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A new approach to the intelligent decision support system for individual hearing aid selection and acquisition. 个人助听器选择与获取智能决策支持系统的新方法。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-08-11 DOI: 10.1080/20565623.2025.2543175
Rolandas Drejeris, Saulius Vaitkus, Greta Minelgaite, Aurelija Kustiene, Egle Drejeriene

Background: The intelligent decision support system (IDSS) is designed for patients to acquire hearing aids that better meet their needs, because they often agree to pay from their funds for a better, more customized hearing aid.

Objective: The article aims to present the IDSS for selecting personal hearing aids in healthcare institutions.

Methods: The article proves that the SAW (simple additive waiting) multi-criteria evaluation method is the most suitable for creating the IDSS. Hearing aids are evaluated according to 12 reasonable criteria, which are differentiated into two groups. The proposed methodology is flexible, allowing for changing the significance of differentiated criteria groups.

Results: The created IDSS system helps increase the effectiveness of choosing the best hearing aid. Even 92% of the surveyed patients positively evaluated the choice of hearing aid. This situation indicates greater patient satisfaction than usual when selecting these measures.

Conclusion: The proposed IDSS is suitable for adaptation in a computer program, and such a solution greatly facilitates the selection of a hearing aid. Applying the proposed IDSS makes the choice more objective, thus better meeting patients' needs.

背景:智能决策支持系统(IDSS)是为患者获得更符合他们需求的助听器而设计的,因为他们经常同意从他们的资金中支付更好,更定制的助听器。目的:介绍医疗机构选配助听器的IDSS。方法:本文论证了SAW(简单加性等待)多准则评价方法最适合于创建IDSS。根据12个合理的标准对助听器进行评估,并将其分为两组。所建议的方法是灵活的,允许改变不同标准组的重要性。结果:建立的IDSS系统有助于提高选择最佳助听器的有效性。甚至有92%的受访患者对助听器的选择给予了积极的评价。这种情况表明,在选择这些措施时,患者的满意度比通常更高。结论:所提出的IDSS可在计算机程序中适配,大大方便了助听器的选择。应用所提出的IDSS使选择更加客观,从而更好地满足患者的需求。
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引用次数: 0
Spectrophotometric analysis of artesunate injections available in community pharmacies in Northern and Western Uganda. 乌干达北部和西部社区药房提供的青蒿琥酯注射剂的分光光度分析。
IF 2.4 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-06-12 DOI: 10.1080/20565623.2025.2511444
Ebere Emilia Ayogu, Emmanuel Aryon Ngolryeko, Joseph Obiezu Chukwujekwu Ezeonwumelu, Ibrahim Garba Wawata, Bashir Olaniyi Sadiq

Aim: The surge in different brands of artesunate injection in Uganda, has raised the need for this study, which aimed at quantifying the actual amount of artesunate in different brands of artesunate injections available in Northern and Western Uganda.

Materials and methods: The wavelength at maximum absorbance of pure artesunate powder was determined using Ultraviolet-visible spectrophotometer and Beer Lambert's plot was generated. This was validated and used to assay 27 brands of artesunate.

Results: In the spectrophotometric assay method used, Beer Lambert's law was obeyed within the range of 20 µg/ml-140 µg/ml with linear regression equation of y = 0.012 + 0.030 and correlation coefficient of (R2) 0.999 (n = 9). The limits of detection (sensitivity) and quantification were found to be 0.83 mg/ml and 2.09 mg/ml respectively. About 66.6% (18) and 33.3% (9) had actual artesunate content higher and lower than labeled claim respectively, while 40.7% (11) had deviations from labeled claim that were within acceptable limits.

Conclusion: Most brands of artesunate injection assayed deviated from labeled claim, regional/environmental factor impacted much on the stability of artesunate thus there is need for further screening of the quality of artesunate injection in circulation in view of the therapeutic consequences of substandard artesunate injection.

