Effect of Tongguan Capsules ((sic)&x51a0;&x80f6;&x56ca;) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial
机构:[1]Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China广东省中医院深圳市中医院深圳医学信息中心[2]Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou (510120), China大德路总院重症医学科大德路总院重症医学科广东省中医院[3]Doctoral Candidate of Guanzhou University of Chinese Medicine, Guangzhou (510006), China
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 ((sic)& x51a0;& x80f6;& x56ca;), 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)
基金:
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)
and SHI Zai-xiang Academic Thought Inheritance Studio (No.
201461)
第一作者机构:[1]Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China[2]Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou (510120), China[3]Doctoral Candidate of Guanzhou University of Chinese Medicine, Guangzhou (510006), China
通讯作者:
通讯机构:[1]Key Discipline of Integrated Traditional Chinese and Western Medicine, Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou (510405), China[2]Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou (510120), China
推荐引用方式(GB/T 7714):
Zhou Yuan-shen,Mao Shuai,Guo Li-heng,et al.Effect of Tongguan Capsules ((sic)&x51a0;&x80f6;&x56ca;) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial[J].CHINESE JOURNAL OF INTEGRATIVE MEDICINE.2021,27(1):16-23.doi:10.1007/s11655-020-2722-6.
APA:
Zhou Yuan-shen,Mao Shuai,Guo Li-heng,Gao Xiong-yi,Zou Xu&Zhang Min-zhou.(2021).Effect of Tongguan Capsules ((sic)&x51a0;&x80f6;&x56ca;) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial.CHINESE JOURNAL OF INTEGRATIVE MEDICINE,27,(1)
MLA:
Zhou Yuan-shen,et al."Effect of Tongguan Capsules ((sic)&x51a0;&x80f6;&x56ca;) on Restenosis after Coronary Stent Implantation: Study Protocol for A Randomized Controlled Trial".CHINESE JOURNAL OF INTEGRATIVE MEDICINE 27..1(2021):16-23