优泌乐25病例
优泌乐25病例ppt课件
– 对于A1C很高的患者，预混胰岛素类似物可有效降 低空腹血糖，促进达标
火灾袭来时要迅速疏散逃生，不可蜂 拥而出 或留恋 财物， 要当机 立断， 披上浸 湿的衣 服或裹 上湿毛 毯、湿 被褥勇 敢地冲 出去
火灾袭来时要迅速疏散逃生，不可蜂 拥而出 或留恋 财物， 要当机 立断， 披上浸 湿的衣 服或裹 上湿毛 毯、湿 被褥勇 敢地冲 出去
思路：该如何对该患调整用药？
• 该患者血糖控制的目标？
– 达标值：？
火灾袭来时要迅速疏散逃生，不可蜂 拥而出 或留恋 财物， 要当机 立断， 披上浸 湿的衣 服或裹 上湿毛 毯、湿 被褥勇 敢地冲 出去
4.4- 6.1
3.9- 7.2
≤ 5.5
餐后2小时血糖
4.4- 8.0
<10*
(2h PPG mmol/L)
＜ 7.8
* 餐后血糖峰值
American Diabetes Association, Standards of Medical Care in Diabetes-2007.Diabtes Care 2008;31(suppl 1):s18 2008IDF,Guideline for Management of Postmeal Glucose 中国糖尿病防治指南2007
火灾袭来时要迅速疏散逃生，不可蜂 拥而出 或留恋 财物， 要当机 立断， 披上浸 湿的衣 服或裹 上湿毛 毯、湿 被褥勇 敢地冲 出去
主要实验室检查
• 血糖：FBG 11.9mmol/L PBG 16.5mmol/L
• HbA1c 10.2% TG 2.6 mmol/L
优泌乐25治疗老年2型糖尿病临床观察
优泌乐25治疗老年2型糖尿病临床观察王国焕;张颖【期刊名称】《浙江中西医结合杂志》【年(卷),期】2013(000)005【总页数】3页(P383-384,385)【关键词】老年人;糖尿病;优泌乐25【作者】王国焕;张颖【作者单位】浙江省绍兴市安康医院绍兴 312000;浙江省绍兴市第二医院内分泌科【正文语种】中文糖尿病治疗过程中，常常要兼顾老年人体质特点。
笔者对预混胰岛素类似物优泌乐25和重组胰岛素优泌林治疗2型糖尿病进行比较，观察两种方案治疗老年糖尿病的疗效和安全性。
1 临床资料1.1 一般资料选择2009年8月—2011年10月间本院住院60岁以上初诊老年2型糖尿病住院患者98例，未曾服用过降糖药物。
随机分为优泌乐25组51例，男26例，女25例，年龄0.5～78.6岁，平均（68.4±6.4）岁；平均病程（7.8±2.1）年；体质指数（BMI）（23.1±1.4）kg/m2，空腹血糖（11.2±2.7）mmol/L。
优泌林组47例，男25例，女22例，年龄(61.6～82.1)岁，平均(69.2±8.9)岁；平均病程（6.7±2.3）年；BMI（22.4±1.8）kg/m2，空腹血糖（10.8±1.9）mmol/L。
两组年龄、病程、BMI、空腹血糖比较差异无统计学意义（P均＞0.05），具有可比性。
1.2 诊断标准诊断均符合1999年WHO制定的糖尿病诊断标准[1]。
排除：1型糖尿病；严重的心、肺、肝、肾功能不全者及服用免疫抑制剂、激素等影响血糖药物者。
2 治疗方法两组患者均控制饮食及运动，不服用磺脲类降糖药，睡前少吃粮食制品。
优泌乐组三餐前即刻皮下注射优泌乐25，起始剂量：早餐前8U，中餐前4U，晚餐前8U，逐步调整；优泌林组，三餐前30min注射优泌林R，起始剂量各6U；晚8点注射优泌林N，起始剂量为4U，逐步调整。
优泌乐强化方案病例分享
杜玉茗，中国老年学杂志 2009, 29(20)
初步治疗结果
该患者接受上述治疗3天后，监测血糖结果为 早餐前 6.7 早餐后9.8
午餐前 6.9 午餐后 11
晚餐前7.8 晚餐后 10.8
睡前10
问题，血糖控制仍不满意，如何调整胰岛素用量？
如何调整胰岛素用量？
2010年中国2型糖尿病防治指南中指出：
胰岛素剂量调整
基础与餐时胰岛素的选择
基础胰 岛素
中效胰岛素 长效胰岛素类似物
长效胰岛素
餐时胰岛 素
速效胰岛素类似物
短效胰岛素
基础与餐时胰岛素作用时间特点
胰岛素制剂
短效胰岛素（）
速效胰岛素类似物 （门冬胰岛素）
速效胰岛素类似物 （赖脯胰岛素）
起效时间 15-60 10-15
10-15
峰值时间 2-4h 1-2h
调整后血糖控制情况
该患者于剂量调整后3天测定7点血糖 早餐前 6.7 早餐后9.8 午餐前 6.9 午餐后 9 晚餐前6.9 晚餐后 9.8
睡前8.9 血糖控制满意，可出院
问题：出院后能否采取更简化的治疗方案？
基础-餐时胰岛素转为预混每日两次
该患者出院后保持胰岛素总量不变，将基础加三餐前优泌乐改为优泌 乐50 29（早餐前）+20U（晚餐前），结果血糖保持稳定，2个月后 测A1C降至6.8%
*因该患者使用的是速效胰岛素类似物优泌乐，故使用1800
经调整胰岛素泵输注，血糖控制满意
经上述调整后，患者血糖控制满意：
早餐前 6.5 早餐后9.0
午餐前 6.0 午餐后 9.2
晚餐前6.6 晚餐后 9.8
睡前8.9
凌晨 7.0短期胰岛素泵治疗如何向转换？
优泌乐25治疗2型糖尿病的临床观察_刘美茹
优泌乐25治疗2型糖尿病的临床观察刘美茹赵向晖【摘要】目的观察优泌乐25治疗2型糖尿病的临床疗效。
方法选择52例需胰岛素治疗的2型糖尿病患者，随机分为两组，A组为优泌乐25组，B组为优泌林70/30组，治疗12周。
结果两组治疗后空腹血糖控制水平相似，A组餐后2h血糖控制优于B组，且HbA1c下降较B组明显，胰岛素用量少，低血糖发生率低。
结论优泌乐25可以更加有效地控制餐后血糖，减少低血糖发生，安全性好。
【关键词】优泌乐25；2型糖尿病本研究对口服降糖药物继发失效的2型糖尿病患者采用优泌乐25日2次皮下注射，并与预混人胰岛素比较，观察临床疗效。
1资料与方法1.1一般资料选择2009年6月至2011年10月在辽宁省盘锦市中心医院内分泌科住院的2型糖尿病患者52例，均符合1999年WHO糖尿病诊断标准，入选前均口服降糖药物，未曾使用胰岛素治疗。
年龄32 55岁，男性28例，女性24例，病程3 14年，排除严重心、肝、肾功能不全，无急性并发症及应激因素。
两组患者在性别、年龄、病程、BMI、治疗前血糖水平及糖化血红蛋白等方面无统计学差异，具有可比性。
1.2方法两组患者均停用原口服降糖药物，给予同等的糖尿病知识教育，并进行饮食管理，A组改为优泌乐25注射液，早、晚餐前皮下注射，B组给予优泌林70/30注射液，早、晚餐前30min皮下注射，起始剂量均为0.4 0.5U/（kg·d），治疗12周。
采用强生稳豪血糖仪，每天测全天血糖（3餐前及3餐后2h，凌晨3时），达标后每周1次全天血糖监测，有低血糖症状的随时查血糖并记录，出院后每周门诊随访1次，根据血糖监测值调整药物用量。
目标血糖值FPG4.4 6.1mmol/L，2hPG4.4 8.0mmol/L，血糖﹤3.9mmol/L定义为低血糖。
1.3观察指标观察两组治疗前后空腹血糖、餐后2h血糖、HbA1c、胰岛素用量、低血糖发生次数等指标，进行统计学分析。
盐酸二甲双胍缓释片联合优泌乐25治疗2型糖尿病30例临床观察
盐酸二甲双胍缓释片联合优泌乐25治疗2型糖尿病30例临床观察发表时间：2016-04-19T16:33:26.280Z 来源：《医师在线》2015年12月第24期供稿作者：王雪芹[导读] 优泌乐25在餐前即刻注射或餐后立即注射，极大方便了快捷奏的患者；也为进餐时间不固定的患者提供了新的选择。
王雪芹摘要目的：探讨盐酸二甲双胍缓释片联合优泌乐25治疗2型糖尿病(T2DM)患者的临床疗效及不良反应。
方法：对30例盐酸二甲双胍缓释片联合优泌乐25治疗的T2DM患者进行回顾性总结分析。
疗程三个月，观察治疗前后血糖(FBG、2hBG)、糖化血红蛋白(HbAIc)、血脂、肝肾功能、体重的变化及付作用。
结果：治疗3个月后，FBG、2hBG、HbAlc、TG均显著下降(p<0.001),肝肾功能、体重无变化；3例低血糖反应，4例轻度恶心，未停药。
结论：盐酸二甲双胍缓释片联合优泌乐25治疗T2DM效果显著，付作用小，减少胰岛素用量，体重不增加，值得临床推广。
关键词盐酸二甲双胍缓释片优泌乐252型糖尿病(T2DM)是常见的慢性代谢性疾病，胰岛β细胞功能进行性损伤和胰岛素抵抗干扰了`治疗效果，我们于2011年5月-2012年5月用盐酸二甲胍缓释片联合优泌乐25治疗T2DM效果较好，现报告如下：1资料与方法1．1一般资料：全部30例T2DM来自糖尿病门诊，符合1999年世界卫生组织(WHO)制定的T2DM诊断标准(1)。
均经饮食、运动管理及口服降糖药治疗控制不佳的T2DM患者。
排除标准：①T1DM 、妊娠糖尿病、糖尿病急性并发症、心、肝肾功能不全，②有感染和应激等。
其中男性14例，女性16例，年龄45-70岁，平均55.6±2.1,病程1-20年，平均7.4±1.2年。
血糖FBG 8.3-15.4MMOL/l,2hBG 12.3-22.5mmol/L HbAlc>10%。
1．2治疗方法 30例T2DM患者全部停用原口服磺脲类及其它降糖药，进行糖尿病教育，制定科学食谱、合理的有氧运动计划，优泌乐25采用早晚餐前即刻皮下注射，起始剂量为0.3-0.5u(/kg.d),每周来院测FBG、2hBG(平时可在家监测)，根据血糖调整胰岛素剂量，盐酸二甲双胍缓释片0.5g早进餐时口服，直至血糖达标。
预混胰岛素类似物优泌乐致皮下脂肪萎缩3例报道
预混胰岛素类似物优泌乐致皮下脂肪萎缩3例报道石雪;陈琰;王嘉欣;刘莹莹;赵淑杰;张川;王彦君【期刊名称】《中国现代医学杂志》【年(卷),期】2017(27)25【摘要】目的探讨在临床治疗中皮下注射优泌乐25和优泌乐50所致皮下脂肪萎缩的现象及其机制.方法对该院3例皮下注射优泌乐25和优泌乐50的糖尿病患者的病史、治疗方法、皮下脂肪情况进行观察,并结合文献对其机制进行探讨.结果 3例患者长期皮下注射优泌乐20和优泌乐50,注射部位皮下脂肪萎缩,并进行性加重,更换胰岛素注射方案或停药后皮下脂肪萎缩停止,但随访半年,萎缩部位脂肪未见明显恢复.结论在临床治疗中可见长期皮下注射优泌乐20和优泌乐50导致局部皮下脂肪大面积萎缩的病例,可能与免疫机制有关,是否与特殊体质相关需进一步研究.【总页数】2页(P126-127)【作者】石雪;陈琰;王嘉欣;刘莹莹;赵淑杰;张川;王彦君【作者单位】吉林大学第二医院内分泌科,长春吉林,130041;吉林大学第二医院内分泌科,长春吉林,130041;吉林大学第二医院内分泌科,长春吉林,130041;吉林大学第二医院内分泌科,长春吉林,130041;吉林大学第二医院内分泌科,长春吉林,130041;吉林大学第二医院内分泌科,长春吉林,130041;吉林大学第二医院内分泌科,长春吉林,130041【正文语种】中文【中图分类】R587.1【相关文献】1.预混胰岛素类似物（优泌乐25R）和预混胰岛素（优泌林70/30）治疗老年2型糖尿病临床观察 [J], 范晓涛;陈世清;张宏伟2.优泌乐50治疗预混胰岛素控制不佳糖尿病疗效观察 [J], 郑冬良3.胰岛素类似物致皮下脂肪萎缩一例 [J], 陈诚;向光大4.胰岛素类似物优泌乐的临床应用与进展 [J], 甘佩珍;高凌5.胰岛素类似物致皮下脂肪萎缩1例分析 [J], 陈丽湘;孙慧伶因版权原因，仅展示原文概要，查看原文内容请购买。
磺脲类药物继发失效
Lilly Diabetes
2型糖尿病是一种异质性很强的疾病
胰岛素分泌
100% 50% 0
胰岛素敏感性
0 50% 100%
发病 胰岛素分泌功能 胰岛素需要量
10
Company Confidential © 2012 Eli Lilly and Company
3
6
9
12
Lilly Diabetes
时间（小时）
病例 1
中餐前加优泌乐25 4-6 U，２周后血糖满意控制。午餐后血糖降至 8.2 ，24小时动态血糖监测未发现血糖值低于4.0mM 。
患者每３月复诊１次，患者体重逐渐恢复至54kg。FBG: 5.3-6.5, HbA1c 6.２%。病情稳定。
Insulin(usually basal)
highest high risk gain hypoglycemiac variable
Three-drug combinations
If needed to reach individualized HbA1c target after~3 months,proceed to three-drug combination (order not meant to denote any specific preference):
血糖(mmol/L）
胰岛素(mU/L)
10.8
7.8
18.4
11.2
17.1
14.5
15.6
15.3
Company Confidential © 2012 Eli Lilly and Company
优泌乐25、来得时和诺和锐30治疗2型糖尿病临床疗效分析
