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Análisis del programa de apoyo al paciente de evolocumab (Repatha®) para pacientes con enfermedades cardiovasculares en Colombia 哥伦比亚心血管疾病患者evolocumab (Repatha®)患者支持计划分析
IF 1.6 Q3 Medicine Pub Date : 2023-11-01 DOI: 10.1016/j.arteri.2023.04.005
Ángel Alberto García-Peña , Mariana Pineda-Posada , Carol Páez-Canro , César Cruz , Daniel Samacá-Samacá

Background

Cardiovascular diseases are considered the leading cause of death globally. This study describes the demographic characteristics, treatment patterns, self-reported compliance and persistence, and to explore variables related to non-adherence of patients enrolled in the cardiovascular patient support program (PSP) for evolocumab treatment in Colombia.

Methods

This retrospective observational of the data registry of patients who entered the evolocumab PSP program.

Results

The analysis included 930 patients enrolled in the PSP (2017-2021). Mean age was 65.1 (SD ± 13.1) and49.1% patients were female. The mean compliance rate to evolocumab treatment was 70.5% (SD ± 21.8). A total of 367 patients (40.5%) reported compliance higher than 80%. Persistence analysis included 739 patients (81.5%) where 87.8% of these patients were considered persistent to treatment. A total of 871 patients (93.7%) reported the occurrence of at least one adverse event during the follow-up period (mostly non-serious).

Conclusion

This is the first real-life study describing patient characteristics, compliance and continuity of treatment for dyslipidemia in a patient support program in Colombia. The overall adherence found was higher than 70%; similar to findings reported in other real-life studies with iPCSK9. However, the reasons for low compliance were different, highlighting the high number of administrative and medical reasons for suspension or abandonment of treatment with evolocumab.

背景:心血管疾病被认为是全球死亡的主要原因。本研究描述了人口统计学特征、治疗模式、自我报告的依从性和持久性,并探索与哥伦比亚心血管患者支持计划(PSP)中evolocumab治疗的患者不依从性相关的变量。方法回顾性观察进入evolocumab PSP项目的患者的注册数据。结果该分析包括930名参与PSP(2017-2021)的患者。平均年龄为65.1 (SD±13.1)岁,女性占49.1%。evolocumab治疗的平均依从率为70.5% (SD±21.8)。367例患者(40.5%)的依从性高于80%。持续性分析纳入739例患者(81.5%),其中87.8%的患者被认为坚持治疗。共有871例患者(93.7%)报告在随访期间至少发生一次不良事件(多为非严重事件)。结论:这是哥伦比亚患者支持项目中第一个描述血脂异常患者特征、依从性和治疗连续性的现实研究。总体依从性高于70%;与iPCSK9在现实生活中的其他研究结果相似。然而,低依从性的原因各不相同,突出表明暂停或放弃evolocumab治疗的行政和医学原因较多。
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引用次数: 0
Percepción de los médicos frente al consumo de vino tinto y la salud cardiovascular 医生对红酒消费与心血管健康的看法
IF 1.6 Q3 Medicine Pub Date : 2023-11-01 DOI: 10.1016/j.arteri.2023.05.002
Javier Espíldora-Hernández , Salvador Martín-Cortés , María José Benítez-Toledo , Inmaculada Coca-Prieto , Miguel Ángel. Sánchez-Chaparro , Pedro Valdivielso

Introduction

The consumption of red wine has historically been associated with a reduction in cardiovascular risk, with sometimes controversial scientific evidence.

Method

A survey was carried out via whatsapp dated 09/01/22 to a cohort of doctors from the province of Malaga, asking about possible healthy red wine consumption habits, differentiating: never, 3-4 glasses per week, 5 -6 weekly drinks and one daily drink.

Results

A total of 184 physicians answered, with a mean age of 35 years ± 11.1, of which 84 (45.6%) were women, distributed in different specialties, the majority being internal medicine with 52 (28.2%). The most frequently chosen option was D (59.2%), followed by A (21.2%), C (14.7%) and B (5%).

Conclusions

More than half of the doctors surveyed recommended zero consumption, and only 20% indicated that a daily drink could be healthy in non-drinkers.

