慢性肾衰竭非透析期中西医结合临床路径构建的优化研究
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摘要
一、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。2004年我国开始试点实施单病种限价制度,降低住院费用。为了能更准确、更科学的限定单病种的住院费用,保证医院的效益,临床路径的管理模式不断被各家医院采纳。现已证实临床路径可缩短住院天数,节约住院费用,又可达到预期的治疗效果。
慢性肾功能衰竭(CRF)病程长、病情复杂,往往住院天数长、住院费用昂贵、再入院率高,构建慢性肾功能衰竭的临床路径,规范住院管理流程,在保证医疗质量的前提下,缩短住院天数,降低住院费用,已成为当务之急。
临床路径的核心是科学的诊疗方案。目前尚无特效药物延缓肾衰竭进展。多年的临床实践经验表明,中医药在缓解慢性肾衰竭症状、保护残余肾功能、延缓早中期肾功能进展、推迟进入替代治疗等方面取得了明显疗效。因此,将优化的中医诊疗方案纳入临床路径,制定慢性肾衰竭中西医结合临床路径,既能规范住院管理流程,又能充分发挥中医特色优势,有效延缓慢性肾衰竭进展。
二、研究目的
(一)根据临床路径构建的科学性原则,对慢性肾衰竭非透析期中医诊疗方案进行优化,初步形成证据充分、共识度高、推广性强的中医诊疗方案。为临床路径的构建提供核心内容。
(二)对慢性肾衰竭非透析期临床路径进行初步临床观察,通过与我院回顾性病案分析结果的比较,初步探讨慢性肾衰竭非透析期临床路径的临床效益,为路径进一步自我优化提供依据。三、研究内容
本研究分为两部分,第一部分研究重点在于慢性肾衰竭非透析期中医诊疗方案的优化,为临床路径的构建提供核心内容。第二部分研究是对构建的慢性肾衰(非透析期)中西医结合临床路径进行了初步临床观察,与我院回顾性病案统计结果进行前后对比。
(一)慢性肾衰非透析期中西医结合临床路径构建的优化研究
1.慢性肾衰非透析期中医诊疗方案的优化研究
(1)全国慢性肾衰诊疗方案梳理工作
通过全国慢性肾衰诊疗方案梳理工作,总结目前全国慢性肾衰竭非透析期诊疗概况,提取共识度高、疗效好、推广性强的中医诊疗措施,尚存在分歧的中医诊疗措施,以便进行下一步文献研究。
(2)文献研究
中文检索选用CBM数据库、维普数据库,检索年限为1999年至2009年。英文检索选用Pubmed数据库,检索年限为2004年至2009年。制定文献纳入、排除标准。填写文献登记表,构建文献相关数据库。采用内容分析法,对文献内容进行分析总结。
(3)专家咨询研究
针对共识度较低、尚无充分文献证据支持的诊疗措施进行专家咨询。制定专家咨询问卷,选择20名国内中医或中西医结合专家以书面的形式进行咨询。通过两轮咨询后,形成初步诊疗方案,将该方案进行第三轮专家咨询,征求专家的认可意见。
2.在优化的中医诊疗方案的基础上构建临床路径
结合我院回顾性研究结果,确定临床路径的管理时限和时间点,制定路径纳入标准、排除标准。设计路径实施流程图。根据2009年卫生部下发的临床路径实施方案,制定慢性肾衰竭非透析期临床路径表单。
(二)慢性肾衰非透析期中西医结合临床路径的临床观察研究
收集2010年1月至2010年3月纳入临床路径的慢性肾衰竭患者,共33例。记录患者实施路径前后临床症状、实验室指标改善情况,住院天数,住院费用等指标。同时纳入我院2004年1月至2007年12月符合路径纳入标准的病案,进行回顾性研究,分析既往病案的住院天数、住院费用及实验室指标住院前后改善情况。通过前后比较,初步探讨临床路径的临床效益。
四、研究结果
(一)慢性肾衰非透析期中西医结合临床路径构建的优化研究
1、慢性肾衰非透析期中医诊疗方案的优化研究
(1)全国慢性肾衰诊疗方案梳理工作
中医综合疗法疗效肯定,共识度高,推广性强。但其组成形式多种多样,较难统一。中医综合疗法中,中药汤剂辨证治疗分歧较大,有待进一步文献研究。中成药方面,尿毒清、虫草制剂、海昆肾喜胶囊,使用频率较高。中医特色疗法方面,中药灌肠疗效肯定、共识度高。通过信息提取、频数分析,初步总结中药灌肠基本方：生大黄,蒲公英、生牡蛎,阳虚者加附子。
慢性肾衰竭非透析期中医治疗优势还体现在慢性并发症的中医治疗,目前疗效肯定的主要有肾性贫血、肾性营养不良。但中医治疗切入点、具体治则治法和选方用药形式多样,尚不统一。有待进一步文献研究。
(2)文献研究
中医综合治疗方法,文献报道有二联疗法、三联疗法、四联疗法。其中二联及三联疗法较多。二联疗法主要为中药口服加灌肠。三联疗法主要有中药内服+静滴+灌肠,中药口服+灌肠+皮肤透析,中药内服+灌肠+外敷,中药口服+灌肠+穴位注射或药敷、电刺和激光照射穴位。
中医口服汤药辨证治疗方面,具体的辨证分型多不统一,有待进一步专家咨询研究。