优泌乐25、来得时和诺和锐30治疗2型糖尿病临床疗效分析赵芬;许燕【期刊名称】《南通大学学报（医学版）》【年(卷),期】2013(000)006【摘要】目的：观察优泌乐25、来得时和诺和锐30治疗2型糖尿病的临床疗效。
方法：将97例经口服药治疗无效的2型糖尿病患者，随机分为3组，分别给予优泌乐25(34例)、来得时(30例)和诺和锐30(33例)，优泌乐25及诺和锐30早、晚餐前注射，来得时睡前注射1次联合口服拜唐苹，均治疗12周，观察3组患者空腹血糖(fasting plasma glucose， FPG)、餐后2 h 血糖(2-hour postprandial blood glucose，2hPG)、糖化血红蛋白(hemoglobin A1c，HbA1c)、血清糖化白蛋白(glycated albumin，GA)、胰岛素用量、血糖达标时间、体质量指数(body mass index， BMI)、低血糖的发生情况等各项指标的变化，并比较治疗效果。
结果：3组患者治疗后FPG、2hPG、HbA1c、GA水平均明显低于治疗前(P＜0.05)；来得时组较其他2组治疗后HbA1c水平更低，胰岛素用量少，低血糖发生率低，差异有统计学意义(P＜0.05)。
结论：来得时联合拜唐苹治疗2型糖尿病，能在保持患者血糖平稳的同时降低低血糖的发生率，且能减少胰岛素用量，是目前治疗2型糖尿病的较佳方案，值得临床推广应用。
【总页数】2页(P556-557)【作者】赵芬;许燕【作者单位】南京医科大学附属苏州医院内分泌科，苏州 215001;南京医科大学附属苏州医院内分泌科，苏州 215001【正文语种】中文【中图分类】R587.1【相关文献】1.来得时联合拜唐苹和诺和锐30治疗口服降糖药疗效不佳的高龄2型糖尿病患者的临床观察 [J], 邵莉;滕丽莉;牛宪萍;李明珠;葛剑力;江华2.诺和锐30和优泌乐25治疗2型糖尿病的初步比较 [J], 黄宾协3.优泌乐25及诺和锐30在治疗2型糖尿病中的疗效比较 [J], 张凡;何军;韩艳4.诺和锐30和优泌乐25治疗2型糖尿病疗效比较 [J], 王芬5.2型糖尿病患者使用诺和锐30与优泌乐25治疗对FPG、2h PG及HbA1c水平的调节作用 [J], 刘宝英;梁干雄;叶凯云因版权原因，仅展示原文概要，查看原文内容请购买。
优泌乐50与优泌乐25降餐后血糖的临床分析
优泌乐50与优泌乐25降餐后血糖的临床分析摘要目的观察优泌乐50与优泌乐25治疗糖尿病降低餐后血糖水平的临床效果。
方法选取63例糖尿病患者，随机分为实验组（32例）和对照组（31例）。
两组患者均予以常规饮食治疗和健康教育，在此基础上观察组给予优泌乐50餐前皮下注射，对照组给予优泌乐25餐前皮下注射，连续1周记录两组患者注射优泌乐后餐后血糖的变化情况，分析比较优泌乐50与优泌乐25降低餐后血糖的临床效果。
结果两组患者治疗1周后的空腹血糖水平均降低，但差异无统计学意义（P>0.05），治疗后两组患者的日常三餐的餐后2 h血糖水平也均降低，观察组患者餐后血糖水平明显低于对照组，差异具有统计学意义（P ＜0.05）。
结论优泌乐50降低餐后血糖水平的效果明显较优泌乐25优越。
关键词糖尿病；优泌乐50；优泌乐25；餐后血糖Clinical analysis of Humalog 50 and Humalog 25 for regulating postprandial blood glucose LI Lan-sheng. Nanjing City Pukou District Puchang Hospital，Nanjing 210031，China【Abstract】Objective To observe clinical effect of Humalog 50 and Humalog 25 for treating diabetes mellitus and regulating postprandial blood glucose. Methods A total of 63 diabetes mellitus patients were randomly divided into experimental group （32 cases）and control group （31 cases）. Both groups received conventional dietary therapy and health education. The observation group received additional Humalog 50 by preprandial subcutaneous injection，and the control group received Humalog 25 by preprandial subcutaneous injection. Changes of postprandial blood glucose after injection of Humalog were recorded for 1 week in the two groups. Results Both groups had decreased fasting blood glucose after 1 week of treatment，but their difference had no statistical significance （P>0.05）. They also had decreased 2 h postprandial blood glucose after daily meals. The observation group had much lower level of postprandial blood glucose than the control group，and their difference had statistical significance （P＜0.05）. Conclusion Humalog 50 provides remarkably better effect in regulating postprandial blood glucose than Humalog 25.【Key words】Diabetes mellitus；Humalog 50；Humalog 25；Postprandial blood glucose糖尿病是目前危害人类健康三大慢性疾病的其中之一，随着生活水平的提高和环境因素的改变，糖尿病的发病率逐年提高。
病例优泌乐
1小时 3.47 2.86-10.3 18.6 4.4-10.0
2小时 4.24 2.66-9.34 21.3 4.4-7.8
3小时 2.78 0.55-3.26 13.2 4.4-6.1
入院诊断：2型糖尿病合并周围神经病变 2级高血压
治疗方案：1 严格控制饮食 2 改善微循环
3营养神经，抗氧化 4降糖 5 控制血压
降糖治疗过程介绍 胰岛素 优泌林70/30 （早20u 晚18u） 口服药 二甲双胍tid(早0.5g 午0.5g 晚0.5g),
• 血糖监测及胰岛素调整 • D1-3 优泌林70/30 （早20u 晚18u）
日期 d2
空腹 9.3
早餐后 2h
中餐前
中餐后 2h
晚餐前
晚餐后 2h
3am
13.2 8.1 11.7 7.6 9.8 6.7
问题
• 1空腹血糖得到有效控制 • 2餐后血糖仍不理想（三餐后血糖均大于9
mmol/L） • 3晚餐前及夜间低血糖风险增加（患者在血糖低于
4 mmol/L即有心慌手抖及出冷汗等不适）
下一步治疗策略
• 与患者进行沟通，强调控制餐后血糖的重要性及 低血糖对身体带来的危害
• 同意接受赖脯胰岛素50预混制剂皮下注射
• 初始剂量 优泌乐50 早20u 晚18u
•
二甲双胍 0.5 tid
血糖监测结果（第9天早餐前剂量增至22u）
日期
空腹
早餐后 2h
中餐前
中餐后 2h
晚餐前
晚餐后 2h
3am
d8 6.5 9.2 7
8.6 6.7 8.8 7
d9 5.8 8.2 6.3 7.5 5.6 7.4 6.3
继续按此方案监测血糖
优泌乐临床使用病例
1 2
-0.5
MIX 50 tid+OAMs n=158 Basal/Bolus+OAMs n=158
A1C的变化 (%)
-1 -1.5 -2 -2.5
-2.09 %
-1.87 %
D*=-0.22% (90% CI:-0.38%, -0.07) 非劣效性界值是 -0.3% %
Rosenstock J, et al. Diabetes Care 2008; 31:20-25
1/6 量 (优泌乐)
1/6 量 (优泌乐)
3/6 量 (甘精胰岛素)
餐前血糖目标 <6.1 mmol/L (110 mg/dL)
Rosenstock J, et al. Diabetes Care 2008; 31:20-25
优泌乐 50 tid 与基础/餐时 的比较： 完成研究的人群中与基线比较的HbA1C变化
3. 停用口服降糖药，预混胰岛素类似物制剂bid
– 优点：方案简单；注射方便；血糖控制全面，尤其是餐后血糖 – 缺点：2次注射
4. 强化胰岛素治疗（三短一长，4次/日)
– 优点：符合生理分泌，血糖控制最好，有益于ß 细胞功能保护及延缓并发 症发生 – 缺点：注射次数多，不易被患者接受
认识中国2型糖尿病的特点之一
Rosenstock J, et al. Diabetes Care 2008; 31:20-25
* p=0.02
优泌乐50 tid与基础/餐时的比较： 基线时患者HbA1c 的分布
图A 比较试验餐 后血糖升高反应
图B 使用不同剂 型胰岛素后, AUCglucose 0-4的比 较
Clin Ther. 2006;28:1649-1657
《优泌乐25病例》课件
部分患者可能会出现过敏反应、脂肪萎缩或注射部位疼痛等副作用，需及时就医 处理。
04
CATALOGUE
优泌乐25与类似药物比较
药物作用机制比较
优泌乐25
属于速效、短效胰岛素类似物，通过 与胰岛素受体结合，促进细胞对葡萄 糖的摄取和利用，降低血糖水平。
其他类似药物
如赖脯胰岛素、门冬胰岛素等，同样 通过与胰岛素受体结合发挥降糖作用 ，但作用机制略有不同。
治疗方案
诊断
2型糖尿病
治疗目标
控制血糖，预防并发症，提高生活质量
治疗方案
优泌乐25（混合胰岛素类似物）每日早晚餐前注 射，配合饮食和运动治疗
02
CATALOGUE
优泌乐25介绍
药物成分
赖脯胰岛素（速效成分）
与常规人胰岛素相比，赖脯胰岛素的吸收速度更快，起效时 间短，峰浓度更高，作用持续时间短。
05
CATALOGUE
使用建议
使用方法
起始剂量
根据患者的具体情况，起始剂量 通常为每日1-2次，每次1-2片。
调整剂量
根据患者的血糖控制情况，医生可 适当调整剂量，以达到最佳治疗效 果。
服用时间
优泌乐25应在餐前即刻服用，或餐 后立即服用，以减少胃肠道反应。
注意事项
监测血糖
使用优泌乐25期间，应定 期监测血糖，以便及时调 整剂量。
避免低血糖
如出现心慌、出汗、头晕 等低血糖症状时，应及时 补充糖分，并减少药物剂 量。
饮食控制
优泌乐25不能替代饮食控 制，患者应保持合理的饮 食结构，控制总热量摄入 。
禁忌症
01
02
03
04
对优泌乐25成分过敏者禁用 。
优泌乐25联合胰岛素增敏剂治疗2型糖尿病疗效分析
HEILONGJIANG MEDICIAE AND PHARMACY Feb.0077,Vol.44No.1•71・优泌乐25联合胰岛素增敏剂治疗2型糖尿病疗效分析①司雯雯（河南科技大学第一附属&隐第一药房，河南洛阳47709）摘要：目的：探讨优泌乐25联合胰岛素增敏剂治疗磺D类药物继发失效7型糖尿病患者的临床疗效。
方法:选取我院7型糖尿病患者708例，随机数字表法分为观察组（/=54）、对照组（/=54），对照组采用优泌乐25治疗，观察组于对照组基础上联合胰岛素增敏剂治疗。
比较两组治疗前后血糖［餐后2h血糖（27PG）、糖化血红蛋>（H9A7c）、空腹血糖（FPG）］水平及胰岛功能［胰岛素抵抗指数（HOMA-IR）、胰岛0细胞功能指数（HOMA-0）、空腹胰岛素（FINS）］水平。
结果：治疗17周后,观察组2hPG、H9A7c、FPG、HOMA-IR水平低于对照组，FINS、HOMA-0水平高于对照组（P<0.05）。
结论：优泌乐25联合胰岛素增敏剂治疗磺D类药物继发失效2型糖尿病患者疗效显著,可改善患者胰岛功能，有效控制其血糖水平。
关键词：优泌乐25；胰岛素增敏剂；继发性失效2型糖尿病;胰岛功能中图分类号:R587.1文献标识码:B文章编号：1008-074（2021）07-077-02近年来,2型糖尿病发病率呈逐年上升趋势，若未及时有效治疗，血糖水平长期升高可诱发糖尿病视网膜病变、糖尿病肾病、神经病变等，严重危及患者生命安全71o磺7类药物为临床治疗2型糖尿病常用药物，据报道,采用磺7类药物治疗的2型糖尿病患者，每年约5%出现继发性失效,针对此类患者应采取何种方案治疗已成为研究热点71o优泌乐25由75%精蛋白胰岛素、25%赖脯胰岛素组成，可于餐前或进餐时皮下注射,可显著降低餐后血糖,调节血糖浓度。
