Newling D W, Robinson M R, Smith P H, Byar D, Lockwood R, Stevens I, De Pauw M, Sylvester R
Free University Hospital, Department of Urology, Amsterdam, The Netherlands.
Eur Urol. 1995;27(2):110-6. doi: 10.1159/000475139.
This double-blind randomised phase III trial was designed to assess the effect of pyridoxine administration on the recurrence of Ta and T1 transitional cell tumours of the bladder. The trial accrued 291 patients and showed no significant difference between the pyridoxine and placebo treatment groups with respect to the time to first recurrence or the recurrence rate. Adjustment for the main prognostic factors, namely the recurrence rate prior to entry, the number of tumours at entry, the G grade and the levels of the tryptophan metabolites kynurenine plus acetyl kynurenine at entry do not change the overall conclusions.
这项双盲随机III期试验旨在评估服用吡哆醇对膀胱Ta和T1期移行细胞肿瘤复发的影响。该试验纳入了291名患者，结果显示，在首次复发时间或复发率方面，吡哆醇治疗组和安慰剂治疗组之间没有显著差异。对主要预后因素进行调整，即入组前的复发率、入组时的肿瘤数量、G分级以及入组时色氨酸代谢产物犬尿氨酸加乙酰犬尿氨酸的水平，并不会改变总体结论。
