Xie Feng-Qun, Wang Yi-Sheng, Zhang Lei, Zhu Wen, Cheng Jie, Lu Yun-Yan, Xu Shao-Hua, Li Xian-Kai, Feng Qi-Mao
Department of Cardiology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.
Department of Cardiology, Tenth People's Hospital, Tongji University, Shanghai 200072, China.
Heliyon. 2024 Aug 3;10(16):e35747. doi: 10.1016/j.heliyon.2024.e35747. eCollection 2024 Aug 30.
The objective of this study was to evaluate the efficacy and safety of Formula in the treatment of coronary microvascular disease.
We conducted a randomized, double-blind, placebo-controlled study simultaneously in two hospitals, consisting of 80 participants. Using a random number table, we assigned patients to the treatment and control groups. Patients in both groups received conventional Western medicine for coronary microvascular disease. In addition, those in the treatment group received formula granules, while those in the control group received a placebo. The treatment course for both groups was three months, and the follow-up duration was six months. The primary efficacy indicators were coronary blood flow reserve and cardiovascular adverse events; the secondary efficacy indicators were the traditional Chinese medicine (TCM) syndrome score, the angina symptom score, the Seattle Angina Questionnaire (SAQ) score, left ventricular function, and adverse reactions.
After treatment, patients in the treatment group showed significantly higher variation in the coronary flow reserve (CFR) levels (CFR >2) and improvement of diastolic function (peak filling rate, or PFR >2.5) than those in the control group ( < 0.05). After 6 months of follow-up, the incidence of cardiovascular events in the treatment group was significantly lower than that in the control group ( < 0.05). After 3 months of treatment and 6 months of follow-up, the total effective rates of TCM symptoms and angina symptoms, as well as the total SAQ standard scores, in the treatment group were higher than those in the control group ( < 0.05). There were no serious adverse reactions in either group before or after treatment, and there was no significant change ( > 0.05).
We found that Formula combined with conventional Western medicine can significantly improved the level of coronary blood flow reserve, reduced the occurrence of cardiovascular adverse events, improved the clinical symptoms of patients, and enhanced the quality of life of patients with coronary microvascular disease with favorable safety.
本研究旨在评估方剂治疗冠状动脉微血管疾病的疗效和安全性。
我们在两家医院同时进行了一项随机、双盲、安慰剂对照研究，共有80名参与者。使用随机数字表，我们将患者分为治疗组和对照组。两组患者均接受冠状动脉微血管疾病的常规西药治疗。此外，治疗组患者服用方剂颗粒，而对照组患者服用安慰剂。两组的疗程均为三个月，随访时间为六个月。主要疗效指标为冠状动脉血流储备和心血管不良事件；次要疗效指标为中医证候评分、心绞痛症状评分、西雅图心绞痛问卷（SAQ）评分、左心室功能和不良反应。
治疗后，治疗组患者的冠状动脉血流储备（CFR）水平变化（CFR>2）和舒张功能改善（峰值充盈率，或PFR>2.5）明显高于对照组（P<0.05）。随访6个月后，治疗组心血管事件的发生率明显低于对照组（P<0.05）。治疗3个月和随访6个月后，治疗组中医症状和心绞痛症状的总有效率以及SAQ总标准评分均高于对照组（P<0.05）。两组治疗前后均未出现严重不良反应，且无明显变化（P>0.05）。
我们发现方剂联合常规西药可显著提高冠状动脉血流储备水平，减少心血管不良事件的发生，改善患者临床症状，提高冠状动脉微血管疾病患者的生活质量，且安全性良好。
