Clinical observation on the curative effect of gemcitabine intravesical instillation in the treatment of recurrent non-muscle-invasive bladder cancer
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摘要: 目的:观察并评价吉西他滨(GEM)膀胱灌注在治疗复发性非肌层浸润性膀胱癌(NMIBC)患者中的疗效及安全性。方法:采用随机数表法将80例经尿道膀胱肿瘤电切术(TURBt)术后行羟基喜树碱常规膀胱灌注治疗1年内首次复发且经膀胱镜活检证实为NMIBC的患者分为观察组和对照组,每组各40例。两组患者入院后均接受第2次TURBt,术后即刻行膀胱灌注治疗,观察组患者采取GEM 1 000 mg剂量进行膀胱灌注,而对照组患者则继续采取羟基喜树碱30 mg剂量进行膀胱灌注。所有患者定期行膀胱镜检查,临床随访时间设定为2年,随访期内观察两组患者在肿瘤复发率、再次复发时间及不良反应发生率方面的差异。结果:随访期间,两组患者生存率均为100%,观察组患者复发率明显低于对照组(27.5% vs.52.5%,P<0.05),肿瘤复发时间明显长于对照组[(18.35±2.46)个月vs.(10.83±3.07)个月,P<0.05]。观察组与对照组的不良反应发生率分别为12.5%与10.0%,两组比较差异无统计学意义(P>0.05)。不良反应主要表现为膀胱刺激症状,经暂停膀胱灌注治疗后自行缓解,所有患者均未出现严重的血液学及其他不良事件。结论:相较于羟基喜树碱,GEM在膀胱灌注治疗复发性NMIBC患者方面有其独特优势,它能显著提高膀胱灌注治疗的疗效,降低肿瘤患者的复发率并延长复发时间,且无严重不良反应。Abstract: Objective: To investigate and evaluate the efficacy and safety of intravesical instillation with gemcitabine(GEM) after failure of first-line intravesical chemotherapy with hydroxycamptothecin in the treatment of recurrent non-muscle-invasive bladder cancer(NMIBC) patients. Method: Eighty NMIBC patients who underwent routine intravesical instillation with hydroxycamptothecin after TURBt and who relapsed within 1 year after surgery were randomly divided into observation group and control group, with 40 cases in each group. Patients in the observation group received intravesical GEM irrigation at a dose of 1000 mg, whereas patients in the control group received intravesical hydroxycamptothecin irrigation at a dose of 30 mg, respectively. All patients were treated by immediate intravesical perfusion after TURBt operation and an urethrocystoscopy was performed routinely. The 2-year tumor recurrence rate, second recurrence time, rate and time of tumor progression and adverse reactions of chemotherapy were compared between the two groups. Result: In those two groups, the survival rates were both 100%. For observation group, the 2-year tumor recurrence rate(27.5%) was significantly lower than that of control group(52.5%). Meanwhile, the mean time of recurrence of observation group was longer than that of the control group[(18.35±2.46) months vs.(10.83±3.07) months, P<0.05]. Moreover, the adverse reaction rate was 12.5% in the observation group, 10.0% in the control group, which the difference was not statistically significant(P>0.05). The adverse reaction was mainly manifested as bladder irritation symptoms, which was relieved by suspending intravesical instillation. There were no severe hematology or other adverse events occurred in all patients.Conclusion: As compared with hydroxycamptothecine, intravesical chemotherapy with GEM harbors unique advantages and can obviously reduce the recurrence rate and extend the recurrence time of NMIBC patients. Moreover, there were no serious side effects observed in the present study.
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