Yin Xiao-Yun, Zhang Yun-Mei, Shen Ai-Dong, Wang Jing-Ping, Lian Zhe-Xun, Shao Yi-Bing, Zhang Wen-Qi, Zhang Shu-Ying, Zheng Yang, Cheng Kang, Xu Biao, Shen Cheng-Xing, Huang Rong-Chong, Guo Jin-Cheng, Fu Guo-Sheng, Shan Dong-Kai, Li Dan-Dan, Chen Yun-Dai
Senior Department of Cardiology, the Sixth Medical Centre, Chinese PLA General Hospital, Beijing, China.
Medical School of Chinese PLA, Beijing, China.
J Geriatr Cardiol. 2023 Apr 28;20(4):256-267. doi: 10.26599/1671-5411.2023.04.001.
To evaluate the feasibility and tolerability of metoprolol standard dosing pathway (MSDP) in Chinese patients with acute coronary syndrome (ACS).
In this multicenter, prospective, open label, single-arm and interventional study that was conducted from February 2018 to April 2019 in fifteen Chinese hospitals. A total of 998 hospitalized patients aged ≥ 18 years and diagnosed with ACS were included. The MSDP was applied to all eligible ACS patients based on the standard treatment recommended by international guidelines. The primary endpoint was the percentage of patients achieving the target dose at discharge (V2). The secondary endpoints included the heart rate and blood pressure at V2 and four weeks after discharge (V4), and percentage of patients experiencing bradycardia (heart rate < 50 beats/min), hypotension (blood pressure < 90/60 mmHg) and transient cardiac dysfunction at V2 and V4.
Of the 998 patients, 29.46% of patients achieved the target dose (≥ 95 mg/d) at V2. The total population was divided into two groups: target group (patients achieving the target dose at V2) and non-target group (patients not achieving the target dose at V2). There was significant difference in the reduction of heart rate from baseline to discharge in the two groups (-4.97 ± 11.90 beats/min -2.70 ± 9.47 beats/min, = 0.034). There was no significant difference in the proportion of bradycardia that occurred in the two groups at V2 (0 0, = 1.000) and V4 (0.81% 0.33%, = 0.715). There was no significant difference in the proportion of hypotension between the two groups at V2 (0.004% 0.004%, = 1.000) and V4 (0 0.005%, = 0.560). No transient cardiac dysfunction occurred in two groups during the study. A total of five adverse events (1.70%) and one serious adverse event (0.34%) were related to the pathway in target group.
In Chinese ACS patients, the feasibility and tolerability of the MSDP have been proved to be acceptable.
评估美托洛尔标准给药方案(MSDP)在中国急性冠状动脉综合征(ACS)患者中的可行性和耐受性。
本多中心、前瞻性、开放标签、单臂干预性研究于2018年2月至2019年4月在中国15家医院进行。共纳入998例年龄≥18岁且诊断为ACS的住院患者。根据国际指南推荐的标准治疗方案,对所有符合条件的ACS患者应用MSDP。主要终点是出院时达到目标剂量(V2)的患者百分比。次要终点包括V2时以及出院后4周(V4)时的心率和血压,以及V2和V4时出现心动过缓(心率<50次/分钟)、低血压(血压<90/60 mmHg)和短暂性心脏功能障碍的患者百分比。
998例患者中,29.46%的患者在V2时达到目标剂量(≥95 mg/d)。将总体人群分为两组:目标组(V2时达到目标剂量的患者)和非目标组(V2时未达到目标剂量的患者)。两组从基线到出院时心率降低幅度存在显著差异(-4.97±11.90次/分钟对-2.70±9.47次/分钟,P = 0.034)。两组在V2时(0对0,P = 1.000)和V4时(0.81%对0.33%,P = 0.715)发生心动过缓的比例无显著差异。两组在V2时(0.004%对0.004%,P = 1.000)和V4时(0对0.005%,P = 0.560)低血压的比例无显著差异。研究期间两组均未发生短暂性心脏功能障碍。目标组共有5例不良事件(1.70%)和1例严重不良事件(0.34%)与该方案相关。
在中国ACS患者中,已证明MSDP的可行性和耐受性是可接受的。