Chronic

慢性
  • 文章类型: Journal Article
    背景:COVID-19(PASC)的后遗症,也被称为长科维德,是急性COVID-19后一系列长期症状的广泛分组。这些症状可能发生在一系列生物系统中,导致在确定PASC的危险因素和该疾病的病因方面面临挑战。对预测未来PASC的特征的理解是有价值的,因为这可以为识别高风险个体和未来的预防工作提供信息。然而,目前有关PASC危险因素的知识有限。
    目的:使用来自国家COVID队列合作组织的55,257名患者(其中1名PASC患者与4名匹配对照)的样本,作为美国国立卫生研究院长期COVID计算挑战的一部分,我们试图从一组经筛选的临床知情协变量中预测PASC诊断的个体风险.国家COVID队列合作组织包括来自美国84个地点的2200多万患者的电子健康记录。
    方法:我们预测了个体PASC状态,给定协变量信息,使用SuperLearner(一种集成机器学习算法,也称为堆叠)来学习梯度提升和随机森林算法的最优组合,以最大化接收器算子曲线下的面积。我们基于3个级别评估了变量重要性(Shapley值):个体特征,时间窗口,和临床领域。我们使用一组随机选择的研究地点从外部验证了这些发现。
    结果:我们能够准确预测个体PASC诊断(曲线下面积0.874)。观察期长度的个体特征,急性COVID-19和病毒性下呼吸道感染期间卫生保健相互作用的数量对随后的PASC诊断最具预测性.暂时,我们发现基线特征是未来PASC诊断的最具预测性的,与之前的特征相比,during,或急性COVID-19后。我们发现医疗保健使用的临床领域,人口统计学或人体测量学,和呼吸因素是PASC诊断的最具预测性的因素。
    结论:这里概述的方法提供了一个开放源代码,使用超级学习者使用电子健康记录数据预测PASC状态的应用示例,可以在各种设置中复制。在个体预测因子和临床领域,我们一致发现,与医疗保健使用相关的因素是PASC诊断的最强预测因子.这表明,任何使用PASC诊断作为主要结果的观察性研究都必须严格考虑异质医疗保健的使用。我们的研究结果支持以下假设:临床医生可能能够在急性COVID-19诊断之前准确评估患者的PASC风险,这可以改善早期干预和预防性护理。我们的发现还强调了呼吸特征在PASC风险评估中的重要性。
    RR2-10.1101/2023.07.27.23293272。
    BACKGROUND: Postacute sequelae of COVID-19 (PASC), also known as long COVID, is a broad grouping of a range of long-term symptoms following acute COVID-19. These symptoms can occur across a range of biological systems, leading to challenges in determining risk factors for PASC and the causal etiology of this disorder. An understanding of characteristics that are predictive of future PASC is valuable, as this can inform the identification of high-risk individuals and future preventative efforts. However, current knowledge regarding PASC risk factors is limited.
    OBJECTIVE: Using a sample of 55,257 patients (at a ratio of 1 patient with PASC to 4 matched controls) from the National COVID Cohort Collaborative, as part of the National Institutes of Health Long COVID Computational Challenge, we sought to predict individual risk of PASC diagnosis from a curated set of clinically informed covariates. The National COVID Cohort Collaborative includes electronic health records for more than 22 million patients from 84 sites across the United States.
    METHODS: We predicted individual PASC status, given covariate information, using Super Learner (an ensemble machine learning algorithm also known as stacking) to learn the optimal combination of gradient boosting and random forest algorithms to maximize the area under the receiver operator curve. We evaluated variable importance (Shapley values) based on 3 levels: individual features, temporal windows, and clinical domains. We externally validated these findings using a holdout set of randomly selected study sites.
    RESULTS: We were able to predict individual PASC diagnoses accurately (area under the curve 0.874). The individual features of the length of observation period, number of health care interactions during acute COVID-19, and viral lower respiratory infection were the most predictive of subsequent PASC diagnosis. Temporally, we found that baseline characteristics were the most predictive of future PASC diagnosis, compared with characteristics immediately before, during, or after acute COVID-19. We found that the clinical domains of health care use, demographics or anthropometry, and respiratory factors were the most predictive of PASC diagnosis.
