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目的 在体外诊断试剂(IVDR)临床试验中,准确快速地完成EP09c的统计分析工作。方法 利用MedCalc软件对差异图(Difference Plot)执行偏倚量化;利用SPSS或MedCalc软件的回归模型对散点图(Scatter Plot)执行偏倚量化;差异图和散点图被用于确认偏倚量化结果的正确性。结果 MedCalc的差异图确定工作样本的低浓度数据符合恒定标准差分布,偏倚为0.10(0.09,0.28);高浓度数据符合恒定变异系数分布,偏倚为-5.0%(中位数:-7.2%,1.5%)或-3.2%(Hodges-Lehmann中位数:-5.5%,-0.8%)。散点图确认Passing&Bablok回归和加权线性回归(权重1/xi 1.4)适用于工作样本的数据,回归方程分别为y=0.122+0.952x(R2=0.983)和y=0.269+0.977x(R2=0.981)。结论 偏倚量化结果必须得到差异图和散点图的确认,否则结果的正确性无法保证。
Objective To perform accurate and efficient statistical analysis of EP09c in clinical studies of in vitro diagnostic reagents(IVDR).Methods Bias quantification was performed on the difference plot using MedCalc.Bias quantification was conducted on the scatter plot using regression modeling in SPSS and MedCalc.The difference plot and scatter plot were employed to corroborate the accuracy of the bias quantification results.Results Difference plots demonstrated that the low-concentration data of the working sample exhibited a constant standard deviation distribution with a bias of 0.10(0.09,0.28),while the high-concentration data conformed to a constant coefficient of variation distribution with a bias of -5.0%(median:-7.2%,1.5%) or -3.2%(Hodges-Lehmann median:-5.5%,-0.8%).Scatter plots confirmed that Passing & Bablok(P-B) regression and weighted least square(WLS) regression(weight 1/xi 1.4) were applicable to the data from the working sample,with the resulting regression equations being y=0.122+0.952x(R2=0.983) and y=0.269+0.977x(R2=0.981),respectively.Conclusions The results of bias quantification must be confirmed by difference plot and scatter plot,otherwise the correctness of the results cannot be assured.
目的 开发一款针对慢性阻塞性肺疾病(COPD)患者居家症状管理的微信小程序,并全面评价其可用性,旨在为患者提供智能化、个性化的居家管理工具。方法 首先采用半结构化访谈分析患者及照顾者的核心需求。随后,组建多学科团队,基于需求分析结果开发了名为“呼吸哨兵”的微信小程序,包含5大功能模块。开发完成后,通过纳入10名测试者的内部测试,采用整体评估可用性问卷(PSSUQ)进行初步评估与迭代优化。最终,纳入52例COPD患者进行为期1个月的用户测试,采用系统可用性量表(SUS)及开放式问卷评价其最终可用性。结果 成功开发了“呼吸哨兵”微信小程序,包括用户登录、症状管理、健康日志、健康教育、沟通互动五大模块。内部测试后,针对PSSUQ评分高于基准值的4个题项进行了优化,关键指标如任务完成效率评分从3.50分降至2.90分。最终用户测试显示,小程序的SUS总分均值为(76.15±6.58)分,处于“良好”水平。此外,81%的用户表示愿意继续使用并推荐给其他病友。结论 “呼吸哨兵”小程序内容与功能设计针对性强,整体可用性良好,能够满足COPD患者居家康复管理的核心需求。
Objective To develop a WeChat mini program for home-based symptom management for patients with chronic obstructive pulmonary disease(COPD)and to evaluate its usability.Methods Semi-structured interviews were used to analyze the needs of patients and caregivers.A multidisciplinary team was formed to develop the “The Breath Sentinel” mini program with five functional modules.Initially,an internal test involving 10 users was conducted using the Post-Study System Usability Questionnaire(PSSUQ)for iterative optimization.Following this,52 COPD patients were recruited for a one-month user test,and the System Usability Scale(SUS)along with an open-ended questionnaire were used for the final usability evaluation.Results We successfully developed “The Breath Sentinel” WeChat mini program.Internal testing led to targeted optimizations,improving key metrics such as the task efficiency score from 3.50 to 2.90.The final user test with 52 users showed that the mean SUS score was(76.15±6.58),indicating “good” usability.Furthermore,81% of users expressed their willingness to continue using and recommend the mini program.Conclusions The content and functions of “The Breath Sentinel” mini program are well-targeted and comprehensive.It demonstrates good usability and can meet the home rehabilitation management needs of COPD patients.
