采用EQ-5D测量日本Ⅱ型糖尿病病人健康相关生存质量

目的:采用日文版欧洲生命质量量表(EQ-5D)测量糖尿病病人健康相关生存质量(HRQL),考察病人临床状况与健康状况(health status)之间的关系。方法:1998年11月17日至12月24日,对到日本琦玉县(Saitama Prefecture)一家医院门诊的220名Ⅱ型糖尿病病人开展了该项研究。病人采用5个维度以及视觉模拟法(visual analog scale,VAS)评价了他们的健康状况。EQ- 5D积分根据病人回答的5个问题的答案,采用事先确定的日文版分值表计算。结果:没有病人回答极度严重等级的问题;有并发症的病人在活动性(mobility)和焦虑与沮丧(anxiety/ depression)两个维度回答有些问题的频率显著高于无并发症的病人(活动性:27.4%和14.4%;焦虑与沮丧:25.7%和13.5%)。有并发症病人EQ-5D平均得分为0.846(95%置信区间0.817～0.874),无并发症病人平均得分为0.884(95%置信区间0.855～0.914)。有糖尿病并发症病人与无糖尿病并发症病人的VAS得分统计学差异显著,有视网膜病变病人与无视网膜病变病人的VAS得分有显著差异。结论:本研究的发现提示我们重视糖尿病病人健康状况测量的价值,因为这使我们能比较全面地评价病人的健康情况,并且为病人主观症状与实验室检查数据增加另一个维度的资料。     

采用EQ-5D测量中国急性缺血性脑卒中患者生存质量的相关性实证研究

目的:通过EQ-5D量表中EQ-5D健康描述系统和EQ-VAS(直观相似尺度)评分对急性缺血性脑卒中患者健康相关生存质量测量的相关性进行研究.方法:采用前瞻性的随机对照试验设计,对220例急性缺血性脑卒中患者从就诊第0天、第8天、出院至第90天的生存质量和健康状况,运用EQ-5D健康描述系统和EQ-VAS进行研究.结果:以EQ-5D指数得分(健康描述系统评分)和EQ-VAs得分对患者四个阶段生存质量的表达进行线性回归模型拟合,发现两者对患者生存质量的表达趋势一致;进而进行的无控制变量和有控制变量(教育程度和从事职业)的相关性分析显示两者的相关系数均较高(>0.500;P=0.000),且相关性的稳定性也较好.结论:EQ-5D健康描述系统和EQ-VAS的相关性较好,两者的配合使用适用于我国急性缺血性脑卒中患者生存质量和健康状况测量,能够反映其变化情况,也适宜做进一步的成本-效用分析.     

不同体重指数对初发2型糖尿病并发症及治疗方案的影响

目的探讨体重指数(BMI)对初发2型糖尿病患者的并发症及治疗方案的影响。方法以2015年6月至2016年1月沈阳医学院附属第二医院收治的初发2型糖尿病患者120例为研究对象,依据BMI值将其分为甲组(BMI值<25 kg/m2)30例、乙组(BMI值为25~28 kg/m2)40例及丙组(BMI值>28 kg/m2)50例,对3组患者进行随访,记录其糖尿病并发症发生情况,并比较其治疗方法。结果丙组患者血肌酐、尿白蛋白、尿钠水平均明显高于甲组、乙组(均P<0.05),乙组血肌酐、尿白蛋白、尿钠水平与甲组比较差异均无统计学意义(均P>0.05)。3组患者尿肌酐水平、糖尿病肾病发生率比较差异均无统计学意义(均P>0.05)。3组患者糖尿病视网膜病变发生率比较差异有统计学意义(P<0.05)。丙组患者糖尿病足、周围神经病变、低糖型晕厥、酮症酸中毒及高渗性昏迷并发症发生率均明显高于甲组、乙组(均P<0.05),但乙组患者糖尿病足、周围神经病变、低糖型晕厥、酮症酸中毒及高渗性昏迷并发症发生率与甲组比较,差异均无统计学意义(均P>0.05)。随着BMI增大,饮食控制、一种降糖药物治疗的患者呈下降趋势,而应用胰岛素治疗的患者呈上升趋势,差异均有统计学意义(均P<0.05)。结论 BMI越高,初发2型糖尿病患者并发症发生率越高,且对治疗方案的要求也就越高,故而在初发2型糖尿病患者治疗中进行体重控制是十分必要的。     

