卡介苗联合吉西他滨胱灌注治疗浅表性膀胱癌TURBt术患者的临床研究  

Clinical trial of Bacillus Calmette-Guéri combined with gemcitabine for treatment of patients with superficial bladder cancer TURBt

作　　者：王君君 王旌 WANG Jun-jun;WANG Jing(Department of Urinary Surgery,Wuhan Eighth Hospital,Wuhan 430013,Hubei Province,China;Department of Pharmacy,Wuhan Eighth Hospital,Wuhan 430013,Hubei Province,China)

机构地区：[1]武汉市第八医院泌尿外科,湖北武汉430013 [2]武汉市第八医院药剂科,湖北武汉430013

出　　处：《中国临床药理学杂志》2023年第24期3584-3588,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 探讨不同剂量卡介苗(BCG)联合吉西他滨(GEM)膀胱灌注用于浅表性膀胱癌经尿道膀胱肿瘤电切除(TURBt)术患者临床效果及复发风险分析。方法 将进行TURBt术治疗的浅表性膀胱癌患者随机数表法分为对照组和试验组。对照组患者术后采取BCG(120 mg)联合GEM(1 000 mg)膀胱灌注治疗,试验组采取BCG(60 mg)联合GEM(1 000 mg)膀胱灌注治疗,连续治疗12个月。比较2组患者的临床疗效、术后复发率、首次复发时间、肿瘤标志物水平、炎症因子水平、免疫指标和药物不良反应发生情况。结果 对照组和试验组各51例。试验过程中共脱落2例,最终试验组和对照组均纳入50例。试验组和对照组的疾病控制率分别为88.00%(44例/50例)和78.00%(39例/50例),差异无统计学意义(P>0.05)。试验组术后1年、2年复发率和首次复发时间分别为12.00%、18.00%、(10.69±2.47)个月,与对照组的10.00%、16.00%、(11.84±2.62)个月比较,差异均无统计学意义(均P>0.05)。术后6、12个月时,2组浅表性膀胱癌患者的血清可溶性细胞间黏附分子1(sICAM-1)、可溶性血管细胞黏附分析1(sVCAM-1)、趋化因子配体5(CXCL5)和尿核基蛋白质22(NMP22)、细胞角蛋白19片段(CYFRA21-1)、膀胱肿瘤抗原(BTA)水平均低于术后(均P<0.05),且术后12个月均低于术后6个月(均P<0.05),但2组间比较差异均无统计学意义(均P>0.05)。术后6、12个月时,2组浅表性膀胱癌患者的血清白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)水平均低于术后(均P<0.05),且试验组均低于对照组(均P<0.05),免疫球蛋白M(IgM)、免疫球蛋白G(IgG)、免疫球蛋白A(IgA)水平均高于术后(均P<0.05),且试验组均高于对照组(均P<0.05)。试验组治疗过程中药物不良反应发生率为26.00%,低于对照组的10.00%(P>0.05)。结论 BCG 120 mg、60 mg联合膀胱灌注对浅表性膀胱癌TURBt术患者治疗疗效相当,且剂量BCG 60 mg不会增加患者术后复发率。Objective To explore the influences of different doses of Bacillus Calmette-Guéri(BCG) combined with gemcitabine(GEM)bladder perfusion on clinical effect and recurrence risk in patients with superficial bladder cancer after transurethral resection of bladder tumor(TURBt).Methods According to random number table method,102patients with superficial bladder who cancer underwent TURBt were divided into control group and treatment group.The control group was treated with BCG(120 mg) and GEM(1 000 mg) bladder perfusion,while treatment group was treated with BCG(60 mg) and GEM(1 000 mg) bladder perfusion for 12 months.The clinical effect,postoperative recurrence rate,the first recurrence time,levels of tumor markers,inflammatory factors and immune indexes and adverse reactions were compared between the two groups.Results There were 2 cases lost during the experiment,and there were 50 cases in treatment group and 50 cases in control group,respectively.The difference in disease control rate between treatment group and control group was not statistically significant [88.00%(44 cases/50 cases) vs 78.00%(39 cases/50 cases),P>0.05].The difference in recurrence rates at 1 year and 2years after surgery,and the first recurrence time between treatment group and control group was not statistically significant [12.00%,18.00%,(10.69±2.47) months vs 10.00%,16.00%,(11.84±2.62) months,P> 0.05].At 6 and 12 months after surgery,levels of serum soluble intercellular adhesion molecule-1(sICAM-1),soluble vascular cell adhesion molecule-1(sVCAM-1) and chemokine ligand 5(CXCL5),urinary nuclear matrix protein22(NMP22),cytokerantin-19-fragment(CYFRA21-1) and bladder tumor antigen(BTA) in both groups were decreased(all P <0.05),which at 12 months after surgery were lower than those at 6 months after surgery(all P <0.05),but there was no significant difference between the two groups(all P> 0.05).At 6 and 12 months after surgery,levels of serum interleukin(IL)-6 and tumor necrosis factor-α(TNF-α) in both groups were decreased(all P <0.05),whi

关 键 词：吉西他滨 卡介苗 浅表性膀胱癌 经尿道膀胱肿瘤电切除手术 复发 

分 类 号：R979.1[医药卫生—药品]