[Treatment of Chronic Heart Failure Patients with Qi-Yang Deficiency and Blood Stasis Resistance Syndrome by Xnmallong Injection: a Multi-center Randomized Control Study].

To evaluate the efficacy and safety of Xinmailong Injection (XI) in treatment of chronic heart failure (CHF) patients with qi-yang deficiency and blood stasis resistance syndrome (QY-DBSRS).Totally 238 CHF patients with QYDBSRS were assigned to the treatment group (118 cases) and the control group (120 cases) by randomized, double-blind, placebo parallel controlled method. Patients in the treatment group received routine therapy and XI (100 mg/2 mL, by dripping at 5 mg/kg, twice per day for 5 consecutive days), while those in the control group received routine therapy and XI mimetic agent (100 mg/2 mL, by dripping at 5 mg/kg, twice per day for 5 consecutive days). The heart function classification of New York Heart Association (NYHA), 6-min walking distance, left ventricular ejection fraction (LVEF), scores for Chinese medical symptoms were observed before and after treatment, and safety assessed.Totally 235 patients actually entered full analysis set (FAS), including 120 cases in the control group and 115 cases in the treatment group. The total effective rate of heart function, 6-min walking distance and increased post-pre-treatment distance in the experimental group were superior to those of the control group with statistical difference (all P 0.05).XI could improve the heart function of CHF patients, improve Chinese medical symptoms, elevate exercise tolerance, and improve LVEF. It had no obvious toxic and side effects.