by the type and incidence of treatment-related adverse events (AEs). Results The median PFS in the experimental group was significantly longer than that in the control group (16months vs 9months, P=0.034). The 1-year and 2-year recurrence rates in the experimental group were significantly lower than in the control group (7.5% vs 15.0%, P=0.034; 12.5% vs 22.5%, P=0.019). The radiological progression rate in the experimental group was significantly lower than that in the control group (7.5% vs 20.0%, P=0.019). No treatment-related deaths occurred in either group. The incidence of fatigue was significantly higher in the experimental group than in the control group (25.0% vs 10.0%, P=0.048), while other adverse events showed no significant differences and were predominantly mild to moderate (Grade 1-2), manageable with symptomatic treatment. Conclusion Tislelizumab intravenous injection combined with pirarubicin intravesical instillation significantly prolongs PFS, reduces recurrence rates, and inhibits tumor progression in NMIBC patients, with good safety and tolerability. This combination offers a safe and effective new strategy for postoperative NMIBC management. |
| keywords:Non-muscle-invasive bladder cancer Tislelizumab Pirarubicin Efficacy Safety |
| 查看全文 查看/发表评论 下载PDF阅读器 |
|
|
|
