| 1 BackgroudIn 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 methodsThis 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 literatureAncient 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 literatureWe 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 TCMWe 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 consultationWe 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 pathwayBy 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 Results4.1 Constructing of CHF clinical pathway with integrated traditional and western medicine4.1.1 Constructing of CHF Chinese diagnosis and treatment scheme4.1.1.1 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 literatureLiterature 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 TCMVeteran 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 consultationThrough 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 Conclusion5.1 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.
|
PDF Full Text Request