共识制定委员会：中国心力衰竭中心联盟专家委员会
共识制定工作组
组长：杨杰孚、李为民、廖玉华
主要执笔人：廖玉华、余淼、袁璟、廖梦阳
中国心力衰竭中心联盟专家委员会：
杨杰孚、李为民、廖玉华、董吁钢、李新立、周京敏、项美香、郭延松、傅向华、李广平、严激、王华、苑海涛、艾力曼·马合木提、金玮、张庆、孙志军、王江、孔洪、黎励文、张瑶、董蔚、白玲、徐东杰、袁璟、刘晨、任景怡、杨萍、陈牧雷、毛威、徐验、孙健、李萍、杨丽霞、华伟、井海云
Consensus of Chinese experts on the clinical application of SGLT2 inhibitors in heart failure
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摘要: 钠-葡萄糖协同转运蛋白-2(SGLT2)抑制剂已经被推荐为治疗心力衰竭的新四联药物之一。本专家共识重点介绍SGLT2抑制剂治疗心力衰竭的作用机制、药物代谢动力学特征、循证医学证据以及临床实践经验，为中国心力衰竭患者提供临床应用的规范与建议。
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关键词:
- 心力衰竭 /
- 钠-葡萄糖协同转运蛋白-2抑制剂 /
- 血流动力学 /
- 心脏代谢重构
Abstract: Sodium glucose cotransporter-2(SGLT2) inhibitors have been recommended as one of the four foundational therapies for heart failure. This expert consensus focuses on the mechanism, pharmacokinetic characteristics, evidence-based medicine, and clinical experience of SGLT2 inhibitors in the treatment of heart failure, and provides clinical standards and suggestions for patients with heart failure in China. -
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图 1 SGLT2抑制剂治疗心衰的临床应用路径
Figure 1. Clinical application of SGLT2 inhibitors in the treatment of heart failure
表 1 常见SGLT2抑制剂药物代谢动力学参数
Table 1. Pharmacokinetic parameters of common SGLT2 inhibitors
药物代谢动力学参数 达格列净 恩格列净 卡格列净 艾托格列净 索格列净 绝对口服生物利用度(OBA)/% 78 78 65 100 N/A 达峰时间(Tmax)/h 2 1~2 1~2 0.5~1.5 2 血浆分布体积(Vd)/L 118 73.8 83.5 86 N/A 血浆蛋白结合率(PPB)/% 98 86 99 93 N/A 药物代谢酶 UGT1A9 UGT1A3/UGT1A8/UGT1A9/UGT2B7 UGT1A9/UGT2B4/CYP3A4 UGT1A9/UGT2B7/CYP3A4 UGT1A1/UGT1A9/UGT2B7/UGT3A4 消除半衰期(T1/2)/h 12.9 12.4 10~13 11~17 13.5~20.7 清除部位 肠道、胆汁、肾脏 N/A N/A N/A N/A 尿排泄率/% 75 54 33 51 N/A 粪排泄率/% 21 41 60 41 N/A 抑制浓度(IC50)/nM 1.2 3.1 2.7 0.9 N/A SGLT2/SGLT1(IC50)* 1∶1400 3∶8300 3∶700 N/A 2∶40 心衰研究主要终点
HR (95% CI)DAPA-HF
0.74(0.65, 0.85)EMPEROR-Reduced
0.75(0.65, 0.86)- - SOLOIST-WHF
0.67(0.52, 0.85)*药物对不同SGLT受体的选择性。IC50代表半抑制浓度。 
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表 2 SGLT2抑制剂治疗心衰临床应用的建议
Table 2. Recommendations for the clinical application of SGLT2 inhibitors in the treatment of heart failure
共识 建议 推荐级别 证据水平 2022年《心力衰竭SGLT2抑制剂临床应用的中国专家共识》 2型糖尿病无论是已有心血管疾病还是心血管风险高危的患者，都应该使用SGLT2抑制剂预防心衰住院 Ⅰ A 对于有症状的慢性HFrEF患者，无论是否有2型糖尿病，建议使用SGLT2抑制剂来减少心衰住院率和心血管死亡率 Ⅰ A 对于无糖尿病，体重指数(BMI)>22 kg/m2的中国心衰患者，建议使用SGLT2抑制剂治疗心衰，增加临床获益 Ⅰ C* 对于AHF或心衰恶化患者，待病情稳定后，建议尽早使用SGLT2抑制剂治疗心衰，增加临床获益 Ⅱa B 对于有症状的慢性HFpEF患者，SGLT2抑制剂有助于降低心衰住院率和心血管死亡率 Ⅱa B *本文列举所有的SGLT2抑制剂治疗心衰CVOT临床试验，纳入2型糖尿病或非糖尿病患者的BMI基本上为28(24~32) kg/m2，中国人BMI最佳值为20~22 kg/m2，由于SGLT2抑制剂具有减重作用，专家建议中国非糖尿病BMI>22 kg/m2的心衰患者推荐应用SGLT2抑制剂。
推荐级别：Ⅰ级指已证实和(或)一致公认有益、有用和有效的操作或治疗，推荐使用；Ⅱ级指有用和(或)有效的证据尚有矛盾或存在不同观点的操作或治疗；Ⅱa级指有关证据/观点倾向于有用和(或)有效，应用这些操作或治疗是合理的，应当考虑使用；Ⅱb级指有关证据/观点尚不能被充分证明有用和(或)有效，可以考虑使用；Ⅲ级指已证实和(或)一致公认无用和(或)无效，并对一些病例可能有害的操作或治疗，不推荐使用。证据水平：A级资料来源于多项随机对照研究或荟萃分析；B级资料来源于单项随机对照研究或大型非随机对照研究；C级资料来源于专家共识和(或)小型研究、回顾性分析、注册研究。
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