新型口服水解蛋白制剂对正常人群耐受性的研究

The tolerance study of an oral formulation of hydrolyzed protein in the normal population

目的:探讨一种新型水解蛋白制剂在健康成年人群使用的耐受状况及其护理措施,为临床病人安全使用提供理论依据。方法:采用前瞻性随机对照研究,将100例健康受试者随机分为试验组和对照组,每组50例。对照组人群给予统一的正常三餐饮食,试验组在低氮饮食[蛋白质摄入量<0.4 g/(kg·d)]的基础上,通过规范的护理指导,服用短肽型专项蛋白补充剂口服水解蛋白,平均使用剂量为6袋/次,3次/d,持续3 d。观察并比较两组胃肠道不耐受症状的发生情况、肝肾功能、红细胞和白细胞等。结果:对照组未发生胃肠道不耐受症状,试验组有2例(4%)受试者发生轻微的恶心症状。两组病人红细胞、白细胞、总胆红素、肌酐、尿素氮差异均无统计学意义。结论:口服水解蛋白制剂在健康人群具有良好的耐受性,对人体无明显伤害,可作为一种新型的短肽型专项蛋白补充剂在临床营养治疗中推荐使用,在其使用过程中规范的护理措施有利于使用者的耐受。

Objective：To explore the tolerance and nursing of enteral nutrition with peptide in healthy people.Methods：100 volunteers were selected and grouped into Study and Control randomly.All subjects in control group were given normal diet.The subjects in the experimental group were given oral hydrolyzed protein on the basis of low-nitrogen diet for three days through standard nursing guidance.The average dose of oral hydrolyzed protein was 6 bags each time and 3 times per day.The demographic characteristics,intolerance symptoms,liver and renal function and routine blood was compared between two groups.Results：Only 2 subjects had obvious intolerance in the experimental group.There was no significant differences between the two groups （P 〉 0.05） in routine blood,total bilirubin,creatinine,and urea nitrogen between study group and control group.Conclusion：The hydrolyzed protein preparation has good tolerance in healthy people and can be used safely as a novel peptide-based protein supplements.Effective nursing practice can improve its tolerance.