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中华检验医学杂志
中华检验医学杂志

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1009-9158

cjlm@cma.org.cn

010-85158273

100710

北京市东城区东四西大街42号

中华检验医学杂志/Journal Chinese Journal of Laboratory MedicineCSCD北大核心CSTPCD
查看更多>>1978年9月创刊，中华医学会主办。本刊主要读者群是广大中高级检验医学技术人员、医学实验室科研人员和临床各科医师。作为我国检验医学领域专业人员发表研究成果和进行学术交流的重要平台，深受广大读者喜爱。已经连续7次荣获“百种中国杰出学术期刊”称号，入围“中国期刊方阵”期刊，并多次获得中华医学会优秀期刊奖。主要栏目包括：述评、综述、血液与体液学、临床化学、临床微生物学、临床免疫学、分子诊断、实验室质量管理、试剂与仪器评价、经验与技术交流、病例报告、读者来信、专题笔谈等。特色栏目有展望、对话、临床病例（理）研究、继续教育等，深受广大读者喜爱。
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    被忽视的丁型肝炎

    庄辉唐栋
    205-209页
    查看更多>>摘要：丁型肝炎病毒（HDV）是一种有缺陷病毒，需要乙型肝炎表面抗原（HBsAg）才能复制。HDV感染呈世界性流行，但全球不同区域的HDV感染人数不一，目前尚无丁型肝炎确切的全球流行率数据。我国属于抗-HDV低度流行地区，然而内蒙古自治区和新疆维吾尔自治区抗-HDV阳性率较高。与HBV单独感染比较，慢性HBV/HDV重叠感染会更快、更易进展为肝硬化、肝失代偿和肝细胞癌。抗HBV核苷酸类似物（NAs）对控制HDV感染无效，新批准药物布尔韦肽（BLV）治疗慢性丁型肝炎有较好的安全性和有效性，目前也未发现耐药突变。 Hepatitis D virus (HDV) is a defective virus that requires hepatitis B surface antigen (HBsAg) to replicate. HDV infection is prevalent worldwide, but the number of HDV infections varies in different regions of the world, and there is no exact global prevalence data for hepatitis D. China belongs to an area with low prevalence of anti-HDV. However, the positive rates of anti-HDV are relatively high in Inner Mongolia Autonomous Region and Xinjiang Uygur Autonomous Region. compared to HBV monoinfection chronic HBV/HDV coinfection progresses more rapidly and frequently to cirrhosis,liver decompensation and hepatocellular carcinoma. Anti-HBV nucleotide analogues (NAs) that inhibit HBV replication are ineffective in controlling HDV infection. The newly approved drug Burweipeptide (BLV) has demonstrated good safety and efficacy in the treatment of chronic hepatitis D, and no drug-resistant mutations have been found so far.

    肝炎,丁型慢性丁型肝炎流行病学自然史诊断治疗

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    戊型肝炎的实验室诊断指标与临床应用

    应东夏宁邵郑子峥唐栋...
    210-215页
    查看更多>>摘要：戊型肝炎病毒（HEV）感染引起的戊型肝炎已成为我国最主要的急性病毒性肝炎之一。近年来HEV各检测指标，包括HEV RNA、HEV抗原、抗-HEV IgM及抗HEV-IgG等指标，在方法学上有了新进展及在实验室诊断中有了新发现。急性戊型肝炎患者、慢性戊型肝炎患者、肝外临床症状患者诊断以及病原体携带者、相关职业体检人员检测等不同人群中应进行多指标联合诊断。不同人群各指标检测结果有各自的临床意义。 Hepatitis E virus (HEV) is the major pathogen responsible for acute viral hepatitis in China. Recently, there have been new advances in the methodologies and novel discoveries in the laboratory diagnosis of HEV, including various diagnostic markers such as HEV RNA, HEV antigen, anti-HEV IgM, and anti-HEV IgG. A multi-indicator diagnostic approach should be applied across different populations, including patients with acute or chronic hepatitis E, individuals with extra-hepatic clinical symptoms, asymptomatic carriers, and specific occupational groups undergoing health assessments. The clinical significance of test results for each marker varies among these different groups.

