健心颗粒对早期慢性左室心力衰竭的临床及实验研究
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摘要
目的
充血性心力衰竭(cHF)发生发展的基本机制是心室重构。探讨临床上健心颗粒对早期慢性左室心力衰竭(cHF)患者证属气阴两虚,痰瘀互结型患者的心功能、心室重塑及远期生活质量的影响。在取得较好临床论证的基础上,并进一步通过动物实验探讨健心颗粒防治大鼠早期左心衰的作用机理。
方法
临床观察方法选择我院2006年至2007年中的住院病人,共观察80例,所有病例均符合中华心血管委员会心力衰竭研究组1995年制定的《充血性心力衰竭诊断和治疗对策》、《中药新药治疗充血性心力衰竭指导原则》和1998年制定的《心血管药物临床试验评价方法的建议》的诊断标准及心功能判断标准及Framingham标准拟定。将所有病例随机分为治疗组和对照组各40例。两组间性别、年龄、病程、心功能和基础病情差异均无显著性意义(P＞0.05),具有可比性。治疗组在常规西药抗心衰治疗的基础上,加用中药健心颗粒服用;对照组仅以常规西药抗心衰治疗。疗程均为半年。观察其治疗前后的临床症状疗效,心功能分级水平及左室射血分数,并做统计学处理,比较其疗效。治疗前后实验室检查血常规、尿常规、粪常规、肝肾功能及电解质作为安全性指标,以确定健心颗粒是否有毒、副作用。
动物实验方法采用清洁级sD大鼠80只,体重300-400g,随机取12只作假手术组,余68只为手术组,手术组采用腹主动脉缩窄术制作压力超负荷早期慢性左心衰大鼠模型并随机分为模型组,西药组,健心颗粒高剂量和低剂量组。假手术组仅分离出腹主动脉,不行缩窄术,其它操作均同手术组。6周后每组随机取2只共10只大鼠行预实验判断心衰模型构建成功。造模6周后分别给予假手术组每只蒸馏水1m1/100g灌服,模型组每只予1m1/100g蒸馏水灌服,西药组每只予洛汀新0.36mg/100g混悬液灌服,健心颗粒高剂量组每只予健心颗粒4g/100g混悬液灌服,健心颗粒低剂量组每只予健心颗粒1g/100g混悬液灌服,给药6周后检测不同组的大鼠血流动力学及左室肥大指标,来比较健心颗粒与ACEI类药洛汀新对大鼠早期心衰的血流动力学及左室肥大指标的影响,并做统计学处理。
结果
1.临床观察中治疗组与对照组两组治疗前后比较,均可改善早期患者临床症状疗效(P＜0.05),左室收缩功能指标LVEF及心功能分级水平有统计学意义(P＜0.01,P＜0.05)。且其中治疗组作用更强,与对照组比较有差异(P＜0.01)。
2.动物实验健心颗粒高、低剂量组与西药组均可改善早期左心衰大鼠的血流动力学及左室肥大指标,与模型组比较均有显著差异(P＜0.01,P＜0.05)。且健心颗粒高剂量组与西药洛汀新组比较无显著差异(p＞0.05),并优于低剂量组(p＜0.05)。
结论
1.健心颗粒对于早期慢性左室心力衰竭患者有确切疗效,可以缓解各种基础疾病引起的早期左室慢性充血性心力衰竭的临床症状,且未发生毒、副作用。
2.健心颗粒可以有效改善早期左室慢性心衰患者的心功能,抑制心室重构的发展和减轻心衰症状。
3.健心颗粒改善早期左心衰大鼠的血流动力学及左室肥大指标,抑制心室重构的发展。
Objective:
Congested heart failure(CHF) has the development basic mechanism is ventricle restructuring,observe the clinical effect of the Jian xin granular(JXKL)on the heart function,the ventricle remould (VR) and the forward quality of life influence.In obtains the good clinical proof in the foundation,and further discusses the Jian xin granular through the animal experimentation to prevent and control the action mechanism which the big mouse early time heart failure.
Methods:
The clinical observation method chooses my hospital 2006 to 2007 inpatient,Altogether observes 80 examples,All case of illness conformed to《Chinese native medicine New Medicine Treatment Congested Heart failure Guiding principle》in 1995 to formulate《Congested Heart failure Diagnosis And Treatment Countermeasure》with the Chinese Cardiovascular Committee heart failure study team, In 1998 formulated《Cardiovascular Medicine Clinical test Assess -ment method Suggestion》the diagnosis standard and the heart function judgment standard and the Framingham standard drew up. Divides into the treatment group and control group each 40 examples stochastically.Two groups of sexes,the age,the course of an illness,the heart function and the foundation condition diff- erences do not have the significance significance(P＜0.05),has the commeasurability.The treatment group fades in the treatment foundation in the conventional western medicine anti-heart,adds takes with the Chinese medicine Jianxin granular;The control group only fades take the conventional western medicine anti-heart the treatment,the treatment course as half year.Observes around its treatment the heart function graduation level and the left room shoots the menstruation number,and makes statistics processing, compared with its curative effect.Around the treatment the labo -ratory inspection routine blood test,the routine urine test,the excrement convention,the hepatorenal function took the secure target,by determines the Jianxin granular whether virulent,side effect.
