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目的:为了解医疗途径中增塑剂邻苯二甲酸二(2-乙基己基)酯(DEHP)的溶出及其对人体的安全性提供参考。方法:查阅相关文献,从DEHP的理化性质、毒性作用、溶出及体内药动学、各种医疗途径中人体的摄入量及耐受摄入量、目前国际上对含DEHP医疗器材的规定等方面进行分析。结果:DEHP易从聚氯乙烯医疗器材中溶出,进入人体后产生慢性毒性,毒性大小取决于摄入量和个体敏感性,其中新生儿接受全静脉营养、肠道营养、换血、体外心肺循环以及成人接受肠道营养、大量输血(外伤)、体外心肺循环、冠状动脉绕道、人工心脏移植等医疗途径时,会处于DEHP介导的不良反应的高风险中。结论:部分医疗途径中存在因DEHP释放使人体摄入量超过了耐受摄入量而产生危害的风险,应引起有关方面的高度重视。
OBJECTIVE: To provide a reference for understanding the dissolution of plasticizer di (2-ethylhexyl) phthalate (DEHP) in medical treatment and its safety to human body. Methods: According to the physical and chemical properties of DEHP, toxicity, dissolution and in vivo pharmacokinetics, human intake and tolerable intake of various medical approaches, the current international regulations on DEHP-containing medical devices, etc. Analysis. Results: DEHP was easily eluted from polyvinyl chloride medical equipment. After entering the body, DEHP produced chronic toxicity. The toxicity depends on intake and individual sensitivity. Among them, the newborn received total parenteral nutrition, intestinal nutrition, blood transfusion, cardiopulmonary bypass and Adult patients at high risk of DEHP-mediated adverse reactions when receiving gut nutrition, extensive blood transfusions (traumas), cardiopulmonary bypass, coronary artery bypass, and artificial heart transplant. Conclusion: There is a risk that some medical approaches may cause harm due to the release of DEHP, which leads to the human body taking in excess of the tolerable intake, which should arouse the attention of the parties concerned.