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  • 文章类型: Journal Article
    心力衰竭(HF)继续影响全球人群,患病率不断增加。虽然HF的病理生理学非常复杂,自主神经系统的失调,就像交感神经活动增强一样,作为新疗法和HF的有吸引力的病理生理目标。已经发现神经激素激活的程度与症状的严重程度相关,功能能力下降,和死亡率。自主神经系统的神经调节旨在恢复交感神经系统和副交感神经系统之间的平衡。鉴于自主神经失调在HF的发展和进展中起主要作用,恢复这种平衡可能会对核心病理生理机制和各种HF综合征产生影响。自主调节已被提出作为旨在减少全身性炎症的潜在治疗策略。这种疗法,以药物和器械为基础的补充疗法可改善患者预后并降低疾病负担.目前,大多数专业协会都没有提供关于在HF中使用神经调节技术的明确建议。这些包括直接和间接的迷走神经刺激,脊髓刺激,压力反射激活疗法,颈动脉窦刺激,主动脉弓刺激,内脏神经调制,心肺神经刺激,去肾交感神经。在这次审查中,我们提供了HF神经调节的全面概述。
    Heart failure (HF) continues to impact the population globally with increasing prevalence. While the pathophysiology of HF is quite complex, the dysregulation of the autonomic nervous system, as evident in heightened sympathetic activity, serves as an attractive pathophysiological target for newer therapies and HF. The degree of neurohormonal activation has been found to correlate to the severity of symptoms, decline in functional capacity, and mortality. Neuromodulation of the autonomic nervous system aims to restore the balance between sympathetic nervous system and the parasympathetic nervous system. Given that autonomic dysregulation plays a major role in the development and progression of HF, restoring this balance may potentially have an impact on the core pathophysiological mechanisms and various HF syndromes. Autonomic modulation has been proposed as a potential therapeutic strategy aimed at reduction of systemic inflammation. Such therapies, complementary to drug and device-based therapies may lead to improved patient outcomes and reduce disease burden. Most professional societies currently do not provide a clear recommendation on the use of neuromodulation techniques in HF. These include direct and indirect vagal nerve stimulation, spinal cord stimulation, baroreflex activation therapy, carotid sinus stimulation, aortic arch stimulation, splanchnic nerve modulation, cardiopulmonary nerve stimulation, and renal sympathetic nerve denervation. In this review, we provide a comprehensive overview of neuromodulation in HF.
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  • 文章类型: Journal Article
    目的:管道Vantage栓塞装置(PVED)是一种新型的涂层分流器,具有减小的线径,可改善新内皮化和支架孔隙率。本系统综述基于现有文献评价PVED的安全性和有效性。
    方法:遵循系统评价和荟萃分析(PRISMA)指南的首选报告项目,使用PubMed进行了彻底的文献检索,EMBASE,还有Cochrane.随机效应模型用于计算治疗30天内主要神经系统并发症的估计值作为主要安全终点,≤1年完全闭塞率作为主要疗效终点。
    结果:六项单臂研究(5项回顾性研究,1个前瞻性),包括392例患者和439个动脉瘤(破裂的6.8%)。抗血小板治疗方案多种多样,但大多数采用双重抗血小板治疗.合并技术成功率为99.0%(95CI,98.0%-100%),每次手术平均植入1.2个装置。在17.0%(95CI,6.4-27.6%)中进行了球囊血管成形术,在28.0%(95CI,17.8-38.2%)中进行了辅助卷绕,这两个变量都有显著的异质性。主要神经系统并发症的汇总估计为3.5%(95CI,1.7%-5.2%),总缺血事件为4.1%(95%CI,1.6%-6.6%),出血性事件为1.0%(95%CI,0.0%-1.9%)。平均随访7个月,血管造影完全闭塞率为75.7%(95CI,70.7%-80.6%),支架内狭窄占8.1%(95CI,4.5%-11.8%)。
    结论:PVED的安全性和有效性似乎与竞争器械相当,与第一代分流器相比,并发症可能更少。需要长期和比较研究来进一步证实这些结果。
    OBJECTIVE: The Pipeline Vantage Embolization Device (PVED) is a novel coated flow diverter with reduced wire diameters to improve neoendothelialization and stent porosity. This systematic review evaluates the safety and efficacy of the PVED based on the current literature.
