Goldfarb David S, Modersitzki Frank, Asplin John R
Nephrology Section, New York Harbor VA Medical Center and New York University School of Medicine, New York, NY 10010, USA.
Clin J Am Soc Nephrol. 2007 Jul;2(4):745-9. doi: 10.2215/CJN.00600207. Epub 2007 May 30.
Urinary oxalate excretion is an important contributor to calcium oxalate stone formation. Methods of reducing oxalate excretion are not wholly satisfactory, and no controlled trials using them have been performed to prevent stone recurrence. Some lactic acid bacteria can degrade oxalate in vitro. This study sought to reduce urinary oxalate excretion in calcium stone formers with idiopathic hyperoxaluria.
DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: A randomized, double-blind, placebo-controlled trial was performed of Oxadrop, a mix of four lactic acid bacterium species. This preparation previously reduced oxalate excretion in stone formers with idiopathic and enteric hyperoxaluria. Patients were selected from two stone prevention clinics. Twenty people with calcium stones and idiopathic hyperoxaluria (>40 mg/d) were enrolled and randomly assigned 1:1 in placebo and active preparation arms. Both groups took 3.6 g of granulate each day: Either placebo or the experimental preparation. Participants performed two consecutive 24-h urine collections at baseline, at 28 d of therapy, and at 56 d, after being off the preparation for 4 wk. Diet was replicated at each point.
There was no effect of the study preparation: Mean 24-h urinary oxalate excretion in placebo-treated patients was 73.9 mg at baseline and 72.7 mg after treatment, whereas the Oxadrop-treated patients had 59.1 mg at baseline and 55.4 mg after treatment. The preparation was well tolerated; three participants on active treatment experienced mild constipation.
In this randomized, placebo-controlled trial, Oxadrop did not reduce urinary oxalate excretion in participants with idiopathic hyperoxaluria.
尿草酸排泄是草酸钙结石形成的重要因素。降低草酸排泄的方法并不完全令人满意，且尚未进行对照试验来预防结石复发。一些乳酸菌可在体外降解草酸。本研究旨在降低特发性高草酸尿症钙结石患者的尿草酸排泄。
设计、地点、参与者及测量方法：对一种包含四种乳酸菌的制剂Oxadrop进行了一项随机、双盲、安慰剂对照试验。该制剂先前已降低了特发性和肠道高草酸尿症结石患者的草酸排泄。患者选自两家结石预防诊所。招募了20名患有钙结石和特发性高草酸尿症（>40mg/d）的患者，并以1:1的比例随机分配至安慰剂组和活性制剂组。两组患者每天均服用3.6g颗粒剂：安慰剂或试验制剂。参与者在基线、治疗28天以及停药4周后的56天，连续进行两次24小时尿液收集。每个时间点的饮食均重复。
研究制剂无效果：安慰剂治疗患者的24小时尿草酸平均排泄量在基线时为73.9mg，治疗后为72.7mg，而Oxadrop治疗患者在基线时为59.1mg，治疗后为55.4mg。该制剂耐受性良好；三名接受活性治疗的参与者出现轻度便秘。
在这项随机、安慰剂对照试验中，Oxadrop未降低特发性高草酸尿症参与者的尿草酸排泄。
