射血分数保留的心力衰竭诊断与治疗中国专家共识 2025

1 背景介绍

1.1 HFpEF 的流行病学

西方国家成人心力衰竭患病率约为1%~2%,总患病率呈上升趋势[5]。基于中国高血压调查研究的结果显示,我国$\ge 35$岁人群心力衰竭患病率约为1.3%,估计心力衰竭患者890万[6];基于0.5亿中国城镇职工医疗保险数据的调查发现,我国$\ge 25$岁人群心力衰竭患病率约为1.1%,估计心力衰竭患者1210万,每年新增300万[7]。由于研究对象纳入标准以及心力衰竭分类定义存在差异,既往研究得出的HFpEF在心力衰竭中所占比例不同,但大多数研究中HFpEF的比例接近50%[8-11]。HFpEF的发生与增龄以及肥胖、高血压、糖尿病、心房颤动(房颤)等主要风险因素增加有关。

HFpEF 患者的病死率与 HFrEF 相当。西方国家社区人群的观察性研究数据显示, HFpEF 患者的院内、1年、5年病死率分别为2.4%~4.9%、20%~29%、53%~74%[9],心血管死亡是 HFpEF 患者死亡的主因,占60%~70%[12-14]。基于我国心力衰竭中心数据库的研究显示,41 708 例住院 HFpEF 患者出院后1年全因再入院率和心力衰竭再入院率分别为22.2%和13.6%,1年全因死亡率和心血管

死亡率分别为8.5%和3.1%[15]。2024年发表的基于更大样本量心衰中心数据库的研究显示,我国住院HFpEF 患者出院后30天、1年、3年死亡率分别为2.0%、11.9%以及25.4%[16]。

1.2 HFpEF 的发病机制

HFpEF 发病机制复杂,涉及多个方面:(1)系统性炎症:这是HFpEF发生的重要机制。超重/肥胖(特别是心外膜脂肪)、高血压、糖尿病和慢性阻塞性肺疾病等多种因素均可诱发系统性炎性反应,炎症通过信号级联作用引起患者的心室重构和舒张功能障碍[17-20];(2)利钠肽不足:利钠肽是一种心肌细胞受到牵张刺激而后分泌的激素,通过增加环磷酸鸟苷(cGMP)对抗心肌细胞纤维化和肥厚,也有利尿和血管舒张的作用,利钠肽不足使心力衰竭的代偿机制减弱而易发心力衰竭;(3)神经内分泌激活:HFpEF也存在肾素-血管紧张素-醛固酮系统(RAAS)和交感神经系统等神经内分泌系统激活,与不良预后关系密切[21];(4)代谢异常:在HFpEF患者中,肥胖、糖尿病以及与之相关的代谢综合征等常见,且与高龄因素相互作用显著增加HFpEF发生风险[22]。代谢紊乱也可以通过心外膜脂肪组织在舒张功能不全中发挥作用[23]。(5)其他机制:包括脂联素缺乏、内皮功能异常[24-27]、自主神经功能障碍等。上述各种机制引起心室重构、左心室舒张功能不全、左心室长轴收缩功能降低、心室运动不同步、心房功能不全、右心室功能不全、肺动脉高压、心包限制性改变、血管硬化与功能障碍、心脏变时功能不良、全身性改变(例如骨骼肌异常、贫血)等[28],这些改变最终导致左心室舒张末期压力升高和HFpEF的临床表现。

HFpEF 最早曾被描述为舒张性心力衰竭,但由于舒张功能不全并非这种类型心力衰竭唯一的机制,且这类心力衰竭也存在一定程度的心室收缩功能异常,故舒张性心力衰竭的命名存在很大的局限性。欧洲和美国心力衰竭指南分别于2012年和2013年开始推荐依据 LVEF 进行心力衰竭的分类,提出了HFpEF的概念[29-30]。由于临床对HFpEF 的认识时间相对较短,以及HFpEF异质性大、病因复杂多样、临床表现缺乏特异性,目前国内外心力衰竭指南针对HFpEF的诊断与治疗均未提出系统性的证据整合和推荐意见,临床实践中HFpEF的诊断与治疗均存在较大差异。因此,规范HFpEF的诊断、治疗和长期管理成为亟待解决的问题。我国2020年发布的《舒张性心力衰竭诊断和治疗专家共识》对