    CONCLUSIONS: The methods outlined here provide an open-source, applied example of using Super Learner to predict PASC status using electronic health record data, which can be replicated across a variety of settings. Across individual predictors and clinical domains, we consistently found that factors related to health care use were the strongest predictors of PASC diagnosis. This indicates that any observational studies using PASC diagnosis as a primary outcome must rigorously account for heterogeneous health care use. Our temporal findings support the hypothesis that clinicians may be able to accurately assess the risk of PASC in patients before acute COVID-19 diagnosis, which could improve early interventions and preventive care. Our findings also highlight the importance of respiratory characteristics in PASC risk assessment.
    UNASSIGNED: RR2-10.1101/2023.07.27.23293272.
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  • 文章类型: Journal Article
    目的:临床评估先前开发的疼痛量表[驴慢性疼痛复合疼痛量表(DCP-CPS),驴慢性疼痛面部疼痛评估(DCP-FAP)和驴慢性疼痛综合量表(DCPS)],包括基于行为和面部表情的变量,用于评估驴的慢性疼痛。
    方法:前瞻性,盲法临床研究。
    方法:一组77只驴(34例患者和43只健康对照动物)。
    方法:由两名不知道动物状况的观察者评估动物。
    结果:DCP-CPS和DCP-FAP,以及由此产生的DCPS综合得分,显示出良好的观察者间可靠性[组内相关系数(ICC)=0.91,95%置信区间(CI)=0.86-0.95,p<0.001;ICC=0.71,CI=0.50-0.83,p<0.001和ICC=0.84,CI=0.72-0.91,p<0.001]。所有分数(DCP-CPS,在所有时间点,患者的DCP-FAP和所得的组合DCPS)均显着高于对照组(所有三个量表的p<0.001)。DCP-CPS识别疼痛(临界值>3)的敏感性和特异性分别为73.0%和65.1%,DCP-FAP分别为60.9%和83.3%,分别。对于组合的DCPS,敏感性为87.0%,特异性为90.9%(临界值>6)。
    结论:基于基于行为和面部表情的变量,DCPS被证明是一种有前途且可重复的工具,可用于评估驴的不同类型的慢性疼痛。基于行为和面部表情的变量的组合在当前研究中显示出最佳的区分特征。需要进一步的研究来完善这些工具。
    OBJECTIVE: To clinically evaluate previously developed pain scales [Donkey Chronic Pain Composite Pain Scale (DCP-CPS), Donkey Chronic Pain Facial Assessment of Pain (DCP-FAP) and combined Donkey Chronic Pain Scale (DCPS)], including behavioural and facial expression-based variables, for the assessment of chronic pain in donkeys.
    METHODS: Prospective, blinded clinical study.
    METHODS: A group of 77 donkeys (34 patients and 43 healthy control animals).
    METHODS: Animals were assessed by two observers that were blinded to the condition of the animals.
    RESULTS: Both DCP-CPS and DCP-FAP, and resulting combined DCPS scores, showed good interobserver reliability [intraclass correlation coefficient (ICC) = 0.91, 95% confidence interval (CI) = 0.86-0.95, p < 0.001; ICC = 0.71, CI = 0.50-0.83, p < 0.001 and ICC = 0.84, CI = 0.72-0.91, p < 0.001, respectively]. All scores (DCP-CPS, DCP-FAP and the resulting combined DCPS) were significantly higher for patients than for controls at all time points (p < 0.001 for all three scales). Sensitivity and specificity for identification of pain (cut-off value >3) was 73.0% and 65.1% for DCP-CPS, and 60.9% and 83.3% for DCP-FAP, respectively. For the combined DCPS, sensitivity was 87.0% and specificity 90.9% (cut-off value >6).
