Alfthan O, Tarkkanen J, Gröhn P, Heinonen E, Pyrhönen S, Säilä K
Eur Urol. 1983;9(1):6-9. doi: 10.1159/000474033.
The effect of Tigason (etretinate) in the prevention of the recurrence of superficial bladder tumors (Ta-T1, grade 0 papilloma and grade 1 and 2 carcinoma) was studied in 30 patients in a double-blind, placebo-controlled study. Before beginning treatment, the bladder was cleared from all visible tumors by electrocoagulation or TUR. The duration of treatment ranged from 10 to 26 months. The overall preventive effect was significantly better (p less than 0.01) in Tigason-treated patients than in patients given placebo. Tigason was more effective in preventing the recurrence of grade 1 and 2 carcinoma than placebo. On grade 0 papilloma this difference was not so marked. Side effects were common and disturbing at high doses (50 mg/day), but Tigason was well tolerated at the final maintenance dose (25 mg/day). The results obtained from this first clinical study with Tigason in the prevention of recurrence of superficial bladder tumors are promising.
在一项双盲、安慰剂对照研究中,对30例患者研究了银屑灵(依曲替酯)预防浅表性膀胱肿瘤(Ta-T1期,0级乳头状瘤以及1级和2级癌)复发的效果。在开始治疗前,通过电凝或经尿道切除术清除膀胱内所有可见肿瘤。治疗持续时间为10至26个月。银屑灵治疗组患者的总体预防效果显著优于给予安慰剂的患者(p<0.01)。银屑灵在预防1级和2级癌复发方面比安慰剂更有效。在0级乳头状瘤方面,这种差异不那么明显。高剂量(50毫克/天)时副作用常见且令人困扰,但在最终维持剂量(25毫克/天)时,银屑灵耐受性良好。这项关于银屑灵预防浅表性膀胱肿瘤复发的首次临床研究取得的结果很有前景。