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

doi:10.19803/j.1672-8629.20230543

Abstract

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

CLC Number:

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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