Flaminio L M, De Angelis L, Ferazza M, Marinovich M, Galli G, Galli C L
Institute of Pharmacological Sciences, University of Milan, Italy.
Int J Artif Organs. 1988 Nov;11(6):435-9.
In two groups of patients on chronic haemodialysis treatment, the common PVC-DEHP blood tubing was replaced with tubing containing tri-(2-ethylhexyl)-trimellate (TOTM) as plasticizer. The aim of the present study was to measure the amount of TOTM and/or its metabolites (TAE s) in plasma, resulting from TOTM that might leach from the dialysis tubes. The arterial levels of TAE s at the start of the dialysis sessions were monitored by Selected Ion Monitoring (SIM) analysis once a week for a period of 42 days. A gradual decrease in TAE was observed during the first 21 days of the haemodialysis treatment with the PVC-TOTM tubes. After three weeks, the TAE levels remained constant until the end of the study. On day 120 of the haemodialysis treatment, the plasma TAE concentrations from the inflow and outflow tubes of the dialyzer were monitored during a single haemodialysis session at different times after starting dialysis. At the beginning of the dialysis session, the mean concentration of TAE was 55.81 +/- 14.98 ng/ml (mean +/- standard error), while at the end the levels were 73.34 +/- 17.05 ng/ml. There were no significant differences between venous and arterial sampling points in the trimellitic ester concentrations. Less TOTM is apparently leached from haemodialysis than DEHP. TOTM can be recommended as an alternative plasticizer to DEHP, but its possible toxicity in humans should be investigated before it can be used routinely.
在两组接受慢性血液透析治疗的患者中，将常用的聚氯乙烯-邻苯二甲酸二（2-乙基己基）酯（PVC-DEHP）血液管路替换为含有偏苯三酸三（2-乙基己基）酯（TOTM）作为增塑剂的管路。本研究的目的是测量血浆中可能从透析管中沥出的TOTM及其代谢物（TAE）的量。在为期42天的时间里，每周通过选择离子监测（SIM）分析监测透析开始时TAE的动脉水平。在使用PVC-TOTM管进行血液透析治疗的前21天观察到TAE逐渐下降。三周后，TAE水平保持恒定直至研究结束。在血液透析治疗的第120天，在开始透析后的不同时间，在单次血液透析过程中监测透析器流入管和流出管中的血浆TAE浓度。在透析开始时，TAE的平均浓度为55.81±14.98 ng/ml（平均值±标准误差），而结束时水平为73.34±17.05 ng/ml。偏苯三酸酯浓度在静脉和动脉采样点之间没有显著差异。显然，血液透析中沥出的TOTM比DEHP少。TOTM可被推荐作为DEHP的替代增塑剂，但在常规使用之前应研究其对人类可能的毒性。
