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Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial(Open Access)

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机构: [1]Department of Cardiology,THe First Affiliated Hospital of Nanjing Medical University, Nanjing, China [2]Department of Statistics of Nanjing Medical University, Nanjing, China [3]National University Heart Centre, National University Hospital, Singapore [4]Department of Cardiology,THe First Affiliated Hospital of Bengbu Medical College, Bengbu, China [5]Department of Cardiology, Chinese Academy of Medical Sciences Fuwai Cardiovascular Hospital, Beijing, China [6]Department of Cardiology, Renmin Hospital of Wuhan University,Wuhan, China [7]Department of Cardiology,THe Second Affiliated Hospital of Nanchang University, Nanchang, China [8]Department of Cardiology,THe First Affiliated Hospital of China Medical University, Shenyang, China [9]Department of Cardiology,THe Second Hospital of Tianjin Medical University, Tianjin, China [10]Department of Cardiology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China [11]Department of Cardiology, Xiangya No. 2 Hospital Central South University, Changsha, China [12]Department of Cardiology, No.1 Hospital of Jilin University, Changchun, China [13]Department of Cardiology, First People's Hospital of Yunnan Province, Kunming, China [14]Department of Cardiology,THe 252nd𝑑Hospital of Chinese People's Liberation Army, Beijing, China [15]Department of Cardiology, First Affiliated of Liaoning Medical University, Shenyang, China [16]Department of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, China [17]Department of Cardiology,THe Department of Cardiology, People's Hospital of Baoji City, Baoji, China [18]Department of Cardiology, Jinzhou Central Hospital, Jinzhou, China
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Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% (p < 0.001) and increased MHR by 10.9% (p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement (p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775. © 2019 Fengxiang Zhang et al.

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大类 | 4 区 医学
小类 | 3 区 全科医学与补充医学
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Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE
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第一作者机构: [1]Department of Cardiology,THe First Affiliated Hospital of Nanjing Medical University, Nanjing, China
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