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Accuracy evaluation of Roche Accu-Chek Performa blood glucose meters at low glucose concentrations: A nine-year retrospective study 罗氏 Accu-Chek Performa 血糖仪在低血糖浓度下的准确性评估:一项为期九年的回顾性研究
Pub Date : 2024-06-17 DOI: 10.1002/ila2.49
Zhipeng Zhao, Runqing Li, Xiuying Zhao, Lina Zhang, Tengjiao Wang, Song Yang, Ning Han, Dong Zhu

Objective

To evaluate the accuracy of Roche Accu-Chek Performa glucose meters at a low glucose concentration of <5.55 mmol/L (100 mg/dL) over a 9-year period.

Methods

The accuracy of the Roche Accu-Chek Performa glucose meters at low glucose concentrations was evaluated using annual comparison data for 9 consecutive years from 2015 to 2023, according to the acceptability criteria specified in International Organization for Standardization (ISO) 15197:2013. Blood samples with low glucose concentrations of <5.55 mmol/L were prepared by incubation and glycolysis. The glucose concentration was detected using Roche Accu-Chek Performa glucose meters and a biochemical analyzer in the central laboratory.

Results

A total of 2978 pairs of comparison results from 211 glucose meters at a low glucose concentration of <5.55 mmol/L were retrospectively analyzed from 2015 to 2023. The clinical use duration spanned from 1 to 9 years and 40.76% (86 out of 211 glucose meters) had been used for more than 2 years. The correlation coefficient r between glucose meter measurements and laboratory reference values was 0.98 (p < 0.001). The mean according to Roche Accu-Chek Performa glucose meters was 0.05 mmol/L (0.9 mg/dL) higher than that of the biochemical analyzer (Z = −13.82, p < 0.0001). The results showed that 100.00% (211 out of 211) of the Roche Accu-Chek Performa glucose meters met the acceptability criteria specified in ISO 15197:2013. At a low glucose concentration of <5.55 mmol/L, 99.90% (2975 out of 2978) of the comparative data pairs in the error distribution fell within the range of ±0.83 mmol/L (15 mg/dL). Parkes consensus error grid analysis showed that 100.00% (2978 out of 2978) of comparative data pairs fell within region A.

Conclusions

This study demonstrated that Roche Accu-Chek Performa glucose meters successfully met the accuracy standards of ISO 15197:2013 for measuring blood glucose within the hypoglycemic range. Greater attention should be given to the performance of blood glucose monitoring systems in the low glycemic range, especially for patients with diabetes who are prone to hypoglycemia and require precise measurements.

目的 评价罗氏 Accu-Chek Performa 血糖仪在<5.55 mmol/L (100 mg/dL) 低血糖浓度下的准确性,为期 9 年。 方法 根据国际标准化组织 (ISO) 15197:2013 规定的可接受性标准,使用 2015 年至 2023 年连续 9 年的年度对比数据,对罗氏 Accu-Chek Performa 血糖仪在低血糖浓度下的准确性进行了评估。通过孵育和糖酵解制备出低糖浓度为<5.55 mmol/L的血液样本。中心实验室使用罗氏 Accu-Chek Performa 血糖仪和生化分析仪检测葡萄糖浓度。 结果 回顾性分析了 2015 年至 2023 年期间 211 台血糖仪在<5.55 mmol/L 低血糖浓度下的 2978 对对比结果。临床使用时间从 1 年到 9 年不等,40.76%(211 台血糖仪中的 86 台)的使用时间超过 2 年。血糖仪测量值与实验室参考值之间的相关系数r为0.98(p < 0.001)。罗氏 Accu-Chek Performa 血糖仪的平均值比生化分析仪的平均值高 0.05 mmol/L(0.9 mg/dL)(Z = -13.82,p < 0.0001)。结果显示,100.00% 的罗氏 Accu-Chek Performa 血糖仪(211 台中的 211 台)符合 ISO 15197:2013 中规定的可接受性标准。在 5.55 毫摩尔/升的低血糖浓度下,99.90%(2978 个数据中的 2975 个)的比较数据对误差分布在 ±0.83 毫摩尔/升(15 毫克/分升)的范围内。Parkes 共识误差网格分析表明,100.00% 的对比数据对(2978 个中的 2978 个)位于 A 区域内。 结论 本研究表明,罗氏 Accu-Chek Performa 血糖仪在测量低血糖范围内的血糖时成功达到了 ISO 15197:2013 的准确度标准。应更加关注血糖监测系统在低血糖范围内的性能,尤其是对于容易发生低血糖并需要精确测量的糖尿病患者。
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引用次数: 0
A case of central nervous system infection with Scedosporium boydii 一例中枢神经系统感染博伊德孢子虫病例
Pub Date : 2024-06-11 DOI: 10.1002/ila2.48
Zhen Cai, Dongchao Pan, Ronghua Geng, Jidi Fu, Fen Qu

Scedosporium boydii is considered an opportunist fungal pathogen in immunocompromised patients. It also causes serious and fatal central nervous system infections. In this study, a man with brain abscesses infected with S. boydii was diagnosed using multiple methods, including microscopy, culture combined with Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MOLDI-TOF MS), internal transcribed spacer sequencing and Metagenomic next-generation sequencing (mNGS). This successful diagnosis highlights the importance of using a variety of techniques to identify and treat infections caused by this dangerous fungus.