慢性肾衰竭慢性并发症的中医治疗,目前报道较多的是肾性营养不良、肾性贫血。肾性营养不良的中医治则主要为补肾健脾和胃、活血化瘀、通腑降浊、清热化湿。肾性贫血的中医治则多为补肾填精,滋肝健脾,益气生血,祛湿化瘀排毒。治疗方面多为中西医结合治疗,尚无单纯中医治疗报道。选方多为自拟方,共识度较低。有待进一步专家咨询研究。
(3)专家咨询研究
慢性肾衰竭非透析期的中医辨证治疗方式建议本虚标实混合辨证,但确定基本证型要素；针对本虚证基本证型形成基本方剂；标实证采用随证加减用药。
慢性肾衰竭非透析期中医基本证型可分为本虚证(脾肾气虚证、气阴两虚证、肝肾阴虚证、脾肾阳虚证、阴阳两虚证),标实证(湿浊证、湿热证、血瘀证、水气证、浊毒证)。脾肾气虚证可选用香砂六君子汤加减,气阴两虚证可选用参芪地黄丸加减,肝肾阴虚证可选用六味地黄丸合二至丸加减,脾肾阳虚证可选用济生肾气丸加减,阴阳两虚证可选用金匮肾气丸合二至丸加减。标实证均在本虚证的基础上加减用药
慢性肾衰合并症肾性贫血、肾性营养不良的中医治疗：治疗方式建议在原来中医辨证论治的基础上加减用药。肾性营养不良的中医切入点：目前主要有两种意见,按临床分期,认为是氮质血症以前(包括氮质血症期),另一个是按营养不良严重程度,认为是轻、中度营养不良。肾性贫血的切入点：大部分专家认为血红蛋白在80-110 g／L可不用促红素治疗,采用单纯中医辨证治疗。
肾性营养不良的治则主要采用维护胃气,健脾温肾泻浊,补益气血。基本方为黄芪、党参、白术、当归、熟地、山萸肉、淮山、太子参、丹参、枸杞、仙灵脾。肾性贫血的治则主要采用补益气血、健脾补肾、填精、活血化瘀、泻浊排毒。基本方组成：北芪、当归、党参、熟地、何首乌、菟丝子、白术、枸杞、阿胶、仙灵脾、白芍、紫河车。
第三轮专家咨询结果：20位专家中有8位专家完全认可,12位专家基本认可。
2.在优化的中医诊疗方案的基础上构建临床路径
(二)慢性肾衰非透析期中西医结合临床路径的临床观察研究
临床路径治疗前后,患者的倦怠乏力、食少纳呆、面浮肢肿、腰膝酸软、口干口苦、恶心、畏寒肢冷、脘腹胀满、大便干结等症状改善明显(P<0.05或P<0.01)。与回顾病案统计结果相比,住院天数、西药治疗费用、检查费用均较之明显减少(P<0.05)。肾功能、住院总费用、中药费、中成药费虽实施路径后有所改善,但与回顾性病案结果比较无显著性差异(P>0.05)。
五、结论
(一)慢性肾衰竭非透析期中西医结合临床路径的核心是中医诊疗方案。本研究通过对全国30家肾病重点专科慢性肾衰竭诊疗方案的梳理、文献研究及专家咨询研究,初步确定了慢性肾衰竭非透析期中医诊疗方案。该方案主要包括中医综合疗法、慢性并发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、中药灌肠。初步确定了口服中药汤剂治疗的中医辨证分型、基本选方用药,中药灌肠的基本方药,慢性并发症的中医切入点、中医治则及方药。
(二)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,制定路径目标人群及退出路径标准,路径总时限,路径实施流程。完成路径表单。
(三)实施临床路径,规范了我们的住院管理流程,使住院天数较前缩短,同时病人临床症状改善明显,保证了医疗质量。虽然,总住院费用的下降、中药费用的上升与回顾性病案统计结果相比无显著性差异,但是西药费和检查费都有明显下降且有显著性差异,说明通过临床路径的规范化管理,加强了中医特色的应用。肾功能改善方面,临床路径治疗前后并无统计学差异,考虑因路径管理时间较短,短期内肾功能改善尚不明显。有待进一步随访研究。
Background
In recent years, with rising medical costs, the inadequate and overly expensive medical services increasingly obtain society and public attention. In 2004, China began to implement system of limited price for single disease, for reducing hospitalization cost price. In order to more accurately, more scientific limite hospital expense, ensure the hospitalization expense benefit, hospital management mode of clinical pathway has been adopted by various hospitals. Clinical pathway can shorten inpatient days, save costs and ensure hospitalization desired therapeutic effect.
