Linear models

线性模型
  • 文章类型: Journal Article
    背景:尽管已经建立了氧化应激与胰岛素抵抗(IR)之间的关系,复合膳食抗氧化指数(CDAI)及其组分与胰岛素抵抗(IR)替代指数的关系,甘油三酯-葡萄糖指数(TyG),仍然不清楚。
    方法:本研究分析了2003年至2018年国家健康与营养检查调查(NHANES)的横截面数据。多元线性回归,加权分位数和(WQS)回归,和贝叶斯核机回归(BKMR)用于分析CDAI及其组件与TyG的关联。此外,我们进行了亚组分析和一些敏感性分析.
    结果:共纳入14,673名具有完整数据的参与者,平均年龄为50岁,女性为7,257名(49%)。多元线性回归表明,经过充分调整后,CDAI与TyG呈显著负相关[β:-0.005,95%CI:(-0.008,-0.002),p=0.002]。6种营养素相互校正的模型显示,维生素E(每SD增加)与TyG[β:-0.062,95%CI:(-0.074,-0.050),p<0.0001]。在WQS模型中,抗氧化剂饮食的WQS指数与TyG呈负相关(β:-0.060;P<0.0001)。在BKMR分析中观察到类似的效果。值得注意的是,在WQS和BKMR模型中,维生素E成为最具影响力的成分。此外,在亚组分析中,在超重或肥胖和糖尿病人群中,CDAI与TyG之间的关联显著减弱.
    结论:抗氧化饮食,尤其是维生素E,与TyG呈显著负相关。本研究强调补充维生素E对改善IR的重要价值。然而,体重管理不良和糖尿病患者似乎从抗氧化饮食中获益较少.
    BACKGROUND: Although the relationship between oxidative stress and insulin resistance (IR) has been established, the associations of the composite dietary antioxidant index (CDAI) and its components with the surrogate index of insulin resistance (IR), triglyceride-glucose index (TyG), is still not clear.
    METHODS: This study analyzed the cross-sectional data of the National Health and Nutrition Examination Survey (NHANES) from 2003 to 2018. Multivariate linear regression, weighted quantile sum (WQS) regression, and Bayesian kernel machine regression (BKMR) were used to analyze the associations of the CDAI and its components with the TyG. In addition, subgroup analysis and several sensitivity analyses were conducted.
    RESULTS: A total of 14,673 participants with complete data were included, with a median age of 50 years and 7,257 women (49%). Multivariate linear regression showed that after full adjustment, the CDAI was significantly negatively associated with the TyG [β: -0.005, 95% CI: (-0.008, -0.002), p = 0.002]. The model in which six nutrients were mutually corrected showed that vitamin E (per-SD increase) was most strongly associated with the TyG [β: -0.062, 95% CI: (-0.074, -0.050), p < 0.0001]. In the WQS model, the WQS index of the antioxidant diet was negatively associated with the TyG (β: -0.060; P < 0.0001). Similar effects were observed in the BKMR analysis. Notably, in the WQS and BKMR models, vitamin E became the most influential component. In addition, in the subgroup analysis, the association between the CDAI and the TyG in overweight or obese and diabetic populations was significantly weaker.
    CONCLUSIONS: Antioxidant diets, especially vitamin E, are significantly negatively correlated with TyG. This study emphasizes the important value of supplementing vitamin E to improve IR. However, patients with poor weight management and diabetes seem to benefit less from antioxidant diets.
