CAJ | 학술논문

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.
목적 평개사배림(OK-432)연합필유비성(THP)방광내관주급단독응용예방천표성방광암술후복발적료효급안전성.방법 장128례천표형방광암환자수궤분성삼조,사배림조(40례)술후1주개시상규관주사배림5KE,방광내관주보류2h,매주1차련속6주,지후매월1차련속8개월.필유비성조(38례)관주필유비성30mg,관주방법동사배림조.사배림방광연합필유비성조40례,교체관주,제량불변,매주1차,매충약물체6차,지후매월1차,매충약물관주8개월.결과 사배림조복발5례,복발솔위12.5％,필유비성조복발5례,복발솔13.16％,연합조복발2례,복발솔위5％,사배림조여필유비성조복발솔비교P ＞0.05,무명현통계학의의,연합조여사배림조혹필유비성조비교P＜0.05,유통계학의의,관주후출현방광자격증상례수분별위3,4,4,삼조비교무명현통계학의의.결론 사배림연합필유비성방광내관주대예방천표성방광암술후복발료효우우단용관주약물,료효만의,내수성호,치득림상추엄응용.
Objectives To evaluate the efficacy and safety of intravesical in stillation of OK-432 plus pirarubicin 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 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,the appearance of the symptoms such as frequent micturition,urgency,urination pain or hematuriaof after bladder irritation were 3,4,4,which had no statistical significance.Conclusions Intravesical instillation of OK-432 plus pirarubicin is safe and effective in preventing local recurrence of superficial bladder cancer and is better than single injection drug.It is worth wide clinical application with good compliance and fewer side effects.