The Xiaozhiling Intravesical Instillation Against Bladder Cancer Recurrence, Randomized, Controlled Clinical Trials (preliminary Report)

Objective:①To observe the clinical curative effect and safety of the combination of hemorrhoid injection and hydroxycamptothecin of different dose to treat superficial bladder tumor;②To preliminarily expore the effictive dose and mechanism of using hemorrhoid injection and hydroxycamptothecin to treat superficial bladder tumor:probably this combination can cut down the patients' blood VEGF levelMaterials:(1)The groups of case:According to the selected standard,we select 90 patients whom been after operation and divide 3 groups at random,every group have 30 patients.Group A:patients received a single dose o f 40mg hydroxycamptothecin;Group B:patients received 20ml hemorrhoid injection and 40 mg hydroxycam- ptothecin;Group C:patients received 20ml hemorrhoid injection and 20mg hydroxycam ptothecin;(2)Empirical method:After operation,the instillation will be repeated one time one week for two months and one time one month for ten months.(3)The index:To observe the index before operation and 3 months,6 months and 12 months after operation.A:BUS,cystoscope,sternite(CT or MRI p.r.n);B:Scores of KPS;C:The blood VEGF level;D:Blood RT,Urine RT,Liver and renal function,Biochemistry;E:Record the adverse effect; Results:At present,we have observed 38 patients in 3 to 6 months.We compared the data of 3 months after operation to which before operation,and give a phase summary:The racurrence of group A is 14.3%(2/14),group B is 8.3%(1/12),group C is 8.3%(1/12),p＞0.05,so in this aspect,three groups have no significant deviation.In three groups,we compared the data of VEGF after instillations to before,p＞0.05,so we presume that this three metheods all can cut down the patients'VEGF level.Compared group A and B,p＜0.05,so we think that in the effection of cutting down patients'VEGF level,group B do better than group A. Compared group A and C,we found group C also do better than group A.Compared group B and C,p＜0.05,so we think in the effection of cutting down patients' VEGF level,group B and C have no significant deviation.③We compred three groups in the aspect of side effection,p＞0.05,so in this aspect three metheods have no significant deviation.④Compred three groups in the aspect of KPS score,p＞0.05,so in this aspect three metheods have no significant deviation.Conclusions:With the comprehension of the data,we presume that with the combition of hemorrhoid injection,irrigation of bladder can do better in cutting down patients' VEGF level,probably can reduce the racurrence of bladder tumour and do not increase the side effections such as bladder fibrosis,bladder contraction,urethral stricture and so on.This result still need large sample and long clinicl reseach to check.