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  • 文章类型: Journal Article
    目的:本研究的目的是比较选择性和非选择性融合在术后前5年的术后结果。
    方法:从多中心检索患者参数,prospective,数据库。包括Lenke1-6,B和C畸形的患者。患者分为2组:选择性融合(SF),如果最后一个器械椎骨(LIV)位于腰椎顶点或颅骨,或非选择性融合(NSF)。使用广义线性模型(GLMs)在1-,术后2年和5年的结果。术后五年的影像学分类结果,灵活性,脊柱侧弯研究学会评分(SRS),比较两组再手术率。创建匹配的队列用于亚组分析。
    结果:416(SF:261,NF:155)患者,这项研究包括353名女性。术前平均胸椎和腰椎Cobb角分别为57.3±8.9和45.3±8.0。SF组术后冠状畸形更大(p<0.01);两组之间的差异没有随时间变化(p>0.05),表明术后畸形矫正相对稳定。SF组腰椎Cobb≥26度的发生率更高(p<0.01)。NSF组在术后5年表现出更差的前向和侧向灵活性(p<0.05)。SF组和NSF组术后SRS评分无差异。两组再手术率相似。
    结论:选择性融合导致较大的冠状面畸形;然而,与非选择性融合相比,这种畸形不会随着时间的推移而显著进展.选择性脊柱融合术对于比先前确定的更大的患者子集可能是有益的选择。
    方法:III.
    OBJECTIVE: The purpose of this study is to compare postoperative outcomes between selective and non-selective fusions longitudinally over the first five postoperative years.
    METHODS: Patient parameters were retrieved from a multicenter, prospective, database. Patients with Lenke 1-6, B and C deformities were included. Patients were stratified into 2 groups: selective fusion (SF), if the last instrumented vertebra (LIV) was at or cranial to the lumbar apex, or non-selective fusion (NSF). Differences in coronal and sagittal radiographic outcomes were assessed with generalized linear models (GLMs) at 1-, 2- and 5- year postoperative outcomes. Five-year postoperative categorical radiographic outcomes, flexibility, scoliosis research society scores (SRS), and reoperation rates were compared between groups. Matched cohorts were created for subgroup analysis.
    RESULTS: 416 (SF:261, NF:155) patients, including 353 females were included in this study. The mean preoperative thoracic and lumbar Cobb angles were 57.3 ± 8.9 and 45.3 ± 8.0, respectively. GLMs demonstrated greater postoperative coronal deformity in the SF group (p < 0.01); however, the difference between groups did not change overtime (p > 0.05) indicating a relatively stable postoperative deformity correction. The SF group had a greater incidence of lumbar Cobb ≥ 26 degrees (p < 0.01). The NSF group demonstrated worse forward and lateral flexibility at 5-year postoperative outcome (p < 0.05). There was no difference in postoperative SRS scores between the SF and NSF groups. Reoperation rates were similar between groups.
    CONCLUSIONS: Selective fusion results in greater coronal plane deformity; however, this deformity does not progress significantly over time compared to non-selective fusion. Selective spinal fusion may be a beneficial option for a larger subset of patients than previously identified.
    METHODS: III.
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  • 文章类型: Journal Article
    目的:Klotho是一种与人类衰老密切相关的蛋白质。可溶性Klotho(S-Klotho)是一种循环蛋白,其水平随着全身性炎症而降低。血小板/高密度脂蛋白胆固醇比值(PHR)新出现的炎症指数,S-Klotho浓度尚不清楚。此外,已证实平均血小板体积与S-Klotho浓度呈显著负相关,但血小板计数(PC)与S-Klotho浓度之间的关系尚未报道。
    方法:检索了2007年至2016年五个周期内参加国家健康与营养调查(NHANES)的个人的数据进行分析。线性回归,两分段线性回归,和有限三次样条(RCS)方法用于分析PHR指数及其成分与S-Klotho浓度的关联。此外,进行亚组分析和效应修正试验。
    结果:共有11,123名参与者(5463名男性(48.17%)),平均年龄为56.2岁,包括在内。完全调整后,PHR最高四分位数组(β:-51.19,95%CI:-75.41至-26.97,P<0.001)和PC最高四分位数组(β:-72.34,95%CI:-93.32至-51.37,P<0.0001)的参与者的S-Klotho水平显着低于各自的最低四分位数组,四组间呈明显下降趋势(P分别为趋势<0.05)。然而,高密度脂蛋白胆固醇(HDL-C)浓度与S-Klotho浓度无显著相关性.RCS显示PHR和PC与S-Klotho浓度呈非线性相关;两分段线性回归显示拐点分别为175.269和152,这些关联在拐点之后略有减弱。根据亚组分析,肝病状态增强了PC和S-Klotho浓度之间的关联。
    结论:PHR和PC均与S-Klotho浓度呈显著负相关,这些关联是非线性的。HDL-C和S-Klotho浓度之间没有显著关联。肝病状态增强PC和S-Klotho浓度之间的负相关性,具体机制值得进一步探索。
    OBJECTIVE: Klotho is a protein that is closely related to human aging. Soluble Klotho (S-Klotho) is a circulating protein, and its level decreases in response to systemic inflammation. The relationship between the platelet/high-density lipoprotein cholesterol ratio (PHR), an emerging inflammatory index, and S-Klotho concentrations is still unclear. In addition, the mean platelet volume has been confirmed to have a significant negative association with S-Klotho concentrations, but the relationship between the platelet count (PC) and S-Klotho concentrations has not yet been reported.