    CONCLUSIONS: Based on behavioural and facial expression-based variables, DCPS proved a promising and reproducible tool to assess different types of chronic pain in donkeys. The combination of behavioural and facial expression-based variables showed the best discriminatory characteristics in the current study. Further studies are needed for refinement of these tools.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    背景:数字医疗保健服务迅速扩展,将测量和改善数字健康准备的需要作为优先事项。作为回应,我们的研究团队开发了以移动为中心的数字健康准备情况:健康素养和公平量表(mDiHERS)来衡量数字健康准备情况.
    目标:我们的目标是开发和验证评估数字健康准备的量表,包括识字和公平,并确保有效使用以移动为中心的数字医疗服务。
    方法:这项研究于2021年10月至2022年10月进行,以开发和验证mDiHERS。参与者包括炎症性肠病患者,这是一种需要持续管理的慢性病,和医学和护理信息学专家。量表的开发涉及文献综述,焦点小组访谈,和内容效度评价。总共招募了440名炎症性肠病患者进行验证阶段,403完成调查。通过探索性因子分析和Cronbachα评估量表的效度和信度。翻译以及双语和母语研究人员将该量表翻译成英文,确保其在不同环境中的适用性。
    结果:mDiHERS由6个领域的36个项目组成,用5分的李克特量表来回答。验证过程证实了量表的结构有效性,4个因素解释了总方差的65.05%。量表的可靠性是由Cronbachα值在0.84到0.91之间建立的。该量表的开发考虑了参与健康移动应用程序和设备所需的技术熟练程度,反映了主观信心和客观技能在数字健康素养中的重要性。
    结论:mDiHERS是衡量患者使用数字医疗服务的准备和能力的有效工具。mDiHERS评估用户特征,数字可访问性,识字,和公平有助于有效利用数字医疗服务,提高可及性。mDiHERS的开发和验证强调了信心和能力在数字化管理健康方面的重要性。需要不断改进,以确保所有患者都能从数字医疗保健中受益。
    BACKGROUND: There has been a rapid expansion of digital health care services, making the need for measuring and improving digital health readiness a priority. In response, our study team developed the Mobile-Centered Digital Health Readiness: Health Literacy and Equity Scale (mDiHERS) to measure digital health readiness.
    OBJECTIVE: We aim to develop and validate a scale that assesses digital health readiness, encompassing literacy and equity, and to ensure the effective use of mobile-centered digital health services.
    METHODS: This study was conducted from October 2021 to October 2022 to develop and validate the mDiHERS. Participants included patients with inflammatory bowel disease, which is a chronic condition requiring continuous management, and experts in medical and nursing informatics. The scale development involved a literature review, focus group interviews, and content validity evaluations. A total of 440 patients with inflammatory bowel disease were recruited for the validation phase, with 403 completing the survey. The scale\'s validity and reliability were assessed through exploratory factor analysis and Cronbach α. The scale was translated into English by translators and bilingual and native researchers, ensuring its applicability in diverse settings.
    RESULTS: The mDiHERS consists of 36 items across 6 domains, with a 5-point Likert scale for responses. The validation process confirmed the scale\'s construct validity, with 4 factors explaining 65.05% of the total variance. The scale\'s reliability was established with Cronbach α values ranging from 0.84 to 0.91. The scale\'s development considered the technical proficiency necessary for engaging with health mobile apps and devices, reflecting the importance of subjective confidence and objective skills in digital health literacy.
    CONCLUSIONS: The mDiHERS is a validated tool for measuring patients\' readiness and ability to use digital health services. The mDiHERS assesses user characteristics, digital accessibility, literacy, and equity to contribute to the effective use of digital health services and improve accessibility. The development and validation of the mDiHERS emphasize the importance of confidence and competence in managing health digitally. Continuous improvements are necessary to ensure that all patients can benefit from digital health care.
