生脉胶囊治疗慢性充血性心力衰竭的临床研究

Clinical trial of Shengmai capsules in the treatment of patients with chronic congestive heart failure

目的观察生脉胶囊治疗慢性充血性心力衰竭的临床疗效和安全性。方法将84例慢性充血性心力衰竭患者随机分为对照组42例和试验组42例。对照组予以安慰剂每次0.3 mg,tid,口服;试验组予以生脉胶囊每次0.3 mg,tid,口服。2组患者均治疗2周。比较2组患者的临床疗效、心率、左心室射血分数(LVEF)、舒张早期最大血流速度(E)、E/舒张晚期最大血流速度(E/A)、肺动脉收缩压(PAS)、慢性心力衰竭超声心动图多参数评分(HF-EMPS),以及药物不良反应的发生率。结果治疗后,试验组和对照组的总有效率分别为90.47%(38例/42例)和73.81%(31例/42例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的HR分别为(66.54±7.02)和(72.12±8.14)beat·min^(-1),LVEF分别为(46.03±5.56)%和(41.26±5.12)%,E分别为(92.48±14.32)和(75.41±13.62)cm·s^(-1),E/A分别为1.65±0.34和1.35±0.31,PAS分别为(24.85±4.21)和(30.12±4.22)mm Hg,HF-EMPS分别为(7.03±1.12)及(7.68±1.32)分,差异均有统计学意义(均P<0.05)。2组患者治疗期间均未发生药物不良反应。结论生脉胶囊治疗慢性充血性心力衰竭的临床疗效确切,且安全性较高。

Objective To observe the clinical efficacy and safety of Shengmai capsules in the treatment of chronic congestive heart failure. Methods Eighty -four patients with chronic congestive heart failure were randomly divided into control group and treatment group with 42 ca- ses per group. Control group was given placebo 0. 3 mg each time, tid, orally. Treatment group was given Shengmai capsule 0. 3 mg each time, tid, orally. Two groups were treated for 2 weeks. The clinical efficacy, heart rate,left ventricular ejection fraction （LVEF）, maximal velocity of bicuspid blood flow in the early （E）, E/ maximal velocity of bicuspid blood flow in the advanced （ E/A）, pulmonary artery pressure （ PAS）, heart function echocardiographic multi - parameter scores （ HF - EMPS） and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 90.47% （38 cases/42 cases） and 73.81% （31 cases/42 cases） with significant difference （ P 〈 0. 05 ）. After treatment, the main inde- xes in treatment and control groups were compared： heart rate were （66.54 ±7.02） and （72.12 ±8.14）beat · min-1, LVEF were（46.03±5.56）% and （41.26 ±5.12）%, E were（92.48 ±14.32）and（75.41 ±13.62）em · s-1,E/A were 1.65 sO, 34 and 1.35 ± 0. 31, PAS were （ 24.85 ± 4. 21 ） and （ 30. 12 ± 4. 22 ） mmHg, I-IF - EMPS were （7.03 ± 1, 12） and （7.68 ± 1.32） points, with significant difference （ all P 〈 0. 05 ）. There were no adverse drug reactions occurred during the treatment in two groups Conclusion Shengmai capsules have a definitive clinical efficacy and safety in the treatment of ehronic congestive heart failure.