优化新生脉散方联合西药治疗慢性心力衰竭单病例交叉随机对照研究  

Optimized New Shengmai Powder(新生脉散) Combined with Western Medicine Treating Chronic Heart Failure: a N-of-1 Crossover Study

作　　者：王贤良[1] 袁杨 毛静远[1] 李彬[1] 周瑞娟[1] 张晓亮[3] 王帅[1] 王拴虎[3] 

机构地区：[1]天津中医药大学第一附属医院、天津市南开区鞍山西道314号,300193 [2]天津市滨海新区塘沽中医医院 [3]天津中医药大学

出　　处：《中医杂志》2015年第21期1849-1853,共5页Journal of Traditional Chinese Medicine

基　　金：天津市高等学校科技发展基金计划项目(20110222);教育部“创新团队发展计划”(IRT1276)

摘　　要：目的观察优化新生脉散方、新生脉散原方对慢性心力衰竭气虚血瘀水饮证患者的临床疗效和安全性。方法采用单病例交叉随机对照设计,将20例患者随机分组并按不同顺序分别接受优化新生脉散方治疗联合西药规范治疗、单纯西药规范治疗、新生脉散原方联合西药规范治疗,每阶段4周,中药治疗后加设2周洗脱期,期间只使用单纯西药治疗。试验结果分析时,将使用单纯西药阶段的20例患者命名为对照组,使用新生脉散原方阶段的20例患者为原方组,使用优化新生脉散方阶段20例患者为优化组。于治疗前及3种治疗结束时观察心功能分级、中医症状积分、生存质量评分、六分钟步行距离、超声心动图指标。结果对照组、原方组、优化组治疗后心功能分级疗效总有效率分别为50.0%、60.0%、85.0%,优化组优于原方组及对照组(P<0.05或P<0.01)。治疗后优化组中医症状积分总分及气短、乏力、面肢浮肿的单项积分均优于原方组(P<0.05)。治疗后原方组、优化组患者生存质量、六分钟步行距离、超声心动图射血分数均较治疗前显著改善(P<0.05或P<0.01),且优化组优于原方组(P<0.05)。结论优化新生脉散方治疗慢性心力衰竭具有较好的临床疗效及安全性,在缓解临床症状、改善生存质量、增加六分钟步行距离及提高射血分数方面较新生脉散原方更具优势。Objective To observe the clinical effect and safety of optimized New Shengmai Powder and original New Shengmai Powder treating chronic heart failure（ CHF） patients of blood stasis and fluid retention syndrome.Methods The study was a crossover randomized controlled trial with individual patient. Twenty patients were randomized into groups and given standard treatment of optimized New Shengmai Powder combined with western medicine,western medicine alone and original New Shengmai Powder combined with western medicine respectively according to different order for 4 weeks in every stage. After Chinese medicine treatment,a washout period of 2 weeks was added and western medicine alone was applied during the period. When analyzing trial results,researchers named the20 patients in the stage of western medicine alone as treatment control group,the 20 patients in the stage of original New Shengmai Powder as treatment original prescription group and the 20 patients in the stage of optimized New Shengmai Powder as treatment optimization group. Observed cardiac functional grading,scores of Chinese medicine symptoms,scores of life quality,6-miniutes walk distance and indexes of ultrasound cardiogram before treatment and at the end of 3 treatments. Results After treatment,total effective rate of cardiac functional grading effect of control,original prescription and optimization groups was 50. 0%,60. 0% and 85. 0% respectively. Optimization group was superior to original prescription and control groups（ P〈0. 05 or P〈0. 01）. After treatment,total score of Chinese medicine symptoms and item scores of shortness of breath,weakness and edema of face and limbs of optimization group were superior to those of original prescription group（ P〈0. 05）. After treatment,quality of life,6-miniutes walk distance and ultrasound cardiogram ejection fraction of original prescription and optimization groups were improved（ P〈0. 05 or P〈0. 01）; optimization group was superior to original prescription group（ P〈0. 05）.Con

关 键 词：慢性心力衰竭 优化新生脉散方 心功能分级 射血分数 

分 类 号：R541.6[医药卫生—心血管疾病]