胰岛素增敏剂为过氧化物酶增殖体激活受体激动剂，可增强机体胰岛素敏感性，抑制胰岛素抵抗，促使胰岛素充分发挥作用，已广泛应用于临床治疗中71o基于此，本研究选取75例磺7类药物继发性失效2型糖尿病患者，旨在探究优泌乐29联合胰岛素增敏剂的临床治疗效果。
优泌乐25联合二甲双胍治疗2型糖尿病30例疗效
表1伴冠心病患者的临床特点一般资料A组（n=83）B组（n=151）性别（男/女）52/3187/64年龄（岁）68.1ʃ4.865.4ʃ5.71）病程7.2ʃ4.7 5.8ʃ2.92）吸烟n（%）19（22.89）28（18.54）BMI27.4ʃ3.524.2ʃ3.11）SBP（mmHg）140.1ʃ9.6138.7ʃ6.1DBP（mmHg）80.8ʃ7.178.5ʃ6.32）TC 6.48ʃ2.52 5.91ʃ3.592）TG 1.83ʃ0.25 1.74ʃ0.682）HDL－C0.61ʃ0.250.94ʃ0.651）LDL－C 3.87ʃ0.84 3.15ʃ0.461）APO－A1 1.27ʃ0.24 1.38ʃ0.74APO－B 1.58ʃ0.43 1.45ʃ0.64FBG8.3ʃ2.68.5ʃ1.8P2BG18.7ʃ3.117.4ʃ3.61）HbA1c7.26ʃ1.087.15ʃ1.12UA314ʃ57.1268ʃ41.91）Hs－CRP9.1ʃ5.38.5ʃ5.9注：与A组比较，1）P＜0.01，2）P＜0.05。
聚集与溶解。
（2）尿酸可促进LDL氧化和脂质过氧化，并伴随氧自由基生成的增加，参与到炎性反应中。
（3）参与血小板的活化与聚集，导致血栓形成。
有资料显示，高尿酸血症可引起脂代谢紊乱，使生长激素的作用增加，导致动脉斑块和血管壁细胞增生［4］。
但也有研究认为血尿酸升高不能作为冠心病的独立危险因素，在缺乏其他代谢异常存在时，血尿酸升高可能与冠心病的发生有关［5］。
有研究发现：2型糖尿病患者血清C－反应蛋白水平较常人为高，而体内C－反应蛋白水平较高者更易发展成为冠心病［6］。
我们的研究结果显示并发冠心病在年龄，病程，体重指数，舒张压，血脂，餐后2小时血糖，血尿酸密切相关。
参考文献1.中国心脏调查组．中国住院冠心病患者糖代谢异常研究———中国心脏调查．中华内分泌代谢杂志2006；22：7－10．2．张化冰，向红丁，杨玉芝，等．十五省市1991－2005年住院糖尿病病人死因调查．中国糖尿病杂志2009；17（1）：6－8．3．Prior J O，Quiňones M J，Hernadez－Pampalon M，et al．Coronary Circulatory Dysfunction in Insulin Resistance，Impaired Glu-cose Tolerance and Type2Diabetes Mellitus．Circulation2005；111：2291－2298．4．李彪，齐海梅，裕东洁，等．老年人群慢性肾脏疾病流行病学研究．中华老年医学杂志2009；28（3）：250－253．5．苏工，米树华，陶红，等．代谢综合征患者血尿酸水平与冠心病的关系．中华内分泌代谢杂志2005；21（1）：66－67．6．潘云红．冠心病合并2型糖尿病患者C反应蛋白和尿酸的变化．临床内科杂志2010；27（6）：428．（2011—04—28收稿）优泌乐25联合二甲双胍治疗2型糖尿病30例疗效分析乌鲁木齐市第一人民医院（830011）孙燕古兰贝尔摘要30例T2DM在合理饮食、适当运动定期监测血糖等措施的基础上给予优泌乐25联合二甲双胍口服治疗。
优泌乐25说明书
PV 5551 AMPHUMALOG® Mix75/25TM75% INSULIN LISPRO PROTAMINE SUSPENSION AND25% INSULIN LISPRO INJECTION(rDNA ORIGIN)100 UNITS PER ML (U-100)DESCRIPTIONHumalog® Mix75/25™ [75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermediate-acting blood glucose-lowering agent. Chemically, insulin lispro is Lys(B28), Pro(B29) human insulin analog, created when the amino acids at positions 28 and 29 on the insulin B-chain are reversed. Insulin lispro is synthesized in a special non-pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered to produce insulin lispro. Insulin lispro protamine suspension (NPL component) is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation.Insulin lispro has the following primary structure:Insulin lispro has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin.Humalog Mix75/25 vials and Pens contain a sterile suspension of insulin lispro protamine suspension mixed with soluble insulin lispro for use as an injection.Each milliliter of Humalog Mix75/25 injection contains insulin lispro 100 units, 0.28 mg protamine sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 1.76 mg Metacresol, zinc oxide content adjusted to provide 0.025 mg zinc ion, 0.715 mg phenol, and Water for Injection. Humalog Mix75/25 has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may have been added to adjust pH.CLINICAL PHARMACOLOGYAntidiabetic ActivityThe primary activity of insulin, including Humalog Mix75/25, is the regulation of glucose metabolism. In addition, all insulins have several anabolic and anti-catabolic actions on many tissues in the body. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly, promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat.Insulin lispro, the rapid-acting component of Humalog Mix75/25, has been shown to be equipotent to Regular human insulin on a molar basis. One unit of Humalog® has the sameglucose-lowering effect as one unit of Regular human insulin, but its effect is more rapid and of shorter duration. Humalog Mix75/25 has a similar glucose-lowering effect as compared with Humulin® 70/30 on a unit for unit basis.PharmacokineticsAbsorption — Studies in nondiabetic subjects and patients with type 1 (insulin-dependent) diabetes demonstrated that Humalog, the rapid-acting component of Humalog Mix75/25, is absorbed faster than Regular human insulin (U-100). In nondiabetic subjects given subcutaneous doses of Humalog ranging from 0.1 to 0.4 U/kg, peak serum concentrations were observed 30 to 90 minutes after dosing. When nondiabetic subjects received equivalent doses of Regular human insulin, peak insulin concentrations occurred between 50 to 120 minutes after dosing. Similar results were seen in patients with type 1 diabetes.Figure 1: Serum Immunoreactive Insulin (IRI) Concentrations, After Subcutaneous Injection of Humalog Mix75/25 or Humulin 70/30 in Healthy Nondiabetic Subjects. Humalog Mix75/25 has two phases of absorption. The early phase represents insulin lispro and its distinct characteristics of rapid onset. The late phase represents the prolonged action of insulin lispro protamine suspension. In 30 healthy nondiabetic subjects given subcutaneous doses(0.3 U/kg) of Humalog Mix75/25, peak serum concentrations were observed 30 to 240 minutes (median, 60 minutes) after dosing (see Figure 1). Identical results were found in patients with type 1 diabetes. The rapid absorption characteristics of Humalog are maintained with Humalog Mix75/25 (see Figure 1).Figure 1 represents serum insulin concentration versus time curves of Humalog Mix75/25 and Humulin 70/30. Humalog Mix75/25 has a more rapid absorption than Humulin 70/30, which has been confirmed in patients with type 1 diabetes.Distribution — Radiolabeled distribution studies of Humalog Mix75/25 have not been conducted. However, the volume of distribution following injection