OBJECTIVE: To verify the efficacy and safety of intravesical instillation of pirarubicin combined with hyaluronic acid after TURBT in non-muscle invasive bladder cancer patients. METHODS: We conducted a prospective study recruiting 127 eligible patients from 2008 to 2010. Patients were randomly assigned to Group A (pirarubicin combined with hyaluronic acid) and Group B (pirarubicin alone). Patients' demographics, treatment efficacy on recurrence, visual analog scale score, and postoperative complications were evaluated and analyzed during observation. RESULTS: After the first month of intravesical chemotherapy, a perceptible relief of pelvic pain and urinary symptoms was detectable in Group A when compared with Group B (Fig. 2; P = 0.04). From objective analysis, the clinicians observed a consistent better improvement in Group A than in Group B on clinical conditions (P = 0.02). Frequency, urgency, and odynuria are relieved effectively in Group A (21/64 32.9%) and in Group B (41/63 65.1%), with significant difference observed (P = 0.001). No statistical evidence of benefit was observed in terms of recurrence. No obvious hyaluronic acid-related adverse event was observed. CONCLUSIONS: As compared to intravesical instillation of pirarubicin alone, the administration of pirarubicin combined with HA for prevention from postoperative recurrence was satisfactory and safe. The relief of pelvic pain and urinary symptoms is more rapid and more durable.
RCT Entities:
OBJECTIVE: To verify the efficacy and safety of intravesical instillation of pirarubicin combined with hyaluronic acid after TURBT in non-muscle invasive bladder cancerpatients. METHODS: We conducted a prospective study recruiting 127 eligible patients from 2008 to 2010. Patients were randomly assigned to Group A (pirarubicin combined with hyaluronic acid) and Group B (pirarubicin alone). Patients' demographics, treatment efficacy on recurrence, visual analog scale score, and postoperative complications were evaluated and analyzed during observation. RESULTS: After the first month of intravesical chemotherapy, a perceptible relief of pelvic pain and urinary symptoms was detectable in Group A when compared with Group B (Fig. 2; P = 0.04). From objective analysis, the clinicians observed a consistent better improvement in Group A than in Group B on clinical conditions (P = 0.02). Frequency, urgency, and odynuria are relieved effectively in Group A (21/64 32.9%) and in Group B (41/63 65.1%), with significant difference observed (P = 0.001). No statistical evidence of benefit was observed in terms of recurrence. No obvious hyaluronic acid-related adverse event was observed. CONCLUSIONS: As compared to intravesical instillation of pirarubicin alone, the administration of pirarubicin combined with HA for prevention from postoperative recurrence was satisfactory and safe. The relief of pelvic pain and urinary symptoms is more rapid and more durable.
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