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.     

多西他赛联合顺铂、5-氟尿嘧啶治疗晚期胃癌的Meta分析

目的对三周多西他赛联合顺铂、5-氟尿嘧啶治疗晚期胃癌的有效性和安全性进行荟萃分析，以期更有效地指导临床用药。方法采用Cochrane协作网提供的专用软件RevMan5．0对各纳入研究进行Meta分析。结果与结论三周多西他赛联合顺铂、5-氟尿嘧啶（DCF方案）对晚期胃癌的近期疗效总体优于其他临床常用化疗方案：（RR 1．30，95％CI 1．11-1．51），然而，III-Ⅳ级白细胞减少的发生情况总体显著高于其他对照组（RR1.54．95％CI1．15—2．07），III—IV级恶心呕吐的发生情况总体则与其他对照组无差别（RR1．00，95％CI0．80-1．26）。     

欧洲五维健康量表(EQ-5D)中文版应用介绍

本文总结了目前中国应用欧洲五维健康量表(EQ-5D)中文版的现状.在此基础上介绍了EQ-5D的构成和如何应用EQ-5D来描述健康状况和生存质量.文章整理了英国、美国和日本三个国家的时间权衡法(TTO)效用值换算表,以便研究者获得EQ-5D指数得分,进而用此得分进行生存质量研究和成本-效用分析.     

评估-沟通-监测-患者-环境管理模式在老年2型糖尿病患者社区护理中的应用价值

目的 探讨评估-沟通-监测-患者-环境（ACMPE）管理模式在老年2型糖尿病患者社区护理中的应用价值。方法 选取2019年1月至2021年12月高安市骨伤医院管辖的社区内诊治的100例老年2型糖尿病患者作为研究对象,按随机数字表法分为对照组和试验组,各50例。对照组采用常规社区管理模式,试验组采用ACMPE管理模式,干预6个月后对两组患者的血糖控制情况、自我管理能力以及生命质量进行比较,同时统计两组患者并发症发生情况。结果 与对照组比较,试验组干预6个月后空腹血糖、餐后2 h血糖、糖化血红蛋白水平均明显降低（P<0.05）;与对照组比较,试验组干预6个月后自我管理能力各维度评分均明显升高（P<0.05）;试验组干预6个月后生命质量各维度评分低于对照组（P<0.05）;试验组并发症发生率低于对照组（P<0.05）。结论 与常规管理措施比较,ACMPE管理模式更利于改善老年2型糖尿病患者的血糖控制情况,提高自我管理能力及生命质量,降低并发症发生风险,具有较高的临床应用价值。     

护理干预在糖尿病患者中的应用价值

目的：探讨护理干预在糖尿病患者中的应用价值。方法将2013年9月至2014年5月收治的156糖尿病患者资料完全随机分为观察组79例和对照组77例,对照组患者采取常规护理,观察组患者在其基础上进行护理干预,比较两组患者的护理效果。结果观察组患者的血糖监测、饮食控制、低血糖处理、自我总效能等DSES评分明显优于对照组,且糖化血红蛋白、空腹血糖、餐后2 h血糖等指标明显高于对照组,护理总有效率明显高于对照组,差异均有统计学意义（均P＜0.05）。结论对内分泌内科糖尿病患者实施护理干预能加强对患者血糖的控制,降低并发症发生率,提高患者的生活质量。     

基于欧洲五维度五水平健康量表和中文版低视力者生活质量量表测量老年性黄斑变性患者健康相关生命质量

目的 使用普适性量表和眼科疾病特异性量表全面评价老年性黄斑变性（AMD）患者的健康相关生命质量状况并分析其影响因素。方法 采用欧洲五维度五水平健康量表（EQ-5D-5L）和中文版低视力者生活质量量表（CLVQoL）对210例住院AMD患者进行面对面问卷调查,采用Spearman相关、秩和检验、Tobit回归及多重线性回归等进行统计分析。结果 EQ-5D-5L的5个维度中,焦虑/沮丧维度报告有问题的比例最高（50.48%）,基于EQ-5D-5L测量的AMD患者健康效用值为0.83±0.22,EQ-5D-5L和CLVQoL均能区分不同严重程度视力损伤的AMD患者,回归分析显示较佳眼远视力（BEVA）和年龄对AMD患者健康相关生命质量具有一定影响（P<0.05）。结论 AMD对患者健康相关生命质量造成较大影响,BEVA和年龄是影响患者健康相关生命质量的主要因素。     

