益气养阴中药调治气阴两虚型慢性心衰患者的临床研究
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摘要
目的:本课题旨在通过应用益气养阴中药汤剂(强心汤加生地、麦冬)治疗慢性心衰气阴两虚型的患者,观察该方对慢性心衰气阴两虚型患者的治疗效果,并对益气养阴法治疗慢性心衰进行规范的临床研究,拟为临床提供一条实际而有价值的途径。同时用统计学的方法检测中药汤剂治疗慢性心衰的时间节点疗效,以及中药汤剂在改善中医症状方面的优势疗效,并评价强心汤加生地、麦冬的临床疗效和安全性,初步探讨其作用机制,为今后的新药开发打下基础。
材料与方法:本临床研究的全部病例均来自辽宁中医药大学附属医院心内科2009年7月至2010年7月的门诊患者,并符合诊断标准及纳入标准者,共计60例。据随机数字表按1:1产生的随机数字分为治疗组、对照组,每组各30例。采用随机对照法对合格受试者进行前瞻性随机对照临床研究。对照组给予西医规范治疗,治疗组在西医规范治疗的基础上加用益气养阴中药汤剂(强心汤加生地、麦冬),药物组成有黄芪40g、人参15g、红花15g、丹参30g、生地20g、麦冬20g、益母草20 g、三七5 g等。每日一剂,分三次口服。观察时间为3个月,观察两组病例治疗前后心衰疗效积分、心功能分级、中医症状、中医证候积分、生活质量积分的变化,并常规监测不良反应指标。
结果:
1.两组病例治疗前的一般情况、心功能分级、心衰积分、中医证候总积分、中医证侯分级和生活质量积分,经统计学方法检验,无显著差异(P>0.05),说明两组具有可比性;
2.两组病例心功能分级、心衰积分的总有效率(显+有效率)、无效率、加重率,统计学均无显著差异(P>0.05),两组的显效率和有效率对比有显著差异(P<0.05);
3.两组患者中医证候总积分在治疗1月、2月、3月时与自身治疗前对照可见:治疗组中医症状总积分与疗前比较,差异均有统计学意义,(P均<0.05或P均<0.01);对照组中医症状总积分与疗前比较,差异均有统计学意义,(P均<0.05或P<均0.01);两组患者中医证候总积分组间比较,经统计学t检验,差异均有显著差异,(P<均0.01);
4.两组病例中医症状总体疗效经Ridit分析,治疗组与对照组比较(P均<0.05),有统计学意义;
5.两组患者用药后在中医症状、舌象、脉象方面与用药前比较,差异有统计学意义(P<0.01);两组组间比较,均有显著的统计学意义(P均<0.01);用药后两组症状经秩和检验,均有显著统计学意义(P<0.01);治疗组用药前后症状经秩和检验,均有显著统计学意义(P<0.01);对照组用药前后症状经秩和检验,均有显著统计学意义(P<0.01);
6.两组在改善患者的生活质量积分上差异有显著统计学意义(P<0.05)。且两组患者接受治疗后,各项生活质量评分明显改善,各项与治疗前比较均有显著性差异(P<0.01或P<0.05)。治疗组治疗后生活质量总积分与对照组比较,有显著性差异(P<0.01)。;
7.两组患者均无明显或严重的毒副反应,安全性和耐受性均良好。
结论:
1.益气养阴中药治疗慢性心力衰竭,在改善慢性心衰患者的心功能方面的疗效与单纯西药规范治疗的疗效相当,在改善中医证侯的起效时间和疗效上优于对照组。
2.益气养阴中药可以明显改善气阴两虚型慢性心衰患者的症状。尤其在对改善心悸、胸闷、气短、乏力、头晕等主要症状和舌脉象方面具有非常明显的治疗作用。
3.益气养阴中药能明显提高慢性心衰患者的生活质量,且疗效明显优于对照组。
4.益气养阴中药治疗慢性心衰患者无明显毒副作用及不良反应,是治疗慢性心衰的有效药物,在慢性心力衰竭患者的预后方面可能具有很好的临床应用价值。
5.益气养阴中药所代表的益气养阴法在慢性心力衰竭的干预治疗方面有明显的作用,存在重要的研究价值。
Purpose:This topic through the application Chinese to qi treatmentresult (strong heart tonga origin, the dwarf lilyturf) treatment of qi and Yin and chronic heart failure patients with two empty type, watching the party of qi and Yin and chronic heart failure patients with two empty the therapeutic effect of type, and the treatment of chronic heart failure qi method for standard clinical research, intends to provide a practical for clinical and valuable way. Also with statistical methods of traditional Chinese medicine treatment of chronic heart failure detection treatmentresult time of traditional Chinese medicine, and the node curative effect in improving the treatmentresult advantages of TCM symptoms, and to evaluate curative effect strong heart tonga origin, the dwarf lilyturf clinical efficacy and safety, discussed the mechanism for future drug development to lay the foundation.