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  • 文章类型: Journal Article
    急性撕裂伤(ALW)是印度尼西亚最常见的损伤之一,具有潜在的重大发病率。在农村地区,聚维酮碘和蜂蜜通常用作伤口敷料。这项研究旨在确定与石蜡纱布和常用的聚维酮碘相比,蜂蜜在改善ALW愈合时间方面的有效性。
    这项研究是单盲的,试点随机对照试验(RCT),包括三个干预组(蜂蜜,聚维酮碘,和石蜡)。结果是伤口愈合时间,缓慢愈合,二次愈合,感染的迹象,伤口裂开,水肿,浸渍,坏死,渗出物和成本。
    共有35名患者(男女比例:4:1),平均年龄为22.5岁(范围:6-47岁),根据伤口位置和伤口敷料的选择,使用预定的随机化方法纳入并随机分配到治疗组:蜂蜜组,n=12;聚维酮碘组,n=11;石蜡组,n=12,其中一名患者失去随访。所有组都实现了及时愈合,聚维酮碘和石蜡组的平均愈合时间为9.45±5.31天和11.09±5.14天,分别,蜂蜜组的中位愈合时间为10(3-19)天(p>0.05)。与其他组相比,蜂蜜组中更多的伤口在≤10天内愈合。聚维酮碘和蜂蜜组的不良事件较少,后者的成本最低。
    在这项研究中,与石蜡相比,蜂蜜在临床上有效地加速愈合时间,成本更低,与聚维酮碘相当。未来应进行样本量较大的随机对照试验,以确定蜂蜜在ALW治疗中的作用。
    UNASSIGNED: Acute laceration wound (ALW) is one of the most common injuries in Indonesia with potential significant morbidities. In rural areas, povidone-iodine and honey are commonly used as wound dressings. This study aimed to identify the effectiveness of honey compared to paraffin gauze and the commonly used povidone-iodine in improving ALW healing time.
    UNASSIGNED: This study was a single-blind, pilot randomised controlled trial (RCT) with three intervention groups (honey, povidone-iodine, and paraffin). The outcomes were wound healing time, slow healing, secondary healing, signs of infection, wound dehiscence, oedema, maceration, necrosis, exudate and cost.
    UNASSIGNED: A total of 35 patients (male to female ratio: 4:1), with a mean age of 22.5 (range: 6-47) years, were included and randomised to treatment groups using predetermined randomisation according to wound location and wound dressing selection: honey group, n=12; povidone-iodine group, n=11; paraffin group, n=12 with one patient lost to follow-up. All groups achieved timely healing, with a mean healing time of 9.45±5.31 days and 11.09±5.14 days for the povidone-iodine and paraffin groups, respectively, and a median healing time of 10 (3-19) days for the honey group (p>0.05). More wounds in the honey group achieved healing in ≤10 days compared with the other groups. Both povidone-iodine and honey groups had fewer adverse events, with the latter having the lowest cost.
    UNASSIGNED: In this study, honey was clinically effective in accelerating healing time with a lower cost compared to paraffin, and was comparable to povidone-iodine. Future RCTs with a larger sample size should be pursued to determine honey\'s role in ALW treatment.
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  • 文章类型: Journal Article
    目的:女性运动员的慢性身体压力会降低心理健康和运动表现。因此,需要一种慢性身体压力评估方法。
    方法:这项研究检查了头发皮质醇浓度(HCC)是否可以预测大学女足球运动员的慢性身体压力变化。我们在8月和12月进行了测量,就在日本大学全国锦标赛之前。
    结果:自我报告的训练负荷与HCC呈显著正相关。根据《情绪状态简介》第2版或《大学生压力源量表》中的压力源,自我报告的训练负荷与疲劳没有显着关系。在空间Stroop任务中,HCC与反应时间呈负相关,尽管重复相关分析表明无显著关系。
    结论:这些结果表明,女性足球运动员所经历的慢性身体压力无法通过心理指标来预测;然而,它们可以由HCC预测,这可以用来防止这些运动员过度训练。
    OBJECTIVE: Chronic physical stress in female athletes can reduce mental health and athletic performance. Therefore, a chronic physical stress assessment method is required.
