李可老中医“破格救心汤”治疗充血性心力衰竭的临床研究
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摘要
背景：
破格救心汤是山西名中医李可先生救治心力衰竭的经验方。经临床初步验证,该方对救治急危重心衰有效,其临床疗效、远期预后、用药安全,处方加减均缺乏科学依据,阻碍了该方在危重症领域的推广和应用。
目的：
1.本课题在常规抗心衰治疗基础上,运用李可老中医经验方“破格救心汤”治疗心力衰竭(心功能Ⅲ-Ⅳ级)患者,观察其临床疗效及远期预后,评估其实用性。
2.对“破格救心汤”运用超常规剂量的毒性药物进行安全性观察和评估。
3.了解并证实“破格救心汤”加减与合方的科学性。
方法：
1.本研究属前瞻性、同期、开放、非随机对照试验,选择54例符合入选标准的心力衰竭患者(心功能Ⅲ-Ⅳ级),分别进入治疗组或对照组,对照组给予常规抗心衰治疗治疗组在此基础上加用破格救心汤治疗,观察2-3周,随访6个月,治疗前后记录主要症状变化,评估心功能分级、Lee氏心衰计分、中医证候评分,复查BNP,记录不良事件,随访复发再入院率和生存曲线分析。
2.进行破格救心汤急性毒性实验,获取实验安全性数据：同时记录入选心衰患者每日运用毒性药物的剂量,采集治疗后安全性数据,与治疗前对比,对破格救心汤临床用药的安全性加以评估。
3.采用数据挖掘方法分析运用破格救心汤前后的临床症状变化,分析其加减与合方规律。
结果：
1.临床实用性方面,“破格救心方”治疗组住院次日中医证候总分(P<0.01)、六个月随访复发再入院率(P<0.049)、复发住院次数(P<0.01)等方面明显优于常规治疗组。
2.实验安全性方面,破格救心汤急性毒性实验小鼠一天所服用的破格救心汤量约相当于50kg体重人一天用量的75倍。实验结果：除了两例因灌胃不慎致食管穿孔而死亡外,试验组小鼠无死亡,无明显不良反应。
3.临床安全性方面,运用超常规毒性药物的心力衰竭患者在治疗过程中未出现中毒表现,治疗后复查血常规、肝肾功能无异常,治疗全程无异常心电波动,未出现严重不良反应。
4.用药科学性方面,证实在破格救心汤基础上,合用三生饮、真武汤可进一步改善气促症状,合用三潜、肾四味、乌梅、引火汤或熟地对神疲、纳差、眠差等症状有明显改善。
结论：
1.“破格救心汤”治疗严重心力衰竭确切有效,远期预后良好;
2.在辨病辨证的前提下,运用超常规剂量毒性药物的“破格救心汤”具有良好的安全性。
3.“破格救心汤”的加减合方原则遵循“扶正”“祛邪”的规律,具有相当的科学性。
4.本研究为中医药治疗严重心力衰竭作出有益的探讨,为中医在急危重症领域的开拓打下了扎实的基础。
Background
Shanxi Chinese medicine (CM) practitioner, Dr. Li Ke created the decoction Po Ge Jiu Xin Decoction. The formula has rescued more than1,000patients from heart failure. While preliminary clinical observation of the decoction in the treatment of critically ill patients with heart failure shows promising results, there is a lack of objective, evidence based research to support the claims, confirm prognosis, assure its safety and support the modifications of the prescription when used as an intervention in the field of critical care.
Objectives
1. Observation and evaluation of short-term and long-term clinical efficacy in patients with chronic cardiac insufficiency (heart function grade Ⅲ-Ⅳ) patients using biomedicine diagnosis and treatment according to clinical guidelines for heart failure treatment with the additional treatment, of taking Po Ge Jiu Xin Decoction.
2. Po Ge Jiu Xin Decoction, contains a large dose of toxic drugs, therefore it is necessary to evaluate the safety of the drug.
3. Observe the use and results of Po Ge Jiu Xin Decoction and its modifications in order to provide an objective basis for its CM pattern differentiation application.
Methods
1.This is a pioneering study. Over the same time period, using an open, non-randomized controlled trial design,54subjects who met the inclusion criteria (all patients in-hospital) were selected who were experiencing an acute exacerbation of their chronic heart failure condition. They were divided into the treatment group or the control group. The control group was given standard conventional therapy; the treatment group was given Po Ge Jiu Xin Decoction in addition to standard conventional therapy; continuous interviews were conducted for6months prior to and following treatment recording cardiac-function grading, Lee's cardiac risk index, BNP scoring, the main symptoms and signs in CM, CM pattern differentiation scoring, occurrence and recurrence of adverse events and mortality rates for statistical analysis were taken.