从历史上看,饮用红酒与降低心血管风险有关,但有时科学证据存在争议。方法通过whatsapp于22年9月1日对马拉加省的一组医生进行了一项调查,询问他们可能的健康红酒消费习惯,区分为:从不喝、每周喝3-4杯、每周喝5 -6杯和每天喝一次。结果共184名受访医师,平均年龄(35岁±11.1岁),其中女性84人(45.6%),分布在不同专科,以内科为主,52人(28.2%)。选择最多的选项是D(59.2%),其次是A(21.2%)、C(14.7%)和B(5%)。超过一半的受访医生建议不要饮酒,只有20%的医生表示不饮酒者每天喝一杯酒是有益健康的。
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引用次数: 0
Long-term treatment persistence and maintained reduction of LDL-cholesterol levels with evolocumab over 30 months: Results from the Spanish cohort of the European prospective HEYMANS study evolocumab在30个月的长期治疗中持续降低ldl -胆固醇水平:来自欧洲前瞻性HEYMANS研究的西班牙队列结果
IF 1.6 Q3 Medicine Pub Date : 2023-11-01 DOI: 10.1016/j.arteri.2023.04.004
Agustín Blanco Echevarría , Juan De Dios García Díaz , Assumpta Caixas , Núria Plana Gil , Miguel Ángel Rico Corral , Ian Bridges , Nafeesa Dhalwani , Sònia Gatell Menchen , Kausik K. Ray

Aims

Limited data exist on low-density lipoprotein-cholesterol (LDL-C) level variability or long-term persistence with the monoclonal antibody evolocumab in routine clinical practice. HEYMANS (NCT02770131) is the first multi-country, multicenter, observational study of European patients initiating evolocumab as part of their routine clinical management, based on local reimbursement criteria (overall data recently published). The aim of this analysis is to describe clinical characteristics, baseline and changes in LDL-C levels, treatment patterns and persistence to evolocumab over 30 months in the Spanish cohort using data from the HEYMANS Registry.

Methods

HEYMANS was a prospective study of adult patients (≥18 years) who received at least one dose of evolocumab. A total of 1951 patients were enrolled from 12 countries and were followed up for 30 months after evolocumab initiation. Data were collected for 6 months before evolocumab initiation and up to 30 months thereafter. The Spanish cohort included patients who started evolocumab in routine clinical practice from March 2016 to September 2019. Demographic and clinical characteristics, lipid-lowering therapies (LLT), and lipid levels were collected.

Results

In total, 201 patients were included in the Spanish cohort. Median follow-up (Q1–Q3) was 30.0 (12–30) months. A total of 61.7% of patients were men and the mean (standard deviation) age was 59.5 (10.8) years. Most patients (68.7%) had experienced a prior cardiovascular event, 45.3% had coronary artery disease or stable angina, and 60.2% had a diagnosis of familial hypercholesterolemia. Overall, 57.7% of patients were receiving treatment with statins, most of them with high-intensity statins (85.3%); 45.8% of patients were intolerant to statins, and 26.4% of patients did not receive any LLT. At baseline, median (Q1–Q3) LDL-C levels were 151 (123–197) mg/dL. After 3 months of treatment, baseline LDL-C decreased by 66% to a median of 50 (30–83) mg/dL and these levels were maintained over time, with a median LDL-C of 55 (40–99) mg/dL at 30 months. At months 10–12 of treatment, LDL-C levels < 55 mg/dL were achieved by 56.3% of patients. LDL-C levels < 70 mg/dL were achieved by 70.1% of patients, and a lowering of LDL-C levels ≥50% was achieved by 76.8% of patients. The percentage of patients on evolocumab treatment was 95% at 12 months and 93% at 30 months.

Conclusions

In the Spanish cohort in routine clinical practice, evolocumab therapy provided a reduction in LDL-C levels consistent with that reported in previous clinical trials, which was sustained during 30 months of follow-up. Treatment with evolocumab was started at LDL-C levels 50% higher than those recommended by The Spanish Society of Arteriosclerosis and the Therapeutic Positioning Report. The pro