    肝炎病毒,戊型戊型肝炎抗体戊型肝炎抗原病原学诊断

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    临床质谱实验室发展中的机遇与挑战

    邱玲张钧周洲周伟燕...
    216-223页
    查看更多>>摘要：质谱技术凭借其高灵敏度、高特异性、可同时检测多个化合物等优势，备受临床检验专家的关注并广泛应用于临床检验实验室。近年来，质谱技术在病原微生物鉴定，微量元素及重金属、小分子激素、维生素、氨基酸、多肽和蛋白质的检测，治疗药物监测以及中毒物质筛查等领域不断取得重要成果。为深入探讨质谱技术进入临床实验室所带来的机遇和挑战，中华检验医学杂志特邀来自检验医学领域的知名专家，围绕质谱技术在临床实验室中的定位、质谱技术对临床实验室的发展和改善、质谱检测结果解读面临的挑战、临床质谱实验室运营管理面临的挑战以及临床质谱实验室改进方法等议题发表他们的经验和看法。专家们一致认为，质谱技术的引入为临床实验室和科研带来了新的发展方向和机遇，同时也面临样本前处理难度大、质谱技术成本高且操作复杂、数据处理和解读复杂、标准和规范的缺乏及质谱收费问题等一系列挑战。 Clinical application of mass spectrometry technology has attracted the attention of clinical laboratory experts due to its high sensitivity, high specificity, and capacities of simultaneous detection of multiple compounds. In recent years, mass spectrometry technology has made significant achievements in the fields of identification of pathogenic microorganism, detection of trace elements and heavy metals, small molecule hormones, vitamins, amino acids, peptides and proteins, as well as therapeutic drug monitoring (TDM) and poisoning drugs screening. In order to further clarify the opportunities and challenges brought by this complex mass spectrometry technology in the field of clinical laboratory, the Chinese Journal of Laboratory Medicine invited experts and scholars of laboratory medicine to share their experience and opinions on related items focusing on the positioning of mass spectrometry technology in the clinical laboratory, the development and improvement of the clinical laboratory by mass spectrometry technology, the challenges of interpreting mass spectrometry test results, the challenges of operating and managing clinical mass spectrometry laboratories, and ways of improving the application of clinical mass spectrometry laboratories with this technology. Agreement was achieved in that the introduction of mass spectrometry technology into the clinical laboratory could bring new directions and opportunities for clinical testing and research, and also is associated with a series of challenges such as the difficulty of sample pretreatment, the high cost and complexity of mass spectrometry technology, the complexity of data processing and interpretation, the lack of standards and norms, and the issue of determining the price of mass spectrometry examinations.

    质谱分析法临床实验室技术

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    临床微生物检验自动化流水线应用专家共识

    王传新徐英春干岭
    224-233页
    查看更多>>摘要：全自动微生物自动化流水线在我国的应用尚处于起步阶段，缺乏临床微生物检验自动化流水线应用的相关标准。为推进自动化技术的发展，中华医学会检验医学分会和中国医学装备协会检验医学分会组织制定了《临床微生物检验自动化流水线应用专家共识》。共识围绕自动化流水线的临床应用问题，讨论了应用前期需要考虑的实际要素，评价了应用过程中流水线的技术特点，特别指出应用后实验室面临的检验流程再造等问题，最后提出实施微生物自动化流水线的挑战和展望。该共识为推动医学检验自动化仪器的应用，临床微生物检验由传统手工操作转向自动化检测的变革提供指导。 The application of laboratory automation in clinical microbiology in China is still in initial stage, and there is a lack of relevant standards in this field. In order to promote the clinical development of this technology, the Chinese Society of Laboratory Medicine and the China Society of Medical Laboratory Equipment organized experts to formulate this consensus. Present expert consensus focuses on the application of laboratory automation in clinical microbiology, discusses the practical factors that need to be considered in the early application of this technology, evaluates the technical characteristics of the automation assembly line in the application process, especially points out the problems of the inspection process reengineering faced by laboratories after application, and finally highlights the challenges and prospects of the implementation of laboratory automation in clinical microbiology. This consensus might promote the clinical application of laboratory automation instruments, the transformation of clinical microbiological testing from traditional manual operation to automatic testing.

    微生物临床实验室技术自动化周转时间

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    化学发光法丁型肝炎病毒IgG抗体检测试剂性能评价