目的 利用心脏代谢指数(CMI)和轻量级梯度提升机(LightGBM)模型评估代谢综合征(MetS)患者靶器官损害风险,探究其性别特异性关联,为精准干预提供依据。方法 纳入2022年8月至2025年2月在惠州市第一人民医院住院的132例MetS患者以及健康体检者400例(即对照组,仅作为基线对比参数),以心肾损害、大血管病变为复合靶器官损害终点,选取CMI、年龄等为核心特征;构建LightGBM分类模型(70%训练集、30%测试集分层抽样),并采用100次随机拆分验证得出曲线下的面积(AUC)和95%置信区间(CI)并绘制校准曲线;以AUC评估性能,结合沙普利加性解释算法(SHAP)和偏依赖图(PDP)进行可解释性及性别分层分析。结果 基线对比显示,MetS患者CMI(6.8±2.3)高于对照组(3.2±1.1),靶器官损害(TOD)阳性率(57.6%)高于对照组(12.0%)(P均<0.001);LightGBM模型预测AUC达0.812,CMI为最重要预测特征(相对贡献度31.5%),且CMI与性别交互作用检验差异有统计学意义(P<0.01);CMI与靶器官损害呈非线性S形关联,风险拐点为5.7,高危平台期为7.5;女性风险加速阈值(CMI 5.0)早于男性(CMI 6.5)。结论 以健康人群为对照明确了MetS患者的高CMI水平与高TOD风险特征,LightGBM-SHAP框架明确了CMI的核心预测价值,性别特异性阈值为制定男女个性化早期干预策略提供量化指导,具有良好的临床应用潜力。
Objective This study aims to use the cardiometabolic index(CMI)and the LightGBM model to assess the risk of target organ damage(TOD)in metabolic syndrome(MetS)patients,explore its gender-specific associations,and provide a basis for precise intervention.Methods MetS patients meeting diagnostic criteria and healthy individuals(the control group,used only as a baseline reference parameter)were enrolled.The composite endpoint of TOD was defined as cardiorenal damage and macro/microvascular lesions.Core features selected included CMI and age.A LightGBM classification model was constructed(70% training set,30% test set with stratified sampling),and 100 random splits were used for validation to generate the area under the curve(AUC) with 95% confidence interval(CI)and draw the calibration curve.Performance was assessed using AUC,combined with the SHAP algorithm and Partial Dependence Plot(PDP)for interpretability and gender-stratified analysis.Results Baseline comparison showed that the CMI level of MetS patients(6.8±2.3)was significantly higher than that of the control group(3.2±1.1),and the positive rate of TOD(57.6%)was significantly higher than that of the control group(12.0%)(both P<0.001).The LightGBM model achieved an AUC of 0.875 in prediction,with CMI as the most important predictive feature(relative contribution of 31.5%),and the interaction test between CMI and gender showed a significant difference(P<0.01).CMI showed a non-linear S-shaped association with TOD,with a risk inflection point at 5.7 and a high-risk plateau at 7.5.Significant gender differences were observed:the threshold for accelerated risk in females(CMI 5.0)was earlier than that in males(CMI 6.5).Conclusions Using healthy individuals as controls clarifies the characteristics of high CMI levels and high TOD risk in MetS patients.The LightGBM-SHAP framework clarifies the core predictive value of CMI.The gender-specific thresholds provide quantitative guidance for formulating personalized early intervention strategies for males and females,demonstrating good potential for clinical application.
