The Study Of Treatment And Safety On Xiaoshui Navel Plaster With Ascites In Patients With Liver Cirrhosis

ObjectiveProspective study to observe the clinical efficacy and safety of Xiaoshui-navel-plaster in liver cirrhosis patients with ascites syndrome of blood and water stasis. The study is guided by the principle of TCM differentiation and treatment, which uses the Xiaoshui-navel-plaster acupoint application umbilical. To observe the clinical effect of the treatment of ascites in patients with liver cirrhosis and ascites with blood stasis syndrome by exerting drugs and acupoint meridians effect. At the same time to observe the safety of TCM eighteen antagonism kansui with Glycyrrhiza in the external aspects of the umbilicus.The clinical efficacy and safety of Xiaoshui-navel-plaster in the treatment of ascites due to cirrhosis were objectively evaluated by comparison with the treatment of ascites by western medicine. The clinical research foundation for the treatment of liver ascites by Xiaoshui-navel-plaster for external application of TCM, and lay the foundation for further research and development of hospital preparation.MethodsThis study collected in 2013 February to December 2014 in Guangdong Second Traditional Chinese Medicine Hospital Stomach outpatient inpatient, who diagnosed as blood stasis and water stop syndromes of liver cirrhosis ascites of patients with a total of 70 cases, according to the visiting sequence were randomly divided into treatment group and control group,35 cases in each.Xiaoshui-navel-plaster treatment group:after the morning urination using the water elimination paste umbilical, once a day, each time deposited umbilical 12 hours. The general western medicine treatment including limitation on water and sodium, etiological treatment, nourish the liver and reducing enzyme measures, without the use of diuretics, albumin and the traditional Chinese medicine preparation.control group:Western conventional treatment, including water restrictions, limiting sodium, cause of treatment, protecting the liver and other basic measures. Prohibit the use of diuretics and albumin.Course of treatment:treatment lasted seven days, seven days of follow-up after treatment.Validity index observation:to recorded the first day, third days, seventh days in patients with abdominal circumference (measured in the morning from supine on the level of the umbilicus) as the standard,24h urine volume, weight, abdominal distension integral, the first urine from paste umbilical therapy time and TCM symptom score. Abdominal B ultrasound score before and after treatment.Follow-up observation in treatment after 8 days observed two effective cases in patients with abdominal circumference (measured morning lying flat umbilical level standard),24h urine volume, weight, abdominal distension degree integral, ultrasound scores and skin irritation.Safety index observation:patients before and after treatment:blood, urine, stool routine+occult blood, liver function (alt, AST, bun, Cr), Pt prothrombin time, electrocardiogram and blood potassium, sodium measurement.Local skin irritation reactions:in the 1 day,3 days,7 days and treatment after 8 days, observe the sticking site skin allergic reaction and degree (erythema, edema, dry desquamation, burning, itching degree evaluation in fire water paste the skin irritation and sensitization rate).After data collection, the data were analyzed by SPSS13.0 statistical software package, and the data were expressed by the standard deviation, and the count data were t test.Results1、Comprehensive efficacy:treatment group (34 cases). The total effective rate was 85.29%, markedly effective rate 38.24%; 33 cases in the control group, the total efficiency of was 57.58%, markedly effective rate was 9.09%(P <0.05) in two groups of clinical efficacy between the treatment group than the control group.2、The TCM syndromes integral aspects:before treatment, the treatment group:7.42±15.06, the control group:15.03+6±38, the score of the two groups shows no difference. After treatment, the treatment group:5.52±6.15, the control group:10.55±6.25, compared with P<0.05 after treatment, the TCM syndrome of the treatment group was better than the control group.3、Ascites evaluation index:integration of ascites,24 hour urine volume, body weight difference, difference of girth, medicine pasting first micturition time:(1) the two groups of patients with abdominal distension integral treatment before the two groups had no significant difference (P >0.05). And in the treatment group compared before and after the test has a significant difference (P<0.05), after treatment, the treatment group and the control group with significant difference (P<0.05), group, the degree of abdominal distension treatment compared with the control group improved obviously. (2) two groups of patients with body weight difference, difference of girth,24 hour urine volume, ascites B integral comparison with differences (P< 0.05), and treatment group, the body weight, waist circumference reduction was significantly better than the control group,24h urine volume was higher than that of the control group; (3) the treatment group in plaster after first micturition time compared with the control group was significantly shorter, two groups compared with statistical difference (P<0.05), fire water paste with rapid onset. (4)the two groups patients with abdominal distention scores of the treatment no significant statistical difference (P >0.05), and in the treatment group compared before and after the test has a significant difference (P<0.05). After the treatment, the treatment group and the control group with significant difference (P<0.05), the treatment group, the degree of abdominal distention compared with the control group improved obviously.4、Follow-up:after the end of treatment, the eighth day of the follow-up, patients’weight, abdominal circumference, urine volume, abdominal distension score, ascites B ultra score, ultrasound score and treatment after compared no significant difference (P>0.05).5、Safety terms of symptoms:after treatment, the patients in the two groups of blood routine, urine routine, stool routine+occult blood, liver and kidney function, Pt prothrombin time, electrocardiogram, blood potassium blood sodium detection had no obvious abnormalities.2 patients had mild skin flushing, mild itching, no desquamation of pain and symptoms after withdrawal of the disappeared, sensitization rate was 4.5%, indicating that the fire water paste in ascites due to cirrhosis is safe and effective, no obvious side effects.ConclusionA treated by Xiaoshui-navel-plaster acupoint application umbilical of liver cirrhosis ascites effect faster, have certain curative effect, high safety, lasting effect and external use convenient. This study provides a new method for treating cirrhosis ascites, which is worthy of further clinical research and popularization.