目的:在常规临床实践中,单克隆抗体evolocumab的低密度脂蛋白-胆固醇(LDL-C)水平变异性或长期持久性的数据有限。HEYMANS (NCT02770131)是首个多国、多中心、观察性研究,研究对象是欧洲患者,根据当地的报销标准,将evolocumab作为其常规临床管理的一部分。本分析的目的是描述临床特征、基线和LDL-C水平的变化、治疗模式和evolocumab在西班牙队列中超过30个月的持续使用,数据来自HEYMANS Registry。sheymans是一项前瞻性研究,研究对象是接受至少一剂evolocumab治疗的成年患者(≥18岁)。共有来自12个国家的1951名患者入组,并在evolocumab启动后随访30个月。evolocumab起始治疗前6个月和起始治疗后最多30个月收集数据。西班牙队列包括2016年3月至2019年9月在常规临床实践中开始使用evolocumab的患者。收集人口统计学和临床特征、降脂疗法(LLT)和血脂水平。结果西班牙队列共纳入201例患者。中位随访(Q1-Q3)为30.0(12-30)个月。61.7%的患者为男性,平均(标准差)年龄为59.5(10.8)岁。大多数患者(68.7%)既往有心血管事件,45.3%有冠状动脉疾病或稳定型心绞痛,60.2%诊断为家族性高胆固醇血症。总体而言,57.7%的患者正在接受他汀类药物治疗,其中大部分是高强度他汀类药物(85.3%);45.8%的患者对他汀类药物不耐受,26.4%的患者未接受任何LLT治疗。基线时,中位(Q1-Q3) LDL-C水平为151 (123-197)mg/dL。治疗3个月后,基线LDL-C下降了66%,中位数为50 (30 - 83)mg/dL,并且随着时间的推移这些水平保持不变,30个月时中位数LDL-C为55 (40-99)mg/dL。在治疗10-12个月时,LDL-C水平<56.3%的患者达到55 mg/dL。LDL-C水平<70.1%的患者达到70mg /dL, 76.8%的患者达到LDL-C水平降低≥50%。接受evolocumab治疗的患者百分比在12个月时为95%,在30个月时为93%。在常规临床实践中的西班牙队列中,evolocumab治疗提供了与先前临床试验报告一致的LDL-C水平降低,并持续了30个月的随访。evolocumab治疗开始时LDL-C水平比西班牙动脉硬化学会和治疗定位报告推荐的水平高50%。通过联合治疗,达到2019年ESC/EAS LDL-C目标的可能性将会提高,并且在开始使用evolocumab时,LDL-C阈值也会降低。在随访期间,evolocumab的持续性仍然很高,停药的百分比非常低(12个月时为5%;30个月为7%)。
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引用次数: 0
Estudio observacional de pacientes de una Unidad de Lípidos en tratamiento hipolipemiante para prevención primaria y secundaria: Estudio ULFI 一单位脂类患者一级和二级预防降脂治疗的观察性研究:ULFI研究
IF 1.6 Q3 Medicine Pub Date : 2023-11-01 DOI: 10.1016/j.arteri.2023.06.002
Àlex Vila , Estel Pons , Patricia Trinidad García , Daniel Vidal , Sara López , Armand Grau

Objectives

To evaluate the achievement of low-density lipoprotein cholesterol (LDLc) goals established by the 2019 European Guidelines for the Management of Dyslipidemias and 2021 Cardiovascular Disease Prevention Guidelines, describe the lipid-lowering treatment received, analyze the achievement of goals according to the lipid-lowering treatment received and study the factors associated with therapeutic success.

Design

Observational study that included 185 patients of both sexes aged 18 or over undergoing lipid-lowering treatment for primary or secondary prevention, attended at the Lipid Unit.

Results

62.1% of the patients had a very high cardiovascular risk (CVR) according to the 2019 guidelines, and 60.5% according to the 2021 guidelines. Of the total cases, 22.7% achieved adequate control of LDLc according to the 2019 guidelines and 20% according to the 2021 guidelines. 47.6% of the patients received very high intensity lipid-lowering treatment, and 14.1% received extremely high intensity lipid-lowering treatment. 76% of subjects with very high CVR on extremely high intensity lipid-lowering treatment achieved the therapeutic objectives of both guides. In the multivariate analysis, factors associated with therapeutic success were the presence of arteriosclerotic cardiovascular disease, the intensity of lipid-lowering treatment, diabetes mellitus, and low to moderate alcohol consumption.

Conclusions

Dyslipidemia control is improvable. High or extremely high intensity lipid-lowering treatments can contribute to optimizing control of patients with higher CVR.