目的:乌干达不同品牌的青蒿琥酯注射液的激增,提高了对这项研究的需求,该研究旨在量化乌干达北部和西部不同品牌的青蒿琥酯注射液中青蒿琥酯的实际含量。材料与方法:采用紫外-可见分光光度计测定纯青蒿琥酯粉末的最大吸光度波长,并建立Beer Lambert图。该方法已被验证并用于27个牌子的青蒿琥酯的分析。结果:所采用的分光光度法在20µg/ml ~ 140µg/ml范围内符合比尔朗伯定律,线性回归方程为y = 0.012 + 0.030,相关系数为(R2) 0.999 (n = 9)。检测限(灵敏度)和定量限分别为0.83 mg/ml和2.09 mg/ml。分别有66.6%(18)和33.3%(9)药品的实际青蒿琥酯含量高于和低于说明书,40.7%(11)药品的实际青蒿琥酯含量与说明书偏差在可接受范围内。结论:大部分被检测的青蒿琥酯注射液品牌偏离标签声明,区域/环境因素对青蒿琥酯的稳定性影响较大,鉴于不合格青蒿琥酯注射液的治疗后果,有必要进一步对流通中青蒿琥酯注射液的质量进行筛选。
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引用次数: 0
Chemo-immunotherapy sequential with radiotherapy in advanced or metastatic esophageal squamous cell carcinoma. 晚期或转移性食管鳞状细胞癌的化疗免疫治疗序贯放疗。
IF 2.4 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-07-16 DOI: 10.1080/20565623.2025.2527497
Xiang Han, Zhongfa Zhang, Ling Zhang, Yunhong You, Xiajuan Xu, Yuchao Niu, Zhimei Zhao, Xiuhui Guo, Youxin Ji, Qiuyu Hou, Keke Nie

Background: To evaluate the efficacy and safety of chemo-immunotherapy combined with residual lesions irradiation of advanced stage esophageal squamous cell carcinoma.

Methods: Treatment-naïve patients with radiologically and histologically confirmed advanced or metastatic squamous-cell esophageal carcinoma were enrolled. Participants received four cycles of the TP regimen combined with the PD-1 inhibitor sintilimab. Patients who completed four cycles of chemo-immunotherapy with stable disease (SD) or partial response (PR) subsequently received 50 Gy of radiation in 25 fractions for residual tumors. Maintenance sintilimab therapy was administered every 21 days for up to 31 cycles or until disease progression or intolerable toxicity occurred.

Results: A total of 39 patients were enrolled in this study, of whom 30 were evaluable for efficacy and toxicity. The complete response (CR) rate was 6.7% (2/30), the partial response (PR) rate was 53.3% (16/30). The median depth of response (DpR) was 34.5% for chemo-immunotherapy and increased to 64.0% after radiotherapy. The progression-free survival (PFS) was 16.4 months, while overall survival (OS) has not yet been reached.

Conclusions: Chemo-immunotherapy followed by radiotherapy for residual tumors and maintenance sintilimab, demonstrated high response rates, prolonged PFS, and tolerable toxicity as a first-line treatment for patients with advanced or metastatic esophageal squamous-cell carcinoma.

背景:评价化疗免疫联合残余病灶照射治疗晚期食管鳞状细胞癌的疗效和安全性。方法:Treatment-naïve纳入影像学和组织学证实的晚期或转移性鳞状细胞食管癌患者。参与者接受了四个周期的TP方案联合PD-1抑制剂辛替单抗。完成4个化疗免疫治疗周期且病情稳定(SD)或部分缓解(PR)的患者随后接受25次50 Gy的残余肿瘤放射治疗。维持辛替单抗治疗每21天施用一次,最多31个周期,或直到疾病进展或无法忍受的毒性发生。结果:本研究共纳入39例患者,其中30例可评估疗效和毒性。完全缓解(CR)率为6.7%(2/30),部分缓解(PR)率为53.3%(16/30)。化疗免疫治疗的中位缓解深度(DpR)为34.5%,放疗后增加到64.0%。无进展生存期(PFS)为16.4个月,总生存期(OS)尚未达到。结论:作为晚期或转移性食管鳞状细胞癌患者的一线治疗方法,化疗免疫治疗后放疗治疗残留肿瘤和维持辛替单抗具有高反应率,延长PFS和可耐受的毒性。
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引用次数: 0
Thymic rebound after adjuvant chemotherapy in breast cancer: a case report. 乳腺癌辅助化疗后胸腺反弹1例。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-09-11 DOI: 10.1080/20565623.2025.2560241
Myriam Ayari, Sarah Ben Azouz, Amira Chehaider, Sarra Ben Rejeb, Taieb Jomni