    袁榕晨程方明向宽辉李永聪...
    234-238页
    查看更多>>摘要：目的 对抗丁型肝炎病毒（HDV）IgG试剂（化学发光法）的性能进行评价。 方法 用基于磁微粒化学发光免疫分析平台的抗-HDV IgG试剂、厦门万泰凯瑞抗-HDV IgG试剂（国产试剂A）、基于酶联免疫吸附法的北京万泰抗-HDV IgG试剂（国产试剂B）和基于荧光定量PCR检测平台的HDV RNA试剂分别对1 909例乙型肝炎表面抗原（HBsAg）阳性样本进行检测，并结合检测的阴/阳性结果评价3种抗体试剂的特异度和正确率之间的差异；同时，参照美国临床和实验室标准化协会的EP5-A2文件，采用高、中和低3个浓度水平的阳性样本对抗-HDV IgG试剂进行精密度评价。用抗-HDV IgG试剂对545份HBsAg阳性且HDV IgG阴性样本和北京大学肝炎试剂研究中心的200份甲型肝炎病毒IgM抗体（HAV IgM）阳性样本、350份丙型肝炎病毒抗体（anti-HCV）阳性样本、200份健康人体检样本进行检测，以评价抗-HDV IgG试剂的特异性。最后，用抗-HDV IgG试剂与国产试剂A测试545例HBsAg阳性且抗-HDV IgG阴性样本和37例抗-HDV IgG阳性样本，对抗-HDV IgG试剂的符合率进行评价。 结果 4种试剂在对1 909份HBsAg阳性样本的检测中，筛查到19份抗-HDV IgG真阳性样本；抗-HDV IgG试剂的正确率和特异度较好；抗-HDV IgG试剂对高、中和低3个水平样本检测的批内精密度CV值在1.57%~4.30%之间，批间精密度CV值在1.71%~4.67%之间，精密度良好；与国产试剂A进行比较，阴/阳性符合率一致。 结论 本研究中抗-HDV IgG试剂（化学发光法）对临床样本的检测具有较高特异度，表现出与商品化试剂一致的符合率，可用于HBsAg阳性样本中抗-HDV IgG的筛查。 Objective This study evaluates the performance of chemiluminescence assay, which is designed to detect Hepatitis D Virus (HDV) Immunoglobulin G (IgG) antibodies. Methods A comparative analysis was conducted among chemiluminescence anti-HDV IgG reagent, the magnetic particle-based domestic reagent A and domestic reagent B, and the Robo Gene HDV RNA kit, using 1909 HBsAg-positive plasma samples. This comparison aimed to delineate clinical specificity and detection accuracy. The anti-HDV IgG reagent precision was assessed at three different concentration levels following the Clinical Laboratory Standards Institute EP5-A2 guidelines. The specificity of the assay was validated using 200 HAV IgM positive, 545 HBsAg-positive but anti-HDV IgG-negative, 350 anti HCV positive plasma samples and 200 healthy human blood samples. Additionally, a concordance study was conducted with 545 HBsAg-positive and 37 anti-HDV IgG-positive plasma samples, comparing the anti-HDV IgG reagent against reagent A. Results 1 909 HBsAg-positive plasma samples were tested using 3 anti HDV IgG reagent and 1 HDV RNA reagent, 19 samples were identified as anti-HDV IgG-positive. The anti-HDV IgG demonstrated superior accuracy and specificity. The assay exhibited excellent precision, with intra-assay coefficient of variation (CV) values ranging from 1.57% to 4.30%, and inter-assay CV values between 1.71% and 4.67% for detecting samples at high, medium, and low concentration levels. Concordance with Reagent A showed consistent results in both positive and negative detections. Conclusion In this study, the anti-HDV IgG reagent (chemiluminescence method) displayed outstanding specificity in detecting clinical samples and exhibited a high conformity rate with commercialized reagents, making it potentially suitable for screening anti-HDV IgG in HBsAg-positive samples.

    肝炎,丁型丁型肝炎病毒抗-HDVIgG化学发光法

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    国产丁型肝炎病毒核酸检测试剂的性能评估和初步临床应用