Chronic renal failure, with long and complex course, often has longer inpatient days, higher hospital expense, and higher readmission rate. Shaping the clinical pathway, to standard hospital management process, short inpatient days, reduce hospitalization fees, has become a top priority.
Medical scheme is the core of the clinical pathway. At present, there is no effective drugs delay renal failure. Years of clinical experience show that Chinese medicine has made the obvious effect in some aspects, such as alleviating symptoms of chronic renal failure, protecting residual renal function, slowing progress in mid early renal function, delaying into replacement therapy. Therefore, formulation of chronic renal failure of combining traditional Chinese and western medicine clinical pathway through optimizing of TCM therapy in clinical pathway, will standard hospital management process,fully play TCM special advantage, effectively relieve chronic renal failure.
Research purposes
1. According to the scientific principle of clinical pathway construction, we optimized the TCM diagnosis scheme of chronic renal failure, and initially formed a TCM therapy with high degree of consensus, sufficient evidence, and powerful generalization, for providing the core content of clinical pathway.
2. With preliminary clinical observation of chronic renal failure clinical pathway, we preliminary discuss clinical effect of chronic renal failure clinical pathway of nondialytic period, through comparison of results of retrospectively analyzed records, to provide basis for further optimization of clinical pathway.
Research content
This research is divided into two parts. The first part of the research focuses optimization of chronic renal failure of nondialytic treatment scheme of TCM. The second part of the research is to carry on the preliminary clinical observation of chronic renal failure combine traditional Chinese and western medicine clinical pathway.
1. constructing optimal research of clinical pathway
(1) Optimization of chronic renal failure nondialytic treatment scheme of TCM
Through the survey of the chronic renal failure diagnosis and treatment scheme, we summarize the medical situation of chronic renal failure, and extract TCM treatment, which has high degree of consensus, good curative effect, and powerful generalization. And which should do further literature research, because there are differences of TCM diagnosis and treatment.
In literature research, we explore Chinese literature from 1999 to 2009, using CBM database and VIP database, and English literature from 2004 to 2009, using pubmed database. By formulating the inclusion and exclusion criteria for literature, filling in registration document, constructing the document database, we analyze and summary the content of literature using content analysis.
In expert consultation, we consult the twenty experts advice for diagnosis and treatment with low degree of consensus, no sufficient evidence to support. We form the consulting questionnaire, using written form of counseling. After two rounds of consulting, we form the preliminary diagnosis and treatment scheme and for expert advice by the third round.
(2) Formulating clinical pathway based on TCM diagnosis of the optimization scheme
With regard to the retrospective study results, we determine the management time of clinical pathway, and formulate inclusion and exclusion criteria, and then design implementation flow path. According to the clinical pathway issued by health ministry in 2009, we formulate clinical pathway of chronic renal failure of nondialytic period.
2. clinical observation research of clinical pathway
We collect 33 patients with chronic renal failure of clinical pathway form January to March in 2010. then we recorded clinical symptoms, lab indexes, hospital stay, and Hospital expense before implementation and after. Also we included records with path into standard from January 2004 to December 2007, and analysis the record number, hospitalization cost and improved hospital lab index before hospitalization and after. Through the comparison, we discussed the clinical benefits of clinical pathway.
Research results
1. constructing optimal research of clinical pathway
(1) Optimization of chronic renal failure nondialytic treatment scheme of TCM
①The survey of the chronic renal failure diagnosis and treatment scheme
The survey of the chronic renal failure diagnosis and treatment scheme Traditional Chinese medicine combined therapy has curative effect, high degree of consensus, and powerful generalization. But it is difficult to unity because varied form. TCM syndrome differentiation and treatment has divergence needing further literature research. In Chinese patent medicine, uremic clearance granule, Chongcao preparation, and haikunshenxijiaonang have high using frequency. In Characteristics of therapy, Traditional enema has curative effect, high degree of consensus. Through analyzing information extraction and frequency analysis, we preliminary summary the basic formula.
Therapeutic advantage also reflects in the treatment of chronic complications. Currently, renal anemia, renal malnutrition have certain curative effect. But the point of TCM therapy, pathogenic factor and the application in various forms are not uniform, needing further literature research.
②literature research.
Traditional Chinese medicine combined therapy, reported in the literature, has two couplet therapy, Sanlian therapy and quad therapy. Among the many therapy, two couplet therapy and sanlian therapy have been frequently used. The two couple therapy mainly includes oral medicine and enema. Sanlian therapy are mainly Chinese medicine + static drops + enema, Oral medicine+enema+skin dialysis, Herbal medicine+enema+topical, Oral medicine+enema+point injection or apply medicine, acupuncture spurs and laser irradiation.
TCM diagnosis and treatment of oral liquid form, Specific syndrome type has not unified, needing further studies expert advice.
