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1.
Artículo en Inglés | MEDLINE | ID: mdl-38963157

RESUMEN

The fundamental function of an optimal cervical pillow is to provide sufficient support to maintain normal spinal alignment and minimize biological stress on the contact surface throughout sleep. The recent advancements in cervical pillows have mainly focused on the subjective and objective evaluations of support comfort, as well as the relationship between pillow height and cervical vertebrae posture. However, only a few studies have addressed shape design guidelines and mechanical performances of the pillows themselves. In this study, a two-sectional contour cervical pillow comprising an arc and a Bezier curve is designed to support the head and neck. The design of the arc-shaped neck section incorporates the Cobb's angle and Borden value from healthy individuals to reflect the consistency of normal cervical anatomical features. The Bezier curve-based head section takes the head length and neck depth into account as significant individual differences. Static analysis and lattice optimization are performed in ANSYS Workbench to develop a variable-density cellular structure, aimed at improving air permeability and reducing the risk of pressure ulcers associated with the cervical pillow. The rapid prototyping technique fused deposition modeling (FDM) and thermoplastic material polylactic acid (PLA) are employed for fabricating different cellular structures. The results demonstrate that the neck section experiences less stress and greater deformation in comparison to the head section, indicating good comfort and support provided by the designed cervical pillow. Additionally, the compressive, bending, and cushion properties of the 3D-printed cervical pillow with variable-density cellular structure are experimentally validated, further confirming its effectiveness.

2.
Clin Nucl Med ; 2024 Jul 04.
Artículo en Inglés | MEDLINE | ID: mdl-38968578

RESUMEN

ABSTRACT: Benign metastasizing leiomyoma (BML) is a rare disease associated with pelvic leiomyoma. We report 18F-FDG and 68Ga-FAPI PET/CT findings in a 51-year-old woman with multiple BMLs. The mass in the abdominopelvic cavity and other metastatic lesions showed highly increased 68Ga-FAPI uptake, whereas uptake of 18F-FDG in those lesions was low. Our report demonstrates that 68Ga-FAPI PET/CT showed a different result in detecting BML to 18F-FDG PET/CT, and 68Ga-FAPI PET/CT may be a promising method for whole-body evaluate metastases.

3.
Cureus ; 16(6): e61932, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38978901

RESUMEN

This case report details a rare instance of gallbladder diverticulum, highlighting the diagnostic and therapeutic challenges associated with this condition. Gallbladder diverticulum is an uncommon anomaly that often mimics the symptoms of more prevalent gallbladder diseases, making an accurate diagnosis challenging. The patient, a 55-year-old female, presented with atypical abdominal pain and was initially suspected to have chronic cholecystitis. Ultrasound examinations and subsequent enhanced computed tomography imaging revealed a gallbladder diverticulum without the presence of gallstones or polyps. Given the rarity of this condition and the potential for complications, a laparoscopic cholecystectomy was performed. The surgery was successful, and the patient's symptoms were completely resolved postoperatively, confirming the diagnosis. This report underscores the importance of considering gallbladder diverticulum in the differential diagnosis for atypical gallbladder symptoms and advocates for prompt surgical intervention to prevent complications. Our findings contribute to the limited literature on this rare condition and emphasize the need for awareness among clinicians to achieve optimal patient outcomes.