2型糖尿病的标准胰岛素治疗方案——来自英国NICE的推荐

郑亚明等人撰写的《2型糖尿病患者的胰岛素标准治疗方案——来自英国NICE的推荐》介绍了英国国立临床优化研究院（NICE）对于2型糖尿病治疗中胰岛素标准治疗方案的推荐。该推荐涉及对血糖控制标准、血糖控制的治疗步骤及胰岛素治疗安全注意事项等相关问题的建议。尤其是,该文章对《2型糖尿病临床指南（临床指南66号）》的2009年更新版《2型糖尿病临床指南：新治疗药物（临床指南87号）》也给予了介绍。对NICE2型糖尿病患者胰岛素治疗方案正确解读将有助于我国临床医生更加合理地选择治疗方案,同时也可以让糖尿病患者及其家人、护理人员以及对这一疾病感兴趣的人更进一步了解糖尿病的治疗,参与治疗方案的选择,从而有利于患者的健康。     

糖化血红蛋白在2型糖尿病检测中的应用

目的探讨糖化血红蛋白(HbAlc)在2型糖尿病检测中的临床应用。方法对150例2型糖尿病患者进行HbAlc检测为研究组,同时选取100例肝功能体检正常者为对照组。结果研究组HbAlc<4%~5%有38例血糖控制稳定;6.5%~10.0%有42例血糖控制不理想,2型糖尿病仍处于预警状态,血糖高于正常;≥10%有70例患者血糖控制失败,需要调整治疗方案,且研究组患者HbAlc和空腹血糖与对照组均有显著差异。结论糖化血红蛋白是一项说服力较强,数据较客观,稳定性较好的检验项目,能反映患者2~3个月以内的糖代谢情况,在糖尿病学上有较高的临床参考价值。     

3种胰岛素类似物联合口服降糖药物治疗血糖控制欠佳2型糖尿病患者的疗效比较

目的：探讨血糖控制欠佳的2型糖尿病患者使用3种胰岛素类似物联合口服降糖药物的临床治疗效果。方法3组患者均给予口服二甲双胍药物治疗,A组同时给予甘精胰岛素注射液,B组同时给予预混人胰岛素30 R注射液,C 组同时给予预混门冬胰岛素注射液。记录3组患者给药前后各时间段血糖变化情况,给予统计学分析。结果经治疗后3组患者各时间段血糖值均较治疗前明显下降,A组患者下降幅度更为明显,A组与B组、C组患者治疗后血糖值对比,差异有统计学意义（P＜0.05）。结论临床医生应根据血糖控制欠佳的2型糖尿病患者实际情况,选择合适的胰岛素类似物联合口服降糖药物治疗方案,从而保障患者生活质量及生命安全。     

Mapping AcroQoL scores to EQ-5D to obtain utility values for patients with acromegaly

Aims: To estimate a preference-based single index for the disease-specific instrument (AcroQoL) by mapping it onto the EQ-5D to assist in future economic evaluations.

Materials and methods: A sample of 245 acromegaly patients with AcroQoL and EQ-5D scores was obtained from three previously published European studies. The sample was split into two: one sub-sample to construct the model (algorithm construction sample, n?=?184), and the other one to confirm it (validation sample, n?=?61). Various multiple regression models including two-part model, tobit model, and generalized additive models were tested and/or evaluated for predictive ability, consistency of estimated coefficients, normality of prediction errors, and simplicity.

