| Hemodialysis is one of main alternative therapeutic ways on which the patients of end-stage renal disease （ESRD） relays for existence. Along with economic development and reformation of medical system in our country, the patients of ESRD who are able to receive hemodialysis increase year by year.The purpose of modern hemodialysis is to improve the long-term survival rates and improving the qualities of life the in patients accepted hemodialysis. As technology increases the survival time of patients is extended. Now the patient’s five-year survival rate is over than75%, many patients can survive20years. However, those patients have many problems in physiology, psychology and social functions as well as associative qualities of life condition arousing general concern.Recently, many studies show that the physiology, psychology and social functions are very important influence factors except hemodialysis. Therefore, to find a new effective method that can improve the qualities of life in the patients accepted hemodialysis has been became the focus of clinical studies.The nutritional status is a very important influence factor of the qualities of life in the patients accepted hemodialysis. The key factor of malnutrition is that the inappetence, taste alteration and mental pressure lead to eating less caused by uremia. The Traditional Chinese Medicine considers that the influence factor mentioned above is due to the deficiency of spleen and the stomach. So regulating spleen and stomach can increase appetite and improving nutritional status and qualities of life in patients. Because of many patients accepted hemodialysis have to be controlled the quantity of drinking water, the Chinese herbal medicine and patent medicines are inconvenient in clinical application.Zusanli（足三里ST36） and Sanyinjiao（三阴交SP6） have the function of promoting health and strengthening the spleen and stomach, which was been tested by the modern medical research. We ever made the one-centre clinical research on improving the qualities of life in patients accepted hemodialysis by using regulating spleen-stomach moxibustion. The results displayed that regulating spleen-stomach moxibustion could improve partly the qualities of life in patients accepted hemodialysis. Until now we have not fund other relative study, so we continue to make this multi-central clinical study. 1Introduction:A multi-center randomized and controlled clinical trial were performed to evaluate the efficacy and safety of spleen and stomach meridian on improving the quality of life for end-stage kidney disease patients on maintenance hemodialysis, and establishing the elementary clinical practices and health care methods for patients with uremia.2Methods:2.1Case selecting and grouping:109cases of end-stage renal disease on maintenance hemodialysis were selected from three centers （namely, Wangjing Hospital of CATCM, Beijing Zhongguancun Hospital and Beijing Coal Group General Hospital） and divided into the observation group （58） and the control group （51） by stratified random method from June2008to January2010.2.2Treatments:Routine hemodialysis and medicine treatment Standard bicarbonate hemodialysis, dialysis2-3times weekly; routine hemodialysis therapy, including erythropoietin, iron for renal anemia, phosphorus binding （calcium carbonate）, Calcitriol or alfacalcidol alcohol treatment of secondary hyperparathyroidism, etc.Moxibustion methods:according to the environmental requirement of blood purification centre smokeless moxibustion was applied by using the paper tube moxa cone made by the Moxibustion Research Institute, Taizhou City, Jiangsu Province. Two points of Zusanli（足三里ST36） and Sanyinjiao（三阴交SP6）（alternating left and right selection） was selected, moxibustion per point1to2zhuang, with patients keeping warm feeling for the degree of local skin flushing, weekly treatment for2-3times.Group therapy and treatment:The treatment phase of the control group using Western conventional treatment methods, the observation group in Western conventional treatment given above moxibustion method. Follow-up phase of the both groups were followed up on Western conventional treatment methods. All patients of Both groups were treated4weeks as a course of treatment,3courses as a period of observation （total12weeks as the treatment period）, with3months as follow-up period observation, a total of the observation is6months.2.3Outcome measures2.3.1The quality of life: To evaluate the quality of life using by Kidney disease quality of life short form (KDQOL-SFTM1.3)2.3.2Symptom grading quantification score-assessing methodIn reference to the symptom grading quantification table in Clinical Research Guidance of New Chinese Herbal Medicine.2.3.3Nutritional statusSubjective assessment:the use of international standards and improved quantitative subjective evaluation form （Modified Global Assessment, the Quantitative Subjective MQSGA）.Objective indicators:measuring ALBã€HGB and grip strength.2.3.4Dialysis adequacyUsing URR and Kt/V to evaluate the quality of life with the United States Renal Disease Foundation, published in2002of kidney disease prognosis Quality Guidelines （National Kidney Foundation, USA. Kidney Disease Outcome