沙库巴曲缬沙坦对不同射血分数心力衰竭患者的疗效及预后

黎冉; 谢丽娟; 焦长青; 陆红红; 周碧蓉

doi:10.16766/j.cnki.issn.1674-4152.001716

沙库巴曲缬沙坦对不同射血分数心力衰竭患者的疗效及预后

doi: 10.16766/j.cnki.issn.1674-4152.001716

安徽医科大学第一附属医院心血管内科，安徽合肥 230032

基金项目:

安徽省卫生健康适宜技术推广项目 2018-TG03

安徽省教育厅医学科研课题重点项目 KJ2018A0708

安徽省学术和技术带头人及后备人选学术科研项目 2017H118

详细信息

通讯作者:
周碧蓉，E-mail: ahmubrz@163.com

中图分类号: R541.6 R972
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出版历程
- 收稿日期: 2020-08-25
- 网络出版日期: 2022-02-19

Clinical effect and prognosis of sacubitril-valsartan in treating heart failure patients with different ejection fraction

Department of Cardiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230032, China

摘要

摘要: 目的观察沙库巴曲缬沙坦对于不同射血分数慢性心力衰竭(chronic heart failure, CHF)患者的疗效、预后及治疗安全性。方法选取2019年1—12月于安徽医科大学第一附属医院心内科住院的CHF患者78例，根据射血分数情况分为射血分数减少(HFrEF)组(共40例)和射血分数保留(HFpEF)组(共38例)。2组患者均接受常规心力衰竭治疗，在此基础上均接受沙库巴曲缬沙坦治疗。比较2组治疗6个月后脑钠肽(BNP)、血钾、肾功能和左房内径(LAD)、左室舒张末内径(LVEDD)及纽约心功能分级(NYHA)变化，并记录治疗的安全性。同时以心血管死亡或心衰再住院为终点事件，采用Kaplan-Meier生存曲线法比较2组患者治疗6个月内累积无终点事件生存率。结果 HFrEF组治疗6个月后较其治疗前BNP水平下降，LAD、LVEDD减低，NYHA分级改善(均P＜0.05)；HFpEF组治疗6个月后亦较其治疗前BNP水平下降，LAD、LVEDD减低，NYHA分级改善(均P＜0.05)；HFrEF组患者BNP水平的下降程度和NYHA分级的改善程度较HFpEF组更佳；HFrEF组和HFpEF组累积无终点事件生存率比较差异无统计学意义(81.9% vs. 85.0%, P=0.694)。2组安全性均较好。结论沙库巴曲缬沙坦对于射血分数保留性心衰有一定的疗效，在临床上值得推荐使用，但与射血分数减低性心衰相比疗效稍差。两者6个月累积无终点事件生存率和安全性方面未见明显差异。
- 沙库巴曲缬沙坦 /
- 心力衰竭 /
- 射血分数
Abstract: Objective To observe the clinical effect, prognosis and safety of sacubitril-valsartan in treating chronic heart failure (CHF) patients with different ejection fraction. Methods Seventy-eight patients were obtained from the Department of Cardiology of The First Affiliated Hospital of Anhui Medical University from January 2019 to December 2019. The patients were divided into the HFrEF group and HFpEF group on the basis of ejection fraction: 40 patients in the HFrEF group and 38 patients in the HFpEF group. All patients were treated with sacubitril-valsartan on the basis of routine heart failure treatment. Brain natriuretic peptide (BNP), renal function, serum potassium, left ventricular ejection fraction (LVEF), left atrial diameter (LAD), left ventricular end diastolic diameter (LVEDD) and New York heart function classification (NYHA) of both groups were compared after 6 months of treatment. Treatment safety was also assessed. The end point event was cardiovascular death or hospitalisation for worsening heart failure. The accumulated end-point event-free survival rate in 6 months between the two groups was compared by the Kaplan-Meier survival curve method. Results After 6 months of treatment, the HFrEF group showed significantly decreased BNP, LAD and LVEDD; significantly increased LVEF and significantly improved NYHA classification (all P < 0.05) compared with that before treatment. After 6 months of treatment, the HFpEF group also showed significantly decreased BNP, LAD and LVEDD; significantly increased LVEF and significantly improved NYHA classification (all P < 0.05) compared with that before treatment. However, the degree of decrease in the BNP levels and improvement in NYHA class were better in the HFrEF group than that in the HFpEF group. No difference in cumulative event-free survival was found between the HFrEF and HFpEF groups (81.9% vs. 85.0%, P=0.694). Safety was good in both groups. Conclusion Sacubitril-valsartan has a certain effect on heart failure with preserved ejection fraction, which shows potential clinical application, but it is slightly less effective on heart failure with reduced ejection fraction. There is no significant difference in prognosis and safety between the two groups.
- Sacubitril-valsartan /
- Heart failure /
- Ejection fraction

