Dysphagia

吞咽困难
  • 文章类型: Journal Article
    胃食管反流病(GERD)是一种普遍的健康问题,具有多种症状和生活质量的损害。保守治疗不能在高达30%的患者中提供足够的症状缓解。患有无效食管运动(IEM)和GERD的患者可能表现出从轻度到重度的症状。在这种不同的患者群体需要手术干预的情况下,重要的是要考虑术后吞咽困难的潜在发生。RefluxStop是一种新的替代抗反流手术,有可能降低术后吞咽困难的发生率。在这项双中心三级医院观察性研究中,纳入了接受RefluxStop植入的诊断为PPI难治性GERD和IEM的连续患者。进行了首次安全性和有效性评估,包括临床检查和GERD-HRQL问卷。包括40名患者(25名男性和15名女性)。31例患者(77.5%)在手术时使用PPI,平均酸暴露时间为8.14%±2.53。中位住院时间为3天。GERDHRQL总分从32.83±5.08提高到6.6±3.71(p<0.001)。PPI使用量减少84%(p<0.001)。36例患者(90%)表现出消失或改善的症状,并在首次随访时感到满意。需要提及的两个严重不良事件:一个RefluxStop术后滑倒,需要在术后第一天立即进行修正手术(Clavien-Dindo评分3b),一个装置迁移,无需进一步干预。在GERD和IEM患者的短期随访中,RefluxStop装置植入是安全有效的。需要进一步的研究和更长时间的随访才能证明长期的积极作用。
    Gastroesophageal reflux disease (GERD) presents a general health problem with a variety of symptoms and an impairment of life quality. Conservative therapies do not offer sufficient symptom relief in up to 30% of patients. Patients who suffer from ineffective esophageal motility (IEM) and also GERD may exhibit symptoms ranging from mild to severe. In cases where surgical intervention becomes necessary for this diverse group of patients, it is important to consider the potential occurrence of postoperative dysphagia. RefluxStop is a new alternative anti-reflux surgery potentially reducing postoperative dysphagia rates. In this bicentric tertiary hospital observational study consecutive patients diagnosed with PPI refractory GERD and IEM that received RefluxStop implantation were included. A first safety and efficacy evaluation including clinical examination and GERD-HRQL questionnaire was conducted. 40 patients (25 male and 15 female) were included. 31 patients (77.5%) were on PPI at time of surgery, with mean acid exposure time of 8.14% ± 2.53. The median hospital stay was 3 days. Postoperative QoL improved significantly measured by GERD HRQL total score from 32.83 ± 5.08 to 6.6 ± 3.71 (p < 0.001). A 84% reduction of PPI usage (p < 0.001) was noted. 36 patients (90%) showed gone or improved symptoms and were satisfied at first follow-up. Two severe adverse events need mentioning: one postoperative slipping of the RefluxStop with need of immediate revisional operation on the first postoperative day (Clavien-Dindo Score 3b) and one device migration with no necessary further intervention. RefluxStop device implantation is safe and efficient in the short term follow up in patients with GERD and IEM. Further studies and longer follow-up are necessary to prove long-lasting positive effects.
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  • 文章类型: Journal Article
    约80%的帕金森病(PD)患者出现吞咽困难的症状。虽然认知障碍可能导致吞咽困难,很少有研究调查PD神经心理学特征与吞咽功能障碍的客观指标之间的关联。由于吞咽功能包括非自愿行动,也包括自愿行动,我们假设在PD相关吞咽困难中可以强调注意力和执行功能的具体措施.因此,这项研究的目的是广泛调查PD患者吞咽咽期的注意力和执行功能与安全性/效率之间的相关性和关系。所有参与者都接受了吞咽的光纤内窥镜评估,并使用穿透抽吸量表(PAS)进行评估;耶鲁咽部残留物严重程度评定量表(IT-YPRSRS),和功能性口腔摄入量表(FOIS-IT)。参与者还接受了涵盖全球认知状况的神经心理学评估,注意,和额叶执行功能。计算了神经心理学措施与吞咽成分之间的相关性和关联。21名PD患者(平均年龄69.38±6.58岁,平均病程8.38±5.31年;平均MDS-UPDRSIII43.95±24.18)完成了所有评估。注意功能(即,StroopTime),和执行功能(即,Raven的渐进矩阵,数字向后和语义流畅),和FOIS-IT,PAS,和IT-YPRSRS鼻窦和瓣膜。这些关联不受疾病持续时间的影响。这些结果表明,注意过程和/或执行功能的功能障碍可能导致中期PD参与者的渗透和咽部残留物的存在。