Results: Across these studies, mean age was 50–60 years and the proportion of males was 36–59%. At overall level the percentage of patients with controlled disease was 37.4%. Mean (SD) scores for AcroQoL Global Score and EQ-5D utility were 62.3 (18.5) and 0.71 (0.28), respectively. The best model for predicting EQ-5D was a generalized regression model that included the Physical Dimension summary score and categories from questions 9 and 14 as independent variables (Adj. R²?=?0.56, with mean absolute error of 0.0128 in the confirmatory sample). Observed and predicted utilities were strongly correlated (Spearman r?=?0.73, p?<?.001) and paired t-Student test revealed non-significant differences between means (p?>?.05). Estimated utility scores showed a minimum error of ≤10% in 45% of patients; however, error increased in patients with an observed utility score under 0.2. The model’s predictive ability was confirmed in the validation cohort.

Limitations and conclusions: A mapping algorithm was developed for mapping of AcroQoL to EQ-5D, using patient level data from three previously published studies, and including validation in the confirmatory sub-sample. Mean (SD) utilities index in this study population was estimated as 0.71 (0.28). Additional research may be needed to test this mapping algorithm in other acromegaly populations.     

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.     

Cost-effectiveness of switching to biphasic insulin aspart from human premix insulin in a US setting

Objectives: To evaluate the cost-effectiveness of switching to biphasic insulin aspart (BIAsp 30) from human premix insulin for type 2 diabetes patients in the United States (US) setting.

Methods: The previously published and validated IMS Core Diabetes Model was used to project life expectancy, quality-adjusted life expectancy (QALE) and costs over 30 years. Patient characteristics and treatment effects were based on Canadian patients included the IMPROVE observational study (n = 311). Mean glycohaemoglobin (HbA_1c) was 8.4%, duration of diabetes 16 years and prevalence of complications high at baseline. Simulations were conducted from the perspective of a third-party payer, with costs accounted in 2008 US dollars ($).

Results: BIAsp 30 was projected to improve life expectancy by 0.202 years and QALE by 0.301 quality-adjusted life-years (QALYs), due to a reduced incidence of most diabetes-related complications. BIAsp 30 was associated with increased lifetime direct medical costs ($76,517 vs. 67,518) and an incremental cost-effectiveness ratio of $29,870 per QALY gained. Long-term outcomes were sensitive to the impact of BIAsp 30 on hypoglycaemia and changes in HbA_1c.

Conclusions: BIAsp 30 may represent a cost-effective treatment option in the US setting for advanced type 2 diabetes patients experiencing poor glycaemic control or hypoglycaemia on human premix insulin.

Limitations: The application of treatment effect data derived from a Canadian cohort to the US setting was a limitation of the cost-effectiveness analysis. The findings of this cost-effectiveness analysis are not applicable to insulin-naïve diabetes patients.     

综合干预在高血压病患者中的应用探讨

目的探讨综合干预对高血压病的治疗作用及对其后的影响。方法对高血压病患者进行定点、定点监测,同时进行家庭随访,综合干预,并与对照组进行前瞻性对照研究。结果入组前患者收缩压(157.5±9.0)mmHg(1mmHg=0.133kPa)、舒张压(95.0±16.5)mmHg,3年后收缩压(130.6±11.0)mmHg、舒张压(80.0±12.0)mmHg,与对照组比较,P<0.001;两组之间的降压幅度比较,P<0.05。患者的生活习惯有了改善,生活质量明显提高,并发症、致残率和病死率是对照组的20%。两组90项症状比较,干预组总分下降具有显著意义。结论高血压病严重威胁健康,社区家庭干预和健康宣教疗效肯定;公众教育、专业人员教育和高血压病患者教育还任重而道远。     

Long-term health economic benefits of sensor-augmented pump therapy vs continuous subcutaneous insulin infusion alone in type 1 diabetes: a UK perspective

Aims/hypothesis:

Continuous subcutaneous insulin infusion (CSII) is an important treatment option for type 1 diabetes patients unable to achieve adequate glycemic control with multiple daily injections (MDI). Combining CSII with continuous glucose monitoring (CGM) in sensor-augmented pump therapy (SAP) with a low glucose-suspend (LGS) feature may further improve glycemic control and reduce the frequency of hypoglycemia. A cost-effectiveness analysis of SAP?+?LGS vs CSII plus self-monitoring of blood glucose (SMBG) was performed to determine the health economic benefits of SAP?+?LGS in type 1 diabetes patients using CSII in the UK.