    李永聪袁榕晨向宽辉欧国敏...
    239-244页
    查看更多>>摘要：目的 对一种国产丁型肝炎病毒核酸定量试剂（简称“国产HDV RNA试剂”）进行质量评估和初步临床应用探索。 方法 基于Bio-Rad CFX Opus 96实时荧光定量PCR分析系统的国产HDV RNA试剂对WHO HDV RNA国际标准品系列稀释样本进行分析，对国产HDV RNA试剂的灵敏度和准确度进行评价，并将人工合成的假病毒或病毒培养物稀释后用于国产HDV RNA试剂线性范围评价；采用国产HDV RNA试剂对HAV、HBV、HCV感染的阳性样本以及HEV国家参考品进行分析，对其特异性进行评价；用国产HDV RNA试剂测试高、低两个水平的样本，进行精密度评价；用基于ABI 7500 FAST DX荧光定量PCR仪的RoboGene HDV RNA作为对比试剂与国产HDV RNA试剂平行检测30例丁型肝炎病毒抗体IgG（HDV IgG）阳性样本，采用Pearson相关系数（r）评价2种试剂的相关性。 结果 国产HDV RNA试剂的灵敏度为6 IU/ml，与对比试剂宣称的灵敏度一致；对WHO HDV RNA标准品的标定曲线的斜率为-3.286，扩增效率为101.6%，对8种HDV基因型的线性检测范围为10~108 IU/ml；与HAV、HBV、HCV和HEV不发生交叉反应；对5个浓度水平样本的准确度评价符合要求，对高、低两个水平样本的批内精密度变异系数在1.20%~4.20%，批间精密度变异系数在1.20%~7.90%。对HDV IgG阳性样本的检测结果与对比试剂一致（r=0.984，P<0.001），与测序结果比较准确率为100%。 结论 本研究中国产HDV RNA试剂表现出较好的特异性、准确度、精密度和较宽的线性范围，灵敏度达到国际同类型试剂的水平。 Objective This study aims to evaluate the quality and explore the preliminary clinical applications of a domestically developed hepatitis D virus nucleic acid quantification reagent (abbreviated as"domestic HDV RNA reagent"). Methods The sensitivity and accuracy of the reagent were evaluated in accordance with the WHO HDV RNA international standard, employing the Bio-Rad CFX Opus 96 real-time fluorescence quantitative PCR analysis system. Serial dilutions of pseudo-viruses or cell culture-derived virus were used to determine the linear range of the domestic HDV RNA reagent. Specificity was assessed using positive samples of HAV, HBV, HCV infection, and HEV national reference materials. Precision was evaluated with samples at both high and low concentrations. In a comparative analysis, 30 HDV IgG positive samples were tested using both the domestic HDV RNA reagent and the RoboGene HDV RNA kit based on the ABI 7500 FAST DX system. The Pearson correlation coefficient (r) was used to examine the correlation between the two reagents. Results The domestic HDV RNA reagent demonstrated a high sensitivity of up to 6 IU/ml, consistent with that of the comparator reagent. The calibration curve for WHO HDV RNA standards had a slope of -3.286, with an amplification efficiency of 101.6%. The linear detection range spanned from 10 to 108 IU/ml for eight HDV genotypes. The domestic HDV RNA reagent exhibited exceptional specificity, without cross-reactivity observed with HAV, HBV, HCV, or HEV. Accuracy assessments at five concentration levels met the required standards, with intra-assay precision coefficient of variation (CV) ranging from 1.20% to 4.20%, and inter-assay precision CV from 1.20% to 7.90%. The detection results for HDV IgG positive samples were highly correlated with the comparator reagent (r=0.984, P<0.001), achieving a diagnostic accuracy of 100% compared to sequencing results. Conclusion In this study, the domestic HDV RNA reagent possesses excellent specificity, accuracy, precision, and a broad linear range, attaining a sensitivity level on par with international reagents of the same type.