2. Acute toxicity test was done to obtain the experimental safety data; collection of daily toxic drugs doses, safety information data and assess the drug safety for patients with heart failure given Po Ge Jiu Xin Decoction was conducted.
3. Data mining methods were used to analyze the effect of Po Ge Jiu Xin Decoction and its modifications based on the observation of clinical signs before and after its application.
Results
1. Our clinical research shows that there is a significant difference in the CM pattern differentiation score on the day following treatment (p<0.01), the six-month follow-up relapse rate (P<0.049), relapses (p<0.01), patients treated with Po Ge Jiu Xin Decoction is superior to the conventional therapy group.
2. The mice were given a daily dosage of Po Ge Jiu Xin Decoction equivalent to about75times that of a50kg human weight dosage in an acute toxicity test. Experimental results:while two mice died due to incorrect gavaging causing esophageal perforation, none of the mice in the test group died or showed nor did they show any significant adverse reactions.
3. Blood test results showed that in the34cases taking Po Ge Jiu Xin Decoction liver and kidney function were normal, no abnormal ECG fluctuations and no significant adverse events occurred.
4. Observation of modifications made to Po Ge Jiu Xin Decoction showed that combining it with San Sheng Yin, Zhen Wu Tang further improve shortness of breath symptoms; combination with3qian (9g) of Sheng Si Wei, ebony, Yin Huo Tang or Rehmannia significantly improved fatigue, anorexia and insomnia.
Conclusion
1. In serious heart failure, Po Ge Jiu Xin Decoction is efficactive and provides good long-term prognosis;
2. Po Ge Jiu Xin Decoction is safe if decocted using the standardized decoction process.
3. Po Ge Jiu Xin Decoction and its modifications follow the principle of "supporting the healthy qi and dispelling the pathogenic qi "
4. In this study, a unique and important exploration into the use of CM treatment for acute exacerbation of congestive heart failure was made. It has laid a good foundation for the use of CM in the field of intensive care medicine.
破格救心汤是山西名中医李可先生救治心力衰竭的经验方。经临床初步验证,该方对救治急危重心衰有效,其临床疗效、远期预后、用药安全,处方加减均缺乏科学依据,阻碍了该方在危重症领域的推广和应用。
目的：
1.本课题在常规抗心衰治疗基础上,运用李可老中医经验方“破格救心汤”治疗心力衰竭(心功能Ⅲ-Ⅳ级)患者,观察其临床疗效及远期预后,评估其实用性。
2.对“破格救心汤”运用超常规剂量的毒性药物进行安全性观察和评估。
3.了解并证实“破格救心汤”加减与合方的科学性。
方法：
1.本研究属前瞻性、同期、开放、非随机对照试验,选择54例符合入选标准的心力衰竭患者(心功能Ⅲ-Ⅳ级),分别进入治疗组或对照组,对照组给予常规抗心衰治疗治疗组在此基础上加用破格救心汤治疗,观察2-3周,随访6个月,治疗前后记录主要症状变化,评估心功能分级、Lee氏心衰计分、中医证候评分,复查BNP,记录不良事件,随访复发再入院率和生存曲线分析。
2.进行破格救心汤急性毒性实验,获取实验安全性数据：同时记录入选心衰患者每日运用毒性药物的剂量,采集治疗后安全性数据,与治疗前对比,对破格救心汤临床用药的安全性加以评估。
3.采用数据挖掘方法分析运用破格救心汤前后的临床症状变化,分析其加减与合方规律。
结果：
1.临床实用性方面,“破格救心方”治疗组住院次日中医证候总分(P<0.01)、六个月随访复发再入院率(P<0.049)、复发住院次数(P<0.01)等方面明显优于常规治疗组。
2.实验安全性方面,破格救心汤急性毒性实验小鼠一天所服用的破格救心汤量约相当于50kg体重人一天用量的75倍。实验结果：除了两例因灌胃不慎致食管穿孔而死亡外,试验组小鼠无死亡,无明显不良反应。
3.临床安全性方面,运用超常规毒性药物的心力衰竭患者在治疗过程中未出现中毒表现,治疗后复查血常规、肝肾功能无异常,治疗全程无异常心电波动,未出现严重不良反应。
4.用药科学性方面,证实在破格救心汤基础上,合用三生饮、真武汤可进一步改善气促症状,合用三潜、肾四味、乌梅、引火汤或熟地对神疲、纳差、眠差等症状有明显改善。
结论：
1.“破格救心汤”治疗严重心力衰竭确切有效,远期预后良好;
2.在辨病辨证的前提下,运用超常规剂量毒性药物的“破格救心汤”具有良好的安全性。
3.“破格救心汤”的加减合方原则遵循“扶正”“祛邪”的规律,具有相当的科学性。
4.本研究为中医药治疗严重心力衰竭作出有益的探讨,为中医在急危重症领域的开拓打下了扎实的基础。
Background
Shanxi Chinese medicine (CM) practitioner, Dr. Li Ke created the decoction Po Ge Jiu Xin Decoction. The formula has rescued more than1,000patients from heart failure. While preliminary clinical observation of the decoction in the treatment of critically ill patients with heart failure shows promising results, there is a lack of objective, evidence based research to support the claims, confirm prognosis, assure its safety and support the modifications of the prescription when used as an intervention in the field of critical care.