4.
Small ; : e2403835, 2024 Jul 10.
Artículo en Inglés | MEDLINE | ID: mdl-38984921

RESUMEN

Bone regeneration is a well-orchestrated process synergistically involving inflammation, angiogenesis, and osteogenesis. Therefore, an effective bone graft should be designed to target multiple molecular events and biological demands during the bone healing process. In this study, a biodegradable gelatin methacryloyl (GelMA)-based Janus microsphere delivery system containing calcium phosphate oligomer (CPO) and bone morphogenetic protein-2 (BMP-2) is developed based on natural biological events. The exceptional adjustability of GelMA facilitates the controlled release and on-demand application of biomolecules, and optimized delivery profiles of CPO and BMP-2 are explored. The sustained release of CPO during the initial healing stages contributes to early immunomodulation and promotes mineralization in the late stage. Meanwhile, the administration of BMP-2 at a relatively high concentration within the therapeutic range enhances the osteoinductive property. This delivery system, with fine-tuned release patterns, induces M2 macrophage polarization and creates a conducive immuno-microenvironment, which in turn facilitates effective bone regeneration in vivo. Collectively, this study proposes a bottom-up concept, aiming to develop a user-friendly and easily controlled delivery system targeting individual biological events, which may offer a new perspective on developing function-optimized biomaterials for clinical use.

5.
Aging Med (Milton) ; 7(3): 334-340, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38975312

RESUMEN

Objective: Sarcopenia is a geriatric syndrome that occurs with age and is characterized by a gradual decline in muscle mass, power, and functionality. It serves as a prominent contributor to frailty, disability, and mortality among older individuals. Currently, no standardized global guidelines exist for the diagnosis of sarcopenia. This study aimed to establish the correlation between sarcopenia and the constitutions of traditional Chinese medicine (TCM), considering the connection between physical functioning and sarcopenia. Methods: A total of 1441 participants in this study were diagnosed with sarcopenia. The Asian Working Group for Sarcopenia (AWGS) proposed a sarcopenia definition algorithm. To determine the constitution of each participant, classification and determination standards were used in traditional Chinese medicine. This study evaluated the demographics, lifestyles, and self-reported medical history of individuals diagnosed with sarcopenia through a self-administered questionnaire. The constitution of the participants was determined using TCM classification and determination standards. Subsequently, we analyzed the results of univariate analysis and multivariate regression and constructed a receiver operating characteristic (ROC) curve. Results: Participants who were diagnosed with sarcopenia had substantially lower original Neutral constitution scores (P < 0.050). In comparison to those without sarcopenia, individuals with sarcopenia exhibited notably elevated original Qi-deficiency, Yang-deficiency, Yin-deficiency, Blood-stagnation, and Qi-stagnation scores in contrast to those in the healthy group (P < 0.050). The identified risk factors associated with sarcopenia included the following: Neutral (OR = 0.903), Qi-deficiency (in males, OR = 1.126), Yang-deficiency (OR = 1.062), Phlegm-dampness (in males, OR = 0.833), and Blood-stagnation (in females, OR = 1.089). The highest area under the curve (AUC) was observed for the original neutral constitution score, followed by the Yang-deficiency and blood-stagnation scores (0.644, 0.613, and 0.611, respectively). Additionally, the AUC for the combined original scores of all nine constitutions among males reached 0.778. Conclusions: In this cross-sectional study of older people with higher original Qi-deficiency, Yin deficiency, Yang-deficiency, Blood-stagnation, and Qi-stagnation were associated with sarcopenia. Notably, various TCM constitutions are significantly linked to sarcopenia. There was a significant occurrence of various body constitution types among individuals diagnosed with sarcopenia. The mixture of the nine original constitution scores exhibited good diagnostic performance for sarcopenia in males.

6.
J Med Chem ; 2024 Jul 12.
Artículo en Inglés | MEDLINE | ID: mdl-38996002

RESUMEN

Targeting Ca2+/calmodulin-dependent protein kinase γ (CaMKIIγ) in macrophages using RNAi nanotechnology represents an innovative and promising strategy in the diagnosis and treatment of atherosclerosis. Nevertheless, it remains elusive because of the current challenges associated with the systemic delivery of siRNA nanoparticle (NP) to atheromatous plaques and the complexity of atherosclerotic plaques. Here, we demonstrate the potential of a thienothiadiazole-based near-infrared-II (NIR-II) organic aggregation-induced emission (AIE) platform encapsulated with the Camk2g siRNA to effectively target CaMKIIγ in macrophages for dynamic imaging and image-guided gene therapy of atherosclerosis. The nanoparticles effectively decreased CaMKIIγ expression and increased the expression of the efferocytosis receptor MerTK in plaque macrophages, leading to a reduction in the necrotic core area of the lesion in an aortic plaque model. Our theranostic approach highlights the substantial promise of near-infrared II (NIR-II) AIEgens for imaging and image-guided therapy of atherosclerosis.

