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

doi:10.19803/j.1672-8629.20230543

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (9): 1044-1050.
DOI: 10.19803/j.1672-8629.20230543

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

王以金¹, 唐静¹, 杨超¹, 徐凯², 张梦蝶², 高健³, 吴晓丽⁴, 张粤¹, 牛晓兵¹, 蒋鹤松¹, 茆飞¹, 周闪⁵, 姜熙¹, 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,*

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

收稿日期:2023-08-31 出版日期:2024-09-15 发布日期:2024-09-14
通讯作者: ^*傅广波,男,博士,副教授·硕导,临床医学。E-mail:fgb200@vip.163.com。^#为共同通信作者。
作者简介:王以金,男,硕士,泌尿外科学。
基金资助:
国家自然科学基金资助项目（72074123）

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

WANG Yijin¹, TANG Jing¹, YANG Chao¹, XU Kai², ZHANG Mengdie², GAO Jian³, WU Xiaoli⁴, ZHANG Yue¹, NIU Xiaobing¹, JIANG Hesong¹, MAO Fei¹, ZHOU Shan⁵, JIANG Xi¹, GUO Zhongying⁶, SUN Su'an⁶, XU Ming⁵, XU Zongyuan¹, WANG Hengbing¹, LI Xin^2#, FU Guangbo^1,*

¹Department of Urology ,The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an Jiangsu 223300, China;
²School of Pharmacy, Nanjing Medical University, Nanjing Jiangsu 211166, China;
³Inpatient Medical Records Room ,The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an Jiangsu 223300, China;
⁴Department of Pharmacy ,The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an Jiangsu 223300, China;
⁵Department of Ultrasound ,The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an Jiangsu 223300, China;
⁶Department of Pathology ,The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an Jiangsu 223300, China

Received:2023-08-31 Online:2024-09-15 Published:2024-09-14

摘要/Abstract

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+TURBT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% vs 92.31%,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-rank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 5.77 QALYs。与TURBT治疗方案相比,SIOG+TURBT治疗方案提高了0.21 QALYs,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。

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

Abstract: 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.

Key words: non-muscle invasive bladder cancer（NMIBC）, transurethral resection of bladder tumors（TURBT）, Gemcitabine, submucosal injection, Markov model, clinical research, pharmacoeconomic evaluation

中图分类号:

王以金, 唐静, 杨超, 徐凯, 张梦蝶, 高健, 吴晓丽, 张粤, 牛晓兵, 蒋鹤松, 茆飞, 周闪, 姜熙, 郭忠英, 孙苏安, 徐明, 徐宗源, 王恒兵, 李歆, 傅广波. 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[J]. 中国药物警戒, 2024, 21(9): 1044-1050.

WANG Yijin, TANG Jing, YANG Chao, XU Kai, ZHANG Mengdie, GAO Jian, WU Xiaoli, ZHANG Yue, NIU Xiaobing, JIANG Hesong, MAO Fei, ZHOU Shan, JIANG Xi, GUO Zhongying, SUN Su'an, XU Ming, XU Zongyuan, WANG Hengbing, LI Xin, FU Guangbo. 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[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1044-1050.

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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

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