沙培林膀胱灌注对浅表性膀胱癌患者术后疗效观察

The therapeutic effect of intravesical instillation of OK -432 after operation of superficial bladder tumor

目的研究沙培林（OK-423）膀胱灌注预防浅表性膀胱癌术后的疗效及安全性。方法将78例浅表型膀胱癌患者随机分成两组。沙培林组（40例）术后1周开始常规灌注沙培林5KE，膀胱内灌注保留2h，每周1次连续6周，之后每月1次连续8个月。对照组（38例）灌注吡柔比星30mg，灌注方法同沙培林组。结果随访6～36个月。原发病人复发率沙培林组为2．7％，对照组为10．8％，差异有统计学意义（P〈0．05）；复发病人无论是处在高危或低危因素，两组都能降低复发率，但比较差异无统计学意义（p〉0．05），复发率高的病人肿瘤大都是不带蒂，较大，多病灶，高级别的。在沙培林组，病人耐受性好，无不良反应，而对照组7例病人在灌注后出现了膀胱刺激症状或血尿，两组比较差异有统计学意义。结论沙培林膀胱内灌注对预防浅表性膀胱癌术后复发疗效比较满意，全身或局部不良反应少，病人易耐受，值得以后临床广泛推广应用。

Objectives Objective To study the efficacy and safety of intravesical instillation of OK -432 after resection of superficial bladder tumor. Methods Seventy eight patients of superficial bladder tumor were divided randomly into two groups. OK-432 group： 5KE OK -432 was instilled into bladder and retained for 2 hours the first day after operation. The instillation was performed once a week for 6 weeks, and then once a month for 8 months. The control group ：30rag Pirarubicin was perfused with the same method as in Group OK -432. Results The patients were followed up for 6 - 36 months, The recurrence rate of primary disease were 2.7% and 10.8% in OK -432 Group and control Group respectively, which had statistical significance（ p 〈0.05 ）. In patients with the recurrent disease, two groups lowered the recurrence rate but had no statistical significance, multiple, large, sessile and high grade tumors had high recurrence rate . In OK -432 group ,patients had good compliance and no side effects,but control Group 7 eases showed up symptoms such as frequent mictufitian,urgency,urination pain or hematuria,which had statistical significance. Conclusions Intravesical instillation of OK -432 is safe and effective in preventing local recurrence of superficial bladder cancer, it is worth wide clinical application with good compliance and fewer side effects.