8.
iScience ; 27(7): 110150, 2024 Jul 19.
Artículo en Inglés | MEDLINE | ID: mdl-39040065

RESUMEN

Targeting the stimulator of interferon genes (STING) pathway is a promising strategy to overcome primary resistance to immune checkpoint inhibitors in non-small cell lung cancer with the STK11 mutation. We previously found metformin enhances the STING pathway and thus promotes immune response. However, its low concentration in tumors limits its clinical use. Here, we constructed high-mesoporous Mn-based nanocarrier loading metformin nanoparticles (Mn-MSN@Met-M NPs) that actively target tumors and respond to release higher concentration of Mn2+ ions and metformin. The NPs significantly enhanced the T cells to kill lung cancer cells with the STK11 mutant. The mechanism shows that enhanced STING pathway activation promotes STING, TBKI, and IRF3 phosphorylation through Mn2+ ions and metformin release from NPs, thus boosting type I interferon production. In vivo, NPs in combination with a PD-1 inhibitor effectively decreased tumor growth. Collectively, we developed a Mn-MSN@Met-M nanoactivator to intensify immune activation for potential cancer immunotherapy.

9.
Front Pharmacol ; 15: 1416010, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39035987

RESUMEN

Background: With the remarkable effect of controlling the increase in drug costs by the first batch of National Key Monitoring and Rational Use Drugs (first NKMRUDs), the National Health Commission of the People's Republic of China releases the second NKMRUDs to further strengthen the reasonable use of drugs. Unfortunately, the second NKMRUDs include some drugs of National Volume-based Procurement and National Essential Medicines, which challenges the management of pharmaceutical affairs on the three kinds of drugs. Objective: The main objective of this study was to investigate the prevalence of the second NKMRUDs and explore their monitoring indicators. Methods: An adapted WHO methodology for point prevalence surveys was conducted for the second NKMRUDs. For the monitoring indicators, we sought to explore whether the defined daily dose (DDD) and days of therapy (DOT) can be suitable for the second NKMRUDs through comparing differences between DDD and DOT with the prescribed daily dose (PDD). Results: Among the 935 included patients, 29.20% of the patients received at least one of the second NKMRUDs. A total of 273 patients were administered with 487 times of the second NKMRUDs. Among them, 162 , 62 , and 49 patients were receiving one, two, and three or more agents, respectively. The most commonly prescribed second NKMRUDs were compound amino acids, budesonide, and ceftazidime. The total DDDs and DOTs of the second NKMRUDs were 3360.68 and 1819.80, respectively, with the PDDs of 1865.26. The deviations (80.17%) of DDDs from PDDs were significantly greater than those (-2.44%) of DOTs. Conclusion: The prevalence of the second NKMRUDs was obtained by using the adapted PPS methodology at a tertiary university hospital. The DOT indicator is found to more accurately reflect actual consumption than the DDD indicator for second NKMRUDs. It is recommended to use the DOT indicator to monitor second NKMRUDs.

