艾迪注射液膀胱灌注预防非肌层浸润性膀胱尿路上皮癌术后复发的临床观察

Clinical observation of intravesical instillation with AIDI injection in preventing postoperative recurrence of non muscle-invasive bladder cancer

目的探讨用中药制剂——艾迪注射液膀胱灌注预防非肌层浸润性膀胱尿路上皮癌术后复发的临床效果及不良反应。方法 95例非肌层浸润性膀胱尿路上皮癌保留膀胱手术后随机分为3组,分别采用丝裂霉素(MMC)、沙培林、艾迪注射液进行膀胱灌注,定期随访,观察治疗效果及毒副反应。结果 95例患者随访14～57个月(平均37.1个月),共有30例出现肿瘤复发(Ta9例,T121例;G114例,G29例,G37例),肿瘤复发率为31.6%。MMC组、沙培林组和艾迪注射液组的肿瘤复发率分别为48.5%、28.1%和16.7%。MMC组及艾迪注射液组与沙培林组的肿瘤复发率差异无统计学意义(P>0.05);艾迪注射液组肿瘤复发率明显低于MMC组(P<0.05)。MMC组、沙培林组和艾迪注射液组出现明显不良反应者分别为7例(21.2%)、3例(9.4%)和0例。结论中药制剂——艾迪注射液膀胱灌注预防非肌层浸润性膀胱尿路上皮癌术后复发疗效较好,无明显不良反应,临床使用安全、可靠。

Objective To evaluate the clinical efficacy and toxicity of intravesical instillation with AIDI injection in preventing postoperative recurrence of non muscle-invasive bladder cancer.Methods 95 patients with non muscle-invasive bladder cancers were randomized divided into three groups.Mitomycin,Shapeilin and AIDI injection were used separately for intravesical instillation to prevent recurrence of bladder cancer after reserved operation.Results Following-up for 14-57 months （mean 37.1 months）,30 （31.6%,Ta 9,T1 21;G1 14,G2 9,G3 7） patients had tumor recurrences.The tumor recurrence rates was 48.5% in group of Mitomycin,28.1% in group of Shapeilin,16.7% in group of AIDI injection.The difference of the rates between Mitomycin and Shapeilin,Shapeilin and AIDI injection had not statistical significance （P0.05）,but the tumor recurrence in the group of Mitomycin was higher significantly than AIDI injection （P0.05）.Major adverse events,including hematuria,cystourethritis symptom,gastrointestinal complaint,efflorescence,occurred in 7 （21.2%） patients in group of Mitomycin,in 3 （9.4%） patients in group of Shapeilin,and 0 in group AIDI injection.Conclusions Intravesical instillation with AIDI injection is effective with no obvious adverse events in preventing non muscle-invasive bladder cancer after bladder-reserved operations.