Material and method:This clinical study of all patients were from liaoning university of traditional Chinese medicine hospital heart medicine July 2009 to 2010 July clinic patients, and conform to the diagnostic criteria and the inclusion criteria, total 60 cases. According to random number table by the random number according to 1:1 divided into the treatment group, the control group, 30 cases per groups. Using randomized method for the qualified subjects prospective randomized clinical research. The control group give western medicine standardized treatment, the treatment group in the western standard treatment on the basis of traditional Chinese medicine combined with qi treatmentresult (strong heart tonga origin, the dwarf lilyturf), drug composition 40g, ginseng 15g, astragalus 15g, danshen 30g red and raw land 20g, radix ophiopogonis 20g 20 g, notoginseng, motherwort 5 g, etc. Daily a agent, points three times oral. Observation time for 3 months, observe two groups before and after the treatment effect hf patients grading, cardiac function, integral, TCM symptoms, syndromes integral, the quality of life, integral change, and regular monitoring adverse reaction index.
Results
1.two groups of cases of the general conditions before treatment, cardiac grading, heart failure integral, syndromes total score, TCM syndrome grading and quality of life score by statistical methods, inspection, no significant difference (P > 0.05), explain two groups of comparable;
2.Two cases of grading, cardiac function of the total effective rate (hf integral show + efficient), no efficiency, increase rate, there were no significant difference of statistics (P > 0.05), two groups of significant efficiency and efficient contrast significant difference (P < 0.05).
3.two groups of patients total score syndromes in the treatment of January, February, march before treatment with itself controlled visible: treatment group total score and healing TCM symptoms are compared, differences before statistical significance, (P < 0.05) or P are all < 0.01); The control group total score and healing TCM symptoms are compared, differences before statistical significance, (P < 0.05) or both (P < 0.01); both Two groups of patients total score syndromes by statistical comparison between groups, the difference, t-test, significantly (P < 0.01);
4.two groups of cases by TCM symptoms Ridit overall efficacy analysis, the treatment group compared with controls (P < 0.05), have both statistical significance;
5.two groups after treating patients in TCM symptoms, tongue, compared with medication pulse condition before a statistically significant difference (P < 0.01); Two comparison between qol all had significant statistically significant (P < 0.01); both When the drug by rank and two group of symptoms, all have statistically significant inspection significance (P < 0.01); Before and after the treatment group by rank and drug inspection, the symptoms are statistically significant meaning (P < 0.01); The control group by rank and drug around symptom, all have statistically significant inspection significance (P < 0.01);
6.two groups in improving the quality of life of patients with a statistically significant differences on integral significance (P < 0.05). And the two groups of patients treated, the quality of life score improved obviously, compared with before treatment are the significant difference (P < 0.01 or P < 0.05). After treatment, the quality of life in treatment group total score compared with controls, there is significant difference (P < 0.01). ;7 two groups of patients were not significantly or serious adverse reactions, safety and tolerability is good.
Conclusion
1.fundermental Chinese medicine in the treatment of chronic heart failure patients with chronic heart failure, the heart function to improve the effect of western norms with simple the therapeutic effect of TCM syndrome in improving, equivalent of ho effect-acting period and curative effect on better than control.
2.TCM can obviously improve qi qi and Yin deficiency type two symptoms in patients with chronic heart failure. Especially in to improve heart palpitations, chest tightness, shortness of breath, fatigue, dizziness main symptom and tongue has very obvious pulse treatment function.
3.fundermental Chinese medicine can obviously increase the quality of life of patients with chronic heart failure, and efficacy is obvious better than control.
