ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of intravesical instillation of high-dose pirarubicin during perioperative period to prevent bladder carcinoma recurrence.</p><p><b>METHODS</b>A prospective randomized controlled clinical trial was carried out. A total of 120 patients with bladder transitional cell carcinoma (TNM I-II) underwent partial cystectomy or transurethral resection of bladder tumour were randomly divided into 2 groups, which were chosen from the patients were hospitalized during June 2003 to May 2009. There were 62 patients were in group A and 58 patients were in group B. In group A, intravesical instillation of high-dose pirarubicin during perioperative period was conducted. In group B, intravesical perfusion of pirarubicin was performed regularly after operation. All the patients were followed up in order to record the relapse rates and adverse reaction.</p><p><b>RESULTS</b>No significant difference was found between group A and group B from gender, age, pathological stage and operation methods (P > 0.05). The recurrence rates were 8.1% in group A, and 20.7% in group B. The adverse effect rates of urethrostenosis in group A and group B were 3.2% and 18.9%. The adverse effect rates of cystic stimulation including irritation signs of bladder and hematuria in group A and group B were 4.8% and 27.6%. There were significant differences in recurrence rates and adverse effect rates between the two groups (P > 0.05).</p><p><b>CONCLUSION</b>Intravesical instillation of high-dose pirarubicin during perioperative period is an effective procedure for the prevention of bladder cancer recurrence.</p>