Among chronic complications of chronic renal failure of TCM therapy, currently reported more is renal malnutrition and renal anemia. The TCM treatment principle of renal malnutrition include nourishing kidney, spleen and stomach, invigorating blood, droping turbidity, clearing away heat and eliminating dampness. The TCM treatment principle of renal anemia include filling kidney essence, nourishing liver and spleen, tonifying qi and producing blood, removing stagnation and detoxification. There is treatment for combining traditional Chinese and western medicine treatment, still no Chinese medicine treatment. Also the formula has low degree of consensus.
〦xpert consultation
It is suggested using differentiation mixed by deficiency in the origin and excess in the superficiality in chronic renal failure of TCM. The doctors should determine the basic syndrome factor, form basic type certificate, according to the deficiency of the basic.
The basic types of syndromes of CKD 3-4 period include the syndrome of deficiency Ben(deficiency of spleen and kidney cured with xiangshaliujunzi soup; deficiency of qi and yin cured with shenqidihuang pill; deficiency syndrome of both liver and kidney yin cured with liuweidihuang soup and erzhi pill; deficiency syndrome of both spleen and kidney yang cured with jishengshenqi pill; deficiency of yang and yin cured with jinkuishenqi pill and erzhi pill), and the syndrome of excessive Biao(dampness syndrome; Dampness-heat syndrome; blood stasis syndrome; water-dampness syndrome; chaotic-toxic syndrome). We treat the syndrome of excessive Biao through increasing and decreasing some traditional herbs according the syndrome of deficiency Ben.
The TCM therapy of chronic renal failure complication renal anemia and malnutrition was suggested add herbals on the basis of TCM syndrome differentiation. There are two TCM treatment points of renal malnutrition, one is according to the clinical stages, before the azotemia period. Another is by severe malnutrition, that is light, medium malnutrition. Most experts think hemoglobin in 80 ~ 11 g/L can not use erythropoietin treatment, only TCM syndrome differentiation and treatment.
Renal malnourished therapeutic rule mainly adopts nourishing kidney, spleen and stomach, invigorating blood, droping turbidity. The basic formula contains huangqi, dangsheng, baishu, danggui, shudi, shanyurou, huaishan, taizisheng, dansheng, gouqi, xiulinpi. TheTCM treatment principle of renal anemia include filling kidney essence, nourishing liver and spleen, tonifying qi and producing blood, removing stagnation and detoxification. The basic formula contains beiqi, danggui, dangsheng, shudi, heshouwu, tusizi, baishu, gouqi, ajiao, xianlinpi, baishao, ziheche.
In the third round of expert advice, eight experts completely agree with the scheme,12 experts basic agree with the scheme in 20 specialists.
(2) Formulating clinical pathway based on TCM diagnosis of the optimization scheme
2. the clinical observation research of clinical pathway
Before and after the treatment of clinical pathway, symptoms of patient improved obviously, such as weakness and fatigue, eat less, floating face limb swelling, lumbar debility, mouth dry and bitter, nausea, chills limb cold, abdominal distension, move bowels dry(P<0.05或P<0.01). Compared with the results of medical statistics review, days, western medicine therapy cost, and inspection charges obviously reduced(P<0.05). Kidney and hospitalization expenses improved after the implementation of path. But there were non-significance difference with the retrospectively medical results.
Conclusion
1. The core of clinical pathway, combining traditional Chinese and western medicine, of Chronic renal failure in nondialytic period is TCM treatment scheme. This research primarily formulates TCM therapy of chronic renal failure in nondialytic period, through investigation of diagnosis and treatment TCM scheme of chronic renal failure nationwide, Literature research, and expert consultation. We preliminary made of TCM therapy of chronic renal failure in nondialytic period, which include traditional Chinese medicine combined therapy, and chronic complications of TCM therapy. Traditional Chinese medicine combined therapy include oral herbal medicine, Chinese patent drug, and traditional enema. We Preliminary determine the TCM syndrome differentiation, basic formula of oral herbal medicine, the basic Chinese medicine of enema, the TCM therapy point of Chronic complications.
2. With regard to the retrospective study, we determine target population and the exit criteria of path, total path time limit, implement processes of path on the basis of optimized scheme. Also we form path form, according to path form format issued by the state ministry.
3. The clinical pathway regulates the management of our hospital process, shortens hospitalization days, improves patient clinical symptoms; ensure the quality of medical treatment. Althoughthe total hospital expenses dropped, with the rising medical costs were no significant differences compared with statistical results. But the cost of western medicine and examination has obviously decreased with significant differences. Explanation of clinical pathway standardized management and strengthen the characteristics of the application. Renal improvement has no statistically significant differences, before and after treatment of clinical pathway. Further follow-up study is necessary.
