机构:[1]Second Clinical Medical College, Guangzhou University ofChinese Medicine, Guangzhou (510405), China深圳市中医院深圳医学信息中心[2]Heart Center,Guangdong Provincial Hospital of Chinese Medicine, Guangzhou(510120), China广东省中医院[3]Faculty of Medicine, University of Toronto,Toronto M5G 0A4, Canada[4]Beijing University of ChineseMedicine, Beijing (100029), China
BackgroundMany patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (???????, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic (ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events (MACE) in stable anginal patients.MethodsA total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR (10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up.DiscussionThis study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events. (Trial registration No. ChiCTR-TRC-14004504)
基金:
Foundation from Department of Science and Technology of Guangdong Province [2012A032500017]; Foundation from Guangdong Provincial Academy of Traditional Chinese Medicine [YN2014LN07, YK2013B1N10, A2016192]; Science Foundation of Guangdong ProvinceNational Natural Science Foundation of Guangdong Province [2015A030310437, 2015A030306049]; National Natural Science FoundationNational Natural Science Foundation of China [81403341, 81703877]
第一作者机构:[1]Second Clinical Medical College, Guangzhou University ofChinese Medicine, Guangzhou (510405), China[2]Heart Center,Guangdong Provincial Hospital of Chinese Medicine, Guangzhou(510120), China
通讯作者:
通讯机构:[1]Second Clinical Medical College, Guangzhou University ofChinese Medicine, Guangzhou (510405), China[2]Heart Center,Guangdong Provincial Hospital of Chinese Medicine, Guangzhou(510120), China[4]Beijing University of ChineseMedicine, Beijing (100029), China
推荐引用方式(GB/T 7714):
Mao Shuai,Xu Dan-ping,Dang Xiao-jing,et al.Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial[J].CHINESE JOURNAL OF INTEGRATIVE MEDICINE.2019,25(2):96-102.doi:10.1007/s11655-018-3017-z.
APA:
Mao Shuai,Xu Dan-ping,Dang Xiao-jing,Li, Winny&Wu Huan-lin.(2019).Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial.CHINESE JOURNAL OF INTEGRATIVE MEDICINE,25,(2)
MLA:
Mao Shuai,et al."Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Trial".CHINESE JOURNAL OF INTEGRATIVE MEDICINE 25..2(2019):96-102