10.
Front Plant Sci ; 15: 1415006, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39036354

RESUMEN

This study addresses the challenges of low detection precision and limited generalization across various ripeness levels and varieties for large non-green-ripe citrus fruits in complex scenarios. We present a high-precision and lightweight model, YOLOC-tiny, built upon YOLOv7, which utilizes EfficientNet-B0 as the feature extraction backbone network. To augment sensing capabilities and improve detection accuracy, we embed a spatial and channel composite attention mechanism, the convolutional block attention module (CBAM), into the head's efficient aggregation network. Additionally, we introduce an adaptive and complete intersection over union regression loss function, designed by integrating the phenotypic features of large non-green-ripe citrus, to mitigate the impact of data noise and efficiently calculate detection loss. Finally, a layer-based adaptive magnitude pruning strategy is employed to further eliminate redundant connections and parameters in the model. Targeting three types of citrus widely planted in Sichuan Province-navel orange, Ehime Jelly orange, and Harumi tangerine-YOLOC-tiny achieves an impressive mean average precision (mAP) of 83.0%, surpassing most other state-of-the-art (SOTA) detectors in the same class. Compared with YOLOv7 and YOLOv8x, its mAP improved by 1.7% and 1.9%, respectively, with a parameter count of only 4.2M. In picking robot deployment applications, YOLOC-tiny attains an accuracy of 92.8% at a rate of 59 frames per second. This study provides a theoretical foundation and technical reference for upgrading and optimizing low-computing-power ground-based robots, such as those used for fruit picking and orchard inspection.

11.
Artículo en Inglés | MEDLINE | ID: mdl-39039380

RESUMEN

The value of cardiovascular magnetic resonance (CMR) in assessing and predicting acute right ventricular (RV) dysfunction in patients with anterior ST-segment elevation myocardial infarction (STEMI) remains ascertained. Eighty eight patients with anterior STEMI were prospectively recruited and underwent CMR examinations within one week following the coronary intervention. Patients with RV ejection fraction (RVEF) less than 2 standard deviations below the average at the center (RVEF ≤ 45.0%) were defined as having RV dysfunction. The size of infarction, segmental wall motion, and T1 and T2 mapping values of global myocardium and the interventricular septum (IVS) were measured. Predictive performance was calculated using receiver-operating characteristic curve analysis and logistic regression test. Twenty two patients presented with RV dysfunction. The RV dysfunction group had a larger IVS infarct extent (54.28 ± 10.35 vs 33.95 ± 15.09%, P < 0.001) and lower left ventricle stroke volume index (33.93 ± 7.96 vs 42.46 ± 8.14 ml/m2, P < 0.001) compared to the non-RV dysfunction group. IVS infarct extent at 48.8% best predicted the presence of RV dysfunction with an area under the curve of 0.864. Left ventricular stroke volume index (LVSVI) and IVS infarct extent were selected by stepwise multivariable logistic regression analysis. Lower LVSVI (odds ratio [OR] 0.90; 95% confidence interval [CI], 0.79 to 0.99; P = 0.044) and higher IVS infarct extent (OR 1.16; 95% CI 1.05 to 1.33; P = 0.01) were found to be independent predictors for RV dysfunction. In patients with anterior STEMI, those with larger IVS infarct extent and worse LV function are more likely to be associated with RV dysfunction.

12.
Animals (Basel) ; 14(13)2024 Jun 27.
Artículo en Inglés | MEDLINE | ID: mdl-38998005

RESUMEN

Egg production traits are crucial in the poultry industry, including age at first egg (AFE), egg number (EN) at different stages, and laying rate (LR). Ducks exhibit higher egg production capacity than other poultry species, but the genetic mechanisms are still poorly understood. In this study, we collected egg-laying data of 618 Peking ducks from 22 to 66 weeks of age and genotyped them by whole-genome resequencing. Genetic parameters were calculated based on SNPs, and a genome-wide association study (GWAS) was performed for these traits. The SNP-based heritability of egg production traits ranged from 0.09 to 0.54. The GWAS identified nine significant SNP loci associated with AFE and egg number from 22 to 66 weeks. These loci showed that the corresponding alleles were positively correlated with a decrease in the traits. Moreover, three potential candidate genes (ENSAPLG00020011445, ENSAPLG00020012564, TMEM260) were identified. Functional enrichment analyses suggest that specific immune responses may have a critical impact on egg production capacity by influencing ovarian function and oocyte maturation processes. In conclusion, this study deepens the understanding of egg-laying genetics in Peking duck and provides a sound theoretical basis for future genetic improvement and genomic selection strategies in poultry.