4.fundermental Chinese medicine therapy and chronic heart failure patients without obvious side effects and adverse reaction, is the treatment of chronic heart failure mid effective drugs, in the prognosis of patients with chronic heart failure may have very good value of clinical applications.
5. the fundermental Chinese medicine represents qi method in chronic heart failure in the medium-term intervention has obvious effect, there are important research value.
材料与方法:本临床研究的全部病例均来自辽宁中医药大学附属医院心内科2009年7月至2010年7月的门诊患者,并符合诊断标准及纳入标准者,共计60例。据随机数字表按1:1产生的随机数字分为治疗组、对照组,每组各30例。采用随机对照法对合格受试者进行前瞻性随机对照临床研究。对照组给予西医规范治疗,治疗组在西医规范治疗的基础上加用益气养阴中药汤剂(强心汤加生地、麦冬),药物组成有黄芪40g、人参15g、红花15g、丹参30g、生地20g、麦冬20g、益母草20 g、三七5 g等。每日一剂,分三次口服。观察时间为3个月,观察两组病例治疗前后心衰疗效积分、心功能分级、中医症状、中医证候积分、生活质量积分的变化,并常规监测不良反应指标。
结果:
1.两组病例治疗前的一般情况、心功能分级、心衰积分、中医证候总积分、中医证侯分级和生活质量积分,经统计学方法检验,无显著差异(P>0.05),说明两组具有可比性;
2.两组病例心功能分级、心衰积分的总有效率(显+有效率)、无效率、加重率,统计学均无显著差异(P>0.05),两组的显效率和有效率对比有显著差异(P<0.05);
3.两组患者中医证候总积分在治疗1月、2月、3月时与自身治疗前对照可见:治疗组中医症状总积分与疗前比较,差异均有统计学意义,(P均<0.05或P均<0.01);对照组中医症状总积分与疗前比较,差异均有统计学意义,(P均<0.05或P<均0.01);两组患者中医证候总积分组间比较,经统计学t检验,差异均有显著差异,(P<均0.01);
4.两组病例中医症状总体疗效经Ridit分析,治疗组与对照组比较(P均<0.05),有统计学意义;
5.两组患者用药后在中医症状、舌象、脉象方面与用药前比较,差异有统计学意义(P<0.01);两组组间比较,均有显著的统计学意义(P均<0.01);用药后两组症状经秩和检验,均有显著统计学意义(P<0.01);治疗组用药前后症状经秩和检验,均有显著统计学意义(P<0.01);对照组用药前后症状经秩和检验,均有显著统计学意义(P<0.01);
6.两组在改善患者的生活质量积分上差异有显著统计学意义(P<0.05)。且两组患者接受治疗后,各项生活质量评分明显改善,各项与治疗前比较均有显著性差异(P<0.01或P<0.05)。治疗组治疗后生活质量总积分与对照组比较,有显著性差异(P<0.01)。;
7.两组患者均无明显或严重的毒副反应,安全性和耐受性均良好。
结论:
1.益气养阴中药治疗慢性心力衰竭,在改善慢性心衰患者的心功能方面的疗效与单纯西药规范治疗的疗效相当,在改善中医证侯的起效时间和疗效上优于对照组。
2.益气养阴中药可以明显改善气阴两虚型慢性心衰患者的症状。尤其在对改善心悸、胸闷、气短、乏力、头晕等主要症状和舌脉象方面具有非常明显的治疗作用。
3.益气养阴中药能明显提高慢性心衰患者的生活质量,且疗效明显优于对照组。
4.益气养阴中药治疗慢性心衰患者无明显毒副作用及不良反应,是治疗慢性心衰的有效药物,在慢性心力衰竭患者的预后方面可能具有很好的临床应用价值。
5.益气养阴中药所代表的益气养阴法在慢性心力衰竭的干预治疗方面有明显的作用,存在重要的研究价值。
Purpose:This topic through the application Chinese to qi treatmentresult (strong heart tonga origin, the dwarf lilyturf) treatment of qi and Yin and chronic heart failure patients with two empty type, watching the party of qi and Yin and chronic heart failure patients with two empty the therapeutic effect of type, and the treatment of chronic heart failure qi method for standard clinical research, intends to provide a practical for clinical and valuable way. Also with statistical methods of traditional Chinese medicine treatment of chronic heart failure detection treatmentresult time of traditional Chinese medicine, and the node curative effect in improving the treatmentresult advantages of TCM symptoms, and to evaluate curative effect strong heart tonga origin, the dwarf lilyturf clinical efficacy and safety, discussed the mechanism for future drug development to lay the foundation.