    丁型肝炎病毒RNA病毒逆转录实时荧光聚合酶链式反应诊断质量评价

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    戊型病毒性肝炎的流行率及其血清学指标特征研究

    卞成蓉刘新韩蕊蕊赵利利...
    245-251页
    查看更多>>摘要：目的 探讨戊型肝炎病毒（HEV）感染患者的流行情况及其血清学指标对HEV感染患者的筛查价值。 方法 回顾分析北京市解放军总医院第五医学中心和佑安医院2018年1月1日至2023年8月31日同时检测抗-HEV IgM和IgG的数据97 440例，其中男性61 005例，女性36 435例，年龄（51.65±13.05）岁。根据抗-HEV特异性抗体阴阳性分为抗-HEV IgM阳性组（3 588例）、抗-HEV IgG阳性组（18 083例）和抗-HEV 抗体阴性组（78 892例），收集其患者的HEV RNA、肝功能、AFP、PIVKA-Ⅱ和PT检测结果及基本临床资料，统计HEV感染患者的流行情况，以及抗-HEV特异性抗体阴阳性与患者的各年龄段、HEV RNA及临床特征的关系。 结果 97 440例同时检测抗-HEV IgM和IgG患者中，抗-HEV IgM阳性率为3.68%（3 588/97 440），抗-HEV IgG阳性率为18.56%（18 083/97 440）。2018—2023年间，北京2家医院整体来看抗-HEV IgM的阳性率依次为2.51%、2.53%、3.02%、4.59%、5.72%和4.26%（χ²=1 401.73，P<0.001），抗-HEV IgG阳性率依次为12.56%、12.32%、12.85%、22.65%、27.42%和26.66%（χ²=1 058.29，P<0.001），均是缓慢上升至2023年开始下降。就诊患者在1~30岁、>30~60岁和>60岁的抗-HEV IgM阳性率（2.28%、3.60%、4.47%）（χ²=89.62，P<0.001）和IgG的阳性率（4.71%、17.86%、25.94%）（χ²=2 017.32，P<0.001）均随着年龄的增加而升高。抗-HEV IgM阳性组患者的年龄和ALB值低于IgG阳性组，而男性比例、TBIL、ALT、AFP和PT值高于IgG阳性组，差异有统计学意义（P均<0.05）；抗-HEV IgM和IgG阳性组患者的年龄、男性比例、TBIL、ALT、AFP、PIVKA-Ⅱ和PT值均高于抗-HEV阴性组，两组ALB值均低于抗-HEV阴性组，都具有统计学意义（P均<0.05）。2 162例HEV感染患者根据HEV RNA阴阳性分组，HEV RNA阳性组患者抗-HEV IgM单阳性、IgG单阳性、IgM+IgG双阳性和抗体阴性比例分别为5.42%（18/332）、3.62%（12/332）、90.36%（300/332）和0.60%（2/332）；其中，HEV RNA阳性组抗-HEV IgM+IgG双阳性患者比例高于HEV RNA阴性组（χ²=302.87，P<0.001），抗-HEV IgG单阳性（χ²=174.36，P<0.001）和抗-HEV抗体阴性（χ²=59.28，P<0.001）患者比例低于HEV RNA阴性组。此外，抗-HEV IgM阳性、IgG阳性和抗体阴性患者的HEV RNA的阳性率依次为29.23%（318/1 088）、17.59%（312/1 774）和0.65%（2/306）。 结论 就诊患者HEV感染率在2023年开始下降。HEV感染与年龄相关，老年人更易感。HEV感染时肝功能异常，黄疸多见。抗-HEV特异性抗体阴性不能说明没有HEV感染，还需检测HEV RNA和/或HEVAg来诊断。 Objective This study aims to explore the prevalence of hepatitis E virus (HEV) infection in patients and the screening value of serological indicators for HEV infection patients. Methods Retrospective analysis was conducted on 97 440 cases of anti-HEV IgM and IgG simultaneously tested in two Beijing hospitals from January 1, 2018 to August 31, 2023. Among them, there were 61 005 males and 36 435 females, with an average age of 51.65±13.05 years old. According to the positivity of anti HEV specific antibodies, they were divided into anti-HEV IgM positive group (3 588 cases), anti-HEV IgG positive group (18 083 cases), and anti-HEV antibody negative group (78 892 cases). Results of HEV RNA, liver function, AFP, PIVKA-Ⅱ and PT were collected, and their basic clinical information were recorded. The prevalence of HEV infection in patients, as well as the relationship between the positivity of anti-HEV specific antibodies and the patient′s age group, HEV RNA, and clinical characteristics were analyzed. Results Among 97 440 patients who tested anti-HEV IgM and IgG simultaneously, the positivity rate of anti-HEV IgM was 3.68% (3 588/97 440), and was 18.56% for anti-HEV IgG (18 083/97 440). The overall positivity rates of anti-HEV IgM in two Beijing hospitals from 2018 to 2023 were 2.51%, 2.53%, 3.02%, 4.59%, 5.72%, and 4.26% (χ²=1 401.73, P<0.001), while the positivity rates of anti-HEV IgG were 12.56%, 12.32%, 12.85%, 22.65%, 27.42%, and 26.66% (χ²=1 058.29, P<0.001). These rates showed a gradual increase until 2023 when a decline was observed. The positivity rates of anti-HEV IgM (2.28%, 3.60%, 4.47%) (χ²=89.62, P<0.001) and IgG (4.71%, 17.86%, 25.94%) (χ²=2 017.32, P<0.001) increased with age in patients who aged 1-30, >30-60, and over 60 years old. The age and ALB values of patients in the anti-HEV IgM positive group were lower than the IgG-positive group, while the proportion of males, TBIL, ALT, AFP and PT values were higher than the IgG-positive group, and the differences were statistically significance (P<0.05). Furthermore, patients in both the anti-HEV IgM and IgG positive groups had higher age, male proportion, TBIL, ALT, AFP, PIVKA-Ⅱ, and PT values than the anti-HEV negative group. Additionally, both groups had lower ALB values than the anti-HEV negative group, all of which were statistically significant (P<0.05). 2 162 HEV infected patients were grouped based on HEV RNA positivity. The proportion of anti-HEV IgM single positive, IgG single positive, IgM+IgG double positive, and antibody negative patients in the HEV RNA positive group were 5.42% (18/332), 3.62% (12/332), 90.36% (300/332), and 0.60% (2/332), respectively. Among them, the proportion of anti-HEV IgM+IgG double positive patients in the HEV RNA positive group was higher than that in the HEV RNA negative group (χ²=302.87, P<0.001), while the proportion of anti-HEV IgG single positive (χ²=174.36, P<0.001) and anti-HEV antibody negative patients (χ²=59.28, P<0.001) were lower than that in the HEV RNA negative group, both of which were statistically significant (P<0.001). In addition, the positive rates of HEV RNA in anti-HEV IgM positive, IgG positive, and antibody negative patients were 29.23% (318/1 088), 17.59% (312/1 774), and 0.65% (2/306), respectively. Conclusion The HEV infection rate among patients declined in 2023. HEV infection is age-related, with older individuals being more susceptible. Abnormal liver function and jaundice were commonly observed during HEV infection. It is crucial to note that the absence of anti-HEV specific antibodies cannot rule out HEV infection therefore, additional testing for HEV RNA and/or HEV Ag is necessary for accurate diagnosis.

