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Objective: To investigate the protective effect of Shenfu Injection (参附注射液, SFI) against myocardium ischemia/reperfusion injury (IRI) initral valve replacement (MVR) with cardiopulmonary bypass (CPB). Methods: Forty patients undergoing selective MVR were randomly assigned to the control group and trial Groups ⅠⅡ,Ⅲ, and Ⅳ according to the different administrations of SFI, 8 patients in each group. The changes of systolic blood pressure (SBP), mean blood pressure (MBP), diastolic blood pressure (DBP) in each group were monitored, respectively. The recovering percentage of spontaneous heart beat, the heart rate (HR) and cardiac rhythm as well as the abnormal duration of ECG-ST segment were recorded after the restoration of heart beat. The serum concentration of cardiac troponin Ⅰ (cTnl), malondialdehyde (MDA) and the activity of superoxide dismutase (SOD) were determined as well. Results: (1) The SBP, MBP and DBP values, the recovering rate of spontaneous heart beat, HR, ECG-ST, atrioventricular block and ventricular arrhythmia were significantly improved in group Ⅳ compared with any other groups. (2) Compared with the control group, the postoperative serum contents of cTnl and MDA were significantly decreased, but the activity of SOD was significantly increased in group Ⅳ. Conclusions: SFI had a certain protective effect against myocardium IRI. Moreover, better efficacy was seen with the administration of 1.5 mL/kg SFI into CPB priming fluid and pumping 1.5 mL/kg SFI via CPB as soon as the clamped aorta was unclamped.