在免疫力低下的病人中,童贞癣菌被认为是一种机会性真菌病原体。它还会导致严重的致命性中枢神经系统感染。在本研究中,采用多种方法对一名脑脓肿患者进行了诊断,包括显微镜检查、培养结合基质辅助激光解吸电离飞行时间质谱(MOLDI-TOF MS)、内部转录间隔测序和元基因组新一代测序(mNGS)。这次成功的诊断凸显了使用多种技术识别和治疗这种危险真菌引起的感染的重要性。
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引用次数: 0
Hypermethylation of GSTM5 and its effect on oxidation in myelodysplastic syndrome 骨髓增生异常综合征中 GSTM5 的高甲基化及其对氧化的影响
Pub Date : 2024-06-11 DOI: 10.1002/ila2.47
Chi Wang, Yafei Yu, Qing Chang, Tengteng Dong, Liye Wang, Mianyang Li

Background

Hypermethylation of glutathione-S-transferase 5 (GSTM5) and its effect on oxidation in the pathogenesis of myelodysplastic syndrome (MDS) were investigated.

Methods

GSTM5 methylation was detected in bone marrow (BM) samples from MDS patients, acute myeloid leukemia (AML) patients, and control individuals using methylation-specific PCR and MassARRAY analysis. Bisulfite sequencing PCR was performed to verify methylation levels, while mRNA levels were determined using reverse transcription polymerase chain reaction. Correlations between GSTM5 methylation and clinical parameters were analyzed. The MDS cell line, SKM-1, was treated with decitabine, buthionine sulfoximine, or overexpression of GSTM5, and the glutathione level and cell viability were detected.

Results

The MassARRAY analysis revealed significant differences in GSTM5 methylation levels between the MDS and control groups. GSTM5 methylation levels were significantly increased in the high-risk subgroup and showed a significant association with MDS progression to AML (hazard ratio = 3.6). Levels of GSTM5 mRNA were significantly decreased in the MDS group, exhibiting a negative correlation with the GSTM5 gene methylation level. Normal BM HS-5 cells exhibited significantly lower levels of GSTM5 methylation than SKM-1 cells. Overexpression of GSTM5 in SKM-1 cells or treatment with buthionine sulfoximine or decitabine resulted in inhibition of proliferation and significantly decreased glutathione levels.

Conclusions

GSTM5 plays an anti-oxidative role in MDS and the tumor suppressor effect of GSTM5 may be mediated by reducing glutathione levels. GSTM5 hypermethylation and low levels of GSTM5 expression may be prognostic markers for MDS.

采用甲基化特异性 PCR 和 MassARRAY 分析方法检测了骨髓增生异常综合征(MDS)患者、急性髓性白血病(AML)患者和对照组的骨髓(BM)样本中谷胱甘肽-S 转移酶 5(GSTM5)的高甲基化及其在骨髓增生异常综合征(MDS)发病机制中对氧化作用的影响。进行亚硫酸氢盐测序 PCR 验证甲基化水平,同时使用反转录聚合酶链反应测定 mRNA 水平。分析了 GSTM5 甲基化与临床参数之间的相关性。用地西他滨、丁硫亚胺或过表达 GSTM5 处理 MDS 细胞株 SKM-1,检测谷胱甘肽水平和细胞活力。高危亚组的GSTM5甲基化水平明显升高,并与MDS进展为AML有显著关联(危险比=3.6)。MDS 组 GSTM5 mRNA 水平明显下降,与 GSTM5 基因甲基化水平呈负相关。正常BM HS-5细胞的GSTM5甲基化水平明显低于SKM-1细胞。GSTM5在MDS中发挥抗氧化作用,GSTM5的抑瘤作用可能是通过降低谷胱甘肽水平介导的。GSTM5的高甲基化和低表达水平可能是MDS的预后标志。
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引用次数: 0
Bridging the divide: Harmonizing polarized clinical laboratory medicine practices 弥合分歧:协调两极分化的临床实验医学实践
Pub Date : 2024-05-30 DOI: 10.1002/ila2.46
Yi-Wei Tang, Joseph D. Yao

In today's healthcare, clinical laboratory medicine stands as a cornerstone of patient care, providing vital diagnostic insights that inform decisions in disease management. Yet, within this crucial field, a dichotomy persists between two predominant models of laboratory testing to support clinical practice: point-of-care testing (PoCT) and central laboratory testing [1]. This schism, while born of practical necessity and evolving technology, presents both opportunities and challenges that warrant closer examination.

Point-of-care testing, characterized by its immediacy and accessibility, offers rapid results at or near the patient's location, facilitating swift clinical interventions and enhancing patient satisfaction [2]. Devices used for PoCT are often compact and portable, enabling testing in diverse settings, from emergency departments to remote clinics [3]. This model provides healthcare providers with real-time data to make timely care decision, as a result of reducing the time to diagnosis and treatment initiation.

Conversely, central laboratory testing operates on a larger scale, often in dedicated facilities equipped with advanced instrumentation and automation. Central clinical laboratories boast a wide menu of tests, offering comprehensive diagnostic capabilities that encompass a spectrum of medical specialties. Standardization and quality control measures are rigorously enforced, ensuring the sensitivity, reliability, and accuracy of test results. Furthermore, central laboratories facilitate economies of scale, driving down costs and promoting efficiency in resource utilization.

However, this division between PoCT and central laboratory testing has fostered challenges in interoperability, data management, and standardization. Integration of PoCT results into electronic health records (EHR) remains a significant hurdle, limiting the seamless exchange of clinical data across different care settings [4]. In addition, differences in testing methods and quality assurance protocols between PoCT devices and central laboratory assays may introduce discrepancies in results and interpretation of results, posing risks to patient safety and clinical decision-making.

Yet, amidst these challenges, there exists a growing recognition of the need for synergy between PoCT and central laboratory testing. Collaborative efforts are underway to bridge the gap, leveraging technological innovations to enhance connectivity, streamlining data exchange, and harmonizing testing methods across different care settings. Interoperable EHR systems and middleware solutions are facilitating the seamless integration of PoCT results into central laboratory databases and EHR, fostering an integrated approach to patient care.