老年2型糖尿病患者常见并发症的临床特点及治疗

目的：探讨老年2型糖尿病患者常见并发症的临床特点及针对性的治疗,评价其临床应用价值。方法选取在我院进行治疗的2型糖尿病老年患者320例,对其并发症进行详细记录,通过调查问卷的方式对相关危险因素进行排查,分析患者并发症与年龄和病程的相关性,揭示临床特点,并对患者进行针对性的治疗。结果患者心血管疾病、肾脏病变、皮肤症状和低血糖等并发症的发生与年龄因素有关,而且随着年龄的增高,心血管疾病和肾脏病变的发生率明显增加,差异有统计学意义（P＜0.05）。患者心血管疾病、肾脏病变、视网膜病变和周围神经病变的发生率也随病程的延长,呈逐渐上升趋势,差异有统计学意义（P＜0.05）。结论2型糖尿病患者心血管疾病以及肾脏病变等并发症的发生率随年龄增长以及病程的延长呈逐渐上升趋势,临床治疗过程中应给予针对性的治疗。     

2型糖尿病患者的心电图分析

目的探讨2型糖尿病（T2DM）患者的心电图改变及其临床意义。方法对我院就诊的100例T2DM患者的心电图表现进行分析。结果 100例患者中有84例（84.0%）出现心电图异常,其中以ST-T段改变、窦性心动过缓、窦性心动过速、房室传导阻滞较常见。结论心电图主要体现T2DM患者缺血样病变和各种心律失常,故需定期做心电图检查,对于观察T2DM患者病情变化、制订治疗方案、有效控制病情及治疗T2DM合并症具有重要作用。     

2型糖尿病患者合并冠心病的危险因素的Meta分析

目的对2型糖尿病合并冠心病的危险因素进行分析,为2型糖尿病患者的冠心病预防提供依据。方法检索中国期刊全文数据库（CNKI）,外文数据库EMBASE、MEDLINE,对入选的文献应用STATA软件进行Meta分析。结果 TG因素的中文研究合并SMD值为0.59（P=0.000）,英文研究合并SMD值为0.01（P=0.921）;TC因素的中文研究合并SMD值为0.41（P=0.000）,英文研究合并SMD值为0.19（P=0.025）;年龄因素的中文研究合并SMD值为0.443（P=0.003）,英文研究合并SMD值为0.31（P=0.000）;HDL因素的中文研究合并SMD值为-0.473（P=0.006）,英文研究合并SMD值为-0.51（P=0.000）;吸烟因素的中文研究合并RR值为0.957（P=0.701）,英文研究合并RR值为1.606（P=0.000）;冠心病家族史因素的合并RR值为1.134（P=0.361）。在敏感性分析中,得到了类似的结果。结论合并冠心病组的TC、年龄因素显著高于对照组患者,而HDL则显著较低,说明TC、年龄、HDL是2型糖尿病患者诱发冠心病的显著性影响因素。     

采用胰岛素泵治疗老年2型糖尿病效果观察

目的观察分析老年2型糖尿病（T2DM）采用胰岛素泵治疗的效果。方法选取我院收治的48例老年T2DM患者,双盲法随机分为观察组和对照组,对照组采用皮下注射诺和灵N或诺和灵RZ治疗,观察组采用胰岛素泵持续皮下泵入诺和灵R治疗。分别观察记录两组患者治疗1个月、3个月的空腹及餐后2h血糖、胰岛素的用量、低血糖发生率、HbAlc、胰岛素分泌指数。结果治疗1个月两组患者均能达到血糖的控制目标。观察组的血糖达标时间明显少于对照组（P＜0.01）,胰岛素平均用量、空腹时血糖、餐后2h 的血糖均优于对照组（P＜0.05）;治疗3个月后观察组的胰岛素用量、低血糖发生率明显低于对照组（P＜0.05）,胰岛素的分泌指数明显优于对照组（P＜0.05）。两组HbAlc水平差异无统计学意义（P＞0.05）。结论胰岛素泵的强化治疗是老年T2DM患者安全有效的治疗方法,值得在临床上推广应用。     

