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吉西他滨联合乌苯美司膀胱灌注对膀胱肿瘤经尿道电切术后非肌层浸润性膀胱癌患者的临床疗效

Clinical efficacy of intravesical gemcitabine combined with ubenimex in patients with non-muscle-invasive bladder carcinoma after transurethral resection of bladder tumor.

作者信息

Shao Li-Jun, Wang Hai-Jiang, Wang Jia-Rong, Yuan Xiao-Fei, Sha Quan

机构信息

Li-jun Shao, Department of Urology, Baoding No.1 Hospital, Baoding, 071000, Hebei, P.R. China.

Hai-jiang Wang, Department of Urology, Baoding No.1 Hospital, Baoding, 071000, Hebei, P.R. China.

出版信息

Pak J Med Sci. 2022 May-Jun;38(5):1243-1249. doi: 10.12669/pjms.38.5.4599.

Abstract

OBJECTIVES

To evaluate the clinical value of intravesical gemcitabine combined with immunotherapy in patients with non-muscle-invasive bladder carcinoma (NMIBC) after transurethral resection of bladder tumor (TURBT).

METHODS

Eighty patients with non-muscle-invasive urothelial carcinoma treated in Baoding No.1 Hospital from November 2016 to November 2019 were randomly divided into two groups, with 40 patients in each group. Both groups underwent TURBT. After surgery, the research group was treated with intravesical chemotherapy using gemcitabine combined with ubenimex, while the control group was given 40 mg pirarubicin by intravesical instillation. Postoperative condition was evaluated by cystoscopy every three months in both groups. The recurrence six months, one year and two years after treatment, the incidence of lower urinary tract symptoms such as dysuria, hematuria and frequent urination, general adverse drug reactions such as rashes, liver function damage and gastrointestinal reaction, as well as the changes in CD3, CD4, CD8 and CD4/CD8 T lymphocyte subsets before and after treatment were comparatively analyzed between the two groups.

RESULTS

The recurrence rate showed no statistical significance between the two groups 6 months after treatment (=0.17), but significant differences one year (=0.04) and two years (=0.03) after treatment, which were significantly lower in the research group than the control group. The incidence of adverse drug reactions was 22.5% in the research group and 7.5% in the control group, without significant difference (=0.36). The incidence of lower urinary tract symptoms was 32.5% and 55%, respectively, in the research group and the control group. The incidence of lower urinary tract symptoms in the research group was significantly lower compared with the control group, with a statistically significant difference (=0.04). After treatment, CD3, CD4 and CD4/CD8 levels in the research group increased significantly than those in the control group, with statistically significant differences (CD3, =0.01; CD4, =0.00; CD4/CD8, =0.00).

CONCLUSIONS

For NMIBC patients receiving bladder-preserving surgery, intravesical gemcitabine combined with immunotherapy can reduce the recurrence rate, relieve lower urinary tract symptoms, increase the tolerance of patients to intravesical chemotherapy and significantly improve the function of T lymphocytes, without obvious increase in adverse drug reactions. Therefore, it is safe and effective, and has certain clinical value.

摘要

目的

评估膀胱内吉西他滨联合免疫疗法在经尿道膀胱肿瘤电切术(TURBT)后非肌层浸润性膀胱癌(NMIBC)患者中的临床价值。

方法

选取2016年11月至2019年11月在保定市第一医院接受治疗的80例非肌层浸润性尿路上皮癌患者,随机分为两组,每组40例。两组均接受TURBT。术后,研究组采用吉西他滨联合乌苯美司进行膀胱内化疗,而对照组采用膀胱内灌注40mg吡柔比星。两组均每三个月通过膀胱镜评估术后情况。比较分析两组治疗后6个月、1年和2年的复发情况、尿痛、血尿和尿频等下尿路症状的发生率、皮疹、肝功能损害和胃肠道反应等一般药物不良反应,以及治疗前后CD3、CD4、CD8和CD4/CD8 T淋巴细胞亚群变化。

结果

治疗后6个月两组复发率无统计学意义(=0.17),但治疗后1年(=0.04)和2年(=0.03)有显著差异,研究组显著低于对照组。研究组药物不良反应发生率为22.5%,对照组为7.5%,无显著差异(=0.36)。研究组和对照组下尿路症状发生率分别为32.5%和55%。研究组下尿路症状发生率显著低于对照组,差异有统计学意义(=0.04)。治疗后,研究组CD3、CD4和CD4/CD8水平显著高于对照组,差异有统计学意义(CD3,=0.01;CD4,=0.00;CD4/CD8,=0.00)。

结论

对于接受保膀胱手术的NMIBC患者,膀胱内吉西他滨联合免疫疗法可降低复发率,缓解下尿路症状,提高患者对膀胱内化疗的耐受性,并显著改善T淋巴细胞功能,且药物不良反应无明显增加。因此,其安全有效,具有一定临床价值。

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