of Humalog is identical to that of Regular human insulin, with a range of 0.26 to 0.36 L/kg.Metabolism — Human metabolism studies of Humalog Mix75/25 have not been conducted. Studies in animals indicate that the metabolism of Humalog, the rapid-acting component of Humalog Mix75/25, is identical to that of Regular human insulin.Elimination — Humalog Mix75/25 has two absorption phases, a rapid and a prolonged phase, representative of the insulin lispro and insulin lispro protamine suspension components of the mixture. As with other intermediate-acting insulins, a meaningful terminal phase half-life cannot be calculated after administration of Humalog Mix75/25 because of the prolonged insulin lispro protamine suspension absorption.PharmacodynamicsStudies in nondiabetic subjects and patients with diabetes demonstrated that Humalog has a more rapid onset of glucose-lowering activity, an earlier peak for glucose-lowering, and a shorter duration of glucose-lowering activity than Regular human insulin. The early onset of activity of Humalog Mix75/25 is directly related to the rapid absorption of Humalog. The time course of action of insulin and insulin analogs, such as Humalog (and hence Humalog Mix75/25), may vary considerably in different individuals or within the same individual. The parameters of Humalog Mix75/25 activity (time of onset, peak time, and duration) as presented in Figures 2 and 3 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, exercise, and other variables (see General under PRECAUTIONS).In a glucose clamp study performed in 30 nondiabetic subjects, the onset of action and glucose-lowering activity of Humalog, Humalog® Mix50/50™, Humalog Mix75/25, and insulin lispro protamine suspension (NPL component) were compared (see Figure 2). Graphs of mean glucose infusion rate versus time showed a distinct insulin activity profile for each formulation. The rapid onset of glucose-lowering activity characteristic of Humalog was maintained in Humalog Mix75/25.In separate glucose clamp studies performed in nondiabetic subjects, pharmacodynamics of Humalog Mix75/25 and Humulin 70/30 were assessed and are presented in Figure 3. Humalog Mix75/25 has a duration of activity similar to that of Humulin 70/30.Figure 2: Insulin Activity After Injection of Humalog, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine Suspension (NPL Component) in 30 NondiabeticSubjects.Figure 3: Insulin Activity After Injection of Humalog Mix75/25 and Humulin 70/30 inNondiabetic Subjects.Figures 2 and 3 represent insulin activity profiles as measured by glucose clamp studies in healthy nondiabetic subjects.Figure 2 shows the time activity profiles of Humalog, Humalog Mix50/50, HumalogMix75/25, and insulin lispro protamine suspension (NPL component).Figure 3 is a comparison of the time activity profiles of Humalog Mix75/25 (see Figure 3a) and of Humulin 70/30 (see Figure 3b) from two different studies.Special PopulationsAge and Gender — Information on the effect of age on the pharmacokinetics of HumalogMix75/25 is unavailable. Pharmacokinetic and pharmacodynamic comparisons between men and women administered Humalog Mix75/25 showed no gender differences. In large Humalog clinical trials, sub-group analysis based on age and gender demonstrated that differences between Humalog and Regular human insulin in postprandial glucose parameters are maintained across sub-groups.Smoking — The effect of smoking on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied.Pregnancy — The effect of pregnancy on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied.Obesity — The effect of obesity and/or subcutaneous fat thickness on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied. In large clinical trials, which included patients with Body Mass Index up to and including 35 kg/m2, no consistent differences were observed between Humalog and Humulin® R with respect to postprandial glucose parameters.Renal Impairment — The effect of renal impairment on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied. In a study of 25 patients with type 2 diabetes and a wide range of renal function, the pharmacokinetic differences between Humalog and Regular human insulin were generally maintained. However, the sensitivity of thepatients to insulin did change, with an increased response to insulin as the renal function declined. Careful glucose monitoring and dose reductions of insulin, including HumalogMix75/25, may be necessary in patients with renal dysfunction.Hepatic Impairment — Some studies with human insulin have shown increased circulating levels of insulin in patients with hepatic failure. The effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of Humalog Mix75/25 has not been studied. However, in a study of 22 patients with type 2 diabetes, impaired hepatic function did not affect the subcutaneous absorption or general disposition of Humalog when compared with patients with no history of hepatic dysfunction. In that study, Humalog maintained its more rapid absorption and elimination when compared with Regular human insulin. Careful glucose monitoring and dose adjustments of insulin, including Humalog Mix75/25, may be necessary in patients with hepatic dysfunction.INDICATIONS AND USAGEHumalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog Mix75/25 has a more rapid onset of glucose-lowering activity compared with Humulin 70/30 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.CONTRAINDICATIONSHumalog Mix75/25 is contraindicated during episodes of hypoglycemia and in patients sensitive to insulin lispro or any of the excipients contained in the formulation.WARNINGSHumalog differs from Regular human insulin by its rapid onset of action as well as a shorter duration of activity. Therefore, the dose of Humalog Mix75/25 should be given within 15 minutes before a meal.Hypoglycemia is the most common adverse effect associated with the use of insulins, including Humalog Mix75/25. