摘要
1研究背景
近年来,医疗费用不断上涨,“看病难、看病贵”问题日益成为社会各界和人民群众普遍关注的热点问题。为促进此问题的解决,卫生部、国家中医药管理局提出要制定实施临床路径规范管理的要求。然而临床路径在国际上主要使用在西医医院中规范西医诊疗服务,要在中医或中西医结合医院推行此种管理模式规范中医或中西结合服务,还是一种新的尝试。因此,广东省中医院受国家中医药管理局的委托,自2007年开始成立“基于糖尿病周围神经病变等7个单病种中医最佳诊疗方案的临床路径共性技术研究”专项,探索中医或中西医结合临床路径的制定与实施问题。
在上述背景下,本研究重点探索慢性心力衰竭中西医结合临床路径的构建与实施问题。文章先从临床路径概念与发展状况、中医临床路径现状、慢性心力衰竭临床路径简介、中医药诊治慢性心力衰竭现状及慢性心力衰竭中西医结合临床路径的必要性等综述入手,接着介绍了基于循证医学的中西医结合临床路径的构建,其中重点阐释慢性心力衰竭中医诊疗方案的优化；此外,收集该路径在广东省中医院进行临床试验的相关数据进行分析,初步评价该路径的执行效果。
2研究目的
2.1根据临床路径构建的原则与方法,构建证据充分、共识度高、推广性强的中西医诊疗方案,为临床路径的构建提供核心内容。
2.2采用前瞻对照试验,对慢性心力衰竭中西医结合临床路径的实施效果进行初步评价,为进一步完善临床路径提供依据。
3研究内容与方法
3.1慢性心力衰竭中西医结合临床路径构建过程
3.1.1慢性心力衰竭中医诊疗方案的构建过程
3.1.1.1古文献证据调研结果
心衰病因学说主要有“邪痹心脉学说”、“情志内伤学说”、“水饮凌心学说”、“虚损学说”,病机概括起来则有“心脉痹阻学说”、“阳虚水泛学说”及“脏腑失常学说”。据此,心衰的常见治法有“补益心气”、“温振阳气”、“补阴”、“治水气”、“祛瘀血”、“化痰饮”等。至于具体方药,我们选择了真武汤、生脉散、葶苈大枣泻肺汤、五苓散、人参养荣汤及苓桂术甘汤等；单方有补坎益离丹、疏凿饮子、导水茯苓汤等。
3.1.1.2现代文献调研
文献分析发现：中医病名可统一为心衰病,对病机的认识比较一致的是气虚阳虚为本,水饮、痰浊、瘀血为标,病位以心为主,并涉及肺脾肾等其他脏器,证属本虚标实,气虚、阳虚、阴虚为本,水饮、痰浊、瘀血为标。
从证候的发展演变来看,心气虚、心阳虚是心衰的发病基础,可涉及阴伤,瘀血水停是病程中必然出现的病理状态,水肿是最终结果,气血水相互为病,而气虚血瘀是贯穿心衰发生发展的始终。
治则治法方面,补虚重在益气温阳,驱邪重在活血化瘀,化痰利水,其中益气温阳、活血利水是心衰的关键,但需要兼顾养阴,而益气活血之法应贯穿始终。
多个随机对照临床试验表明：益气活血利水、益气温阳活血利水、益气活血、益气温阳活血、益气养阴等治法治疗心衰有效。真武汤、生脉散等中药汤剂,参附注射液、参麦注射液、生脉注射液、黄芪注射液等中药注射液,芪苈强心胶囊,暖心胶囊、补心气口服液等中成药,对于慢性心衰有较好效果。
具体用药上,文献报道亦多为温阳益气活血利水之类,益气多选黄芪、人参、党参、红参、白术、山萸肉、五味子、大枣等,温阳常用黑附子、桂枝、肉桂、干姜、补骨脂、鹿角霜、仙灵脾等,活血化瘀可选水蛭、当归、川芎、赤芍、桃仁、红花、三七,益母草、牛膝、琥珀、酒大黄等,利水可选葶苈子、车前子、五加皮、桑白皮、茯苓、泽泻、猪苓、瓜蒌、细辛、枳壳、半夏、椒目等。一些文献认为,中医药在治疗慢性心力衰竭合并症或并发症如肺部感染、心律失常、利尿剂抵抗、低血压状态及洋地黄中毒等情况有一定优势,但文献报道数量较少。3.1.1.3名老中医经验
名老中医均认为心衰多属本虚标实,本虚以气虚、阳虚为主；标实以瘀血、水饮、痰浊居多。本虚(心阳气亏虚)是心衰发病的关键,以气虚、阳虚为主。标实乃因本虚所致,主要表现为血瘀、水停及水邪上泛、痰浊。急性发作期是在气虚、阳虚基础上偏于标实(水饮、瘀血、痰浊),缓解期偏于本虚(气虚、阳虚、阴虚)。治疗益气温阳、活血利水是心衰的重要治则,同时需要兼顾养阴。到具体的方药落实上,我们通过了专家共识的方法解决。
3.1.1.4专家咨询研究结果
通过专家咨询,确定了中西医诊断的依据,并将心衰病名统一为“心衰病”。
多数专家认为心衰基本病机为本虚标实,本虚为气虚、阳虚、阴虚,标实为水饮、瘀血、痰浊。分为急性加重期和稳定期两个阶段进行中医辨证,急性加重期本虚为阳虚、气虚,标实为水饮、瘀血、痰浊；稳定期本虚为气虚、阳虚、阴虚,标实为瘀血。
急性加重期辨证分为“气虚血瘀水停”、“阳虚水泛,瘀血阻络”2个证型,稳定期辨证分为“气虚血瘀”、“气阴两虚血瘀”、“气阳两虚血瘀”3个证型,并确立了各证型的主症、次症、舌脉以及治法、方剂、中药、中成药。其中气虚血瘀水停证型选择五苓散合桃红饮加减,阳虚水泛、瘀血阻络型选择真武汤合葶苈大枣泻肺汤加减,气虚血瘀型选择人参养荣汤合桃红四物汤加减,气阴两虚血瘀型选择生脉散合血府逐瘀汤加减,气阳两虚血瘀型选择参附汤合血府逐瘀汤加减。
在慢性心力衰竭常见并发症与合并症治疗方面,专家认为合并肺部感染可加化痰药物；合并洋地黄中毒出现胃肠道症状时,加用降气止逆类中药；合并非致命性心律失常时,快速性心律失常加养阴镇静药物,缓慢性心律失常加温阳药物；合并利尿剂抵抗时,以阳虚水泛、瘀血内停较为常见,加用温阳活血利水药物；合并低血压状态,以阳气虚脱较为常见,加温阳益气固脱药物。
3.1.2在优化的中医诊疗方案的基础上构建临床路径
在慢性心力衰竭专业小组全体成员努力下,在病例回顾性调研的基础上,确定了路径各时段的管理,明确路径目标人群、纳入标准、排除标准及退出标准,并通过专家共识制定出院标准与路径流程图,最后制定相应的临床观察表单,初步完成慢性心力衰竭中西医结合临床路径的构建。
4研究结果
4.1慢性心力衰竭中西医结合临床路径构建过程
4.1.1慢性心力衰竭中医诊疗方案的构建过程
