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Evidence-based guideline on immunonutrition in patients with cancer 癌症患者免疫营养循证指南
Pub Date : 2023-03-01 DOI: 10.1097/PN9.0000000000000031
J. Cui, Yudi Liu, Fan Li, W. Zhuo, Lan Huang, Chuan Xu, Wei Li, Jianyong Qin, Xuejun Sun, H. Tian, Tingting Liang, Ping-An Chen, Bo Chen, Qiuyan Liu, J. Ying, Ningning Li, An-ping Zhang, Yang Yu, Zhi-Feng Zhou, Xiu-Dong Wu, Xiao‐Kai Guo, Lingdi Zhao, Junya Zhai, Zhao-yang Yang, J. Yang, Xia Li, Yong Li, Guo-en Liu, Guo-rui Sun, Zhenguo Han, Xiaojun Yang, Wei Cui, F. Chen, Yuehua Wu, Liang Liu, Gui-Rong Li, Jing Dai, Zheng Zhao, B. Zhao, Xiaoyan Kuang, Xinfeng Zhou, Y. Tan, Han-ping Shi
Background: Malnutrition in patients with malignant tumors caused by the tumor or related treatment is a significant problem in clinical practice. “Cancer immunonutrition” therapy improves patients’ nutritional condition and immune function. It uses specific nutrients to improve the nutritional status of patients with cancer and regulates the body’s immune and inflammatory responses. To date, cancer immunonutrition has been used in surgery, chemoradiotherapy, hematopoietic stem cell transplantation (HSCT), treatment of tumor complications, and other fields. Therefore, we aimed to develop rigorous and detailed evidence-based practice guidelines for cancer immunonutrition therapy. Methods: The guideline strictly followed the latest guidelines from the Institution of Medicine and was constructed according to the World Health Organization handbook for guideline development. It was written according to the Reporting Items for practice Guidelines in Healthcare criteria. The quality of evidence and strength of the recommendations were assessed using the Grading of Recommendations Assessment, Development, and Evaluation method. Results: Twenty-three recommendations were formulated regarding surgery, chemoradiotherapy, HSCT, treatment of tumor complications, and other fields. Conclusions: We developed clinical practice guidelines for cancer immunonutrition therapy based on the latest evidence-based practice to provide more comprehensive and detailed advice to healthcare providers. This guideline broadens the application scope of immunonutrition therapy for cancer and promotes its standardized application in clinical practice.
背景:恶性肿瘤患者因肿瘤所致的营养不良或相关治疗是临床实践中的一个重要问题。“癌症免疫营养”疗法改善了患者的营养状况和免疫功能。它使用特定的营养素来改善癌症患者的营养状况,并调节身体的免疫和炎症反应。迄今为止,肿瘤免疫营养已应用于外科手术、放化疗、造血干细胞移植(HSCT)、肿瘤并发症的治疗等领域。因此,我们的目标是为癌症免疫营养治疗制定严格和详细的循证实践指南。方法:本指南严格遵循美国医学研究院最新指南,根据世界卫生组织指南编制手册编制。它是根据医疗保健标准中实践指南的报告项目编写的。证据的质量和建议的强度使用分级建议评估,发展和评价方法进行评估。结果:针对手术、放化疗、造血干细胞移植、肿瘤并发症的治疗等方面提出23条建议。结论:基于最新的循证实践,我们制定了癌症免疫营养治疗的临床实践指南,为医疗保健提供者提供更全面和详细的建议。本指南拓宽了肿瘤免疫营养治疗的应用范围,促进了肿瘤免疫营养治疗在临床的规范化应用。
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引用次数: 2
Association between serum albumin and new-onset hyperuricemia among participants with hypertension 高血压患者血清白蛋白与新发高尿酸血症的关系
Pub Date : 2023-03-01 DOI: 10.1097/PN9.0000000000000027
Chun Zhou, Rui Li, Shaojie Zhang, Qinqin Li, P. He, Zhuxian Zhang, Mengyi Liu, Yuanyuan Zhang, Huan Li, Chengzhang Liu, Bin-yan Wang, X. Qin
Background and Objective: The prospective relationship between serum albumin and new-onset hyperuricemia is still uncertain. Our current study aimed to examine the association between serum albumin and new-onset hyperuricemia among participants with hypertension, and to explore the potential factors that might modify the association. Methods: This study included 10,617 hypertensive patients with normal uric acid (UA) concentrations (<357 μmol/L) at baseline from the UA Substudy of the China Stroke Primary Prevention Trial (CSPPT). The primary study outcome was new-onset hyperuricemia, which was defined as a UA concentration at the exit visit ≥357 μmol/L in women or ≥417 μmol/L in men. Results: During the median follow-up duration of 4.4 years, 1664 (15.7%) new-onset hyperuricemia cases were documented. Overall, there was a significantly inverse relation of serum albumin with risk of new-onset hyperuricemia (per SD increment; odds ratio [OR], 0.74; 95% confidence interval [CI]: 0.70, 0.79). Consistently, when serum albumin was evaluated as quartiles, compared with participants in the first quartile (<46.1 g/L), a significantly lower risk of new-onset hyperuricemia was observed among those in the fourth quartile (≥51.7 g/L; OR, 0.55; 95% CI: 0.47, 0.65). The findings were consistent among participants with different baseline characteristics. Conclusions: There was a significantly inverse association between serum albumin and risk of new-onset hyperuricemia in adults with hypertension.