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., Regular, NPH, analog), species, or method of manufacture may result in the need for a change in dosage.PRECAUTIONSGeneralHypoglycemia and hypokalemia are among the potential clinical adverse effects associated with the use of all insulins. Because of differences in the action of Humalog Mix75/25 and other insulins, care should be taken in patients in whom such potential side effects might be clinically relevant (e.g., patients who are fasting, have autonomic neuropathy, or are using potassium-lowering drugs or patients taking drugs sensitive to serum potassium level). Lipodystrophy and hypersensitivity are among other potential clinical adverse effects associated with the use of all insulins.As with all insulin preparations, the time course of Humalog Mix75/25 action may vary in different individuals or at different times in the same individual and is dependent on site of injection, blood supply, temperature, and physical activity.Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during illness, emotional disturbances, or other stress.Hypoglycemia — As with all insulin preparations, hypoglycemic reactions may be associated with the administration of Humalog Mix75/25. Rapid changes in serum glucose concentrations may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control.Renal Impairment — As with other insulins, the requirements for Humalog Mix75/25 may be reduced in patients with renal impairment.Hepatic Impairment — Although impaired hepatic function does not affect the absorption or disposition of Humalog, careful glucose monitoring and dose adjustments of insulin, including Humalog Mix75/25, may be necessary.Allergy — Local Allergy — As with any insulin therapy, patients may experience redness, swelling, or itching at the site of injection. These minor reactions usually resolve in a few days to a few weeks. In some instances, these reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.Systemic Allergy — Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reaction, may be life threatening. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient. Antibody Production — In clinical trials, antibodies that cross-react with human insulin and insulin lispro were observed in both human insulin mixtures and insulin lispro mixtures treatment groups.Information for PatientsPatients should be informed of the potential risks and advantages of Humalog Mix75/25 and alternative therapies. Patients should not mix Humalog Mix75/25 with any other insulin. They should also be informed about the importance of proper insulin storage, injection technique, timing of dosage, adherence to meal planning, regular physical activity, regular blood glucose monitoring, periodic hemoglobin A1c testing, recognition and management of hypo- and hyperglycemia, and periodic assessment for diabetes complications.Patients should be advised to inform their physician if they are pregnant or intend to become pregnant.Refer patients to the Patient Information leaflet for information on normal appearance, timing of dosing (within 15 minutes before a meal), storing, and common adverse effects.For Patients Using Insulin Pen Delivery Devices: Before starting therapy, patients should read the Patient Information leaflet that accompanies the drug product and the User Manual that accompanies the delivery device and re-read them each time the prescription is renewed. Patients should be instructed on how to properly use the delivery device, prime the Pen to a stream of insulin, and properly dispose of needles. Patients should be advised not to share their Pens with others.Laboratory TestsAs with all insulins, the therapeutic response to Humalog Mix75/25 should be monitored by periodic blood glucose tests. Periodic measurement of hemoglobin A1c is recommended for the monitoring of long-term glycemic control.Drug InteractionsInsulin requirements may be increased by medications with hyperglycemic activity such as corticosteroids, isoniazid, certain lipid-lowering drugs (e.g., niacin), estrogens, oral contraceptives, phenothiazines, and thyroid replacement therapy.Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients.Carcinogenesis, Mutagenesis, Impairment of FertilityLong-term studies in animals have not been performed to evaluate the carcinogenic potential of Humalog, Humalog Mix75/25, or Humalog Mix50/50. Insulin lispro was not mutagenic in a battery of in vitro and in vivo genetic toxicity assays (bacterial mutation tests, unscheduled DNA synthesis, mouse lymphoma assay, chromosomal aberration tests, and a micronucleus test). There is no evidence from animal studies of impairment of fertility induced by insulin lispro. PregnancyTeratogenic Effects — Pregnancy Category B — Reproduction studies with insulin lispro have been performed in pregnant rats and rabbits at parenteral doses up to 4 and 0.3 times, respectively, the average human dose (40 units/day) based on body surface area. The results have revealed no evidence of impaired fertility