Swallowing safety

  • 文章类型: English Abstract
    通过实验验证自行开发的热稳定增稠剂对标准浓度的肠内营养溶液的文字特征的影响及其在改善吞咽困难方面的适用性。
    不同剂量的自行研制的增稠剂(1.0g,1.5g,2.0g,2.5g,和3.0g)和三种常用的商业增稠剂与溶解在85mL纯净水中的23.391g完全营养配方粉混合,以制备100mL标准浓度的营养液。文本参数(凝聚力,粘度,厚度,和硬度)使用质地分析仪在各种温度梯度(20℃,40℃,60℃,和80℃)来比较它们的热稳定性。通过会厌切除术建立吞咽困难大鼠模型,以探讨增稠剂对肺组织损伤评分和炎症标志物水平的影响。将大鼠分为试验干预组,阳性对照组,阴性对照组,和空白对照组(禁食一天后不手术和正常进食),每组15只大鼠。手术后禁食一天,试验干预组饲喂标准浓度的营养液,用自行研制的增稠剂增稠,阳性对照组给予标准浓度的产品3增稠营养液,阴性对照组饲喂正常饮食。所有组均用食品级绿色染料染色的食物喂养两周。一般条件,体重,观察和记录食物摄入量。两周后,收集腹主动脉血液,和心,肝脏,脾,脾肺,取肾组织并称重,计算肺组织器官系数。使用常规H&E染色评估器官状况,并根据Mikawa评分标准对肺损伤进行半定量分析。收集血液上清液以测量总血清蛋白和白蛋白水平以确定大鼠的营养状况。RT-qPCR检测IL-6和TNF-α基因在肺组织中的表达。肺组织中IL-6和TNF-α蛋白表达水平,肺组织匀浆,用ELISA法测定血清。计算误吸发生率。
    在1.0g至3.0g的剂量范围内,与三种市售增稠剂相比,测试样品中自行开发的增稠剂在粘结性方面表现出优异的热稳定性,差异有统计学意义(P<0.01)。自行研制的增稠剂与三种市售增稠剂的粘度和硬度的热稳定性差异无统计学意义。自开发的增稠剂的粘度稳定性最佳,其次是市售增稠剂1和3,其中增稠剂2最不稳定,差异无统计学意义(P>0.05)。产品1在厚度方面表现出最佳的热稳定性,其次是自行开发的增稠剂和产品2,而产品3表现最差,差异有统计学意义(P<0.01)。自研制的增稠剂在20℃~80℃的温度范围内具有最佳的硬度热稳定性。其次是产品1和2,产品3最不稳定。然而,差异无统计学意义(P>0.05)。动物实验结果表明,阳性对照组和试验干预组的体重增加低于空白组和阴性对照组(P<0.01)。干预组的脾脏系数低于阳性对照组和空白对照组(P<0.01)。而心脏,肝脏,肾系数均低于空白对照组(P<0.01)。干预组与其他三组的肺系数差异无统计学意义。试验干预组TP和ALB水平,阳性对照组,阴性对照组均低于空白对照组,差异具有统计学意义(P<0.01)。ELISA结果显示,空白组和试验干预组血清IL-6水平均低于阴性组和阳性对照组(P<0.05)。其他指标在四组间差异无统计学意义(P>0.05)。四组肺组织损伤病理评分差异无统计学意义,或肺组织中IL-6和TNF-α基因表达水平。各组误吸发生率均为0%。
    自行开发的肠内营养增稠剂表现出优异的热稳定性和吞咽安全性。有必要进一步研究以探索其在吞咽困难患者中的应用。
    UNASSIGNED: To experimentally validate the effects of a self-developed heat-stable thickening agent on the textual characteristics of enteral nutrition solutions of standard concentration and its applicability in improving dysphagia.