4.1.1.1古文献证据调研结果
心衰病因学说主要有“邪痹心脉学说”、“情志内伤学说”、“水饮凌心学说”、“虚损学说”,病机概括起来则有“心脉痹阻学说”、“阳虚水泛学说”及“脏腑失常学说”。据此,心衰的常见治法有“补益心气”、“温振阳气”、“补阴”、“治水气”、“祛瘀血”、“化痰饮”等。至于具体方药,我们选择了真武汤、生脉散、葶苈大枣泻肺汤、五苓散、人参养荣汤及苓桂术甘汤等；单方有补坎益离丹、疏凿饮子、导水茯苓汤等。
4.1.1.2现代文献调研
文献分析发现：中医病名可统一为心衰病,对病机的认识比较一致的是气虚阳虚为本,水饮、痰浊、瘀血为标,病位以心为主,并涉及肺脾肾等其他脏器,证属本虚标实,气虚、阳虚、阴虚为本,水饮、痰浊、瘀血为标。
从证候的发展演变来看,心气虚、心阳虚是心衰的发病基础,可涉及阴伤,瘀血水停是病程中必然出现的病理状态,水肿是最终结果,气血水相互为病。而气虚血瘀是贯穿心衰发生发展的始终。
治则治法方面,补虚重在益气温阳,驱邪重在活血化瘀,化痰利水,其中益气温阳、活血利水是心衰的关键,但需要兼顾养阴,而益气活血之法应贯穿始终。
多个随机对照临床试验表明：益气活血利水、益气温阳活血利水、益气活血、益气温阳活血、益气养阴等治法治疗心衰有效。真武汤、生脉散等中药汤剂,参附注射液、参麦注射液、生脉注射液、黄芪注射液等中药注射液,芪苈强心胶囊,暖心胶囊、补心气口服液等中成药,对于慢性心衰有较好效果。
具体用药上,文献报道亦多为温阳益气活血利水之类,益气多选黄芪、人参、党参、红参、白术、山萸肉、五味子、大枣等,温阳常用黑附子、桂枝、肉桂、干姜、补骨脂、鹿角霜、仙灵脾等,活血化瘀可选水蛭、当归、川芎、赤芍、桃仁、红花、三七,益母草、牛膝、琥珀、酒大黄等,利水可选葶苈子、车前子、五加皮、桑白皮、茯苓、泽泻、猪苓、瓜蒌、细辛、枳壳、半夏、椒目等。
一些文献认为,中医药在治疗慢性心力衰竭合并症或并发症如肺部感染、心律失常、利尿剂抵抗、低血压状态及洋地黄中毒等情况有一定优势,但文献报道质量较少。
4.1.1.3名老中医经验
名老中医均认为心衰多属本虚标实,本虚以气虚、阳虚为主；标实以瘀血、水饮、痰浊居多。本虚(心阳气亏虚)是心衰发病的关键,以气虚、阳虚为主。标实乃因本虚所致,主要表现为血瘀、水停及水邪上泛、痰浊。急性发作期是在气虚、阳虚基础上偏于标实(水饮、瘀血、痰浊),缓解期偏于本虚(气虚、阳虚、阴虚)。治疗益气温阳、活血利水是心衰的重要治则,同时需要兼顾养阴。到具体的方药落实上,我们通过了专家共识的方法解决。
4.1.1.4专家咨询研究结果
通过专家咨询,确定了中西医诊断的依据,并将心衰病名统一为“心衰病”。
多数专家认为心衰基本病机为本虚标实,本虚为气虚、阳虚、阴虚,标实为水饮、瘀血、痰浊。分为急性加重期和稳定期两个阶段进行中医辨证,急性加重期本虚为阳虚、气虚,标实为水饮、瘀血、痰浊；稳定期本虚为气虚、阳虚、阴虚,标实为瘀血。
急性加重期辨证分为“气虚血瘀水停”、“阳虚水泛,瘀血阻络”2个证型,稳定期辨证分为“气虚血瘀”、“气阴两虚血瘀”、“气阳两虚血瘀”3个证型,并确立了各证型的主症、次症、舌脉以及治法、方剂、中药、中成药。其中气虚血瘀水停证型选择五苓散合桃红饮加减,阳虚水泛、瘀血阻络型选择真武汤合葶苈大枣泻肺汤加减,气虚血瘀型选择人参养荣汤合桃红四物汤加减,气阴两虚血瘀型选择生脉散合血府逐瘀汤加减,气阳两虚血瘀型选择参附汤合血府逐瘀汤加减。
在慢性心力衰竭常见并发症与合并症治疗方面,专家认为合并肺部感染可加化痰药物；合并洋地黄中毒出现胃肠道症状时,加用降气止逆类中药；合并非致命性心律失常时,快速性心律失常加养阴镇静药物,缓慢性心律失常加温阳药物；合并利尿剂抵抗时,以阳虚水泛、瘀血内停较为常见,加用温阳活血利水药物；合并低血压状态,以阳气虚脱较为常见,加温阳益气固脱药物。
4.1.2在优化的中医诊疗方案的基础上构建临床路径
在慢性心力衰竭专业小组全体成员努力下,在病例回顾性调研的基础上,确定了路径各时段的管理,明确路径目标人群、纳入标准、排除标准及退出标准,并通过专家共识制定出院标准与路径流程图,最后制定相应的临床观察表单,初步完成慢性心力衰竭中西医结合临床路径的构建。
4.2慢性心力衰竭中西医结合临床路径实施结果评价
4.2.1路径组平均住院天数与住院天数中值均低于常规组(11.19d vs 13.21d;11.00dvs 12.00d),两组住院天数比较差异有统计学意义(P<0.05)。路径组平均住院总费用与住院总费用中值均低于常规组(￥8656.8 vs￥11609.7;￥7556.9 vs￥9853.9),两组住院总费用比较差异有显著性统计学意义(P<0.01)进一步对住院费用主要项目进行比较,发现其中患者床位费、西药费、检查费与放射费等项目差异有统计学意义(P<0.05),路径组较常规组明显下降；而中成药费、中草药费、治疗费与化验费组间比较差异无统计学意义(P>0.05),说明路径组在这些项目上的费用并未下降。
4.2.2路径组与常规组心功能疗效比较差异有统计学意义(P<0.05),路径组显效率高于常规组(49.3%vs 38.3%),而有效率与无效率均低于常规组(50%vs 59.6%；0.7%vs 2.1%),提示两组经治疗后心功能改善明显,而路径组心功能疗效较常规组更优。此外,无论路径组还是常规组,收缩压、舒张压及心率比较出院与入院比较差异均有显著的统计学意义(P<0.01),路径组出院时收缩压、舒张压及心率均较入院时下降,并且处于相对平稳状态,常规组亦有类似结果。而出院时路径组与常规组收缩压、舒张压及心率组间比较差异均无统计学意义(P>0.05)。
路径组与常规组心衰中医证候总疗效比较,差异无统计学意义(P>0.05)。进一步对两组主要症状疗效情况进行比较,结果两组间在形寒肢冷与小便短少两项比较差异具有显著的统计学意义(P<0.01),路径组优于常规组。