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。2004年我国开始试点实施单病种限价制度,降低住院费用。为了能更准确、更科学的限定单病种的住院费用,保证医院的效益,临床路径的管理模式不断被各家医院采纳。现已证实临床路径可缩短住院天数,节约住院费用,又可达到预期的治疗效果。
慢性肾功能衰竭(CRF)病程长、病情复杂,往往住院天数长、住院费用昂贵、再入院率高,构建慢性肾功能衰竭的临床路径,规范住院管理流程,在保证医疗质量的前提下,缩短住院天数,降低住院费用,已成为当务之急。
临床路径的核心是科学的诊疗方案。目前尚无特效药物延缓肾衰竭进展。多年的临床实践经验表明,中医药在缓解慢性肾衰竭症状、保护残余肾功能、延缓早中期肾功能进展、推迟进入替代治疗等方面取得了明显疗效。因此,将优化的中医诊疗方案纳入临床路径,制定慢性肾衰竭中西医结合临床路径,既能规范住院管理流程,又能充分发挥中医特色优势,有效延缓慢性肾衰竭进展。
二、研究目的
(一)根据临床路径构建的科学性原则,对慢性肾衰竭非透析期中医诊疗方案进行优化,初步形成证据充分、共识度高、推广性强的中医诊疗方案。为临床路径的构建提供核心内容。
(二)对慢性肾衰竭非透析期临床路径进行初步临床观察,通过与我院回顾性病案分析结果的比较,初步探讨慢性肾衰竭非透析期临床路径的临床效益,为路径进一步自我优化提供依据。三、研究内容
本研究分为两部分,第一部分研究重点在于慢性肾衰竭非透析期中医诊疗方案的优化,为临床路径的构建提供核心内容。第二部分研究是对构建的慢性肾衰(非透析期)中西医结合临床路径进行了初步临床观察,与我院回顾性病案统计结果进行前后对比。
(一)慢性肾衰非透析期中西医结合临床路径构建的优化研究
1.慢性肾衰非透析期中医诊疗方案的优化研究
(1)全国慢性肾衰诊疗方案梳理工作
通过全国慢性肾衰诊疗方案梳理工作,总结目前全国慢性肾衰竭非透析期诊疗概况,提取共识度高、疗效好、推广性强的中医诊疗措施,尚存在分歧的中医诊疗措施,以便进行下一步文献研究。
(2)文献研究
中文检索选用CBM数据库、维普数据库,检索年限为1999年至2009年。英文检索选用Pubmed数据库,检索年限为2004年至2009年。制定文献纳入、排除标准。填写文献登记表,构建文献相关数据库。采用内容分析法,对文献内容进行分析总结。
(3)专家咨询研究
针对共识度较低、尚无充分文献证据支持的诊疗措施进行专家咨询。制定专家咨询问卷,选择20名国内中医或中西医结合专家以书面的形式进行咨询。通过两轮咨询后,形成初步诊疗方案,将该方案进行第三轮专家咨询,征求专家的认可意见。
2.在优化的中医诊疗方案的基础上构建临床路径
结合我院回顾性研究结果,确定临床路径的管理时限和时间点,制定路径纳入标准、排除标准。设计路径实施流程图。根据2009年卫生部下发的临床路径实施方案,制定慢性肾衰竭非透析期临床路径表单。
(二)慢性肾衰非透析期中西医结合临床路径的临床观察研究
收集2010年1月至2010年3月纳入临床路径的慢性肾衰竭患者,共33例。记录患者实施路径前后临床症状、实验室指标改善情况,住院天数,住院费用等指标。同时纳入我院2004年1月至2007年12月符合路径纳入标准的病案,进行回顾性研究,分析既往病案的住院天数、住院费用及实验室指标住院前后改善情况。通过前后比较,初步探讨临床路径的临床效益。
四、研究结果
(一)慢性肾衰非透析期中西医结合临床路径构建的优化研究
1、慢性肾衰非透析期中医诊疗方案的优化研究
(1)全国慢性肾衰诊疗方案梳理工作
中医综合疗法疗效肯定,共识度高,推广性强。但其组成形式多种多样,较难统一。中医综合疗法中,中药汤剂辨证治疗分歧较大,有待进一步文献研究。中成药方面,尿毒清、虫草制剂、海昆肾喜胶囊,使用频率较高。中医特色疗法方面,中药灌肠疗效肯定、共识度高。通过信息提取、频数分析,初步总结中药灌肠基本方：生大黄,蒲公英、生牡蛎,阳虚者加附子。
慢性肾衰竭非透析期中医治疗优势还体现在慢性并发症的中医治疗,目前疗效肯定的主要有肾性贫血、肾性营养不良。但中医治疗切入点、具体治则治法和选方用药形式多样,尚不统一。有待进一步文献研究。
(2)文献研究
中医综合治疗方法,文献报道有二联疗法、三联疗法、四联疗法。其中二联及三联疗法较多。二联疗法主要为中药口服加灌肠。三联疗法主要有中药内服+静滴+灌肠,中药口服+灌肠+皮肤透析,中药内服+灌肠+外敷,中药口服+灌肠+穴位注射或药敷、电刺和激光照射穴位。
中医口服汤药辨证治疗方面,具体的辨证分型多不统一,有待进一步专家咨询研究。
慢性肾衰竭慢性并发症的中医治疗,目前报道较多的是肾性营养不良、肾性贫血。肾性营养不良的中医治则主要为补肾健脾和胃、活血化瘀、通腑降浊、清热化湿。肾性贫血的中医治则多为补肾填精,滋肝健脾,益气生血,祛湿化瘀排毒。治疗方面多为中西医结合治疗,尚无单纯中医治疗报道。选方多为自拟方,共识度较低。有待进一步专家咨询研究。
(3)专家咨询研究
慢性肾衰竭非透析期的中医辨证治疗方式建议本虚标实混合辨证,但确定基本证型要素；针对本虚证基本证型形成基本方剂；标实证采用随证加减用药。
慢性肾衰竭非透析期中医基本证型可分为本虚证(脾肾气虚证、气阴两虚证、肝肾阴虚证、脾肾阳虚证、阴阳两虚证),标实证(湿浊证、湿热证、血瘀证、水气证、浊毒证)。脾肾气虚证可选用香砂六君子汤加减,气阴两虚证可选用参芪地黄丸加减,肝肾阴虚证可选用六味地黄丸合二至丸加减,脾肾阳虚证可选用济生肾气丸加减,阴阳两虚证可选用金匮肾气丸合二至丸加减。标实证均在本虚证的基础上加减用药
慢性肾衰合并症肾性贫血、肾性营养不良的中医治疗：治疗方式建议在原来中医辨证论治的基础上加减用药。肾性营养不良的中医切入点：目前主要有两种意见,按临床分期,认为是氮质血症以前(包括氮质血症期),另一个是按营养不良严重程度,认为是轻、中度营养不良。肾性贫血的切入点：大部分专家认为血红蛋白在80-110 g／L可不用促红素治疗,采用单纯中医辨证治疗。