or harm to the fetus due to insulin lispro. There are, however, no adequate and well-controlled studies with Humalog, Humalog Mix75/25, or Humalog Mix50/50 in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing MothersIt is unknown whether insulin lispro is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when Humalog Mix75/25 is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in Humalog Mix75/25 dose, meal plan, or both. Pediatric UseSafety and effectiveness of Humalog Mix75/25 in patients less than 18 years of age have not been established.Geriatric UseClinical studies of Humalog Mix75/25 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should take into consideration the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this population.ADVERSE REACTIONSClinical studies comparing Humalog Mix75/25 with human insulin mixtures did not demonstrate a difference in frequency of adverse events between the two treatments.Adverse events commonly associated with human insulin therapy include the following:Body as a Whole — allergic reactions (see PRECAUTIONS).Skin and Appendages — injection site reaction, lipodystrophy, pruritus, rash.Other — hypoglycemia (see WARNINGS and PRECAUTIONS).OVERDOSAGEHypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneousglucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. DOSAGE AND ADMINISTRATIONTable 1*: Summary of Pharmacodynamic Properties of Insulin Products (Pooled Cross-Study Comparison)Insulin Products Dose, U/kg Time of Peak Activity, Hours After Dosing Percent of Total Activity Occurring in the First 4 Hours Humalog 0.3 2.4 (0.8 - 4.3) 70% (49 - 89%) Humulin R 0.32 (0.26 - 0.37) 4.4 (4.0 - 5.5) 54% (38 - 65%) Humalog Mix75/25 0.3 2.6 (1.0 - 6.5) 35% (21 - 56%) Humulin 70/30 0.3 4.4 (1.5 - 16) 32% (14 - 60%) Humalog Mix50/50 0.3 2.3 (0.8 - 4.8) 45% (27 - 69%) Humulin 50/50 0.3 3.3 (2.0 - 5.5) 44% (21 - 60%) NPH 0.32 (0.27 - 0.40) 5.5 (3.5 - 9.5) 14% (3.0 - 48%) NPL component 0.3 5.8 (1.3 - 18.3) 22% (6.3 - 40%) * The information supplied in Table 1 indicates when peak insulin activity can be expected and the percent of the total insulin activity occurring during the first 4 hours. The information was derived from 3 separate glucose clamp studies in nondiabetic subjects. Values represent means, with ranges provided in parentheses.Humalog Mix75/25 is intended only for subcutaneous administration. Humalog Mix75/25 should not be administered intravenously. Dosage regimens of Humalog Mix75/25 will vary among patients and should be determined by the healthcare provider familiar with the patient’s metabolic needs, eating habits, and other lifestyle variables. Humalog has been shown to be equipotent to Regular human insulin on a molar basis. One unit of Humalog has the same glucose-lowering effect as one unit of Regular human insulin, but its effect is more rapid and of shorter duration. Humalog Mix75/25 has a similar glucose-lowering effect as compared with Humulin 70/30 on a unit for unit basis. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate of insulin lispro from subcutaneous tissue.Humalog Mix75/25 starts lowering blood glucose more quickly than Regular human insulin, allowing for convenient dosing immediately before a meal (within 15 minutes). In contrast, mixtures containing Regular human insulin should be given 30 to 60 minutes before a meal. The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables. As with all insulin preparations, the time course of action of Humalog Mix75/25 may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques.Humalog Mix75/25 should be inspected visually before use. Humalog Mix75/25 should be used only if it appears uniformly cloudy after mixing. Humalog Mix75/25 should not be used after its expiration date.HOW SUPPLIEDHumalog Mix75/25 [75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin)] is available in the following package sizes: each presentation containing 100 units insulin lispro per mL (U-100).10 mL vials NDC 0002-7511-01 (VL-7511)5 x 3 mL prefilled insulin delivery devices (Pen) NDC 0002-8794-59 (HP-8794)5 x 3 mL prefilled insulin delivery devices (KwikPen™) NDC 0002-8797-59 (HP-8797)Storage — Humalog Mix75/25 should be stored in a refrigerator [2° to 8°C (36° to 46°F)], but not in the freezer. Do not use Humalog Mix75/25 if it has been frozen. Unrefrigerated [below 30°C (86°F)] vials must be used within 28 days or be discarded, even if they still contain Humalog Mix75/25. Unrefrigerated [below 30°C (86°F)] Pens, and KwikPens must be used within 10 days or be discarded, even if they still contain Humalog Mix75/25. Protect from direct heat and light. See table below:Not In-Use (Unopened) Room Temperature [Below 30°C (86°F)] Not In-Use (Unopened)RefrigeratedIn-Use (Opened) RoomTemperature [Below30°C (86°F)]10 mL Vial 28 days Until expiration date 28 days,refrigerated/roomtemperature.3 mL Pen and KwikPen (prefilled) 10 days Until expiration date 10 days. Do notrefrigerate.Literature revised March 16, 2009KwikPens manufactured byEli Lilly and Company, Indianapolis, IN 46285, USAPens manufactured byEli Lilly and Company, Indianapolis, IN 46285, USA orLilly France, F-67640 Fegersheim, FranceVials manufactured byEli Lilly and Company, Indianapolis, IN 46285, USA orLilly France, F-67640 Fegersheim, Francefor Eli Lilly and Company, Indianapolis, IN 46285, USACopyright © 2007, 2009, Eli Lilly and Company. All rights reserved.PV 5551 AMP PRINTED IN USA。
优泌乐25起始方案-病例分享PPT课件
-
25
第三个问题
下一步，选择怎样调整降糖方案?
