摘要
目的比较1%托吡卡胺和2.5%去氧肾上腺素复方制剂与0.5%托吡卡胺和0.5%去氧肾上腺素复方制剂在2型糖尿病患者中的散瞳效果。方法采用双盲、随机对照研究设计,纳入2024年6—9月在天津医科大学眼科医院眼底病门诊就诊的需要散瞳检查的中国深色虹膜2型糖尿病患者90例90眼,采用随机数字表法将参与者分为对照组、高浓度组和半量稀释组,每组30例30眼。对照组患者接受2滴由0.5%托吡卡胺和0.5%去氧肾上腺素构成的复方制剂点眼,高浓度组患者接受2滴由1%托吡卡胺和2.5%去氧肾上腺素构成的复方制剂点眼,半量稀释组患者先接受1滴由1%托吡卡胺和2.5%去氧肾上腺素构成的复方制剂,再接受1滴生理盐水点眼。在患者点眼前和点眼后40 min使用瞳孔计测量患者的瞳孔直径。结果对照组、高浓度组、半量稀释组首次点药后40 min瞳孔直径达到7 mm的比例分别为56.7%(17/30)、86.7%(26/30)和66.7%(20/30),总体比较差异有统计学意义(χ^(2)=6.667,P=0.036),其中高浓度组首次点药后40 min瞳孔直径达到7 mm的比例高于对照组,差异有统计学意义(P<0.05)。对照组、高浓度组、半量稀释组首次点药后40 min瞳孔直径分别为(7.01±0.86)、(7.64±0.61)和(7.49±1.15)mm,总体比较差异有统计学意义(F=4.019,P=0.021),其中高浓度组瞳孔直径明显大于对照组,差异有统计学意义(P=0.024)。对照组、高浓度组、半量稀释组首次点药后40 min瞳孔直径变化量分别为(3.23±0.81)、(3.82±0.60)和(3.62±0.75)mm,总体比较差异有统计学意义(F=5.121,P=0.008),其中高浓度组瞳孔直径变化量大于对照组,差异有统计学意义(P=0.007)。结论1%托吡卡胺和2.5%去氧肾上腺素复方制剂的散瞳效果优于0.5%托吡卡胺和0.5%去氧肾上腺素复方制剂,推荐糖尿病患者在门诊进行眼底检查前使用较高浓度的散瞳剂散瞳。
Objective To compare the mydriatic effects of a combination of 1%tropicamide and 2.5%phenylephrine with a 0.5%tropicamide and 0.5%phenylephrine combination in patients with type 2 diabetes.Methods A randomized,double-blind,controlled trial was conducted.Ninety Chinese patients(90 eyes)with dark irises and type 2 diabetes who needed mydriasis examination at the Fundus Disease Clinic of Tianjin Medical University Eye Hospital from June to September 2024 were included.The subjects were divided into control group(30 patients 30 eyes),high concentration group(30 patients 30 eyes)and half-dilution group(30 patients 30 eyes)using the random number table method,which received 2 drops of a mixture of 0.5%tropicamide and 0.5%phenylephrine,2 drops of a mixture of 1%tropicamide and 2.5%phenylephrine,1 drop of a mixture of 1%tropicamide and 2.5%phenylephrine+1 drop of saline respectively.The pupil diameter of the patients was measured with a pupillometer 40 minutes before and after instillation.The study adhered to the Declaration of Helsinki and the study protocol was approved by the Ethics Committee of Tianjin Medical University Eye Hospital(No.2024KY-16).Written informed consent was obtained from all participants.Results The proportions of patients whose pupil diameters reached 7 mm 40 minutes after the initial administration in the control group,high-concentration group,and half-dilution group were 56.7%(17/30),86.7%(26/30)and 66.7%(20/30),respectively,with a statistically significant overall difference(χ^(2)=6.667,P=0.036).The proportion of patients in the high-concentration group whose pupil diameter reached 7 mm 40 minutes after the initial administration was higher than that in the control group,and the difference was statistically significant(P<0.05).The pupil diameters 40 minutes after the initial administration in the control group,the high-concentration group and the half-dilution group were(7.01±0.86),(7.64±0.61)and(7.49±1.15)mm,respectively,with a statistically significant overall difference(F=4.019,P=0.021),and the pupil diameter of the high-concentration group was significantly higher than that of the control group(P=0.024).Changes in pupil diameter 40 minutes after the initial administration in the control group,high-concentration group and half-dilution group were(3.23±0.81),(3.82±0.60)and(3.62±0.75)mm,respectively,with a statistically significant overall difference(F=5.121,P=0.008),and the change in pupil diameter in the high-concentration group was higher than that in the control group(P=0.007).Conclusions The combination of 1%tropicamide and 2.5%phenylephrine has better pupil dilation than the combination of 0.5%tropicamide and 0.5%phenylephrine.It is recommended that pupil dilation be performed with a high-concentration mydriatic drug prior to outpatient fundus examination for diabetic patients.
作者
周怡凡
荣华
李志清
于丹阳
刘若煊
李昊儒
王子荀
魏瑞华
Zhou Yifan;Rong Hua;Li Zhiqing;Yu Danyang;Liu Ruoxuan;Li Haoru;Wang Zixun;Wei Ruihua(Tianjin Key Laboratory of Retinal Functions and Diseases,Tianjin Branch of National Clinical Research Center for Ocular Disease,Eye Institute and School of Optometry,Tianjin Medical University Eye Hospital,Tianjin 300384,China;Department of Ophthalmology,Tianjin Children's Hospital(Tianjin University Children's Hospital),Tianjin Key Laboratory of Birth Defects for Prevention and Treatment,Tianjin 300134,China)
出处
《中华实验眼科杂志(中英文)》
北大核心
2025年第8期739-744,共6页
Chinese Journal Of Experimental Ophthalmology
基金
天津市医学重点学科(专科)建设项目(TJYXZDXK-037A)。
