FOLLOWUS
1.Cardiovascular Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing (100010), China
2.Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
Prof. LIU Hong-xu, E-mail: liuhongxu@bjzhongyi.com
录用日期:2024-08-12,
网络出版日期:2024-12-02,
纸质出版日期:2025-03
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宽胸气雾剂对择期经皮冠状动脉介入治疗不稳定型心绞痛患者围手术期冠状动脉微循环的影响:一项随机对照试验[J]. 中国结合医学杂志(英文版), 2025,31(3):206-214.
LIU Zi-hao, XING Wen-long, LIU Hong-xu, et al. Effect of Kuanxiong Aerosol on Perioperative Coronary Microcirculation in Patients with Unstable Angina Undergoing Elective PCI: A Pilot Randomized Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(3): 206-214.
宽胸气雾剂对择期经皮冠状动脉介入治疗不稳定型心绞痛患者围手术期冠状动脉微循环的影响:一项随机对照试验[J]. 中国结合医学杂志(英文版), 2025,31(3):206-214. DOI: 10.1007/s11655-024-4000-5.
LIU Zi-hao, XING Wen-long, LIU Hong-xu, et al. Effect of Kuanxiong Aerosol on Perioperative Coronary Microcirculation in Patients with Unstable Angina Undergoing Elective PCI: A Pilot Randomized Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(3): 206-214. DOI: 10.1007/s11655-024-4000-5.
目的:
2
评价宽胸气雾剂 (KXA) 对择期经皮冠状动脉介入治疗 (PCI) 不稳定型心绞痛 (UA) 患者围手术期冠状动脉微循环的即刻影响.
方法:
2
选取2021年2月至2023年7月
仅在左前降支 (LAD) 行经皮冠状动脉介入治疗的UA住院患者. 生成随机数字
以1:1的比例将患者分为试验组和对照组. PCI前测量冠状动脉微循环阻力指数 (IMR)
试验组给予两次KXA
对照组不给药. PCI后再次测量IMR
术前和术后24小时检测心肌肌钙蛋白I (cTnI) 和肌酸激酶同工酶MB (CK-MB)
并记录30天的主要心血管不良事件 (MACE) . 对数据统计及分析人员采用盲法.
结果:
2
共筛查859例患者
其中62例参与本研究. 最后
试验组中有1名患者未能完成经皮冠状动脉介入治疗后的IMR并被排除
在外
30名患者被纳入数据分析
而对照组中有31名患者被列入数据分析. 两组的基线数据 (年龄、性别、危险因素、既往病史、生化指标和药物治疗等) 没有显著差异. 此外
两组术前IMR、cTnI和CK-MB的差异无统计学意义. 经皮冠状动脉介入治疗后
试验组的IMR水平低于对照组 (19.56±14.37
vs
.27.15±15.03
P
=0.048) . 此外
试验组围手术期心肌损伤 (PMI) 的发生率较低
但差异无统计学意义 (6.67%对16.13%
P
=0.425) . 两组均未报告MACE.
结论:
2
KXA具有改善冠状动脉微血管功能障碍的潜在作用. 本研究为KXA在接受选择性经皮冠状动脉介入治疗的UA患者中的应用提供了参考. (注册号ChiCTR2300069831) .
Objective:
2
To evaluate the immediate effect of Kuanxiong Aerosol (KXA) on perioperative coronary microcirculation in patients with unstable angina (UA) suffering from elective percutaneous coronary intervention (PCI).
Methods:
2
From February 2021 to July 2023
UA inpatients who underwent PCI alone in the left anterior descending (LAD) branch were included. Random numbers were generated to divide patients into the trial group and the control group at a ratio of 1:1. The index of coronary microcirculation resistance (IMR) was measured before PCI
and the trial group was given two sprays of KXA
while the control group was not given. IMR was measured again after PCI
cardiac troponin I (cTnI) and creatine kinase isoenzyme-MB (CK-MB) were detected before and 24 h after surgery
and major cardiovascular adverse events (MACEs) were recorded for 30 days. The data statistics and analysis personnel were blinded.
Results:
2
Totally 859 patients were screened
and 62 of them were involved into this study. Finally
1 patient in the trial group failed to complete the post-PCI IMR and was excluded
30 patients were included for data analysis
while 31 patients in the control group were enrolled in data analysis. There was no significant difference in baseline data (age
gender
risk factors
previous history
biochemical index
and drug therapy
etc.) between the two groups. In addition
differences in IMR
cTnI and CK-MB were not statistically significant between the two groups before surgery. After PCI
the IMR level of the trial group was significantly lower than that of the control group (19.56±14.37
vs
. 27.15±15.03
P
=0.048). Besides
the incidence of perioperative myocardial injury (PMI) was lower in the trial group
but the difference was not statistically significant (6.67%
vs
.16.13%
P
=0.425). No MACEs were reported in either group.
Conclusions:
2
KXA has the potential of improving coronary microvascular dysfunction. This study provides reference for the application of KXA in UA patients undergoing elective PCI. (Registration No. ChiCTR2300069831)
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