13.
Cell Biosci ; 14(1): 90, 2024 Jul 06.
Artículo en Inglés | MEDLINE | ID: mdl-38971765

RESUMEN

Metabolic disorders are currently threatening public health worldwide. Discovering new targets and developing promising drugs will reduce the global metabolic-related disease burden. Metabolic disorders primarily consist of lipid and glucose metabolic disorders. Specifically, metabolic dysfunction-associated steatosis liver disease (MASLD) and alcohol-associated liver disease (ALD) are two representative lipid metabolism disorders, while diabetes mellitus is a typical glucose metabolism disorder. In this review, we aimed to summarize the new drug candidates with promising efficacy identified in clinical trials for these diseases. These drug candidates may provide alternatives for patients with metabolic disorders and advance the progress of drug discovery for the large disease burden.

14.
Environ Sci Pollut Res Int ; 31(32): 45310-45325, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38961022

RESUMEN

Soil-bentonite (S-B) barriers have been widely used for heavy metal pollution containment. This study conducted batch adsorption tests and diffusion-through tests to evaluate how ionic strength and bentonite ratio influence the migration of Cr(VI) in natural clay-bentonite mixtures. The test results indicated that the adsorption of Cr(VI) exhibited an obvious anion adsorption effect, the pH of the soil mixture increased with the addition of bentonite, resulting in a decrease in the positive surface charge. This change led to a decrease in Cr(VI) adsorption capacity, from 775.19 mg/kg for pure clay to 378 mg/kg for mixture samples with excessive bentonite. Furthermore, as the ionic strength increases from 0 to 0.1 M, the Cr(VI) adsorption capacity increases slightly due to the weakening of electrostatic repulsion on the clay particle surface, but the effective diffusion coefficient (De) increases by 21.97%. The compression of the diffusion double layer (DDL) under high ionic strength conditions enlarges the diffusion path and enhances the migration of Cr(VI) through the pore flow paths. Moreover, hydrated bentonite effectively fills the interaggregate pores of natural clay, thus creating narrower and more tortuous flow paths. However, excessive bentonite increases the pH value and pore volume, resulting in changes to the soil microstructure and disrupting the continuous skeleton of natural clay, which is unfavorable for Cr(VI) containment. Based on the study of the Cr(VI) contaminated site, a bentonite ratio of 2:10 is recommended for optimal natural performance of the natural clay-bentonite barrier.


Asunto(s)
Bentonita , Cromo , Arcilla , Contaminantes del Suelo , Suelo , Bentonita/química , Concentración Osmolar , Adsorción , Cromo/química , Suelo/química , Arcilla/química , Contaminantes del Suelo/química , Concentración de Iones de Hidrógeno
15.
IEEE Trans Cybern ; PP2024 Jul 17.
Artículo en Inglés | MEDLINE | ID: mdl-39018209

RESUMEN

The aim of this article is to investigate the stability of sampled-data systems (SDSs) by introducing a sawtooth-characteristic-based hierarchical integral inequality (SCBHII) and to obtain the maximum allowable sampling period that maintains the stability of the system. First, by associating the sawtooth characteristics of the input delay in SDSs with free matrices, an SCBHII is proposed; its accuracy improves as the hierarchy increases. Subsequently, a high-order two-sided looped-functional, which considers both the sampling multi-integral states and the sawtooth pattern, is introduced to cater to the aforementioned inequality. In addition, the system variables are augmented by sawtooth pattern-related terms, which eliminates the need for additional secondary processing when determining the negative-definiteness of derivatives with high-order terms. By combining the high-order two-sided looped-functional with the proposed SCBHII, a stability criterion for SDSs with reduced conservatism is achieved, presented in the form of linear matrix inequalities. The proposed inequality technique and the stability criterion are shown to be effective and superior through three numerical examples and a real-world simplified power market model.