Quality Initiative, NKF-K/DOQI）.2.4Statistical analysis:All of the data use SPSS13.0statistics software for statistical analysis. Metering information is used for statistical description ofx±S, the comparison between the two groups using the t-test, multiple sets of comparison using analysis of variance and two comparison with LSD. Count data comparison test with X2,P<0.05considers differences statistically.3The results:3.1Quality of lifeAfter treatment, two groups of patients with Physical function, General health, Energy,MQSGA scores and of the statistical analysis showed statistical differences, P<0.05.The difference was not statistically significant. And the treatment than before, the observation group with Physical function, General health, Energy, Symptoms problem list, MQSGA scores and of the statistical analysis showed statistical differences, by t test, P<0.05.Follow-up, the two groups of patients with Physical function, General health, emotional well-being, social function, energy, MQSGA scores and of the statistical analysis showed statistical differences, P<0.05. And the treatment than before, the observation group with Energy, symptoms problem list, cognitive function, MQSGA scores and of the statistical analysis showed statistical differences, by t test, P<0.05.3.2Symptom scores and syndrome curative effectAfter treatment, the two groups of patients TCM symptoms integral, by t test, P＜0.05, the difference was statistically significant.In the observation group, after treatment the scores of all the symptoms had some improvement with significant differences, P<0.05. In the control group, the scores of all the symptoms had not improvement with no significant differences, P>0.05.After treatment, the two groups of syndrome curative effect, the observation group got25.9%,37.9%effective, invalid36.2%; the control group got2.0%,13.7%effective, and not84.3%, compared to two groups, P<0.05, the difference was statistically significant.Follow-up, the two groups of patients TCM symptoms integral, by t test, P＜0.05, the difference was statistically significant.In the observation group, after treatment the scores of all the symptoms had some improvement with significant differences, P<0.05.In the control group, the scores of all the symptoms had not improvement with no significant differences, P>0.05. After follow-up, the two groups of syndrome curative effect, the observation group got24.1%,41.4%effective, invalid34.5%; the control group got2.0%,26.5%effective, and not71.4%, compared to two groups, P<0.05, the difference was statistically significant.3.3Nutrition3.3.1MQSGA subjective assessment:After treatment, the two groups of patients MQSGA subjective score were compared, P<0.05.The observation group patients MQSGA subjective nutrition score were compared with before treatment, P<0.05. The control group patients MQSGA subjective nutrition score were compared with before treatment, P>0.05. After treatment, the observation group patients normal nutrition is occupied62.1%, mild-to-moderate malnutrition accounted for37.9%; the control group normal nutrition is occupied43.1%, mild-to-moderate malnutrition56.9%, compared to two groups, the chi-square test, P<0.05, the difference was statistically significant.Follow-up the two groups of patients MQSGA subjective score were compared, P＜0.05.The observation group patients MQSGA subjective nutrition score were compared with before treatment, P<0.05. The control group patients MQSGA subjective nutrition score were compared with before treatment, P>0.05. Follow-up, the observation group patients normal nutrition is occupied70.1%, mild-to-moderate malnutrition accounted for29.3%; The control group normal nutrition is occupied41.2%, mild-to-moderate malnutrition58.8%, compared to two groups, the chi-square test, P<0.05, the difference was statistically significant.3.3.2Objective indicators evaluation results:After treatment, two groups of patients’albumin were compared with before treatment, P<0.05, the t test P<0.05, the difference was statistically significant.Follow-up, two groups of patients’albumin were compared with before treatment, P<0.05. The t test P<0.05, the difference was statistically significant.3.4Dialysis sufficiencyAfter treatment, the two groups of patients Kt/V, URR were compared, P>0.05, the two groups of patients Kt/V, URR were compared with before treatment, P>0.05.Follow-up, the two groups of patients Kt/V, URR were compared, P>0.05, the two groups of patients Kt/V, URR were compared with before treatment, P>0.05.4Conclusions:The results of the study has shown that regulating spleen-stomach moxibustion can improve the function of dialysis patients in Physical function, General health, Energy, Symptoms problem list,patients have beneficial influence on psychology, and then improve emotional well-being, social function, effects of kidney disease, cognitive function in the fields of the quality of life; can effectively relieve the clinical symptoms, and it has some therapeutic effect on the deficiency syndrome, improve the nutritional status in hemodialysis patients. And this smokeless moxibustion is convenient and safety, which is suitable for in blood purification center. |
