| Objective: To evaluate the clinical efficacy and safety of Jianpihuazhuo ointment and to provide theoretical basis and reference for its clinical treatment,the effect of Jianpihuazhuo ointment combined with basic western medicine treatment and simple application of basic western medicine treatment on patients with Decompensated ascites in liver cirrhosis with Dampness-filled spleen deficiency was observed.Methods: A total of 48 patients with Decompensated ascites of liver cirrhosis with Dampness-filled type of Spleen deficiency were included as standard and randomly divided into treatment group and control group.The control group(n = 24)was treated with simple basic western medicine(Regular work and rest;Dietary control of sodium intake;Adhere to antiviral and other etiological treatment;Supplement of albumin and diuresis for hypoproteinemia.);In the treatment group,24 cases were treated with Jianpi huazhuo ointment combined with basic treatment of western medicine.Total treatment: 12 weeks.The changes of TCM syndrome scores,Liver function indexes,Abdominal ultrasound indexes,Serum sodium value,Liver hardness value,Abdominal circumference and Body weight,24-hour urine volume and Clinical efficacy were recorded in both groups.The experimental data were integrated,and the statistical software SPSS 23.0 was used to select appropriate statistical methods for data analysis according to the data types of observation indicators(such as independent sample t test for measurement data,rank sum test for grade data,and chi-square test for counting data).Results α=0.05 was used as the test standard,and P≤0.05 indicated that the results were statistically significant.P > 0.05 indicated no statistical significance.Results: After 12 weeks of observation.The final research results are as follows:1.TCM symptom score treatment,abdominal distention,loss of appetite,fatigue,abdominal and lower extremities edema,thin stools and other TCM symptoms in 2groups were improved(P<0.05),the treatment group was better than the control group(P<0.05);There was no statistical significance in the TCM syndrome scores of sallow complexion and tongue pulse symptoms between the two groups(P>0.05).The total effective rate of treatment group was higher than that of control group(P <0.05).2.Liver functionAfter treatment,ALT,AST and TBIL in both groups were significantly decreased compared with before treatment,while ALB was increased,with statistical significance(P <0.05).The improvement of ALT,AST and ALB in treatment group was better than that in control group(P<0.05).There was no significant difference in TBIL value between groups(P >0.05).3.Liver hardness valueT test showed that after treatment,The hardness of cirrhosis in both treatment group and control group could be improved,with statistically significant difference(P<0.05).There was no significant difference in efficacy between the two groups(P> 0.05).4.Blood sodium comparisonAfter treatment,The serum sodium value of the treatment group and the control group increased,with statistically significant difference(P<0.05),and the treatment group was higher than the control group(P<0.05).5.Weight,abdominal circumference,and 24-hour urine volumeBoth the treatment group and the control group could improve the changes of Body weight,Abdominal circumference,and 24-hour urine volume,and there were significant differences compared with before treatment(P<0.05).The treatment group was better than the control group in improving the changes of body weight,and 24-hour urine volume(P<0.05).There was no significant difference in the improvement of abdominal circumference between the two groups(P>0.05).6.Ultrasound examinationAfter treatment,there was significant difference in Spleen thickness in the treatment group(P<0.05),but no significant difference in the control group(P>0.05).The improvement of Spleen thickness in treatment group was better than that in control group(P<0.05).There was no significant improvement in The internal meridian of portal vein trunk between the two groups(P>0.05).There were significant differences in abdominal moisture content between the two groups after treatment(P<0.05).Compared with the control group,the treatment effect of abdominal moisture content in the treatment group was significantly more effective(P<0.05).7.Clinical efficacy of the two groups after treatmentAfter 12 weeks of treatment,the total effective rate of the treatment group reached 87.5%.The total effective rate of the control group was79.1%.The therapeutic effect of the treatment scheme in the treatment group was stronger than that in the control group.8.Safety indicatorsAfter 12 weeks of treatment,the 48 patients in the treatment group and the control group showed stable vital signs,no abnormalities in the three routine tests,ECG,renal function and electrolyte,and no complications such as peritonitis,upper gastrointestinal bleeding and liver cancer,and no tendency of disease aggravation.Conclusions:1.Jianpi Huazhuo Ointment combined with basic western medicine treatment has a more significant effect on the clinical efficacy of patients with Decompensated cirrhosis ascites of Spleen deficiency and dampness,which is better than basic western medicine treatment alone in general.2.Jianpi Huazhuo Ointment has no obvious side effects after recent observation,and can be further promoted clinically. |