如何提高糖尿病性视网膜病变患者的生活质量

糖尿病性视网膜病变发生时间一般在患糖尿病5年之后开始出现,其发生的早晚和严重程度与血糖控制好坏、血脂、血压等有关。DR是糖尿病常见的严重并发症,发生率很高。一旦发生将伴随患者的一生,直接造成患者视力下降,间接影响患者情感及情绪,严重影响其生活质量。文中就提高糖尿病性视网膜病变患者的生活质量的一些体会。     

2型糖尿病患者的临床治疗分析

本文通过对2型糖尿病患者采用药物以及综合治疗进行分析,对于提高患者自我护理能力,寻找糖尿病的最佳治疗途径具有重要作用。以期在治疗过程中使2型糖尿病患者对临床表现、病因、治疗方法及并发症等相关知识加深了解。     

社会支持对老年人健康相关生命质量影响研究——基于南通的实证

应用欧洲五维健康量表(EQ-5D)和社会支持量表(SSRS)分别评价南通市老年人健康相关生命质量和社会支持现状,实证分析社会支持对老年人健康相关生命质量的影响。数据来源于2010年南通市老年人健康与居家养老服务课题调查,包括了377名农村老年人和383名城市老年人。用OLS回归模型估计社会支持对老年人EQ-5D指数得分影响,用Logistic回归模型估计社会支持对老年人生命质量各维度的影响。社会支持显著提高了老年人健康相关生命质量指数得分。政府应该加强老年人社会支持体系的建立,尤其是农村,提高老年人健康相关生命质量,实现健康老龄化。     

Understanding the effects on HR-QoL of treatment for overactive bladder: a detailed analysis of EQ-5D clinical trial data for mirabegron

Abstract

Background:

Analysis of EQ-5D data often focuses on changes in utility, ignoring valuable information from other parts of the instrument. The objective was to explore how the utility index, EQ-5D profile, and EQ-VAS captured change in clinical trials of mirabegron, a new treatment for overactive bladder (OAB).

Data:

Data were pooled from three phase III clinical trials that investigated the efficacy and safety of mirabegron vs placebo. Tolterodine ER 4?mg was included as an active control in one study: (1) placebo, mirabegron 50?mg and 100?mg, and tolterodine 4?mg ER; (2) placebo, mirabegron 50?mg and 100?mg; (3) placebo, and mirabegron 25?mg and 50?mg. Data were collected at baseline, week 4, 8, and 12.

Methods:

Analyses were performed on full analysis and modified intention to treat (ITT) data sets using UK utilities. Analysis controlled for relevant patient characteristics. Analysis of Covariance identified changes from baseline at each time point in utilities and EQ-VAS. Areas Under the Curve were estimated to summarize inter-temporal differences in effect. EQ-5D profile data were analysed using the Paretian Classification of Health Change.

Results:

In modified ITT analyses, mirabegron 50?mg was superior to tolterodine 4?mg in changes from baseline utilities after 12 weeks (p?<?0.05); similarly, AUC results showed mirabegron 50?mg to be superior to tolterodine (p?<?0.05) and placebo (p?<?0.05) with the benefit already apparent at 4 weeks (p?<?0.05). EQ-VAS more consistently indicated superior outcomes: all three mirabegron doses showed statistically significant greater effectiveness compared to tolterodine at 12 weeks. Individual EQ-5D dimensions and the overall profile showed no significant differences between study arms.

Conclusion:

Mirabegron showed quicker and superior improvement in HR-QoL compared to tolterodine 4?mg ER. A limitation of the study is that EQ-5D was a secondary outcome in the pivotal trials, which were not powered to measure differences on EQ-5D.     

EQ-5D health utilities: exploring ways to improve upon responsiveness in psoriasis

Aims: To determine if EuroQoL 5-Dimension Health Questionnaire (EQ-5D) health utility scores were able to discriminate among different levels of improvement in psoriasis severity following therapy.

Materials and methods: Data were from three placebo-controlled phase 3 ixekizumab studies (UNCOVER-1, UNCOVER-2, and UNCOVER-3) with patients who had baseline Dermatology Life Quality Index scores >10 (DLQI >10). Psoriasis severity (Psoriasis Area and Severity Index [PASI]), general health utility (EQ-5D), and psoriasis-specific utility (EQ-PSO, UNCOVER-3 only) were assessed. EQ-5D-5L utility scores were generated using the England EQ-5D-5L value set, a crosswalk applied to the EQ-5D-3L United States (US) and United Kingdom (UK) value sets, and a regression-based exploratory scoring function for the EQ-PSO (UK). Analysis of variance was used to estimate change in EQ-5D-5L from baseline to Week 12 per PASI improvement level: PASI <50, PASI 50 to <75, PASI 75 to <90, PASI 90 to <100, and PASI 100. Missing data were imputed using the last observation carried forward method. Value sets for the UK, England, and the US were applied.