背景与目的:血清白蛋白与新发高尿酸血症之间的前瞻性关系尚不确定。我们目前的研究旨在检测高血压患者血清白蛋白与新发高尿酸血症之间的关系,并探讨可能改变这种关系的潜在因素。方法:本研究纳入了中国脑卒中一级预防试验UA子研究(CSPPT)中10617名基线尿酸浓度正常(<357μmol/L)的高血压患者。主要研究结果为新发性高尿酸血症,定义为女性出诊时UA浓度≥357μmol/L,男性≥417μmol/L。结果:在4.4年的中位随访期间,记录了1664例(15.7%)新发高尿酸血症病例。总的来说,血清白蛋白与新发高尿酸血症的风险呈显著的负相关(每SD增量;比值比[OR],0.74;95%置信区间[CI]:0.70,0.79) g/L),在第四个四分位数的人群中观察到新发高尿酸血症的风险显著降低(≥51.7 g/L;或0.55;95%可信区间:0.47,0.65)。具有不同基线特征的参与者的研究结果是一致的。结论:成人高血压患者血清白蛋白与新发高尿酸血症的风险呈显著负相关。
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引用次数: 0
Variation trends of malnutrition status among malignancy inpatients in China from 2014 to 2021 2014 - 2021年中国恶性肿瘤住院患者营养不良状况变化趋势
Pub Date : 2023-03-01 DOI: 10.1097/PN9.0000000000000028
Mingming Zhou, Hongxia Xu, Jiuwei Cui, Kunhua Wang, M. Weng, Zengqing Guo, Qinghua Yao, F. Zhou, Ming Liu, Chunling Zhou, Y. Ba, Zhikang Chen, Hu-sai Ma, Tao Li, M. Cong, Suyi Li, Xian Wu, Zengning Li, Qingchuan Zhao, Qiuge Qiao, Yong Feng, Wei Li, Hanping Shi, C. Song
Objective: We explored the malnutrition status of Chinese malignancy inpatients from 2014 to 2021 and analyzed the trends in the rates or ratios of various nutrition-related indicators in oncology patients over 8 years. Methods: A total of 34,878 oncology patients admitted to hospitals from 2014 to 2021 were enrolled (INSCOC study). Nutritional Risk Screening 2002 (NRS 2002) and Patient-Generated Subjective Global Assessment (PG-SGA) were used to screen patients for nutritional risk and assess their nutritional status, and nutritional therapy data was gathered. Results: From 2014 to 2021, there was an overall decreasing trend in the prevalence of nutritional risk and malnutrition among oncology inpatients (χ2trend = 108.154, P < 0.001; χ2trend = 70.230, P < 0.001), with malnutrition in patients falling from 68.1% in 2014–2015 to 57.2% in 2020–2021, while malnutrition rates in patients with cervical cancer and malignant lymphoma are gradually increasing. The overall rate of total nutritional therapy for patients is on the rise (χ2trend = 67.548, P < 0.001), increasing from 39.4% (2014–2015) to 44.7% (2020–2021). A trend of rising and then falling rate of parenteral nutrition therapy was observed in patients, whereas the rate of enteral nutrition therapy grew annually (P for trend < 0.001). Nutritional therapy rates for malnourished patients are on an increasing trend, a slight increase, however, remains for well-nourished patients (P for trend < 0.001). Moreover, the prevalence in elderly oncology patients (≥60 years) also showed a downward trend in both nutritional risk and malnutrition (χ2trend = 38.897, P < 0.001; χ2trend = 75.616, P < 0.001), but malnutrition rates were higher in elderly patients than in individuals under 60 years at different years (P < 0.05). Conclusions: The great majority of patients with malignancy have a significantly decreased prevalence of nutritional risk or malnutrition from 2014 to 2021, and the rate of nutritional therapy is on the rise. However, the nutritional status of individuals with cervical cancer and malignant lymphoma remains poor. The problem of malnutrition remains prominent in elderly patients despite improvements in their nutritional status.