    UNASSIGNED: A gradient of different doses of the self-developed thickening agent (1.0 g, 1.5 g, 2.0 g, 2.5 g, and3.0 g) and three commonly used commercial thickeners were mixed with 23.391 g of a complete nutrition formula powder dissolved in 85 mL of purified water to prepare 100 mL standard concentration nutrition solutions. The textual parameters (cohesiveness, viscosity, thickness, and hardness) of these nutrition solutions were measured using a texture analyzer at various temperature gradients (20 ℃, 40 ℃, 60 ℃, and 80 ℃) to compare their thermal stability. A dysphagia rat model was created via epiglottectomy to explore the effects of the thickener on lung tissue damage scores and levels of inflammatory markers. The rats were divided into a test intervention group, a positive control group, a negative control group, and a blank control group (no surgery and normal feeding after fasting for one day), with 15 rats in each group. After fasting for one day post-surgery, the test intervention group was fed with the standard concentration nutrition solution thickened with the self-developed thickener, while the positive control group was given a standard concentration nutrition solution thickened with product 3, and the negative control group was fed a normal diet. All groups were fed for two weeks with food dyed with food-grade green dye. General conditions, body mass, and food intake were observed and recorded. After two weeks, abdominal aorta blood was collected, and heart, liver, spleen, lung, and kidney tissues were harvested and weighed to calculate the lung tissue organ coefficient. The organ conditions were evaluated using routine H&E staining, and lung damage was semi-quantitatively analyzed based on the Mikawa scoring criteria. Blood supernatants were collected to measure the total serum protein and albumin levels to determine the nutritional status of the rats. The expression of IL-6 and TNF-α genes in lung tissues was measured by RT-qPCR. IL-6 and TNF-α protein expression levels in lung tissues, lung tissue homogenate, and serum were measured by ELISA. The aspiration incidence rate was calculated.
    UNASSIGNED: Within the dosage range of 1.0 g to 3.0 g, the self-developed thickener in the test samples exhibited superior thermal stability in cohesiveness compared to the three commercially available thickeners, with a statistically significant difference (P<0.01). The differences in the thermal stability of viscosity and hardness between the self-developed thickener and the three commercially available thickeners were not statistically significant. The viscosity stability was optimal for the self-developed thickener, followed by the commercially available thickeners 1 and 3, with thickeners 2 being the least stable, though the differences were not statistically significant (P>0.05). Product 1 showed the best thermal stability in thickness, followed by the self-developed thickener and product 2, while the product 3 exhibited the worst performance, with the difference being statistically significant (P<0.01). The self-developed thickener had the best thermal stability in hardness at temperatures ranging from 20℃ to 80 ℃, followed by products 1 and 2, with product 3 being the least stable. However, the differences were not statistically significant (P>0.05). Animal experiment results indicated that the body weight gain in the positive control group and the test intervention group was lower than that in the blank and negative control groups (P<0.01). The spleen coefficient of the intervention group was lower than that of the positive control group and the blank control group (P<0.01), while the heart, liver, and kidney coefficients were lower than those of the blank control group (P<0.01). The differences in the lung coefficient of the intervention group and those of the other three groups were no statistically significant. Levels of TP and ALB in the test intervention group, the positive control group, and the negative control group were all lower than those in the blank control group, with statistically significant differences (P<0.01). ELISA results showed that serum IL-6 levels in the blank and test intervention groups were lower than those in the negative and positive control groups (P<0.05), while the difference in the other indicators across the four groups were not statistically significant (P>0.05). There were no statistically significant differences among the four groups in terms of lung tissue damage pathology scores, or in the levels of IL-6 and TNF-α gene expression in lung tissues. The aspiration incidence rate was 0% in all groups.
    UNASSIGNED: The self-developed enteral nutrition thickening agent demonstrated excellent thermal stability and swallowing safety. Further research to explore its application in patients with dysphagia is warranted.
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  • 文章类型: Journal Article
    吞咽安全是痴呆症的首要健康问题之一。咳嗽和窒息(咳嗽/窒息)是吞咽安全性受损的迹象。这项研究旨在调查基于定期体育锻炼的吞咽干预在痴呆症日托中心减少咳嗽窒息的有效性。这是一个来自医疗记录数据的回顾性分析,包括年龄,临床痴呆等级(CDR),以及十天内咳嗽/窒息的频率(十天咳嗽/窒息)。那些遵守锻炼计划的人被分配到基于锻炼的组(n=22),那些不能服从的人被分配到非运动组(n=7).与基于运动的组相比,非基于运动的组显示出更高的年龄和更高的CDR(p<0.05)。10天咳嗽/窒息在基于运动的组中在5个月和19个月以及在基于非运动的组中在5个月时显示出显著减少(p<0.05)。我们的发现表明,定期进行基于体育锻炼的吞咽干预有效地缓解了老年痴呆症患者的咳嗽/窒息问题,其有效性是持久的。对于那些不能遵守锻炼计划的人,随着年龄的增长和痴呆症的增加,有效吞咽干预期为短期.
