| Objective The purpose of this clinical study was to observe the symptom scores of Traditional Chinese Medicine syndromes,Digital Symbol Test and Number Connection Test,liver function(ALT,AST,TBIL),Blood Ammonia(BA)and inflammatory cytokines(IL-6,TNF-α)in the Minimal Hepatic Encephalopathy patients after hepatitis B cirrhosis,by treating them with rhubarb decoction retention enema(vinegar rhubarb 30 g,ebony 30g).To evaluate the clinical efficacy and drug safety of this treatment in patients with Minimal hepatic encephalopathy.To explore the efficacy mechanism of rhubarb decoction retention enema in treatment of Minimal Hepatic Encephalopathy.And to provide a theoretical basis for the clinical treatment of Minimal Hepatic Encephalopathy.Methods(1)All cases were from the hospitalized patients in Wuhan General Hospital of Chinese People’s Liberation Army,Geriatrics,Gastroenterology and Infectious Diseases Departments from October 2015 to October 2017,53 cases diagnosed as the Minimal Hepatic Encephalopathy(MHE)caused by hepatitis B cirrhosis decompensation.Among the patients above,3 of the patients with MHE were exfoliated due to poor compliance or withdrawal from the test,the final inclusion of this clinical observation is 50 cases totally.(2)The control group was given comprehensive medical treatment actively,mainly including eliminating the causes,limiting the protein intake,protecting the liver,correcting the amino acid imbalance,correcting water and electrolyte imbalance and acid-base metabolic disorders,and then given Aspartate Ornithine 10 g into 5% glucose 250 ml,intravenous infusion,twice a day,course of treatment for 7 days.(3)On the basis of the control group,the treatment group was given 200 ml of rhubarb decoction once a day for 7 days.The best solution of the Rhubarb decoction retention enema treating the Minimal Hepatic Encephalopathy is the enema temperature 40 ℃,retention time of 120 minutes,intubation depth of 30 cm,enema right lateral position.The specific operation as follows: the enema used in the application were warmed to 40 ℃,50 m Lsyringe extraction,connected to the 14 th anal canal,the patient take the left lateral position to raise the buttocks,the anal canal gently inserted into the rectum 30 cm above the slow infusion of drugs Liquid,hand squeeze the buttocks squeeze the anus after extubation,oppression anal sphincter about 5min,after the operation turned to the right lateral position,the drug in the intestine as far as possible to maintain more than 120 minutes.(4)To observe the changes of Digital Symbol Test and Number Connection Test,the symptom scores of Traditional Chinese Medicine syndromes,liver function(ALT,AST,TBIL),Blood Ammonia(BA)and inflammatory cytokines(IL-6、TNF-α)and safety indicators.Results (1)The difference of basic information:the treatment group and control group,gender,age,duration and other aspects of the data by statistical tests,all P>0.05,indicating homogeneous with good clinical data comparable.(2)Comparison of NCT-A time and DST score before and after the treatment: After one week of treatment,the NCT-A time and DST score of the treatment group and the control group both improved compared with those before treatment,and the treatment group shortened the NCT-A time and increased DST scores better than the control group,the difference was statistically significant(P<0.05).(3)The change of TCM symptom scores before and after the treatment:,the Traditional Chinese Medicine symptom scores of the two groups are all improved after one week of treatment,and the TCM symptom score of the treatment group was better than that of the control group(P<0.05).(4)After one week of treatment,the clinical curative effect of TCM syndrome in the treatment group was obviously better than that in the other group,there are significant difference(P<0.05).(5)Comparison of liver function(ALT,AST,TBIL),blood ammonia(BA),inflammatory cytokines(IL-6、TNF-α)before and after the treatment: One week after the treatment,the liver function(ALT,AST,TBIL),blood ammonia(BA)and inflammatory cytokines(IL-6、TNF-α)of the treatment group and the control group all decreased.The reduction in the rhubarb decoction group was more marvelous to that in the control group(P<0.05).(6)Safety indicators: During the course of treatment,both groups of patients closely monitored the dynamic changes of vital signs such as temperature(T),pulse(P),respiration(R),and blood pressure (BP).Compare the results of all patients before and after treatment,such as the three major routines:blood analysis,urine analysis,stool routine and occult blood test.Routine inspection such as the electrolyte,coagulation and renal function,electrocardiogram and other safety indicators by statistical analysis,there were no statistical differences in the above indicators.(P>0.05).(7)Adverse reactions: There were no significant adverse reactions in both groups before and after treatment.One patient in the treatment group shedding(poor patient compliance)and two patients in the control group shedding(one patient voluntarily requested to withdraw from the trial and one patient was poor compliance).The remaining patients in the course of the test in good compliance,the treatment group and the control group of safe and reliable drugs,no obvious side effects.Conclusion(1)On the basis of comprehensive medical treatment,aspartate ornithine intravenous infusion combined with rhubarb decoction retention enema,can significantly improve the symptom scores of Traditional Chinese Medicine syndromes in the patients with Minimal hepatic encephalopathy,the clinical efficacy of traditional Chinese medicine syndrome is better than pure aspartate ornithine intravenous infusion.(2)On the basis of comprehensive medical treatment,aspartate ornithine intravenous infusion combined with rhubarb decoction retention enema,can significantly improve the NCT-A time and DST scores in the patients with Minimal hepatic encephalopathy,that is,to improve the patient’s neuropsychiatric situation.(3)On the basis of comprehensive medical treatment,aspartate ornithine intravenous infusion combined with rhubarb decoction retention enema,can significantly improve liver function(ALT,AST,TBIL),reduce blood ammonia and inflammatory cytokines(IL-6、TNF-α)levels,the effect is better than pure aspartate ornithine intravenous infusion. |