| Objective:The purpose of this study was to observe efficacy and safety of JiangqianZhiXie decoction in antibiotic associated diarrhea patients with Spleen-kidney Yang deficiency Syndrome.Methods:This study was a random,controlled clinical study.60 cases of AAD patients were recruited from Chinese Academy of Chinese Medical sciences.Wangjing Hospital on 2017 January to 2017 December.This study included 28 males and 32 females(male to female ratio 1:1.07).The mean age was 81.24 plus or minus 8.09 years.Inclusion criteria:Reference to "western medicine in 2001,the ministry of health hospital infection diagnostic criteria(trial)",antimicrobial cid-associated diarrhea diagnosis standards,with reference to refer to the internal medicine of traditional Chinese medicine(the second edition of new century,Professional books on traditional Chinese medicine,2007),Chinese medicine refers to the internal science of traditional Chinese medicine(the second edition of traditional Chinese medicine in the new century),the guidelines for the diagnosis and treatment of digestive diseases in traditional Chinese medicine and the guiding principles for the clinical research of new drugs in TCM(China medical science and technology press,2002).It was randomly divided into treatment group had 30 cases,control group had 30 cases.The treatment group was treated with JiangQianzhixie decoction,and the specific drug composition was:dried ginger 10g,gordon euryale seed 30g,fried atractylodes macrocephala koidz 20g,dangshen 20g,fupian 6g,agastache rugosus 10g,fangfeng 10g,and licorice 3g.In the morning and evening,each 100 ml was fed by oral or nasal.Metronidazole tablets 0.2g,three times a day,oral or nasal feeding;Bifidobacterium triplex live bacteria capsule was once 630mg,three times a day,with oral or nasal feeding.Both groups were treated for 7 days.The control group was treated with metronidazole tablet+bifidobacterium triplex.Symptom integral evaluation:Before treatment,3 days.7 days and a week after stopping drug,the total integrals and individual scores were evaluated respectively on the TCM and western medicine symptoms of scores.Safety evaluation:one week before and a week after stopping drug,the safety indexes of routine blood、routine urinary、stool rootine pluse Latent blood、Liver and kidney function、Blood sedimentation、Electrocardio-gram will be evaluated.Results:A total of 58 cases were observed,including 30 in the treatment group and 28 in the control group.l.Symptom scores evaluation:(1)General information comparison:Treatment group and control group patients’age,height,gender,weight and other demographic data and the basic vital signs such as systolic pressure,diastolic pressure and pulse are no statistical difference.There was no statistically significant difference between the total score of TCM symptoms andthe total score of western medicine before treatment and the scores of individual symptoms(P>0.05),It’s comparable.(2)Overall efficiency evaluation:The overall effectiveness of TCM symptoms in the treatment group and the control group was 3 days3(53.33%VS21.42%),7days(70%VS42.86%),a week after stopping drug(73.33%VS46.43%),and the differences were statistically significant(P<0.05).The overall effect of western medicine was 3 days(60%VS25%),7 days(66.67%VS36.67%),a week after stopping drug(70%VS42.86%),and the difference was statisticall-y significant(P<0.05).(3)The TCM symptom assessment:After 3 days,7 days and a week after stopping drug treatment,the total score of TCM symptoms in the treatment group and the control group was significantly lower than that before treatment,and the difference was statistically significant(P<0.05).The overall improvement of TCM symptoms was better than that of the control group.The scores of individual symptoms were significantly reduced in 3 days,7 days and a week after stopping drug before treatment(P<0.05).The overall improvemen-t of TCM symptoms was better than that of the control group.All the individual symptom scores were significantly lower than before treatment in 3 days and 7 days(P<0.05).The 7 days later and a week after stopping drug after the treatment group defecation,abdominal distension and abdominal pain,bowel singing,stomach and abdominal overfill,fear of cold feet、loss of appetite、the waist knee ache,with a single symptom integral drop degree was better than that of control group,the difference has statistical significance(P<0.05).The results showed that the treatment group had significant curative effect,and could effectively improve the symptoms such as diarrhea,abdominal distension and abdominal pain,bowel singing,stomach and abdominal overfill,fear of cold feet,loss of appetite,and knee pain.(4)Western medicine symptom evaluation:The treatment group and the control group were significantly reduced in the treatment of western medicine symptoms in 3 days,7 days and a week after stopping drug,and the difference was statistically significant(P<0.05).The total score difference of the treatment group was higher than the control group after 7 days and a week after stopping drug,and the difference was statistically significant(P<0.05).The decrease of the symptom score of the frequency of diarrhea and shit character in treatment group was higher than that in the control group,and the difference was statistically significant(P<0.05).2.The safety evaluationThere was no significant adverse reaction between the two groups during the whole intervention.Clinical observation of 58 patients before and a week after stopping drug of routine blood routine,urinary routine,routine+latent blood,liver function(ALT,AST),renal function(BUN,CRE)and electrocardiogram were not abnormal.Conclusions:l.The effect of JiangQianZhiXie Detection in the treatment of spleen-kidney Yang deficiency on Antibiotic associated diarrhea was more effective than that of western medicine.2.JiangQianZhiXie decoction can effectively improve the symptoms of Chinese medicine and western medicine in patients with spleen-kidney Yang deficiency type AAD,especially for the improvement of the patient’s defecate diarrhea,abdominal distension abdominal pain,bowel singing,fear of cold limbs,stomach and abdominal overfill,loss of appetite,waist-knee pain.3.TCM treatment of spleen and kidney Yang deficiency type AAD was safety,no side effects. |
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