    Around 80% of persons with Parkinson\'s disease (PD) present symptoms of dysphagia. Although cognitive impairment may contribute to dysphagia, few studies have investigated the association between the PD neuropsychological profile and objective measures of swallowing dysfunction. Since the swallowing function comprises involuntary but also voluntary actions, we hypothesize that specific measures of attention and executive functions can be underlined in PD-related dysphagia. Therefore, the aim of this study was to extensively investigate the correlation and the relationship between attentive and executive functions and safety/efficiency of pharyngeal phase of swallowing in people with PD. All participants received a fiberoptic endoscopic evaluation of swallowing and were evaluated using the Penetration Aspiration Scale (PAS); the Yale Pharyngeal Residue Severity Rating Scale (IT-YPRSRS), and the Functional Oral Intake Scale (FOIS-IT). Participants also underwent a neuropsychological assessment covering global cognitive status, attention, and frontal executive functions. Correlations and associations between neuropsychological measures and swallowing components were calculated. Twenty-one participants with PD (mean age 69.38 ± 6.58 years, mean disease duration 8.38 ± 5.31 years; mean MDS-UPDRS III 43.95 ± 24.18) completed all evaluations. The most significant correlations were found between attentive functions (i.e., Stroop Time), and executive functions (i.e., Raven\'s Progressive Matrices, Digit Backward and Semantic Fluency), and FOIS-IT, PAS, and IT-YPRSRS sinuses and valleculae. These associations were not influenced by disease duration. These results suggest that a dysfunction to attentional processes and/or to executive functions can contribute to penetration and the presence of pharyngeal residue in participants with middle-stage PD.
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  • 文章类型: Journal Article
    本研究旨在评估经导管胃化疗栓塞(GTC)联合全身化疗(SYS)与单用SYS治疗吞咽困难的有效性。改善晚期胃贲门癌(AGCC)患者的生活质量(QoL)和营养状况。使用2018年1月至2022年12月经历吞咽困难并单独使用SYS或SYS联合GTC的AGCC连续患者的数据进行回顾性审查。进行倾向评分匹配(PSM)分析以解决潜在的混杂因素。Ogilvie吞咽困难评分用于评估吞咽困难,癌症治疗功能评估-一般7(FACT-G7)用于评估QoL,患者主观综合评估(PG-SGA)用于评价营养状况.PSM之后,共有228名患者被纳入分析,每组114人。在初始治疗后4周和8周,GTC+SYS组的Ogilvie评分中位数显著低于SYS单独组(P<0.001).同样,初始治疗后4周,GTC+SYS组的PG-SGA评分中位数为2.0,单独SYS组为6.0.GTC+SYS组的FACT-G7评分中位数为13.0,而单用SYS组为10.5。这些差异在8周时仍然显著(P<0.001)。总之,在SYS中加入GTC可以更有效和及时地缓解吞咽困难,在出现吞咽困难的AGCC患者中,与单独使用SYS相比,改善营养状况并提高QoL。
    The present study aimed to assess the effectiveness of gastric transcatheter chemoembolization (GTC) combined with systemic chemotherapy (SYS) compared with SYS alone in managing dysphagia, and improving the quality of life (QoL) and nutritional status of patients with advanced gastric cardiac cancer (AGCC). A retrospective review was performed using data from consecutive patients with AGCC who experienced dysphagia and underwent either SYS alone or SYS combined with GTC from January 2018 to December 2022. Propensity score matching (PSM) analysis was performed to address potential confounding factors. Ogilvie dysphagia scores were used to assess dysphagia, the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) was used to assess QoL, and the Patient-Generated Subjective Global Assessment (PG-SGA) was used to evaluate nutritional status. After PSM, a total of 228 patients were included in the analysis, with 114 in each group. At 4 and 8 weeks after the initial treatment, the GTC + SYS group demonstrated significantly lower median Ogilvie scores compared with the SYS alone group (P<0.001). Similarly, the median PG-SGA score at 4 weeks after the initial treatment was 2.0 in the GTC + SYS group and 6.0 in the SYS alone group. The median FACT-G7 scores in the GTC + SYS group was 13.0, compared with 10.5 in the SYS alone group. These differences remained significant at 8 weeks (P<0.001). In conclusion, the addition of GTC to SYS may more effectively and promptly relieve dysphagia, improve nutritional status and enhance QoL compared with SYS alone in patients with AGCC presenting with dysphagia.