    METHODS: Data from individuals who participated in the National Health and Nutrition Examination Survey (NHANES) during the five cycles from 2007 to 2016 were retrieved for analysis. Linear regression, two-piecewise linear regression, and restricted cubic spline (RCS) methods were used to analyze the associations of the PHR index and its components with S-Klotho concentrations. In addition, subgroup analysis and effect modification tests were conducted.
    RESULTS: A total of 11,123 participants (5463 men (48.17%)), with an average age of 56.2 years, were included. After full adjustment, the S-Klotho levels of participants in the highest quartile group of PHR (β: -51.19, 95% CI: -75.41 to -26.97, P < 0.001) and the highest quartile group of PC (β: -72.34, 95% CI: -93.32 to -51.37, P < 0.0001) were significantly lower than those in their respective lowest quartile groups, and a significant downward trend was presented among the four groups (P for trend < 0.05, respectively). However, high-density lipoprotein cholesterol (HDL-C) concentrations were not significantly associated with S-Klotho concentrations. RCS revealed that the PHR and PC were nonlinearly associated with S-Klotho concentrations; two-piecewise linear regression revealed that the inflection points were 175.269 and 152, respectively, and that these associations slightly weakened after the inflection point. According to the subgroup analysis, liver disease status enhanced the association between the PC and S-Klotho concentrations.
    CONCLUSIONS: Both the PHR and PC were significantly negatively associated with S-Klotho concentrations, and these associations were nonlinear. There was no significant association between HDL-C and S-Klotho concentrations. Liver disease status enhances the negative association between the PC and S-Klotho concentrations, and the specific mechanism deserves further exploration.
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  • 文章类型: Journal Article
    研究日本成年人及其父母中HCT的儿童-父母协会。使用Pearson相关系数和Studentt检验分析了3,574个儿子和7,203个女儿与血细胞比容(HCT)相关的因素。多元线性回归分析,通过单变量分析和与父母生活在一起的因素进行调整,在242个儿子父母三重奏和587个女儿父母三重奏中进行。当在多元线性回归分析中观察到儿童-父母关联时,使用随机家庭方法(RFM)进行验证.在单变量分析中,儿子的HCT与年龄相关(相关系数=-0.072),白细胞(WBC)(0.19),丙氨酸氨基转移酶(ALT)(0.20),甘油三酯(0.11),和估计的肾小球滤过率(eGFR)(-0.087)。女儿的HCT与白细胞(0.014)有关,ALT(0.18),和eGFR(-0.17)。在多元线性回归分析中,儿子的HCT与儿子的WBC相关(系数=3.48×10-4),儿子的eGFR(0.031),父亲的HCT(0.11),和母亲的HCT(0.17)。RFM确认了儿子和父亲的HCT之间的关联(p=0.0070)以及儿子和母亲的HCT之间的关联(p=0.0011)。女儿的HCT与白细胞(2.6×10-4)有关,ALT(0.037),和母亲的HCT(0.14)。RFM证实了女儿和母亲的HCT之间的关联(p=0.00043)。HCT的儿童-父母关联在儿子-父亲之间得到证实,儿子-母亲,和女儿和母亲的关系,并且根据孩子和父母的性别而有所不同。
    To examine child-parent associations of HCT among Japanese adults and their parents. Factors associated with hematocrit (HCT) were analyzed in 3,574 sons and 7,203 daughters using Pearson\'s correlation coefficient and Student\'s t-test. Multiple linear regression analysis, adjusted by the factors identified by univariate analyses and by living with parents, was performed on 242 son-parent trios and 587 daughter-parent trios. When a child-parent association was observed in the multiple linear regression