目的 探索Nrf2/HO-1通路是否参与远志皂苷元(远志)在脑出血体外细胞模型中对BV2小胶质细胞炎症反应的调控作用。方法 采用红细胞与BV2小鼠小胶质细胞共培养构建体外脑出血模型。分别给予远志单独处理、远志联合Nrf2抑制剂ML385处理,检测炎症因子水平。收集细胞上清制备条件培养基,用于培养SH-SY5Y人神经母细胞瘤细胞,并检测其铁死亡水平。结果 模型组BV2细胞炎症因子(IL-1β,IL-6,TNF-α)水平较对照组显著升高(P<0.001);高浓度远志(20 μM)可降低炎症因子水平,并上调Nrf2/HO-1通路蛋白表达,而ML385能逆转该作用。模型组条件培养基可诱导SH-SY5Y细胞铁死亡,而经远志处理的BV2细胞条件培养基则减轻该现象;ML385预处理可削弱远志对SH-SY5Y细胞的保护作用,远志组铁离子、丙二醛、转铁蛋白受体1水平低于远志联合ML385组(P<0.05),铁转运蛋白、谷胱甘肽和谷胱甘肽过氧化物酶水平高于远志联合ML385组(P<0.05)。结论 远志皂苷元通过激活Nrf2/HO-1通路抑制BV2小胶质细胞炎症反应,并在脑出血体外模型中发挥神经保护作用。
Objective To investigate whether the Nrf2/HO1 signaling pathway is involved in the regulatory effect of tenuigenin(TEN)on the inflammatory response of BV2 microglial cells in an in vitro intracerebral hemorrhage(ICH)model.Methods An in vitro ICH model was established by coculturing BV2 murine microglial cells with red blood cells.Cells were treated with TEN alone or in combination with the Nrf2 inhibitor ML385,and the levels of inflammatory factors were measured.The conditioned medium collected from the cell supernatant was used to culture SHSY5Y human neuroblastoma cells,and ferroptosis levels were assessed.Results The levels of inflammatory factors(IL-1β,IL-6,TNF-α)in BV2 cells of the model group were significantly higher than those in the control group(P<0.001).High concentration of TEN(20 μM)could reduce the levels of inflammatory factors and up-regulate the expression of Nrf2/HO-1 pathway proteins,while ML385 could reverse this effect.The conditioned medium of the model group could induce ferroptosis in SH-SY5Y cells,while the conditioned medium of BV2 cells treated with TEN could alleviate this phenomenon.Pretreatment with ML385 could weaken the protective effect of TEN on SH-SY5Y cells.The levels of iron ions,malondialdehyde and transferrin receptor protein 1 in the TEN group were lower than those in the TEN combined with ML385 group(P<0.05),while the levels of ferroportin glutathione and glutathione peroxidase 4 were higher than those in the TEN combined with ML385 group(P<0.05).Conclusions TEN inhibits the inflammatory response of BV2 microglial cells by activating the Nrf2/HO1 pathway and exerts a neuroprotective effect in the in vitro ICH model.