Furthermore, advancements in point-of-care technologies, such as lab-on-a-chip devices, hand-held devices, and mobile phone applications, hold promise in expanding t

在当今的医疗保健领域,临床实验室医学是病人护理的基石,它提供重要的诊断信息,为疾病管理决策提供依据。然而,在这一至关重要的领域中,支持临床实践的两种主要实验室检测模式之间仍然存在着对立:护理点检测(PoCT)和中心实验室检测[1]。床旁检测以其即时性和可及性为特点,可在患者所在地或附近提供快速检测结果,有利于迅速采取临床干预措施并提高患者满意度[2]。用于 PoCT 的设备通常小巧便携,可在从急诊科到偏远诊所等各种环境中进行检测[3]。这种模式可为医疗服务提供者提供实时数据,以便及时做出护理决策,从而缩短诊断和开始治疗的时间[4]。相反,中心实验室检测的规模较大,通常设在配备先进仪器和自动化设备的专用设施中。中心临床实验室的检测项目繁多,具有全面的诊断能力,涵盖一系列医学专科。标准化和质量控制措施得到严格执行,确保了检验结果的灵敏度、可靠性和准确性。此外,中心实验室有利于实现规模经济,降低成本,提高资源利用效率。然而,PoCT 和中心实验室检测之间的这种分工,在互操作性、数据管理和标准化方面带来了挑战。将 PoCT 结果纳入电子健康记录(EHR)仍是一个重大障碍,限制了不同医疗机构之间临床数据的无缝交换[4]。此外,PoCT 设备与中心实验室检测之间在检测方法和质量保证协议上的差异可能会导致结果和结果解释上的差异,从而给患者安全和临床决策带来风险。然而,在这些挑战中,人们越来越认识到 PoCT 与中心实验室检测之间协同增效的必要性。目前,各方正在共同努力弥合这一差距,利用技术创新来加强连通性、简化数据交换并协调不同医疗机构的检测方法。可互操作的电子病历系统和中间件解决方案有助于将 PoCT 结果无缝集成到中心实验室数据库和电子病历中,从而促进对患者的综合护理。此外,芯片实验室设备、手持设备和手机应用程序等护理点技术的进步有望扩大 PoCT 的范围和能力,同时保持中心实验室检测的严谨性和可靠性[5]。在呼吸道病毒病原体检测方面,协调 PoCT 和中心实验室检测对优化患者护理至关重要[8]。PoCT 可提供快速结果,以便立即做出临床决策,而中心实验室检测则可提供全面诊断和质量保证。总之,虽然临床检验医学中 PoCT 和中心实验室检验的二分法可能会带来固有的挑战,但也为创新和协作提供了机会。通过采用超越传统界限的综合方法,医疗保健相关方可以利用两种检测方法的优势,为患者提供最佳护理。通过持续的合作、标准化和技术进步,我们可以为临床检验医学铺平道路,走向更加综合、以患者为中心的未来:构思(主导);撰写-原稿(主导);撰写-审稿&;编辑(等同)。约瑟夫-姚(Joseph D. Yao):作者声明无利益冲突。
{"title":"Bridging the divide: Harmonizing polarized clinical laboratory medicine practices","authors":"Yi-Wei Tang,&nbsp;Joseph D. Yao","doi":"10.1002/ila2.46","DOIUrl":"https://doi.org/10.1002/ila2.46","url":null,"abstract":"<p>In today's healthcare, clinical laboratory medicine stands as a cornerstone of patient care, providing vital diagnostic insights that inform decisions in disease management. Yet, within this crucial field, a dichotomy persists between two predominant models of laboratory testing to support clinical practice: point-of-care testing (PoCT) and central laboratory testing [<span>1</span>]. This schism, while born of practical necessity and evolving technology, presents both opportunities and challenges that warrant closer examination.</p><p>Point-of-care testing, characterized by its immediacy and accessibility, offers rapid results at or near the patient's location, facilitating swift clinical interventions and enhancing patient satisfaction [<span>2</span>]. Devices used for PoCT are often compact and portable, enabling testing in diverse settings, from emergency departments to remote clinics [<span>3</span>]. This model provides healthcare providers with real-time data to make timely care decision, as a result of reducing the time to diagnosis and treatment initiation.</p><p>Conversely, central laboratory testing operates on a larger scale, often in dedicated facilities equipped with advanced instrumentation and automation. Central clinical laboratories boast a wide menu of tests, offering comprehensive diagnostic capabilities that encompass a spectrum of medical specialties. Standardization and quality control measures are rigorously enforced, ensuring the sensitivity, reliability, and accuracy of test results. Furthermore, central laboratories facilitate economies of scale, driving down costs and promoting efficiency in resource utilization.</p><p>However, this division between PoCT and central laboratory testing has fostered challenges in interoperability, data management, and standardization. Integration of PoCT results into electronic health records (EHR) remains a significant hurdle, limiting the seamless exchange of clinical data across different care settings [<span>4</span>]. In addition, differences in testing methods and quality assurance protocols between PoCT devices and central laboratory assays may introduce discrepancies in results and interpretation of results, posing risks to patient safety and clinical decision-making.</p><p>Yet, amidst these challenges, there exists a growing recognition of the need for synergy between PoCT and central laboratory testing. Collaborative efforts are underway to bridge the gap, leveraging technological innovations to enhance connectivity, streamlining data exchange, and harmonizing testing methods across different care settings. Interoperable EHR systems and middleware solutions are facilitating the seamless integration of PoCT results into central laboratory databases and EHR, fostering an integrated approach to patient care.</p><p>Furthermore, advancements in point-of-care technologies, such as lab-on-a-chip devices, hand-held devices, and mobile phone applications, hold promise in expanding t","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.46","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141435642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The exploration of cell population data in clinical use: Beyond infectious diseases 细胞群数据在临床应用中的探索:超越传染病
Pub Date : 2024-05-20 DOI: 10.1002/ila2.41
Shayuanzi Huang, Yin Liu, Liu Qian, Juan Zhou, Dong Wang