    戊型肝炎病毒属戊型肝炎抗体流行率临床特征

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    戊型肝炎病毒感染慢性肝病人群重症化早期临床预测模型的构建与应用

    徐亚洲陈文君胡波唐栋...
    252-258页
    查看更多>>摘要：目的 建立慢性肝病患者重叠感染戊型肝炎病毒（HEV）后的早期临床预测模型，快速评估患者发生重症肝炎的概率。 方法 回顾分析2018年5月至2023年9月在中山大学附属第三医院住院治疗的抗-HEV IgG、抗-HEV IgM抗体双阳性的慢性肝病患者87例，根据患者临床症状、病史资料、实验室检查等将患者分为重症组（TBIL>171 μmol/L且PTA<40%）53例与非重症组（TBIL<171 μmol/L且PTA>40%）34例。使用LASSO回归及最优子集建模等方法筛选影响重症肝炎发生的独立变量并绘制列线图评估重症肝炎发生概率。分别通过曲线下面积（AUC）及校准曲线的平均绝对误差等方法评估模型效果。 结果 重症组患者血清总胆汁酸［240.00（183.30，268.70）μmol/L］水平高于非重症组患者［93.40（20.10，271.70）μmol/L，U=269.00，P=0.002］，载脂蛋白A1［0.32（0.18，0.48）g/L］、尿酸［156.15（117.00，202.00）umol/L］水平显著低于非症重症组患者APOA1［0.77（0.63，1.06）g/L，U=71.00，P<0.001］、UA［334.05（243.70，401.00）μmol/L，U=83.00，P<0.001］；载脂蛋白A1和尿酸为患者重症化的独立变量；为提高模型效果，将两个独立变量联合总胆汁酸纳入模型绘制列线图，AUC为0.963（95%CI 0.927~0.998），校准曲线的平均绝对误差为0.024。列线图临界值为129分，阳性预测值和阴性预测值分别为94.0%和88.2%。 结论 通过回顾分析，建立早期快速评估慢性肝病患者重叠感染HEV后重症化概率的列线图模型，可准确有效的预测患者重症发生的风险。 Objective To establish an early clinical prediction model for patients with chronic liver disease who are coinfected with hepatitis E virus (HEV), and quickly evaluate the probability of severe hepatitis in patients. Methods A retrospective analysis was conducted on 87 patients with chronic liver diseases who were hospitalized at the Third Affiliated Hospital of Sun Yat-sen University from May 2018 to September 2023. Clinical features and laboratory indexes were analyszed and patients were classified to severe (TBIL >171 μmol/L with PTA <40%) and non-severe (TBIL <171 μmol/L with PTA >40%) groups. and Independent factors identified using LASSO regression were incorporated into a novel nomogram to identify patients at high risk of severe hepatitis in the early stages. The performance of the nomogram was evaluated using the area under the curve and the mean absolute error of the calibration curve. Results Significant difference was observed in the serum total bile acid (TBA) level between the severe group [240.00 (183.30, 268.70) umol/L] and the non-severe group [93.40 (20.10, 271.70) μmol/L, U=269.00, P=0.002]. Additionally, the levels of apolipoprotein A1 (APOA1) [0.32 (0.18, 0.48) g/L] and uric acid (UA) [156.15 (117.00, 202.00) μmol/L] were significantly lower in the severe group compared to the non-severe group (APOA1: [0.77 (0.63, 1.06) g/L,U=71.00, P<0.001] UA: [334.05 (243.70, 401.00) μmol/L,U=83.00, P<0.001]). The researchers developed a nomogram, which incorporated two independent factors (APOA1 and UA) and an additional variable (TBA), exhibiting a strong predictive ability, with an area under the curve (AUC) of 0.963 (95% confidence interval: 0.927-0.998) and a well-fitted calibration curve. Positive and negative predictive values of 94.0% and 88.2% were calculated, and a nomogram score of 129 or greater was considered indicative of a higher likelihood of developing severe illness. Conclusions This nomogram offers a rapid and accurate means of evaluating the probability of severe illness in patients with chronic liver disease after overlapping infection with HEV, which can accurately and effectively predict the risk of severe illness in patients.