目的 评估年龄调整内脏脂肪指数(AVAI)与骨关节炎患病率之间的关联。方法 采用加权多元Logistic回归模型和平滑曲线拟合分析AVAI和骨关节炎患病率之间的关系,通过亚组分析和交互作用检验探讨这一关系在不同亚组人群之间的效应差异。此外,通过受试者工作特征曲线(ROC)分析评估AVAI对骨关节炎的预测效能。结果 本研究基于美国国家健康与营养调查(NHANES)2011—2018年数据,共纳入5 929例参与者。较高的AVAI指数与骨关节炎患病率呈正相关(OR=1.22,95%CI:1.07~1.40)。随着AVAI指数的增加,骨关节炎患病风险呈现先上升后缓慢下降的趋势,AVAI的拐点为-4.48。在性别、年龄、教育程度和婚姻状况亚组中观察到交互作用。结论 AVAI与骨关节炎患病率之间存在非线性关系,当AVAI低于-4.48时,骨关节炎的患病风险增加。AVAI可作为一种有效、便捷的筛查工具,用于早期识别骨关节炎高风险人群。
Objective This study aimed to evaluate the association between the age-adjusted visceral adiposity index(AVAI)and the prevalence of osteoarthritis(OA).Methods Survey-weighted multivariable logistic regression models and smooth curve fitting were used to examine the relationship between AVAI and OA prevalence.Subgroup analyses and interaction tests were conducted to explore potential effect modifications across different population subgroups.Additionally,the predictive capability of AVAI for osteoarthritis was assessed using receiver operating characteristic(ROC)curve analysis. Results A total of 5 929 participants from the National Health and Nutrition Examination Survey(NHANES)2011–2018 were included.Higher AVAI levels were significantly associated with an increased prevalence of OA(OR=1.22;95%CI:1.07–1.40).As AVAI increased,the risk of OA initially rose and then gradually declined,with an inflection point observed at ?4.48.Significant interactions were found across subgroups stratified by sex,age,education level,and marital status.Conclusions There exists a nonlinear relationship between AVAI and OA prevalence,with a significant increase in osteoarthritis risk observed when AVAI falls below -4.48.AVAI serves as an effective and convenient screening tool for identifying individuals at high risk of OA at an early stage.
目的 探讨通过优化病案首页质控体系提高误入DRG低权重组病例转出率的效果。方法 采用PDCA循环法,通过实施分层级编码培训、基于AI赋能的专项质控模式及智能化反馈机制构建等系统性地改进措施优化质控体系。通过对比分析质控系统优化前后(2022年1—7月和2023年1—7月)DRG低权重组病例的病案首页质控过程、“经质控低权重病例入组率”和“误入低权重组病例转出率”等指标,评估质控体系优化的实施效果。结果 质控体系优化后,低权重组病例转出率由3.27%提升至4.15%(P=0.018),经质控低权重病例入组率由16.98%降至14.96%(P<0.001)。结论 AI赋能的专项质控、分层级编码培训与智能化反馈机制三项措施并举可以系统优化质控体系,进而提升DRG低权重组病例转出率。
Objective To investigate the effect of optimizing the medical record front page quality control system on improving the transfer-out rate of cases mistakenly assigned to low-weight DRG groups.Methods The Plan-Do-Check-Act(PDCA)cycle methodology was employed.Systemic improvements were implemented to optimize the medical record front page quality control system,including hierarchical coding training,innovation of a specialized quality control model based on AI empowerment,and establishment of an intelligent feedback mechanism.The implementation effectiveness was evaluated by comparative analysis of the following indicators before(January-July 2022)and after(January-July 2023)optimization:the medical record quality control process for low-weight DRG cases,the rate of low-weight cases assigned to groups after quality control,and the transfer-out rate of cases mistakenly entering low-weight groups.Results After optimizing the medical record front page quality control system,the transfer-out rate of cases from low-weight groups increased from 3.27% to 4.15%(P=0.018),while the rate of low-weight cases assigned to groups after quality control decreased from 16.98% to 14.96%(P<0.001).Conclusions Implementing a three-pronged approach—AI-powered specialized quality control,hierarchical coding training,and an intelligent feedback mechanism—can systematically optimize the medical record front page quality control system,thereby improving the transfer-out rate of cases mistakenly assigned to low-weight DRG groups.
