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沙库巴曲缬沙坦钠治疗顽固性高血压的临床观察:一项随机临床试验。

Clinical observation of sacubitril valsartan sodium in the treatment of resistant hypertension: A randomized clinical trial.

作者信息

Lyu Tian-Jiao, Liu Ying, Zhang Hong, Li Ling-Yan, He Rui-Qing, Gao Jun-Qing, Liu Zong-Jun

机构信息

Department of Cardiology, Putuo Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Front Cardiovasc Med. 2022 Dec 16;9:1099043. doi: 10.3389/fcvm.2022.1099043. eCollection 2022.

Abstract

OBJECTIVE

To investigate the effectiveness and safety of sacubitril valsartan sodium in the treatment of resistant hypertension (RH).

METHODS

This study is a single-center, prospective, randomized controlled study. According to the inclusion and exclusion criteria, patients with RH who met the criteria were screened, and all patients adjusted their drug treatment (valsartan 80 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg). After 4 weeks of drug elution, the random envelope method was used for random grouping. The treatment group took sacubitril valsartan sodium 200 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg, and the control group took valsartan 80 mg, amlodipine 5 mg, and hydrochlorothiazide 12.5 mg for 8 weeks. The 24 h ambulatory blood pressure (BP) and the echocardiography index using the office sphygmomanometer were observed in the patients.

RESULTS

A total of 100 patients with RH were included in the two groups, with 50 cases in each group. There were no significant differences in sex, age, or comorbid diseases between the two groups. During the 8-week follow-up, the office BP of the research group were significantly decreased (24.78/17.86 mmHg) compared with those of the control group. In the research group the 24 h average BP, daytime average BP, and nighttime average BP were 144.84/79.82, 147.10/82.06, and 138.67/76.31 mmHg at baseline, and reduced to 128.96/73.32, 131.50/74.94, and 122.11/69.27 mmHg at week 8, which were significantly decreased ( < 0.05 or < 0.01), and the left ventricular ejection fraction was significantly increased ( < 0.05), compared with the control group.

CONCLUSION

Sacubitril valsartan sodium can effectively reduce BP and improve cardiac function in RH.

摘要

目的

探讨沙库巴曲缬沙坦钠治疗顽固性高血压(RH)的有效性和安全性。

方法

本研究为单中心、前瞻性、随机对照研究。根据纳入和排除标准,筛选出符合标准的RH患者,所有患者均调整药物治疗(缬沙坦80mg、氨氯地平5mg和氢氯噻嗪12.5mg)。经过4周的洗脱期后,采用随机信封法进行随机分组。治疗组服用沙库巴曲缬沙坦钠200mg、氨氯地平5mg、氢氯噻嗪12.5mg,对照组服用缬沙坦80mg、氨氯地平5mg、氢氯噻嗪12.5mg,疗程8周。观察患者使用诊室血压计测量的24小时动态血压(BP)及超声心动图指标。

结果

两组共纳入100例RH患者,每组50例。两组患者在性别、年龄或合并疾病方面无显著差异。在8周的随访期间,研究组的诊室血压较对照组显著降低(24.78/17.86mmHg)。研究组在基线时24小时平均血压、日间平均血压和夜间平均血压分别为144.84/79.82、147.10/82.06和138.67/76.31mmHg,在第8周时降至128.96/73.32、131.50/74.94和122.11/69.27mmHg,与对照组相比显著降低(<0.05或<0.01),且左心室射血分数显著升高(<0.05)。

结论

沙库巴曲缬沙坦钠可有效降低RH患者的血压并改善心脏功能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/036d/9800823/e85421c820e6/fcvm-09-1099043-g001.jpg

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