Cell population data (CPD) is regarded as the fingerprint of a blood cell at a given moment. CPD parameters harbor information associated with cell morphology and can be automatically generated using modern hematological analyzers. Various studies have revealed many unique clinical applications for CPD, especially for infectious diseases, such as sepsis. For example, one monocyte-related CPD parameter is the monocyte distribution width (MDW), which can be generated using a Beckman Coulter hematological analyzer. MDW has received FDA and CE approval for aiding in sepsis diagnosis in adult patients in the emergency department. Additionally, MDW can serve as a diagnostic biomarker in patients infected with SARS-CoV-2. CPD has also been widely explored for possible clinical applications beyond infectious diseases, such as for predicting myelodysplastic syndromes, screening for hematological malignancies, and detecting sterile inflammation. CPD parameter measurements are easily obtained and quite cost-effective, making them practical for clinical use. However, there are some potential drawbacks of CPD parameters. Some pre-analytical conditions can affect CPD values. Furthermore, CPD are specific to certain hematological analyzers and the result cannot be transferred between different analyzers. The practical usefulness of CPD reference intervals is also still questionable. In this review, wesummarize the current studies related to CPD and its clinical applications. Additional well-designed clinical studies related to CPD are still expected.

细胞群数据(CPD)被视为血细胞在特定时刻的指纹。CPD 参数包含与细胞形态相关的信息,可通过现代血液分析仪自动生成。各种研究揭示了 CPD 的许多独特临床应用,尤其是在败血症等感染性疾病方面。例如,单核细胞相关 CPD 参数之一是单核细胞分布宽度 (MDW),可使用贝克曼库尔特血液分析仪生成。MDW 已获得 FDA 和 CE 认证,可用于急诊科成人患者的败血症诊断。此外,MDW 还可作为 SARS-CoV-2 感染者的诊断生物标志物。CPD 还被广泛应用于传染病以外的临床领域,如预测骨髓增生异常综合征、筛查血液恶性肿瘤和检测无菌性炎症。CPD 参数测量容易获得,成本效益高,因此可用于临床。不过,CPD 参数也有一些潜在的缺点。一些分析前的条件会影响 CPD 值。此外,CPD 仅适用于某些血液分析仪,其结果不能在不同的分析仪之间转换。CPD 参考区间的实用性也仍然值得怀疑。在本综述中,我们总结了目前与 CPD 及其临床应用相关的研究。预计还会有更多与 CPD 相关的设计良好的临床研究。
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引用次数: 0
Candidate reference measurement procedure for serum 17-hydroxyprogesterone quantification via isotope dilution liquid chromatography–tandem mass spectrometry 通过同位素稀释液相色谱-串联质谱法定量血清 17-羟孕酮的候选参考测量程序
Pub Date : 2024-04-25 DOI: 10.1002/ila2.39
Ji Zhang, Yang Jiang, Ting Liu, Xiongwei Liu, Hui Huang, Yanxiang Cheng, Jieyan Li, Bangning Cheng, Chungen Qian, Xufu Xiang, Jun-Fa Xu

Background

Accurate quantification of 17-hydroxyprogesterone (17-OHP) in serum is vital for clinical and research applications. However, inter-laboratory variability in test results exists owing to the lack of a standardized reference measurement procedure (RMP). Therefore, in this study, we developed a highly accurate, cost-effective, and user-friendly candidate RMP (cRMP) for analyzing 17-OHP in serum.

Methods

We quantified 17-OHP in serum using a one-step liquid–liquid extraction method with the addition of 17-OHP-13C3, followed by liquid chromatography–tandem mass spectrometry. The ability of these methods to suppress interference was evaluated by chromatographic analysis. We assessed accuracy, specificity, the lower limit of quantitation, linearity, and matrix effects by following the standards specified by the Clinical and Laboratory Standards Institute. The consistency between the developed cRMP and the chemiluminescence method was evaluated through experiments with 120 clinical samples.

Results

The developed cRMP required only 8 min for accurate quantification of serum 17-OHP without bias from matrix effects or interference from 19 metabolites added as potential interferents. The method exhibited favorable measurement performance, with a quantitation limit of 0.086 ng/mL, linear range of 0.1–400 ng/mL, a total imprecision of ≤2.90%, spike recovery of 100.1%–100.6%, and relative deviations from assigned target values (RfB Institution) of −2.91% to 1.10%. The cRMP demonstrated good consistency with the conventional assay (chemiluminescence method), with a correlation coefficient R of 0.96977.

Conclusion

A cRMP with high accuracy, cost-effectiveness, and convenient operation was developed for quantifying 17-OHP in serum. Its simplicity and robust performance make it an invaluable addition to the arsenal of analytical tools available for laboratories. This method can enhance the accuracy and reliability of 17-OHP measurements across various laboratories.