➢ 继续在就寝前使用38u长效胰岛素 增加餐时胰岛素使用： 晚餐时增加速效胰岛素 ： 0.1u/kg 即：80 kg x 0.1u = 8u
➢ 改为预混胰岛素：优泌乐25 20u早餐前，晚餐前18u
-
26
患者意见征询
拒绝第一种方案： ➢ 目前方案的医药费用过高，不能承受（基础胰岛素4～5支/月， 格列美脲，二甲双胍；还要增加餐时速效胰岛素的使用） ➢ 两针注射，两种剂型，两种装置——复杂，易混淆
接受第二种方案： ➢ 一种剂型，一种装置，两次注射，相对简单 ➢ 停用胰岛素素促泌剂，方案简化 ➢ 明显减少医药费用
➢ 需要及时启动胰岛素治疗
➢ 根据患者血糖监测结果：患者空腹和餐后血糖升高明显： FBG12.4mmol/L,2hPBG24.1mmol/L，需要兼顾提供基础/ 餐时胰岛素
➢ 预混胰岛素类似物两次注射，相对三短一长的强化方案，更为 简便，同时兼顾安全、有效
-
7
降糖方案选择：优泌乐25起始
➢ 停服口服药物， ➢ 给予优泌乐25：早10IU，晚10IU ➢ 三天后监测血糖:
➢ 当前长效胰岛素剂量：睡前38u（0.5u/kg） ➢ 在过去一个月，发生2次轻度的晨间低血糖；
进食饼干或口服糖块得以缓解
-
23
4 周后得到的血糖状况A1C=7.4% ——长效胰岛素剂量调整后结果
早餐前 (mg/dL) (mmol/L)
星期日
6.9
星期一
星期二
6.6
星期三
星期四
优泌乐25多次注射对老年2型糖尿病的安全性与疗效观察
优泌乐25多次注射对老年2型糖尿病的安全性与疗效观察[摘要] 目的：观察优泌乐25每日多次注射治疗对老年2型糖尿病的安全性及疗效。
方法：2014年01月至2015年03月在我院门诊及住院的100例65岁以上老年2型糖尿病患者，经2种以上口服降糖药治疗效果不佳者。
随即分为A、B两组，A组（50）例给予优泌乐25 (美国礼来公司生产的精蛋白锌赖脯胰岛素25) 早、晚餐前，每日2次皮下注射；B组（50）例给予优泌乐25早、中、晚餐前，每日3次皮下注射，根据血糖水平，每3天调整一次胰岛素剂量，以空腹血糖 (FPG)<8.0mmol/L，餐后血糖(2hPG)<10.0mmol/L为治疗目标，共治疗12周，观察FPG、2hPG、糖化血红蛋白(HbA1c) 水平，体质量指数（BMI），胰岛素用量及低血糖反应情况，并比较2组治疗前后效果。
结果：治疗12周后，A、B两组患者FPG、2HPG、HbA1c水平均较治疗前明显降低（P<0.05）；B组中餐后2hPG（7.02±1.49） mmol/L，A组中餐后2hPG（10.05±1.63） mmol/L，A、B两组中餐后2hPG比较有统计学差异（P<0.05）； B组较A组HbA1c下降幅度要大，但两组比较无统计学差异（P>0.05）；低血糖反应B组2例（4%）A组8例（16%），两组比较差异有统计学意义（P<0.05）；结论：优泌乐25每日3次皮下注射或每日2次皮下注射，治疗口服降糖药血糖控制不佳的老年2型糖尿病，均能达到较好的血糖控制效果。
但每日三次注射其全日血糖谱（FPG、2hPG、睡前血糖）、HbA1c控制更理想，血糖波动小，低血糖反应发生率相对更低，故每日3次皮下注射优泌乐25的方法可安全用于老年2型糖尿病，并且效果满意。
[关键词]老年 2型糖尿病优泌乐25DOI:10.3760/cma.j.issn.0376-2491.2016.04.033作者单位：312000，浙江省绍兴市，浙江省绍兴市立医院内分泌科糖尿病是一种慢性进展性疾病，其胰岛β细胞功能将随着年龄的增长、病程的延长逐渐下降，导致口服降糖药继发性药效降低甚至失效，最终只能选择胰岛素治疗[1]，以达到控制血糖，减少或延缓糖尿病慢性并发症的发生。
王晓光疑难病例
• 辅助检查：随机血糖：HI。心电图：正常。
病情介绍
• • 入院诊断： 中医：消渴病（气阴两虚） 昏厥（阴阳离绝） • 西医：2型糖尿病 高血糖高渗状态？ • 治疗：1、内科Ⅰ级护理，心电监护，血压、血氧监测，记录24小时出入水量。 2、补液，静点胰岛素控制血糖。 3、急检血气分析，BNP,凝血四项，尿常规，血常规，心肌肌钙蛋白， 血尿淀粉酶，肾功+血脂+肝功+心肌酶谱+血糖。
理化回报
9月13日 12：50 • 血气分析：PH：6.866，PCO2：11.4mmHg，P02：158mmHg， BE<-30mmol/L,HCO3：2.1mmol/L，TCO2<5mmol/L，SO2：97%。
• 血常规：WBC：20.85（10∧9/L），NEU%：88.0（%）
• 凝血四项：PT：18.4s，APTT：48.10s，TT：28.8s，FBG： 1.441g/L。
292.08mOsm/L，AG：27.0，尿素：25.1mmol/L，肌酐：123umol/L，GLU：42.48，
UA：904umol/L。 • 心肌钙蛋白：0.049ng/ml。
根据理化回报提示该患存在：糖尿病酮症酸中毒 电解质紊乱（低钠、低氯血症） 血脂异常症
9月13日
13：45
王东主任看过病人，目前患者意识模糊。查体：双瞳孔等大等圆，双侧对光反射灵敏，颈部无抵 抗，双肺未闻及明显干湿啰音，心律齐，腹平软，右肋下压痛（＋），无反跳痛，无肌紧张， Murpphy征（±），移动性浊音阴性，肝区扣痛（＋），双侧肾区无扣痛，肠鸣音正常，4次/分， 无气过水声。四肢肌力5－级，肌张力正常，生理反射存在，病理反射未引出。心电监护示：BP： 76/47mmHg，P：92次/分，R：20次/分，血氧饱和度：99%。 根据生化及血气分析，王东主任考虑患者存在糖尿病酮症酸中毒。并存在因低钠血症导致意识
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小结
• 糖尿病病史11年，多种口服降糖药联合治疗效果差 • 年龄偏大，有高血压，冠心病，不能耐受低血糖的风险 • 血糖水平高，胰岛β细胞功能检查显示β细胞功能差，需补充外源胰岛 素
• 优泌乐®25一天三次的短期强化治疗，快速控制血糖，解除糖毒性，使
β细胞功能有所恢复，转换为一天二次后血糖仍控制良好，且没有体
FBG 4.6～6.3mmol/L 2h-PBG 6.2 ～ 8.4mmol/L
1M
2M
6.1
6.9
8.4
7.7
6.4
6.7
9.3 10.1
6.5
7.4
8.5
8.2
6.3
6.6
18u
16u
14u
12u
随访
3个月后复查： 空腹血糖6.4-7.3mmol/l， 餐后血糖7.7-10.6mmol/l，HbA1c 7.0% 10个月后复查：空腹血糖5.4-7.4mmol/l， 餐后血糖6.2-11.1， HbA1c 6.8% 患者认为目前治疗方案即方便又有效，且 安全。
HbA1c (%) Diabetes Care 2003;26:881
• 无论患者在何种A1C水平，都要兼顾空腹血 糖和餐后血糖控制 • 预混胰岛素类似物同时提供快速的餐时胰岛 素和中效胰岛素，兼顾控制空腹和餐后血糖
– 对于A1C不太高的患者，预混类似物通过降低餐后
高血糖，有效达标，可作为胰岛素起始治疗的选 择 – 对于A1C很高的患者，预混胰岛素类似物可有效降 低空腹血糖，促进达标