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HFpEF 的诊断与治疗的规范化有了较大的推动[23]。

2 共识的制定过程与方法

本共识根据世界卫生组织(WHO)指南制定的标准和方法以及参考中华医学会发布的“制定/修订临床诊疗指南的基本方法及程序”。本共识在国际实践指南注册与透明化平台注册(http://guidelines-registry.cn/),注册号是IPGRP-2022CN344。共识制定工作组包括共识指导委员会、共识制定组、共识秘书组(证据合成与评价组)、共识外部评审组。使用PICO[人群(Population)、干预(Intervention)、比较(Comparison)、结果(Outcome)]格式制定关键推荐问题;委托证据检索;应用推荐意见的分级评估、制定及评价(GRADE)方法来评估证据的确定性;并使用证据到决策(EtD)框架,在制定建议时考虑GRADE结果和背景因素。

共识指导委员会: 支持起草共识范围和准备规划提案, 包括制定关键问题以及为共识制定组推荐潜在成员、利益声明和利益冲突的管理。

共识制定组:由临床专家、循证医学、临床流行病学、卫生统计学、专业期刊编辑等领域的多学科、不同地域的专家组成;临床专家包括心内科、心外科、慢病管理等学科,其中心内科医师占70%~80%。

共识秘书组(证据合成与评价组):共识指导委员会确定方法学专家,确保他们在问题和结果的优先排序、证据综合、证据分级、将证据转化为建议和共识制定过程方面具有专业知识。方法学专家支持关键问题的规划、范围界定和发展、并协助共识制定组以透明和明确的方式制定循证建议。

共识外部评审组:由对本共识主题感兴趣的专业人士组成。该组的作用是识别任何错误或缺失的证据,并就清晰度、特定背景问题和对实施的影响提出评论。预计该组不会更改共识制定制定的建议。对于外部审核人员提出与建议相关的主要问题的情况,这些问题将被带回共识制定组讨论。外部审阅者的意见已酌情纳入修订后的共识。最终草案已分发给共识制定组。

2.1 临床问题和结局指标的收集和遴选

共识制定组在共识指导委员会的指导下进行临床问题和结局指标的收集和遴选,初拟临床问题和结局指标清单,采用德尔菲法,对临床问题和结局指标进行归类、去重与合并,PICO 原则构建临床问题;结局指标清单拟定基于召开的多次线上和线下共识会议,最终确定考虑了患者代表的意愿和价值

观。

2.2 证据的检索、合成与评价方法

共识秘书组对每个优先临床问题相关的发表和未发表的研究进行广泛搜索,纳入研究对象符合HFpEF诊断、年龄>18岁的临床研究、系统评价/Meta 分析或者相关指南、共识;不限定研究类型是否随机,不限定干预措施和对比措施,也不限定结局指标;排除重复发表文献。共识制定组还考虑系统收集有关背景因素的证据,以制定EtD框架。

检索英文数据库包括:PubMed、EMBASE、The Cochrane Library;中文数据库包括:中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普网(VIP)和万方数据库。检索时间为从建库到2025年6月。指南相关资源:美国国家临床指南中心(NGC, www.ngc.gov)、英国国家卫生与临床技术优化研究所(NICE, www.nice.org.uk/guidance)、指南国际网络(GIN, www.g-i-n.net)、WHO(www.who.int/publications/guidelines/en/)、基于循证医学原则的临床决策支持系统(Uptodate, www.uptodate.com/contents/search)。系统评价/Meta 分析注册相关检索资源:PROSPERO 注册平台。临床研究相关资源:世界卫生组织国际临床研究注册平台(WHO-ICTRP)。