analysis, it was validated using the random family method (RFM). In univariate analyses, the son\'s HCT was associated with age (correlation coefficient = -0.072), white blood cell (WBC) (0.19), alanine aminotransferase (ALT) (0.20), triglyceride (0.11), and estimated glomerular filtration rate (eGFR) (- 0.087). The daughter\'s HCT was associated with WBC (0.014), ALT (0.18), and eGFR (- 0.17). In multiple linear regression analysis, the son\'s HCT was associated with the son\'s WBC (coefficient = 3.48 × 10-4), the son\'s eGFR (0.031), the father\'s HCT (0.11), and the mother\'s HCT (0.17). RFM confirmed the association between the son\'s and father\'s HCT (p = 0.0070) and between the son\'s and mother\'s HCT (p = 0.0011). The daughter\'s HCT was associated with WBC (2.6 × 10-4), ALT (0.037), and the mother\'s HCT (0.14). RFM confirmed the association between the daughter\'s and mother\'s HCT (p = 0.00043). Child-parent association of HCT was confirmed between son-father, son-mother, and daughter-mother relationships, and differed depending on the sex of the child and the parents.
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  • 文章类型: Journal Article
    基于奖励的众筹是一个典型的双向平台(筹款方和支持者方),信息不对称程度很高。虽然现有研究表明,来自筹款人和支持者的信号会影响众筹绩效,这些信号之间的相互作用值得进一步调查。借鉴信号理论,本研究采用配置视角,利用fsQCA方法和线性回归来研究筹款人参与(更新和筹款人评论)的综合影响,第三方认可(支持者评论和Facebook分享),和项目准备(视频,image,和描述)关于众筹绩效。从基于奖励的众筹平台Indiegogo中提取数据,这项研究指出,这些信号不能单独产生更好的众筹绩效,并研究了不同信号之间的替代和互补效应。根据线性回归和fsQCA结果,确定了导致高众筹绩效的配置。我们发现,项目准备工作必须与其他信号一起工作,才能产生较高的众筹绩效。此外,我们将这些配置总结为两种模式,可能会导致高的众筹绩效:筹款人参与驱动模式和第三方认可驱动模式。这项研究为信号如何协同工作以减轻众筹中的信息不对称提供了一种可配置的观点和有价值的见解。
    Reward-based crowdfunding is a typical two-sided platform (fundraiser side and backer side) with high information asymmetry. While existing research indicates that signals from fundraisers and backers can impact crowdfunding performance, the interplay among these signals warrants further investigation. Drawing on signaling theory, this study adopts a configurational perspective and utilizes the fsQCA method and linear regression to investigate the combined effects of fundraiser engagement (update and fundraiser comment), third-party endorsement (backer comment and Facebook sharing), and project preparedness (video, image, and description) on crowdfunding performance. Drawing data from the reward-based crowdfunding platform Indiegogo, this research pointed out that these signals cannot generate better crowdfunding performance alone and examined substitution and complementary effects among different signals. Based on the linear regression and fsQCA results, configurations that lead to high crowdfunding performance are identified. We found that project preparedness must work with other signals to produce high crowdfunding performance. Besides, we summarized these configurations into two patterns that may lead to high crowdfunding performance: a fundraiser engagement-driven pattern and a third-party endorsement-driven pattern. This study contributes a configurational perspective and valuable insights into how signals can work together to mitigate information asymmetry in crowdfunding.