血清中 17- 羟孕酮(17-OHP)的准确定量对于临床和研究应用至关重要。然而,由于缺乏标准化的参考测量程序(RMP),实验室间的检测结果存在差异。因此,在本研究中,我们开发了一种高度准确、经济高效、操作简便的候选参考测量程序(cRMP),用于分析血清中的 17-OHP。我们采用添加 17-OHP-13C3 的一步式液液萃取法,然后用液相色谱-串联质谱法定量检测血清中的 17-OHP。通过色谱分析评估了这些方法抑制干扰的能力。我们按照临床和实验室标准协会规定的标准评估了准确性、特异性、定量下限、线性和基质效应。通过对 120 份临床样本的实验,评估了所开发的 cRMP 与化学发光法之间的一致性。所开发的 cRMP 只需 8 分钟就能准确定量血清中的 17-OHP,而不会受到基质效应的影响,也不会受到作为潜在干扰物加入的 19 种代谢物的干扰。该方法具有良好的测量性能,定量限为 0.086 ng/mL,线性范围为 0.1-400 ng/mL,总不精密度≤2.90%,加标回收率为 100.1%-100.6%,与指定目标值的相对偏差(RfB 机构)为-2.91%-1.10%。cRMP 与传统检测方法(化学发光法)具有良好的一致性,相关系数 R 为 0.96977。该方法简便易行、性能稳定,是实验室分析工具库中的宝贵补充。该方法可提高不同实验室测定 17-OHP 的准确性和可靠性。
{"title":"Candidate reference measurement procedure for serum 17-hydroxyprogesterone quantification via isotope dilution liquid chromatography–tandem mass spectrometry","authors":"Ji Zhang,&nbsp;Yang Jiang,&nbsp;Ting Liu,&nbsp;Xiongwei Liu,&nbsp;Hui Huang,&nbsp;Yanxiang Cheng,&nbsp;Jieyan Li,&nbsp;Bangning Cheng,&nbsp;Chungen Qian,&nbsp;Xufu Xiang,&nbsp;Jun-Fa Xu","doi":"10.1002/ila2.39","DOIUrl":"10.1002/ila2.39","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Accurate quantification of 17-hydroxyprogesterone (17-OHP) in serum is vital for clinical and research applications. However, inter-laboratory variability in test results exists owing to the lack of a standardized reference measurement procedure (RMP). Therefore, in this study, we developed a highly accurate, cost-effective, and user-friendly candidate RMP (cRMP) for analyzing 17-OHP in serum.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We quantified 17-OHP in serum using a one-step liquid–liquid extraction method with the addition of 17-OHP-<sup>13</sup>C<sub>3</sub>, followed by liquid chromatography–tandem mass spectrometry. The ability of these methods to suppress interference was evaluated by chromatographic analysis. We assessed accuracy, specificity, the lower limit of quantitation, linearity, and matrix effects by following the standards specified by the Clinical and Laboratory Standards Institute. The consistency between the developed cRMP and the chemiluminescence method was evaluated through experiments with 120 clinical samples.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The developed cRMP required only 8 min for accurate quantification of serum 17-OHP without bias from matrix effects or interference from 19 metabolites added as potential interferents. The method exhibited favorable measurement performance, with a quantitation limit of 0.086 ng/mL, linear range of 0.1–400 ng/mL, a total imprecision of ≤2.90%, spike recovery of 100.1%–100.6%, and relative deviations from assigned target values (RfB Institution) of −2.91% to 1.10%. The cRMP demonstrated good consistency with the conventional assay (chemiluminescence method), with a correlation coefficient <i>R</i> of 0.96977.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>A cRMP with high accuracy, cost-effectiveness, and convenient operation was developed for quantifying 17-OHP in serum. Its simplicity and robust performance make it an invaluable addition to the arsenal of analytical tools available for laboratories. This method can enhance the accuracy and reliability of 17-OHP measurements across various laboratories.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.39","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140655961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Concomitant and sequential administration of nirmatrelvir-ritonavir and azvudine in patients with COVID-19 caused by the Omicron variant: Safety and efficacy 对由Omicron变体引起的COVID-19患者同时和依次服用尼尔马特韦-利托那韦和阿兹夫定:安全性和有效性
Pub Date : 2024-04-22 DOI: 10.1002/ila2.40
Guang-Bin Chen, You-Rou Zheng, Yun-Ni Yu, Li-Mian Liang, Chao Chen, Ying-Xia Liu, Hong-Zhou Lu

Background

This study assessed the safety and efficacy of nirmatrelvir-ritonavir (Paxlovid®) and azvudine when administered sequentially or concomitantly in patients with coronavirus 2019 (COVID-19) caused by the Omicron variant.

Methods

Ninety-three patients confirmed to be infected with the Omicron variant by nucleic acid detection were retrospectively investigated. Information was collected on general health status, medication, and adverse drug reactions (ADRs) according to whether nirmatrelvir-ritonavir and azvudine were administered sequentially or concomitantly. Data on times of onset, clinical manifestations, and outcomes of ADRs and on conversion to a negative nucleic acid test were also recorded.

Results

Possible ADRs were recorded in 41 patients (44.1%). There were 22 gastrointestinal reactions in 18 patients and 18 hematological abnormalities in 16 after sequential or concomitant treatment with nirmatrelvir-ritonavir and azvudine. Liver enzyme levels increased in nine cases and creatinine clearance decreased in two. Cases of atrial fibrillation (n = 1), sleep disorder (n = 2), rash (n = 2), dizziness (n = 1), and weakness (n = 5) were also documented. Only vomiting, poor appetite, diarrhea, xerostomia, bitter taste, and rash were considered probable ADRs; others were thought to be possible ADRs. In all cases, the nucleic acid test did not turn negative after the first antiviral was applied. The nucleic acid test of 28 patients did not turn negative before discharge. The remaining 65 patients (69.9%) returned a negative nucleic acid test after receiving the second antiviral agent.

Conclusions

Treatment with nirmatrelvir-ritonavir and azvudine is safe and effective whether administered sequentially or concomitantly in patients with COVID-19 caused by the Omicron variant.