The animal experimentation method uses clean level SD big mouse 80,body weight 300-400g,takes 12 to counterfeit stochastically the surgery group,-odd 68 are the surgery groups.The surgery group uses the abdomen aorta to shrink the narrow technique manufacture pressure excess load early time chronic heart to fade the big mouse model and divides into the model group stochastically,the western medicine group,Jianxin granular high dose and low monitoring team. After makes the mold 6 weeks separately to give sham-operation group each distilled water 1ml/100g to i.g.,the model group each only gives the 1ml/100g distilled water to i.g.,Western medicine group give Luo ding xin suspension 1ml/100gi.g.,jianxin granular high monitoring team give jianxin granular suspension 1ml /100gi.g., jian-xin granular low monitoring team give jianxin granular sus -pension 0.25ml/100gi.g.,Examination different group of big mouse blood stream dynamics and the left room large target,observe the jianxin granular influence in the blood stream dynamics and the left room large target which fades to the big mouse early time heart, and makes statistics processing,Compared with jianxin granular and Luo Ding xin effect.
Result:
1.In around the clinical observation treatment group and the control group two groups treats compares,May improve left room contraction function target LVEF and the heart function graduation level,has statistics significance(P＜0.01,P＜0.05).Treatment group function is more remarkable,has the significance with the control group comparison difference(P＜0.05).
2.The animal experimentation jianxin granular height monitoring team and the western medicine group may improve the early heart failure big mouse's blood stream dynamics and the left room large target,has statistics significance(p＜0.01,p＜0.05).The jianxin granular high monitoring team and Luo Ding Xin compares the not remarkable difference(p＞0.05),the jianxin granular high monitoring team and the low monitoring team have the remarkable difference(p＜0.05).
Conclusions:
1.The jianxin granular has the accurate curative effect regarding the chronic heart failure patient,may alleviate the chronicity congested heart failure clinical symptom which each kind of foundation disease causes,also has not had the poison,the side effect.
2.The jianxin granular may improve the old age chronic heart failure effectively patient's heart function,suppresses development which the ventricle restructures,reduces fades careless the symptom.
3.The jianxin granular improvement early time heart failure big mouse's blood stream dynamics and the left room large target
充血性心力衰竭(cHF)发生发展的基本机制是心室重构。探讨临床上健心颗粒对早期慢性左室心力衰竭(cHF)患者证属气阴两虚,痰瘀互结型患者的心功能、心室重塑及远期生活质量的影响。在取得较好临床论证的基础上,并进一步通过动物实验探讨健心颗粒防治大鼠早期左心衰的作用机理。
方法
临床观察方法选择我院2006年至2007年中的住院病人,共观察80例,所有病例均符合中华心血管委员会心力衰竭研究组1995年制定的《充血性心力衰竭诊断和治疗对策》、《中药新药治疗充血性心力衰竭指导原则》和1998年制定的《心血管药物临床试验评价方法的建议》的诊断标准及心功能判断标准及Framingham标准拟定。将所有病例随机分为治疗组和对照组各40例。两组间性别、年龄、病程、心功能和基础病情差异均无显著性意义(P＞0.05),具有可比性。治疗组在常规西药抗心衰治疗的基础上,加用中药健心颗粒服用;对照组仅以常规西药抗心衰治疗。疗程均为半年。观察其治疗前后的临床症状疗效,心功能分级水平及左室射血分数,并做统计学处理,比较其疗效。治疗前后实验室检查血常规、尿常规、粪常规、肝肾功能及电解质作为安全性指标,以确定健心颗粒是否有毒、副作用。
动物实验方法采用清洁级sD大鼠80只,体重300-400g,随机取12只作假手术组,余68只为手术组,手术组采用腹主动脉缩窄术制作压力超负荷早期慢性左心衰大鼠模型并随机分为模型组,西药组,健心颗粒高剂量和低剂量组。假手术组仅分离出腹主动脉,不行缩窄术,其它操作均同手术组。6周后每组随机取2只共10只大鼠行预实验判断心衰模型构建成功。造模6周后分别给予假手术组每只蒸馏水1m1/100g灌服,模型组每只予1m1/100g蒸馏水灌服,西药组每只予洛汀新0.36mg/100g混悬液灌服,健心颗粒高剂量组每只予健心颗粒4g/100g混悬液灌服,健心颗粒低剂量组每只予健心颗粒1g/100g混悬液灌服,给药6周后检测不同组的大鼠血流动力学及左室肥大指标,来比较健心颗粒与ACEI类药洛汀新对大鼠早期心衰的血流动力学及左室肥大指标的影响,并做统计学处理。
结果
1.临床观察中治疗组与对照组两组治疗前后比较,均可改善早期患者临床症状疗效(P＜0.05),左室收缩功能指标LVEF及心功能分级水平有统计学意义(P＜0.01,P＜0.05)。且其中治疗组作用更强,与对照组比较有差异(P＜0.01)。
2.动物实验健心颗粒高、低剂量组与西药组均可改善早期左心衰大鼠的血流动力学及左室肥大指标,与模型组比较均有显著差异(P＜0.01,P＜0.05)。且健心颗粒高剂量组与西药洛汀新组比较无显著差异(p＞0.05),并优于低剂量组(p＜0.05)。
结论
1.健心颗粒对于早期慢性左室心力衰竭患者有确切疗效,可以缓解各种基础疾病引起的早期左室慢性充血性心力衰竭的临床症状,且未发生毒、副作用。
2.健心颗粒可以有效改善早期左室慢性心衰患者的心功能,抑制心室重构的发展和减轻心衰症状。
3.健心颗粒改善早期左心衰大鼠的血流动力学及左室肥大指标,抑制心室重构的发展。
Objective:
Congested heart failure(CHF) has the development basic mechanism is ventricle restructuring,observe the clinical effect of the Jian xin granular(JXKL)on the heart function,the ventricle remould (VR) and the forward quality of life influence.In obtains the good clinical proof in the foundation,and further discusses the Jian xin granular through the animal experimentation to prevent and control the action mechanism which the big mouse early time heart failure.