Chemotherapy, especially for malignant tumors, can affect the thymus, leading to its atrophy and a decreased production of naïve T lymphocytes. However, regenerative process can occur in children and rarely in adults manifesting as thymic hyperplasia. A 49-year-old female patient was diagnosed with stage I breast cancer. She was treated with surgery, adjuvant chemotherapy followed by radiotherapy and hormonotherapy. Follow-up computed tomography scan showed a mediastinal retro-sternal mass, raising concern for tumor recurrence. However, no other signs of relapse were evident. A thymic rebound was suspected, with the lesion presenting as a triangular-shaped mediastinal mass suggestive of thymic morphology and consisting of mixed fat and soft tissue density with smooth borders. Close monitoring was then decided. A follow-up CT scan of the chest showed regression of the mediastinal mass. The diagnosis of thymic rebound after chemotherapy was then retained. The patient is currently in remission, seven years from her original diagnosis of breast cancer. Thymic hyperplasia after chemotherapy can rarely occur in adults. Clinicians should be aware of this unusual presentation to prevent needless investigation and therapy.

化疗,尤其是针对恶性肿瘤的化疗,可影响胸腺,导致其萎缩和naïve T淋巴细胞的产生减少。然而,再生过程可以发生在儿童,很少在成人表现为胸腺增生。一名49岁的女性患者被诊断为I期乳腺癌。她接受了手术、辅助化疗、放疗和激素治疗。随后的计算机断层扫描显示纵隔胸骨后肿块,引起肿瘤复发的关注。然而,没有其他明显的复发迹象。怀疑胸腺反弹,病变表现为一个三角形纵隔肿块,提示胸腺形态,由混合脂肪和软组织密度组成,边界光滑。于是决定密切监测。随后的胸部CT扫描显示纵隔肿块消退。保留化疗后胸腺反弹的诊断。该患者目前处于缓解期,距离她最初诊断为乳腺癌已有七年时间。成人化疗后胸腺增生很少发生。临床医生应该意识到这种不寻常的表现,以防止不必要的调查和治疗。
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引用次数: 0
Reporting and representation of race and ethnicity data in phase III clinical trials for hematological malignancies. 血液学恶性肿瘤III期临床试验中种族和民族数据的报告和代表。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-09-22 DOI: 10.1080/20565623.2025.2563483
Tianyi Wang, Ambily Banerjee, Dina Gifkins

Background: The recruitment of underrepresented racial and ethnic groups in clinical trials remains a challenge.

Methods: The ClinicalTrials.gov database was queried for phase III trials related to non-Hodgkin lymphoma (NHL), leukemia, and multiple myeloma (MM). A reference population was sourced from the Surveillance, Epidemiology, and End Results (SEER) database.

Results: A total of 53,821 pooled participants from 119 phase III trials were included in the analyses. Race and ethnicity data were reported in 95.8% and 81.5% of trials, respectively. Globally, the majority of participants were predominantly White (77.3%), followed by Asian (8.2%), Black/African American (5.4%), American Indian/Alaska Native (0.4%), and Native Hawaiian/Other Pacific Islander (0.2%), while Hispanic/Latino individuals constituted 11.0% of trial participants. In comparison to data in SEER, the proportions were lower for Asian/Pacific Islander and Hispanic/Latino across all cancers, and for Black/African American and American Indian/Alaska Native in leukemia and MM in US only trials.