目的:了解2014-20121年中国恶性肿瘤住院患者营养不良状况,分析8年来肿瘤患者各种营养相关指标的发生率或比率的变化趋势。方法:2014年至2021年,共有34878名肿瘤患者入院(INSCOC研究)。2002年营养风险筛查(NRS 2002)和患者生成的主观全局评估(PG-SGA)用于筛查患者的营养风险并评估其营养状况,并收集营养治疗数据。结果:从2014年到2021年,肿瘤住院患者的营养风险和营养不良患病率总体呈下降趋势(χ2trend=108.154,P<0.001;χ2trend=70.230,P<0.001),患者营养不良率从2014-2015年的68.1%下降到2020-2021年的57.2%,而宫颈癌症和恶性淋巴瘤患者的营养不良率逐渐升高。患者的总营养治疗率正在上升(χ2trend=67.548,P<0.001),从39.4%(2014-2015)上升到44.7%(2020-2021)。在患者中观察到肠外营养治疗率有上升然后下降的趋势,而肠内营养治疗率每年都在增长(P<0.001)。营养不良患者的营养治疗率呈上升趋势,但营养良好的患者仍略有上升(P<001)。此外,老年肿瘤患者(≥60岁)的患病率在营养风险和营养不良方面也呈下降趋势(χ,但不同年龄段老年患者的营养不良率均高于60岁以下个体(P<0.05)。结论:2014年至2021年,绝大多数恶性肿瘤患者的营养风险或营养不良发生率显著降低,营养治疗率呈上升趋势。然而,宫颈癌症和恶性淋巴瘤患者的营养状况仍然很差。尽管老年患者的营养状况有所改善,但营养不良问题仍然突出。
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引用次数: 1
Pterostilbene induces browning of white adipocytes via AMPK/PGC-1α pathway 二苯乙烯通过AMPK/PGC-1α途径诱导白色脂肪细胞褐变
Pub Date : 2023-03-01 DOI: 10.1097/PN9.0000000000000032
Jiawei Zheng, Wujian Liu, Jun‐dong Zhu
Background: Many studies have demonstrated that certain dietary polyphenols exert anti-obesity effects by increasing energy expenditure as heat via activating brown adipose and/or browning of white adipose. Pterostilbene, a resveratrol dimethyl ether analogue, has been demonstrated to have anti-obesity effects. However, studies on the mechanisms by which pterostilbene exert anti-obesity effect are still inadequate. As such, the current study tests the hypothesis that pterostilbene administration induces browning of white adipose, thus controlling body weight gain. Method: The effects of pterostilbene administration on white adipocytes browning in inguinal white adipose tissue (iWAT) of rats and 3T3-L1 adipocytes as well as their underlying mechanisms were investigated in the current study. Results: The administration of pterostilbene for 8 weeks reduced rats’ body weight gain and iWAT index. Furthermore, pterostilbene increased the content of mitochondria and the expression of brown and beige adipocyte markers such as uncoupling protein 1 (UCP1), PR domain-containing 16 (PRDM16), and transmembrane protein 26 (TMEM26) in iWAT. Pterostilbene treatment also activated AMP-activated protein kinase (AMPK) and increased expression of peroxisome proliferator-activated receptor-gamma coactivator-1 alpha (PGC-1α) in iWAT. In agreement with the in vivo findings, the in vitro results showed that 1 μM pterostilbene treatment also activated AMPK and increased PGC-1α expression, and stimulated formation of brown-like adipocytes as evidenced by the increased mitochondria content and expression of brown and beige adipocytes markers in 3T3-L1 adipocytes. However, those positive effects of pterostilbene on 3T3-L1 adipocytes were significantly inhibited by pretreatment with an AMPK inhibitor (compound C) or PGC-1α siRNA. Conclusion: These findings suggest that pterostilbene exerts body weight gain-lowering effect by inducing white adipocytes browning via the AMPK/PGC-1α pathway.
