Clinical Study And Cost - Effect Analysis Of Chronic Heart Failure Treated By Syndrome Differentiation

Objective:1. The purpose of this study was to evaluate the efficacy of Traditional Chinese Medicine (TCM) in the treatment of chronic heart failure(CHF) according to syndrome elements with randomized controlled clinical study objectively.2 Evaluation of pharmacoeconomics on treatment plan for chronic heart failure was made by cost-effectiveness analysis and cost-utility analysis.Materials and Methods1 In this study, a multi-center, randomized study was designed.112 CHF patients caused by coronary heart disease (CHD) and hypertension were collected in seven secondary hospitals of Chinese medicine. Patients were randomly divided into two groups, namely the treatment group (conventional western medicine+Chinese herbal medicine according to syndrome elements) and the control group (conventional western medicine). Four indexes were observed at baseline and 28 days, as the echocardiography, TCM symptom score, SF-36 questionnaire condensed condition, and scale for evaluating the quality of life in CHF with TCM and western medicine. The analysis implement was SPSS20.0 statistical software. The method to analysis included full analysis set and per-protocol set.2 Direct medical costs was only discussed in this pharmacoeconomics evaluation which divided into total charge,expenses for medicine and expenses of examination, so all receipts were collected referred to remedy for CHF happened during the observation no matter out-patient or in-patient.Results1 Randomized controlled trial1.1 Baseline data analysisThere was no statistical significance between two groups on basic demographic data as well as the basic disease condition. No statistical significance between two groups also exit on concomitant diseases, NYHA functional classification, the index of echocardiography, TCM syndrome score, (except weak breath,dizziness,soreness and weakness of waist and knees diuresis) the score of SF-36 (except emotional health)and scale for evaluating the quality of life in CHF with TCM and western medicine(P>0.05). 1 Effect analysis1.2.1 Comparison of the efficacy of NYHA functional classification① Comparison of the efficacy of NYHA functional classification distribution:There was a significant difference between two groups after treatment(P<0.05). ② Comparison of the improved level of NYHA functional classification:The improved level of NYHA functional classification in treatment group was similar to control group after 28 days’ treatment(P>0.05). ③ Effect analysis on NYHA functional classification in subgroups: Patients with NYHA Ⅱ got better improvement in treatment group than those in control group in comparison of the improved level of NYHA functional classification in FAS analysis as well as NYHA III happened(P<0.05). The reverse appeared in PPS analysis(P>0.05).1.2.2 The effective rate of symptoms①The score of symptoms:After 28 days’ treatment, the core of symptoms in treatment group was less statistically than that in control group (P<0.05). There was a significant difference within each group compared to pre-treatment at last time points (P<0.05). The result of PPS analysis was the same as that of FAS ② Effective rate of symptoms and signs:The effective rate of treatment group was higher than control group with remarkable difference(P<0.05) in FAS analysis. No difference showed in PPS analysis (P>0.05).1.2.3 Scale for evaluating the quality of life in CHF with TCM and western medicineFAS analysis:There was a significant difference on total score of the scale within each group (P<0.05) meaning the quality of patient life got better than before, while no statistical disparity between two groups after 28 days’cure (P>0.05). There were remarkablely different at all six separate terms within each group (P<0.05). Physical function in treatment patients made more progress than control group (P<0.05). The result of PPS did not differe with that of FAS.1.2.4 SF-36 scale score analysisFAS analysis:There was statistical difference between two groups on energy, social ability, emotional function and mental health (P<0.05), which mean patients improved higher in treatment group, while patients felt no difference on physical function, physical ability, body pain, general health and health change at post-treatment(P>0.05). Comparising to pre-treatment, patients felt better obviously within each group at following terms of physical function, body pain, social ability and health change (P<0.05).while treatment got higher score at some terms after observion, such as physical ability, general health, energy, emotional function (P<0.05).The situation in PPS was similar to that in FAS.1.2.5 Comparison of the efficacy of Left ventricular ejection fractionLeft ventricular ejection fraction (LVEF) has no significance between two groups after28 days’treatment(.P>0.05). The same result was observed in each group compared to pre-treatment (P>0.05).The result of PPS analysis was the same as that of FAS 1.2.6 The distance of 6MWT in treatment group was farther than control group with statistical difference (P<0.05). The patients in treatment group had more remarkable effect than control group compared to pre-treatment (P<0.05).There were no difference between FAS and PPS.2 Evaluation of pharmacoeconomics on CHF. 1 Comparison of cost:FAS analysis:There was no significant difference on total charge, expenses for medicine and expenses of examination between two groups (P>0.05). PPS analysis:There was no significant difference on total charge and expenses for medicine (P>0.05)except for expenses of examination (P<0.05).2 Cost-effectiveness analysis:① FAS analysis:The efficacy rate of treatment group was higher than control group(P<0.05). The cost effectiveness ratio of treatment group was lower than control group. PPS analysis:Cost minimization analysis was adopted as no significant difference appeared between the two efficacy rates which indicated the treatment group was the better one. ② LVEF:Cost minimization analysis was used to show that the treatment group was greater than control group as LVEF made no difference between two groups(P>0.05).③ 6MWT:The treatment group was superior to control group because of the low C/E by means of CEA. The situation in PPS was similar to that in FAS either in LVEF comparison or 6MWT.Conclusion:1 Treatment on CHF by discriminating syndrome elements could improve the score of symptoms, SF-36questionnaire and scale of chronic heart failure not only, but also make a progress on the quality of life.2 Treatment by discriminating syndrome elements was the better plan from the aspect of pharmacoecono mic s.