Heart Rate Reduction via Electrical Cardiac Neuromodulation in an Animal Model
Heart Rate Reduction via Electrical Cardiac Neuromodulation in an Animal Model
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在动物模型中通过心脏电神经调节降低心率
DOI：
10.1111/ner.12333
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发表时间：
2015
期刊：
影响因子：
2.8
通讯作者：
N. Hatam
中科院分区：
文献类型：
--
作者：
A. Pohl;T. Breuer;J. Orschulik;A. Goetzenich;R. Autschbach;P. Schauerte;S. Leonhardt;N. Hatam
糖尿病是一种慢性疾病，预计到2030年全球患病率将达到4.4%，相当于3.66亿人。大约三分之一的糖尿病患者预计会出现疼痛性糖尿病神经病变（PDN），这是糖尿病最致残和最昂贵的并发症。脊髓刺激（SCS）是一种公认的神经调节技术，用于治疗神经性疼痛，如复杂性局部疼痛综合征1和背部手术失败综合征。2最近有报道称，SCS可显著减轻难治性疼痛性糖尿病神经病变患者的疼痛并改善其生活质量。3生活质量（QoL）分析基于EQ-5D视觉模拟量表评分。我们现在已经根据EQ-5D的指数值对进行本试验的国家的QoL进行了评价。方法所使用的方法，患者的人口统计学和随机对照试验的结果在其他地方报道。3采用EQ-5D量表评定生活质量。健康相关生活质量来自参与者对广泛使用的EuroQoL EQ-5D-3L问卷的回答。使用荷兰关税将答复转换为单一（公用事业）指数。采用配对t检验评价组内生活质量变化。进行ANCOVA分析，以比较两组之间的QoL，同时调整基线评分。通过Mann-Whitney检验（用于组间分析）和Wilcoxon符号秩检验（用于组内分析）评价EQ-5D-3L亚类的变化。使用统计软件STATA（版本13;学院站，TX：StataCorp LP）进行统计分析。CMP组在基线和6个月随访期间的VASPI、EQ-5D效用或EQ-5D VAS评分方面未观察到统计学显著改善（表1）。在基线和6个月随访之间，观察到SCS组患者的所有结局指标均出现统计学显著改善。通过EQ-5D效用评分和EQ-5D VAS测量，与随机分配至CMP的患者相比，随机分配至SCS的患者的疼痛缓解程度和QoL改善程度更大。组间相互作用和QoL基线评分不显著F（1，50）= 2.391，p= 0.128。在调整基线评分的同时，比较两组间QoL的ANCOVA显著F（1，50）= 14.274，p< 0.001。在EQ-5D子类别中，6个月时，随机分配至SCS组的患者报告了5个维度中的4个维度与基线相比显著改善：活动性、日常活动、疼痛/不适和焦虑/抑郁（图1）。在疼痛/不适EQ-5D维度方面，观察到组间存在统计学显著性差异。结论SCS有可能成为治疗难治性PDN的一种替代方法。除了在de Vos等人的RCT中观察到疼痛显著减轻外，SCS似乎还导致该人群的QoL显著改善。目前正在进行经济评估，以评估SCS用于治疗难治性PDN的成本效益。参考资料1. Kemler MA，Barendse GA，货车Kleef M，de Vet HC，et al. N Engl J Med 2000; 343：618-24.2. Kumar K，Taylor RS，Jacques L，Eldabe S，et al. Pain 2007; 132：179-88.3. de Vos CC，Meier K，Zaalberg PB，Nijhuis HJ，et al. Pain 2014; 155：2426-31
INTRODUCTIONDiabetes mellitus is a chronic condition with an increasing prevalence estimated to be 4.4% worldwide in 2030, the equivalent to 366 million people. Around one-third of diabetic patients are expected to develop painful diabetic neuropathy (PDN), which is the most disabling and costly complication of diabetes. Spinal cord stimulation (SCS) is a recognised neuromodulation technique for the management of neuropathic pains such as complex regional pain syndrome 1 and failed back surgery syndrome. 2 Recently it has been reported that SCS results in significantly reduced pain and improved quality of life in patients with refractory painful diabetic neuropathy. 3 The quality of life (QoL) analysis was based on the EQ-5D visual analogue scale scores. We have now evaluated QoL based on index values of the EQ-5D for the countries where this trial was conducted. METHODSThe methods used, patient demographics and results from the randomised controlled trial are reported elsewhere. 3Quality of life was assessed using the EQ-5D questionnaire. Health-related quality of life was derived from participants’ responses to the widely used EuroQoL EQ-5D-3L questionnaire. Responses were converted into single (utility) indices using the Dutch tariff. Paired samples t-test were conducted to evaluate within group QoL changes. An ANCOVA analysis was undertaken to compare QoL between the groups while adjusting for the baseline score. Changes in sub-categories of the EQ-5D-3L were evaluated through the Mann-Whitney test for between-group analyses and the Wilcoxon signed-rank test for within-group analyses. Statistical analyses were conducted using the statistical software STATA (Release 13; College Station, TX: StataCorp LP). RESULTSNo statistically significant improvements were observed for the CMP group between baseline and six-month follow-up for the VASPI, EQ-5D utility or EQ-5D VAS scores (Table 1). Statistically significant improvements were observed for all outcome measures for the patients in the SCS group between baseline and six-month follow-up. Patients randomised to SCS experience greater pain relief and grater improvement in QoL as measured by the EQ-5D utility scores and EQ-5D VAS than those patients randomised to CMP. The interaction between groups and QoL baseline score was not significant F (1, 50)= 2.391, p= 0.128. The ANCOVA comparing QoL between groups while adjusting for the baseline score was significant F (1, 50)= 14.274, p< 0.001. On the EQ-5D sub-categories, at six-months the patients randomised to SCS reported significant improvements in four out of five dimensions: mobility, usual activities, pain/discomfort and anxiety/depression when compared to baseline (Figure 1). Statistically significant differences were observed between groups for the pain/discomfort EQ-5D dimension. CONCLUSIONSCS has the potential to be an alternative for the management of refractory PDN. In addition to the significant reduction in pain observed in the de Vos et al RCT, SCS also appears to lead to significant improvements in QoL in this population. An economic evaluation is now in progress to evaluate the cost-effectiveness of SCS for the management of refractory PDN. REFERENCES1. Kemler MA, Barendse GA, van Kleef M, de Vet HC, et al. N Engl J Med 2000; 343: 618-24.2. Kumar K, Taylor RS, Jacques L, Eldabe S, et al. Pain 2007; 132: 179-88.3. de Vos CC, Meier K, Zaalberg PB, Nijhuis HJ, et al. Pain 2014; 155: 2426-31