背景:许多研究表明,某些膳食多酚通过激活棕色脂肪和/或使白色脂肪变褐,以热量的形式增加能量消耗,从而发挥抗肥胖作用。紫檀芪,一种白藜芦醇二甲醚类似物,已被证明具有抗肥胖作用。然而,关于紫檀芪抗肥胖作用机制的研究仍然不足。因此,目前的研究验证了紫檀芪可以诱导白色脂肪变褐,从而控制体重增加的假设。方法:观察紫檀芪给药对大鼠腹股沟白色脂肪组织(iWAT)和3T3-L1脂肪细胞褐变的影响及其机制。结果:紫檀芪给药8周后,大鼠体重增加明显减轻,iWAT指数下降。此外,紫菀芪增加了iWAT中线粒体的含量以及褐色和米色脂肪细胞标志物如解偶联蛋白1 (UCP1)、PR结构域16 (PRDM16)和跨膜蛋白26 (TMEM26)的表达。紫芪还激活了amp活化蛋白激酶(AMPK),并增加了过氧化物酶体增殖体活化受体- γ辅激活因子-1α (PGC-1α)在iWAT中的表达。与体内实验结果一致,体外实验结果表明,1 μM紫芪也能激活AMPK,增加PGC-1α的表达,并刺激褐色样脂肪细胞的形成,3T3-L1脂肪细胞中线粒体含量和褐色和米色脂肪细胞标记物的表达增加。然而,紫檀芪对3T3-L1脂肪细胞的积极作用被AMPK抑制剂(化合物C)或PGC-1α siRNA预处理显著抑制。结论:紫檀芪可能通过AMPK/PGC-1α通路诱导白色脂肪细胞褐化,从而起到降低体重的作用。
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引用次数: 1
Digital twin enabled personalized nutrition 数字孪生实现个性化营养
Pub Date : 2023-03-01 DOI: 10.1097/PN9.0000000000000030
Yu Wang, C. Lu, Wei Chen, Qi Wang, Hua Jiang
The concept of precision medicine paved a way to personalize nutritional diagnosis and treatment. This article begins with the challenges of current clinical nutritional diagnosis and treatment and outlines their limitations. We propose a concept of digital twin for personalized nutrition. It is based on a digital clinical platform and elaborates on how to apply digital twin technique to establish a multimodule, multiscale simulation and prediction platform for patient. This kind of platform can result in real-time decision-making assistance and provides a new paradigm for personalized precision nutrition treatment.
精准医学的概念为个性化营养诊断和治疗铺平了道路。本文从目前临床营养诊断和治疗的挑战开始,概述了它们的局限性。我们提出了个性化营养的数字孪生概念。以数字化临床平台为基础,阐述了如何应用数字孪生技术建立多模块、多尺度的患者模拟预测平台。这种平台可以实现实时决策辅助,为个性化精准营养治疗提供了新的范例。
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引用次数: 1
A prospective birth cohort study of maternal prenatal cigarette smoking assessed by self-report and biomarkers on childhood risk of overweight or obesity. 通过自我报告和儿童超重或肥胖风险的生物标志物评估母亲产前吸烟的前瞻性出生队列研究。
Pub Date : 2022-12-07 eCollection Date: 2022-12-01 DOI: 10.1097/PN9.0000000000000017
Wenpin Hou, Mingyu Zhang, Yuelong Ji, Xiumei Hong, Guoying Wang, Richard Xu, Liming Liang, Suchi Saria, Hongkai Ji

Background: Most studies on the association of in utero exposure to cigarette smoking and childhood overweight or obesity (OWO) were based on maternal self-reported smoking status, and few were based on objective biomarkers. The concordance of self-report smoking, and maternal and cord blood biomarkers of cigarette smoking as well as their effects on children's long-term risk of overweight and obesity are unclear.