4.2.3从患者满意度调查表结果来看,无论路径组还是常规组,几乎很少有病人觉得不满意或很不满意。
患者对诊疗过程的满意度相关详细项目比较中,仅指导服药方法组间比较差异无统计学意义(P>0.05),其余七项满意度组间比较差异均有统计学意义(P<0.05),患者对诊疗过程的满意度路径组高于常规组。对等候时间的满意度进行比较,结果除出院等候时间两组比较差异无统计学意义外(P>0.05),患者对接待时间、候诊时间和检查时间满意度比较差异均有统计学意义(P<0.01),路径组满意度高于常规组。在服务态度满意度比较上,路径组与常规组除临床医生态度满意度差异有统计学意义外(P<0.01),其余如护士态度、护工态度及检查医生态度的满意度比较差异无统计学意义(P>0.05)。整体满意情况比较差异具有显著性的统计学意义(P<0.01),路径组整体满意度高于常规组。再对满意度进行积分转化,比较各项满意度评分,结果显示除服务态度满意度积分两组之间比较无差异外,医疗过程、等候时间、整体满意度等三项组间比较差异均有显著的统计学意义(P<0.01),路径组满意度均高于常规组。
4.2.4出院后三个月内两组死亡率无统计学意义(P>0.05),两组三个月内因心衰发作再次入院率比较差异无统计学意义(P>0.05),两组出院后生活质量(采用明尼苏达心衰生活质量量表评分)比较差异无统计学意义(P>0.05),无论路径组还是常规组,出院后3个月与刚入院时生存质量比较差异均有统计学意义(P<0.05)
4.2.5对临床路径执行情况进行初步分析发现,入院第1天时,除动态心电图外,其他各项检查执行度基本上都接近或超过90%,总体而言执行力度尚较理想。具体药物使用上,口服利尿剂的使用率最高,使用率超过95%,静脉利尿剂使用率随着住院时间延长而减少；β受体阻滞剂的使用率随着住院时间的延长而有所增高,总使用率为79.4%；ACEI或ARB类药物各阶段使用率均超过80%,总使用率为89.7%；醛固酮受体阻滞剂总使用率为76.5%；地高辛使用率为50-60%；扩血管药物使用率最低,且随着住院时间的延长,使用率有所下降。各阶段中成药使用率均为90%左右,活血类中成药(静脉)使用率最高,其次为益气类(静脉),最后为温阳类中成药(静脉),至稳定期时基本上将静脉中成药改为口服中成药。
路径组与常规组三大常规、电解质、心电图、凝血、BNP等检查应用情况比较差异无统计学意义(P>0.05),胸片、心脏彩超、动态心电图等检查应用情况比较差异有统计学意义(P<0.05),路径组使用率高于常规组,提示路径组在患者入院第1天对其心脏情况评估积极性更高。
具体药物比较发现,路径组与常规组ACEI/ARB、地高辛、醛固酮受体阻滞剂与扩血管药物使用情况比较差异有统计学意义(P<0.05),路径组ACEI/ARB使用率高于常规组,而地高辛、醛固酮受体阻滞剂与扩血管药物等药物使用率低于常规组,利尿剂与β受体阻滞剂使用情况比较差异无统计学意义(P>0.05)。4.2.6为进一步完善路径,对路径实施过程中出现的变异进行初步分析。结果总变异频数为649,变异的最主要原因来自CHF病情的复杂性。其中病人病情所致变异高达392次,因急诊室先行诊治所致变异频数共94次,医护人员所致的变异频数共38次。
排除退出路径变异后,进一步对各阶段主要变异因素进行归类分析,发现患者入院第1天变异频数最高(261),其次为第4-7天(135),接着为第2-3天(94)、第8-13天(85),变异频数出现最少时间为第14天(59)。各阶段中,疾病原因所占频数均最高,其次为病人因素,医务人员因素,其他因素主要为急诊住院,仅出现在入院第1天。
对患者变异性质按正性、负性与不确定进行归类,对住院时间而言,不确定性变异比例最高,达313次,占49.4%,负性变异达171次,占26.9%,正性变异达150次,占23.7%。
对住院费用而言,不确定性变异比例最少,达84次,占13.2%,负性变异最高,达387次,占61.0%,正性变异达163,占44.8%。
将变异按可控、难控及不确定进行分类,结果发现可控变异频数为144次,占变异总频数的22.7%；不可控变异频数为423次,占变异总频数的66.7%；不确定变异为67次,占变异总频数的10.6%。
5研究结论
5.1慢性心力衰竭中西医结合临床路径构建的关键与难点是中医诊疗方案。本研究通过古代文献整理、现代文献梳理、名老中医经验总结及专家咨询研究,初步确定了慢性心力衰竭中医诊疗方案。该方案主要包括CHF中医综合疗法、常见并发症与合并症的中医治疗两部分。中医综合疗法主要包括辨证中药汤剂口服、中成药、中医特色疗法。初步确定了CHF分期管理的诊疗模式、不同辨证分型的诊断、治法以及相应的口服中药汤剂的基本选方用药、常见静脉中药制剂与口服中成药及中医特色疗法。此外,还确立了慢性心力衰竭常见并发症与合并症的中医诊疗措施。
5.2在优化方案的基础上,结合我院回顾性研究及国家卫生部发布的路径表单格式,制定路径目标人群,纳入、排除与退出路径的标准,路径总时限,路径实施流程。同时,通过专家咨询,制定了CHF患者的出院标准。最后完成临床路径病例观察表单的设计。
5.3实施临床路径,规范了我们的住院管理流程,使住院时间缩短,住院费用降低,同时明显改善患者临床症状与心功能,保证了医疗质量,提高患者满意度。
5.4由于CHF的复杂性,路径在实施过程中存在非常多的变异,其中大部分属于难控性变异,且趋向于延长住院时间和增加住院费用。总体而言,参与本研究的医护人员执行本路径的力度尚较为理想。
1 Backgroud