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  • 文章类型: Journal Article
    目的:实验和急性暴露研究表明锰影响红细胞生成。然而,环境暴露与红细胞分布宽度(RDW)之间的关系尚待探索。这项研究旨在评估美国普通人群中血锰水平与RDW之间的相关性。
    方法:采用加权多元线性回归模型,我们利用2011-2018年全国健康和营养检查调查(NHANES)的数据评估了血液中锰水平与RDW之间的相关性.还采用了受限制的三次样条图和两分段线性回归模型。
    结果:该分析共包括15882名参与者,我们确定了参与者之间血锰水平与RDW之间的独立正相关关系(β=0.079,P<0.001)。此外,我们在总参与者(血锰拐点:7.32ug/L)和校正协变量后的不同亚组中发现了血锰水平与RDW之间的J形关联.女性表现出更明显的联想,即使在控制了调整后的协变量之后。
    结论:我们确定了血锰水平与RDW之间的J形关系,血锰的拐点为7.32ug/L。然而,需要基础研究和大样本前瞻性研究来确定血锰水平与RDW的相关程度.
    OBJECTIVE: Experimental and acute exposure studies imply that manganese affects red blood cell production. Nevertheless, the association between environmental exposure and red blood cell distribution width (RDW) has yet to be explored. This research sought to assess the correlation between blood manganese levels and RDW within the general population of the United States.
    METHODS: Employing weighted multiple linear regression models, data from the 2011-2018 National Health and Nutrition Examination Survey (NHANES) were utilized to assess the correlation between manganese levels in the blood and RDW. Restricted cubic spline plots and two-piecewise linear regression models were also employed.
    RESULTS: The analysis included a total of 15882 participants in which we determined an independent positive relationship between blood manganese levels and RDW among participants(β = 0.079, P<0.001). Moreover, we identified a J-shaped association between blood manganese levels and RDW in total participants (inflection point for blood manganese: 7.32 ug/L) and distinct subgroups following adjusted covariates. Women exhibited a more pronounced association, even after controlling for adjusted covariates.
    CONCLUSIONS: We determined a J-shaped relationship between blood manganese levels and RDW with an inflection point at 7.32 ug/L for blood manganese. Nevertheless, fundamental research and large sample prospective studies are needed to determine the extent to which blood manganese levels correlate with RDW.
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  • 文章类型: Journal Article
    不断升级的街头暴力和犯罪凶杀对心理健康产生不利影响。然而,这些后果很难评估。使用最近验证的量表,我们旨在评估对犯罪恐惧对生活在农村地区受地方性暴力影响的中老年人心理状况的影响.
    参与者是从先前研究中针对人群心理困扰的Atahualpa居民中选择的。使用经过验证的量表来客观地量化参与者对犯罪的恐惧。基线和随访之间抑郁和焦虑症状的差异被用作不同的因变量,恐惧犯罪量表的连续得分被用作自变量。拟合线性回归模型来评估暴露与结果之间的关联,在调整了相关的混杂因素后。
    共有653名参与者(平均年龄=53.2±11.5岁;57%的女性)完成了要求的测试。我们发现,与往年相比,该村暴力高峰期的抑郁和焦虑症状增加了13%。线性回归模型显示,恐惧犯罪问卷的总分与抑郁症状(β=.24;95%CI=0.14-0.35)和焦虑(β=.31;95%CI=0.24-0.37)之间存在显着关联,在调整相关混杂因素后。
    这项研究表明,对犯罪的恐惧对先前存在的抑郁和焦虑症状具有显着的加重作用,并且这些状况对总体幸福感具有有害影响。
    UNASSIGNED: Escalating street violence and criminal homicides have an adverse impact on psychological well-being. However, these consequences have been difficult to evaluate. Using a recently validated scale, we aimed to assess the impact of fear of crime on the psychological status of middle-aged and older adults living in a rural setting afflicted by endemic violence.
    UNASSIGNED: Participants were selected from Atahualpa residents included in previous studies targeting psychological distress in the population. A validated scale was used to objectively quantify fear of crime in participants. Differences in symptoms of depression and anxiety between baseline and follow-up were used as distinct dependent variables and the continuous score of the fear of crime scale was used as the independent variable. Linear regression models were fitted to assess the association between the exposure and the outcomes, after adjusting for relevant confounders.
