Chunxiao Zhang1, Yaguang Zheng2, Tao Chen3, Shengyu Wang4, Meng Xu4. 1. Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: chunxiaozhangmd@outlook.com. 2. The University of Pittsburgh School of Nursing, Pittsburgh, PA USA. 3. Department of Clinical Sciences, Liverpool School of Tropical Medicines, Pembroke Pl, Liverpool, L3 5QA, UK. 4. Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Abstract
OBJECTIVE: examine the efficacy and safety of Shenmai to the cardiac rehabilitation in patients received coronary artery bypass grafting. DESIGN: a single-center randomized, single blind clinical trial. SETTING: Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. SUBJECTS:Patients with coronary artery disease who receivedcoronary artery bypass grafting in our center were studied. They must be competent to complete the 6-minute walking test without any assistance and without any severe comorbidity. INTERVENTIONS: in Shemmai group, the participants were treated with Shenmai injection (100 ml/day) right after the surgery to discharge for 9.28 ± 3.75 days and then capsule (3.6 g/day) sequentially for 30 days in addition to the cardiac rehabilitation. In control group, only cardiac rehabilitation was conducted. MAIN MEASURES: the 6-Minute Walking Test was measured at three time points: one day before operation, on the day of discharge and 30 days follow up. RESULTS:The sample (n = 166) was predominately male (84%), with mean age was 61.12 ± 9.13 years. There was no significant difference between groups in baseline characteristics and the procedural characteristics. There was one death in control group and one stroke in Shenmai group right after the surgery. Overall, there was group (p = .005) and time effect (p < .001) on the 6-minute walking distance. Participants in the Shenmai group walked longer distance in meters compared with control group on the day of discharge (314.54 ± 64.14 vs. 271.29 ± 76.82, P < .001), while no significant differences before operation (399.72 ± 93.19 vs. 403.67 ± 91.99, p = .78) and on 30-day follow up (436.54 ± 67.64 vs. 421.64 ± 83.53, p = .21). CONCLUSION:Shenmai improves the exercise tolerance in the early stage of the cardiac rehabilitation for patients received coronary artery bypass grafting.
RCT Entities:
OBJECTIVE: examine the efficacy and safety of Shenmai to the cardiac rehabilitation in patients received coronary artery bypass grafting. DESIGN: a single-center randomized, single blind clinical trial. SETTING: Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. SUBJECTS:Patients with coronary artery disease who received coronary artery bypass grafting in our center were studied. They must be competent to complete the 6-minute walking test without any assistance and without any severe comorbidity. INTERVENTIONS: in Shemmai group, the participants were treated with Shenmai injection (100 ml/day) right after the surgery to discharge for 9.28 ± 3.75 days and then capsule (3.6 g/day) sequentially for 30 days in addition to the cardiac rehabilitation. In control group, only cardiac rehabilitation was conducted. MAIN MEASURES: the 6-Minute Walking Test was measured at three time points: one day before operation, on the day of discharge and 30 days follow up. RESULTS: The sample (n = 166) was predominately male (84%), with mean age was 61.12 ± 9.13 years. There was no significant difference between groups in baseline characteristics and the procedural characteristics. There was one death in control group and one stroke in Shenmai group right after the surgery. Overall, there was group (p = .005) and time effect (p < .001) on the 6-minute walking distance. Participants in the Shenmai group walked longer distance in meters compared with control group on the day of discharge (314.54 ± 64.14 vs. 271.29 ± 76.82, P < .001), while no significant differences before operation (399.72 ± 93.19 vs. 403.67 ± 91.99, p = .78) and on 30-day follow up (436.54 ± 67.64 vs. 421.64 ± 83.53, p = .21). CONCLUSION: Shenmai improves the exercise tolerance in the early stage of the cardiac rehabilitation for patients received coronary artery bypass grafting.