目的评价2019年欧洲血脂异常管理指南和2021年心血管疾病预防指南制定的低密度脂蛋白胆固醇(LDLc)目标的实现情况,描述所接受的降脂治疗,根据所接受的降脂治疗分析目标的实现情况,研究治疗成功的相关因素。设计一项观察性研究,纳入185名18岁及以上、在脂质科接受一级或二级预防降脂治疗的患者。结果根据2019年指南,62.1%的患者心血管风险极高(CVR),根据2021年指南,60.5%的患者心血管风险极高。在所有病例中,22.7%根据2019年指南实现了LDLc的充分控制,20%根据2021年指南实现了LDLc的充分控制。47.6%的患者接受了非常高强度的降脂治疗,14.1%的患者接受了极高强度的降脂治疗。在接受极高强度降脂治疗的非常高CVR患者中,76%达到了两个指南的治疗目标。在多变量分析中,与治疗成功相关的因素是动脉硬化性心血管疾病的存在、降脂治疗的强度、糖尿病和低至中度饮酒。结论血脂控制有明显改善。高强度或极高强度的降脂治疗有助于优化高CVR患者的控制。
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引用次数: 0
Update of HDL in atherosclerotic cardiovascular disease 动脉粥样硬化性心血管疾病中高密度脂蛋白的更新。
IF 1.6 Q3 Medicine Pub Date : 2023-11-01 DOI: 10.1016/j.arteri.2023.10.002
Leonie Schoch , Sebastián Alcover , Teresa Padró , Soumaya Ben-Aicha , Guiomar Mendieta , Lina Badimon , Gemma Vilahur

Epidemiologic evidence supported an inverse association between HDL (high-density lipoprotein) cholesterol (HDL-C) levels and atherosclerotic cardiovascular disease (ASCVD), identifying HDL-C as a major cardiovascular risk factor and postulating diverse HDL vascular- and cardioprotective functions beyond their ability to drive reverse cholesterol transport. However, the failure of several clinical trials aimed at increasing HDL-C in patients with overt cardiovascular disease brought into question whether increasing the cholesterol cargo of HDL was an effective strategy to enhance their protective properties. In parallel, substantial evidence supports that HDLs are complex and heterogeneous particles whose composition is essential for maintaining their protective functions, subsequently strengthening the “HDL quality over quantity” hypothesis.

The following state-of-the-art review covers the latest understanding as per the roles of HDL in ASCVD, delves into recent advances in understanding the complexity of HDL particle composition, including proteins, lipids and other HDL-transported components and discusses on the clinical outcomes after the administration of HDL-C raising drugs with particular attention to CETP (cholesteryl ester transfer protein) inhibitors.

流行病学证据支持高密度脂蛋白胆固醇(HDL-C)水平与动脉粥样硬化性心血管疾病(ASCVD)之间的负相关,将HDL-C确定为主要的心血管风险因素,并假设HDL-C具有不同的血管和心脏保护功能,超出了其驱动胆固醇反向转运的能力。然而,几项旨在提高显性心血管疾病患者HDL-C的临床试验的失败,让人怀疑增加HDL-C的胆固醇含量是否是增强其保护特性的有效策略。同时,大量证据支持高密度脂蛋白是复杂和不均匀的颗粒,其组成对维持其保护功能至关重要,从而强化了“高密度脂素质量高于数量”的假说。以下最新综述涵盖了对高密度脂蛋白在ASCVD中作用的最新理解,深入探讨了在理解包括蛋白质在内的高密度脂素颗粒组成的复杂性方面的最新进展,脂质和其他HDL转运成分,并讨论了服用HDL-C升高药物后的临床结果,特别关注CETP(胆固醇酯转移蛋白)抑制剂。
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引用次数: 0
EL VINO: ¿ES REALMENTE SALUDABLE? 葡萄酒:真的健康吗?
IF 1.6 Q3 Medicine Pub Date : 2023-11-01 DOI: 10.1016/j.arteri.2023.11.001
Ramón Estruch
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引用次数: 0
Accuracy of visceral adiposity indices and lipid accumulation products in the identification of adults at high cardiovascular risk 内脏脂肪指数和脂质积聚产物在识别心血管高危成年人中的准确性。
IF 1.6 Q3 Medicine Pub Date : 2023-09-01 DOI: 10.1016/j.arteri.2023.04.002
Ana Maria Gonçalvez Milla , Eduardo B.F. Chagas , Vitor Fernando Bordin Miola , Bárbara de Oliveira Zanuso , Elen Landgraf Guiguer , Adriano Cressoni Araújo , Ricardo José Tofano , Karina R. Quesada , Lucas F. Laurindo , Sandra M. Barbalho