文献筛选和资料提取:由共识秘书组2名评价员依据纳入和排除标准独立筛选文献,首先阅读题目、摘要排除不相关的文献,查阅可能符合纳入标准的研究全文,确定纳入全文。由至少2名评价员依据预先制定的资料提取表提取相关资料。对以上过程出现的不同意见经过讨论解决或咨询第三方意见协商确定。

证据的确定性考虑了研究设计、可能导致降低确定性的因素(偏倚风险、不一致性、间接性、效果估计的不精确性和发表偏倚)以及导致确定性评级提高的因素(大效应量和剂量反应效应)。确定性评估中使用的术语指的是与推荐问题相关的效果估计中的确定性水平,而不一定是所审查调查的科学质量。使用中国指南研究与评价工具(AGREE-China)评价相关指南方法学质量。

2.3 制定推荐意见

证据整合和评价相关材料提供给共识制定组的所有成员,然后通过面对面或在线会议或电子邮件通信对最终建议进行讨论,按EtD框架中包含的标准制定推荐意见并达成共识。在某些情况下,匿名投票用于判断不同标准并制定最终建议以减少同行压力。

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2.4 共识的外审

共识重新征求意见稿由外部同行专家评审, 根据多次线下和线上会议讨论进行完善。最后由共识制定组将共识提交共识指导委员会批准, 并且通过心衰中心专家委员会经邮件发送给相关人员。

2.5 传播与实施

本共识发布后,共识发起单位联合通过以下方式对本共识进行传播与推广:(1)在相关学术会议中介绍和解读共识;(2)有计划地在全国范围内组织相关医务工作者学习共识相关内容并能正确使用;(3)通过其他途径和媒介传播。

2.6 共识更新计划

共识制定工作组计划在本共识发布后3~4年进

行更新,更新方法依据国际指南更新流程进行。

3 相关专业术语的定义

HFrEF 定义为 LVEF ≤ 40% 的心力衰竭; HFmrEF 定义为 LVEF 41%~49% 的心力衰竭; HFpEF 定义为 LVEF ≥ 50% 的心力衰竭; HFimpEF 定义为 LVEF ≤ 40%, 治疗后随访 LVEF >40% 并较基线增加 ≥ 10%。HFpEF 的病因分型见表 1[31]。

H₂FPEF 评分细则见图1。H₂FPEF 评分[32]包括肥胖、高血压、房颤、肺动脉高压、高龄和左心室充盈压增加。根据分值,把HFpEF可能性分为低(0~1分)、中(2~5分)、高(6~9分)三类。0~1分可基本排除HFpEF,6~9分则HFpEF可能性很大,而2~5分需要进一步检查。

4 证据体的证据质量分级和推荐说明

本共识对证据体的证据质量分级以 GRADE 方法为基础,参照2022年美国心脏病学会(ACC) /美国心脏协会(AHA)发布的证据质量和推荐强度分级进行调整[2],具体含义见表2。本共识提出了两种类型的推荐:(1) GRADE 两级推荐意见的方法,即强推荐与有条件的推荐:推荐意见由指南指定小组使用GRADE 方法制定,得到证据系统评价的支持,并对

证据的确定性进行正式评估;(2)基于非直接证据或专家意见和经验形成的推荐(GPS):陈述没有得到系统性证据的支持,通过广泛协商制定的专家共识。

5 临床问题与推荐意见

本共识共形成18条推荐意见,包含HFpEF诊断与治疗两方面相关临床问题,并给出了详细的推荐强度与证据质量,推荐强度与证据质量采用表2中 GRADE 分级(表3)。

