Ettinger B, Tang A, Citron J T, Livermore B, Williams T
N Engl J Med. 1986 Nov 27;315(22):1386-9. doi: 10.1056/NEJM198611273152204.
In a double-blind study, we examined the efficacy of allopurinol in the prevention of recurrent calcium oxalate calculi of the kidney. Sixty patients with hyperuricosuria and normocalciuria who had a history of calculi were randomly assigned to receive either allopurinol (100 mg three times daily) or a placebo. After the study, the placebo group had 63.4 percent fewer calculi (P less than 0.001), whereas the allopurinol group had 81.2 percent fewer calculi (P less than 0.001). During the study period, the mean rate of calculous events was 0.26 per patient per year in the placebo group and 0.12 in the allopurinol group. When the treatment groups were compared by actuarial analysis, the allopurinol group was found to have a significantly longer time before recurrence of calculi (P less than 0.02). We conclude that allopurinol is effective in the prevention of calcium oxalate stones in patients with hyperuricosuria. The large reduction in the frequency of calculi in the placebo group underscores the positive treatment bias that regularly occurs in trials of prophylaxis against renal calculi when historical controls are used.
在一项双盲研究中，我们检验了别嘌醇预防复发性肾草酸钙结石的疗效。60例有结石病史的高尿酸尿症和正常钙尿症患者被随机分配接受别嘌醇（每日3次，每次100毫克）或安慰剂治疗。研究结束后，安慰剂组的结石减少了63.4%（P<0.001），而别嘌醇组的结石减少了81.2%（P<0.001）。在研究期间，安慰剂组每位患者每年结石事件的平均发生率为0.26次，别嘌醇组为0.12次。通过精算分析比较治疗组时，发现别嘌醇组结石复发前的时间显著更长（P<0.02）。我们得出结论，别嘌醇对预防高尿酸尿症患者的草酸钙结石有效。安慰剂组结石频率的大幅降低突出了在使用历史对照进行预防肾结石试验时经常出现的积极治疗偏倚。
