替雷利珠单抗注射液联合吉西他滨注射剂和顺铂注射剂治疗晚期膀胱尿路上皮癌患者的临床研究  

Clinical trial of tislelizumab injection combined with gemcitabine injection and cisplatin injection in the treatment of patients with advanced bladder urothelial carcinoma

作　　者：裴夏明[1] 刘侃 许镇州 戴涛 黄亮 曹健 曾恭谦 叶明佶 PEI Xia-ming;LIU Kan;XU Zhen-zhou;DAI Tao;HUANG Liang;CAO Jian;ZENG Gong-qian;YE Ming-ji(Department of Urology,Hunan Cancer Hospital,Changsha 410013,Hunan Province,China)

机构地区：[1]湖南省肿瘤医院泌尿外科,湖南长沙410013

出　　处：《中国临床药理学杂志》2023年第11期1533-1537,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察替雷利珠单抗联合吉西他滨和顺铂治疗晚期膀胱尿路上皮癌患者的临床疗效及安全性。方法将晚期膀胱尿路上皮癌患者随机分为对照组和试验组。试验组用吉西他滨(1000 mg·m^(-2))联合顺铂(70 mg·m^(-2))+替雷利珠(200 mg)的治疗方案;对照组用吉西他滨(1000 mg·m^(-2))联合顺铂(70 mg·m^(-2))的治疗方案,3周为1个疗程。于治疗2个疗程后,用酶联免疫吸附法分析治疗前后患者血清中γ干扰素(IFN-γ)、白细胞介素-2(IL-2)、血管内皮生长因子(VEGF)和基质金属蛋白酶-2(MMP-2)的表达水平,用计算机断层扫描术或磁共振成像扫描评价肿瘤体积的变化,并评价2组患者的临床疗效及药物不良反应的发生情况。结果试验过程共脱落8例,最终试验组和对照组分别纳入60例。治疗后,试验组和对照组的总有效率分别为56.67%(34例/60例)和36.67%(22例/60例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的IFN-γ分别为(35.68±5.24)和(3.42±0.84)μg·L^(-1),IL-2分别为(180.55±20.31)和(12.26±2.18)ng·mL^(-1),VEGF分别为(9.35±1.45)和(18.32±1.89)μg·L^(-1),MMP-2分别为(38.39±4.31)和(56.35±6.48)μg·L^(-1),无进展生存期分别为10.20和5.25个月,总生存期分别为18.36和13.32个月。试验组的上述指标与对照组比较,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心、白细胞计数降低、免疫相关性皮疹、免疫相关性甲状腺功能减退,对照组的药物不良反应主要有恶心、白细胞计数降低。试验组和对照组的Ⅰ~Ⅱ级总药物不良反应发生率分别为65.00%和58.33%,差异无统计学意义(P>0.05)。结论替雷利珠单抗联合吉西他滨和顺铂治疗晚期膀胱尿路上皮癌患者可以有效地提高临床疗效,延长患者的中位PFS和OS,抑制肿瘤的生长及发展。Objective To observe the clinical efficacy and safety of tislelizumab injection combined with gemcitabine injection and cisplatin injection in the treatment of patients with advanced bladder uroepithelial carcinoma.Methods Patients with advanced bladder urothelial carcinoma were randomly divided into control group and treatment group.The treatment group was treated with gemcitabine(1000 mg·m^(-2))combined with cisplatin(70 mg·m^(-2))+tislelizumab(200 mg).The control group was treated with gemcitabine(1000 mg·m^(-2))combined with cisplatin(70 mg·m^(-2))regimen,3 weeks as a course of treatment.After 2 courses of treatment,the expression levels of interferon-γ(IFN-γ),interleukin-2(IL-2),vascular endothelial growth factor(VEGF)and matrix metalloproteinase-2(MMP-2)in serum of patients before and after treatment were analyzed by enzyme-linked immunosorbent assay.The changes of tumor volume were evaluated by computed tomography(CT)or magnetic resonance imaging(MRI)scan,and the efficacy and adverse drug reactions of patients were evaluated.Results A total of 8 cases were lost during the trial,and 60 cases were included in the treatment group and the control group respectively.After treatment,the total effective rates in treatment and control groups were 56.67%(34/60)and 36.67%(22/60),respectively,with significant difference(P<0.05).After treatment,IFN-γin treatment group and control group were(35.68±5.24)and(3.42±0.84)μg·L^(-1);IL-2 were(180.55±20.31)and(12.26±2.18)ng·mL^(-1);VEGF were(9.35±1.45)and(18.32±1.89)μg·L^(-1);MMP-2 were(38.39±4.31)and(56.35±6.48)μg·L^(-1),respectively.The progression-free survival(PFS)of the treatment group and the control group was 10.20 and 5.25 months,and the overall survival(OS)was 18.36 and 13.32 months,respectively.The above indexes in the treatment group were significantly different from those in the control group(all P<0.05).The adverse drug reactions in the treatment group were mainly nausea,decreased white blood cell count,immune-related rash,and immune-related

关 键 词：替雷利珠单抗 吉西他滨 顺铂 膀胱尿路上皮癌 一线化疗 

分 类 号：R979.1[医药卫生—药品]