    戊型肝炎病毒属肝炎,慢性重叠感染列线图

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    个体间生物学特征和采血时间对肌钙蛋白T浓度影响的研究

    林依婷周琰周佳烨张春燕...
    259-263页
    查看更多>>摘要：目的 探讨性别、年龄、采血时间及季节和 cTnT 检测值变化的相关性。 方法 本研究选取了 2019 年 1月1日至12月31日，复旦大学附属中山医院就诊的 3 548 例非心血管疾病的人群。收集基础资料，包括性别、年龄、采血时间、病史、临床诊断和 cTnT 检测结果，最终入组了男性1 840例，女性1 708例，年龄分布为65（53，75）岁。使用 Kolmogorov-Smirnov（K-S）检验评估数据分布，其中非正态分布的数据以M（Q1，Q3）表示。使用 Mann-Whitney U 检验比较男性与女性之间的 cTnT 浓度，分析性别因素对cTnT检测结果的影响，使用 Kruskal-Wallis 检验比较各性别组之间的 cTnT 水平，分析不同采血时间、季节等因素与 cTnT 浓度的相关性。 结果 在 60 岁以上的人群中，男性和女性的cTnT 浓度均随着年龄的增长而逐渐升高，cTnT 在 90 岁以上的个体中达到最高水平（男性为 0.028 ng/ml，女性为 0.018 ng/ml）。全年龄组分析中显示，男性cTnT 水平（0.012 ng/ml）均高于女性（0.009 ng/ml）（H=6.340，P<0.01）。不同采血时间点的 cTnT 浓度不同。在男性和女性中，cTnT 浓度在 8：00 和 13：00 达到最大值（分别为 0.013 ng/ml 和 0.012 ng/ml）。分析季节对cTnT分泌的生理性影响，结果显示春季和冬季的cTnT 水平（0.012 ng/ml）通常高于夏、秋两季（0.010 ng/ml）。 结论 cTnT 检测值与性别、年龄、采血时间和季节等因素相关。临床工作中分析cTnT检测结果时，应综合考虑个体的性别和年龄，以及采血时间点和季节因素的影响。 Objective To investigate the correlation between gender, age, blood collection time, season and changes in cTnT concentration. Methods In this study, 3548 patients (non-cardiovascular diseases) in Zhongshan Hospital of Fudan University were selected from 1 January to 31 December 2019. The basic data of the patients were collected, including gender, age, time of blood collection, medical history, clinical diagnosis, and results of cTnT testing. 1 840 males and 1 708 females were finally enrolled, with an age distribution of 65 (53, 75) years. The distribution of the data was assessed using the Kolmogorov-Smirnov (K-S) test, where non-normally distributed data were expressed as M(Q1, Q3). The Mann-Whitney U-test was used to compare cTnT concentrations between men and women, and to analyse the influence of gender on cTnT results. The Kruskal-Wallis test was used to compare cTnT levels between gender groups, to analyse the correlation between different times of blood collection, seasons, and other factors and cTnT concentrations. Result cTnT concentrations increased with age in both males and females over the age of 60 years. cTnT levels were highest in individuals over the age of 90 years (0.028 ng/ml in males and 0.018 ng/ml in females). cTnT levels were higher in males (0.012 ng/ml) than in females (0.009 ng/ml) in all age groups (H=6.340,P<0.01). The concentrations of cTnT varied at different time points of blood collection. In both males and females, cTnT concentrations reached a maximum at 8:00 and 13:00 (0.013 ng/ml and 0.012 ng/ml, respectively). Analysis of the physiological effect of season on cTnT secretion showed that cTnT levels were generally higher in spring and winter(0.012 ng/ml) than in summer and autumn(0.010 ng/ml). Conclusions cTnT concentration is influenced by gender, age, time of blood collection and season. When analysing cTnT results in clinical practice, the gender and age of the individual should be taken into account, as well as the time point of blood collection and seasonal factors.

    肌钙蛋白生物学因素性别年龄采血时间季节变化

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    N末端B型利钠肽原在植入磁液悬浮左心室辅助装置终末期心衰患者中应用价值初探