In recent years, the government of different countries and people pay more attention to the problems of excessive health care cost caused by the increasing consumption of health care resources.To solve this problem, the State Administration of Chinese Medicine proposed to establish and carry out clinical pathway. However, CP is mainly used at hospitals of western medicine to standize western medical service, so it is a new try for using CP as one management at Chinese medicine hospitals or integrated hospitals to standize medical service. Therefore, Guangdong hospital of TCM, commissioned by the State Administration of Chinese Medicine, has began the program of "CP commonnessly technological research based on diabetic neuropathy of seven single diseases for the best Chinese diagnosis and treatment scheme", in order to explore Chinese or integrated CP on establishment and implementation.
On the base of what has stated above,this research emphasize on the implementation and formulation of Clinical Pathway with integrated traditional and western medicine on chronic heart failure diagnosis scheme. It analized definition and developing history, situation of chinese clinical pathway, brief introduction of CHF CP, Chinese medicine for treating CHF and essentiality of integrated CHF CP, to introduce a formulation of evidence-based Chinese clinical pathway, state optimization for CHF diagnosis scheme; further to collect the relevant datas for analysis which was from the 2rd affiliated hospital of Guangzhou University TCM by using CHF CP for clinical trial, in order to evaluate execution effect.
2 Objective
2.1 According to the scientific principle and methods of clinical pathway construction to initially form a TCM therapy with sufficient evidence, high degree of consensus, and powerful generalization, for providing the core content of clinical pathway.
2.2 By prospective study to initially evaluate the implementation effect of CHF CP with integrated traditional and western medicine, to provide basis for further optimization of clinical pathway.
3 Research content and methods
This research was divided into two parts. The first part of the research focused on optimization of chronic heart failure of TCM treatment scheme, on order to initially form a TCM therapy with sufficient evidence, high degree of consensus, and powerful generalization. The second part was to observe the formed CHF CP with integrated traditional and western medicine by collecting all observed cases datas, then make comparison with the non-observered ones.
