| Objective:This study intends to observe the clinical efficacy of Xifeng Huashi Granules and the western medicine Pinaverium Bromide in the therapy of IBS-D(liver stagnation and spleen deficiency syndrome),and to verify and evaluate the clinical efficacy and safety of traditional Chinese medicine(TCM)Xifeng Huashi Granules,which in order to provide experimental basis for its clinical application.At the same time,using data mining technology to study and analyze the cases of Professor Tian Yaozhou in the diagnosis and therapy of IBS-D,summarize Professor Tian Yaozhou’s medication rules,and provide new therapeutic ideas for the clinic.Methods:This study includes two parts:clinical efficacy observation and data mining.The 96 subjects were randomly divided into a experimental group of 48 cases(TCM Xifeng Huashi granules treatment)and a control group of 48 cases(Western medicine Pinaverium Bromide 50mg orally three times a day),the course of therapy was 4 weeks;The subjects were followed up for the first visit and the fourth week of therapy.The scores of TCM syndromes,anxiety and depression scores,IBS symptom severity scores,IBS quality of life scores were compared between the two groups of subjects.Objectively evaluate the clinical efficacy and safety of TCM Xifeng Huashi Granules.At the same time,collect the cases that meet the diagnostic criteria and have effective TCM therapeutic method in the outpatient clinic of Professor Tian Yaozhou from September 2018 to December 2020,and record the basic information of the collected 183 patients,the syndrome types and prescriptions of the first consultation into the database,and use the statistical software conducts frequency analysis,cluster analysis and association rule analysis,combined with the clinical experience of the tutor,further summarizes the medication rule of Professor Tian Yaozhou in the therapy of IBS-D,and also provides more data for the effectiveness of Xifeng Huashi Granules support.Outcome:The clinical efficacy observation results show:1.Both the experimental group and the control group can effectively improve the clinical symptoms of TCM(P<0.01);and the curative effect of TCM Xifeng Huashi Granules is significantly superior than the western medicine Pinaverium Bromide(P<0.05),however,in terms of improving the "nerdiness" and "two threats fullness",the curative effect of TCM Xifeng Huashi granules is equivalent to that of western medicine Pinaverium Bromide(P>0.05).2.After therapy,the two groups of subjects could effectively reduce the SAS and SDS scores,relieve the severity of IBS symptoms,and improve the quality of life of IBS(P<0.01),and the curative effect of the TCM Xifeng Huashi Granules was significantly superior than that of the western medicine Pinaverium Bromide(P<0.01).3.The overall response rate of TCM Xifeng Huashi Granules in treating IBS-D is 89.58%,and the overall response rate of western medicine Pinaverium Bromide is 68.75%.4.Safety evaluation results:The enrolled subjects did not complain of discomfort during the therapy process,and no adverse reactions occurred.Data mining results display:1.Frequency analysis:183 patients have a total of 183 prescriptions.The total frequency of Chinese medicines herbs use is 2723 times,and a total of 96 Chinese medicines herbs are used.There are 40 Chinese medicines herbs used more than 10 times,accounting for 86.41%of the total frequency,and the use frequency is greater than 50%.There are 14 Chinese medicines herbs,which are raw licorice,coptis,fried white peony root,fried white peony,fried atractylodes,scutellaria,woody,Uncaria,Tribulus terrestris,parsnip,nutmeg,pomegranate peel,dried ginger,tangerine peel,and Patriniaceae.40 high-frequency Chinese medicines herbs can be divided into 12 categories according to their efficacy:deficiency medicine,heat-clearing medicine,Qi regulating medicine,astringent medicine,liver and wind soothing medicine,antiphlegm medicine,temperature-warming medicine,antidote medicine,dampness-reducing medicine,moisture-enhancing medicine,blood-promoting medicine,heat-clearing and phlegm removing medicine.The distribution of syndrome types is liver depression and spleen deficiency syndrome(62.84%),spleen deficiency and dampness syndrome(14.20%),spleen and stomach damp-heat syndrome(10.93%),cold-heat complex syndrome(10.38%),spleen and kidney yang deficiency syndrome(1.60%).2.Cluster analysis:Through the cluster analysis of 4 high-frequency Chinese medicines herbs,three cluster combinations were obtained:the first category:Poria,Codonopsis,Jiao Hawthorn,Liu Shenqu,Stir-fried Malt,Stir-fried Grain Sprout;Second category:Green peel,Galangal,Purslane;the third category:woody,fried atractylodes,uncaria,parsnip,white tribulus,pomegranate peel,nutmeg,coptis,scutellaria,fried white peony,paeoniaceae,tangerine peel,dried ginger,licorice.3.Association rule analysis:Using the Apriori algorithm to analyze the association rules of 40 high-frequency Chinese medicines herbs,the minimum support is 75%,the confidence is minimum 80%,Lift≥ 1.20,which can obtain 3 two-Chinese medicines herb association rules,29 three-Chinese medicines herb association rules,and 10 four-Chinese medicines herb association rules.Conclusion:1.The TCM Xifeng Huashi Granules can effectively improve the clinical symptoms of patients with IBS-D.Compared with the western medicine Pinaverium Bromide,it has the advantage of therapeutic effect.2.The safety of Xiefeng Huashi granules is high.3.Through data mining,it is found that Xifeng Huashi Granules are used as the basis for clinical therapy of IBS-D with a high usage rate and effective.It is suggested that TCM is safe and effective in treating IBS-D,and it is worthy of clinical promotion. |