|表2 GRADE 证据质量与推荐强度分级|表2 GRADE 证据质量与推荐强度分级|表2 GRADE 证据质量与推荐强度分级|表2 GRADE 证据质量与推荐强度分级| |---|---|---|---| |类别|含义|含义|含义| |证据质量分级|||| |高 (A)|非常确信真实的效应值接近效应估计值,并认为进一步的研究不太可能改变现有的结果||| |中 (B)|对效应估计值有中等程度的信心:真实值可能接近估计值,但认为进一步研究仍有可能改变现有的结果||| |低 (C)|对效应估计值的信心较低:认为进一步研究很可能得出真实值与现有大不相同的结果||| |极低 (D)|对效应估计值几乎没有信心||| |推荐强度分级|||| |强|明确利大于弊,所有人或几乎所有人都会选择某种干预措施||| |有条件的推荐*|利弊不确定,有些患者应该接受推荐的干预,这取决于许多背景因素,例如可行性、可接受性、高成本等问题,表明参与共同决策制定过程非常重要||| |GPS|基于非直接证据、专家意见和经验形成的推荐||| |注:GRADE: 推荐意见的分级评估、制定及评价;良好实践声明,基于专家意见和经验形成的推荐。:有条件的推荐通常又称“条件推荐”。||||

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(续表3)

|临床问题与推荐意见|推荐强度|证据质量| |---|---|---| |HFpEF 治疗相关临床问题||| |推荐在 HFpEF 病因分型基础上,对病因与合并症进行针对性管理|GPS|-| |推荐有液体潴留的患者使用利尿剂以减轻症状和体征|强|A| |推荐使用 SGLT2i 降低心力衰竭住院或心血管死亡复合终点事件风险|强|A| |推荐使用沙库巴曲缬沙坦,尤其是LEVF 相对较低(LVEF ≤ 57%)的HFpEF 患者,以降低心力衰竭住院风险|强|B| |推荐使用非奈利酮降低心力衰竭恶化事件或心血管死亡复合终点风险|强|A| |如非奈利酮不可及,可考虑使用螺内酯以降低症状性HFpEF 患者的心力衰竭住院风险|条件|B| |合并肥胖的HFpEF患者,无论是否2型糖尿病,均推荐(1)使用GLP-1RA降低体重、改善心力衰竭相关症状和运动能力;(2)使用GIP/GLP-1RA以降低心血管死亡或心力衰竭恶化复合风险、改善健康状况|条件|B| |如果 ARNI 不可及,可考虑使用ARB 以降低心力衰竭住院风险,尤其对于LEVF 相对较低的患者|条件|B| |不推荐使用β受体阻滞剂,除非患有β受体阻滞剂使用适应证的基础疾病或合并症|条件|B| |不推荐使用伊伐布雷定、外源性硝酸盐、PDE5抑制剂、sGC 刺激剂|条件|C| |不推荐心房分流装置用于治疗HFpEF|-|-| |推荐运动康复治疗以改善HFpEF患者的运动耐量和生活质量|强|B| |治疗流程|GPS|-|

注:HFpEF:射血分数保留的心力衰竭;HFrEF:射血分数降低的心力衰竭;BNP:B型利钠肽;NT-proBNP:N末端B型利钠肽原;SGLT2i:钠-葡萄糖共转运蛋白2抑制剂;LVEF:左心室射血分数;GLP-1RA:胰高血糖样肽-1受体激动剂;GIP/GLP-1RA:葡萄糖依赖性促胰岛素多肽/胰高血糖素样肽-1双受体激动剂;ARNI:血管紧张素受体脑啡肽酶抑制剂;ARB:血管紧张素II受体拮抗剂;PDE5:磷酸二酯酶-5;sGC:可溶性鸟苷酸环化酶;GPS:良好实践声明,基于专家意见和经验形成的推荐。-:无。

5.1 HFpEF 诊断相关临床问题

HFpEF的诊断具有挑战性,目前HFpEF的诊断主要依赖于临床表现、超声心动图和利钠肽水平,但灵敏度与特异度均较低。我国医护人员需要提高对HFpEF的认识,在HFpEF的诊断流程上应优先考虑可获得的检测方法。