3.1 Constructing of CHF combined traditional Chinese and western medicine clinical pathway.
As the CHF western medicine diagnosis scheme had sufficient literature foundation at present, the core was how to strictly carry out the guides, optimize the procesure, use all effective treatment on the CP. So the key point and difficulty was to establish the CHF Chinese medicine diagnosis and treatment scheme.
3.1.1 For the CHF Chinese medicine diagnosis scheme, the key point was differentiation, treatment, formula, herbs, commonly used Chinese patent medicine and treatment for complication by Chinese medicine. Therefore, based on built-in Chinese diagnosis and treatment routin and retrospective investigation of CHF cases, we collected evidence, evaluated literature, sorted doctors'experience, experts'consensus to form optimized CHF Chinese diagnosis scheme. The process was simple introduced as following:
3.1.1.1 Research on ancient literature
Ancient literature search was Chinese medical books, preliminary searching 207 books and 722 relevant articles. Save the documents completely as possible, establish database, and choose the most universal documents to make summary.
3.1.1.2 Research on modern literature
We explored Chinese literature from 1999 to 2009, using CBM database and VIP database, and English literature from 2004 to 2009, using pubmed database. By filling in registration document, constructing the document database, we analyzed and summarized the content of literature using content analysis.
3.1.1.3 Reseach on veteran doctors'experience of TCM
We chose 10 veteran doctors of TCM in modern times, who had higher prestige and more discussion in treating CHF, and summarized the experience by common strategies.
3.1.1.4 In expert consultation
We consulted twenty experts'advice for diagnosis and treatment with low degree of consensus, no sufficient evidence to support. We formed the consulting questionnaire, using written form of counseling. After two rounds of consulting, we formed the preliminary diagnosis and treatment scheme. 3.1.2 Formulating clinical pathway based on TCM diagnosis of the optimization scheme.
With regard to the retrospective study results, we determined the management time of clinical pathway, and formulated inclusion and exclusion criteria, then designed implementation flow path. According to the clinical pathway issued by health ministry in 2009, we formulated clinical pathway of chronic heart failure.
