Clinical Efficacy and Safety of Sacubatril Valsartan in Patients with Reduced Ejection Fraction Combined with Hypotensive Heart Failure
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摘要:
目的 观察射血分数降低合并低血压心衰患者服用沙库巴曲缬沙坦的临床疗效及安全性。 方法 收集昆明市第一人民医院2020年1月2021年12月心内科诊治的射血分数降低合并低血压心衰的患者100例为研究对象。随机分为观察组与对照组各50例，2组患者均给予含利尿、β受体阻滞剂等心衰规范治疗,给予沙库巴曲缬沙坦从小剂量25～50 mg每天2次开始，根据患者耐受情况，剂量每2～4周倍増1次，直至达到维持剂量。治疗12个月后，比较2组患者治疗前后心功能LVEF、LVDd、LVDs，观察SBP、DBP、血K+、血Na+、CTNT、NT-proBNP水平。 结果 治疗后2组患者LVEF较治疗前均升高、LVDd、LVDs均有降低，2组LVEF、LVDs相比差异有统计学意义（P < 0.05），LVDd差异无统计学意义（P > 0.05）。2组血K+、血Na+、CTNT治疗后有升高，差异无统计学意义（P > 0.05）；NT-proBNP治疗后降低差异有统计学意义（P < 0.05）。2组治疗后收缩压实验组较治疗前有升高，对照组无明显变化,差异无统计学意义（P > 0.05），2组治疗后舒张压无明显变化，差异无统计学意义（P > 0.05）。 结论 治疗HFrEF合并低血压的患者服用沙库巴曲缬沙坦能改善患者心功能、对血压无影响，具有安全性。 Abstract:Objective To observe the clinical efficacy and safety of sacubitril-valsartan in patients with reduced ejection fraction and hypotensive heart failure. Methods A total of 100 patients with decreased ejection fraction combined with hypotension and heart failure who were admitted to the Department of Cardiology of Kunming First People’s Hospital from January 2020 to December 2021 were included in the study. The patients were randomly divided into an observation group and a control group, with 50 cases in each group. The patients in the two groups were given standard treatment for heart failure including diuresis and β -receptor blockers. The patients were given sacubatril valsartan at a small dose of 25–50 mg twice a day. According to the patient’s tolerance, the dose was doubled and increased once every 2–4 weeks until the maintenance dose was reached. After 12 months of treatment, the LVEF, LVDd and LVDs of cardiac function in two groups were compared before and after treatment, and the SBP, DBP, blood K+, blood Na+, CTNT, NT-proBNP were observed. Results After treatment, the LVEF of patients in the two groups was increased, while the LVDd and LVDs were decreased. There was statistical difference in LVEF and LVDs between the two groups （P < 0.05）, but no statistical difference in LVDd （P > 0.05）. After treatment, the levels of blood K+, blood Na+, and CTNT increased in the two groups , there was no significant difference between the two groups after treatment （P > 0.05）; NT proBNP decreased significantly after treatment （P < 0.05）. After treatment, the systolic blood pressure in the experimental group increased compared with that before treatment, while there was no significant change in the control group （P > 0.05）, and there was no significant difference in diastolic blood pressure between the two groups （P > 0.05）. Conclusion The treatment of HFrEF combined with hypotension in patients taking sacubatril valsartan can improve heart function, it has no effect on blood pressure, and is safe. -
Key words:
- HFrEF /
- Hypotension /
- Sacubatril valsartan sodium tablets /
- Clinical efficacy /
- Blood pressure
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表 1 实验组与对照组一般资料对比[（
$ \bar x \pm s $ ）/n（%）]Table 1. Comparison of the general data of the experimental group and the control group [（
$ \bar x \pm s $ ）/n（%）]变量 分类 实验组 对照组 χ2 P 年龄（岁） 59.46 ± 15.94 61.04 ± 12.30 −.555 0.580 性别 男 33（33.0） 37（37.0） 0.762 0.383 女 17（17.0） 13（13.0） 心功能分级 Ⅰ级 0（0.0） 3（3.0） 4.311 0.230 Ⅱ级 13（13.0） 10（10.0） Ⅲ级 12（12.0） 16（16.0） Ⅳ级 25（25.0） 21（21.0） 
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表 2 2组患者心功能比较（
$ \bar x \pm s $ ）Table 2. Comparison of cardiac function between the two groups of patients （
$ \bar x \pm s $ ）组别 LVEF（%） LVDs（mm） LVDd（mm） 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 实验组 29.40 ± 6.12 46.74 ± 11.70# 57.32 ± 8.11 47.96 ± 12.68# 66.36 ± 8.41 61.32 ± 12.03 对照组 30.43 ± 5.76 36.11 ± 9.82# 58.16 ± 9.04 53.00 ± 10.60＃ 67.18 ± 8.93 64.68 ± 9.72 t −0.870 4.920 −0.489 −2.156 −0.473 −1.536 P 0.386 < 0.001* 0.626 0.034* 0.637 0.128 *P < 0.05；与同组治疗前比较，#P < 0.05。
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表 3 2组患者血K+、血Na+、CTNT、NT-proBNP水平比较（
$ \bar x \pm s $ ）Table 3. Comparison of blood K+，blood Na+，CTNT，NT-proBNP levels between the two groups （
$ \bar x \pm s $ ）组别 血钾（mmol/L） 血钠（mmol/L） CTNT（μg/L） NT-proBNP（pg/mL） 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 实验组 4.21 ± 0.71 4.05 ± 0.58 138.66 ± 4.20 138.42 ± 4.20 0.23 ± 0.77 0.10 ± 0.22 9428.29 ± 7907.72 2938.68 ± 3287.50# 对照组 4.14 ± 0.57 4.09 ± 0.47 139.55 ± 3.06 138.67 ± 3.18 0.14 ± 0.43 0.10 ± 0.17 9052.25 ± 8328.91 5656.00 ± 6050.10# t 0.544 1.012 −1.209 −0.857 0.698 0.979 0.229 −2.791 P 0.587 0.314 0.229 0.394 0.487 0.330 0.819 0.007* *P < 0.05；与同组治疗前比较，#P < 0.05。
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表 4 2组患者治疗前后血压的比较[（
$ \bar x \pm s $ ），mmHg ]Table 4. Comparison of blood pressure before and after treatment in the two groups of patients [（
$ \bar x \pm s $ ），mmHg ]组别 收缩压 舒张压 治疗前 治疗后 治疗前 治疗后 实验组 100.35 ± 12.84 106.74 ± 14.92 68.10 ± 10.43 68.68 ± 10.60 对照组 102.36 ± 10.76 102.85 ± 13.62 69.71 ± 11.06 69.23 ± 12.44 t −1.435 −0.104 −0.173 0.107 P 0.160 0.918 0.863 0.916 *P < 0.05；与同组治疗前比较，#P < 0.05。
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