| Obj ection:Systematic evaluation of the efficacy and safety of traditional Chinese medicine applied umbilical therapy for cirrhosis ascites,and further verification through standardized clinical research,thus providing a basis for clinical application.Method:(1)Cochrane systematic reviews were focus on systematic searching clinical observation studies randomized controlled trials in five databases,including CNKI,Wanfang data,VIP,CBM and PubMed.The search date was 1989.1-2019.1.We used the bias risk assessment criteria recommended by the Cochrane Collaboration to evaluate the quality of the included studies,and Review Manager 5.3 software for meta-analysis(2)Clinical observations were based on a prospective,random,double-blind and parallel controlled trial.Forty patients.are randomly divided into the treatment group and the control group,both of two groups were treated ten plus or minus three days.The patients of treatment group were treated with traditional Chinese medicine applying umbilicus combined with western medicine routine therapy,while the patients of control group were treated with western medicine and herbal placebo.All of them were applied umbilicus for two hours,once a day.We used IBM SPSS Statistics 20 software to entry data and statistical analyze efficacy(treatment efficiency,body weight,abdominal circumference,24-hour urine volume,ultrasonic ascites depth,etc.)and safety(routine blood test,routine urine test,routine stool test and occult blood test,blood biochemical examination,ECG,etc.)evaluation index before and after treatment.Result:(1)Systematic review:A total of 321 related studies were retrieved,and the language types were all in Chinese.After screening,10 studies were included,including 728 subj ects.Meta-analysis results showed that the total treatment efficiency(OR=2.89,95%CI=[1.95,4.30]),body weight(WMD=-4.82,95%CI=[-7.61,-2.02]),abdominal circumference(WMD=-6.64,95%CI=[-9.73,-3.55]),24-hour urine volume(WMD=181.94,95%CI=[-34.92,414.08]),ALT(WMD=-3.98,95%CI:[-5.94,-2.01]),AST(WMD=-3.49,95%CI:[-5.27,-1.70]),the treatment group was superior to the control group(P<0.05).Report analysis of adverse reaction events showed that Chinese medicine applied umbilical therapy for the treatment of cirrhosis ascites has better safety.(2)Clinical research:In terms of treatment efficiency,the total treatment efficiency of the treatment group was 95%,and the total treatment efficiency of the control group was 68.42%.The effective rate of the treatment group was better than the control group(P=0.029<0.05).In terms of body weight,abdominal circumference,24-hour urine volume and ultrasonic ascites depth,the treatment group had better body weight,abdominal circumference and 24-hour urine output after treatment than the control group(P<0.05).In terms of liver function,there were significant differences between ALT,AST,LDH in the treatment group and ALT,AST,GGT,LDH in the control group before and after treatment(P<0.05).In the evaluation of TCM symptoms,the efficacy of TCM symptoms in the treatment group was more effective than the control group(P=0.044<0.05).In the treatment group,the improvement of TCM symptom scores such as anorexia greasy,limbs,and drowsiness was better than that of the control group(P<0.5).In terms of safety,there was no significant difference in blood routine,urine routine,renal function,ion and ECG between the treatment group and the control group(P>0.05),and no adverse reaction occurred during the test.Conclusion:Traditional Chinese medicine applied umbilical therapy for the treatment of cirrhosis ascites has good curative effect and safety,especially in improving body weight,abdominal circumference and 24-hour urine volume.In the future,it is necessary to carry out in-depth multi-center,large-sample randomized controlled trials and develop corresponding standard operating procedures to provide evidence-based medical evidence for the treatment of cirrhotic ascites with traditional Chinese medicine applied umbilical therapy. |
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