陈述1: 患者当前或既往有心力衰竭症状是 HFpEF 诊断的必要条件, 非充分条件, HFpEF 和 HFrEF 临床表现相似。

病史: 推荐关注下列临床情况: 年龄>60岁、女性、心血管疾病(高血压、冠心病、房颤)、代谢性疾病(肥胖、糖尿病)、慢性肾脏病、慢性阻塞性肺疾病、贫血。

症状：当前或既往至少有一种心力衰竭症状。推荐首先关注呼吸困难（包括劳力性呼吸困难、夜间阵发性呼吸困难、端坐呼吸）、乏力、纳差及双下肢浮肿。

体征: 可能有或没有相应体征。推荐关注颈静脉充盈、肺部啰音、心脏听诊第三心音、双侧踝部水肿。

推荐强度:GPS

证据概述：共识制定工作组进行了定性研究，共纳入可提取HFpEF病史、临床症状和体征的文献11篇[1, 3, 23, 33, 36-42]，其中包括5篇其他机构指南，这5篇指南系统评估了病史、临床症状和(或)体征

在 HFpEF 诊断中的作用,报告了高龄、女性、房颤、超重/肥胖、代谢综合征、糖尿病、慢性肾脏病在 HFpEF 诊断中的重要性。1篇原始研究阐述了HFpEF 和 HFrEF 临床表现的相似性[42]。

推荐说明:本推荐意见主要基于2024年中国心力衰竭诊断和治疗指南、2019年ESC-HFA HFpEF诊断专家共识、2020年中国舒张性心力衰竭诊断和治疗专家共识、2021年ESC心力衰竭指南、2022年AHA/ACC/美国心力衰竭学会(HFSA)心力衰竭指南以及本共识制定工作组专家意见。HFpEF与HFrEF具有相似的症状和体征,劳力性呼吸困难具有较高灵敏度但特异度较差,而端坐呼吸和夜间阵发性呼吸困难具有较高特异度但灵敏度较低。需要注意的是,在老年患者中,运动耐量减退、乏力、纳差、体重增加、下肢水肿也属于常见的心脏外表现。推荐意见同时考虑到病史、临床症状和(或)体征评估的临床应用可行性以及成本效益。

陈述2: 在“陈述1”相关临床情况、症状和体征的基础上, 疑似HFpEF患者的血清利钠肽水平 [B型利钠肽(BNP)或N末端B型利钠肽(NT-proBNP)] 有助于HFpEF诊断。HFpEF的诊断阈值为: 美性心律患者: BNP ≥ 35 pg/ml 或 NT-proBNP ≥ 125 pg/ml; 房颤患者: BNP ≥ 105 pg/ml 或 NT-proBNP ≥ 365 pg/ml。但上述诊断

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阈值的灵敏度和特异度均有限,必须综合其他临床特征解读。

推荐强度：强 证据质量：B

证据概述:共识制定工作组进行了定性研究,共纳入文献6篇,证据存在不一致性。AHA 系统收集和评价了2017年前发表的相关研究,BNP或NT-proBNP 具有较高的阴性预测价值(95%~99%)[43]。但一项经常有创血液动力学检查证实的HFpEF 研究发现有20%患者利钠肽水平低于诊断阈值,因此利钠肽水平正常并不能排除HFpEF[44]。另有研究显示,NT-proBNP>125 pg/ml对HFpEF的灵敏度为85%,特异度为88%[45]。有多种因素会影响利钠肽水平,包括肾功能不全(会升高BNP和NT-proBNP水平)[46]、肥胖(会降低BNP和NT-proBNP水平)[47]。BNP>100 pg/ml或NT-proBNP>300 pg/ml均为HFpEF患者不良心血管事件的独立预测因素,但BNP或NT-proBNP水平正常的HFpEF患者同样可能预后不良[48]。其他实验室指标可作为临床常规检测,但在HFpEF诊断中的价值没有相关研究证据支持。

