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在6组前瞻性Ⅱ期研究中,对123例膀胱原位患者进行了Tice BCG膀胱内灌注。疗程为每周1次,至少6次(诱导),后改为每月1次,12次(维持)。剂量为50mg(1～8×10~8菌落形成单位)。评价119例,90例(76%)获完全消退,包括63例曾行膀胱内化疗患者中的45例(71%)。45例(50%)反应者平均反应期已≥48个月,仍然尿细胞学阴性。BCG灌注反应者与反应者之间生存率并无差别,但膀胱切除率有显著差别,反应者为11%(10/90),无反应者为
In a six-stage prospective phase II study, Tice BCG intravesical instillation was performed in 123 patients with bladder in situ. The course of treatment is once a week, at least 6 times (induction), and later changed to 1 time per month and 12 times (maintenance). The dose was 50 mg (1 to 8 x 10~8 colony forming units). Of the 119 patients evaluated, 90 (76%) were completely regressed, including 45 (71%) of 63 patients who had undergone intravesical chemotherapy. The average response period of 45 (50%) responders was ≥ 48 months and was still negative for urine cytology. There was no difference in survival rates between BCG perfusion responders and responders, but there was a significant difference in the rate of cystectomy, with 11% (10/90) responders. No responders were