Material and method:This clinical study of all patients were from liaoning university of traditional Chinese medicine hospital heart medicine July 2009 to 2010 July clinic patients, and conform to the diagnostic criteria and the inclusion criteria, total 60 cases. According to random number table by the random number according to 1:1 divided into the treatment group, the control group, 30 cases per groups. Using randomized method for the qualified subjects prospective randomized clinical research. The control group give western medicine standardized treatment, the treatment group in the western standard treatment on the basis of traditional Chinese medicine combined with qi treatmentresult (strong heart tonga origin, the dwarf lilyturf), drug composition 40g, ginseng 15g, astragalus 15g, danshen 30g red and raw land 20g, radix ophiopogonis 20g 20 g, notoginseng, motherwort 5 g, etc. Daily a agent, points three times oral. Observation time for 3 months, observe two groups before and after the treatment effect hf patients grading, cardiac function, integral, TCM symptoms, syndromes integral, the quality of life, integral change, and regular monitoring adverse reaction index.
Results
1.two groups of cases of the general conditions before treatment, cardiac grading, heart failure integral, syndromes total score, TCM syndrome grading and quality of life score by statistical methods, inspection, no significant difference (P > 0.05), explain two groups of comparable;
2.Two cases of grading, cardiac function of the total effective rate (hf integral show + efficient), no efficiency, increase rate, there were no significant difference of statistics (P > 0.05), two groups of significant efficiency and efficient contrast significant difference (P < 0.05).
3.two groups of patients total score syndromes in the treatment of January, February, march before treatment with itself controlled visible: treatment group total score and healing TCM symptoms are compared, differences before statistical significance, (P < 0.05) or P are all < 0.01); The control group total score and healing TCM symptoms are compared, differences before statistical significance, (P < 0.05) or both (P < 0.01); both Two groups of patients total score syndromes by statistical comparison between groups, the difference, t-test, significantly (P < 0.01);
4.two groups of cases by TCM symptoms Ridit overall efficacy analysis, the treatment group compared with controls (P < 0.05), have both statistical significance;
5.two groups after treating patients in TCM symptoms, tongue, compared with medication pulse condition before a statistically significant difference (P < 0.01); Two comparison between qol all had significant statistically significant (P < 0.01); both When the drug by rank and two group of symptoms, all have statistically significant inspection significance (P < 0.01); Before and after the treatment group by rank and drug inspection, the symptoms are statistically significant meaning (P < 0.01); The control group by rank and drug around symptom, all have statistically significant inspection significance (P < 0.01);
6.two groups in improving the quality of life of patients with a statistically significant differences on integral significance (P < 0.05). And the two groups of patients treated, the quality of life score improved obviously, compared with before treatment are the significant difference (P < 0.01 or P < 0.05). After treatment, the quality of life in treatment group total score compared with controls, there is significant difference (P < 0.01). ;7 two groups of patients were not significantly or serious adverse reactions, safety and tolerability is good.
Conclusion
1.fundermental Chinese medicine in the treatment of chronic heart failure patients with chronic heart failure, the heart function to improve the effect of western norms with simple the therapeutic effect of TCM syndrome in improving, equivalent of ho effect-acting period and curative effect on better than control.
2.TCM can obviously improve qi qi and Yin deficiency type two symptoms in patients with chronic heart failure. Especially in to improve heart palpitations, chest tightness, shortness of breath, fatigue, dizziness main symptom and tongue has very obvious pulse treatment function.
3.fundermental Chinese medicine can obviously increase the quality of life of patients with chronic heart failure, and efficacy is obvious better than control.
4.fundermental Chinese medicine therapy and chronic heart failure patients without obvious side effects and adverse reaction, is the treatment of chronic heart failure mid effective drugs, in the prognosis of patients with chronic heart failure may have very good value of clinical applications.
5. the fundermental Chinese medicine represents qi method in chronic heart failure in the medium-term intervention has obvious effect, there are important research value.
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