| Objective:1.Access and collate literature related to Qi Deficiency Syndrome,and find out the research subjects,research hotspots and evolution trends of Qi Deficiency Syndrome.2.By observing the improvement of various observation indicators before and after the treatment of Qi Deficiency Syndrome,evaluate the efficacy and safety of modified renshen yangrong decoction to the experience summarized based on the method of regulating and invigorating archaeus in the treatment of Qi Deficiency Syndrome and provide reference for alleviating patients' symptoms,promoting clinical application and mechanism research.Method:1.Based on Gephi and Cite Space software,excavate the traditional Chinese medicine literature of Qi Deficiency Syndrome in the past 10 years.2.Using a multi-center,randomized controlled trial design,observe patients aged between 18 and 65 who visited the department of encephalopathy of Hubei Provincal Hospital of Traditional Chinese Medicine,the expert clinic of Hubei University of Traditional Chinese Medicine Guo Yi Tang,and the center for preventive treatment of disease in Wuhan Hospital of Traditional Chinese Medicine from March 2018 to March 2019.Subjects for the diagnosis of TCM Qi Deficiency Syndrome were randomly divided into the granule group or the decoction pieces group according to 1: 1ratio using a random number table method,with 50 cases in each group and a total of 100 cases.The granule group was treated with modified renshen yangrong formula granules,and the decoction pieces group was treated with modified renshen yangrong traditional decoctions.The two groups of patients were continuously taking the medicine for 8 weeks,and the patients were revisited in the fourth and eighth weeks.Observed the changes of two groups in the grading quantification scale of Qi Deficiency Syndrome,Fatigue Scale-14(FS-14),Fatigue Self-Assessment Scale(FSAS),Multidimensional Fatigue Scale(MFI-20),and CD4+/lymphocytes,Ig A,Ig G,Ig M,C3,C4 before and after the treatment,and evaluated the clinical efficacy of modified renshen yangrong formula granules and traditional decoctions in treating Qi Deficiency Syndrome.And by observing the changes of clinical commonly used safety indicators such as vital signs,blood and urine routines,liver and kidney function and 12-lead ECG before and after the medication,and asking the specific medication experience to evaluate the safety.Result:1.The number of Qi Deficiency Syndrome literatures is generally increasing.Li Zegeng et al are high-yielding authors.The research cooperation institutions are mainly concentrated on Beijing University of Chinese Medicine,Liaoning University of Traditional Chinese Medicine,Guang'anmen Hospital of China Academy of Chinese Medical Sciences,and Affiliated Hospital of Liaoning University of Traditional Chinese Medicine et al.Cooperation network is dense.Chinese medicine compound has emerged since 2018 in the Keywords,and the research frequency of Buzhong Yiqi Decoction is relatively high.2.In this study,100 cases were included,8 cases were dropped,and 92 cases were analyzed,including 46 cases in the granule group and 46 cases in the decoction pieces group.The main efficacy indicators: The decoction pieces group had clinical cure rate of 10.9%,a marked efficiency of 43.5%,effective rate of 30.4%,ineffective rate of 15.2%,and the total effective rate was 84.8%.The granule group had clinical recovery rate of 15.2%,significant efficiency of 28.3%,effective rate of 39.1%,and inefficiency of 17.4%,and the total effective rate was 82.6%.The total effective rate of the decoction pieces group was slightly higher than that of the granule group,but the difference between the two was not statistically significant(P>0.05).Secondary efficacy indicators: In terms of the symptoms scores of TCM syndromes,The symptoms scores of TCM syndromes in the two groups at week 4 were lower than those at week 0,with statistical differences(P<0.01,P<0.05).Except that there was no statistically significant difference between the score value of lazy speech at week 8 and week 4 in decoction pieces group(P>0.05),the symptoms scores of the two groups at week 8 decreased compared with week 4,with statistical differences(P<0.01,P<0.05).In addition to shortness of breath and fatigue,there were significant differences in scores between decoction pieces group and granule group at week 0(P<0.05),and there were no significant differences between the other symptom groups(P>0.05).In terms of the scale scores,the scores of the grading quantification scale of Qi Deficiency Syndrome,FS-14,FSAS,MFI-20 after treatment in the granule group and the decoction pieces group were all lower than those before treatment(P<0.05).However,there were no statistical differences between the two groups in reducing difference(P>0.05).In terms of immune function,the levels of CD4+ / lymphocytes,Ig A,Ig G,Ig M,C3,and C4 in the two groups increased to different degrees than before treatment(P <0.01,P <0.05).And only the difference of Ig G between the groups was significantly significant(P<0.05).Safety indicators: 8 cases of adverse reactions occurred in this study,including 4 cases(8.7%)in the granule group and 4 cases(8.7%)in the decoction pieces group.No abnormalities were found in Blood and urine routines,liver and kidney function and 12-lead ECG testing before and after treatment in the two groups.Conclusion:1.Qi Deficiency Syndrome is increasingly concerned by Chinese medicine researchers.In future research,researchers need to further strengthen cooperation and communication between different regions and integrate resources to jointly promote cross-disciplinary integration and development progress.2.This observation initially verified the effectiveness and safety of modified renshen yangrong decoction in the treatment of Qi Deficiency Syndrome,which provided a scientific basis for the clinical application of the empirical formula summarized by the research group based on regulating and invigorating archaeus method,and is of great significance to the inheritance and innovation of traditional Chinese medicine prescriptions.3.Modified renshen yangrong decoction can improve the symptoms of Qi Deficiency Syndrome to a certain extent,and its mechanism may be related to the regulation of the body's immunity. |
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