16.
Insights Imaging ; 15(1): 177, 2024 Jul 18.
Artículo en Inglés | MEDLINE | ID: mdl-39020237

RESUMEN

OBJECTIVES: To develop an innovative magnetic resonance imaging (MRI)-based PUMCH (Peking Union Medical College Hospital) classification system aimed at standardising the diagnosis of congenital cervical malformations (CCMs) by identifying their distinctive MRI features. METHODS: Seventy-nine consecutive patients with CCM underwent pre-treatment pelvic MRI; three experienced gynaecological radiologists retrospectively analysed these images. Qualitative assessments included Rock et al's classification; PUMCH classification; haematometra; cervical signal features; ovarian endometriosis; haematosalpinx; and uterine, vaginal, urinary, and musculoskeletal malformations. Quantitative assessments involved the uterine volume, sagittal cervical length, and maximum ovarian cross-sectional area. The surgical treatment types were also recorded. Statistical methods were used to incorporate differences in clinical features and surgical methods into our classification. RESULTS: Morphologically, CCMs were categorised into three types: type I (53%) was characterised by the presence of a cervix with visible cervical canals; type II (23%) featured an existing cervix with concealed cervical canals; and type III (24%) indicated cervical aplasia, which involves a blind end in the lower part of the uterine corpus. Haematometra was significantly more prevalent in patients with type I CCM than in those with type II (p < 0.001). There were three cervical signal patterns: no signal (27%), no evident layer differentiation (21%), and multi-layer differentiation with haematocele (52%). Most patients (94%) had complete vaginal atresia. Type I CCM patients had a higher likelihood of regaining normal uterovaginal anatomy compared to types II and III. CONCLUSIONS: Our proposed PUMCH classification system has a high potential for enhancing the efficiency of clinical diagnosis among patients with CCM. CRITICAL RELEVANCE STATEMENT: The proposed new PUMCH classification promised to elevate the conventional diagnostic trajectory for congenital cervical malformations, offering a valuable framework to refine the selection and planning of surgical interventions, thereby enhancing overall clinical efficacy. KEY POINTS: Effective classification of congenital cervical malformations is desirable to optimise the diagnostic process. We presented a PUMCH classification of congenital cervical malformations using pelvic MRI. The new classification significantly aids clinical triage for congenital cervical malformations.

18.
Int J Cancer ; 2024 Jun 18.
Artículo en Inglés | MEDLINE | ID: mdl-38894502

RESUMEN

Epstein-Barr virus (EBV) is detected in nearly 100% of nonkeratinizing nasopharyngeal carcinoma (NPC) and EBV-based biomarkers are used for NPC screening in endemic regions. Immunoglobulin A (IgA) against EBV nuclear antigen 1 (EBNA1) and viral capsid antigen (VCA), and recently identified anti-BNLF2b antibodies have been shown to be the most effective screening tool; however, the screening efficacy still needs to be improved. This study developed a multiplex serological assay by testing IgA and immunoglobulin G (IgG) antibodies against representative EBV antigens that are highly transcribed in NPC and/or function crucially in viral reactivation, including BALFs, BNLF2a/b, LF1, LF2, and Zta (BZLF1). Among them, BNLF2b-IgG had the best performance distinguishing NPC patients from controls (area under the curve: 0.951, 95% confidence interval [CI]: 0.913-0.990). Antibodies to lytic antigens BALF2 and VCA were significantly higher in advanced-stage than in early-stage tumors; in contrast, antibodies to latent protein EBNA1 and early lytic antigen BNLF2b were not correlated with tumor progression. Accordingly, a novel strategy combining EBNA1-IgA and BNLF2b-IgG was proposed and validated improving the integrated discrimination by 15.8% (95% CI: 9.8%-21.7%, p < .0001) compared with the two-antibody method. Furthermore, we found EBV antibody profile in patients was more complicated compared with that in healthy carriers, in which stronger correlations between antibodies against different phases of antigens were observed. Overall, our serological assay indicated that aberrant latent infection of EBV in nasopharyngeal epithelial cells was probably a key step in NPC initiation, while more lytic protein expression might be involved in NPC progression.

