α-干扰素加吡柔比星灌注化疗对预防膀胱癌术后复发的疗效

背景与目的浅表性膀胱移行细胞癌术后易复发,本研究旨在探讨α-干扰素(interferon-alpha,IFN-α)联合吡柔比星灌注在降低浅表性膀胱癌术后复发方面的价值。方法应用重组人干扰素和吡柔比星(pirarubicin,THP)进行临床前瞻性试验研究。68例膀胱癌患者术后一周随机数字法分为两组(1)IFN-α+THP组33例,IFN-α3000万IU+THP40mg+5%GS40ml膀胱灌注;(2)THP组35例,THP40mg+5%GS40ml膀胱灌注。每周1次,连续8次,以后每月1次,共10次,12个月为一个疗程。结果随访期为6～32个月(中位随访期18.5个月),每3个月行膀胱镜检和组织活检一次。IFN-α+THP组33例患者中复发4例(12.1%),有4例出现膀胱刺激症状,3例有疲倦症状,1例出现皮疹。THP组复发8例(22.8%),有5例出现膀胱刺激症状,疲倦者3例,两组的不良反应发生率无显著性差异(P>0.05)。IFN-α+THP组比单用THP组有更好的疗效(P<0.05),尤其在预防G2、PT1膀胱肿瘤术后复发的效果优于单用THP组。结论IFN-α加THP灌注化疗对预防膀胱癌术后复发的疗效可能优于单用THP,但是其副作用情况以及是否适宜广泛使用还需作进一步的研究。

Intravesial instillation of recombination interferon-alpha and pirarubicin in the prophylaxis of local recurrence after resection of the superficial bladder cancer

BACKGROUND & OBJECTIVE: Superficial transitional cell carcinoma (TCC) of urinary bladder tends to recur after transurethral surgery. This study was designed to evaluate the effect of interferon-alpha (IFN-alpha)and pirarubicin (THP) on decreasing postoperative recurrence of superficial bladder cancer. METHODS: Recombinant IFN-alpha and THP has been used in clinical study. One week After operation, 68 patients were prospectively enrolled and divided into two groups randomly: IFN-alpha plus THP group and THP group. The protocols of chemoimmunoprophylaxis include 8 weekly and 10 monthly instillation of 3 x 10(7) IU IFN-alpha plus 40 mg THP in 40 ml 5% glucose via catheter. RESULTS: The follow-up period ranged from 6 to 32 months (median 18.2 months). The cytoscopy and cytology with cold cup biopsies had been carried out every 3 months for 2 years. Recurrence after instillation of IFN-alpha combining THP was observed in only 4 cases (12.1%), bladder irritation was found in 4 cases, fatigue in 3 cases, and rash in 1 case as well. Among the 35 cases in THP group, recurrence was found in 8 cases (22.8%), bladder irritation in 5 cases, fatigue in 3 cases. IFN-alpha plus THP yielded better effect than THP alone (P< 0.05),especially in grade 3 and stage PT1 bladder cancer. CONCLUSIONS: IFN-alpha working in coordination with THP would be an effective remedy to prevent the recurrence of bladder cancer. The intravesical IFN-alpha plus THP appears to be more effective against recurrence than THP alone. Further study is needed for side-effect and popularization in such way.