| ObjectiveAdopt out-patient cases from 2007.5 to 2009.2 for treatment at the Wuhan Hospital of TCM of medical research,we observe the Shugan Hewei therapy in the treatment of Piman Zheng.The purpose of this study is to investigate the effects of the treatment,in order to provide a basis for further clinical practice.Methodslclinical data:The topic adopt the single-blinded randomized controlled trial.The cases are selected from 2007.5 to 2009.2 out-patient clinic in Wuhan Hospital of TCM,according to the State Food and Drug Administration《The Guiding Principles of Clinical Research for New Drugs》(2003 version) to develop diagnostic criteria and efficacy criteria.We select the Ganwei Buhe type of Piman Zheng,235 clinical cases of this type of patients are divided into two groups at random,120 cases in treatment group and 115 cases in control group.2The medical usage:The cases in the treatment group uses Chaihu Shugan San,at every time 200 ml,twice a day,one hour after meal.The control group uses Qizhi Weitong Granule(the Third Pharmaceutical Co.Ltd.of Benxi,Liaoning;Approval Number: Z21021522),one pouch at every time,melt with boiled water,three times a day.3Curative effect assessment and Security testing:30 days after medication,we observe the curative effect of TCM Syndrome,points to improve,gastric emptying test,examination of the stomach by gastroscope and safety indicators such as blood regular test,liver functions(ALT,AST)and renal functions(BUN,Scr).4The Statistical methods:After 30 days,we analyze the data, the count materials are examined with x~2,the materials are examined with t-test and the grade materials with Ridit.Results1The curative effect of TCM Syndrome Analysis:The treatment group recover 25 cases of essential,39 cases of effective,42 cases of valid and 14 cases of invalid.The control group recover 17 cases of essential,34 cases of effective,31 cases of valid and 33 cases of invalid.There is significant difference between the two groups(p <0.01),the effects in treatment group are better than that of the control group.2The effective of the TCM symptoms integral calculus:The pre-treatment score of the treatment group are 20.60±1.80 points, after treatment the score are 8.60±1.15 points,the difference between them are 12.00±0.65 points.The pre-treatment score of the control group are 20.40±1.80 points,after treatment the score are 10.60±1.25 points,the difference between them are 9.80±0.55 points.There is statistically significant difference(p <0.01) between the two groups.The effects in treatment group are better than that of the control group.3The improvment of gastric emptying of the two groups:The gastric emptying function are significantly reduced in patients before treatment.It is improved after treatment,the difference between the two groups is significant(p<0.01).4The improvement in endoscopy of the two groups:There are varying degrees of mucosal hyperemia,edema,hemorrhage and erosion before treatment.The endoscopic features reduced the level in most of patients after treatment.There are significantly difference between the two groups(p<0.05),which indicate that the situation in the treatment group are better than that of the control group.5Analysis of the two groups of drug safety:We check the blood regular test,liver and renal functions before and after the treatment.There is no significant change(p> 0.05) in both of the two groups,which indicates that there are none toxic and side effects of the drugs.It is safe and reliable.The two groups have no badness and side-effects to the patients' bodies.ConclusionThe Shugan Hewei therapy for the treatment of Piman Zheng is very well,which can improve the TCM Syndrome points more than the control group.The therpy can improve the gastric emptying function and the performance in endoscopy of patients.Its therapeutic effect is better than the control group.While the clinical trial process,we do not see any side effects and adverse reactions of the drug,which suggest that the treatment is safe and reliable for Piman Zheng.
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