Methods: In this study, we analyzed data from 2351 mother-child pairs in the Boston Birth Cohort, a sample of US predominantly Black, indigenous, and people of color (BIPOC) that enrolled children at birth and followed prospectively up to age 18 years. In utero smoking exposure was measured by maternal self-report and by maternal and cord plasma biomarkers of smoking: cotinine and hydroxycotinine. We assessed the individual and joint associations of each smoking exposure measure and maternal OWO with childhood OWO using multinomial logistic regressions. We used nested logistic regressions to investigate the childhood OWO prediction performance when adding maternal and cord plasma biomarkers as input covariates on top of self-reported data.

Results: Our results demonstrated that in utero cigarette smoking exposure defined by self-report and by maternal or cord metabolites was consistently associated with increased risk of long-term child OWO. Children with cord hydroxycotinine in the fourth quartile (vs. first quartile) had 1.66 (95% confidence interval [CI] 1.03-2.66) times the odds for overweight and 1.57 (95% CI 1.05-2.36) times the odds for obesity. The combined effect of maternal OWO and smoking on offspring risk of obesity is 3.66 (95% CI 2.37-5.67) if using self-reported smoking. Adding maternal and cord plasma biomarker information to self-reported data improved the prediction accuracy of long-term child OWO risk.

Conclusions: This longitudinal birth cohort study of US BIPOC underscored the role of maternal smoking as an obesogen for offspring OWO risk. Our findings call for public health intervention strategies to focus on maternal smoking - as a highly modifiable target, including smoking cessation and countermeasures (such as optimal nutrition) that may alleviate the increasing obesity burden in the United States and globally.

背景:大多数关于子宫内吸烟与儿童超重或肥胖(OWO)关系的研究都是基于母亲自我报告的吸烟状况,很少有基于客观生物标志物的研究。自我报告吸烟与吸烟的母体和脐带血生物标志物的一致性以及它们对儿童超重和肥胖的长期风险的影响尚不清楚。方法:在这项研究中,我们分析了波士顿出生队列中2351对母子的数据,该队列是一个以黑人、土著和有色人种(BIPOC)为主的美国样本,在出生时登记儿童,并前瞻性随访至18岁。通过母体自我报告以及母体和脐带血浆中吸烟的生物标志物:可替宁和羟基可替宁来测量子宫内吸烟暴露量。我们使用多项逻辑回归评估了每项吸烟暴露量表和母亲OWO与儿童OWO的个体和联合相关性。当在自我报告数据的基础上添加母体和脐带血浆生物标志物作为输入协变量时,我们使用嵌套逻辑回归来研究儿童OWO预测性能。结果:我们的研究结果表明,由自我报告和母体或脐带代谢产物定义的子宫内吸烟暴露与儿童长期OWO的风险增加一致。脐带羟基可替宁在第四个四分位数(与第一个四分位相比)的儿童超重的几率是1.66倍(95%置信区间[CI]1.03-2.66),肥胖的几率是1.57倍(95%可信区间1.05-2.36)。如果使用自我报告的吸烟,母体OWO和吸烟对后代肥胖风险的综合影响为3.66(95%CI 2.37-5.67)。在自我报告的数据中添加母体和脐带血浆生物标志物信息提高了长期儿童OWO风险的预测准确性。结论:这项美国BIPOC的纵向出生队列研究强调了母亲吸烟作为后代OWO风险的一个肥胖源的作用。我们的研究结果呼吁制定公共卫生干预策略,将母亲吸烟作为一个高度可改变的目标,包括戒烟和对策(如最佳营养),以减轻美国和全球日益增加的肥胖负担。
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引用次数: 0
Role of glutathione in the pathophysiology of pre-eclampsia: implications for nutritional intervention 谷胱甘肽在子痫前期病理生理中的作用:营养干预的意义
Pub Date : 2022-12-01 DOI: 10.1097/PN9.0000000000000023
Jimmy Gutman, A. Parrilla
Oxidative stress (OS) can be simply defined as an imbalance between free radical formation and antioxidant defenses. Free radicals (reactive oxygen species, reactive nitrogen species) potentially lead to a cascade of biochemical events that disrupt normal cellular function. OS has been proposed that they play a part in the pathogenesis of many disease processes including cancer,[3,4] arteriosclerosis,[5–8] Alzheimer’s Disease,[9,10] pulmonary disease,[11,12] and a number of gynecological pathologies including endometriosis,[13–15] gestational diabetes,[16–18] infertility,[19–21] and polycystic ovary syndrome.[22–24]