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  • 文章类型: Journal Article
    诊断吞咽困难的金标准测试是视频透视吞咽研究(VFSS)。然而,这个测试的准确性取决于专家的技能水平。我们提出了一个基于VFSS的人工智能(AI)Web应用程序来诊断吞咽困难。来自VFSS的视频由包含大约300个图像的多帧数据组成。要标记数据,服务器在上传过程中将它们分成帧,并将它们存储为视频进行分析。然后,将分离的数据加载到标记工具中以执行标记。标签文件已下载,人工智能模型是通过训练你只看一次(YOLOv7)开发的。使用名为SplitFolders的实用程序,整个数据集根据训练比例(70%)进行划分,测试(10%),和验证(20%)。当VFSS视频文件上传到配备开发的AI模型的应用程序时,它被自动分类并标记为口头,咽部,或者食道。一个人的吞咽困难被归类为穿透或误吸,并将最终分析结果显示给观看者。为AI学习创建了以下标记数据集:口头(n=2355),咽部(n=2338),食管(n=1480),渗透率(n=1856),和愿望(n=1320);YOLO模型的学习结果,使用数据集分析吞咽困难,预测精度分别为0.90、0.82、0.79、0.92和0.96。这有望帮助临床医生更有效地建议口咽吞咽困难患者的适当饮食选择。
    The gold standard test for diagnosing dysphagia is the videofluoroscopic swallowing study (VFSS). However, the accuracy of this test varies depending on the specialist\'s skill level. We proposed a VFSS-based artificial intelligence (AI) web application to diagnose dysphagia. Video from the VFSS consists of multiframe data that contain approximately 300 images. To label the data, the server separated them into frames during the upload and stored them as a video for analysis. Then, the separated data were loaded into a labeling tool to perform the labeling. The labeled file was downloaded, and an AI model was developed by training with You Only Look Once (YOLOv7). Using a utility called SplitFolders, the entire dataset was divided according to a ratio of training (70%), test (10%), and validation (20%). When a VFSS video file was uploaded to an application equipped with the developed AI model, it was automatically classified and labeled as oral, pharyngeal, or esophageal. The dysphagia of a person was categorized as either penetration or aspiration, and the final analyzed result was displayed to the viewer. The following labeling datasets were created for the AI learning: oral (n = 2355), pharyngeal (n = 2338), esophageal (n = 1480), penetration (n = 1856), and aspiration (n = 1320); the learning results of the YOLO model, which analyzed dysphagia using the dataset, were predicted with accuracies of 0.90, 0.82, 0.79, 0.92, and 0.96, respectively. This is expected to help clinicians more efficiently suggest the proper dietary options for patients with oropharyngeal dysphagia.
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  • 文章类型: Journal Article
    一名86岁的妇女在就诊前4个月接受气管造口术后,因隐源性进行性呼吸困难和吞咽困难而入院。她表现出波动性复视,双侧声带麻痹,正常神经检查结果,血清抗乙酰胆碱受体和抗肌肉特异性激酶抗体阴性,以及抗LDL受体相关蛋白4(LRP4)的阳性结果。使用edrophonium进行的视频透视吞咽研究(VFSS)显示球麻痹的改善。因此,患者被诊断为双血清阴性重症肌无力(DSN-MG),并开始免疫调节治疗.此案例强调了延髓型DSN-MG的诊断挑战,并强调了带有edrophonium的VFSS用于诊断这种疾病的价值。
    An 86-year-old woman was admitted to our hospital with cryptogenic progressive dyspnea and dysphagia following a tracheostomy procedure 4 months prior to presentation. She exhibited fluctuating diplopia, bilateral vocal fold paralysis, normal nerve test results, negative findings for serum anti-acetylcholine receptor and anti-muscle-specific kinase antibodies, and positive findings for anti-LDL-receptor related protein 4 (LRP4). A videofluoroscopic swallowing study (VFSS) with edrophonium revealed an improvement in bulbar paralysis. Consequently, the patient was diagnosed with double-seronegative myasthenia gravis (DSN-MG) and began immunomodulatory therapy. This case emphasizes the diagnostic challenges of bulbar-type DSN-MG and underscores the value of a VFSS with edrophonium for diagnosing this condition.