Conclusions: Despite progress, reporting and representation of non-White population remain insufficient in trials. Innovative strategies to enhance representation in trial enrollment are warranted, as well as the utilization of real-world data to establish recruitment goals by more effectively assessing the demographic and geographic distribution of target patient populations.

背景:在临床试验中招募代表性不足的种族和族裔群体仍然是一个挑战。方法:在ClinicalTrials.gov数据库中查询与非霍奇金淋巴瘤(NHL)、白血病和多发性骨髓瘤(MM)相关的III期试验。参考人群来源于监测、流行病学和最终结果(SEER)数据库。结果:共有来自119项III期试验的53,821名受试者被纳入分析。95.8%和81.5%的试验报告了种族和族裔数据。在全球范围内,大多数参与者主要是白人(77.3%),其次是亚洲人(8.2%),黑人/非裔美国人(5.4%),美洲印第安人/阿拉斯加原住民(0.4%)和夏威夷原住民/其他太平洋岛民(0.2%),而西班牙裔/拉丁裔个体占试验参与者的11.0%。与SEER的数据相比,在所有癌症中,亚裔/太平洋岛民和西班牙裔/拉丁裔的比例较低,在美国的白血病和MM试验中,黑人/非洲裔美国人和美洲印第安人/阿拉斯加原住民的比例较低。结论:尽管取得了进展,但非白人人群的报告和代表性在试验中仍然不足。通过更有效地评估目标患者人群的人口统计学和地理分布,有必要采用创新策略来提高试验入组的代表性,并利用真实世界的数据来建立招募目标。
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引用次数: 0
Hydrogel-based devices for cancer diagnostics: a systematic review of materials and biomarkers. 基于水凝胶的癌症诊断设备:材料和生物标志物的系统综述。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-11-19 DOI: 10.1080/20565623.2025.2587305
Rosalina Intan Saputri, Adelaide Mensah, Aoife M Rodgers, Petra G Clark, Deborah Lowry, Ahmed Abuelhana, Aaron J Courtenay

A promising trend in complex cancer care is personalized therapy, a molecular profiling to tailor treatments to each patient's unique tumor attributes. Different methodologies have been used to identify cancer's mutation profile, including the use of hydrogel in liquid biopsy. This review aims to assess published works describing the performance of hydrogels as diagnostic devices for cancer biomarker detection. A systematic search was conducted following PRISMA guidelines across five databases: PubMed, Scopus, Embase, MEDLINE, and EBSCO. Studies were screened, selected, and assessed for quality. Relevant data were extracted, including the demographics of the studies, characteristics of the hydrogel, cancer, sample characteristics captured, and detection methods. From 33 studies, various types and forms of hydrogels were discussed. This review identified the most used hydrogel polymers, including acrylamide, PEG, DNA, and alginate. The most frequently observed cancer sites were breast, liver, and cervical uteri. In addition, this work reports that the most captured biomarkers were CTCs and protein markers. Hydrogels have demonstrated a promising platform for detecting cancer biomarkers in the early stages of research. Future investigations are required to optimize and validate the hydrogel application as a diagnostic device in the translational stage.

