Shire Pharmaceuticals Group Plc, Basingstoke, UK.
Ren Fail. 2012;34(3):263-70. doi: 10.3109/0886022X.2011.649657. Epub 2012 Jan 17.
The effectiveness of phosphate binders can be assessed by evaluating urinary phosphorus excretion in healthy volunteers, which indicates the ability of the phosphate binder to reduce gastrointestinal phosphate absorption. Healthy volunteers were enrolled into one of five separate randomized trials; four were open label and one double blind. Following a screening period of ≤28 days, participants received differing tablets containing lanthanum carbonate [LC, 3000 mg/day of elemental lanthanum (in one study other doses were also used)]. Participants received a standardized phosphate diet and remained in the relevant study center throughout the duration of each treatment period. The end point in all studies was the reduction in urinary phosphorus excretion. Reductions in mean 24-h urinary phosphorus excretion in volunteers receiving a lanthanum dose of 3000 mg/day were between 236 and 468 mg/day over the five separate studies. These data in healthy volunteers can be used to estimate the amount of reduction of dietary phosphate absorption by LC. The reduction in 24-h urinary phosphorus excretion per tablet was compared with published data on other phosphate binders. Although there are limitations, evidence suggests that LC is a very effective phosphate binder in terms of binding per tablet.
通过评估健康志愿者的尿磷排泄量,可以评估磷酸盐结合剂的效果,这表明磷酸盐结合剂降低胃肠道磷吸收的能力。健康志愿者被纳入五项单独的随机试验之一;四项为开放标签,一项为双盲。在≤28 天的筛选期后,参与者接受了不同的含镧碳酸盐[LC,每天 3000 毫克元素镧(在一项研究中还使用了其他剂量)]的片剂。参与者接受了标准化的磷酸盐饮食,并在每个治疗期间都留在相关的研究中心。所有研究的终点均为尿磷排泄量减少。在五项单独的研究中,接受 3000 毫克/天镧剂量的志愿者的 24 小时平均尿磷排泄量减少了 236 至 468 毫克/天。这些健康志愿者的数据可用于估计 LC 减少膳食磷吸收的量。每片的 24 小时尿磷排泄量减少与其他磷酸盐结合剂的已发表数据进行了比较。尽管存在局限性,但有证据表明,LC 在结合能力方面是一种非常有效的磷酸盐结合剂。