    Swallowing safety is one of the top health concerns of dementia. Coughing and choking (coughing/choking) are signs of impaired swallowing safety. This study aimed to investigate the effectiveness of regular physical exercise-based swallowing intervention for reducing coughing-choking at the dementia day-care center. This was a retrospective analysis with data from medical records, including age, the clinical dementia rating (CDR), and the frequencies of coughing/choking in ten days (10-day coughing/choking). Those who complied with the exercise programs were assigned to the exercise-based group (n = 22), and those who could not comply were assigned to the non-exercised-based group (n = 7). The non-exercised-based group showed more advanced age and higher CDR than the exercise-based group (p < 0.05). The 10-day coughing/choking showed significant decreases at the 5-month and 19-month in the exercise-based group and at the 5-month in the non-exercise-based group (p < 0.05). Our findings suggested that regular physical exercise-based swallowing intervention effectively alleviated coughing/choking problems of older adults with dementia and its effectiveness was long-lasting. For those who could not comply with exercise programs, noticeably with more advanced age and dementia, the effective swallowing intervention period was short-term.
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  • 文章类型: Journal Article
    目的:研究进食评估工具-10(EAT-10)在不同稠度下检测吞咽后残留和误吸的判别能力。
    方法:连续72例吞咽困难的混合病因患者(男42例,女30例,平均±sd年龄为60.42±15.82)。完成EAT-10后,进行了纤维内窥镜吞咽评估(FEES),以评估吞咽的效率和安全性,以满足以下稠度:稀薄液体,浓浓的花蜜,酸奶,和固体。虽然使用耶鲁咽部残留严重程度评定量表(YPRSRS)评估吞咽效率,采用渗透抽吸量表(PAS)评估吞咽安全性.
    结果:EAT-10问卷在以下一致性和解剖位置上显著识别了有残留物的患者和无残留物的患者:梨状窦中的稀薄液体残留物(截止分数≥10,p=0.009),谷粒中的花蜜浓稠残留物(截止分数≥15,p=0.001),谷中的酸奶残留物(截止分数≥15,p=0.009),梨状窦中的酸奶残留物(截止分数≥9,p=0.015),和谷中的固体残留物(截止分数≥13,p=0.016)。然而,没有发现EAT-10在检测任何一致性的误吸方面具有相同的判别能力.
    结论:EAT-10问卷可作为判断混合病因吞咽困难患者吞咽效率的评估工具,但吞咽安全的情况并不明显。
    OBJECTIVE: To investigate the discriminant ability of the eating assessment tool-10 (EAT-10) to detect postswallow residue and aspiration for different consistencies.
    METHODS: Seventy-two consecutive patients with mixed etiology of dysphagia (42 males and 30 females, mean ± sd age of 60.42 ± 15.82) were included. After completing the EAT-10, Fiberoptic Endoscopic Evaluation of Swallowing (FEES) was performed to assess the efficiency and safety of swallowing for the following consistencies: thin liquid, nectar thick, yogurt, and solid. While swallowing efficiency was evaluated using the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS), the Penetration-Aspiration Scale (PAS) was used to evaluate swallowing safety.
    RESULTS: The EAT-10 questionnaire significantly identified the patients with residue from those without residue for the following consistencies and anatomic locations: thin liquid residue in the pyriform sinus (cutoff score ≥ 10, p = 0.009), nectar thick residue in the vallecula (cutoff score ≥ 15, p = 0.001), yogurt residue in the vallecula (cutoff score ≥ 15, p = 0.009), yogurt residue in the pyriform sinus (cutoff score ≥ 9, p = 0.015), and solid residue in the vallecula (cutoff score ≥ 13, p = 0.016). However, the same discriminant ability of EAT-10 was not found for detecting aspiration in any consistency.
    CONCLUSIONS: The EAT-10 questionnaire can be used as an assessment tool to judge swallowing efficiency in patients with mixed etiology of dysphagia, but the same is not evident for swallowing safety.