    METHODS: This study examined whether hair cortisol concentration (HCC) predicted chronic physical stress changes in female university football players. We took measurements in August and December, just before the Japan college national tournament.
    RESULTS: Self-reported training load was significantly positively correlated with HCC. Self-reported training load had no significant relationship with fatigue as measured by the Profile of Mood States 2nd Edition or with the stressors from the Stressor Scale for College Students. HCC was negatively correlated with reaction time in the spatial Stroop task, although the repeated correlation analysis showed no significant relationship.
    CONCLUSIONS: These results suggest that the chronic physical stress experienced by female footballers cannot be predicted by psychological indicators; however, they can be predicted by HCC, which could be used to prevent overtraining in these athletes.
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  • 文章类型: Journal Article
    UNASSIGNED: To analyze the epidemiological profile of chronic noncommunicable diseases among community health workers and associated factors.
    UNASSIGNED: Cross-sectional study of community health workers in the city of Montes Claros, Minas Gerais, Brazil. Data were collected through a questionnaire designed to characterize demographic and socioeconomic profile, employment profile, self-reported presence of chronic noncommunicable diseases, and lifestyle habits. The variables were compared between participants with and those without chronic noncommunicable diseases, with Pearsons chi-square test used to define statistically significant differences between them.
    UNASSIGNED: 674 community health workers participated in the study, 43.32% of whom self-reported the presence of at least one chronic noncommunicable disease; chronic respiratory diseases and hypertension were the most prevalent, especially in the age group > 34 years, those with > 10 years\' experience as community health workers, overweight or obese participants, sedentary participants, and those employed as a civil servant or service provider.
    UNASSIGNED: Our results show that community health workers have a prevalence of chronic noncommunicable diseases and risk factors thereof similar to that found in the general Brazilian population.
    UNASSIGNED: Analisar o perfil epidemiológico das doenças crônicas não transmissíveis em agentes comunitários de saúde e fatores associados.
    UNASSIGNED: Tratou-se de estudo transversal, cuja população-alvo foram agentes comunitários de saúde no município de Montes Claros, no estado de Minas Gerais. A coleta dos dados foi realizada por meio de um questionário de pesquisa caracterizando o perfil demográfico e socioeconómico dos agentes comunitários de saúde, o perfil laboral, a presença de doenças crônicas não transmissíveis autorreferidas e os hábitos de vida. As variáveis foram avaliadas comparativamente entre não portadores e portadores de doenças crônicas, utilizando-se o teste do qui-quadrado de Pearson para definir diferenças estatisticamente significativas.
    UNASSIGNED: Participaram 674 agentes comunitários de saúde, e aproximadamente 43,32% dos participantes autorreferiram a presença de alguma doença crônica, sendo as doenças respiratórias crônicas e hipertensão arterial sistêmica as mais prevalentes, principalmente na faixa etária > 34 anos, tempo de trabalho como agentes comunitários de saúde > 10 anos, indivíduos com sobrepeso ou obesidade, sedentários e com o vínculo empregatício como concursado ou prestador de serviço.
    UNASSIGNED: Os resultados mostraram que os agentes comunitários de saúde apresentam prevalência de doenças crônicas não transmissíveis e associações com fatores de risco semelhantes às encontradas na população brasileira.
