吉西他滨膀胱灌注化疗的临床研究

Study of gemcitabine intravesical chemotherapy

目的 探讨吉西他滨膀胱灌注预防非肌层浸润性膀胱癌（NMIBC）术后复发的疗效和安全性。方法 选择90例NMIBC患者,经尿道膀胱癌电切术（TUR-BT）后,随机分成3组,每组30例。G1组给予1 000 mg吉西他滨膀胱灌注,G2组给予2 000 mg吉西他滨膀胱灌注,P组给予吡柔比星30 mg膀胱灌注。观察并比较三组的肿瘤复发率及不良反应。结果 随访3~24个月,中位随访15个月。G1组、G2组、P组的2年肿瘤复发率分别为13.33%、16.67%、43.33%,G1组、G2组的肿瘤复发率低于P组（P〈0.05）,但G1组、G2组比较差异无统计学意义（P=0.72）;三组不良反应发生率分别为23.33%、26.67%、33.33%（P〉0.05）。不良反应主要表现为尿频、尿急、尿痛等膀胱刺激症状,经过对症治疗后缓解,均未发生严重的不良反应。结论 吉西他滨膀胱灌注化疗在预防NMIBC术后复发方面疗效较好,有较高的临床价值。

Objective To discuss the therapeutic effect and safety of gemcitabine intravesical chemotherapy in the treatment of non-muscle invasive bladder cancer （NMIBC）. Methods Ninety patients with NMIBC receiving transurethral bladder tumor resection （TUR-BT） were randomly divided into 3 groups （30 cases in each group）. Group G1 received intravesical gemcitabine 1 000 mg, group G2 received gemcitabine 2 000 mg, and group P received 30 mg of pirarubicin. The rate of tumor recurrence and adverse effects of 3 groups were evaluated. Results All the patients were followed up for 3 - 24 months with 15 months as the median. The 2-year tumor recurrent rates of 3 groups were 13.33% ,16. 67% and 43.33% ,respectively. The tumor recurrence rate in group G1 and group G2 was lower than that of group P （P 〈0. 05） ,but no significant difference was found between group G1 and group G2 （P =0.72）. The ad- verse reaction rates of the 3 groups were 23.33% ,26. 67% and 33.33% , respectively （P 〉 0. 05 ）. Adverse reactions mainly characterized by frequent urination, urinary urgency and pain were relieved after symptomatic treatment. No seri- ous adverse effect was observed. Conclusion The therapeutic effect of intravesicai gemcitabine in preventing postoper- ative recurrence in patients with NMIBC is good with high level of clinical value.