Introduction

The lipid accumulation product (LAP) and visceral adipose index (VAI) are clinical markers of visceral obesity and were proposed as simple tools to estimate cardiovascular risk and mortality. The objective of this study was to analyze the accuracy of the VAI and LAP for high cardiovascular risk patients.

Methods

A cross-sectional observational study of accuracy was carried out in 193 patients of both sexes. In addition to the variables VAI and LAP, presence of comorbidities, education, level of physical activity and anthropometric data were obtained. Cardiovascular risk was determined by the Framingham score.

Results

No significant difference was observed in the sample in gender distribution (44.6% women; 55.4% men), 24.4% had low cardiovascular risk, 48.7% intermediate risk and 26.9% high cardiovascular risk. Linear regression analysis showed that VAI and LAP explain, respectively, only 2.4% and 5.2% of the variation in cardiovascular risk expressed by the Framingham score. The analysis of areas under the curve (AUC) for receiver operating characteristic (ROC) indicated a significant effect only of LAP to diagnose individuals with high cardiovascular risk, but with low sensitivity and specificity.

Conclusion

Our results indicate that VAI and LAP explain only a small percentage of the variation in the Framingham cardiovascular risk score. LAP index still deserves more attention in a cohort study, because, even with the limitations of a cross-sectional study, we observed an acceptable sensitivity for it so that the LAP can be used as a screening criterion for requesting more accurate tests.

引言:脂质堆积产物(LAP)和内脏脂肪指数(VAI)是内脏肥胖的临床标志物,被认为是评估心血管风险和死亡率的简单工具。本研究的目的是分析VAI和LAP对心血管高危患者的准确性。方法:对193名男女患者进行横断面观察性准确性研究。除了变量VAI和LAP外,还获得了合并症的存在、教育程度、体育活动水平和人体测量数据。心血管风险由Framingham评分决定。结果:样本的性别分布没有显著差异(女性44.6%;男性55.4%),心血管风险低的占24.4%,心血管风险中等的占48.7%,心血管风险高的占26.9%。线性回归分析表明,VAI和LAP分别只能解释Framingham评分所表达的心血管风险变化的2.4%和5.2%。受试者工作特征曲线下面积(AUC)的分析表明,LAP仅对诊断心血管高危个体有显著影响,但敏感性和特异性较低。结论:我们的研究结果表明,VAI和LAP只能解释Framingham心血管风险评分变化的一小部分。在队列研究中,LAP指数仍然值得更多关注,因为即使有横断面研究的局限性,我们也观察到它的敏感性是可以接受的,因此LAP可以作为要求更准确测试的筛查标准。
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引用次数: 0
“Notas metodológicas”: una nueva e importante sección en Clínica e Investigación en Arteriosclerosis 《方法学笔记》:动脉粥样硬化临床与研究中的一个新的重要部分
IF 1.6 Q3 Medicine Pub Date : 2023-09-01 DOI: 10.1016/j.arteri.2023.09.001
Josep Ribalta, Carlos Lahoz, Xavier Pintó
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引用次数: 0
Alimentos funcionales y nutracéuticos en el tratamiento de la hipercolesterolemia: posicionamiento de la Sociedad Española de Arteriosclerosis 2023 治疗高胆固醇血症的功能性和营养食品:2023年西班牙动脉硬化学会的定位
IF 1.6 Q3 Medicine Pub Date : 2023-09-01 DOI: 10.1016/j.arteri.2023.02.002
Pablo Pérez-Martínez , Emilio Ros , Juan Pedro-Botet , Fernando Civeira , Vicente Pascual , Carmen Garcés , Rosa Solá , Francisco Pérez-Jiménez , José M. Mostaza