19.
Sensors (Basel) ; 24(11)2024 May 24.
Artículo en Inglés | MEDLINE | ID: mdl-38894177

RESUMEN

Visual simultaneous localization and mapping (VSLAM) enhances the navigation of autonomous agents in unfamiliar environments by progressively constructing maps and estimating poses. However, conventional VSLAM pipelines often exhibited degraded performance in dynamic environments featuring mobile objects. Recent research in deep learning led to notable progress in semantic segmentation, which involves assigning semantic labels to image pixels. The integration of semantic segmentation into VSLAM can effectively differentiate between static and dynamic elements in intricate scenes. This paper provided a comprehensive comparative review on leveraging semantic segmentation to improve major components of VSLAM, including visual odometry, loop closure detection, and environmental mapping. Key principles and methods for both traditional VSLAM and deep semantic segmentation were introduced. This paper presented an overview and comparative analysis of the technical implementations of semantic integration across various modules of the VSLAM pipeline. Furthermore, it examined the features and potential use cases associated with the fusion of VSLAM and semantics. It was found that the existing VSLAM model continued to face challenges related to computational complexity. Promising future research directions were identified, including efficient model design, multimodal fusion, online adaptation, dynamic scene reconstruction, and end-to-end joint optimization. This review shed light on the emerging paradigm of semantic VSLAM and how deep learning-enabled semantic reasoning could unlock new capabilities for autonomous intelligent systems to operate reliably in the real world.

20.
Int J Antimicrob Agents ; 64(2): 107235, 2024 Jun 06.
Artículo en Inglés | MEDLINE | ID: mdl-38851462

RESUMEN

BACKGROUND: Nemonoxacin malate is a novel non-fluorinated quinolone for oral and intravenous (IV) administration. This phase 3, multicentre, randomised, double-blind, double-dummy, parallel-controlled clinical trial (NCT02205112) evaluated the efficacy and safety of IV nemonoxacin vs. levofloxacin for the treatment of community-acquired pneumonia (CAP) in adult patients. METHODS: Eligible patients were randomised to receive 500 mg nemonoxacin or levofloxacin via IV infusion, once daily for 7-14 days. The primary endpoint was the clinical cure rate at the test-of-cure (TOC) visit in the modified intent-to-treat (mITT) population. Secondary efficacy and safety were also compared between nemonoxacin and levofloxacin. RESULTS: Overall, 525 patients were randomised and treated with nemonoxacin (n = 349) or levofloxacin (n = 176). The clinical cure rate was 91.8% (279/304) for nemonoxacin and 85.7% (138/161) for levofloxacin in the mITT population (P > 0.05). The clinical efficacy of nemonoxacin was non-inferior to levofloxacin for treatment of CAP. Microbiological success rate with nemonoxacin was 88.8% (95/107) and with levofloxacin was 87.8% (43/49) (P > 0.05) at the TOC visit in the bacteriological mITT population. The incidence of drug-related adverse events (AEs) was 37.1% in the nemonoxacin group and 22.2% in the levofloxacin group. These AEs were mostly local reactions at the infusion site, nausea, elevated alanine aminotransferase/aspartate aminotransferase (ALT/AST), and QT interval prolongation. The nemonoxacin-related AEs were mostly mild and resolved after discontinuation of nemonoxacin. CONCLUSIONS: Nemonoxacin 500 mg IV once daily for 7-14 days is effective and safe and non-inferior to levofloxacin for treating CAP in adult patients.

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