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  • 文章类型: Journal Article
    背景:拔管后吞咽困难(PED)是一种常见的拔管后并发症,可能导致严重问题,例如营养不良和住院和重症监护病房(ICU)停留时间更长。
    目的:探讨拔管后成年危重患者口服摄入准备情况的相关因素。
    方法:这项前瞻性观察性研究涉及125名拔管患者。使用gugging吞咽屏幕(GUSS)评估口服摄入的准备情况,回归分析用于确定其预测因子。
    结果:参与者的中位年龄为40.0岁,51.2%为女性。GUSS评分中位数为12.0(可能范围,0-20),35.2%的患者有严重的吞咽困难(0-9分)。双变量回归分析显示,年龄较大,男性,APACHEII评分更高,体重指数(BMI)≥30,吸烟史,ICU停留时间更长,肌肉松弛剂的使用,大口径气管导管和口胃管以及频繁的插管尝试与较低的GUSS评分相关(p值<.05).多因素回归分析显示,年龄,BMI和吸烟史预测了GUSS评分变异性的37.2%(F=23.865,p值<.001)。加上ICU住院时间,肌肉松弛剂的使用,气管内导管的大小,口胃管的大小和插管频率尝试回归模型将可预测性提高到86.0%(F=88.809,p值<.001).
    结论:超过三分之一的拔管患者患有严重PED,误吸风险高。几个可改变的因素,如肌肉松弛剂的使用和气管和口胃管的大小,预测拔管后口服准备。
    结论:使用适当尺寸的气管导管和口胃管,仔细评估插管困难的高风险患者,以及最少使用肌肉松弛剂可能有助于增加患者拔管后口服摄入的准备。
    BACKGROUND: Post-extubation dysphagia (PED) is a common post-extubation complication that may lead to serious problems, such as malnutrition and longer hospital and intensive care unit (ICU) stays.
    OBJECTIVE: To explore factors associated with the readiness for oral intake in post-extubated critically ill adult patients.
    METHODS: This prospective observational study involved 125 extubated patients. Readiness for oral intake was assessed using the Gugging Swallowing Screen (GUSS), and regression analysis was used to determine its predictors.
    RESULTS: The median age of the participants was 40.0 years, and 51.2% were female. The median GUSS score was 12.0 (possible range, 0-20), and 35.2% of the studied patients had severe dysphagia (scored 0-9). Bivariate regression analysis showed that older age, male, higher APACHE II score, body mass index (BMI) ≥30, smoking history, longer ICU stay, muscle relaxants use, large-bore endotracheal and orogastric tubes and frequent intubation attempts were associated with lower GUSS score (p-value <.05). Multivariate regression analysis showed that age, BMI and smoking history predicted 37.2% of the variability in the GUSS score (F = 23.865, p-value <.001). Adding the ICU length of stay, muscle relaxants use, size of the endotracheal tube, size of the orogastric tube and frequency of intubation attempts to the regression model raised the predictability to 86.0% (F = 88.809, p-value <.001).
    CONCLUSIONS: More than one-third of extubated patients have severe PED with a high risk of aspiration. Several modifiable factors, such as muscle relaxant use and endotracheal and orogastric tube size, predict post-extubation readiness for oral intake.
    CONCLUSIONS: Using endotracheal and orogastric tubes of appropriate sizes, careful assessment of patients with a high risk for difficult intubation, and minimal use of muscle relaxants may help increase patients\' readiness for post-extubation oral intake.