推荐说明:本推荐意见基于已经获得的证据,总体而言,BNP或NT-proBNP水平升高作为HFpEF的诊断依据,均需要结合其他临床证据一起考量。其他实验室指标:血常规、血钠、血钾、血糖、糖化血红蛋白、血脂、尿素氮、血肌酐或估算肾小球滤过率(eGFR)、肝功能、铁蛋白、转铁蛋白饱和度、甲状腺激素、肌钙蛋白应作为HFpEF的常规检查。如在病因评估阶段考虑某些特殊病因(如心脏淀粉样变、神经肌肉疾病、糖原储积症等)所导致时,应进行相应的诊断性检查。

陈述3:HFpEF的初始辅助检查包括心电图、X线胸片、经胸超声心动图。超声心动图用于评估心脏结构和功能、心力衰竭分型(HFrEF、HFmrEF、HFpEF及HFimpEF)。

推荐强度：强 证据质量：C

证据概述:共识制定工作组进行了定性研究,共纳入文献20篇。4篇文献报告了心电图是心力衰竭患者的常规检查,但结果往往不具有特异性[49-52]。1篇文献描述心力衰竭患者常行X线胸片检查,目的是评估肺水肿的征象并确定有无呼吸困难的其他原因。2021年ESC心力衰竭指南和2022年AHA/ACC/

HFSA 心力衰竭指南均推荐心力衰竭的评估包括使用经胸超声心动图评估 LVEF,如果超声心动图不能适当估计 LVEF,建议使用其他无创心脏影像学方法。12 篇文献报告了超声心动图评估左心室充盈压的方法,结果显示 E/e' 的诊断价值最高, E/e' ≥ 15 诊断HFpEF 具有较高的特异度,而灵敏度相对较低。心电图:HFpEF 患者的常见心电图异常包括左心房增大、左心室肥厚、复极异常等。心电图检查更重要的目的是筛查房颤和心肌缺血。若 LVEF>50% 的呼吸困难患者心电图提示房颤,则 HFpEF 的可能性增加 >20 倍[53]。X线胸片:对疑似、急性、新发 HFpEF 患者应行 X线胸片检查,可提供肺淤血/肺水肿和心脏增大等信息,并可用于呼吸道疾病的鉴别诊断,但不论 X线胸片正常与否均需要开展进一步评估[1, 32]。经胸超声心动图:是评估心脏结构和功能的首选方法,是包括 HFpEF 在内所有心力衰竭患者最重要的影像学检查。所有临床怀疑 HFpEF 的患者均需要完善常规经胸超声心动图检查。超声心动图可用于心力衰竭类型的划分(HFrEF、HFmrEF、HFpEF、HFimpEF),也有助于识别心力衰竭的某些特定病因,包括瓣膜性心脏病、先天性心脏病、心肌病等。建议采用二维或三维方法测量 LVEF, LVEF ≥ 50% 用于诊断 HFpEF。值得注意的是,如果患者既往 LVEF ≤ 40%,随访中发现 LVEF ≥ 50%,应归为HFpEF,而非 HFpEF[54]。反映左心室舒张功能的指标 E/e' ≥ 15 可用于诊断 HFpEF。

推荐说明:本推荐意见主要基于已获得的关于HFpEF初始检测的证据中X线胸片、心电图、经胸超声心动图的诊断价值;同时结合了专家访谈结果及共识制定工作组专家意见。另外,本推荐意见参照2021年ESC心力衰竭指南、2022年AHA/ACC/HFSA心力衰竭指南。超声心动图检查需强调心脏形态学和舒张功能的评估。重要的心脏形态学指标包括左心房容积指数(LAVI)、左心室质量指数(LVMI)、室壁厚度、相对室壁厚度(RWT)。舒张功能指标包括:E、室间隔及左心室侧壁e'、三尖瓣反流峰值速度、肺动脉收缩压(PASP)、左心室纵向应变(GLS)。考虑到各级医院技术的可及性与可靠性,本共识强调E/e'、LAVI、左心室室壁厚度(LVWT)、三尖瓣反流峰值速度以及PASP的测量。