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图 1 2组慢性心力衰竭患者随访期内累计无终点事件生存曲线

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表 1 2组慢性心力衰竭患者基线资料比较[例(%)]

组别	例数	年龄(x ±s，岁)	女性	NYHA分级			LAD[M(P₂₅，P₇₅)，cm]	LVEDD(x ±s，cm)	高血压
组别	例数	年龄(x ±s，岁)	女性	Ⅰ级和Ⅱ级	Ⅲ级	Ⅳ级	LAD[M(P₂₅，P₇₅)，cm]	LVEDD(x ±s，cm)	高血压
HFrEF组	40	61.5±17.5	15(37.5)	5(12.5)	22(55.0)	13(32.5)	4.6(4.2, 5.2)	6.53±0.70	16(40.0)
HFpEF组	38	71.0±9.5	18(47.4)	13(34.2)^c	19(50.0)	6(15.8)	4.6(4.5, 5.1)	5.39±0.84	26(68.4)
统计量		-2.181^a	0.778^b	-2.444^d			-0.065^d	5.318^a	6.334^b
P值		0.014	0.378	0.015			0.948	＜0.001	0.012

组别	例数	冠心病	糖尿病	房颤	BNP[M(P₂₅，P₇₅)，pg/mL]	Scr[M(P₂₅，P₇₅)，μmol/L]	eGFR[x ±s，mL/(min·1.73m²)]	血钾(x ±s，mmol/L)
HFrEF组	40	14(35.0)	8(20.0)	9(22.5)	1 327.9(957.0, 2 672.7)	84.2(74.3, 96.9)	83.0±26.9	4.0±0.5
HFpEF组	38	12(31.6)	10(26.3)	18(47.4)	833.7(607.5, 1 117.0)	67.3(56.1, 88.1)	84.4±18.5	3.9±0.5
统计量		0.103^b	0.438^b	5.325^b	-2.652^d	-2.189^d	-0.201^a	0.905^a
P值		0.749	0.508	0.021	0.008	0.029	0.842	0.370
注：^a为t值，^b为χ²值，^d为Z值; HFpEF组与HFrEF组比较，^cP < 0.05。

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表 2 2组慢性心力衰竭患者治疗前后各指标比较[M(P₂₅，P₇₅)]

组别	例数	BNP(pg/mL)		LAD(cm)		LVEDD(x ±s，cm)		NYHA Ⅰ级和Ⅱ级[例(%)]		NYHA Ⅲ级[例(%)]
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
HFrEF组	40	1 327.9(905.7, 2 921.6)	165.9(56.9, 545.5)^b	4.6(4.2, 5.2)	4.4(4.0, 4.9)^b	6.53±0.70	6.34±0.80^b	5(12.5)	20(50.0)	22(55.0)	13(32.5)
HFpEF组	38	833.7(607.5, 1 117.0)	175.2(80.0, 393.2)^b	4.6(4.5, 5.1)	4.5(4.2，5.1)^b	5.39±0.84	5.28±0.78^b	13(34.2)	19(50.0)	19(50.0)	14(36.8)
统计量		-2.652^a	-0.297^a	-0.065^a	-0.614^a	5.318^c	4.404^c	5.174^d	< 0.001^d	0.195^d	0.162^d
P值		0.008	0.767	0.948	0.539	＜0.001	＜0.001	0.023	>0.999	0.659	0.687

组别			例数	NYHA Ⅳ级[例(%)]		Scr(μmol/L)		eGFR[mL/(min·1.73m²)]		血钾(x ±s，mmol/L)
组别			例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
HFrEF组			40	13(32.5)	7(17.5)	84.2(74.3, 96.9)	83.2(69.1，99.6)	84.5(65.3，97.5)	75.0(60.0, 104.0)	4.0±0.5	4.3±0.8
HFpEF组			38	6(15.8)	5(13.2)	67.3(56.1, 88.1)	82.2(58.8，95.7)	84.0(75.0，99.0)	75.0(61.0, 96.0)	3.9±0.5	4.1±0.5
统计量				2.953^d	0.282^d	-2.189^a	-0.600^a	-0.201^a	-0.431^a	0.905^c	-0.996^c
P值				0.086	0.595	0.029	0.549	0.842	0.668	0.370	0.319
注：治疗前，2组NYHA分级比较，Z=-2.444，P=0.015；治疗后，2组NYHA分级比较，Z=-0.181，P=0.856。与治疗前比较，^bP＜0.05；^a为Z值；^c为t值，^d为χ²值。

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参考文献(19)

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