小剂量注射吉西他滨联合经尿道膀胱肿瘤电切术治疗中高危非肌层浸润性膀胱癌的临床研究  

Clinical research of submucosal low-dose gemcitabine injection combined with transurethral resection of bladder tumor in the treatment of medium-high risk non-muscle invasive bladder cancer

作　　者：王以金 唐静[1] 杨超 徐凯 张梦蝶 高健[3] 吴晓丽[4] 张粤 牛晓兵[1] 蒋鹤松 茆飞 周闪 姜熙 郭忠英[6] 孙苏安[6] 徐明[5] 徐宗源[1] 王恒兵[1] 李歆[2] 傅广波[1] WANG Yijin;TANG Jing;YANG Chao;XU Kai;ZHANG Mengdie;GAO Jian;WU Xiaoli;ZHANG Yue;NIUXiaobing;JIANG Hesong;MAO Fei;ZHOU Shan;JIANG Xi;GUO Zhongying;SUN Su'an;XU Ming;XUZongyuan;WANG Hengbing;LI Xin;FU Guangbo(Department of Urology,The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University,Huai’an Jiangsu 223300,China;School of Pharmacy,Nanjing Medical University,Nanjing Jiangsu 211166,China;Inpatient Medical Records Room,The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University,Huai’an Jiangsu 223300,China;Department of Pharmacy,The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University,Huai’an Jiangsu 223300,China;Department of Ultrasound,The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University,Huai’an Jiangsu 223300,China;Department of Pathology,The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University,Huai’an Jiangsu 223300,China)

机构地区：[1]南京医科大学附属淮安第一医院泌尿外科,江苏淮安223300 [2]南京医科大学药学院,江苏南京211166 [3]南京医科大学附属淮安第一医院病案室,江苏淮安223300 [4]南京医科大学附属淮安第一医院药剂科,江苏淮安223300 [5]南京医科大学附属淮安第一医院超声科,江苏淮安223300 [6]南京医科大学附属淮安第一医院病理科,江苏淮安223300

出　　处：《中国药物警戒》2024年第9期1044-1050,共7页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(72074123)。

摘　　要：目的 对比经尿道膀胱肿瘤电切术(TURBT),探讨黏膜下小剂量注射吉西他滨(SIOG)联合TURBT治疗中高危非肌层浸润性膀胱癌(NMIBC)的治疗效果及药物经济学评价。方法 收集2015年1月1日至2020年8月31日本院270例中高危NMIBC患者(TURBT 213例,SIOG+TURBT 57例)的临床资料,应用倾向性评分匹配以1∶1的比例匹配,每组病例为52人,分析2组的临床疗效,核算其成本,构建1年为循环周期,1 000人10年的Markov模型对2组治疗方案进行药物经济学评价。结果 TURBT组患者3、6、12个月肿瘤未复发率和SIOG+TUR BT组患者3、6、12个月肿瘤未复发率分别为90.38%vs 100.00%、84.62%vs 98.08%、78.85%vs92.31%,术后6个月时肿瘤未复发率2组差异具有统计学意义(P <0.05),经log-r a n k检验,2组1年时肿瘤未复发率差异具有统计学意义(P <0.05)。TURBT方案和SIOG+TURBT方案累积人均成本分别为217 117.20元和190 701.12元,获得的健康效果分别为5.56质量调整生命年(quality-adjusted life years,QALYs)和5.77QALYs。与TURBT治疗方案相比,SIOG+TURBT治疗方案提高了0.21QALYs,节约了26 416.08元。SIOG+TURBT方案对于TURBT方案具有成本-效用优势。结论 与TURBT相比,SIOG+TURBT治疗中高危NMIBC具有更优的临床效果及经济性。Objective To compare transurethral resection of bladder tumor(TURBT)with submucosal low-dose gemcitabine injection(SIOG)combined with TURBT in the treatment of medium-high risk non-muscle invasive bladder cancer(NMIBC),and to evaluate their clinical efficacy and pharmacoeconomics.Methods The clinical data of 270 patients with medium-high risk NMIBC(TURBT 213 cases,SIOG+TURBT 57 cases)in our hospital from January 1,2015 to August 31,2020 were collected,and matched on a 1 to 1 scale using propensity score matching and were divided into two groups.Each group had 52 patients.After the clinical efficacy of two groups was analyzed,the cost was calculated,a Markov model with 1 year as a cycle and 10 years for 1000 persons was constructed to evaluate the pharmacoeconomics of the two treatment regimens.Results The rates of non-recurrence at 3,6 and 12 months in the TURBT group and the rates of non-recurrence at 3,6 and 12 months in the SIOG+TURBT group were 90.38%vs 100.00%,84.62%vs 98.08%and 78.85%vs 92.31%,respectively.There was a significant difference in the non-recurrence rate of tumor 6 months after surgery(P<0.05),According to a log-rank test,there was a significant difference in tumor recurrence rate between the two groups at 1 year(P<0.05).The cumulative average costs per person for the treatment protocols of TURBT and SIOG+TURBT were¥217,117.20 and¥190,701.12,with health effects of 5.56 QALYs and 5.77 QALYs respectively.Patients treated with treatment protocols of SIOG+TURBT increased 0.21 QALYs and saved lifetime cost of¥26,416.08.The treatment protocols of SIOG+TURBT had a cost-effectiveness advantage over the treatment protocols of TURBT.Conclusion Compared with the treatment protocols of TURBT,the treatment protocols of SIOG+TURBT had a better clinical effect and cost-effectiveness in the treatment of medium-high-risk NMIBC.This technique is worth promoting in clinical practice.

关 键 词：非肌层浸润性膀胱癌 经尿道膀胱肿瘤电切术 吉西他滨 黏膜下注射 MARKOV模型 临床研究 药物经济学评价 

分 类 号：R916.696[医药卫生—药学] R994.11