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  • 文章类型: Journal Article
    精神兴奋剂兴奋的潜在机制仍然知之甚少。在成年大鼠中,积极的情绪状态与50kHz超声发声(USV)的改变有关:特别是,“颤音”呼叫被提升为“平坦”呼叫。这里,我们调查了急性和反复服用可卡因的效果,并且基于先前对苯丙胺的发现-它们可能依赖于β-肾上腺素能受体。
    成年雄性Long-Evans大鼠在每天记录USV之前接受腹膜内药物或盐水注射。分析了14种50kHz呼叫亚型。在实验1和2中,单独测试可卡因(1-10mg/kg)和普萘洛尔(10mg/kg)。在实验3中,在条件位置偏爱(CPP)程序中寻求普萘洛尔/可卡因的相互作用。实验4研究了可卡因的急性和慢性作用(第一阶段),和普萘洛尔/可卡因在开放领域(第2阶段)或CPP程序(第3阶段)中的相互作用。
    在吸毒的动物中,可卡因提高了50kHz的呼叫率,敏化发展迅速。经过更长时间的曝光,可卡因现在也增加了颤音与平音的相对流行率;还揭示了对其他亚型的影响。β受体阻滞剂普萘洛尔既不能预防可卡因CPP也不能预防可卡因对USV排放或运动的影响,但单独使用时却发挥了与USV相关的显着作用。CPP幅度和USV相关测量值不相关。
    长期腹膜内给药,可卡因可以改变几种50kHz呼叫亚型的相对流行率;它能够促进颤音和平音,特别是,与积极的影响解释一致。可卡因的行为效应(即,USV相关,运动,CPP)似乎与β-肾上腺素能受体活性无关。
    UNASSIGNED: Mechanisms underlying psychostimulant euphoria remain poorly understood. In adult rats, positive emotional states are associated with alterations in 50-kHz ultrasonic vocalizations (USVs): specifically, \"trill\" calls are promoted over \"flat\" calls. Here, we investigated the effects of acute and repeated cocaine administration, and-based on previous findings with amphetamine-their possible dependence on beta-adrenergic receptors.
    UNASSIGNED: Adult male Long-Evans rats received intraperitoneal drug or saline injections before daily USV recording. Fourteen 50-kHz call subtypes were analyzed. In Experiments 1 and 2, cocaine (1-10 mg/kg) and propranolol (10 mg/kg) were tested alone. In Experiment 3, propranolol/cocaine interactions were sought within a conditioned place preference (CPP) procedure. Experiment 4 investigated acute and chronic cocaine effects (Phase 1), and propranolol/cocaine interactions either in an open field (Phase 2) or within a CPP procedure (Phase 3).
    UNASSIGNED: In drug-naïve animals, cocaine increased the 50-kHz call rate, with sensitization developing rapidly. After more extended exposure, cocaine now also increased the relative prevalence of trill versus flat calls; effects on other subtypes were also revealed. The beta-blocker propranolol prevented neither cocaine CPP nor cocaine effects on USV emission or locomotion but exerted significant USV-related effects when given alone. CPP magnitude and USV-related measures were uncorrelated.
    UNASSIGNED: With long-term intraperitoneal administration, cocaine can alter the relative prevalence of several 50-kHz call subtypes; its ability to promote trill versus flat calls, in particular, is consistent with a positive affect interpretation. Cocaine\'s behavioral effects (i.e., USV-related, locomotor, CPP) appear independent of beta-adrenergic receptor activity.
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  • 文章类型: Journal Article
    长期或长期的社会隔离对动物有明显的影响,从改变的应激反应,焦虑和攻击行为增加,甚至增加了死亡率。较短的隔离时间的影响研究要少得多;然而,短期隔离通常用于测试动物行为和生理学。这里,我们研究了一个3小时的分离期间从一个笼状影响三个大脑区域,包含社会决策网络的重要组成部分的神经基因表达,下丘脑,杏仁核的taeniae,和终末纹的床核,使用群居鸟类作为模型(斑马雀)。我们发现了神经活动改变的证据,突触传递,新陈代谢,甚至潜在的疼痛感知,所有这些都可能对涉及隔离动物的实验测试产生共同影响。我们建议需要更好地理解短期社会隔离的影响,并提出隔离动物进行测试的替代方法。
    Prolonged or chronic social isolation has pronounced effects on animals, ranging from altered stress responses, increased anxiety and aggressive behaviour, and even increased mortality. The effects of shorter periods of isolation are much less well researched; however, short periods of isolation are used routinely for testing animal behaviour and physiology. Here, we studied how a 3 h period of isolation from a cagemate affected neural gene expression in three brain regions that contain important components of the social decision-making network, the hypothalamus, the nucleus taeniae of the amygdala, and the bed nucleus of the stria terminalis, using a gregarious bird as a model (zebra finches). We found evidence suggestive of altered neural activity, synaptic transmission, metabolism, and even potentially pain perception, all of which could create cofounding effects on experimental tests that involve isolating animals. We recommend that the effects of short-term social isolation need to be better understood and propose alternatives to isolating animals for testing.