本研究评估了对由Omicron变体引起的冠状病毒2019(COVID-19)患者先后或同时服用尼尔马特韦-利托那韦(Paxlovid®)和阿茲夫定的安全性和有效性。根据尼尔马特韦-利托那韦和阿兹夫定是先后用药还是同时用药,收集了有关一般健康状况、用药和药物不良反应(ADRs)的信息。此外,还记录了药物不良反应的发病时间、临床表现、结果以及转为阴性核酸检测的数据。在连续或同时使用尼马瑞韦-利托那韦和阿兹夫定治疗后,18 名患者出现了 22 种胃肠道反应,16 名患者出现了 18 种血液学异常。9 例患者的肝酶水平升高,2 例患者的肌酐清除率降低。此外,还出现了心房颤动(1 例)、睡眠障碍(2 例)、皮疹(2 例)、头晕(1 例)和虚弱(5 例)。只有呕吐、食欲不振、腹泻、口腔干燥症、苦味和皮疹被认为是可能的不良反应;其他被认为是可能的不良反应。在所有病例中,首次使用抗病毒药物后核酸检测结果均未转为阴性。28 名患者的核酸检测结果在出院前未转为阴性。对于由Omicron变异体引起的COVID-19患者,无论是连续用药还是同时用药,使用nirmatrelvir-ritonavir和阿兹夫定治疗都是安全有效的。
{"title":"Concomitant and sequential administration of nirmatrelvir-ritonavir and azvudine in patients with COVID-19 caused by the Omicron variant: Safety and efficacy","authors":"Guang-Bin Chen,&nbsp;You-Rou Zheng,&nbsp;Yun-Ni Yu,&nbsp;Li-Mian Liang,&nbsp;Chao Chen,&nbsp;Ying-Xia Liu,&nbsp;Hong-Zhou Lu","doi":"10.1002/ila2.40","DOIUrl":"10.1002/ila2.40","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>This study assessed the safety and efficacy of nirmatrelvir-ritonavir (Paxlovid®) and azvudine when administered sequentially or concomitantly in patients with coronavirus 2019 (COVID-19) caused by the Omicron variant.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Ninety-three patients confirmed to be infected with the Omicron variant by nucleic acid detection were retrospectively investigated. Information was collected on general health status, medication, and adverse drug reactions (ADRs) according to whether nirmatrelvir-ritonavir and azvudine were administered sequentially or concomitantly. Data on times of onset, clinical manifestations, and outcomes of ADRs and on conversion to a negative nucleic acid test were also recorded.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Possible ADRs were recorded in 41 patients (44.1%). There were 22 gastrointestinal reactions in 18 patients and 18 hematological abnormalities in 16 after sequential or concomitant treatment with nirmatrelvir-ritonavir and azvudine. Liver enzyme levels increased in nine cases and creatinine clearance decreased in two. Cases of atrial fibrillation (<i>n</i> = 1), sleep disorder (<i>n</i> = 2), rash (<i>n</i> = 2), dizziness (<i>n</i> = 1), and weakness (<i>n</i> = 5) were also documented. Only vomiting, poor appetite, diarrhea, xerostomia, bitter taste, and rash were considered probable ADRs; others were thought to be possible ADRs. In all cases, the nucleic acid test did not turn negative after the first antiviral was applied. The nucleic acid test of 28 patients did not turn negative before discharge. The remaining 65 patients (69.9%) returned a negative nucleic acid test after receiving the second antiviral agent.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Treatment with nirmatrelvir-ritonavir and azvudine is safe and effective whether administered sequentially or concomitantly in patients with COVID-19 caused by the Omicron variant.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.40","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140675770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical characteristics and risk factors for mortality in Candida auris infections 念珠菌感染的临床特征和死亡风险因素
Pub Date : 2024-04-09 DOI: 10.1002/ila2.38
Kang Li, Xin Liu, Danfeng Liu, Yuqi Zhi, Chang Dong, Pengrui Sun, Yueming Dong, Hongfang Pan, Yuxiang Zhang, Hong Lei

Background

Candida auris infections pose a threat to public health, necessitating increased awareness in China. This study aimed to analyze the strains of C. auris, assess the infection status, and investigate clinical characteristics and risk factors for mortality.

Methods

A retrospective analysis was conducted on 18 patients with Candida auris infection. We focused on evaluating basic characteristics, strain sources, and antibacterial susceptibility test results. Statistical methods were used to determine clinical features and identify risk factors for death.

Results

The strain type, composition ratio, and specimen source of C. auris were not associated with mortality. Neither the infection index nor the length of hospitalization showed an association with the prognosis. However, significant risk factors for mortality included cerebral infarction, cardiac disease, renal dysfunction, hypoproteinemia, and anemia (all p < 0.05).

Conclusions

Cerebral infarction, cardiac disease, renal dysfunction, hypoproteinemia, and anemia are significant risk factors for death in C. auris infections. These findings indicate the importance of recognizing and addressing these factors in the clinical management of C. auris infection.