    UNASSIGNED: A total of 653 participants (mean age = 53.2 ± 11.5 years; 57% women) completed the requested tests. We found a 13% increase in symptoms of depression and anxiety during the peak of violence in the village compared with previous years. Linear regression models showed a significant association between the total score on the fear of crime questionnaire and worsening symptoms of depression (β = .24; 95% CI = 0.14-0.35) and anxiety (β = .31; 95% CI = 0.24-0.37), after adjustment for relevant confounders.
    UNASSIGNED: This study shows a significant aggravating effect of fear of crime on pre-existing symptoms of depression and anxiety and a deleterious effect of these conditions on overall well-being.
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  • 文章类型: Journal Article
    人类的发展受到生物和社会因素相互作用的影响。本研究旨在验证社会风险对生物风险与儿童发育关系的调节作用。收集了201名儿童的数据,6至72个月。自变量由生物风险指数衡量,社会风险指数的调节变量通过丹佛II检验进行评估。线性回归,效果大小,和适度分析用于验证BRI与儿童发育(丹佛II)之间的关系,和SRI的调节作用。BRI与儿童发育呈负相关,BRI和SRI之间的相互作用将丹佛II结果的解释方差增加到14%.SRI还是语言和GrossMotor领域的重要主持人。这项研究表明,社会风险调节了生物风险与儿童发育之间的关系,社会风险因素越多,这种关系变得越强。另一方面,可以说,一些社会因素有利于儿童的发展,即使存在生物危险因素。
    Human development is influenced by the interaction between biological and social factors. This study aimed to verify the moderating effect of social risk on the relationship between biological risk and child development. Data were collected on 201 children, aged 6 to 72 months. The independent variable was measured by the biological risk index, and the moderator variable by the social risk index was assessed by the Denver II test. Linear regression, effect size, and analysis of moderation were used to verify the relationship between BRI and the child development (Denver II), and the moderating effect of the SRI. BRI was negatively associated with child development, the interaction between the BRI and SRI increased the explained variance in the Denver II result to 14%. The SRI was also a significant moderator of the Language and Gross Motor domains. This research evidence that social risk moderates the relationship between biological risk and child development, the more social risk factors, the stronger this relationship becomes. On the other hand, it can be said that some social factors favor child development, even in the presence of biological risk factors.
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  • 文章类型: Journal Article
    先前关于肺活量测定与高密度脂蛋白(HDL)胆固醇之间相关性的发现很有趣,但却相互矛盾。这项研究的目的是评估中国慢性阻塞性肺疾病(COPD)患者的HDL水平与肺活量和影像学参数之间的关系。
    本研究共纳入907名COPD患者。参与者从问卷调查中获得完整的数据,血脂谱检查,肺活量测定测试,和计算机断层扫描(CT)扫描包括在分析中.采用广义累加模型来识别HDL水平与肺活量测定和成像参数之间的非线性关系。在存在非线性相关性的情况下,采用分段线性回归模型确定阈值效应。
    在对各种因素进行调整后,我们发现HDL水平和肺活量测定/成像参数之间存在非线性相关性,拐点为4.2(66mg/dL)。当Ln(HDL)低于4.2时,每个单位的增加与支气管扩张剂后FEV1的减少显着相关(0.32L,95%CI:0.09-0.55),预测FEV1%(11.0%,95%CI:2.7-19.3),并降低FEV1/FVC(8.0%,95%CI:4.0-12.0),Ln(LAA-950)显著增加1.20(95%CI:0.60-1.79),Ln(LAA-856)显著增加0.77(95%CI:0.37-1.17)。然而,当Ln(HDL)大于或等于4.2时,未观察到显著关联.
    COPD患者HDL水平与肺功能和CT影像学之间存在非线性相关性。在达到66mg/dL之前,HDL升高与肺功能受损显著相关,更严重的气体滞留和肺气肿。
    UNASSIGNED: The previous findings on the correlation between spirometry and high-density lipoprotein (HDL) cholesterol are intriguing yet conflicting. The aim of this research is to evaluate the relationship between HDL levels and spirometry as well as imaging parameters in patients with chronic obstructive pulmonary disease (COPD) in China.