Methods:

Cost-effectiveness analysis was performed using the CORE diabetes model. Treatment effects were sourced from the literature, where SAP?+?LGS was associated with a projected HbA_1c reduction of ?1.49% vs ?0.62% for CSII, and a reduced frequency of severe hypoglycemia. The time horizon was that of patient lifetimes; future costs and clinical outcomes were discounted at 3.5% and 1.5% per annum, respectively.

Results:

Projected outcomes showed that SAP?+?LGS was associated with higher mean quality-adjusted life expectancy (17.9 vs 14.9 quality-adjusted life years [QALYs], SAP?+?LGS vs CSII), and higher life expectancy (23.8 vs 21.9 years), but higher mean lifetime direct costs (GBP 125,559 vs GBP 88,991), leading to an incremental cost-effectiveness ratio (ICER) of GBP 12,233 per QALY gained for SAP?+?LGS vs CSII. Findings of the base-case analysis remained robust in sensitivity analyses.

Conclusions/interpretation:

For UK-based type 1 diabetes patients with poor glycemic control, the use of SAP?+?LGS is likely to be cost-effective compared with CSII plus SMBG.     

Cost-effectiveness of continuous subcutaneous insulin infusion in people with type 2 diabetes in the Netherlands

Aims: Up to 30% of insulin-treated type 2 diabetes patients are unable to achieve HbA1c targets despite optimization of insulin multiple daily injections (MDI). For these patients the use of continuous subcutaneous insulin infusion (CSII) represents a useful but under-utilized alternative. The aim of the present analysis was to examine the cost-effectiveness of initiating CSII in type 2 diabetes patients failing to achieve good glycemic control on MDI in the Netherlands. Methods: Long-term projections were made using the IMS CORE Diabetes Model. Clinical input data were sourced from the OpT2mise trial. The analysis was performed over a lifetime time horizon. The discount rates applied to future costs and clinical outcomes were 4% and 1.5% per annum, respectively. Results: CSII was associated with improved quality-adjusted life expectancy compared with MDI (9.38 quality-adjusted life years [QALYs] vs 8.95 QALYs, respectively). The breakdown of costs indicated that ～50% of costs were attributable to diabetes-related complications. Higher acquisition costs of CSII vs MDI were partially offset by the reduction in complications. The ICER was estimated at EUR 62,895 per QALY gained and EUR 60,474 per QALY gained when indirect costs were included. Conclusions: In the Netherlands, CSII represents a cost-effective option in patients with type 2 diabetes who continue to have poorly-controlled HbA1c despite optimization of MDI. Since the ICER falls below the willingness-to-pay threshold of EUR 80,000 per QALY gained, CSII is likely to represent good-value for money in the treatment of poorly-controlled T2D patients compared with MDI.     

Quality of life in relation to constipation among opioid users

Abstract

Objective: Opioid users often experience constipation. In this study the impact of constipation on QoL was assessed in patients using opioids either for non-advanced illness or advanced illness.

Methods: Patients using opioids, recruited via public pharmacies, were asked to complete questionnaires on opioid use, constipation and the EuroQol five-dimension questionnaire (EQ-5D). Patients with a severe non-curable disease and relatively short life-expectancy were classified as having an advanced illness; a disabling yet not directly life-threatening condition was defined as non-advanced illness. Constipation was assessed based on questions on opioid side-effects and laxative use. EQ-5D index scores were compared between patients with and without constipation using Wilcoxon two-samples test.

Results: Questionnaires were returned by 588 patients with non-advanced illness, of whom 326 (55%) were classified as having constipation and by 113 patients with advanced illness, of whom 76 (67%) were classified as having constipation. The median EQ-5D index, a weighted health state index score with 1 = full health, was lower in patients with constipation than in patients without constipation (0.31 vs. 0.65, p<?0.01 for non-advanced illness and 0.41 vs. 0.61, p=0.12 for advanced illness).