肾性营养不良的治则主要采用维护胃气,健脾温肾泻浊,补益气血。基本方为黄芪、党参、白术、当归、熟地、山萸肉、淮山、太子参、丹参、枸杞、仙灵脾。肾性贫血的治则主要采用补益气血、健脾补肾、填精、活血化瘀、泻浊排毒。基本方组成：北芪、当归、党参、熟地、何首乌、菟丝子、白术、枸杞、阿胶、仙灵脾、白芍、紫河车。
第三轮专家咨询结果：20位专家中有8位专家完全认可,12位专家基本认可。
2.在优化的中医诊疗方案的基础上构建临床路径
(二)慢性肾衰非透析期中西医结合临床路径的临床观察研究
临床路径治疗前后,患者的倦怠乏力、食少纳呆、面浮肢肿、腰膝酸软、口干口苦、恶心、畏寒肢冷、脘腹胀满、大便干结等症状改善明显(P<0.05或P<0.01)。与回顾病案统计结果相比,住院天数、西药治疗费用、检查费用均较之明显减少(P<0.05)。肾功能、住院总费用、中药费、中成药费虽实施路径后有所改善,但与回顾性病案结果比较无显著性差异(P>0.05)。
五、结论
(一)慢性肾衰竭非透析期中西医结合临床路径的核心是中医诊疗方案。本研究通过对全国30家肾病重点专科慢性肾衰竭诊疗方案的梳理、文献研究及专家咨询研究,初步确定了慢性肾衰竭非透析期中医诊疗方案。该方案主要包括中医综合疗法、慢性并发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、中药灌肠。初步确定了口服中药汤剂治疗的中医辨证分型、基本选方用药,中药灌肠的基本方药,慢性并发症的中医切入点、中医治则及方药。
(二)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,制定路径目标人群及退出路径标准,路径总时限,路径实施流程。完成路径表单。
(三)实施临床路径,规范了我们的住院管理流程,使住院天数较前缩短,同时病人临床症状改善明显,保证了医疗质量。虽然,总住院费用的下降、中药费用的上升与回顾性病案统计结果相比无显著性差异,但是西药费和检查费都有明显下降且有显著性差异,说明通过临床路径的规范化管理,加强了中医特色的应用。肾功能改善方面,临床路径治疗前后并无统计学差异,考虑因路径管理时间较短,短期内肾功能改善尚不明显。有待进一步随访研究。
Background
In recent years, with rising medical costs, the inadequate and overly expensive medical services increasingly obtain society and public attention. In 2004, China began to implement system of limited price for single disease, for reducing hospitalization cost price. In order to more accurately, more scientific limite hospital expense, ensure the hospitalization expense benefit, hospital management mode of clinical pathway has been adopted by various hospitals. Clinical pathway can shorten inpatient days, save costs and ensure hospitalization desired therapeutic effect.
Chronic renal failure, with long and complex course, often has longer inpatient days, higher hospital expense, and higher readmission rate. Shaping the clinical pathway, to standard hospital management process, short inpatient days, reduce hospitalization fees, has become a top priority.
Medical scheme is the core of the clinical pathway. At present, there is no effective drugs delay renal failure. Years of clinical experience show that Chinese medicine has made the obvious effect in some aspects, such as alleviating symptoms of chronic renal failure, protecting residual renal function, slowing progress in mid early renal function, delaying into replacement therapy. Therefore, formulation of chronic renal failure of combining traditional Chinese and western medicine clinical pathway through optimizing of TCM therapy in clinical pathway, will standard hospital management process,fully play TCM special advantage, effectively relieve chronic renal failure.