    METHODS: Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a thorough literature search was conducted using PubMed, EMBASE, and Cochrane. The random effects model was used to calculate estimates with major neurological complications within 30 days of treatment as the primary safety endpoint and ≤1-year complete occlusion rate as the primary efficacy endpoint.
    RESULTS: Six single-arm studies (5 retrospective, 1 prospective) with 392 patients and 439 aneurysms (6.8% ruptured) were included. Antiplatelet regimens varied, but dual antiplatelet therapy was administered in the majority. The pooled technical success rate was 99.0% (95%CI, 98.0%-100%) with an average of 1.2 devices implanted per procedure. Balloon angioplasty was performed in 17.0% (95%CI, 6.4-27.6%) and adjunctive coiling in 28.0% (95%CI, 17.8-38.2%), with significant heterogeneity for both variables. Pooled estimates for major neurological complications were 3.5% (95%CI, 1.7%-5.2%) with total ischemic events in 4.1% (95% CI, 1.6%-6.6%) and hemorrhagic events in 1.0% (95% CI, 0.0%-1.9%). The rate of complete angiographic occlusion was 75.7% (95%CI, 70.7%-80.6%) at a mean follow-up of 7 months, with in-stent stenoses in 8.1% (95%CI, 4.5%-11.8%).
    CONCLUSIONS: The safety and efficacy profile of the PVED appears comparable to competing devices, with potentially fewer complications than first-generation flow diverters. Long-term and comparative studies are needed to further confirm these results.
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  • 文章类型: Journal Article
    对患有先天性心脏病的婴儿进行门诊监测已被证明可以显着降低单心室人群的死亡率。尽管小型化生物传感器和电子产品的发展加速,以及对家庭监控设备日益增长的市场需求,与成人设备的开发相比,这些技术在婴儿和儿童中的应用显着延迟。本文旨在回顾儿科患者可用的监测技术和设备的现状,以描述技术与临床需求之间的差距,目的是发展临床和科学验证的儿科监测设备。
    Outpatient monitoring of infants with congenital heart disease has been shown to significantly reduce rates of mortality in the single ventricle population. Despite the accelerating development of miniaturized biosensors and electronics, and a growing market demand for at-home monitoring devices, the application of these technologies to infants and children is significantly delayed compared with the development of devices for adults. This article aims to review the current landscape of available monitoring technologies and devices for pediatric patients to describe the gap between technologies and clinical needs with the goal of progressing development of clinically and scientifically validated pediatric monitoring devices.
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  • 文章类型: Journal Article
    背景:在中风康复中,选择合适的辅助设备对患者至关重要。具体来说,设备的选择可以显著影响上肢的功能恢复,影响他们的整体活动或功能任务。
    目的:本文旨在全面分析和总结常用辅助器具对脑卒中患者上肢功能影响的随机对照试验(RCTs)的临床证据。
    方法:为了评估中风患者的辅助设备,我们在整个结果综合中定性地总结,比如治疗干预,强度,结果,和结果总结,并检查了偏见的风险,异质性,平均差异,95%置信区间,和I平方值。为了分析,我们使用了RoB2和RevMan5.4。
    结果:定性合成包括31项随机对照试验。随机化过程和结果报告显示最小的偏差,但是预期的干预措施存在偏见,缺失的结果数据带来了一些担忧。定量合成包括16个RCT。两组之间的Fugl-Meyer评估上肢功能(FMA-UE)评分存在显着差异,总平均差(95%置信区间)为2.40(0.21,4.60),异质性值为Tau2=0.32,卡方=8.22,自由度=8(p=0.41),对于FMA-UE,I2=3%,对总体效果的测试在慢性中风患者中产生Z=2.14(p=0.03)。然而,所有其他结局指标均无显著差异.
    结论:上肢机器人在改善上肢功能方面与常规治疗相比没有显著优势,慢性卒中患者的FMA-UE评分除外。FMA-UE的平均差异也低于最低重要差异。尽管如此,上肢机器人的使用可能有助于增强中风患者的功能,因为这些设备支持临床医生,并在特定时间范围内实现更多的运动重复。
    BACKGROUND: In stroke rehabilitation, the selection of appropriate assistive devices is of paramount importance for patients. Specifically, the choice of device can significantly influence the functional recovery of the upper limb, impacting their overall activities or functional tasks.