    侯泽刘雨庭王欣怡叶英楠...
    264-271页
    查看更多>>摘要：目的 探讨终末期心衰（ESHF）患者在植入HeartCon型左心室辅助装置（LVAD）术前和术后N末端B型利钠肽原（NT-proBNP）的变化及对预测心脏不良事件的作用。 方法 回顾性研究，连续选取2020年9月15日至2023年6月20日在泰达国际心血管病医院住院治疗植入HeartCon型LVAD的ESHF患者30例，其中男23例，女7例，年龄54.5（40.8，60.0）岁。分析其临床资料，测量其术前水平和随访期内血液样本中NT-proBNP浓度。对患者定期随访，记录出院后6个月内主要不良心脏事件，包括心源性死亡和右心衰再住院；Logistic回归进行预后分析，ROC曲线评估NT-proBNP对LVAD患者不良预后的辅助诊断价值。通过对NT-proBNP诊断不良预后的临界值分成两组，用Kaplan-Meier进行生存分析，并用Log Rank检验；Cox回归分析随访6个月高水平NT-proBNP是否为LVAD患者不良预后的危险因素。 结果 成功植入HeartCon型LVAD的30例ESHF患者术前NT-proBNP中位水平达到3 251.0（1 544.5，6 401.5）pg/ml，在植入后第7天下降（3 251.0 比 1 815.0 pg/ml，P<0.05），之后下降趋势逐渐变缓，术后第90天下降到1 182.0（620.0，3 385.3）pg/ml。术前NT-proBNP>3 251.0 pg/ml组患者术后住院时间更长（47 d 比 33 d，Z=-2.138，P=0.032）。多因素 Logistic 回归分析发现仅术后第7天NT-proBNP是LVAD患者术后预后不良的预测指标，OR值为1.001（P=0.011）；ROC曲线分析术后第7天NT-proBNP水平对不良预后的辅助诊断价值（cut-off 值为2 083.0 pg/ml），AUC 为0.833（P=0.002）；根据临界值分组，Kaplan-Meier 生存分析结果显示术后第7天NT-proBNP>2 083.0 pg/ml组的6个月内发生心脏不良事件时间明显短于NT-proBNP≤2 083.0 pg/ml组差异有统计学意义（3.538±0.689比5.471±0.323个月，P=0.004）；Cox回归分析显示术后第7天NT-proBNP>2 083.0 pg/ml组心脏不良事件风险是NT-proBNP≤2 083.0 pg/ml组的4.25倍（HR=4.25，P=0.035）。 结论 HeartCon型LVAD患者术前NT-proBNP水平越高术后住院时间越长。术后第7天NT-proBNP水平下降最明显，术后第7天NT-proBNP水平是心脏不良事件发生的危险因子，可作为植入LVAD的终末期心衰患者预后不良事件的预测因素。 Objective To investigate the changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and its role in predicting major adverse cardiac events (MACEs) in patients with end-stage heart failure (ESHF) before and after implanted a HeartCon left ventricular assist device (LVAD). Methods The retrospective study included 30 ESHF patients [23 males and 7 females, aged 54.5 (40.8, 60.0) years], who were admitted to TEDA International Cardiovascular Disease Hospital from September 15, 2020 to June 20, 2023 to receive treatment with HeartCon LVAD implantation. Their clinical data were analyzed and NT-proBNP concentrations in their blood samples were measured preoperatively and during the follow-up period. Patients were followed regularly and MACEs, including cardiac death and rehospitalization for right heart failure, were recorded within 6 months of discharge Logistic regression was used for prognostic analysis, and Receiver Operator Characteristic (ROC) curves were used to assess the adjunctive diagnostic value of NT-proBNP for poor prognosis in LVAD patients. The cut-off values for diagnosing poor prognosis by NT-proBNP were divided into two groups, and survival analysis was performed by Kaplan-Meier and tested by log rank Cox regression was performed to analyze whether high levels of NT-proBNP at 6 months of follow-up wsa a risk factor for poor prognosis in patients with LVAD. Results The median preoperative NT-proBNP level in 30 ESHF patients successfully implanted with HeartCon LVADs was 3 251.0 (1 544.5, 6 401.5) pg/ml. It decreased significantly 7 days postoperatively (3 251.0 vs. 1 815.0 pg/ml, P<0.05), and then the decreasing trend slowed. It decreased to 1 182.0 (620.0, 3 385.3) pg/ml on the 90th post-operative day. The preoperative NT-proBNP>3 251.0 pg/ml group had a longer postoperative hospital stay (47 dvs 33 d, Z=-2.138, P=0.032). Multivariate logistic regression analysis, only NT-proBNP at 7 days postoperatively was found to predict poor prognosis in LVAD patients, with an OR of 1.001 (P=0.01) ROC curves were analyzed for the adjunctive diagnostic value of 7-day postoperative NT-proBNP levels for poor prognosis (cut-off value of 2 083.0 pg/ml), with an AUC of 0.833 (P=0.002) The Kaplan-Meier survival analysis showed that the time to MACEs within 6 months was significantly shorter in the group with NT-proBNP>2 083.0 pg/mL on postoperative day 7 than in the group with NT-proBNP≤2 083.0 pg/ml (3.538±0.689vs. 5.471±0.323 months, P=0.004) Cox regression analysis showed that the risk of MACEs was 4.25 times higher in the 7-day postoperative NT-proBNP>2 083.0 pg/ml group than in the NT-proBNP≤2 083.0 pg/ml group (HR=4.25, P=0.035). Conclusions The higher the preoperative NT-proBNP level, the longer the postoperative hospital stay in HeartCon LVAD patients. NT-proBNP levels decrease most significantly on postoperative day 7 and is a risk factor for MACEs. It may be used as a prognostic predictor in ESHF patients with implanted LVADs.

    心力衰竭左心室辅助装置终末期心力衰竭NT-proBNP

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