Frontiers in Medical Technology最新文献

The evaluation of pharmaceutical innovation and therapeutic value is an increasingly complex exercise for which different approaches are adopted at the national level, despite the need for standardisation of processes and harmonisation of public health decisions. The objective of our analysis was to compare the approaches of the AIFA (Agenzia Italiana del Farmaco) and the HAS (Haute Autorité de Santé) in assessing the same medicinal products. In Italy, the 1525/2017 AIFA Deliberation introduces a transparent scheme for the evaluation of innovative status (innovative, conditional, not innovative) based on the therapeutic added value (TAV), therapeutic need, and quality of evidence. In contrast, in France, the HAS makes judgements using the effective clinical benefit (Service Médical Rendu) and improvement of effective clinical benefit (Amélioration du Service Médical Rendu, ASMR). This analysis focused on medicinal products evaluated both by the AIFA and by the HAS from July 2017 to September 2021. Similarities between AIFA and HAS evaluations were investigated in terms of the TAV, recognition of innovativeness, and the ASMR. Both total and partial agreements were considered relevant. Therefore, raw agreement, Cohen's kappa (weighted and unweighted), and Bangdiwala's B-statistic were estimated. A total of 102 medicinal products were included in this study. Out of these, 38 (37.2%) were orphan drugs, while 56 (54.9%) had a clinical indication for the treatment of cancer. The AIFA and HAS reached a higher level of agreement on the innovativeness status compared with the TAV. A moderate total agreement emerged in the recognition of innovativeness (k = 0.463, p-value ≤0.0001), and partial agreement was substantial (equal weight k = 0.547, squared k = 0.638), while a lack of agreement resulted in a comparison of the TAV according to the AIFA and the ASMR recognised by the HAS. Indeed, whereas the AIFA determined the TAV to be important, the HAS considered it to be moderate. In addition, whereas the AIFA identified a bias towards a moderate TAV, the HAS identified a bias towards a minor ASMR. A higher level of agreement was reached, both on the TAV and on innovative status, for less critical medical products (non-cancer-related, or non-orphan, or with a standard European Medicines Agency approval). These results underline the importance of implementing European procedures that are more broadly aligned in terms of value definition criteria.

Nanotechnology is the emerging and advance field of research for the diagnosis and treatment of various diseases. With the development of nanotechnology, different nanoparticles are used in the treatment of cancer due to their unique optical properties, excellent biocompatibility, surface effects, and small size effects. Nanoparticles are the particles which have the particular size from 1 to 100 nm. These nanoparticles are zero dimension, one dimension, two dimension and three dimension etc. In present scenario a variety of research is focused on the tailored synthesis of nanoparticles for medicinal applications that can be used for cancer treatment based on the morphology, composition, interaction with target cell. The gastrointestinal (GI) tumors are found one of the deadest cancer types with highest reoccurrence rates. The diagnosis and treatment of gastrointestinal cancer is very challenging due to its deep location and complicated surgery. Nanotechnology provides fast diagnosis and immediate treatment for the gastrointestinal disease. A variety of nanomaterials are used for the diagnosis and treatment of GI disease. Nanoparticles target directly to the tumor cell as diagnostic and therapeutic tools facilitating the identification and removal of tumor cells. A number of nanoparticles are developed for the uses are quantum dots (QDs), carbon nanotubes (CNTs), metallic nanoparticles (MNPs), Dendrimers etc. This review article gives an overview of the most promising nanomaterials used for the diagnosis and treatment of GI diseases. This review attempts to incorporate numerous uses for the most current nanomaterials, which have great potential for treating gastrointestinal diseases.

Background: Difficulty getting out of bed is a common night-time and early morning manifestation of Parkinson's disease (PD), rated by 40% of the patients as their most concerning motor symptoms. However, current assessment methods are based on clinical interviews, video analysis, and clinical scales as objective outcome measures are not yet available.