3.2 Evaluation on the implementation of clinical pathway
By prospective randomized controlled trial, We collected patients with chronic heart failure hospitalized at Guangdong hospital of TCM from October 2009 to October 2010, whom were divided into two groups, one CP group, onother control group, then discussed the effect of CHF CP. The evaluation index included:hospital stay, hospital expense, effect of heart function, syndrome, accumulate points, patients'satisfaction, readmission rate and case fatality rate afer discharged 90 days, quality of life score afer discharged 90 days, etc. Analyzing the implementation of key medicine and check at every stage of CP group, variation for Laying the foundation to further improve the clinical pathway.
4 Results
4.1 Constructing of CHF clinical pathway with integrated traditional and western medicine
4.1.1 Constructing of CHF Chinese diagnosis and treatment scheme
4.1.1.1 Evidence of ancient literature findings
Etiology of heart failure were "evil blocking heart and pulse theory", "excessive emotion internal damage theory", "retention of fluid attacking heart doctrine", "consumption theory". Pathogenesis summed up "heart and pluse blocking theory", "yang deficiency and retention of fluid theory", "Abnormal zang-fu viscera doctrine". Accordingly, the common used methods for CHF was "benefiting qi", "warming yang qi ", " nourishing yin", "regulating fluid" "dissipate blood stasis and phlegm" and so on. As for the specific prescriptions, we chose zhenwu decoction, Pulse-Engendering Powder, Pepperweed and Jujube Lung-Draining Decoction, Wuling Powder, Ginseng-Nourishing Decoction, Bighead Atractylodes and Licorice Decoction. Simple recipe were Bukan liyi Dan, Dredging and Channelling Decoction, Water-Abducting Poria Decoction.
4.1.1.2 Survey of modern literature
Literature review found that:TCM disease was named heart failure, the pathogenesis unified on a more consistent understanding was deficiency Qi and Yang as Ben, fluid, turbid phlegm, blood stasis as Biao. The location was at heart, lung, spleen, kidney and other organs as well. Syndromes was defficency ben invovled excessive biao, deficiency Qi, Yang and Yin as ben, fluid, turbid phlegm, blood stasis as Biao.
Seen from the evolution of syndrome, heart qi deficiency, yang deficiency were the basis cause of heart failure, and may relate to damage yin. Blood stasis and water rentation were the inevitable courses of the pathological state, edema was the end result, qi, water and blood were diseases to one another. The qi deficency and blood stasis were always running through the development of heart failure.
The principle and method of treatment was to tonify deficiency especially by benefiting qi and warmly invigorating yang, eliminating evil by promoting blood circulation for removing blood stasis, dissipating phlegm and inducing diuresis, among which benefiting qi and warmly invigorating yang, promoting blood circulation and inducing diuresis were the key points. But it needs to balance for nourish Yin, benefiting qi and promoting blood circulation should be consistent throughout.
Multiple randomized controlled clinical trials showed that:the methods of benefiting qi, promoting blood circulation, inducing diuresis;benefiting qi warmly, invigorating yang, promoting blood circulation, inducing diuresis; benefiting qi, promoting blood circulation; benefiting qi, nourishing yin were effective to CHF. Zhenwu decoction, Pulse-Engendering Powder; injections as shefu, shenmai, shengmai and huangqi; traditional Chinese patent medicines as qili qiangxin capsule, warming heart capsule, buxinqi oral liquid, all were effective for chronic heart failure.
For the specific medication, it was reported warmly invigorating yang, benefiting qi, promoting blood circulation and inducing diuresis herbs. Benefiting qi mainly chose astragalus, ginseng, codonopsis pilosula, ginseng radix rubri, atractylodes macrocephala, fructus corni, fructus schizandrae、Chinese jujube, etc. Warmly invigorating yang mainly chose black sliced aconite, ramulus cinnamomi, cinnamomum cassia, zingiberis, psoralea fruits, cornu cervi degelatinatum, herba epimedii, etc. Promoting blood circulation for removing blood stasis chose sanguisuge, angelica root, szechwan lovage rhizome, paeoniae radix, peach seed, carthamus tinctorius, notoginseng, herba leonuri, achyranthis, succinite, prepared radix etrhizoma rhei with wine, etc. Inducing diuresis chose tansymustard seed, plantaginis, acanthopanacis, Morus alba, poria, Alisma, Polyporus, Trichosanthes, Asarum, Morus alba, Citrus aurantium, Pinellia, bunge pricklyash seed,etc.
Some literature suggested that the complications in the TCM treatment of chronic heart failure, such as pulmonary infection, cardiac arrhythmia, diuretics resistance, hypotension, and digitalis poisoning had certain advantages, but the quatity of literature was rare.