陈述4: 对临床高度疑似,但常规经胸超声 心动图和利钠肽检测未能确诊HFpEF的患者,

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建议进一步行负荷超声心动图检查,仍不能确诊者,有条件可行有创血液动力学检查。推荐运动负荷超声心动图试验:运动过程中超声心动图测得E/ε'≥15可诊断HFpEF。有创血液动力学检查,静息状态下肺毛细血管楔压(PCWP)≥15mmHg(1mmHg=0.133kPa)或左心室舒张末期压力(LVEDP)≥16mmHg,或负荷状态下PCWP≥25mmHg可明确诊断HFpEF。

推荐强度：条件 证据质量：B

证据概述:共识制定工作组进行了定性研究,共纳入文献28篇,其中5篇文献显示负荷超声心动图检查可提高HFpEF诊断率,尤其对于存在运动时呼吸困难的患者[55-59]。5篇文献报道了有创血液动力学检查,是目前HFpEF诊断的金标准。负荷超声心动图分为运动和药物负荷超声心动图。对于HFpEF的诊断,建议选择运动负荷试验,首选踏车运动负荷试验,平板运动负荷作为备选[60]。半卧位或直立位操作的踏车运动负荷试验可在运动期间(低剂量及峰值剂量时)持续不间断成像、评估局部室壁运动,此外还可提供更多的多普勒信息,但患者往往由于腿部肌肉过早疲劳使达到运动负荷极量较为困难[60]。对HFpEF预测价值最高的指标为E/e'和三尖瓣反流峰值速度[32, 57, 61-70]。E/e'≥15伴或不伴有三尖瓣反流峰值速度>3.4 m/s 考虑存在舒张功能异常,但单纯三尖瓣反流峰值速度升高的诊断意义不大[63, 71]。负荷超声心动图检查强调被检查者要尽可能达到试验所要求的最大负荷运动量,且在峰值运动时或达到后即刻完成图像采集。有创血液动力学检查获得的左心室舒张功能不全的证据是HFpEF诊断的金标准。静息状态下PCWP ≥ 15 mmHg或LVEDP ≥ 16 mmHg可确诊HFpEF[32-33, 58, 70, 72-73]。负荷心导管检查:运动负荷试验可选半卧位踏车。峰值运动时PCWP ≥ 25 mmHg可确诊HFpEF[63, 74]。

推荐说明:本推荐意见基于已经获得的证据,并参考2022年AHA/ACC/HFSA心力衰竭指南和2021年ESC心力衰竭指南。推荐意见考虑技术可及性、医疗中心经验以及患者的意愿,当临床怀疑HFpEF,而BNP或NT-proBNP以及静息超声心动图不能确诊时,建议行负荷超声心动图检查。在有条件的医疗中心,高度怀疑HFpEF而上述无创检查不能明确诊断时,推荐行有创血液动力学检查。无论静息还是

运动时 PCWP 升高均与 HFpEF 预后不佳相关。

陈述5:HFpEF患者均需要评估潜在的病因、危险因素与合并症,尤其需要排查特定病因,如未纠正的心肌缺血、严重瓣膜性心脏病、心肌病、心脏淀粉样变等。

推荐强度:GPS

证据概述:对于继发于特定病因的HFpEF,有效治疗的效果往往取决于病因的恰当处理。因此,HFpEF患者必须评估潜在的病因。肥厚型心肌病、限制型心肌病患者早期出现心力衰竭症状、体征时多为HFpEF。HFpEF也可继发于未纠正的心肌缺血、重度瓣膜狭窄或反流。系列病例研究报道发现,HFpEF患者中心脏淀粉样变的比例较既往认识的更多;国际多中心研究表明,60岁以上的HFpEF患者,转甲状腺素蛋白心脏淀粉样变(ATTR-CA)患病率约18%[75]。在病因评估方面,除利用常规检查外,往往还需要依靠心脏磁共振成像以及组织活检、基因检测等手段。