Objective: To study the technical feasibility of multisite wearable sensors in the assessment of the supine-to-stand (STS) task as a determinant of the ability to get out of bed in patients with PD and age-matched control subjects, and develop relevant objective outcome measures.

Methods: The STS task was assessed in 32 patients with PD (mean Hoehn and Yahr; HY = 2.5) in the early morning before their first dopaminergic medication, and in 14 control subjects, using multisite wearable sensors (NIGHT-Recorder®; trunk, both wrists, and both ankles) in a sleep laboratory. Objective getting out of bed parameters included duration, onset, velocity and acceleration of truncal rotation, and angle deviation (a°) from the z-axis when subjects rose from the bed at different angles from the x-axis (10°, 15°, 30°, 45°, and 60°) as measures of truncal lateral flexion. Movement patterns were identified from the first body part or parts that moved. Correlation analysis was performed between these objective outcomes and standard clinical rating scales.

Results: Compared to control subjects, the duration of STS was significantly longer in patients with PD (p = 0.012), which is associated with a significantly slower velocity of truncal rotation (p = 0.003). Moderate and significant correlations were observed between the mean STS duration and age, and the Nocturnal Hypokinesia Questionnaire. The velocity of truncal rotation negatively and significantly correlated with HY staging. Any arm and leg moved together as the first movement significantly correlated with UPDRS-Axial and item #28. Several other correlations were also observed.

Conclusion: Our study was able to demonstrate the technical feasibility of using multisite wearable sensors to quantitatively assess early objective outcome measures of the ability of patients with PD to get out of bed, which significantly correlated with axial severity scores, suggesting that axial impairment could be a contributing factor in difficulty getting out of bed. Future studies are needed to refine these outcome measures for use in therapeutic trials related to nocturia or early morning akinesia in PD.

In this paper, a conformal absorber metasurface has been designed and used for reducing the specific absorption rate (SAR) of an implantable antenna. SAR reduction of implantable antennas is one of the significant design aspects to be considered for their use in modern-day healthcare applications. The introduction of the absorber metasurface restricts the back radiation of the antenna to control the SAR value. This technique decreases the maximum SAR value by 24% and also reduces the average SAR distribution significantly without affecting the desired antenna gain. A reduction in SAR value indicates the decrease in radiation absorption by human tissue, and thus, decreases the possibility of health hazards due to EM radiation. Later, this antenna-absorber system is designed as a capsule module for increased mobility and less-invasiveness. The redundancy of invasive surgery increases acceptance of the capsule module designs of implantable antennas and devices for various biomedical usages. In vitro testing of the fabricated prototype has been carried out inside a multi-layer porcine slab to verify the effectiveness of this unique SAR reduction technique.

Breast cancer (BC) is the most common cancer affecting women worldwide, with over 2 million women diagnosed every year, and close to 8 million women currently alive following a diagnosis of BC in the last 5-years. The side effects such as chemodrug toxicity to healthy tissues and drug resistance severely affect the quality of life of BC patients. To overcome these limitations, many efforts have been made to develop nanomaterial-based drug delivery systems. Among these nanocarriers, lipid-based delivery platforms represented one of the most successful candidates for cancer therapy, improving the safety profile and therapeutic efficacy of encapsulated drugs. In this review we will mainly discuss and summarize the recent advances in such delivery systems for BC metastasis treatment, with a particular focus on targeting the common metastatic sites in bone, brain and lung. We will also provide our perspectives on lipid-based nanocarrier development for future clinical translation.

Aortic stenosis (AS) is a prevalent disease affecting 3.7% of the adult population aged 65 or above. In the past, surgical aortic valve replacement (SAVR) was the only definitive therapy available for the treatment of severe AS. Owing to the invasive nature of open-heart surgery, patients with advanced age and frailty could not benefit from SAVR. The advent of transcatheter aortic valve replacement (TAVR) in the past decade has offered an alternative treatment option for patients with severe AS, particularly those who are deemed to have high surgical risks. Nevertheless, a large proportion of patients also have concomitant peripheral arterial disease (PAD), which increases the risk of peri-procedural vascular complication, and precludes the possibility of transfemoral TAVR owing to inadequate luminal size for delivery system deployment. In this review, the prevalence and outcome of TAVR patients with PAD will be discussed. Furthermore, novel technologies and techniques that enable TAVR to be safely performed using transfemoral or alternative access in patients with severe PAD will be reviewed.