Conclusion: The results of this study suggest that, in patients using opioids either for non-advanced illness or advanced illness, constipation negatively influences QoL. By separately analysing patients with advanced illness and patients with non-advanced illness, possible selective non-response and confounding was accounted for, but not completely solved.     

The impact of different scenarios for intermittent bladder catheterization on health state utilities: results from an internet-based time trade-off survey

Aims: Intermittent catheterization (IC) is the gold standard for bladder management in patients with chronic urinary retention. Despite its medical benefits, IC users experience a negative impact on their quality of life (QoL). For health economics based decision making, this impact is normally measured using generic QoL measures (such as EQ-5D) that estimate a single utility score which can be used to calculate quality-adjusted life years (QALYs). But these generic measures may not be sensitive to all relevant aspects of QoL affected by intermittent catheters. This study used alternative methods to estimate the health state utilities associated with different scenarios: using a multiple-use catheter, one-time-use catheter, pre-lubricated one-time-use catheter and pre-lubricated one-time-use catheter with one less urinary tract infection (UTI) per year.

Methods: Health state utilities were elicited through an internet-based time trade-off (TTO) survey in adult volunteers representing the general population in Canada and the UK. Health states were developed to represent the catheters based on the following four attributes: steps and time needed for IC process, pain and the frequency of UTIs.

Results: The survey was completed by 956 respondents. One-time-use catheters, pre-lubricated one-time-use catheters and ready-to-use catheters were preferred to multiple-use catheters. The utility gains were associated with the following features: one time use (Canada: +0.013, UK: +0.021), ready to use (all: +0.017) and one less UTI/year (all: +0.011).

Limitations: Internet-based survey responders may have valued health states differently from the rest of the population: this might be a source of bias.

Conclusion: Steps and time needed for the IC process, pain related to IC and the frequency of UTIs have a significant impact on IC related utilities. These values could be incorporated into a cost utility analysis.     

A short-term cost-utility analysis of insulin degludec versus insulin glargine U100 in patients with type 1 or type 2 diabetes in Denmark

Background and aims: Insulin degludec is an insulin analog with an ultra-long duration of action that exhibits less intra-patient variability in its glucose-lowering activity, and reduces nocturnal, overall, and severe hypoglycemia relative to insulin glargine. The aim of the present study was to evaluate the cost-effectiveness of insulin degludec relative to insulin glargine in patients with: type 1 diabetes (T1D), type 2 diabetes receiving basal-only therapy (T2DBOT), and type 2 diabetes receiving basal-bolus therapy (T2DBB) in Denmark.

Methods: A short-term (1 year) cost-utility model was developed to model insulin use, non-severe and severe hypoglycemia, and self-monitoring of blood glucose in patients using insulin degludec and insulin glargine from the perspective of a Danish healthcare payer. Where possible, data were derived from Danish patients with diabetes and meta-analyses of clinical trials comparing insulin degludec with insulin glargine. Using these characteristics, the model estimated costs and quality-adjusted life years (QALYs) gained for the two insulin regimens in each of the three diabetes populations.

Results: Insulin degludec dominated insulin glargine (i.e. reduced costs while improving quality-adjusted life expectancy) in patients with T1D and patients with type 2 diabetes using a basal-only insulin regimen. In the T2DBB cohort, insulin degludec was associated with an incremental cost-effectiveness ratio of DKK 221,063 per QALY gained, which would be considered cost-effective at a willingness-to-pay threshold of EUR 30,000 (～DKK 224,000) per QALY gained. Sensitivity analysis showed that results were most affected by changes in hypoglycemia rate ratio assumptions, but were broadly insensitive to changes in individual input parameters.

Conclusions: Insulin degludec reduces incidence of hypoglycemia and improves quality-of-life in patients with diabetes. Over a 1-year time horizon, insulin degludec resulted in cost savings relative to insulin glargine in T1D and T2DBOT cohorts, while being cost-effective in T2DBB.