小剂量结核菌素与羟基喜树碱交替膀胱灌注预防膀胱癌术后复发的临床观察

Clinical observation of low-dose BCG and hydroxycamptothecin alternately intravesical instillation to prevent the post-operative recurrence of bladder cancer

目的 探讨羟基喜树碱（HCPT）、小剂量结核菌素（BCG）交替膀胱灌注预防膀胱癌术后复发的效果.方法 选择312例膀胱癌术后患者,随机分为HCPT和小剂量BCG交替膀胱灌注组（A组）、HCPT膀胱灌注组（B组）各156例.A组：术后第7d用HCPT 10mg＋生理盐水20 mL膀胱灌注,第14d用BCG 10mg＋生理盐水40mL膀胱灌注;之后每隔3d交替灌注1次,至术后第56d;术后第63d开始,每隔1周交替灌注1次,各灌注8次;术后第183d开始,每隔15d交替灌注1次,各灌注8次;术后第438d开始,每隔1个月交替灌注1次至术后2年.B组：自术后第7d起,用HCPT 10mg＋生理盐水20mL膀胱灌注,每周灌注1次,至术后第56d;术后第70d开始,每隔2周灌注1次,共8次;术后第198d开始,每隔1个月灌注1次,共8次;术后第468d开始,每隔2个月灌注1次至术后2年.各种药物灌注剂量同首次灌注.分别观察两组0～18、19 ～24、25 ～60个月的肿瘤复发率及毒副反应.结果 随访60个月,A组复发率分别为0（0～18个月）、3.21％（19 ～24个月）、18.67％（25～60个月）,B组分别为11.54％、7.10％、20.13％,两组0～18个月的复发率比较差异有统计学意义（P＜0.05）;两组均出现非细菌性膀胱炎、血尿、低热、血象异常等毒副反应,但两组比较差异均无统计学意义（P＞0.05）.结论 HCPT和小剂量BCG交替膀胱灌注预防膀胱癌术后复发效果较好,毒副反应较轻且发生率低.

Objectives To investigate the effect of low dose tuberculin （BCG） and hydroxycamptothecin （HCPT） alternately intravesical instillation after the post-operative recurrence of bladder cancer.Methods 312 cases of bladder cancer after operation were randomly divided into the group of alternating intravesical instillation of HCPT and low-dose BCG （A group） and HCPT group（B group）,156 cases in each group.Group A：HCPT 10mg added to normal saline 20ml were vesically irrigated 7 days after operation,BCG 10mg added to normal saline 40ml were vesically irrigated 14 days after operation; then alternately vesical irrigation was given every other 3 day till 56 days after operation; after 63 days of operation,alternately vesical irrigated every 1 week,8 times for each drug; after 183 days of operation,altemately vesical irrigated every 15 days,8 times for each drug; after 438 days of operation,alternately vesical irrigated till 2 years post-operation.Group B：This group was infused with HCPT 10mg added to normal saline 20ml after 7 days of operation,then was given once a week to 56 days of postoperation; then once every other 2 weeks to 197 days of post-operation; once every other 1 month for 8 times; once every other 2 months till 2 years of post-operation.The total dose for each time of irrigation is the same with the first time.The Recurrence rate and side effects were observed 0 ～ 18 months,19 ～ 24months and 25 ～ 60months separately.Results After 60 months of follow-up,the recurrence rate was 0 （0 ～ 18months）,3.21% （19 ～ 24 months） ; 18.67% （25 ～ 60months） for group A,and 11.54%,7.10% and 20.13% for group B separately.The difference between the recurrence rate of the two groups from 0-18 months was significant in statistics （P 〈 0.05）.Nonbacterial cystitis,hema turia,fever and abnormal routine blood test results were observed in both groups,but the difference was not significant in statistics（P 〉 0.05）.Conclusions Low dose tuberculin （BCG） and hydroxycamptothecin alternately intravesical therapy has a good effect on post-operation recurrence prevention with fewer and slighter side effects.