In the management of hypercholesterolemia, besides advising a healthy, plant-based diet, it may be useful to recommend functional foods or nutraceutical with cholesterol-lowering properties. Given the progressive increase in the number of these products and their rising use by the population, the Spanish Society of Arteriosclerosis (SEA) has considered it appropriate to review the available information, select the results of the scientifically more robust studies and take a position on their usefulness, to recommend to health professionals and the general population their potential utility in terms of efficacy and their possible benefits and limitations. The following clinical scenarios have been identified in which these products could be used and will be analyzed in more detail in this document: (1) Hypolipidemic treatment in subjects with statin intolerance. (2) Hypolipidemic treatment «a la carte» in individuals in primary prevention. (3) Long-term cardiovascular prevention in individuals with no indication for lipid-lowering therapy. (4) Patients with optimized lipid-lowering treatment who do not achieve therapeutic objectives.

在高胆固醇血症的治疗中,除了建议健康的植物性饮食外,推荐具有降低胆固醇特性的功能性食品或营养品可能是有用的。鉴于这些产品的数量在逐渐增加,并且越来越多的人使用这些产品,西班牙动脉硬化学会(SEA)认为审查现有信息,选择科学上更有力的研究结果,并对其有用性采取立场是合适的,向卫生专业人员和普通人群推荐其在疗效方面的潜在效用及其可能的益处和局限性。这些产品可用于以下临床场景,并将在本文件中进行更详细的分析:(1)他汀类药物不耐受受试者的降脂治疗。(2) 初级预防中个体的降血脂治疗“点菜”。(3) 没有降脂治疗指征的个体的长期心血管预防。(4) 接受优化降脂治疗但未达到治疗目标的患者。
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引用次数: 0
Un caso de hipocolesterolemia a estudio 低胆固醇血症一例研究
IF 1.6 Q3 Medicine Pub Date : 2023-09-01 DOI: 10.1016/j.arteri.2023.05.003
Ana Camacho , María José Ariza , Nuria Amigó , Patricia Macías Guillén , Miguel Ángel Sánchez Chaparro , Pedro Valdivielso

Primary hypocholesterolemia (or hypobetalipoproteinemia) is a rare disorder of lipoprotein metabolism that may be due to a polygenic predisposition or a monogenic disease. Among these, it is possible to differentiate between symptomatic and asymptomatic forms, in which, in the absence of secondary causes, the initial clinical suspicion is plasma ApoB levels below the 5 th percentile of the distribution by age and sex. Here we describe the differential diagnosis of a case of asymptomatic hypocholesterolemia. We studied proband's clinical data, the lipid profile of the proband and her relatives and the clinical data of the family relevant to carry out the differential diagnosis. We performed a genetic study as the diagnostic test. The information obtained from the differential diagnosis suggested a heterozygous hypobetalipoproteinemia due to PCSK9 loss-of-function variants. The diagnostic test revealed, in the proband, the presence of a heterozygous PCSK9 frame-shift variant of a maternal origin. Plasma levels of LDL cholesterol and PCSK9 of the patient and her relatives were compatible with the segregation of the variant revealed. In conclusion, the diagnostic test performed confirmed the suspected diagnosis of the proband as asymptomatic familial hypobetalipoproteinemia due to a loss-of-function variant in the PCSK9 gene.

原发性低胆固醇血症(或低β脂蛋白血症)是一种罕见的脂蛋白代谢障碍,可能是由多基因易感性或单基因疾病引起的。其中,可以区分有症状和无症状的形式,在没有次要原因的情况下,最初的临床怀疑是血浆ApoB水平低于按年龄和性别分布的第5%。在此,我们描述一例无症状低胆固醇血症的鉴别诊断。我们研究了先证者的临床数据、先证者及其亲属的血脂谱以及相关家族的临床数据,以进行鉴别诊断。我们进行了一项基因研究作为诊断测试。从鉴别诊断中获得的信息表明,PCSK9功能缺失变异导致杂合性低β脂蛋白血症。诊断测试显示,在先证者中,存在母体来源的杂合PCSK9移框变体。患者及其亲属的血浆低密度脂蛋白胆固醇和PCSK9水平与所揭示的变体的分离一致。总之,所进行的诊断测试证实,由于PCSK9基因的功能缺失变体,先证者的疑似诊断为无症状家族性低β脂蛋白血症。
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引用次数: 0
期刊
Clinica e Investigacion en Arteriosclerosis
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