Objectives
1. Observation and evaluation of short-term and long-term clinical efficacy in patients with chronic cardiac insufficiency (heart function grade Ⅲ-Ⅳ) patients using biomedicine diagnosis and treatment according to clinical guidelines for heart failure treatment with the additional treatment, of taking Po Ge Jiu Xin Decoction.
2. Po Ge Jiu Xin Decoction, contains a large dose of toxic drugs, therefore it is necessary to evaluate the safety of the drug.
3. Observe the use and results of Po Ge Jiu Xin Decoction and its modifications in order to provide an objective basis for its CM pattern differentiation application.
Methods
1.This is a pioneering study. Over the same time period, using an open, non-randomized controlled trial design,54subjects who met the inclusion criteria (all patients in-hospital) were selected who were experiencing an acute exacerbation of their chronic heart failure condition. They were divided into the treatment group or the control group. The control group was given standard conventional therapy; the treatment group was given Po Ge Jiu Xin Decoction in addition to standard conventional therapy; continuous interviews were conducted for6months prior to and following treatment recording cardiac-function grading, Lee's cardiac risk index, BNP scoring, the main symptoms and signs in CM, CM pattern differentiation scoring, occurrence and recurrence of adverse events and mortality rates for statistical analysis were taken.
2. Acute toxicity test was done to obtain the experimental safety data; collection of daily toxic drugs doses, safety information data and assess the drug safety for patients with heart failure given Po Ge Jiu Xin Decoction was conducted.
3. Data mining methods were used to analyze the effect of Po Ge Jiu Xin Decoction and its modifications based on the observation of clinical signs before and after its application.
Results
1. Our clinical research shows that there is a significant difference in the CM pattern differentiation score on the day following treatment (p<0.01), the six-month follow-up relapse rate (P<0.049), relapses (p<0.01), patients treated with Po Ge Jiu Xin Decoction is superior to the conventional therapy group.
2. The mice were given a daily dosage of Po Ge Jiu Xin Decoction equivalent to about75times that of a50kg human weight dosage in an acute toxicity test. Experimental results:while two mice died due to incorrect gavaging causing esophageal perforation, none of the mice in the test group died or showed nor did they show any significant adverse reactions.
3. Blood test results showed that in the34cases taking Po Ge Jiu Xin Decoction liver and kidney function were normal, no abnormal ECG fluctuations and no significant adverse events occurred.
4. Observation of modifications made to Po Ge Jiu Xin Decoction showed that combining it with San Sheng Yin, Zhen Wu Tang further improve shortness of breath symptoms; combination with3qian (9g) of Sheng Si Wei, ebony, Yin Huo Tang or Rehmannia significantly improved fatigue, anorexia and insomnia.
Conclusion
1. In serious heart failure, Po Ge Jiu Xin Decoction is efficactive and provides good long-term prognosis;
2. Po Ge Jiu Xin Decoction is safe if decocted using the standardized decoction process.
3. Po Ge Jiu Xin Decoction and its modifications follow the principle of "supporting the healthy qi and dispelling the pathogenic qi "
4. In this study, a unique and important exploration into the use of CM treatment for acute exacerbation of congestive heart failure was made. It has laid a good foundation for the use of CM in the field of intensive care medicine.
引文
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