心脉隆注射液治疗慢性心力衰竭气阳两虚、瘀血内阻证的开放、多中心临床研究

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

目的评价心脉隆注射液治疗慢性心力衰竭气阳两虚、瘀血内阻证的安全性与有效性。方法将25个研究中心的2 104例慢性心力衰竭气阳两虚、瘀血内阻证患者纳入研究,所有患者均在皮试后予心脉隆注射液,每次5 mg/kg静脉滴注,每日两次,用药5天,观察患者用药后8天内(治疗5天及随后3天)的安全性和有效性,后进入全分析集(full analysis set,FAS)和安全性分析集(safety set,SS)进行结果分析。并以年龄(年龄≤65或>65岁)及心衰类型(全心衰、左心衰和右心衰)对心功能疗效和中医证侯疗效进行亚组分析。结果 FAS分析显示治疗后患者心功能疗效显效550例,有效873例,无效673例,恶化8例,显效率为26.14%,总有效率为67.63%;治疗后中医证候疗效显效795例,有效1 009例,无效288例,恶化12例,显效率37.79%,总有效率85.74%;中医症状积分疗效结果显示,治疗前患者中医症状评分为(11.381±4.574)分,治疗后为(4.987±3.894)分,下降率为(56.8±27.0)%,治疗前后比较差异有统计学意义(P<0.01)。亚组分析结果显示,年龄≤65岁组患者心功能疗效及中医证侯疗效显效率优于年龄>65岁组(P<0.01);心功能疗效方面,左心衰组显效率优于右心衰和全心衰组(P<0.01);中医证侯疗效方面,左心衰组和全心衰组显效率及总有效率优于右心衰组(P<0.01)。试验过程中未发生死亡事件及其他严重不良事件。结论心脉隆注射液治疗慢性心力衰竭气阳两虚、瘀血内阻证患者能改善其临床症状,降低中医证候积分,未观察到严重不良事件。

Objective To assess the safety and effectiveness of Xinmailong Injection （Xl） 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 clays 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, deteri- orated 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, ineffec- tive 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~% ~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 pa- tients with left HF or with whole HF than in those with right HF （P〈0.01）. No death occurred during the trial. No severe adverse event occurred either. Conclusions Xl could improve clinical symptoms of CHF patients with QYDBSBS, reduce CM symptom score. No severe adverse event was observed.