Efficacy Observation of Sofre Injection Combined with Isosorbide Mononitrate in the Treatment of Refrac-tory Heart Failure / 中国药师

ABSTRACT

Objective:To observe the clinical efficacy and safety of Sofre injection combined with isosorbide mononitrate in the treatment of refractory heart failure. Methods:Totally 66 cases of patients with refractory heart failure in our hospital were randomly di-vided into the observation group and the control group with 33 cases in each. Each patient received the conventional treatment. On the basis of routine treatment, the control group was treated with isosorbide mononitrate injection (25mg,qd,ivd). On the basis of control group, the observation group was treated with Sofre injection (10ml, qd, ivd). The treatment course was 14 days. Before and after the treatment, the improvement degree clinical symptoms, left ventricular ejection fraction ( LVEF) , left ventricular end diastolic diameter (LVEDD), cardiac index (CI), stroke volume (SV) and 6-min walking distance (6MWD) were observed, and the rate of heart fail-ure hospitalization, heart failure mortality and 6MWT changes were followed up for 6 months in the two groups. The adverse drug reac-tions ( ADR) in both groups during the treatment were recorded as well. Results:After the 2-week treatment, the effective rate and the total effective rate of the observation group were significantly higher than those of the control group (P<0. 05); LVEF, CI, SV and 6MWD of the two groups after the treatment were significantly higher than those before the treatment, and LVEDD significantly de-creased (P<0. 05), and the improvement of the observation group was more obvious than that of the control group (P<0. 05). After the 6-month follow-up, 6MWD was significantly longer in the observation group than that in the control group (P<0. 05), while there were no statistically significant differences in the hospitalization rate and the mortality rate between the groups (P>0. 05). There were no adverse reactions in both groups during the whole treatment. Conclusion:Sofre injection combined with isosorbide mononitrate can significantly improve cardiac function in the patients with refractory heart failure with improved clinical efficacy and good safety.