在复杂的癌症治疗中,个性化治疗是一个有希望的趋势,这是一种针对每个患者独特的肿瘤属性定制治疗的分子分析。已经使用了不同的方法来确定癌症的突变谱,包括在液体活检中使用水凝胶。本综述旨在评估已发表的描述水凝胶作为癌症生物标志物检测诊断设备的性能的作品。系统检索遵循PRISMA指南,跨越5个数据库:PubMed、Scopus、Embase、MEDLINE和EBSCO。对研究进行筛选、选择和质量评估。提取相关数据,包括研究的人口统计学、水凝胶的特征、癌症、捕获的样本特征和检测方法。从33项研究中,讨论了水凝胶的各种类型和形式。本文综述了最常用的水凝胶聚合物,包括丙烯酰胺、聚乙二醇、DNA和海藻酸盐。最常见的癌症部位是乳房、肝脏和子宫颈。此外,本工作报告了捕获最多的生物标志物是ctc和蛋白质标志物。在研究的早期阶段,水凝胶已经证明了一个很有前途的检测癌症生物标志物的平台。未来的研究需要优化和验证水凝胶在转化阶段作为诊断设备的应用。
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引用次数: 0
Endoscopic resection of an adenoma arising in cervical inlet patch: a case report. 内窥镜切除宫颈入口补片腺瘤1例。
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 DOI: 10.1080/20565623.2025.2595904
A Oueslati, G Mohamed, S Bizid, H Ben Abdallah, R Bouali

Cervical inlet patch refers to heterotopic gastric mucosa located in the proximal esophagus, which can be congenital or acquired and has a rare potential for neoplastic transformation. We report a rare case of a tubulovillous adenoma with high-grade dysplasia arising from an inlet patch. A 67-year-old male presented with a complaint of nighttime acid regurgitation and throat discomfort. Endoscopic examination revealed a 20 mm sessile polyp at 16-18 cm from the incisors, arising in an heterotopic gastric mucosa. Following comprehensive diagnostic workup including endoscopic ultrasound and computed tomography, endoscopic mucosal resection was performed. Histopathological examination confirmed a tubulovillous adenoma with high-grade dysplasia developed on gastric heterotopic mucosa with associated intestinal metaplasia. Complete resection was achieved, and follow-up endoscopy at 12 months showed no recurrence with complete resolution of symptoms. This case highlights the neoplastic potential of cervical inlet patches and demonstrates the efficacy of endoscopic resection as a definitive treatment modality for such lesions.

颈入口补片是指位于食管近端的异位胃黏膜,可为先天性或后天,具有罕见的肿瘤转化潜力。我们报告一例罕见的管状绒毛腺瘤与高度不典型增生引起的入口补丁。一名67岁男性主诉夜间反酸和咽喉不适。内窥镜检查显示,在离门牙16-18厘米处有一个20毫米的无梗息肉,产生于异位胃粘膜。经过全面的诊断工作,包括内镜超声和计算机断层扫描,内镜下粘膜切除术。组织病理学检查证实在胃异位粘膜上发生管状绒毛状腺瘤伴高级别发育不良,并伴有肠化生。完全切除,随访12个月的内窥镜检查显示无复发,症状完全缓解。本病例强调了宫颈入口补片的肿瘤潜力,并证明了内镜切除作为此类病变的最终治疗方式的有效性。
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引用次数: 0
Bioanalytical method validation to quantify ketorolac in human vitreous and aqueous via surrogate matrix of human plasma. 通过人血浆替代基质定量人玻璃体和水溶液中酮罗拉酸的生物分析方法验证。
IF 2.4 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-03-19 DOI: 10.1080/20565623.2025.2476866
Prajita Pandey, Brianna A White, Colin Goswell, Neelanjan Bose, Sara Butterworth Connell, Nicolee Schulze, Jim Nevelos, Ana Najafi, Ramin Najafi, Ryan K Cheu

Purpose: Intracameral phenylephrine 1.0%/ketorolac 0.3% (OMIDRIA®) is used during cataract surgery to prevent intraoperative miosis and reduce postoperative pain. Although studied in beagles, no human data exist showing the duration ketorolac remains in the eye postoperatively. A clinical trial measuring ketorolac concentrations in aqueous/vitreous samples necessitated the development of a validation process for acquiring these measurements. Due to limited human aqueous/vitreous humor sample availability, a bioanalytical method was developed and validated to quantify ketorolac levels using human plasma as a surrogate matrix.

Methods: The developed process involves extracting ketorolac and its internal standard (ketorolac-d5) from plasma as a surrogate for aqueous and vitreous humor using a protein precipitation sample preparation technique, followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.