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  • 文章类型: Journal Article
    背景:在严重的脑损伤和昏迷后,患者可能会出现意识障碍(DoC),常伴有严重吞咽困难。因此,吞咽的评估和治疗是其管理的重要方面。目标:本研究旨在评估意识障碍SWADOC工具在昏迷后吞咽评估中的应用。这里,我们验证了它的定量项目,描述初步结果并确定局限性。方法:对14例昏迷后患者进行了简单的意识障碍评估(SECONDs)和SWADOC评估。结果:SWADOC的口腔和咽部分量表的内部一致性良好。测试-重测可靠性表明,所有项目,除两项(口腔内分泌物和支气管充血)外,所有子评分和总分均稳定。与唾液面部口腔治疗吞咽评估(F.O.T.T-SAS)的比较证实,SWADOC评分在评估DoC患者的吞咽能力方面具有更大的定量观察潜力。SECONDs评分与SWADOC总分呈显著正相关(τ=0.78,p<0.001)。结论:这项研究为SWADOC工具的心理测量特性提供了初步但令人鼓舞的结果。它表明该工具作为DoC患者吞咽困难的床边评估是相关且可行的。
    Background: After a severe brain injury and a coma, patients may develop disorders of consciousness (DoC), frequently accompanied by severe dysphagia. The evaluation and therapy of swallowing are therefore essential aspects of their management. Objectives: This study aims to evaluate the SWallowing Assessment in Disorders of Consciousness (SWADOC) tool in the assessment of swallowing in post-comatose patients. Here, we validate its quantitative items, describe preliminary results and identify limitations. Methods: Fourteen post-comatose patients were repeatedly evaluated with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and with the SWADOC. Results: The internal consistency of the oral and pharyngeal subscales of the SWADOC was good. The test-retest reliability showed that all items, all subscores and the total score were stable except for two items (endo-buccal secretions and bronchial congestion). A comparison to the Facial Oral Tract Therapy Swallowing Assessment of Saliva (F.O.T.T-SAS) confirmed that scoring with the SWADOC offers a greater potential for quantitative observations in assessing swallowing abilities among patients with DoC. The SECONDs scores and SWADOC total scores showed a significant positive correlation (τ = 0.78, p < 0.001). Conclusions: This study provides preliminary but encouraging results on the psychometric properties of the SWADOC tool. It shows that this tool is relevant and feasible as a bedside assessment of dysphagia in patients with DoC.
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  • 文章类型: Journal Article
    背景:吞咽困难的制度化个体尤其面临营养不良的风险。这项研究调查了两种质地修饰的吞咽困难患者模型,如下:(i)传统的自制糊状食品(PF)和(ii)从脱水和再水化的瞬时制剂(IPs)获得的均质膳食。方法:进行回顾性试点研究。它包括被CocquioTrevisago疗养院“SacraFamiglia”研究所收治的中度严重吞咽困难患者,瓦雷泽.患者年龄41-81岁,均有复杂的残疾。他们在基线时接受了人体测量和生化参数评估,以及两个月和四个月的随访。结果:该研究涉及30例患者,15收到了IP餐。基线和随访之间的比较没有显示出明显的人体测量和生化参数差异。相反,IP组报告的消费水平和满意度明显更高,使用基于三个微笑级别的改良切尔诺夫量表进行评估,比PF组。结论:本研究结果为改善吞咽困难患者的饮食提供了有希望的适应症,由于用餐满意度是一个相关因素,已被证明与更好的患者情绪有关,吃的动机,坚持规定的饮食。
    Background: Institutionalized individuals with dysphagia are particularly at risk for malnutrition. This study investigated two texture-modified models for patients with dysphagia, as follows: (i) traditional homemade pureed food (PF) and (ii) homogenized meals obtained from dehydrated and rehydrated instantaneous preparations (IPs). Methods: A retrospective pilot study was performed. It included patients affected by medium-severity dysphagia admitted to the nursing home \"Sacra Famiglia\" Institute of Cocquio Trevisago, Varese. The patients were aged 41-81 years old and all had complex disabilities. They underwent anthropometric and biochemical parameter assessments at baseline, as well as at two months and four months follow-up. Results: The study involved 30 patients, 15 received the IP meal. The comparison between the baseline and the follow-up did not show significant anthropometric and biochemical parameter differences. Conversely, the IP group reported significantly higher levels of consumption and satisfaction, evaluated using a modified Chernoff scale based on three levels of smiles, than the PF group. Conclusions: The present findings provide promising indications to improve the diet of patients affected by dysphagia, since meal satisfaction is a relevant factor that has been shown to be associated with better patient mood, motivation to eat, and adherence to prescribed diet.
