摘要
目的评价沙培林（OK-432）联合吡柔比星（THP）膀胱内灌注及单独应用预防浅表性膀胱癌术后复发的疗效及安全性。方法将128例浅表型膀胱癌患者随机分成三组，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。吡柔比星组（38例）灌注吡柔比星30mg，灌注方法同沙培林组。沙培林膀胱联合吡柔比星组40例，交替灌注，剂量不变，每周1次，每种药物达6次，之后每月1次，每种药物灌注8个月。结果沙培林组复发5例，复发率为12．5％，吡柔比星组复发5例，复发率13．16％，联合组复发2例，复发率为5％，沙培林组与吡柔比星组复发率比较P〉0．05，无明显统计学意义，联合组与沙培林组或吡柔比星组比较P〈0．05，有统计学意义，灌注后出现膀胱刺激症状例数分别为3，4，4，三组比较无明显统计学意义。结论沙培林联合吡柔比星膀胱内灌注对预防浅表性膀胱癌术后复发疗效优于单用灌注药物，疗效满意，耐受性好，值得临床推广应用。
Objectives To evaluate the efficacy and safety of intravesical in stillation of OK -432 plus pi- rarubicin in the prophylaxis of recurrence after resection of bladder cancer. Methods 128 cases of superficial bladder cancer patients were randomly divided into three groups. OK -432 group： 5KE OK -432 was instilled into bladder and retained for 2 hours one week after operation. The instillation was performed once a week for 6 weeks, and then once a month for 8 months. The Pirarubicin group ：30mg Pirarubicin was perfused with the same method as in Group OK -432. The group of OK -432 plus pirarubicin was instilled into bladder of alternating perfusion with the same dose,once a week for 6 weeks, each drug amounts to 6, then once a month for 8 months, each drug was perfusion for 8months. Results The patients were followed up for 3 - 18 months, The recurrence rate of primary disease were 12.5% , 13.16% ,5% in OK -432 Group ,Pirarubicin Group,OK -432 plus pirarubicin Group re- spectively, 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 recur- rence rate. In OK - 432 group, patients had good compliance and no side effects, the appearance of the symptoms such as frequent micturition, urgency, urination pain or hematuriaof after bladder irritation were 3,4,4, which had no statis- tical significance. Conclusions Intravesieal instillation of OK -432 plus pirarubicin is safe and effective in pre- venting local recurrence of superficial bladder cancer and is better than single injection drug. It is worth wide elinicai application with good compliance and fewer side effects.
出处
《国际泌尿系统杂志》
2012年第6期735-737,共3页
International Journal of Urology and Nephrology
关键词
膀胱肿瘤
肿瘤复发
局部
毕西巴尼
阿霉素
Bladder Neoplasms
Neoplasm Recurrence, Local
Picibanil
Doxorubiein