• HbA1c 10.2% TG 2.6 mmol/L • 心电图：Ⅱ、Ⅲ、avF ST段下移 • 胰岛β细胞功能检查： 空腹
胰岛素(mIU/L)
C肽(ng/ml)
餐后2小时 11.7
1.62
5.4
0.87
诊断
• • • • • 2型糖尿病 糖尿病伴高血压 糖尿病伴心脏病 高甘油三脂血症 肥胖症
病例特点
与人胰岛素30/70相比，优泌乐®25(BID) 具有以下特点： • 有效降低餐后血糖波动 • 餐时注射，起效更快，使用更方便
使用优泌乐®25，达标更轻松！
优泌乐®25和诺和锐30在控制2型糖尿病患者的 糖化血红蛋白方面没有差异。
诺和锐30
P=0.082 10
HbA1c(%)
优泌乐® 25
8.15
ADA ＜ 7.0
IDF ＜ 6.5
＜ 6.5
4.4- 6.1
3.9- 7.2
≤ 5.5
4.4- 8.0
<10*
＜ 7.8
中国糖尿病防治指南2007
思路：该如何对该患调整用药？
• 该患者血糖控制的目标？
– 达Байду номын сангаас值：？
UKPDS: 控制血糖则可减少并发症
任一糖尿病 相关终点 0 -5 -10 -15 -20 -25 -30 -35 -40 微血管病变 心肌梗死 白内障 摘除术 心衰 周围血管病变
12%
p=0.14
21%
P=0.006
7%
p=0.28
22%
P=0.04
7%
p=0.62
心血管死亡率RRR
P值
12%
P=0.32
35%
P=0.02
32%
P=0.26
Downloaded from on December 18, 2008
The Action to Control Cardiovascular Risk in Diabetes Study Group* N ENGL J MED 358：2545-2559， 2008
优泌乐25临床病例探讨
病例
• 患者男性，76岁，BMI 25.2 kg/m2 • 确诊T2DM 11年余，近2年血糖控制欠佳，曾 多次调整治疗方案 • 现服 格列美脲 4mg Qd 二甲双胍 500mg Tid • 高血压病史6年
主要实验室检查
• 血糖：FBG 11.9mmol/L PBG 16.5mmol/L
有效控制餐后高血糖 • 预混胰岛素的应用大大简化了基础＋餐时胰岛素 方案的使用（一种剂型，两次注射，轻松达标）
预混胰岛素在中国得到更多的认可 ——2010年中国2型糖尿病防 治指南
• 2型糖尿病患者在生活方式和口服降糖药联合治疗的基础上，如果血糖仍然未 达到控制目标，即可开始口服药物和胰岛素的联合治疗。一般经过较大剂量多 种口服药物联合治疗后HbA1c仍大于7.0%时，就可以考虑启动胰岛素治疗。 • • 根据患者的具体情况，可选用基础胰岛素或预混胰岛素起始胰岛素治疗。 基础胰岛素如三个月后空腹血糖控制理想但HbA1c不达标，应考虑调整胰岛 素治疗方案 • • 1型糖尿病在蜜月期阶段，可以短期使用预混胰岛素2-3次/天注射 预混胰岛素包括预混人胰岛素，和预混胰岛素类似物。根据患者的血糖水平，
40
餐前低血糖
正常人分泌曲线
20
夜间低血糖
0
6
10
14
18
22
2
6 hrs
VADT：低血糖是心血管事件的危险因素
研究心血管事件独立危险因素logistic回归分析结果
Risk ratio RR
P Pvalue 值
既往事件
对心血管有益
对心血管有害
EASD2008年会
优泌乐®25，全面降糖，餐后更佳
危险下降（ % ）
21%
14%
19%
16%
37%
43%
UKPDS 35 BMJ 2000; 321:405-412
ADVANCE/ACCORD/VADT研究
ADVANCE研究
主要终点RRR P值 肾脏事件 P值 全因死亡率RRR P值
ACCORD研究
VADT研究
10%
P=0.013
10%
P=0.16 _ _
思路：该如何对该患调整用药？
• 该患者血糖控制的目标？
– 达标值：病程长、老年、存在大血管疾病危险因素，不适宜强化控 制。
该患者应选用何种胰岛素？
– 预混胰岛素是否合适？ – 该患者应选用使用及调整更为安全、可靠、方便的胰岛素。
预混胰岛素容易引起餐前和夜间低血糖
60
胰岛素浓度. (mU/L)
预混胰岛素
治疗经过
治疗方案：
先予优泌乐®25一天三次短期强化治疗，β细 胞功能恢复后转为一天二次治疗
停用口服降糖药
胰岛素剂量调整情况
时 间 基 线 3d 7d 2w 8.1 6.4 空腹 早餐 后 中餐前 中餐后 晚餐 前 晚餐 后 睡 前 优泌乐®25 早 中 晚 12u 7.5 5.9 18u 18u 16u 8 u 8 u 8 u 6 u 12u 14u 14u 12u FBG 11.9mmol/L 2h-PBG 16.5mmol/L 10.4 7.3 8.3 6.5 9.6 8.3 8.2 7.2 8.1 6.3
8.01
8
6
4 2
n=137例2型 糖尿病患者
0
Niskanen L, Jensen LE, Rastam J, et al. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clin Ther 2004;26:531-540.
重增加及明显低血糖
• 优泌乐®25一天三次注射转为一天二次注射，患者易于接受，依从性好,
C . 预混胰岛素一天二次治疗 D . 预混胰岛素类似物一天二至三次治疗 E . 基础-餐时 / 胰岛素泵治疗 F . 其它
• 基础胰岛素治疗联用口服降糖药可以有效地控制 空腹高血糖
• 当HbA1C接近达标时，需要更多的关注餐后血糖
控制，需要在餐前和餐后进行血糖监测，帮助确 定进餐相关的高血糖
• 增加餐时胰岛素或改用预混胰岛素的使用，可以
• 老年男性，2型糖尿病病史11年余 • 近2年血糖控制差，合并高血压，冠心病现口服二 种足量降糖药物联合治疗无效 • 胰岛β细胞功能检查显示β细胞功能差
讨论：下一步可选择何种治疗方案
A . 继续优化口服药治疗？已经是2种较强的降糖 药，再增加疗效不能增加
B . 基础胰岛素加口服药治疗费用大，患者不接受
11 10 Mean ± SEM 血糖 (mmol/L)
*
*
优泌乐®25 人胰岛素30/70
9
8
*p<0.05
n=89例2型 糖尿病患者
7
6
空腹
早餐 2h pp
午餐前
午餐 2h pp
晚餐前
晚餐 2h pp
就寝
3 AM
Mix25的注射与就餐之间的中位时间为3分钟，人胰岛素预混剂为28分钟。
Data derived from Roach P et al. Diabetes Care 1999;22(8):1258-1261.
• 你会建议什么样的血糖控制目 标?
推荐的血糖控制目标：
HbA1c 7%
空腹和餐前血糖：5.6-7mmol/L 餐后2小时血糖：8.0 -10mmol/L 50%的自我监测血糖在靶标值内 没有严重低血糖
80
60
贡献率(%)
餐后血糖
40
空腹血糖
20
0
<7.3 7.3-8.4 8.5-9.2 9.3-10.2 >10.2