4.1.1.3 Veteran doctors'experience of TCM
Veteran doctors'experience of TCM thought that heart failure belonged to deficiency Ben and excessive Biao. Deficiency Ben mainly included deficiency qi and yang. Excessive Biao mainly included stagnant blood, water retention and phlegm-chaotic. The deficiency Ben(deficiency qi and yang of heart) was the key to the pathogenesis of heart failure, especially qi and yang deficiency. Excessive Biao caused by deficiency Ben, mainly included stagnant blood, water retention and phlegm-chaotic. Acute exacerbation biased in favor of excessive Biao (water retention, stagnant blood and phlegm-chaotic) based on deficiency qi and yang. Paracmasis biased in favor of deficiency Ben(deficiency qi, yang and yin). The important therapeutic principle was benefiting vital energy, warming yang, promoting blood flow and alleviating water retention while at the same time nourishing Yin. To the implementation of specific prescriptions, we passed the experts'consensus for solutions.
4.1.1.4 Results of expert consultation
Through expert consultation, we determined the basis for TCM and western diagnosis, and unified heart failure named "heart failure disease". Most experts thought that the basic pathogenesis of heart failure is deficiency Ben and excessive Biao. Deficiency Ben included deficiency qi, yin and yang. Excessive Biao with retention of fluid, stagnant blood and phlegm-chaotic. Divided into acute exacerbation and stabilization in two stages for TCM syndrome differentiation, acute exacerbation of deficiency Ben(deficiency yang and qi),and excessive Biao(fluid, stagnant blood and phlegm-chaotic). Stabilization of deficiency Ben(deficiency qi, yang and yin), and excessive Biao (stagnant blood).
The average hospital costs and the middle of hospital costs in CP group were lower than that in control group (￥8656.8 vs￥11609.7;￥7556.9 vs￥9853.9), the total hospital cost compared the two groups was statistically significant (P<0.01). Further major projects on the hospital costs were compared and found that the patient's bed fees, medicine costs, inspection fees and radiation fees were statistically significant (P<0.05), CP group was significantly lower than control group; traditional Chinese medicine preparation costs, Herbal fees, treatment fees and laboratory fees between the two groups was no significant difference (P> 0.05), showed that these projects had not decline in CP group.
4.2.2 Effect of heart function was statistically significant(P<0.05) between the two groups. More effective ratio in CP group was higher than that in control group(49.3% vs 38.3%), and effective and ineffective ritio were lower than that in control group(50% vs 59.6%; 0.7% vs 2.1%), which showed after treatment it significantly improved patients'cardiac function in both of the two groups, and effect of cardiac function in CP group was better than control group. In addition, regardless of CP group or the control group, systolic blood pressure, diastolic blood pressure and heart rate compared with hospital discharge were significantly different from hospital admission(P<0.01); systolic blood pressure, diastolic blood pressure and heart rate were lower at discharge than those at admission in CP group, and at a relatively steady state; the control group had similar results. Systolic blood pressure, diastolic blood pressure and heart rate between two groups at discharge showed no significant difference(P> 0.05).
Comparing The total effect of TCM syndrome of heart failure, the difference was not significant(P> 0.05). Further compared the effect on the main symptoms, the results was that in cold limbs and short urine between the two groups, there was statistically significant(P<0.01), the CP group was better than control group.
4.2.3 From the survey results of patient satisfaction, regardless of the CP group or control group, rarely patients felt dissatisfied. Patient satisfaction with treatment process detailed projects related to the comparison, only the method of guiding medication, there was no significant difference between two groups (P>0.05), satisfaction of the remaining seven projects were statistically significant between two groups(P<0.05). Patient's satisfaction with the process of treatment in CP group was higher than that in control group.
Compared satisfaction of the waiting time, in addition to the dismission of hospital waiting times which was no significant difference between two groups (P>0.05), patients'satisfaction of receiving time, waiting time and checking time were statistically significant (P<0.01); the satisfaction in CP group was higher than control group.
The satisfaction of service attitude in comparison, clinical doctors' attitude in CP group was more statistically significant than that in control group(P<0.01), the rest of attitudes such as nurses, care workers, examining physician, satisfaction of those were no statistical significance(P>0.05) between two groups. The overall satisfaction was significantly different(P <0.01); overall satisfaction was higher in CP group than that in control group. Then integrating the transformation of satisfaction, compared the satisfaction scores, the results showed that apart from the satisfaction with service attitude was no difference in points between two groups, the medical procedure, waiting time, overall satisfaction, differences in these three projects between the two groups were statistically significant(P<0.01); satisfaction in CP group was higher than that in control group.
4.2.4 Within three months after discharge mortality was no significant in both groups(P> 0.05); within three months after discharge, readmission rate in two groups, the difference was not statistically significant(P>0.05);after discharged the quality of life in the two groups(using the Minnesota Heart Failure Quality of Life Scale scores), there was no significant difference (P>0.05), regardless of the CP group or the control group; 3 months after discharge and the first admission, the quality of life was significantly different in the two groups(P<0.05).