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  • 文章类型: Journal Article
    慢性背痛是最普遍的疾病之一,具有很大的社会经济影响。缺乏常规使用非药物选择和与药物治疗相关的问题强调了背痛治疗中未满足的高度需求。尽管蓝光光疗已在皮肤病学中证明了疗效,关于其在背痛中使用的信息有限。
    在这个概念证明中,随机对照试验,疼痛缓解贴片(PRP)在五个疗程中在背痛部位发出蓝光30分钟。比较器装置发出绿灯5s,但佩戴30分钟。最后一次治疗后进行了随访。主要目的是证明PRP治疗的优越性,与控制装置相比,在治疗期结束时降低疼痛强度。在五个疗程中计算每组的治疗后视觉模拟量表(VAS)疼痛强度评分,并与基线进行比较。次要目标包括残疾评分(Roland-Morris残疾问卷)和安全性。
    整个分析集包括171名患者。使用PRP后疼痛强度显著降低(p<0.02),但该研究未达到其主要目标,即旨在证明在VAS量表上支持PRP有0.6cm差异的优势试验.残疾评分没有显著变化。进行亚组分析以通过患者特征如基线疼痛强度和皮肤类型来鉴定治疗反应。不出所料,安全性数据显示PRP组出现红斑和皮肤变色,而对照组未出现.
    该试验有多个局限性,需要在未来的研究中解决。尽管主要目标没有实现,这项概念验证研究提供了与在慢性背痛治疗中使用蓝光相关的重要疗效和安全性数据,以及可能支持类似器械进一步研究的关键见解.
    ClinicalTrials.gov,标识符NCT01528332。
    UNASSIGNED: Chronic back pain is one of the most prevalent conditions and has a large socio-economic impact. The lack of routine use of non-pharmacological options and issues associated with pharmacological treatments underscore high unmet needs in the treatment of back pain. Although blue light phototherapy has proven efficacy in dermatology, limited information is available about its use in back pain.
    UNASSIGNED: In this proof-of-concept, randomized controlled trial, a pain relief patch (PRP) delivered blue light at the site of back pain for 30 min during five treatment sessions. The comparator device delivered green light for 5 s but was worn for 30 min. A follow-up visit took place after the last treatment. The primary objective was to demonstrate the superiority of treatment by PRP, compared to the control device, in reducing pain intensity at the end of the treatment period. The post-treatment visual analog scale (VAS) pain intensity score for each group was calculated across the five treatment sessions and compared to the baseline. Secondary objectives included the disability score (Roland-Morris Disability Questionnaire) and safety.
    UNASSIGNED: The full analysis set included 171 patients. A statistically significant reduction in pain intensity occurred after the use of PRP (p < 0.02), but the study did not meet its primary objective of a superiority trial aimed at demonstrating a 0.6 cm difference in favor of PRP on the VAS scale. There was no significant change in the disability scores. Subgroup analyses were performed to identify the treatment response by patient characteristics such as pain intensity at baseline and skin type. As expected, safety data showed erythema and skin discoloration in the PRP group but not in the control group.
    UNASSIGNED: This trial had multiple limitations that need to be addressed in future research. Although the primary objective was not achieved, this proof-of-concept study provides important efficacy and safety data in relation to the use of blue light in the treatment of chronic back pain and key insights that may support further research on similar devices.
    UNASSIGNED: ClinicalTrials.gov, identifier NCT01528332.
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