Results: In total, 2085 patients across UNCOVER-1, UNCOVER-2, and UNCOVER-3 had baseline DLQI >10 and available utility scores. At Week 12, mean EQ-5D utility scores increased with increasing PASI improvement levels (p?n?=?645; PASI 90 to <100: 0.141, PASI 100: 0.200; adjusted p?=?0.043).

Limitations: EQ-5D-5L index-based scores have limited ability to differentiate among psoriasis patients at the highest PASI improvement levels.

ConclusionsL Adding psoriasis-specific EQ-PSO dimensions to the EQ-5D may enhance responsiveness to improvement in skin clarity at the highest PASI levels, and, therefore, generate utility scores that better reflect treatment benefit in cost-utility models.     

采用SS-QOL测量中国急性缺血性脑卒中患者生存质量和BI结果值的相关性研究

运用SS-QOL量表随机测量220例急性缺血性脑卒中患者就诊第0天、出院、第90天的生活质量,并对患者的BarthelIndex（BI）评分进行相关性研究,以得出通过SS-QOL量表获得的急性缺血性脑卒中患者健康相关生存质量能否真实反映患者的健康状况。经SS-QOL和BI评分对患者三个阶段生存质量的表达进行线性回归模型拟合发现,两者对患者生存质量的表达趋势一致,进而进行的无控制变量和有控制变量（教育程度和从事职业）的相关性分析也显示两者的相关系数均较高（〉0.600;P=0.000）,且相关性的稳定性较好。SS-QOL量表对生存质量的测量能够反映患者的健康状况,也适宜做进一步的成本-效用分析。     

The impact of non-severe hypoglycemic events on daytime function and diabetes management among adults with type 1 and type 2 diabetes

Abstract

Objectives:

To describe daytime non-severe hypoglycemic events (NSHEs), assess their impact on patient functioning and diabetes self-management, and examine if these impacts differ by diabetes type or country.

Methods:

Internet survey to adults with diabetes in the US, UK, Germany, and France.

Results:

Of 6756 screened respondents, 2439 reported a daytime NSHE in the past month. NSHEs occurred while active (e.g., running errands) (45.1%), 29.6% while not active (e.g., watching TV), and 23.8% at work. On average, it took half a day to respond and recover from NSHE. Respondents monitored their glucose 5.7 extra times on average over the following week. On the day of event, type 1 respondents tested significantly more often than type 2 (p?<?0.05). Type 2 were less likely to confirm NSHE with glucose test (p?<?0.001). Following NSHE, 12.6% of respondents reduced total insulin by an average of 7.6 units (SD?=?8.3). Total units and days with reduced dosing was significantly less, whilst number of additional glucose tests and time to recover was significantly longer if NSHE occurred at work (p?<?0.001). Type 1 decreased insulin doses more often (p?<?0.001); however, type 2 decreased a greater number of units (p?<?0.01). Compared with other countries, US respondents were more likely to eat a light or full meal and respondents in France took significantly longer than all other countries to recognize (p?<?0.05), respond to (p?<?0.001), and recover from (p?<?0.001) NSHE, used significantly more monitoring tests the day of (p?<?0.05) and over the subsequent week (p?<?0.001), and decreased their normal insulin dose more (p?<?0.001). Limitations of the study include potential recall bias and selection bias.

Conclusions:

NSHEs are associated with a significant impact on patient functioning and diabetes management.     

Hypoglycemia in patients with type 2 diabetes using concomitant exenatide BID and long-acting insulin therapy

Abstract

Objective:

The objective of this study was to examine the frequency of hypoglycemia among patients with type 2 diabetes who had concomitantly used exenatide BID (exenatide) and long-acting insulin and continued this combination vs those who continued long-acting insulin alone.

Methods:

Retrospective analyses, using a large managed care database, were used to estimate the frequency of hypoglycemia (episodes/patient/6 months) for patients who concomitantly used exenatide and long-acting insulin during a 6-month follow-up period.