This pilot study aimed to evaluate a continuous glucose monitoring (CGM) based approach to study the effects of a functional drink containing specific amino acids and chromium picolinate (FD) and a combination of FD with a juice (FDJ) on postprandial glucose in a close to real life setting. The predefined primary endpoint for this study was the 120-min incremental area under the glucose curve (iAUC_0-120min ) after meals. It was estimated that using CGM and repeated meals in 6 participants could be sufficient to match the power of the previous study in regards to the quantity of meals. Participants followed a pre-specified meal schedule over 9 days and consumed the drinks three times daily with main meals. Differences between drinks were analyzed by analysis of covariances (ANCOVA) with subject number and activity as random factors and nutrient composition as covariates. In 156 meals available for analysis, a significant 34% reduction of glucose iAUC_0-120min was shown for FDJ (p < 0.001). FD did not show a significant effect on its own, but a significant reduction of 17.6% (p = 0.007) was shown in pooled data for FD and FDJ. While the differences between the two functional drinks used were not the primary focus of this study, it was sufficiently powered to detect previously described effects in 60 participants in a cross-over design under laboratory settings. The design presented defines a novel and cost-effective approach using CGM devices and app-based lifestyle tracking for studying nutritional effects on glucose at home in a close to real-life setting.

Aiming to address clinical requirements subsequent to SARS-CoV-2-related pulmonary disease, multiple research groups and industry groups carried out intensive studies to develop pandemic ventilators (PDVs). In vitro testing to critically evaluate the specific performance of the developed apparatuses is an essential requirement. This study presents a test protocol which promotes a test-oriented, iterative, and agile assessment and consecutive development of such PDVs. It allows for fast identification of specific characteristics of each PDV in the individual test features. The test protocol includes an evaluation of the accuracy of control systems and instruments at changing parameters, the oxygen dynamics, and the response to trigger signals. The test environment is a mechanical lung, which allows reproducing various lung mechanics and to simulate active breathing cycles. A total of three PDVs that are under development were iteratively tested, with a Hamilton T1 as a reference. Continuous testing of the PDVs under development enables quick identification of critical application aspects that deserve further improved. Based on the present test protocol, the ventilators demonstrate a promising performance justifying continued development.

Hypertension is one of the most prevalent chronic diseases that affects more than 20% of the adult population worldwide, but fortunately, most of their blood pressure can be effectively controlled via drug treatment. However, there still remains 5-30% of patients clinically who do not respond well to conventional medication, while the non-drug treatments currently existing are struggling with major drawbacks like irreversible nerve damage, huge side effects, and even non-effectiveness. In this study, based on the physiological regulation mechanism of blood pressure and state-of-the-art neuromodulation technique, we worked along with the vagus nerve stimulation scheme, developed, and explored whether and how a real-time neural recording and stimulation system could provide an insight into self-adaptive modulation in the blood pressure, in the hope to crack a crevice in the closed-loop treatment for resistant hypertension. Unlike traditional neuromodulation devices, additional signal recording and real-time wireless transmission functions are added to the same device to realize the features of a dynamic monitor and modulator. The system is tested both in vitro and in vivo, showing decent electrical performance of 8 kHz sampling rate and flexible stimulation outputs which sufficiently covers our needs in manipulating neural activities of interest. A relatively stable drop in the blood pressure resulting from stimulation was observed and specific patterns in the vagus nerve signals relating to blood pressure could also be primarily identified. This laid a solid foundation for further studies on the final realization of closed-loop automatic adjustment for resistive hypertension treatment.