Research purposes
1. According to the scientific principle of clinical pathway construction, we optimized the TCM diagnosis scheme of chronic renal failure, and initially formed a TCM therapy with high degree of consensus, sufficient evidence, and powerful generalization, for providing the core content of clinical pathway.
2. With preliminary clinical observation of chronic renal failure clinical pathway, we preliminary discuss clinical effect of chronic renal failure clinical pathway of nondialytic period, through comparison of results of retrospectively analyzed records, to provide basis for further optimization of clinical pathway.
Research content
This research is divided into two parts. The first part of the research focuses optimization of chronic renal failure of nondialytic treatment scheme of TCM. The second part of the research is to carry on the preliminary clinical observation of chronic renal failure combine traditional Chinese and western medicine clinical pathway.
1. constructing optimal research of clinical pathway
(1) Optimization of chronic renal failure nondialytic treatment scheme of TCM
Through the survey of the chronic renal failure diagnosis and treatment scheme, we summarize the medical situation of chronic renal failure, and extract TCM treatment, which has high degree of consensus, good curative effect, and powerful generalization. And which should do further literature research, because there are differences of TCM diagnosis and treatment.
In literature research, we explore Chinese literature from 1999 to 2009, using CBM database and VIP database, and English literature from 2004 to 2009, using pubmed database. By formulating the inclusion and exclusion criteria for literature, filling in registration document, constructing the document database, we analyze and summary the content of literature using content analysis.
In expert consultation, we consult the twenty experts advice for diagnosis and treatment with low degree of consensus, no sufficient evidence to support. We form the consulting questionnaire, using written form of counseling. After two rounds of consulting, we form the preliminary diagnosis and treatment scheme and for expert advice by the third round.
(2) Formulating clinical pathway based on TCM diagnosis of the optimization scheme
With regard to the retrospective study results, we determine the management time of clinical pathway, and formulate inclusion and exclusion criteria, and then design implementation flow path. According to the clinical pathway issued by health ministry in 2009, we formulate clinical pathway of chronic renal failure of nondialytic period.
2. clinical observation research of clinical pathway
We collect 33 patients with chronic renal failure of clinical pathway form January to March in 2010. then we recorded clinical symptoms, lab indexes, hospital stay, and Hospital expense before implementation and after. Also we included records with path into standard from January 2004 to December 2007, and analysis the record number, hospitalization cost and improved hospital lab index before hospitalization and after. Through the comparison, we discussed the clinical benefits of clinical pathway.
Research results
1. constructing optimal research of clinical pathway
(1) Optimization of chronic renal failure nondialytic treatment scheme of TCM
①The survey of the chronic renal failure diagnosis and treatment scheme
The survey of the chronic renal failure diagnosis and treatment scheme Traditional Chinese medicine combined therapy has curative effect, high degree of consensus, and powerful generalization. But it is difficult to unity because varied form. TCM syndrome differentiation and treatment has divergence needing further literature research. In Chinese patent medicine, uremic clearance granule, Chongcao preparation, and haikunshenxijiaonang have high using frequency. In Characteristics of therapy, Traditional enema has curative effect, high degree of consensus. Through analyzing information extraction and frequency analysis, we preliminary summary the basic formula.
Therapeutic advantage also reflects in the treatment of chronic complications. Currently, renal anemia, renal malnutrition have certain curative effect. But the point of TCM therapy, pathogenic factor and the application in various forms are not uniform, needing further literature research.
②literature research.
Traditional Chinese medicine combined therapy, reported in the literature, has two couplet therapy, Sanlian therapy and quad therapy. Among the many therapy, two couplet therapy and sanlian therapy have been frequently used. The two couple therapy mainly includes oral medicine and enema. Sanlian therapy are mainly Chinese medicine + static drops + enema, Oral medicine+enema+skin dialysis, Herbal medicine+enema+topical, Oral medicine+enema+point injection or apply medicine, acupuncture spurs and laser irradiation.
TCM diagnosis and treatment of oral liquid form, Specific syndrome type has not unified, needing further studies expert advice.
Among chronic complications of chronic renal failure of TCM therapy, currently reported more is renal malnutrition and renal anemia. The TCM treatment principle of renal malnutrition include nourishing kidney, spleen and stomach, invigorating blood, droping turbidity, clearing away heat and eliminating dampness. The TCM treatment principle of renal anemia include filling kidney essence, nourishing liver and spleen, tonifying qi and producing blood, removing stagnation and detoxification. There is treatment for combining traditional Chinese and western medicine treatment, still no Chinese medicine treatment. Also the formula has low degree of consensus.
〦xpert consultation
It is suggested using differentiation mixed by deficiency in the origin and excess in the superficiality in chronic renal failure of TCM. The doctors should determine the basic syndrome factor, form basic type certificate, according to the deficiency of the basic.