    OBJECTIVE: This review aimed to comprehensively analyze and summarize the clinical evidence from randomized controlled trials (RCTs) regarding the therapeutic effects of commonly used assistive devices on upper extremity function in patients with stroke.
    METHODS: To evaluate assistive devices for patients with stroke, we summarized qualitatively throughout synthesis of results, such as therapeutic intervention, intensity, outcome, and summary of results, and examined risk of bias, heterogeneity, mean difference, 95% confidence interval, and I-squared value. To analyze, we used RoB 2 and RevMan 5.4.
    RESULTS: The qualitative synthesis included 31 RCTs. The randomization process and the reporting of results showed minimal bias, but there were issues with bias from intended interventions, and missing outcome data presented some concerns. The quantitative synthesis included 16 RCTs. There was a significant difference in the Fugl-Meyer assessment-upper extremity functioning (FMA-UE) scores between the groups, with a total mean difference (95% confidence interval) of 2.40 (0.21, 4.60), heterogeneity values were Tau2 = 0.32, chi-square = 8.22, degrees of freedom = 8 (p = 0.41), and I2 = 3% for FMA-UE and the test for the overall effect produced Z = 2.14 (p = 0.03) in patients with chronic stroke. However, there was no significant difference in all other outcome measures.
    CONCLUSIONS: Upper-limb robots did not demonstrate significant superiority over conventional treatments in improving function of upper limbs, with the exception of FMA-UE scores for patients with chronic stroke. The mean difference of FMA-UE was also lower than minimally important difference. Nonetheless, the usage of upper-limb robots may contribute to enhanced function for patients with stroke, as those devices support clinicians and enable a greater number of movement repetitions within specific time frames.
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  • 文章类型: Journal Article
    目的:血流重定向腔内装置(FRED)是颅内动脉瘤的安全有效治疗选择。新型FREDX在未经修改的支架设计上具有抗血栓形成表面涂层(“X技术”)。这项双中心研究评估了FREDX的临床安全性和有效性,并将其与文献进行了比较。
    方法:对2020年至2023年连续治疗的患者的动脉瘤特征进行回顾性分析,手术细节和并发症,和血管造影结果。对FREDX临床试验的文献进行了小型回顾,并使用随机效应模型将结果汇总。
    结果:34例患者(平均年龄56岁)接受了34个动脉瘤的治疗。平均动脉瘤大小为7.7±5.0mm,7例(21%)破裂,6(18%)在先前的治疗后复发,11例(32.3%)位于后循环,和4(12.5%)具有非囊状形态。所有程序在技术上都是成功的,不需要球囊血管成形术。有1例(2.9%)症状性并发症(短暂性脑缺血发作),无手术发病率或死亡率。技术性无症状事件包括1例通过血栓切除术重新开放的手术支架闭塞和3例血管痉挛。平均随访时间为6个月时,完全和足够的闭塞率分别为68%(19/28)和89%(25/28)。分别。这项研究的结果与以前的FREDX研究相当。
    结论:结果表明FREDX具有足够的中期闭塞率,具有较高的可行性和手术安全性。需要长期和比较研究来评估FREDX的全部潜力。
    OBJECTIVE: The flow re-direction endoluminal device (FRED) is a safe and effective treatment option for intracranial aneurysms. The novel FRED X features an antithrombotic surface coating (\"X Technology\") on an otherwise unmodified stent design. This two-center study evaluates the clinical safety and efficacy of FRED X and compares it to the literature.
    METHODS: Consecutive patients treated between 2020 and 2023 were retrospectively reviewed for aneurysm characteristics, procedural details and complications, and angiographic outcomes. A mini-review of the literature for FRED X clinical trials was performed and results were pooled using a random effects model.