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  • 文章类型: Journal Article
    口服药物治疗通常以固体口服剂型(SODF)的形式提供,其必须被吞咽并在整个口食管系统中移动。以前的研究提供了证据,表明SODF的口食管运输取决于它们的形状,尺寸,密度,和表面特征。为了评估食管转运过程中SODF表面涂层的影响,实施了体外系统来研究在人造粘液层的滑动性能。在这项工作中,使用人工粘液层系统评估了由不同的滑脱诱导剂与普通成膜剂组合组成的制剂。黄原胶(XG)和聚乙二醇1500(PEG)作为成膜剂,而巴西棕榈蜡(CW),卵磷脂(LE),角叉菜胶(CA),结冷胶(GG)和海藻酸钠(SA),以及它们与十二烷基硫酸钠(SLS)的组合,作为滑溜诱导成分应用。与阴性对照(未涂覆的圆盘,C,F0),而只有基于CW/SLS的配方在动态摩擦(DF)方面表现出与F0相似的性能。所应用的多变量分析方法允许对评估进行更高水平的细节,并支持更好地鉴定预测改善体内吞咽安全性的赋形剂和相应浓度。
    Oral drug therapy is generally provided in the form of solid oral dosage forms (SODF) that have to be swallowed and move throughout the oro-esophageal system. Previous studies have provided evidence that the oro-esophageal transit of SODF depends on their shape, size, density, and surface characteristics. To estimate the impact of SODF surface coatings during esophageal transit, an in vitro system was implemented to investigate the gliding performance across an artificial mucous layer. In this work, formulations comprised of different slippery-inducing agents combined with a common film forming agent were evaluated using the artificial mucous layer system. Xanthan gum (XG) and polyethylene glycol 1500 (PEG) were applied as film-forming agents, while carnauba wax (CW), lecithin (LE), carrageenan (CA), gellan gum (GG) and sodium alginate (SA), and their combination with sodium lauryl sulfate (SLS), were applied as slippery-inducing components. All tested formulations presented lower static friction (SF) as compared to the negative control (uncoated disc, C, F0), whereas only CW/SLS-based formulations showed similar performance to F0 regarding dynamic friction (DF). The applied multivariate analysis approach allowed a higher level of detail to the evaluation and supported a better identification of excipients and respective concentrations that are predicted to improve in vivo swallowing safety.
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  • 文章类型: Journal Article
    口服药物递送技术主要以固体口服剂型(SODF)的形式提供,所述固体口服剂型必须完整地吞咽并在整个口食管系统中移动以在胃或肠道中释放药物内容物。随着越来越多的证据表明在某些疾病中吞咽功能受损的患病率增加,多发病率和高龄,预测SODF的口食管滑翔行为的体外方法将非常有用。使用通用的体外滑翔系统研究了不同SODF聚合物膜在人造粘液层中的滑翔性能。在第一阶段,当与粘蛋白层接触时,系统测量移动聚合物表面所需的力,在第二阶段,在定义的长度上的电阻行为。获得的结果表明,根据所测试的聚合物膜,可以获得全面的滑行曲线。巴西棕榈蜡和PEG涂层需要较低的滑动峰值力,并且显示出较差的抗滑动性,这表明了自由滑行的能力。相比之下,HPMC,PVP和明胶涂层需要较高的滑动力,并由于与人造粘液层的粘附相互作用而表现出更大的阻力。在粘膜上的聚合物滑动评估期间,获得的曲线与先前的体外数据相关。
    Oral drug delivery technology is mainly provided in the form of solid oral dosage forms (SODF) that have to be swallowed intact and move throughout the oro-esophageal system to release the drug content in the stomach or intestine. As there is growing evidence for an increasing prevalence of impaired swallowing functions in certain diseases, multimorbidity and advanced age, predictive in vitro methods for the oro-esophageal gliding behavior of SODF would be very useful. The gliding performance of different SODF polymer films was investigated across an artificial mucous layer using a versatile in vitro gliding system. In a first phase, the system measures the force required to move the polymer surface when placed in contact with the mucin layer and, in a second phase, the resistance behavior over a defined length. The obtained results showed that comprehensive gliding profiles could be obtained depending on the polymer film tested. The carnauba wax and PEG coatings required lower gliding peak forces and showed poor gliding resistance, which is indicative of free gliding capacity. In contrast, HPMC, PVP and gelatin coatings required higher gliding forces and exhibited greater resistance due to an adhesive interaction with the artificial mucous layer. The obtained profiles correlate with prior in vitro data during polymer gliding evaluations on mucosal membranes.