氧化应激(OS)可以简单地定义为自由基形成和抗氧化防御之间的失衡。自由基(活性氧、活性氮)可能导致一系列破坏正常细胞功能的生化事件。OS被认为在许多疾病过程的发病机制中发挥作用,包括癌症、[3,4]动脉硬化、[5-8]阿尔茨海默病、[9,10]肺病、[11,12]和许多妇科疾病,包括子宫内膜异位症、[13-15]妊娠糖尿病、[16-18]不孕、[19-21]和多囊卵巢综合征。[22-24]
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引用次数: 0
L-arginine regulates the differential expression of apoptosis genes in gastric cancer cells L-精氨酸调节癌症细胞凋亡基因的差异表达
Pub Date : 2022-12-01 DOI: 10.1097/PN9.0000000000000022
Kai Du, Jinhong Han, Zhexi Shi, Yilu Xu, Tingting Yu, Han-gong Xu, X. Shu
Background: According to previous reports, L-arginine may help treat stomach cancer by causing cell apoptosis, but the specific mechanism remains obscure. Objective: The current study aims to discover how L-arginine induces the cell apoptosis in gastric carcinoma. Methods: The cytotoxicity and apoptosis rate of SGC-7901 cells incubated in the RPMI-1640 medium supplemented with L-arginine were detected by CCK8 and flow cytometry. High-throughput RNA-sequencing was performed to search for differentially expressed genes (DEGs). KEGG (Kyoto Encyclopedia of Genes and Genomes) and GO (Gene Ontology) were used to analyze the biological processes and pathways that include the DEGs. Results: In SGC-7901 cells, L-arginine reduced viability in dose- and time-dependent manners. SGC-7901 cells underwent the dose-dependent induction of apoptosis by L-arginine, and the early and late apoptosis rates were 28.33% and 68.2% after 25 mM L-arginine intervention, respectively (both P < 0.0001). The apoptosis-related processes were upregulated, and DNA modification-related processes were downregulated after L-arginine intervention. The hub genes that were significantly increased and decreased after L-arginine incubation were PHLDA1 (pleckstrin homology-like domain family member 1) and DBNL (drebrin-like protein), respectively. Conclusion: Our findings suggested a new treatment target for gastric cancer by demonstrating the enhancement effect of L-arginine on cell apoptosis of gastric cancer.
背景:根据先前的报道,L-精氨酸可能通过引起细胞凋亡来帮助治疗癌症,但其具体机制尚不清楚。目的:探讨L-精氨酸如何诱导胃癌细胞凋亡。方法:用CCK8和流式细胞仪检测在添加L-精氨酸的RPMI-1640培养基中培养的SGC-7901细胞的细胞毒性和凋亡率。进行高通量RNA测序以寻找差异表达基因(DEG)。KEGG(京都基因和基因组百科全书)和GO(基因本体论)被用于分析包括DEG的生物过程和途径。结果:在SGC-7901细胞中,L-精氨酸以剂量和时间依赖的方式降低细胞活力。L-精氨酸对SGC-7901细胞进行了剂量依赖性的凋亡诱导,25天后早期和晚期凋亡率分别为28.33%和68.2% mM L-精氨酸干预后,细胞凋亡相关过程上调,DNA修饰相关过程下调。L-精氨酸孵育后显著增加和减少的枢纽基因分别是PHLDA1(pleckstrin同源性样结构域家族成员1)和DBNL(drebrin样蛋白)。结论:L-精氨酸对癌症细胞凋亡的促进作用为癌症的治疗提供了新的靶点。
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引用次数: 0
China Precision Nutrition and Health-KAP Real World Study (CPN-KAPS): rationale, study design, and protocol 中国精准营养与健康kap现实世界研究(CPN-KAPS):研究原理、研究设计和方案
Pub Date : 2022-12-01 DOI: 10.1097/PN9.0000000000000021
Han-ping Shi, Jianping Li, C. Mao, Bin-yan Wang, X. Qin, H. Bao, Kunhua Wang, W. Ling, Guifan Sun, J. Yang, Zengning Li, Xian Shen, Junqiang Chen, G. Mao, X. Shu, Hai Ma, Qing Dong, Xiaobin Wang, Xiping Xu, N. Sun, Xiaoshu Cheng
