前列地尔治疗高龄糖尿病并慢性肾脏病患者疗效和安全性  

Efficacy and Safety of Alprostadil in Treating Very Elderly Patients with Diabetes Complicated with Chronic Kidney Disease

作　　者：廖淑金[1] 杨川[2] 江慧琦[3] 黄萍[1] 严励[2] 

机构地区：[1]广州市第一人民医院老年病科,广东广州510180 [2]中山大学孙逸仙纪念医院内分泌科,广东广州510120 [3]中山大学孙逸仙纪念医院心外科,广东广州510120

出　　处：《中山大学学报（医学科学版）》2015年第1期120-125,共6页Journal of Sun Yat-Sen University:Medical Sciences

基　　金：2013年国家临床重点专科建设项目补助资金(2100299)

摘　　要：【目的】探讨前列地尔治疗80岁以上糖尿病合并慢性肾脏病患者的疗效及安全性。【方法】2012年10月至2013年5月我院住院的80岁以上糖尿病合并慢性肾脏病患者共52例,按性别分层随机分为A组及B组。采用成组交叉设计,A组先给予前列地尔注射液10μg静推＋基础治疗,每天1次,共14 d,洗脱14 d后再予基础治疗14d;B组则先予基础治疗14d,洗脱14 d后再予前列地尔注射液10μg静推＋基础治疗,每天1次,共14 d。所有患者进入试验前1天、试验第15天、第29天及第43天各采集一次观察指标,试验期间观察药物的安全性。主要观察指标包括：肾功能及尿蛋白（UAER、ACR、Scr、BUN、e GFR）;次要观察指标包括：凝血功能（PLT、PT、APTT、FIB、D-DI）、血脂（CHOL、TRIG、LDL-c、HDL-c）、血糖（FBG、Hb A1c）、肝功能（ALT）、血压;不良反应指标包括：注射部位的反应、过敏反应、血管扩张反应、出血倾向。【结果】两组病人分别用前列地尔治疗后UAER、ACR、CHOL、LDL-c均较治疗前有明显下降,差异有统计学意义（P〈0.05）。PLT、PT、APTT、FIB、D-DI、FBG、Hb A1c在治疗前后差异无统计学意义（P〉0.05）。实验效应分析中,UAER、ACR在＂基础治疗＋前列地尔＂与＂基础治疗＂两种治疗方式的疗效差异有统计学意义（P〈0.05）,基础治疗＋前列地尔治疗后UAER与ACR改善的程度均较基础治疗后大。e GFR为30-59 m L·min^-1·1.73 m^-2组的UAER、ACR、Scr前列地尔治疗后的下降程度较60-89 m L·min^-1·1.73 m^-2组大,差异有统计学意义（P〈0.05）。所有患者在治疗期间均无出现过敏反应、血管扩张反应、出血倾向、肝功能损害,1例出现局部疼痛,1例出现血管炎反应,经对症处理后均能迅速消退,无需特殊处理。【结论】前列地尔对80岁以上糖尿病合并慢性肾脏病患者的尿白蛋白有明显的降低作用,且对e GFR为30-59 m L·min^-1·1.73 m^-2�【Objective】 To explore the effect and safety of alprostadil in treating diabetes complicated with chronic kidney disease in the age 80 and over.【Methods】 Total 52 hospitalized patients in the age 80 and over diagnosed diabetes complicated with chronic kidney disease in our hospital during the period from October,2012 to May,2013 were chosen as the research objects.They were divided into A group and B group through stratified randomization by sex.We chose the group cross-over design ：Firstly A group was given intravenous injection of alprostadil injection 10 μg,once a day ＋ basic treatment,a total of 14 days,and then was just given basic treatment for 14 days after the 14 days of washout period.Conversely,B group was just given basic treatment for 14 days andthen was given intravenous injection of alprostadil injection 10 μg,once a day ＋ basic treatment for 14 days after the 14 days of washout period.We collected respective observation indexes on one day before the experiment,the fifteenth day,the twenty-ninth day and the forty-third day in the experiment period when the safety of the drug was observed.The observation indexes included renal function and urinary albumin（UAER,ACR,Scr,BUN,e GFR）.The main observation indexes included coagulation function（PLT,PT,APTT,FIB,D-DI）,blood glucose（FBG）,liver function（ALT） and blood pressure.The adverse reaction indexes included local injection site reactions,allergic reactions,vasodilator response and hemorrhagic tendency.【Results】 In each groups,UAER,ACR,CHOL and LDL-c after alprostadil treatment significantly decreased than before treatment,and the difference was statistically significant（P 0.05）.Difference of efficacy on PLT,PT,APTT,FIB,D-DI and FBG between pre and post treatment had no statistically significance（P 0.05）.In the analysis of the experimental effect,both of UAER and ACR had statistically significant differences between two kinds of treatment based ＂basic treatment ＋ alprostadil treatment＂ and ＂basic treatmen

关 键 词：前列地尔 老年人 80以上 糖尿病 慢性肾脏病 

分 类 号：R587[医药卫生—内分泌]