Methods:
The clinical observation method chooses my hospital 2006 to 2007 inpatient,Altogether observes 80 examples,All case of illness conformed to《Chinese native medicine New Medicine Treatment Congested Heart failure Guiding principle》in 1995 to formulate《Congested Heart failure Diagnosis And Treatment Countermeasure》with the Chinese Cardiovascular Committee heart failure study team, In 1998 formulated《Cardiovascular Medicine Clinical test Assess -ment method Suggestion》the diagnosis standard and the heart function judgment standard and the Framingham standard drew up. Divides into the treatment group and control group each 40 examples stochastically.Two groups of sexes,the age,the course of an illness,the heart function and the foundation condition diff- erences do not have the significance significance(P＜0.05),has the commeasurability.The treatment group fades in the treatment foundation in the conventional western medicine anti-heart,adds takes with the Chinese medicine Jianxin granular;The control group only fades take the conventional western medicine anti-heart the treatment,the treatment course as half year.Observes around its treatment the heart function graduation level and the left room shoots the menstruation number,and makes statistics processing, compared with its curative effect.Around the treatment the labo -ratory inspection routine blood test,the routine urine test,the excrement convention,the hepatorenal function took the secure target,by determines the Jianxin granular whether virulent,side effect.
The animal experimentation method uses clean level SD big mouse 80,body weight 300-400g,takes 12 to counterfeit stochastically the surgery group,-odd 68 are the surgery groups.The surgery group uses the abdomen aorta to shrink the narrow technique manufacture pressure excess load early time chronic heart to fade the big mouse model and divides into the model group stochastically,the western medicine group,Jianxin granular high dose and low monitoring team. After makes the mold 6 weeks separately to give sham-operation group each distilled water 1ml/100g to i.g.,the model group each only gives the 1ml/100g distilled water to i.g.,Western medicine group give Luo ding xin suspension 1ml/100gi.g.,jianxin granular high monitoring team give jianxin granular suspension 1ml /100gi.g., jian-xin granular low monitoring team give jianxin granular sus -pension 0.25ml/100gi.g.,Examination different group of big mouse blood stream dynamics and the left room large target,observe the jianxin granular influence in the blood stream dynamics and the left room large target which fades to the big mouse early time heart, and makes statistics processing,Compared with jianxin granular and Luo Ding xin effect.
Result:
1.In around the clinical observation treatment group and the control group two groups treats compares,May improve left room contraction function target LVEF and the heart function graduation level,has statistics significance(P＜0.01,P＜0.05).Treatment group function is more remarkable,has the significance with the control group comparison difference(P＜0.05).
2.The animal experimentation jianxin granular height monitoring team and the western medicine group may improve the early heart failure big mouse's blood stream dynamics and the left room large target,has statistics significance(p＜0.01,p＜0.05).The jianxin granular high monitoring team and Luo Ding Xin compares the not remarkable difference(p＞0.05),the jianxin granular high monitoring team and the low monitoring team have the remarkable difference(p＜0.05).
Conclusions:
1.The jianxin granular has the accurate curative effect regarding the chronic heart failure patient,may alleviate the chronicity congested heart failure clinical symptom which each kind of foundation disease causes,also has not had the poison,the side effect.
2.The jianxin granular may improve the old age chronic heart failure effectively patient's heart function,suppresses development which the ventricle restructures,reduces fades careless the symptom.
3.The jianxin granular improvement early time heart failure big mouse's blood stream dynamics and the left room large target
引文
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