| ObjectiveTo systematically evaluate the clinical efficacy and safety of spleen strengthening and dampness eliminating intervention in IGR;to analyze the main active ingredients,key targets and signal pathway of Liujunzi Decoction in the treatment of IGR,and to establish the relationship between "effective ingredients target signal pathway",and to explore the multi-component,multi-target and multi-channel mechanism of action of the Chinese herbal compound in the treatment of IGR,so it can guide the clinical application better;to explore the clinical efficacy and safety evaluation of Liujunzi Decoction on blood glucose reversal and asthenia improvement in IGR(spleen deficiency and phlegm dampness syndrome),in order to be widely used in clinical.Methods1.Retrieve CNKI,WD,Pub Med and EMBASE databases,and incorporate them into the randomized controlled trial of spleen strengthening and dampness treatment for IGR published from the establishment of the database to December 2019.According to the bias risk of "Cochrane risk bias assessment tool" to evaluation report and use the Revman5.3 software to conduct data analysis.2.By using TCMSP database,Huayuan.net,Uni Prot database and search the related literature to obtain the main active components and targets of six traditional Chinese medicines in Liujunzi Decoction,and then construct the network map of drug target interaction.Screen the potential targets of diseases in OMIM database,TTD database and Genecards database,and use the Venny2.1 mapping software and String database to get the PPI network of the drug's components and diseases.Go and KEGG pathway enrichment analysis of core target protein was carried out by using Metascape database,and then get the main pathway and mechanism of Liujunzi Decoction in the treatment of the IGR.3.From November 2018 to December 2019,160 patients with pre diabetes mellitus(spleen deficiency and phlegm dampness syndrome)were selected from Wuqing traditional Chinese Medicine Hospital of Tianjin,Binhai New Area Traditional Chinese Medicine Hospital of Tianjin,Jinghai traditional Chinese Medicine Hospital of Tianjin and Nankai traditional Chinese Medicine Hospital of Tianjin.According to the random number table,the patients in the group were divided into control group(n=80)and experimental group(n=80).Health publicity was carried out in both groups.The experimental group was treated with the Liujunzi Decoction(Traditional Chinese medicine granules),while the control group was treated with the corresponding granules of traditional Chinese Medicine.All of them were expected for 3 months.Observe the changes of blood glucose normalization rate,FS-14 scale,FPG,2h PG,Hb A1 c,BMI,waist to hip ratio,blood lipid and safety indexes etc.Results1.13 studies were included in the first study.The results of the Meta-analysis were as follows:(1)Compared with use the basic life intervention only,the clinical effective rate of the prescription of traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness combined with basic lifestyle intervention in the treatment of the IGR was statistically significant(OR=4.83,95%CI[3.45,6.77],P<0.00001);(2)Compared with use the basic life intervention only,the change of the FPG of the prescription of traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness combined with basic lifestyle intervention in the treatment of the IGR was statistically significant(MD=-0.41,95%CI[-0.47,-0.35],P<0.00001);(3)Compared with use the basic life intervention only,the change of the 2h PG of the prescription of traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness combined with basic lifestyle intervention in the treatment of the IGR was statistically significant(MD=-1.02,95%CI[-1.25,-0.79],P<0.00001);(4)Compared with use the basic life intervention only,the change of the Hb A1 c of the prescription of traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness combined with basic lifestyle intervention in the treatment of the IGR was statistically significant(MD=-0.34,95%CI[-0.40,-0.28],P<0.00001);(5)Compared with use the basic life intervention only,the change of BMI of prescription of the traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness combined with basic lifestyle intervention in the treatment of the IGR was statistically significant(SMD=-0.85,95%CI[-1.07,-0.63],Z=7.63,P<0.00001);(6)Compared with use the basic life intervention only,the recovery rate of blood glucose the and conversion rate of diabetes of the prescription of traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness combined with basic lifestyle intervention in the treatment of the IGR was statistically significant(RR=2.95,95%CI[1.95,4.44],P<0.0001;RR=0.25,95%CI[0.09,0.71],P=0.01).2.Liujunzi Decoction is mainly composed of 143 main chemical components,such as sterols,5-methyl-8-methoxyisoflavones,quercetin,rutin,kaempferol,baicalein,etc.,81 key targets,such as IL6,GSK3 B,MAPK3,TP53,TNF,VEGFA,EGF,JUN,etc.,which are combined by multiple signaling pathways,such as endocrine resistance pathway,insulin signaling pathway,AMPK signaling pathway.3.Results of clinical study:(1)The recovery rate of blood glucose: after three months of intervention,the experimental group was statistically significant(P<0.05)compared with the control group in improving blood glucose normalization rate and reducing the conversion rate of diabetes;(2)FS-14 scale: After 3 months of intervention,the scores of the FS-14 scale of the two groups decrease,and the scores of FS-14 scale in the experimental group were statistically significant compared with those in the control group(P<0.05);(3)Body weight,BMI and the waist to hip ratio: After 3 months of intervention,the body weight,BMI and the waist to hip ratio of the two groups decrease,but there was no significant difference between the two groups(P>0.05);(4)FPG: After 3 months of intervention the two groups' s FPG decrease;the difference between the experimental group and the control group was statistically significant(P<0.05)at 2 and 3 months of intervention;the experimental group's intra group comparison was statistically significant(P<0.05)at 2 and 3 months of intervention;the control group's intra group comparison was not statistically significant(P>0.05)at 1,2 and 3 months of intervention(P>0.05);(5)2h PG: After 1,2 and 3 months of intervention,the two groups' s intra group comparison was no significant difference(P>0.05);after 3 months of intervention the difference between the two groups was statistically significant(P<0.05)(6)Hb A1c: after 3 months of intervention,the difference between the two groups was statistically significant(P<0.05);(7)Four items of blood lipid and non-HDL-C: After 3 months of intervention,the difference between the two groups was not statistically significant(P>0.05).Conclusion1.Prescription of traditional Chinese medicine with the effect of invigorating spleen and eliminating dampness can improve the clinical symptoms and blood sugar of the IGR patients,improve the quality of life of them and with a certain long-term effect and good safety;2.Liujunzi decoction plays a role in the treatment of the IGR through the cooperation of multiple components,multiple targets and multiple pathways;3.Liujunzi Decoction can improve the asthenia symptoms and blood sugar situation of the IGR(spleen deficiency and phlegm dampness syndrome),improve the rate of blood sugar normalization and reduce the conversion rate of diabetes,which is safe and reliable;the adjustment of lifestyle has certain effect on the improvement of body weight,BMI,waist to hip ratio and blood lipid. |
PDF Full Text Request