吡柔比星术后即刻膀胱灌注联合常规灌注预防表浅性膀胱癌术后复发的对照研究

A Comparative Study of Immediately Intravesical Instillation of Pirarubicin Combined with Conventional Intravesical Instillation for Preventing Postoperative Recurrence of Superficial Bladder Cancer

目的:比较吡柔比星两种膀胱内灌注方法预防表浅性膀胱癌术后复发的有效性及安全性。方法:将52例经尿道膀胱癌电切术后表浅性膀胱癌患者随机分为两组。每次吡柔比星灌注剂量30 mg,治疗组术后24 h内膀胱灌注1次,此后每周灌注1次,连续8周,再改为每月灌注1次,至术后1年。对照组术后2周开始灌注,此后每周灌注1次,连续8周,再改为每月灌注1次,至术后1年。结果:全部病例均获随访,时间为12～24个月,平均随访16.3个月。其中治疗组随访期内2例复发,复发率8%;对照组随访期内4例复发,复发率14%,两组复发率比较差异有统计学意义(P<0.05),不良反应主要为尿路刺激症状。结论:本研究显示,吡柔比星膀胱灌注预防表浅性膀胱癌术后复发的疗效满意,用药方便,患者耐受性好;术后即刻膀胱灌注联合常规灌注较常规灌注可以降低肿瘤复发率,值得推荐。

Objective：To Compare the efficacy and safety of intravesical instillation of pirarubicin （THP） to prevent the post--operative recurrence of superficial bladder cancer with two different methods. Methods：A total of 52 cases of superficial bladder cancer after transurethral resection （TURBT） were randomly divided into two groups. Each infusion dose of THP is 30 mg. The treatment group was given within 24 hours after operation, then was given once a week for 8 weeks. And then was given once a month to 1 year after operation. The control group was given after 2 week of operation, then was given once a week for 8 weeks. And then was given once a month to 1 year after operation. Results：All cases received 12- 24 months follow up, with an average follow-up of 16.3 months. In treatment group ,2 patients recurred during the follow-up period, the recurrence rate was 8%, in the control group, 4 cases recurred, the recurrence rate was 14 %. Adverse reactions were mainly urinary tract irritation. Conclusions：This study shows that intravesical instillation of THP was an efficient, convenient, well tolerated method to prevent recurrence of superficial bladder cancer. Immediately intravesical instillation of THP after operation and combined with conventional intravesical instillation can reduce the tumor recurrence rate compared with conventional way alone, it is worth recommending.