    RESULTS: Thirty-four patients (mean age 56 years) were treated for 34 aneurysms. The mean aneurysm size was 7.7 ± 5.0 mm, 7 (21%) were ruptured, 6 (18%) were recurrent after previous treatment, 11 (32.3%) were located in the posterior circulation, and 4 (12.5%) had non-saccular morphology. All procedures were technically successful and no balloon angioplasty was required. There was 1 (2.9%) symptomatic complication (a transient ischemic attack) and no procedural morbidity or mortality. Technical asymptomatic events included 1 procedural stent occlusion that was reopened with thrombectomy and 3 cases of vasospasm. Complete and adequate occlusion rates were 68% (19/28) and 89% (25/28) at a mean follow-up time of 6 months, respectively. The results of this study are comparable to previous FRED X studies.
    CONCLUSIONS: The results demonstrate a high feasibility and procedural safety of the FRED X with adequate mid-term occlusion rates. Long-term and comparative studies are needed to evaluate the full potential of the FRED X.
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  • 文章类型: Journal Article
    Endovascular electrode arrays provide a minimally invasive approach to access intracranial structures for neural recording and stimulation. These arrays are currently used as brain-computer interfaces (BCIs) and are deployed within the superior sagittal sinus (SSS), although cortical vein implantation could improve the quality and quantity of recorded signals. However, the anatomy of the superior cortical veins is heterogenous and poorly characterised. MEDLINE and Embase databases were systematically searched from inception to December 15, 2023 for studies describing the anatomy of the superior cortical veins. A total of 28 studies were included: 19 cross-sectional imaging studies, six cadaveric studies, one intraoperative anatomical study and one review. There was substantial variability in cortical vein diameter, length, confluence angle, and location relative to the underlying cortex. The mean number of SSS branches ranged from 11 to 45. The vein of Trolard was most often reported as the largest superior cortical vein, with a mean diameter ranging from 2.1 mm to 3.3 mm. The mean vein of Trolard was identified posterior to the central sulcus. One study found a significant age-related variability in cortical vein diameter and another identified myoendothelial sphincters at the base of the cortical veins. Cortical vein anatomical data are limited and inconsistent. The vein of Trolard is the largest tributary vein of the SSS; however, its relation to the underlying cortex is variable. Variability in cortical vein anatomy may necessitate individualized pre-procedural planning of training and neural decoding in endovascular BCI. Future focus on the relation to the underlying cortex, sulcal vessels, and vessel wall anatomy is required.
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  • 文章类型: Systematic Review
    背景:第一射线不稳定性(FRI),尤其是过度活动导致内侧纵向弓的结构框架塌陷,这降低了脚成为推进的刚性杠杆的能力,导致进行性足部畸形。早期发现FRI并及时干预有助于预防退行性足部畸形。各种手册,文献中已经描述了FRI定量的基于设备和射线照相诊断测试。我们的目标是进行最新的,全面,系统评价FRI诊断试验的文献报告。
    方法:电子数据库(Medline,Embase和PubMed)和参考书目清单一直搜索到2021年5月,以进行评估FRI诊断测试的研究。使用MeSH术语进行文献检索。作者筛选了所有产生的摘要。根据纳入和排除标准进一步全面评估选定的文章。对相关研究进行了定性评估,并根据测试分组为表格。
    结果:确定了18,176项研究。纳入了32篇全文供评估。根据评估标准排除了十篇文章。18项研究被纳入定性评估:两项研究描述了手动诊断测试,三个评估设备驱动的测试,六项图像引导研究和七项比较研究评估一项新测试与一项既定测试。
    结论:定义FRI的金标准测试需要改进。手动测试表现出显著的主观可变性。射线照相试验,虽然准确,执行复杂而繁琐,因此,没有广泛应用。与仪器相比,背侧标尺显示出混合的结果并显示出可变性。重点是评估外翻(HV)的FRI。需要更多的研究来调查缺乏HV的FRI。
    BACKGROUND: First Ray Instability (FRI) and especially hypermobility leads to the collapse of the medial longitudinal arch\'s structural framework, which reduces the foot\'s ability to become a rigid lever for propulsion, resulting in progressive foot deformities. Early detection of FRI with prompt intervention helps prevent degenerative foot deformities. Various manual, device-based and radiographic diagnostic tests for FRI quantification have been described in the literature. We aim to conduct an up-to-date, comprehensive, systematic review of the literature reporting on diagnostic tests to evaluate FRI.