目的 观察补肾益气方肾俞膏摩治疗结直肠癌康复期癌因性疲乏的临床疗效。方法 收集2023年6月—2024年6月结直肠癌康复期的80例住院及门诊患者,随机平均分为两组。行常规对症支持治疗的为对照组;在常规对症支持治疗上加用补肾益气方肾俞膏摩的为干预组;两组均连续治疗14天。于开始治疗前1天和治疗结束后1天分别进行疗效评估相关指标检测。于治疗前1天、治疗第7天和第14天进行不良反应检测。结果 干预组治疗后Piper评分、中医证候总积分、PSQI评分、KPS评分及免疫功能指标(CD3+ 、CD4+、CD8+ 、CD4+ /CD8+ )较治疗前均有明显改善;干预组发生不良反应少于对照组。结论 补肾益气方肾俞膏摩治疗能够有效改善结直肠癌患者的癌因性疲乏的治疗效果,提高生活质量和免疫功能,减少不良反应。
Objective To observe the clinical observation of Shenshu Tuina combined with Bushen Yiqi herbal ointment in the treatment of cancer-induced fatigue in the convalescent stage of colorectal cancer and evaluate the efficacy.Methods From June 2023 to June 2025,80 inpatients and outpatients of colorectal cancer in the recovery period were collected and randomly divided into two groups.The patients who received routine symptomatic supportive treatment were enrolled as the control group.The intervention group was given Shenshu Tuina combined with Bushen Yiqi herbal ointment on the basis of control group.The relevant indicators for efficacy evaluation were tested one day before treatment and one day after the end of treatment.Adverse reactions were detected on the day before treatment,theseventh day and 14th day during treatment.Results The efficacy evaluation indexes of the intervention group after treatment were obviously improved compared with those before treatment.Adverse reactions occurred less in the intervention group than in the control group.Conclusions Shenshu Tuina combined with Bushen Yiqi herbal ointment can effectively improve the treatment effect of cancer-induced fatigue in patients with colorectal cancer,improve the quality of life and immune function,reduce adverse reactions.
目的 探讨自发性脑出血(SICH)患者静脉血栓栓塞症(VTE)的独立危险因素,并评估针对性分层预防措施的有效性及安全性, 为临床优化防治策略提供依据。方法 回顾性纳入2022年1月—2025年1月收治的86例SICH患者, 根据下肢深静脉超声结果分为深静脉血栓(DVT)组(n=16)与非DVT组(n=70)。采集患者基线资料、临床特征及实验室指标, 采用单因素及多因素Logistic回归分析VTE危险因素, 并基于独立危险因素制定分层预防方案。结果 多因素分析显示, 体质指数(BMI)升高(OR=1.22, 95%CI:1.06~1.41)、中心静脉置管(OR=5.23, 95%CI:1.37~19.95)、止血药物使用(OR=4.80, 95%CI:1.21~19.01)及NIHSS评分升高(OR=1.20, 95%CI:1.02~1.42)是VTE的独立危险因素(均P<0.05)。因此需针对SICH患者进行针对性干预, 包括基于BMI的个体化干预、中心静脉置管的精细化管控、止血药物的动态调控及神经功能保护与早期康复。结论 SICH患者VTE发生与代谢、医源性及神经功能损伤多因素交互作用密切相关, 应针对患者构建基于BMI、中心静脉管理及凝血监测的分层预防策略。
Objective To explore the independent risk factors for venous thromboembolism(VTE)in patients with spontaneous intracerebral hemorrhage(SICH)and to assess the effectiveness and safety of targeted stratified prophylaxis to provide a basis for optimizing prevention and treatment strategies in the clinic.Methods A retrospective analysis was conducted on 86 SICH patients admitted between January 2022 and January 2025.Based on lower-extremity venous ultrasound findings, patients were divided into a deep venous thrombosis(DVT)group(n=16)and a non-DVT group(n=70).Baseline characteristics, clinical features, and laboratory indicators were collected.Univariate and multivariate Logistic regression analyses were performed to identify VTE risk factors, and a stratified prevention protocol was developed based on independent risk factors.Results Multivariate analysis revealed that elevated body mass index(BMI)(OR=1.22, 95%CI:1.06-1.41), central venous catheterization(OR=5.23, 95%CI:1.37-19.95), hemostatic drug use(OR=4.80, 95%CI:1.21-19.01), and higher NIHSS scores(OR=1.20, 95%CI:1.02-1.42)were independent risk factors for VTE(all P<0.05).Consequently, targeted nursing interventions should be implemented for SICH patients, including BMI-based personalized care, refined management of central venous catheters, dynamic regulation of hemostatic drugs, and neuroprotective early rehabilitation.Conclusions VTE in SICH patients is closely associated with the interplay of metabolic, iatrogenic,and neurological injury factors.A stratified prevention strategy incorporating BMI monitoring, central venous catheter management, and coagulation surveillance is critical for reducing thrombotic risk while ensuring safety.