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  • 文章类型: Journal Article
    虽然吞咽功能内窥镜评估(FEES)是评估吞咽困难最有用的诊断测试,它不能评估吞咽的食道阶段。为了评估是否可以通过吞咽空胶囊和上食道筛查来修改FEES检查,以用于早期发现食道吞咽困难。一个潜在的,单中心,试点研究。在标准费用考试结束时,病人被要求吞下一个空胶囊。十五秒后,将内窥镜插入上食管。当在食道中看到胶囊时,定义了病理胶囊测试。在这种情况下,患者被建议接受胃镜检查,MBS,或者食道测压,将其与胶囊测试的结果进行比较。在109名患者中使用胶囊测试。55例患者(57.8%)进行了病理包膜检查。在48例患者(87.3%)中,观察到孤立或合并的食道吞咽困难。胶囊试验与胃肠病学试验相比的准确率为83.3%,灵敏度88.46%,特异性75%,PPV85%,和NPV80%。通过包括空胶囊吞咽测试和上食道检查来修改标准FEES检查可以为食道吞咽困难提供有用的筛查工具。
    While functional endoscopic evaluation of swallowing (FEES) is the most useful diagnostic test for the evaluation of dysphagia, it cannot evaluate the esophageal phase of swallowing. To evaluate if a modification for the FEES exam by swallowing an empty capsule and screening of the upper esophagus could be used for early detection of esophageal dysphagia. A prospective, single-center, pilot study. At the end of a standard FEES exam, the patients were asked to swallow an empty capsule. Fifteen seconds later, the endoscope was inserted into the upper esophagus. A pathological capsule test was defined when the capsule was seen in the esophagus. In such cases, the patient was advised to undergo a gastroscopy, MBS, or esophageal manometry, which were compared to the results of the capsule test. The capsule test was utilized in 109 patients. A pathological capsule test was found in 55 patients (57.8%). In 48 patients (87.3%), an isolated or combined esophageal dysphagia was seen. The accuracy value of the capsule test compared to gastroenterology tests was 83.3%, sensitivity 88.46%, specificity 75%, PPV 85%, and NPV 80%. A modification of the standard FEES exam by including an empty capsule swallow test with an upper esophagus examination may provide a useful screening tool for esophageal dysphagia.
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  • 文章类型: Journal Article
    Omaveloxolone(SKYCLARYS®)被批准用于治疗美国和欧盟(EU)年龄≥16岁的患者的Friedreich共济失调(FA)。推荐剂量为150mg口服给药,每天一次,作为三个50mg胶囊。然而,部分FA患者可能出现口咽吞咽困难或吞咽困难;因此,需要替代的给药方法。一项针对32名健康志愿者的1期临床研究评估了相对生物利用度,安全,与以完整胶囊形式服用时相比,将胶囊内容物撒在苹果酱中并混合时,单剂量奥马维洛酮的耐受性。用问卷评估撒在苹果酱上并混合在苹果酱中的适口性。单次150毫克剂量后,无论采用何种给药方法,奥马维洛酮的峰值和总体暴露量都相似,最大血浆浓度(Cmax)的几何最小二乘平均值(%)的90%CI,AUC0-t,和AUC0-∞在80%至125%参考区间内。Omaveloxolone作为完整胶囊吸收更慢(中位tmax,10小时)与苹果酱上撒的胶囊内容物(中位数tmax,6h).长期每日服用奥美洛酮治疗FA,tmax的4小时差异被认为没有临床意义.苹果酱上撒的奥美洛酮胶囊内容物耐受性良好,适口性可接受,无严重不良事件。考虑到整个胶囊吞下时类似的全身暴露,将omaveloxolone胶囊内容物撒在苹果酱中并混合是一种可行的使用omaveloxolone的替代方法,并且已包含在美国和欧盟的处方信息中。
    Omaveloxolone (SKYCLARYS®) is approved for the treatment of Friedreich ataxia (FA) in patients aged ≥16 years in the United States and European Union (EU). The recommended dosage is 150 mg administered orally once daily as three 50-mg capsules. However, some patients with FA may have oropharyngeal dysphagia or difficulty swallowing whole capsules; therefore, alternate method(s) of administration are needed. A Phase 1 clinical study in 32 healthy volunteers evaluated the relative bioavailability, safety, and tolerability of a single dose of omaveloxolone when capsule contents were sprinkled on and mixed in applesauce compared to when taken as intact capsules. Palatability when sprinkled on and mixed in applesauce was assessed with a questionnaire. After a single 150-mg dose, the peak and overall exposures of omaveloxolone were similar irrespective of administration method, with the 90% CIs of the geometric least squares mean ratio (%) for maximum plasma concentration (Cmax), AUC0-t, and AUC0-∞ within the 80% to 125% reference intervals. Omaveloxolone was absorbed more slowly as intact capsules (median tmax, 10 h) compared with sprinkled capsule contents over applesauce (median tmax, 6 h). With chronic daily administration of omaveloxolone to treat FA, the 4-h difference in tmax is not considered clinically relevant. Sprinkled omaveloxolone capsule contents on applesauce were well tolerated, with acceptable palatability and no serious adverse events. Given the similar systemic exposure when capsules were swallowed whole, sprinkling omaveloxolone capsule contents on and mixing in applesauce is a feasible alternative method of administering omaveloxolone and has been included in both the United States and EU prescribing information.
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