    METHODS: Electronic databases (Medline, Embase and PubMed) and bibliography lists were searched until May 2021 for studies evaluating diagnostic tests for FRI. MeSH terms were used to conduct the literature search. The authors screened all produced abstracts. Selected articles were further assessed in full based on inclusion and exclusion criteria. The relevant studies were qualitatively assessed and grouped into tables based on tests.
    RESULTS: 18,176 studies were identified. Thirty-two full-text articles were included for assessment. Ten articles were excluded based on evaluation criteria. 18 studies were included for qualitative assessment: two studies describing manual diagnostic tests, three evaluating device-driven tests, six image-guided studies and seven comparison studies assessing a new test versus an established one.
    CONCLUSIONS: Gold standard tests in defining FRI need to be improved. Manual tests exhibit significant subjective variability. Radiographic tests, while accurate, are complex and cumbersome to perform and, therefore, are not widely applied. Dorsal rulers have demonstrated mixed results and shown variability when compared to instruments. The focus has been on assessing FRI in hallux valgus (HV). More studies are needed to investigate FRI in the absence of HV.
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  • 文章类型: Journal Article
    背景:这项研究的目的是评估与分流器(FD)治疗颅内动脉瘤(IA)相关的编织变化的总体比率。此外,我们试图提供目前报道的与这些并发症相关的定义的概述.
    方法:从相关文献开始到2023年4月进行了系统搜索,包括六个数据库。纳入的研究集中在用FDs治疗的IAs患者。我们考虑了FD编织变化的四个主要结果指标:(1)鱼嘴,(2)装置编织变窄,(3)装置编织塌陷,和(4)装置编织变形。这些研究的数据使用随机效应模型进行汇总。
    结果:共有48项研究纳入了3572例患者的分析。其中,14项研究(39%)提供了鱼嘴的定义。然而,纳入的研究都没有提供设备编织缩窄的具体定义,崩溃,或变形,尽管这些并发症的报告率为六个,五,和三项研究,分别。编织变化的汇总率如下:3%(95%CI2%至4%,I2=27%)用于鱼嘴,7%(95%CI2%至20%,I2=85%)用于缩小,1%(95%CI0%至3%,I2=0%)用于塌陷,和1%(95%CI1%至4%,I2=0%)为变形。
    结论:这项研究的结果表明,对IAs的FD治疗通常表现出较低的鱼嘴率,设备编织变窄,崩溃,和变形。然而,缺乏标准化定义阻碍了客观比较设备结果的能力,强调在未来FD的前瞻性研究中需要对FD编织变化进行统一定义。
    BACKGROUND: The aim of this study was to evaluate the overall rates of braid changes associated with flow diverter (FD) treatment for intracranial aneurysms (IAs). Additionally, we sought to provide an overview of the currently reported definitions related to these complications.
    METHODS: A systematic search was conducted from the inception of relevant literature up to April 2023, encompassing six databases. The included studies focused on patients with IAs treated with FDs. We considered four main outcome measures as FD braid changes: (1) fish-mouthing, (2) device braid narrowing, (3) device braid collapsing, and (4) device braid deformation. The data from these studies were pooled using a random-effects model.
    RESULTS: A total of 48 studies involving 3572 patients were included in the analysis. Among them, 14 studies (39%) provided definitions for fish-mouthing. However, none of the included studies offered specific definitions for device braid narrowing, collapsing, or deformation, despite reporting rates for these complications in six, five, and three studies, respectively. The pooled rates for braid changes were as follows: 3% (95% CI 2% to 4%, I2=27%) for fish-mouthing, 7% (95% CI 2% to 20%, I2=85%) for narrowing, 1% (95% CI 0% to 3%, I2=0%) for collapsing, and 1% (95% CI 1% to 4%, I2=0%) for deformation.
    CONCLUSIONS: The findings of this study suggest that FD treatment for IAs generally exhibits low rates of fish-mouthing, device braid narrowing, collapsing, and deformation. However, the lack of standardized definitions hinders the ability to compare device outcomes objectively, emphasizing the need for uniform definitions for FD braid changes in future prospective studies on FD.