Results:

From among 2082 patients on concomitant exenatide and long-acting insulin, those who continued this combination (n?=?472) had a lower frequency of hypoglycemia compared to those who remained on long-acting insulin alone (n?=?312) (0.03?±?1.9 vs 0.10?±?1.01 [episodes/patient/6 months]; p?<?0.0001).

Limitations:

Only hypoglycemia that required medical intervention (coded for hypoglycemia) was captured. The study could not evaluate any association between insulin dose titration and hypoglycemia or examine other outcomes such as HbA1c, weight, and body mass index, due to lack of data availability.

Conclusions:

Patients who concomitantly used exenatide BID and long-acting insulin experienced a lower rate of hypoglycemia.     

Cost-effectiveness analysis of dapagliflozin treatment versus metformin treatment in Chinese population with type 2 diabetes

Background and objective: Dapagliflozin is the first SGLT2 inhibitor available in China, where the disease burden of diabetes and its complications is very heavy. Because a new diabetes treatment strategy for diabetes should consider its cost-effectiveness, compared with an existing treatment, this study aimed to examine the cost-effectiveness between dapagliflozin and metformin treatment in China.

Methods: The Cardiff Diabetes Model (CDM) was used to estimate cost effectiveness and macro- and micro-vascular outcomes of dapagliflozin vs metformin. The CDM effectiveness inputs were derived from indirect comparative efficacy data from meta-analysis of 71 studies comparing monotherapy and add-on therapy of dapagliflozin vs metformin: dapagliflozin or metformin monotherapy, add-on therapy with other oral hypoglycemic agents, and add-on therapy with insulin. Direct medication costs and medical costs on treating diabetes were calculated based on published and local sources. A discount rate of 3% was applied to both costs and health effects. Univariate and probabilistic sensitivity analyses (PSA) were performed to assess uncertainties.

Results: The total healthcare costs accumulated over the lifetime on dapagliflozin treatment arm was 8,626 Chinese yuan higher than the metformin treatment arm for an individual patient, and the quality adjusted life years (QALYs) gained with dapagliflozin treatment was 0.8 more than metformin treatment. Therefore, an incremental cost-effectiveness ratio was 10,729 yuan per QALY gained for dapagliflozin treatment arm vs metformin treatment arm. The cost-effectiveness results were robust to various sensitivity analyses.

Conclusion: Dapagliflozin treatment was more cost-effective compared with metformin treatment for Chinese type 2 diabetes patients. However, the findings of favorable cost-effectiveness results for dapagliflozin are largely driven by the effects of favorable weight profile on clinical, utility, and costs in the Cardiff model.     

Insulin degludec versus insulin glargine U100 for patients with type 1 or type 2 diabetes in the US: a budget impact analysis with rebate tables

Background and aims: Drug rebates are almost universally negotiated privately between the manufacturer and the payer in the US. The aim of the present study was to illustrate the use of a “rebate table” to improve the transparency and utility of published budget impact analyses in the US by modeling ranges of hypothetical rebates for two comparators. Worked examples were conducted to illustrate the budgetary implications of using insulin degludec (IDeg) relative to insulin glargine (IGlar) U100 in patients with type 1 or 2 diabetes.

Methods: A short-term (1-year) budget impact model was developed to evaluate the costs of switching to IDeg from IGlar in patients with type 1 or 2 diabetes on basal-bolus and basal-only insulin, respectively. The analysis used insulin dose and hypoglycemia data from recent randomized trials, data on the prevalence of diabetes, and estimates of the proportion of patients using each insulin regimen. The model was configured to run multiple rebate scenarios to generate a rebate table in a hypothetical 1 million member commercial plan.

Results: Relative to IGlar, IDeg resulted in reductions in non-severe and severe hypoglycemia incidence and costs both in patients with type 1 and patients with type 2 diabetes. Insulin acquisition costs were higher, and respective rebates of 7.3% and 10.6% were required for IDeg to break-even with IGlar at the full list price. Incremental per member per month IDeg costs without a rebate were USD 0.04 in type 1 diabetes and USD 0.80 in type 2 diabetes.

Conclusions: Using IDeg instead of IGlar at list price could result in a modest increase in costs when considering insulin and hypoglycemia costs alone, but modest incremental rebates with IDeg would result in cost neutrality relative to IGlar. In addition, IDeg would result in reduced incidence of severe and non-severe hypoglycemia.