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养心氏片改善冠心病患者运动能力:一项随机、双盲、安慰剂对照、多中心试验的结果

Yangxinshi Tablet Improves Exercise Capacity for Patients with Coronary Heart Disease: Results from a Randomized, Double-Blind, Placebo-Controlled, and Multicenter Trial.

作者信息

Zhang Sisi, Shen Yuqin, Liu Peiliang, Meng Xiaoping, Hu Dayi

机构信息

Division of Cardiology, Department of Internal Medicine, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, 430030 Wuhan, Hubei, China.

Department of Cardiovascular Medicine, Research Center for Translational Medicine, Tongji Hospital Affiliated with Shanghai Tongji University, 200065 Shanghai, China.

出版信息

Rev Cardiovasc Med. 2022 Jul 21;23(8):266. doi: 10.31083/j.rcm2308266. eCollection 2022 Aug.

Abstract

OBJECTIVE

To assess the clinical effectiveness of Yangxinshi (YXS) tablets on exercise capacity and symptoms of anxiety and depression in patients with coronary heart disease (CHD).

METHODS AND RESULTS

A randomized, double-blind, placebo-controlled, multicenter clinical trial was performed to assess the effects of YXS tablets on exercise capacity and quality of life in patients with CHD. A total of 82 patients were included in this trial. Compared with the placebo group, the YXS group showed significant improvement in peak (0.22 L/min vs 0.01 L/min; difference 0.1, 95% confidence interval (CI) 0.04-0.16, = 0.000), peak Mets (0.58 vs 0.09; difference 0.3, 95% CI 0.12-0.47, = 0.005), anaerobic threshold (AT) (0.23 L/min vs 0.04 L/min; difference 0.12, 95% CI 0.07-0.18, = 0.000), AT Mets (0.62 vs 0.16; difference 0.35, 95% CI 0.2-0.5, = 0.001), and 6 minutes walking test (6MWT) (50.05 m vs 11.91 m; difference 29.92, 95% CI 18.78-41.07, = 0.000). There were no differences in Hamilton anxiety rating scale (HAM-A score (1.97 vs 2.07; difference 2.03, 95% CI 0.99-3.06, = 0.926) and Hamilton depression rating scale (HAM-D) score (1.06 vs 1.7; difference1.42, 95% CI 0.24-2.6, = 0.592).

CONCLUSIONS

In patients with CHD, YXS tablets, compared with placebo, could improve exercise capacity, without beneficial effects on anxiety and depression symptoms.

摘要

目的

评估养心氏(YXS)片对冠心病(CHD)患者运动能力以及焦虑和抑郁症状的临床疗效。

方法与结果

进行了一项随机、双盲、安慰剂对照、多中心临床试验,以评估YXS片对CHD患者运动能力和生活质量的影响。本试验共纳入82例患者。与安慰剂组相比,YXS组在峰值摄氧量(0.22L/min对0.01L/min;差值0.1,95%置信区间(CI)0.04 - 0.16,P = 0.000)、峰值代谢当量(0.58对0.09;差值0.3,95%CI 0.12 - 0.47,P = 0.005)、无氧阈(AT)摄氧量(0.23L/min对0.04L/min;差值0.12,95%CI 0.07 - 0.18,P = 0.000)、AT代谢当量(0.62对0.16;差值0.35,95%CI 0.2 - 0.5,P = 0.001)以及6分钟步行试验(6MWT)(50.05m对11.91m;差值29.92,95%CI 18.78 - 41.07,P = 0.000)方面有显著改善。汉密尔顿焦虑评定量表(HAM - A评分(1.97对2.07;差值2.03,95%CI 0.99 - 3.06,P = 0.926))和汉密尔顿抑郁评定量表(HAM - D)评分(1.06对1.7;差值1.42,95%CI 0.24 - 2.6,P = 0.592)方面无差异。

结论

在CHD患者中,与安慰剂相比,YXS片可改善运动能力,但对焦虑和抑郁症状无有益影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14d2/11266962/9169999d726f/2153-8174-23-8-266-g1.jpg

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