Background: The burden of chronic diseases and associated morbidities and mortalities are rapidly rising in China. Nutrition and lifestyle are major contributors. Currently, there is a paucity of strong evidence to guide optimal intake of macronutrients and micronutrients for primordial, primary, and secondary prevention of chronic diseases among diverse populations and across life stages in China. Evidence is also lacking on the KAP (Knowledge, Attitude, and Practice) in Chinese populations to inform effective behavior interventions. The China Precision Nutrition and Health-KAP Real World Study (CPN-KAPS) intends to establish a cohort and conduct research in real-world settings to improve KAP and advance precision nutrition. Methods: The CPN-KAPS is a long-term, multicenter, prospective, observational, real-world study that will enroll at least a million adults who meet the inclusion criteria. Each participant will be expected to attend at least 5 follow-up visits (once a year). The primary endpoints include nutritional status and the occurrence, progression, and prognosis of numerous chronic diseases such as cardiovascular and cerebrovascular disease, tumors, chronic kidney disease, Alzheimer’s disease, digestive system diseases, diabetes, mortality, and results of the health KAP survey. Secondary endpoints include malnutrition and changes in various chronic disease-related biomarkers and pharmacoeconomic indicators. Results: The CPN-KAPS is still in a formative stage, but we anticipate this study will establish a rich database and biorepository. These resources will create enormous opportunities for scientific discoveries and clinical public health translation. Conclusion: This large-scale, observational, prospective and real-world research will be of great significance and value for an in-depth understanding of China’s nutrition and health status, to provide precision nutrition intervention strategy for the prevention and treatment of chronic diseases in Chinese Population.
背景:中国慢性病及相关疾病和死亡率的负担正在迅速上升。营养和生活方式是主要因素。目前,缺乏强有力的证据来指导在中国不同人群和不同生命阶段最佳摄入宏量营养素和微量营养素,以进行慢性病的初级、初级和二级预防。中国人群的知识、态度和实践(KAP)也缺乏证据,无法为有效的行为干预提供信息。中国精准营养与健康KAP真实世界研究(CPN-KAPS)旨在建立一个队列,并在现实世界中进行研究,以改善KAP并推进精准营养。方法:CPN-KAPS是一项长期、多中心、前瞻性、观察性、真实世界的研究,将招募至少100万符合纳入标准的成年人。每位参与者将至少参加5次随访(每年一次)。主要终点包括营养状况以及许多慢性疾病的发生、进展和预后,如心脑血管疾病、肿瘤、慢性肾脏疾病、阿尔茨海默病、消化系统疾病、糖尿病、死亡率和健康KAP调查结果。次要终点包括营养不良和各种慢性病相关生物标志物和药物经济学指标的变化。结果:CPN-KAPS仍处于形成阶段,但我们预计本研究将建立一个丰富的数据库和生物库。这些资源将为科学发现和临床公共卫生翻译创造巨大机会。结论:这项大规模、观察性、前瞻性和现实世界的研究,对于深入了解中国的营养和健康状况,为中国人群慢性病的预防和治疗提供精准的营养干预策略,具有重要意义和价值。
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引用次数: 0
A multicentered, randomized, double-blind, parallel-controlled clinical trial on the homocysteine and blood pressure-lowering effects of amlodipine-folic acid versus amlodipine among H-type hypertensive patients intolerant to ACEI: principles and methods 一项多中心、随机、双盲、平行对照的氨氯地平-叶酸与氨氯地平对ACEI不耐受h型高血压患者同型半胱氨酸和降压效果的临床研究:原理和方法
Pub Date : 2022-12-01 DOI: 10.1097/PN9.0000000000000019
Xiao Huang, Yan Li, Ping Li, Zaihua Cheng, Lingling Fu, C. Ding, Zhi-rong Wang, De-Fang Song, Chen Yao, Guangliang Chen, Yi-min Cui, Xiaobin Wang, Y. Huo, Xiaoshu Cheng, Ji-Gwang Wang
