Effect of Tongguan Capsules(通冠胶囊) on Restenosis after Coronary Stent Implantation:Study Protocol for A Randomized Controlled Trial  

作　　者：ZHOU Yuan-shen MAO Shuai GUO Li-heng GAO Xiong-yi ZOU Xu ZHANG Min-zhou 

机构地区：[1]Key Discipline of Integrated Traditional Chinese and WesternMedicine,Second Clinical College,Guangzhou University ofChinese Medicine,Guangzhou(510405),China [2]Departmentof Critical Care Medicine,Guangdong Provincial Hospital ofChinese Medicine,Guangzhou(510120),China [3]DoctoralCandidate of Guanzhou University of Chinese Medicine,Guangzhou(510006),China

出　　处：《Chinese Journal of Integrative Medicine》2021年第1期16-23,共8页中国结合医学杂志（英文版）

基　　金：Supported by the National Natural Science Foundation of China(No.81703848 and No.81703877);the Natural Science Foundation of Guandong Province(No.2017A030310123);CHEN Ke-ji Academic Thought Inheritance Studio(No.201461);SHI Zai-xiang Academic Thought Inheritance Studio(No.201461)。

摘　　要：Background:Although percutaneous coronary intervention(PCI)had become widely employed therapeutic procedure for coronary artery disease,stent restenosis limited the benefits of this revascularization and the question how to prevent such events remained unresolved.While numerous empirical observations suggested Tongguan Capsules(通冠胶囊),a patented Chinese Medicine,could decrease frequency and duration of angina pectoris attacks,evidence supporting its efficacy on restenosis remained inadequate.Objective:This trial was designed to determine whether Tongguan Capsules would reduce restenosis rate in patients after successful stent implantation.Methods:Approximately 400 patients undergoing percutaneous coronary stent deployment were enrolled and randomized to control group or Tongguan Capsules(4.5 g/d)for 3 months.All patients received standard anti-platelet,anti-coagulation and lipid-decreasing treatments,concurrently.The primary clinical endpoint was the 12-month incidence of the major adverse cardiovascular events(defined as cardiac death,myocardial infarction,and recurrence of symptoms requiring additional revascularization).The angiographic end point was restenosis rate at 6 months.Conclusion:This study would provide important evidence for the use of Tongguan Capsules in patients after stent implantation in combination with routine therapies,which may significantly reduce incidence of the restenosis so as to potentially improve the clinical outcomes.(registration number:ChiCTR-TRC-ChiCTR-IIR-17011407)

关 键 词：Tongguan Capsules stent restenosis percutaneous coronary intervention 

分 类 号：R541.4[医药卫生—心血管疾病]