新时代检验医学发展定位与思考

检验医学作为医学科学的重要支撑学科,在疾病早期诊断、病情监测、预后判断与风险评估等方面发挥着重要作用。21世纪是数字信息时代,高新检测技术、计算机科学及互联网大数据等,为检验医学的发展带来巨大的机遇与挑战,新时代下如何借助信息科技革命实现检验医学新发展是检验工作者面临的重要课题。该文回顾检验医学的发展历程,重点关注检验医学在新时代的发展定位及未来发展方向,以求开创检验医学发展新局面。     

桂枝芍药知母汤对类风湿性关节炎患者实验室指标和免疫功能的影响

目的:探讨桂枝芍药知母汤对类风湿性关节炎患者实验室指标和免疫功能的影响。方法:选取2014年12月至2016年12月南京中医药大学附属南京市中西医结合医院收治的类风湿关节炎患者110例作为研究对象，按照随机数字表法分为对照组和观察组，每组55例。对照组采用常规西医治疗，观察组在对照组的基础上联合桂枝芍药知母汤治疗，2组均治疗1个月。比较2组临床效果、临床症状改善情况、实验室指标及免疫功能指标水平；统计2组不良反应发生率。结果:观察组总有效率为92.73%，高于对照组（78.18%，P<0.05）。与治疗前比，治疗1个月后，2组握力均增大，且观察组大于对照组（P<0.05）；2组晨僵时间、20 m步行时间均缩短，且观察组短于对照组（P<0.05）；2组关节压痛数、关节肿胀数、ESR、MPV、PDW及血清CRP、血浆IgA、IgG、IgM、RF水平均降低，且观察组低于对照组（P<0.05）；2组血清C3水平均升高，且观察组高于对照组（P<0.05）。治疗期间，观察组不良反应发生率为0.00%，低于对照组（10.91%，P<0.05）。结论:桂枝芍药知母汤治疗类风湿性关节炎，可改善患者实验室指标，增强免疫功能，提高疗效，安全性较高。     

Cost-effectiveness of maternal immunization against neonatal invasive Group B Streptococcus in the Netherlands

BackgroundNeonatal invasive Group B Streptococcus (GBS) infection causes considerable disease burden in the Netherlands. Intrapartum antibiotic prophylaxis (IAP) prevents early-onset disease (EOD), but has no effect on late-onset disease (LOD). A potential maternal GBS vaccine could prevent both EOD and LOD by conferring immunity in neonates.ObjectiveExplore under which circumstances maternal vaccination against GBS would be cost-effective as an addition to, or replacement for the current risk factor-based IAP prevention strategy in the Netherlands.MethodsWe assessed the maximum cost-effective price per dose of a trivalent (serotypes Ia, Ib, and III) and hexavalent (additional serotypes II, IV, and V) GBS vaccine in addition to, or as a replacement for IAP. To project the prevented costs and disease burden, a decision tree model was developed to reflect neonatal GBS disease and long-term health outcomes among a cohort based on 169,836 live births in the Netherlands in 2017.ResultsUnder base-case conditions, maternal immunization with a trivalent vaccine would gain 186 QALYs and prevent more than €3.1 million in health care costs when implemented in addition to IAP. Immunization implemented as a replacement for IAP would gain 88 QALYs compared to the current prevention strategy, prevent €1.5 million in health care costs, and avoid potentially ~ 30,000 IAP administrations. The base-case results correspond to a maximum price of €58 per dose (vaccine + administration costs; using a threshold of €20,000/QALY). Expanding the serotype coverage to a hexavalent vaccine would only have a limited additional impact on the cost-effectiveness in the Netherlands.ConclusionsA maternal GBS vaccine could be cost-effective when implemented in addition to the current risk factor-based IAP prevention strategy in the Netherlands. Discontinuation of IAP would save costs and prevent antibiotic use, however, is projected to lead to a lower health gain compared to vaccination in addition to IAP.     

Relationship between biological variation and delta check rules performance

ObjectivesThe performance of delta check rules has been considered to be dependent on the biological variation characteristics of the analyte of interest. The assumed relationships have not been formally studied. The mathematical relationship between biological variation and delta check rules is explored in this study.Design and methodsFrom the mathematical model for absolute difference delta check, the threshold for specificity and sensitivity are observed to be normalized differently. For specificity, the threshold is normalized by the within-subject biological variation (expressed as a coefficient of variation, ${\mathit{CV}}_i$), whereas for sensitivity the threshold is normalized by the between-subject biological variation (expressed as a coefficient of variation, ${\mathit{CV}}_g$). This highlights the different roles the two biological variations play in affecting the absolute difference distribution for correct and switched patient samples. Analogous to absolute difference delta checks, for relative difference delta checks, the expressions for specificity and sensitivity are scaled by ${\mathit{CV}}_i$ and ${\mathit{CV}}_g,$ respectively. However, the expressions are independent of ${\mu }_g$(the average of the population).ResultsA comparison between the mathematical model and empirical/ historical laboratory data obtained from patients was conducted for both absolute and relative difference delta checks. In general it was found that the specificity obtained from the historical laboratory data was less than the model predicted values, while on the other hand, good correspondence was obtained between the experimental sensitivity and predicted sensitivity.ConclusionsThe difference in within-subject biological variation in different patients may contribute to the observed discrepancy in predicted and empirical delta check performance.     

探讨尿常规检验的质量管理方法研究

目的分析研究尿常规检验的质量管理方法及应用效果。方法随机抽取在该院行尿常规检查的尿液样本500份作为研究对象,其中2018年1-6月期间的250份作为对照组,该组未实施质量管理,2018年7-12月期间的250份作为研究组,该组实施质量管理。对比两组尿液样本检验的合格率。结果研究组中的样本检验合格率明显高于对照组,组间差异有统计学意义(P<0.05)。结论对在该院进行常规尿液检查的患者进行质量管理可以有效提高尿常规检查的合格率,改善样本污染等情况,具有较高的临床推广价值。