背景念珠菌感染对公众健康构成威胁,因此有必要在中国提高对念珠菌感染的认识。本研究旨在分析念珠菌菌株,评估感染状况,并调查临床特征和死亡风险因素。 方法 对 18 例白色念珠菌感染患者进行回顾性分析。我们重点评估了基本特征、菌株来源和抗菌药敏感性测试结果。采用统计方法确定临床特征并识别死亡风险因素。 结果 Auris 真菌的菌株类型、组成比例和标本来源与死亡率无关。感染指数和住院时间都与预后无关。然而,脑梗塞、心脏病、肾功能不全、低蛋白血症和贫血是导致死亡的重要危险因素(所有 p 均为 0.05)。 结论 脑梗塞、心脏病、肾功能不全、低蛋白血症和贫血是蛔虫感染死亡的重要危险因素。这些研究结果表明,在C. auris感染的临床治疗中识别和处理这些因素非常重要。
{"title":"Clinical characteristics and risk factors for mortality in Candida auris infections","authors":"Kang Li,&nbsp;Xin Liu,&nbsp;Danfeng Liu,&nbsp;Yuqi Zhi,&nbsp;Chang Dong,&nbsp;Pengrui Sun,&nbsp;Yueming Dong,&nbsp;Hongfang Pan,&nbsp;Yuxiang Zhang,&nbsp;Hong Lei","doi":"10.1002/ila2.38","DOIUrl":"https://doi.org/10.1002/ila2.38","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Candida auris</i> infections pose a threat to public health, necessitating increased awareness in China. This study aimed to analyze the strains of <i>C</i>. <i>auris</i>, assess the infection status, and investigate clinical characteristics and risk factors for mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A retrospective analysis was conducted on 18 patients with <i>Candida auris</i> infection. We focused on evaluating basic characteristics, strain sources, and antibacterial susceptibility test results. Statistical methods were used to determine clinical features and identify risk factors for death.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The strain type, composition ratio, and specimen source of <i>C</i>. <i>auris</i> were not associated with mortality. Neither the infection index nor the length of hospitalization showed an association with the prognosis. However, significant risk factors for mortality included cerebral infarction, cardiac disease, renal dysfunction, hypoproteinemia, and anemia (all <i>p</i> &lt; 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Cerebral infarction, cardiac disease, renal dysfunction, hypoproteinemia, and anemia are significant risk factors for death in <i>C</i>. <i>auris</i> infections. These findings indicate the importance of recognizing and addressing these factors in the clinical management of <i>C</i>. <i>auris infection</i>.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.38","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141435644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards 四种血糖监测系统对照五种不同标准在系统准确性可接受性方面的差异
Pub Date : 2024-03-20 DOI: 10.1002/ila2.37
Tengjiao Wang, Lina Zhang, Lijun Gong, Yangmei Xin, Liang Han, Na Li, Peng Peng, Xiuying Zhao, Runqing Li

Objective

This study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.

Methods

The glucose measurement values obtained from four types of BGMSs (Roche Accu-Chek® Performa, Bayer Contour™ TS, Sinomedisite Glupad® H1 Plus, and Sinocare® Gold-Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12-A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.

Results

From 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient r was 0.995 for Roche Accu-Chek® Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad® H1 Plus, and 0.997 for Sinocare® Gold-Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu-Chek® Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad® H1 Plus, and 100.00% (35/35) of Sinocare® Gold-Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu-Chek® Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad® H1 Plus, and 91.43% (32/35) of Sinocare® Gold-Accu.

Conclusions

Among the four types of BGMSs evaluated, the glucose meters of Roche Accu-Chek® Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.

本研究旨在评估四种血糖监测系统(BGMS)的系统准确性,并根据五种不同标准探讨每种血糖监测系统在系统准确性可接受性方面的差异。研究人员将四种血糖监测系统(罗氏Accu-Chek® Performa、拜耳Contour™ TS、华美美迪Glupad® H1 Plus和希诺凯® Gold-Accu)的血糖测量值与中心实验室生化分析仪的参考值进行了对比评估。根据国际标准化组织(ISO)15197:2003、临床实验室标准协会(CLSI)POCT12-A3、ISO 15197:2013、中国检验医学会(CSLM)共识和美国食品和药物管理局(FDA)指南等五项标准的规定,确定了每种BGMS的系统准确性可接受性。从2018年到2022年,从四种BGMS的366台血糖仪中获得了10980对测量值。在 BGMS 的血糖测量值与中心实验室生化分析仪的参考值之间观察到了显著的相关性。罗氏 Accu-Chek® Performa 的相关系数 r 为 0.995,拜耳 Contour™ TS 为 0.994,华美美迪 Glupad® H1 Plus 为 0.983,而 Sinocare® Gold-Accu 为 0.997。罗氏 Accu-Chek® Performa 血糖仪有 100.00% (135/135)、拜耳 Contour™ TS 血糖仪有 100.00% (109/109)、华医美 Glupad® H1 Plus 血糖仪有 81.61% (71/87) 和 Sinocare® Gold-Accu 血糖仪有 100.00% (35/35)符合 ISO 15197:2003 规定的可接受性标准。而罗氏 Accu-Chek® Performa 血糖仪有 99.26% (134/135)、拜耳 Contour™ TS 血糖仪有 88.07% (96/109)、华医美 Glupad® H1 Plus 血糖仪有 58.62% (51/87) 和 Sinocare® Gold-Accu 血糖仪有 91.43% (32/35)符合 ISO 15197:2013 中规定的可接受性标准。对照五种不同标准中规定的可接受性标准,每种血糖仪的系统准确性可接受性都有显著差异。
{"title":"Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards","authors":"Tengjiao Wang,&nbsp;Lina Zhang,&nbsp;Lijun Gong,&nbsp;Yangmei Xin,&nbsp;Liang Han,&nbsp;Na Li,&nbsp;Peng Peng,&nbsp;Xiuying Zhao,&nbsp;Runqing Li","doi":"10.1002/ila2.37","DOIUrl":"10.1002/ila2.37","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The glucose measurement values obtained from four types of BGMSs (Roche Accu-Chek<sup>®</sup> Performa, Bayer Contour™ TS, Sinomedisite Glupad<sup>®</sup> H1 Plus, and Sinocare<sup>®</sup> Gold-Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12-A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>From 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient <i>r</i> was 0.995 for Roche Accu-Chek<sup>®</sup> Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad<sup>®</sup> H1 Plus, and 0.997 for Sinocare<sup>®</sup> Gold-Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu-Chek<sup>®</sup> Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad<sup>®</sup> H1 Plus, and 100.00% (35/35) of Sinocare<sup>®</sup> Gold-Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu-Chek<sup>®</sup> Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad<sup>®</sup> H1 Plus, and 91.43% (32/35) of Sinocare<sup>®</sup> Gold-Accu.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Among the four types of BGMSs evaluated, the glucose meters of Roche Accu-Chek<sup>®</sup> Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.37","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140224341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A preliminary study of the mechanism of compound hearing loss caused by ototoxic drugs combined with impulse noise 耳毒性药物与脉冲噪音导致复合听力损失的机理初探
Pub Date : 2024-03-13 DOI: 10.1002/ila2.34
Xin Qiu, Qing-qing Jiang, Wei-wei Guo, Ning Yu, Shi-ming Yang

