糖尿病患者口服叶黄素安全性的研究

Study on the safety of oral lutein in diabetic patients

目的观察糖尿病患者口服叶黄素后的浓度变化,以及是否存在不良反应,为该药物临床应用安全性提供研究依据。方法2017年10月~2019年2月招募符合条件的经内分泌科确诊为2型糖尿病的患者。所有参加本研究的患者在入组前都签署了书面知情同意书。研究对象通过入选/排除标准后,数据处理系统进行分层随机,分为对照组和用药组。对照组给予赋形剂片1粒/d 1次,用药组给予叶黄素咀嚼片10 mg(1粒)/d 1次。随访时间节点为服药后1个月、3个月、6个月。随访和基线分别询问一般状况和全身症状及体征,并检测血叶黄素浓度和实验室检查,包括肝、肾功能,血糖及糖化血红蛋白等。结果共入组随访糖尿病患者66例,按照随机分层入组。其中对照组34例,用药组32例,2组间年龄、性别、糖尿病视网膜病变程度以及基线的视力和眼压,差异均无统计学意义。服用叶黄素前,对照组和用药组血叶黄素浓度分别为(260.55±19.57)ng/mL和(288.27±24.05)ng/mL,口服叶黄素后血液中叶黄素浓度显著升高并持续保持,差异有统计学意义。实验室检查各项指标服药前后差异无统计学意义。未见严重不良事件。结论糖尿病患者口服叶黄素后与对照组相比,实验室检查指标差异没有统计学意义,表明叶黄素在糖尿病患者中的应用安全性可靠,同时在本次研究中未发现全身及局部不良反应。

Objective To observe the changes of lutein concentration in diabetic patients after oral administration and whether there are adverse reactions,so as to lay a foundation for the application of lutein.Methods From October 2017 to February 2019,eligible patients with type 2 diabetes mellitus(T2DM)confirmed by endocrinology department were recruited.All patients in this study signed written informed consent before trial.Patients who meet grouping criteria were stratified and randomly divided into control group and medication group by the data processing system.The control group was given excipient tablets once a day,while the medication group was given lutein chewable tablets 10 mg(1 tablet)once a day.The set follow-up time points were 1 month,3 months and 6 months after taking medicine.During each follow-up and baseline,patients were questioned about the general condition,general symptoms and signs,and were detected lutein concentration and laboratory tests,including liver and kidney function,blood sugar and glycosylated hemoglobin.Results A total of 66 diabetic patients were followed up and randomly divided into two groups.There were no significant differences in age,sex,degree of diabetic retinopathy,baseline visual acuity and intraocular pressure between the two groups.Before taking lutein,the concentration of serum lutein in control group and medication group was(260.55±19.57)ng/mL and(288.27±24.05)ng/mL,respectively.After taking lutein orally,the concentration of serum lutein was significantly increased and maintained in medication group.There was no significant difference in laboratory tests before and after taking medicine.No serious adverse event was observed.Conclusions Compared with the control group,there was no significant difference in laboratory test of diabetic patients after taking lutein orally,which indicated that lutein is safe and reliable in the application of diabetic patients.Also no systemic and local adverse reaction was reported in this study.