Background: Hypertension is the most important modifiable risk factor for cardiovascular disease (CVD) morbidity and mortality. Elevated plasma total homocysteine (tHcy) coupled with hypertension can synergistically increase the risk for CVD and is highly prevalent in the Chinese population. The China Stroke Primary Prevention Trial has shown the efficacy of taking a daily enalapril-FA tablet in treating hypertension and HHcy. However, a substantial portion of patients cannot tolerate enalapril, an angiotensin-converting enzyme inhibitor (ACEI). The Precision Amlodipine-folic acid Trial to lower tHcy (ClinicalTrials.gov Identifier: NCT01956786) aimed to evaluate whether amlodipine combined with folic acid treatment is more efficacious than amlodipine alone in lowering plasma tHcy and blood pressure (BP) among Chinese patients with hypertension with HHcy and intolerance to ACEI. Methods: This was a multicentered, randomized, double-blind, parallel-controlled clinical trial conducted from December 19, 2013, to March 6, 2014, in 4 study centers across China (Shanghai, Nanchang, Xuzhou, and Anqing). Eligible participants who had mild to moderate hypertension were men and women aged 18 to 75 years, hyperhomocysteinemia and intolerant to ACEI. Eligible patients were randomly assigned in a 1:1:1 ratio to receive either an amlodipine 5 mg and FA 0.4 mg tablet daily (A group); or an amlodipine 5 mg and FA 0.8 mg tablet daily (B group); or an amlodipine 5 mg tablet daily (C group, control group) for a total of 8 weeks. The primary endpoints were tHcy-lowering and BP assessed at 2, 4, 6, and 8 weeks. Planned analyses included intent to treat and per protocol set, and multivariable logistic and linear regression models were used to evaluate the efficacy of amlodipine combined with FA in reducing tHcy and BP. Results: A total of 505 participants were enrolled in the screening period; of those, 458 entered the run-in period, and of those, 360 eligible participants were randomized to one of the 3 treatment groups. Overall, 31.3% of participants were male (n = 110), with a mean age of 63.2 (SD: 6.2) years. The randomization was successful as demonstrated by the well-balanced distribution of baseline characteristics across the 3 groups. Conclusions: This is the first trial of its kind to inform the clinical management of patients with hypertension, HHcy and intolerant to ACEI. The rationale and methods of the trial are introduced in this article, which lays a foundation for subsequent publications.
背景:高血压是心血管疾病(CVD)发病率和死亡率最重要的可改变危险因素。血浆总同型半胱氨酸(tHcy)升高合并高血压可协同增加心血管疾病的风险,这在中国人群中非常普遍。中国脑卒中一级预防试验显示,每日服用依那普利- fa片治疗高血压和HHcy有效。然而,相当一部分患者不能耐受依那普利,一种血管紧张素转换酶抑制剂(ACEI)。氨氯地平-叶酸降低tHcy的精准试验(ClinicalTrials.gov Identifier: NCT01956786)旨在评估氨氯地平联合叶酸治疗在降低hcy合并ACEI不耐受的中国高血压患者血浆tHcy和血压(BP)方面是否比氨氯地平单用更有效。方法:这是一项多中心、随机、双盲、平行对照的临床试验,于2013年12月19日至2014年3月6日在中国4个研究中心(上海、南昌、徐州和安庆)进行。有轻度至中度高血压的受试者年龄为18至75岁,高同型半胱氨酸血症和ACEI不耐受的男性和女性。符合条件的患者按1:1:1的比例随机分配,每天服用氨氯地平5mg和FA 0.4 mg片(a组);或每日一片氨氯地平5毫克和FA 0.8毫克(B组);或每日一片氨氯地平5mg片(C组,对照组),共8周。主要终点是thcy降低和2、4、6和8周时的血压评估。计划分析包括治疗意图和每个方案集,并使用多变量逻辑和线性回归模型来评估氨氯地平联合FA降低tHcy和BP的疗效。结果:筛查期共纳入受试者505人;其中,458人进入了磨合期,其中360名符合条件的参与者被随机分配到三个治疗组中的一个。总体而言,31.3%的参与者为男性(n = 110),平均年龄为63.2岁(SD: 6.2)。随机化是成功的,因为基线特征在三组之间的分布很平衡。结论:这是第一个为高血压、HHcy和ACEI不耐受患者的临床管理提供信息的同类试验。本文介绍了试验的基本原理和方法,为后续发表奠定了基础。
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引用次数: 2
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Precision nutrition
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