Highland Park Hospital, NorthShore University Health System, and University of Chicago, Evanston, Illinois 60035, USA.
Colorectal Dis. 2011 Sep;13(9):e270-5. doi: 10.1111/j.1463-1318.2011.02679.x.
Sodium-phosphate-containing colonoscopy preparations cause renal failure by the development of calcium phosphate nephropathy. Although Fleet's Phospho-Soda has been removed from the US market, sodium phosphate tablets sold as OsmoPrep and Visicol remain available. Our aim was to analyse renal risks of the sodium phosphate tablets.
We conducted a retrospective study using the US Food and Drug Administration Adverse Event Reporting System, a voluntary reporting system available for public access. Renal adverse events were identified using search terms including renal impairment, increased blood urea nitrogen, increased creatinine, renal failure, acute renal failure, chronic renal failure, acute phosphate nephropathy, nephrocalcinosis, renal tubular necrosis, haemodialysis, nephropathy toxic, dialysis, peritoneal dialysis, renal injury, renal tubular disorder, decreased glomerular filtration rate and decreased creatinine clearance. Patient age, gender and body weight were compared with data for the general population in the National Health and Nutrition Examination Survey (NHANES).
In total 2,097,223 files were extracted from the US Food and Drug Administration website for 2004-2008 and the first 9 months of 2009. Of these, 178 patients on tablet preparations (71% women) were identified, with increasing numbers of renal adverse drug reactions reported from tablet preparations each year. The mean weight for women with renal complications from tablet preparations was 68.57 ± 1.78 kg, significantly lower than the national average weight of 74 ± 0.5 kg for the same age group (P = 0.003) in NHANES.
Renal adverse drug reactions from sodium phosphate tablets are more common in women with a mean body weight lower than the national average weight.
含磷的结肠镜检查准备会通过钙磷酸盐肾病的发展引起肾衰竭。尽管菲力特磷酸钠已从美国市场撤出，但作为 OsmoPrep 和 Visicol 销售的磷酸钠片剂仍在销售。我们的目的是分析这些磷酸钠片剂的肾脏风险。
我们使用美国食品和药物管理局不良事件报告系统（一个可供公众访问的自愿报告系统）进行了一项回顾性研究。使用包括肾功能损害、血尿素氮升高、肌酐升高、肾衰竭、急性肾衰竭、慢性肾衰竭、急性磷酸盐肾病、肾钙质沉着症、肾小管坏死、血液透析、肾毒性、透析、腹膜透析、肾损伤、肾小管紊乱、肾小球滤过率降低和肌酐清除率降低在内的搜索词来识别肾脏不良事件。患者年龄、性别和体重与国家健康和营养检查调查（NHANES）中的一般人群数据进行了比较。
从 2004 年至 2008 年以及 2009 年前 9 个月，从美国食品和药物管理局网站上提取了 2,097,223 份文件。其中，178 名接受片剂制剂的患者（71%为女性）被确定为与每年报告的片剂制剂肾脏不良药物反应数量增加。服用片剂制剂导致肾脏并发症的女性的平均体重为 68.57 ± 1.78 公斤，明显低于 NHANES 中同一年龄组的全国平均体重 74 ± 0.5 公斤（P = 0.003）。
服用磷酸钠片剂的肾脏不良药物反应在体重低于全国平均体重的女性中更为常见。