推荐说明:本推荐意见基于已经获得的证据,并参考2022年AHA/ACC/HFSA心力衰竭指南和2021年ESC心力衰竭指南,建议所有HFpEF患者进行潜在病因、合并症和危险因素的筛查。

陈述6: HFpEF的诊断流程图见图3。

推荐强度:GPS

证据概述：共识制定工作组进行了定性研究，汇总陈述1~5中的证据。

推荐说明：为实现 HFpEF 诊断的一致性，共识制定工作组建议各级医疗机构，结合诊断试验的证据等级，综合病史、症状、体征、生物学标志物、心脏形态学和功能学检查及其他特殊检查进行综合评估。由于 HFpEF 诊断缺乏特异性指标，因此临床需排除可引起类似症状的其他疾病和情况，并注意各种测量方法和指标的临床应用局限性，强调左心室充盈压升高对疑似患者诊断的重要性。本推荐意见还强调了利钠肽测定与超声心动图相结合、静息与负荷超声心动图相结合、无创检查与有创血液动力学检查相结合对疑似患者鉴别诊断的重要性。同时，本推荐意见在 E/e'检查基础上，增加了左心房内径、左心室壁厚度及肺动脉收缩压三个可以通过常规超声心动图检查即可获得的参数，进一步优化了 HFpEF 诊断流程，有助于

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减少患者的漏诊与误诊。此外,诊断流程中仍将病因与合并症筛查放在重要位置,突出HFpEF病因诊断

的重要性,也为后续治疗中基于病因分型的HFpEF管理提供了支撑。


5.2 HFpEF 治疗相关临床问题

长期以来, HFpEF 的众多临床药物干预研究结果多为阴性, 其中一个重要原因可能是 HFpEF 的异质性太大, 病因和病理生理改变复杂多样。识别和治疗 HFpEF 的危险因素、病因和共存疾病, 尤其是针对 HFpEF 中的一些特定病因进行干预可改善预后, 如转甲状腺素蛋白心脏淀粉样变使用氯苯唑酸 (tafamidis)。

陈述7:HFpEF病因治疗与合并症管理的目标是改善症状和预后。推荐在HFpEF病因分型基础上,对病因与合并症进行针对性管理。

推荐强度:GPS

证据概述：参照2024年中国心力衰竭指南、2021年ESC心力衰竭指南以及2022年AHA/ACC/HFSA心力衰竭管理指南，以病因分型为框架，分类阐述了HFpEF病因分型基础上的处理原则(表4)。

推荐说明:HFpEF患者病因复杂,应该尽早识

别和评估，遵循相关指南进行治疗和管理。

陈述8: 推荐有液体潴留的患者使用利尿剂以减轻症状和体征。首选祥利尿剂,对祥利尿剂治疗效果不佳的患者可加用噻嗪类利尿剂,合并低钠血症的患者推荐使用托伐普坦。

推荐强度：强证据质量：A

证据概述：鉴于专门针对 HFpEF 患者使用利尿治疗的临床研究极少，共识制定工作组对该部分证据的收集主要参考 2024 年中国心力衰竭指南、2021 年 ESC 心力衰竭指南以及 2022 年 AHA/ACC/HFSA 心力衰竭指南以及共识制定工作组专家意见。在使用利尿剂缓解 HFpEF 患者症状方面，指南推荐较为一致 [1, 76-77]。使用利尿剂主要目的是消除水钠潴留、缓解呼吸困难和水肿，改善运动耐量。

推荐说明：结合我国以及欧美最新心力衰竭诊治指南中的推荐意见，与HFrEF类似，利尿剂缓解HFpEF患者充血、水肿症状体征的疗效明确。

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（收稿日期：2025-07-21）

(编辑: 汪碧蓉)

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