ObjectiveTo evaluat of Gan De Ning of tablet treated chronic hepatitis B liver,deficiency of both the liver and kidney,stagnated heat combined patients with syndrome of the safety and efficacyMethodsThe experiment used a randomized,double-blind,double-dummy,Gan De Ning of tablet and a positive drug Bifendate pills(1:1)of parallel control,multi-center research methods.in 48 cases that has been diagnosed with chronic hepatitis B liver,deficiency of both the liver and kidney,stagnated heat combined patients with syndrome,were randomly divided into experimental group and control group in accordance with the 1:1 ratioThe experimental group was given Gan De Ning of tablet + Bifendate simulated drug pills,the control group was given Bifendate pills + Gan De Ning simulated tablet The subjects were randomly assigned to receive six months of Gan De Ning of tablet or Bifendate pillsTreatment of stage is divided into conventional treatment period of three months and reduction of three-month period of two phases.in completion of six months after treatment,ALT returned to normal or decreased 75 per cent of the cases into the followed-up phase for three months.Conventional treatment of three months period:the experimental group of drug use: Gan De Ning of tablet 3 tablet/time,3 times/day;Bifendate simulated drug pills 5 tablet /time,3 times/day;control group of drug use:Bifendate pills 5 tablet/time,3 times/day; Gan De Ning simulated tablet;3 tablet/time,3 times/dayReduction treatment of three-month period:the experimental group of drug use:reducing the first month:Gan De Ning of tablet 3 tablet/time,tiwce/day;Bifendate simulated drug pills 5 tablet/time,tiwce/day:reducing the second month:Gan De Ning of tablet 2 tablet/time,tiwce/day;Bifendate simulated drug pills 3 tablet/time,tiwce/day; Reducing the thrid month:Gan De Ning of tablet 2 tablet/time,once/day;Bifendate simulated drug pills 3 tablet/time,once/day;control group of drug use:Reducing the first month:Bifendate pills 5 tablet/time,tiwce/day;Gan De Ning simulated tablet 3 tablet /time,tiwce/day.Reducing the second month:Bifendate pills 3 tablet/time,twice /day; Gan De Ning simulated tablet 2 tablet/time,tiwce/day;Reducing the thrid month: Bifendate pills 3 tablet /time,once/day;Gan De Ning simulated tablet 2 tablet/time, once/day.During the trial period patients may not be able to use the combined influence of the efficacy of the various reduced-transaminase and dissipated-jaundice of Chinese and Western medicine.Evaluation criteria:(1)Evaluation of the main indicators: ALT,AST;(2)A secondary effect of indicators:TCM Syndrome score;(3)Security indicators:before and after the treatment checked blood,urine routine,stool,renal function and ECG.ResultGan De Ning of tablet treated chronic hepatitis B,deficiency of both the liver and kidney,stagnated heat combined syndrome and the effect of drug control group of similar to bifendate pills,Gan De Ning of tablet found that the trial did not significantly adverse reaction,suggest that Gan De Ning of table treatment of chronic hepatitis B, deficiency of both the liver and kidney,stagnated heat combined syndrome is effective and safe drugs... |