Results: The validated method can be successfully applied for quantitation of ketorolac over a concentration range of 2.5 ng/mL to 5000 ng/mL. The method met the acceptance criteria with respect to selectivity, specificity, precision, accuracy, linearity, dilution integrity, and stability.

Conclusions: The validated method can use plasma as a surrogate matrix for quantitation of ketorolac in aqueous and vitreous humor, thereby eliminating the need to procure human vitreous and aqueous samples for validation prior to initiation of a clinical trial.

目的:在白内障手术中使用1.0%的苯肾上腺素/ 0.3%的酮罗拉酸(OMIDRIA®),以防止术中缩小,减轻术后疼痛。虽然在比格犬身上进行了研究,但没有人类的数据显示酮罗拉酸在术后的持续时间。一项测量水/玻璃样品中酮酸浓度的临床试验需要开发一种验证过程来获得这些测量值。由于人类水/玻璃体体液样品有限,我们开发并验证了一种生物分析方法,以人类血浆作为替代基质来定量酮咯酸水平。方法:采用蛋白质沉淀样品制备技术,从血浆中提取酮罗拉酸及其内标(酮罗拉酸-d5)作为水、玻璃体的替代物,然后进行液相色谱-串联质谱(LC-MS/MS)分析。结果:本方法可用于测定酮咯酸在2.5 ~ 5000ng /mL浓度范围内的含量。该方法在选择性、特异性、精密度、准确度、线性度、稀释度完整性和稳定性方面均符合验收标准。结论:经验证的方法可以使用血浆作为替代基质定量酮罗拉酸的水和玻璃体体液,从而消除了在开始临床试验之前获取人体玻璃体和水样品进行验证的需要。
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引用次数: 0
Dysadherin expression in prostatic adenocarcinoma and its relationship with E-cadherin and β-catenin. 前列腺腺癌中粘附异常蛋白的表达及其与E-cadherin和β-catenin的关系。
IF 2.4 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-04-28 DOI: 10.1080/20565623.2025.2494972
Rinë Limani, Labinota Kondirolli, Brikenë Blakaj Gashi, Monika Ulamec, Božo Krušlin

Background: We analyzed immunoexpression of Dysadherin, E-cadherin and ß-catenin proteins in prostate.

Methods: 53 radical prostatectomy specimens were included. Dysadherin, E-cadherin and ß-catenin were evaluated in prostatic adenocarcinoma and in adjacent non-tumorous tissue, and correlated with clinicomorphological features in prostatic adenocarcinoma.

Results: We report cytoplasmic/membraneous and nuclear staining for Dysadherin in prostatic tissue. Cytoplasmic/membraneous expression was stronger in prostatic adenocarcinoma when compared to adjacent non-tumorous prostatic tissue (p < 0.001).

Dysadherin positively correlated with T status (rho = 0.326, P = 0.017) and Grade Group (rho = 0.278, P = 0.044). We report no correlation with recurrence, surgical margins status, sPSA and N status. E-cadherin was negatively correlated with recurrence (rho = -0.297, P = 0.031), T status (rho = -0.430, P = 0.001), Grade Group (rho = -0.558, P < 0.001) and positive surgical margins (rho = -0.404, P = 0.003). ß-catenin negatively correlated with Grade Group (rho = -0.557, P < 0,001). No correlation was observed between Dysadherin and E-cadherin and Dysadherin and ß-catenin expression.

Conclusion: Our results suggest a potential role for Dysadherin in tumor progression. No significant correlation between Dysadherin and E-cadherin or ß-catenin indicates potential independence of Dysadherin in its regulatory role in prostatic adenocarcinoma.