Background

Hearing loss (HL) is becoming increasingly common and is more commonly caused by noise, ototoxic substances, or a combination of ototoxic factors. However, so far, few studies have examined the mechanism by which compound factors cause HL. The only relevant study is about occupational ototoxic substances combined with environmental noise at 85–110 dB SPL. In this study, to address the shortcomings of existing research, we innovatively focused on HL induced by loud noise (impulse noise, >160 dB SPL) combined with common ototoxic drugs. The aim of this study was to establish and validate a mature animal model, and then to compare the characteristics of audiology, pathomorphology and molecular features, and to preliminarily predict pathogenesis in compound HL.

Materials and Methods

We selected guinea pigs to construct in vivo HL model groups for different extents of exposure, including a blank control group, a single-drug group, a single-impulse noise group, and a compound group. The animal model of the mature compound HL group was established using gentamicin combined with impulse noise. We then performed audiological and pathological verification. We analyzed the auditory brainstem response (ABR), pathological morphology of the cochlea, and molecules (including important self-radicals, cytokines, and apoptosis signal transduction pathway proteins in the pathogenesis of drug- and noise-induced HL), compared the effect of different extents of exposure on HL, and preliminarily predict the pathogenic mechanism of compound HL.

Results

Four groups of animal models were established successfully and verified by audiology and pathology. Regarding audiology, there were no significant differences in the ABR thresholds before exposure (p > 0.05), but differences emerged among the groups after exposure. Notably, after 3, 7, and 14 days of exposure, there were significant differences in the ABR thresholds between the compound group and both the drug and noise groups (p < 0.01), and after 14 days, the HL of the compound group was much more severe (greater than the linear sum of single-factor HL group). Regarding the pathomorphology, compared with the control group, the cochleae were damaged to different degrees in the factor exposure groups. The drug group had the least severe HL, the noise group had serious HL (p < 0.05), and the compound group had the most severe HL (p < 0.01). The compound group's damage was greater than the linear sum of the single-factor group in many ways, such as the loss and damage o

听力损失(HL)正变得越来越常见,其原因通常是噪音、耳毒性物质或耳毒性因素的综合作用。然而,迄今为止,很少有研究探讨复合因素导致听力损失的机制。唯一的相关研究是关于职业性耳毒性物质与 85-110 dB SPL 的环境噪声的结合。在本研究中,针对现有研究的不足,我们创新性地将研究重点放在了高噪音(脉冲噪音,>160 dB SPL)与常见耳毒性药物联合诱导的 HL 上。本研究的目的是建立和验证成熟的动物模型,然后比较听力学、病理形态学和分子特征的特点,并初步预测复合型 HL 的发病机制。我们选择豚鼠构建了不同暴露程度的体内 HL 模型组,包括空白对照组、单一药物组、单一脉冲噪声组和复合组。成熟的复合 HL 组动物模型是使用庆大霉素与脉冲噪声联合建立的。然后,我们进行了听力学和病理学验证。我们分析了听性脑干反应(ABR)、耳蜗的病理形态和分子(包括药物和噪声诱导 HL 发病机制中重要的自体自由基、细胞因子和细胞凋亡信号转导通路蛋白),比较了不同暴露程度对 HL 的影响,并初步预测了复合 HL 的发病机制。在听力学方面,暴露前各组的 ABR 阈值无显著差异(P > 0.05),但暴露后各组之间出现了差异。值得注意的是,暴露 3、7 和 14 天后,化合物组与药物组和噪声组的 ABR 阈值有显著差异(p < 0.01),14 天后,化合物组的 HL 更严重(大于单因素 HL 组的线性和)。在病理形态学方面,与对照组相比,各因素暴露组的耳蜗均受到不同程度的损伤。药物组耳蜗受损程度最轻,噪音组耳蜗受损程度较重(P < 0.05),而化合物组耳蜗受损程度最重(P < 0.01)。复方组在许多方面的损伤大于单因素组的线性总和,如毛细胞和纤毛的丢失和损伤、毛细胞的形态和排列紊乱、蛋白质代谢、细胞功能和表皮板的结构缺陷(p < 0.01)。从分子角度来看,趋势与病理学和听力学相似,耳毒性药物和脉冲噪声的协同作用显著增加了细胞因子水平(IL-6、ICAM-1、8-OHDG、IL-1 和 TNF-α)、自由基丙二醛([MDA]、▪OH、LPO、O-2ˉ)和细胞凋亡信号转导通路蛋白。利用庆大霉素、脉冲噪声和复合因子诱导 HL 动物模型,并通过听力学和病理学验证,为今后的研究奠定了基础。构建动物模型后,我们发现50 mg/kg庆大霉素10天为亚损伤剂量,50×脉冲噪声可引起部分HL,但两种因素联合具有显著的耳毒性协同作用,使耳蜗内氧化应激水平和炎性细胞因子的瀑布反应水平升高,凋亡相关蛋白表达增强,导致病理形态学和听力学损伤的协同作用。我们初步分析了复合 HL 的致病机制,为进一步研究这一日益严重的全球性问题的机制、预防和治疗奠定了基础。
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