4.2.5 Preliminary analysis on the implementation of clinical pathway showed that on the 1st day after admission, in addition to Holter, the implementation of the other basical check was close to or more than 90%; in general, enforcement was still better. For specific drug use, the highest utilization rates of oral was diuretics, utilization rate was over 95%; utilization rate of intravenous diuretics decreased with hospitalization prolonged;β-blocker usage had been increased as hospital stay lasted, the total utilization rate was79.4%;
ACEI or ARB utilization rates were more than 80% at each stage, total utilization rate was 89.7%; utilization rate of aldosterone receptor blocker was 76.5%; digoxin was 50-60%; vasodilators had the lowest usage, and with hospital stay prolonged, the utilization rate declined. Utilization rate of each stage were about 90% of traditional Chinese patent medicine, traditional Chinese patent medicine(Ⅳ) for promoting blood circulation had the highest utilization rate, followed by medicine for benefiting qi(Ⅳ), the last one was medicine for the warming yang(Ⅳ), basically to stable stage it would be turned intravenous medicine into oral traditional Chinese patent medicine.
Compare CP group and the control group in the three regular test, electrolytes, ECG, blood clotting, BNP and other tests, the application of those was no significant difference(P>0.05), chest radiography, echocardiography, Holter monitoring and other tests, the application had statistically significant difference (P<0.05), rate in CP roup was higher than control group, suggesting that patients were paid more positive attention in the heart assessment when admitted to hospital on the 1st day.
Comparison of specific drugs, we discovered that the application about ACEI/ARB, digoxin, aldosterone receptor blockers and vasodilator drug, there was significantly different(P<0.05) between the two groups. Use of ACEI/ARB in CP group was high than that in control group. And the use rate of digoxin, aldosterone receptor blockers and vasodilators drug in CP group was lower than control group, use of diuretics andβ-blocker was no significant difference (P> 0.05) between the two groups.
4.2.6 To further improve the CP, preliminary analysis the CP variation occurred during the implementation. The results of the total variance were 649 frequency. The main reason for variation was the complexity of the disease from CHF. Among 649, patients' condition due to variations was up to 392 times, due to the emergency room diagnosis and treatment firstly was total 94 times, due to medical members was 38 times.
Ruled out the exit of CP variation, further classify and analyze the major variation factors in each stages, we found that patients admitted to hospital on the 1st day variation frequency was the highest (261), followed by the 4th-7th day(135), followed by the 2nd-3rd day(94), the 8th-13th day(85), few frequency by the 14th day(59). Of every stages, the disease cause shared the highest frequency, followed by patient factors, medical personnel factors, other factors for the emergency admission, only on the 1st day in hospital.
Classified by the nature of the patients with positive, negative and uncertainty, in terms of hospital stay, the highest percentage of uncertain variation was up to 313 times, accounting for 49.4%, negative variation was up to 171 times, accounting for 26.9%, positive variation was 150 times, accounting for 23.7%.
On hospital costs, the uncertainty variation had the least ratio, up to 84 times, accounting for 13.2%, the negative variation had the highes tratio, up to 387 times, accounting for 61.0%, positive variation was up to 163, accounting for 44.8%.
Classified the variation by Controlled, difficult to control and uncertainty, we found that controlled variation frequency was 144 times, accounting for 22.7%; difficult to control was 23 times, accounting for 66.7%, uncertainty variation was 67 times, accounting for 10.6%.
5 Conclusion
5.1 The key point and difficulty for formulating the CHF CP combined with traditional Chinese and western medicine was TCM treatment scheme. This research primarily formulated TCM therapy for chronic heart failure through ancient and modern literature reserch, veteran doctors' experience of TCM, expert consultation, which included traditional Chinese medicine combined therapy, and common complications of TCM therapy. Traditional Chinese medicine combined therapy included oral herbal medicine, Chinese patent medicine and characteristic of TCM therapy. We preliminary determined the CHF diagnosis and treatment patterns of each stage management, diagnosis by syndrome differentiation, methods, the basic formula and herbs, commonly vein-used traditional Chinese medicine preparation and Chinese patent drug, characteristic of TCM therapy. Fothermore, we established traditional Chinese medicine diagnosis and treatment for common complications of chronic heart failure.
5.2 With regard to the retrospective study, we determined target population and the entrance and exit criteria of CP, total CP time limit, implement processes of CP on the basis of optimized scheme. Also we formed CP form, according to CP format issued by the State Ministry. At the same time, it instituted the discharge standard. Finally we finish designing CHF case observed form.
5.3 The clinical pathway regulated the management of hospital process, shortened hospitalization days, lowered the expense, greatly improved patient clinical symptoms and heart function, ensured the quality of medical treatment, elevated patient's satisfaction.
5.4 Due to the complexity of CHF, there were much variation during the implenmation process, among which were uncontrolled, may prolong hospitlal stay and increase costs. Totally speaking, performance of medical personnel who involed in this study are ideal.
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