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  • 文章类型: Journal Article
    大隐静脉移植物(SVG)是冠状动脉旁路移植术(CABG)中最常用的导管,但与动脉导管相比,它们的闭塞率更高仍然是一个问题。以前的研究表明,SVG衰竭主要是由内膜增生引起的,对动脉循环高压的适应性反应。VESTTM设备(血管移植解决方案,特拉维夫,以色列),旨在减轻SVG内膜增生的外部支架,已经在少数临床试验(RCTs)中进行了测试。在这里,我们描述性地评估了VEST装置上的随机证据.
    Saphenous vein grafts (SVGs) are the most frequently used conduits in coronary artery bypass grafting (CABG), but their higher rate of occlusion compared to arterial conduits remains a concern. Previous studies have shown that SVG failure is mainly driven by intimal hyperplasia, an adaptative response to higher pressures of the arterial circulation. The VESTTM device (Vascular Graft Solutions, Tel Aviv, Israel), an external support designed to mitigate intimal hyperplasia in SVGs, has been tested in few clinical trials (RCTs). Herein, we descriptively evaluated the randomized evidence on the VEST device.
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  • 文章类型: Journal Article
    结核病是由病原体引起的空气传播疾病,结核分枝杆菌,主要影响肺部。世界卫生组织(WHO)报告说,使用现有的6个月抗生素治疗方案,约有85%的结核病患者可以治愈。然而,长时间口服大剂量抗结核药物与显著的副作用相关,并导致耐药病例.或者,将现有的抗结核药物重新配制成可吸入的纳米颗粒系统是克服与口服治疗相关的挑战的有前景的策略,因为它们可以增强药物在肺部区域的滞留,从而在感染的肺部达到最佳的药物浓度.因此,这篇综述概述了用于提供抗结核药物的可吸入纳米制剂的文献,包括2000年至2020年之间的配方技术和临床前评估,通过GoogleScholar和PubMed等在线搜索引擎从电子期刊收集。先前的体外和体内研究强调,纳米尺寸,低毒性,和高疗效是影响纳米颗粒系统在肺部沉积后命运的因素之一。尽管许多临床前研究表明,当通过肺部途径递送时,可吸入纳米颗粒可提高治疗效果并最大程度地减少药物不良反应,迄今为止,他们都没有进入临床试验。这可归因于吸入方案的高成本,这是由于纳米颗粒的昂贵生产和表征以及与口服治疗相比需要吸入装置。另一个障碍可能是由于没有足够数量的受过训练的工作人员来教育患者正确使用吸入装置而导致缺乏医疗接受度。因此,应该令人满意地解决这些障碍,使吸入纳米颗粒方案成为结核病治疗的现实.
    Tuberculosis is an airborne disease caused by the pathogen, Mycobacterium tuberculosis, which predominantly affects the lungs. World Health Organization (WHO) has reported that about 85% of TB patients are cured with the existing 6-month antibiotic regimen. However, the lengthy oral administration of high-dose anti-TB drugs is associated with significant side effects and leads to drug resistance cases. Alternatively, reformulating existing anti-tubercular drugs into inhalable nanoparticulate systems is a promising strategy to overcome the challenges associated with oral treatment as they could enhance drug retention in the pulmonary region to achieve an optimal drug concentration in the infected lungs. Hence, this review provides an overview of the literature on inhalable nano-formulations for the delivery of anti-TB drugs, including their formulation techniques and preclinical evaluations between the years 2000 and 2020, gathered from electronic journals via online search engines such as Google Scholar and PubMed. Previous in vitro and in vivo studies highlighted that the nano-size, low toxicity, and high efficacy were among the factors influencing the fate of nanoparticulate system upon deposition in the lungs. Although many preclinical studies have shown that inhalable nanoparticles increased therapeutic efficacy and minimised adverse drug reactions when delivered through the pulmonary route, none of them has progressed into clinical trials to date. This could be attributed to the high cost of inhaled regimes due to the expensive production and characterisation of the nanoparticles as well as the need for an inhalation device as compared to the oral treatment. Another barrier could be the lack of medical acceptance due to insufficient number of trained staff to educate the patients on the correct usage of the inhalation device. Hence, these barriers should be addressed satisfactorily to make the inhaled nanoparticles regimen a reality for the treatment of TB.
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