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  • 文章类型: Journal Article
    Predicting the potential for unintended adhesion of solid oral dosage forms (SODF) to mucosal tissue is an important aspect that should be considered during drug product development. Previous investigations into low strength mucoadhesion based on particle interactions methods provided evidence that rheological measurements could be used to obtain valid predictions for the development of SODF coatings that can be safely swallowed. The aim of this second work was to estimate the low mucoadhesive strength properties of different polymers using in vitro methods based on mechanical forces and to identify which methods are more precise when measuring reduced mucoadhesion. Another aim was to compare the obtained results to the ones achieved with in vitro particle interaction methods in order to evaluate which methodology can provide stronger predictions. The combined results correlate between particle interaction methods and mechanical force measurements. The polyethylene glycol grades (PEG) and carnauba wax showed the lowest adhesive potential and are predicted to support safe swallowing. Hydroxypropyl methylcellulose (HPMC) along with high molecular grades of polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA) exhibited strong in vitro mucoadhesive strength. The combination of rheological and force tensiometer measurements should be considered when assessing the reduced mucoadhesion of polymer coatings to support safe swallowing of SODF.
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  • 文章类型: Journal Article
    固体口服剂型(SODF)是物理学家在初级和次级护理中通常开出的药物载体,因为它们对患者最方便,便于治疗管理。关于SODF在口食管转运过程中意外粘连的担忧仍然存在,尤其是在多患患者中,卧床不起的病人和吞咽困难的病人。因此,在SODF的开发过程中应该考虑这个因素,考虑到吞咽问题的患者,应更多地注意适当的表面条件的设计。这项工作的目的是估计涂层技术中常用的不同药物聚合物的低粘膜粘附强度,因为这种特性被认为对口食管转运过程中SODF的粘膜粘附特性有影响。在使用基于粒子相互作用的体外方法的方法中,聚乙二醇等级(PEG)显示出最低的相互作用力,表明比羟丙基甲基纤维素(HPMC)更有利的体内性能,被发现具有最高的粒子相互作用。应优选具有较低浓度的聚合物和低分子量等级的涂料配方。此外,当针对不良粘膜粘附聚合物时,应采用流变测量。
    Solid oral dosage forms (SODF) are drug vehicles commonly prescribed by physicists in primary and secondary cares, as they are the most convenient for the patient and facilitate therapy management. Concerns regarding unintended adhesion of SODF during oro-esophageal transit remain, especially in multimorbid patients, bedridden patients and patients suffering from dysphagia. Hence, this factor should be considered during the development of SODF, and more attention should be given on the design of appropriate surface conditions considering patients with swallowing problems. The aim of this work was to estimate the low mucoadhesion strength of different pharmaceutical polymers frequently used in coating technologies, since this property is thought to have impact on the mucoadhesive profile of SODF during oro-esophageal transit. In an approach using in vitro methods based on particle interactions, polyethylene glycol grades (PEG) showed the lowest interaction forces suggesting a more favorable in vivo performance than hydroxypropyl methylcellulose (HPMC), which was found to have the highest particle interaction. Preference should be given to coating formulations with lower concentrations of polymer and grades with low molecular weight. In addition, rheological measurements should be adopted when targeting poor mucoadhesive polymers.
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  • 文章类型: Journal Article
    Expiratory muscle strength training (EMST) is efficacious for improving maximum expiratory pressure (MEP), cough function, and swallowing safety in Parkinson disease (PD). However, there are no published reports describing detraining effects following EMST in persons with PD. Moreover, there are no published reports describing detraining effects following any behavioral swallowing intervention. Ten participants with PD underwent 3 mo of detraining following EMST. Measures of MEP and swallowing safety were made prior to beginning EMST (baseline), posttreatment (predetraining), and 3 mo postdetraining. Participants demonstrated, on average, a 19% improvement in MEP from pre- to post-EMST. Following the 3 mo detraining period, MEP declined by 2% yet remained 17% above the baseline value. No statistically significant changes were found in swallowing safety from post-EMST to postdetraining period. Following the 3 mo detraining period, seven participants demonstrated no change in swallowing safety, one worsened, and two had improvements. This preliminary study highlights the need for the design of maintenance programs to sustain function following intensive periods of training.
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