背景:分析前列腺组织中dysherin、E-cadherin和ß-catenin蛋白的免疫表达。方法:53例根治性前列腺切除术标本。检测前列腺腺癌及癌旁非肿瘤组织中dysherin、E-cadherin、ß-catenin的表达,并与前列腺腺癌的临床形态学特征相关。结果:我们报道了前列腺组织的细胞质/膜和核染色。前列腺腺癌细胞质/膜表达较邻近非肿瘤前列腺组织强(p与T状态呈正相关(rho = 0.326, p = 0.017),分级组(rho = 0.278, p = 0.044)。我们报告与复发、手术边缘状态、sPSA和N状态无相关性。E-cadherin与复发(rho = -0.297, P = 0.031)、T状态(rho = -0.430, P = 0.001)、分级组(rho = -0.558, P)呈负相关。dysherin与E-cadherin或ß-catenin之间无显著相关性,提示dysherin在前列腺腺癌中的调节作用可能具有独立性。
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引用次数: 0
Using IgY for diagnosis of respiratory infections: practical application in COVID-19. 利用IgY诊断呼吸道感染:在COVID-19中的实际应用
IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2025-12-01 Epub Date: 2025-08-18 DOI: 10.1080/20565623.2025.2546245
Cícero Matheus Lima Amaral, Valdester Cavalcante Pinto Júnior, Daniel Freire Lima, Hellen Paula Silva da Costa, Danúbio Andrade Bezerra Farias, João Xavier da Silva Neto, Luiz Francisco Wemmenson Gonçalves Moura, Bruno Bezerra da Silva, Ednardo Rodrigues Freitas, Maurício Fraga Van Tilburg, Maria Izabel Florindo Guedes

Aim: The COVID-19 pandemic underscores the need for expanded diagnostic tools to combat respiratory pathogens with pandemic potential, particularly in developing countries. This study aimed to create a Dot Blotting test utilizing IgY antibodies for acute respiratory infection diagnosis, with COVID-19 as the disease model.

Methods: Leghorn chickens were immunized with precipitated SARS-CoV-2 virus, and IgY antibodies were purified via ammonium sulfate precipitation and titrated by ELISA. Dot Blotting detected viral antigens in saliva samples, demonstrating efficacy comparable to ELISA tests.

Results: The IgY antibody was successfully produced and purified, obtaining a titration of 1:16,000. The ability of IgY to detect SARS-CoV-2 in clinical saliva samples showed promising results in terms of accuracy (91.3%), sensitivity (92.5%), specificity (90.0%), positive predictive value (PPV) (90.2%), negative predictive value (NPV) (92.3%), and Cohen's Kappa (0.825).

Conclusion: Chicken antibodies proved effective for early and accurate diagnosis of respiratory infections, including COVID-19. This study validates the efficacy of chicken antibodies in diagnosing respiratory infections, supporting pandemic response in developing nations. Expanding diagnostic capabilities is crucial for combating respiratory pathogens.

目的:2019冠状病毒病大流行突出表明,需要扩大诊断工具,以对抗具有大流行潜力的呼吸道病原体,特别是在发展中国家。本研究旨在以COVID-19为疾病模型,建立一种利用IgY抗体进行急性呼吸道感染诊断的Dot Blotting检测方法。方法:用沉淀的SARS-CoV-2病毒免疫来角鸡,用硫酸铵沉淀法纯化IgY抗体,ELISA法定量。Dot Blotting检测唾液样本中的病毒抗原,显示出与ELISA测试相当的功效。结果:成功制备并纯化了IgY抗体,滴度为1:16 000。IgY检测临床唾液样本中SARS-CoV-2的准确性(91.3%)、敏感性(92.5%)、特异性(90.0%)、阳性预测值(PPV)(90.2%)、阴性预测值(NPV)(92.3%)和Cohen’s Kappa(0.825)均显示出良好的结果。结论:鸡抗体可用于包括COVID-19在内的呼吸道感染的早期准确诊断。这项研究验证了鸡抗体在诊断呼吸道感染方面的功效,为发展中国家的大流行应对提供了支持。扩大诊断能力对于抗击呼吸道病原体至关重要。
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引用次数: 0
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