[Treatment of Chronic Heart Failure with Qi-Yang Deficiency, Blockage of Static Blood Syndrome by Xinmailong Injection: an Open Multi-center Clinical Study].

Objective To assess the safety and effectiveness of Xinmailong Injection (XI) for treating chronic heart failure (CHF) patients with qi-yang deficiency, blockage of static blood syndrome (QYDBSBS). Methods Totally 2 104 patients with QYDBSBS at 25 centers were recruited. XI at 5 mg/kg was intravenously injected to all patients after skin test, twice per day for 5 successive days. The safety and effectiveness were observed within 8 days after injection (5 days of treatment and 3 days of follow- ups). Results were analyzed after full analysis set (FAS) and safety set (SS). Efficacy of heart function (HF) and efficacy of Chinese medicine (CM) syndrome were subgroup analyzed by age ( ≤65 years old or >65 years old) or types of HF (whole HF, right HF, or left HF). Results FAS analysis showed after treatment markedly effective of HF in 550 cases, effective in 873 cases, ineffective in 673 cases, deteriorated in 8 cases. The markedly effective rate was 26.14% and the total effective rate was 67.63%. After treatment markedly effective of CM syndrome was shown in 795 cases, effective in 1 009 cases, ineffective in 288 cases, deteriorated in 12 cases. The markedly effective rate was 37.79% and the total effec- tive rate was 85.74%. Results of CM symptom score: CM symptom score was (11.381 ±4.574) before treatment and (4.987 ±3.984) after treatment, with statistical difference (P <0.01). The decrease rate was 56.8% ±27.0%. Results of subgroup analysis showed that markedly effective rates of HF efficacy and CM syndrome efficacy were superior in patients ≤65 years old than in patients >65 years old (P<0.01 Efficacy of HF was superior in patients with left HF than in those with whole HF or with right HF (P<0.01). In aspect of efficacy of CM, the markedly effective rate and the total effective rate were superior in patients with left HF or with whole HF than in those with right HF (P<0.01 ). No death occurred during the tri- al. No severe adverse event occurred either. Conclusions XI could improve clinical symptoms of CHF patients with QYDBSBS, reduce CM symptom score. No severe adverse event was observed.