The basic types of syndromes of CKD 3-4 period include the syndrome of deficiency Ben(deficiency of spleen and kidney cured with xiangshaliujunzi soup; deficiency of qi and yin cured with shenqidihuang pill; deficiency syndrome of both liver and kidney yin cured with liuweidihuang soup and erzhi pill; deficiency syndrome of both spleen and kidney yang cured with jishengshenqi pill; deficiency of yang and yin cured with jinkuishenqi pill and erzhi pill), and the syndrome of excessive Biao(dampness syndrome; Dampness-heat syndrome; blood stasis syndrome; water-dampness syndrome; chaotic-toxic syndrome). We treat the syndrome of excessive Biao through increasing and decreasing some traditional herbs according the syndrome of deficiency Ben.
The TCM therapy of chronic renal failure complication renal anemia and malnutrition was suggested add herbals on the basis of TCM syndrome differentiation. There are two TCM treatment points of renal malnutrition, one is according to the clinical stages, before the azotemia period. Another is by severe malnutrition, that is light, medium malnutrition. Most experts think hemoglobin in 80 ~ 11 g/L can not use erythropoietin treatment, only TCM syndrome differentiation and treatment.
Renal malnourished therapeutic rule mainly adopts nourishing kidney, spleen and stomach, invigorating blood, droping turbidity. The basic formula contains huangqi, dangsheng, baishu, danggui, shudi, shanyurou, huaishan, taizisheng, dansheng, gouqi, xiulinpi. TheTCM treatment principle of renal anemia include filling kidney essence, nourishing liver and spleen, tonifying qi and producing blood, removing stagnation and detoxification. The basic formula contains beiqi, danggui, dangsheng, shudi, heshouwu, tusizi, baishu, gouqi, ajiao, xianlinpi, baishao, ziheche.
In the third round of expert advice, eight experts completely agree with the scheme,12 experts basic agree with the scheme in 20 specialists.
(2) Formulating clinical pathway based on TCM diagnosis of the optimization scheme
2. the clinical observation research of clinical pathway
Before and after the treatment of clinical pathway, symptoms of patient improved obviously, such as weakness and fatigue, eat less, floating face limb swelling, lumbar debility, mouth dry and bitter, nausea, chills limb cold, abdominal distension, move bowels dry(P<0.05或P<0.01). Compared with the results of medical statistics review, days, western medicine therapy cost, and inspection charges obviously reduced(P<0.05). Kidney and hospitalization expenses improved after the implementation of path. But there were non-significance difference with the retrospectively medical results.
Conclusion
1. The core of clinical pathway, combining traditional Chinese and western medicine, of Chronic renal failure in nondialytic period is TCM treatment scheme. This research primarily formulates TCM therapy of chronic renal failure in nondialytic period, through investigation of diagnosis and treatment TCM scheme of chronic renal failure nationwide, Literature research, and expert consultation. We preliminary made of TCM therapy of chronic renal failure in nondialytic period, which include traditional Chinese medicine combined therapy, and chronic complications of TCM therapy. Traditional Chinese medicine combined therapy include oral herbal medicine, Chinese patent drug, and traditional enema. We Preliminary determine the TCM syndrome differentiation, basic formula of oral herbal medicine, the basic Chinese medicine of enema, the TCM therapy point of Chronic complications.
2. With regard to the retrospective study, we determine target population and the exit criteria of path, total path time limit, implement processes of path on the basis of optimized scheme. Also we form path form, according to path form format issued by the state ministry.
3. The clinical pathway regulates the management of our hospital process, shortens hospitalization days, improves patient clinical symptoms; ensure the quality of medical treatment. Althoughthe total hospital expenses dropped, with the rising medical costs were no significant differences compared with statistical results. But the cost of western medicine and examination has obviously decreased with significant differences. Explanation of clinical pathway standardized management and strengthen the characteristics of the application. Renal improvement has no statistically significant differences, before and after treatment of clinical pathway. Further follow-up study is necessary.
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[89]刘汉胜,郭皖北,李建平,等.益肾排毒液治疗慢性肾功能衰竭尿毒症78例疗效观察.新中医,2003,35(7)：19-21
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[92]邵朝弟,李勇.肾安片治疗慢性肾功能衰竭30例临床研究.中医杂志,2003,44(3)：194-196
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[94]程锦国,董飞侠.芡实合剂治疗慢性肾功能不全胱抑素-C改变的临床观察.浙江中医杂志,2003,38(1)：24-25
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[96]刘润侠,许金玉.益肾降脂胶囊治疗慢性肾功能衰竭的临床观察.中国中西医结合杂志,2002,22(9)：714-715
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[129]王秀芬,刘会英,赵苍朵.真武汤配合灌肠治疗慢性肾功能衰竭108例.陕西中医,2006,27(4)：407-408
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[143]孙雪松.中药治疗慢性肾功能不全21例.中国中医药信息杂志,2000,7(11)：56
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