目的 通过戴明循环管理法的品管圈(QCC)活动, 提升内镜中心病理标本标识的正确率与病理标本管理安全性。方法 采用基于戴明循环管理法的QCC活动, 对内镜中心病理标本标识质量进行现状把握、原因分析并制定对策, 比较QCC活动开展前后内镜病理标本标识的正确率。结果 QCC活动后, 内镜中心病理标本标识的正确率从99.8%提高至100%(P<0.05)。结论 内镜中心通过开展基于戴明循环管理法的QCC活动, 显著提升了内镜病理标本管理安全性与工作效率。
Objective To improve the accuracy of pathological specimen identification and the safety of pathological specimen management in endoscopy center through quality control circle(QCC)activity based on Deming cycle management.Methods QCC activity based on Deming cycle management was used to summarize the status quo,analyze the causes and formulate countermeasures for the quality control of pathological specimen identification in endoscopy center.The accuracy rate of endoscopic pathological specimen identification before and after QCC activity was compared.Results After QCC activity, the accuracy of pathological specimen identification in endoscope center increased from 99.8% to 100%.Conclusions QCC activities based on Deming cycle management can greatly improve the safety and efficiency of endoscopic pathological specimen management.
目的 探索α-突触核蛋白(α-Syn)干预对人单核细胞白血病细胞系(THP-1)巨噬细胞源性泡沫细胞的影响。方法 通过佛波酯(PMA)和氧化型低密度脂蛋白(ox-LDL)构建THP-1巨噬细胞源性泡沫细胞模型,使用不同浓度(33、66、100、133 nmol/L)α-Syn处理泡沫细胞,随后检测细胞胆固醇含量和炎症因子白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)及白细胞介素-8(IL-8)的mRNA表达以及核因子κB(NF-κB)和凝集素样氧化低密度脂蛋白受体-1(LOX-1)的蛋白表达变化。结果 高剂量(100和133 nmol/L)α-Syn处理可以减少THP-1巨噬细胞源性泡沫细胞内胆固醇的含量(P<0.05),并且减少IL-1β、IL-6和IL-8的mRNA表达(P<0.05)。进一步发现(100 nmol/L和133 nmol/L)α-Syn可以降低THP-1巨噬细胞源性泡沫细胞p-NF-κB和LOX-1的蛋白表达(P<0.05)。结论 α-Syn可以降低THP-1源性巨噬细胞泡沫细胞胆固醇蓄积和炎症反应,可能是通过下调p-NF-κB和LOX-1蛋白表达。
Objective To explore the effects of α-synuclein(α-Syn)intervention on human monocytic leukemia cell(THP-1)macrophage-derived foam cells.Methods The THP-1 macrophage-derived foam cell model was constructed by phorbol 12-myristate 13-acetate(PMA)and oxidized low-density lipoprotein(ox-LDL).Foam cells were treated with different concentrations(33, 66, 100, and 133 nmol/L)of α-Syn, and the cellular cholesterol contents, as well as the mRNA expression of IL-1β、IL-6 and IL-8 were detected.Subsequently,alternation in protein expression of NF-κB and LOX-1 was measured.Results High-dose(100 and 133nmol/L)α-Syn treatment significantly reduced the levels of intracellular cholesterol in THP-1-derived macrophage foam cells(P<0.05)and decreased the mRNA expression of IL-1β、IL-6 and IL-8(P<0.05).It was further found that(100 nmol/L and 133 nmol/L)α-Syn decreased the protein expression of p-NF-κB and LOX-1 in THP-1 macrophage-derived foam cells(P<0.05).Conclusions The results of the present study suggest that α-Syn reduces cholesterol accumulation and inflammatory response in THP-1-derived macrophage foam cells, possibly by down-regulating p-NF-κB and LOX-1 protein expression.