吡柔比星联合白细胞介素Ⅱ膀胱灌注防治浅表性膀胱癌复发的研究

Intravesical instillation of pirarubicin(THP) combined with IL-Ⅱ in prevention of postoperative recurrence of superficial bladder cancer.

目的探讨吡柔比星联合白细胞介素Ⅱ在预防浅表性膀胱癌术后复发的有效性及安全性。方法符合入选标准的66例患者，术后2周按随机数字法分为两组。吡柔比星（THP）＋白细胞介素Ⅱ（IL-Ⅱ）组31例，THP30mg＋IL-Ⅱ10万Iu＋5％葡萄溶液40mI膀胱灌注。THP组35例THP30mg＋5％葡萄溶液40m1膀胱灌注。每周1次共8次，以后每月1次，共1年，每次药物在膀胱内保留40min，每3个月膀胱镜检查是否有膀胱肿瘤复发，并记录全身及局部情况。结果66例浅表性膀胱移行细胞癌患者，术后随访时间6～30个月。THP＋IL-Ⅱ组31例患者中复发4例，THP组35例患者中复发12例，两组相比较差异具有显著性（P〈0．05）。结论THP联合IL-Ⅱ灌注化疗对预防膀胱癌术后复发的疗效可能优于单用THP，但是其不良反应情况以及是否适宜广泛应用还需作进-步的研究。

Objective This study was designed to evaluate the efficacy and safety of instillation of pirarubicin （THP） and IL -Ⅱ in prevention of postoperative recurrence of superficial bladder cancer. Methods Patients with superficial transitional cell bladder cancer suited to inclusion criteria were enrolled in this study. They were prospectively enrolled and randomly divided into two groups. Thirty - one patients in THP plus IL - Ⅱ group were treated with instillation of THP 30mg plus IL -Ⅱ 10 x 104 IU in 5% GS 40ml. Thirty - five patients in THP group were treated with instillation of THP 30mg in 5% GS 40ml. They were instilled within two weeks after operation, once a week for eight weeks, followed by once a month till one year. Regular cystoscopy was performed for the follow - up examination. Results All patients were followed up for 6 to 30 months. Recurrence after instillation of THP plus IL -Ⅱ was observed in 5 cases （4/31）. Among the 35 cases in THP group, recurrence was seen in 12 cases. The difference between THP plus IL - Ⅱ group and THP group is very significant （ P 〈 0.05 ）. Conclusion THP combined with IL - Ⅱ would be more effective than THP alone in prevention of recurrence of bladder cancer. Further study is needed for observation of their side effects and popularlzation in such way.