    UNASSIGNED: This study encompasses a total of 907 COPD patients. Participants with complete data from questionnaire interviews, lipid profile examinations, spirometry testing, and computed tomography (CT) scans were included in the analysis. A generalized additive model was employed to identify the non-linear relationship between HDL levels and both spirometry and imaging parameters. In the presence of non-linear correlations, segmented linear regression model was applied to ascertain threshold effects.
    UNASSIGNED: After adjusting for various factors, we found a non-linear correlation between HDL levels and spirometry/imaging parameters, with an inflection point at 4.2 (66 mg/dL). When Ln (HDL) was below 4.2, each unit increase correlated significantly with reduced post-bronchodilator FEV1 (0.32L, 95% CI: 0.09-0.55), decreased predicted FEV1% (11.0%, 95% CI: 2.7-19.3), and lowered FEV1/FVC (8.0%, 95% CI: 4.0-12.0), along with notable increases in Ln (LAA-950) by 1.20 (95% CI: 0.60-1.79) and Ln (LAA-856) by 0.77 (95% CI: 0.37-1.17). However, no significant associations were observed when Ln (HDL) was greater than or equal to 4.2.
    UNASSIGNED: A non-linear correlation existed between HDL levels with lung function and CT imaging in COPD patients. Prior to reaching 66 mg/dL, an elevation in HDL was significantly associated with impaired lung function, more severe gas trapping and emphysema.
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  • 文章类型: Journal Article
    亚硝胺化合物作为潜在的致癌物,促使监管机构加强审查,特别是关于它们在药物中的存在。检测到雷尼替丁中不可接受的N-亚硝基二乙胺(NDMA)水平导致了广泛的召回,驱动对替代药物如尼扎替丁的兴趣,它具有类似的药理学类别,用于治疗各种胃肠道疾病。尽管关于尼扎替丁NDMA水平的报道较少,其结构与雷尼替丁相似,以叔胺为特征,强调了NDMA形成的潜力。解决与亚硝胺检测相关的分析挑战,这项研究的重点是开发和验证一种超高压液相色谱三重四极杆质谱(UHPLC-MS/MS)方法,用于定量尼扎替丁活性药物成分和片剂配方中的NDMA。方法验证遵循国际协调理事会的建议,NDMA的线性范围为0.25-100ng/mL,具有良好的线性(回归系数>0.999),有效回收率在95.98%至109.57%之间。该方法灵敏度高,检测限和定量限为0.25和0.5ng/mL,分别。开发的UHPLC-MS/MS方法提供了一个简单的,精确,准确,以及澳大利亚提供的监测尼扎替丁制剂中NDMA水平的选择性方法,有希望增强的灵敏度和特异性,在ppb和sub-ppb范围内的定量极限。
    Nitrosamine compounds pose a significant concern as potential carcinogens, prompting heightened scrutiny from regulatory bodies, particularly regarding their presence in pharmaceuticals. The detection of unacceptable levels of N-nitrosodiethylamine (NDMA) in ranitidine has led to widespread recalls, driving interest in alternative medications such as nizatidine, which shares a similar pharmacological class and is used to treat various gastrointestinal conditions. Despite fewer reports on NDMA levels in nizatidine, its structural similarity to ranitidine, characterized by a tertiary amine, underscores the potential for NDMA formation. Addressing the analytical challenges associated with nitrosamine detection, this study focuses on developing and validating an ultra-high pressure liquid chromatography triple quadrupole mass spectrometry (UHPLC-MS/MS) method for quantifying NDMA in both nizatidine active pharmaceutical ingredients and tablet formulations. Method validation adheres to International Council for Harmonisation recommendations, with a demonstrated linear range of 0.25-100 ng/mL for NDMA, exhibiting excellent linearity (regression coefficient >0.999) and efficient recovery rates ranging from 95.98% to 109.57%. The method shows high sensitivity, with limits of detection and quantification of 0.25 and 0.5 ng/mL, respectively. The developed UHPLC-MS/MS method offers a simple, precise, accurate, and selective approach for monitoring NDMA levels in nizatidine formulations available in Australia, promising enhanced sensitivity and specificity with limits of quantification in the ppb and sub-ppb ranges.
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