| BackgroudThe core of Traditional Chinese Medicine(TCM)treatment for knee osteoarthritis is evidence-based treatment,whereby doctors give patients a clear diagnosis and appropriate treatment based on the identification of the symptoms.However,medical practitioners and scholars have different understanding and experience of the etiology of KOA and the theory of differentiation and typing.As a result,there is a wide range of TCM classification criteria for KOA,and the identification and typing of KOA is diverse and complex.There is a lack of standardized TCM typing to guide clinical research and treatment.Staging is also the mainstream form of treatment for KOA.The guideline for TCM diagnosis and treatment of knee osteoarthritis(2020 Edition),based on the Delphi method and the consensus conference method,revise the clinical staging of KOA into three stages:exacerbation,remission and recovery,based on the clinical presentation of patients.Further study of this staging,exploring the characteristics of the population in each stage,and exploring its correlation with TCM evidence and imaging,will help to formulate a more reasonable staging plan and guide clinical research and treatment.Objective1.Objective to summarize the traditional Chinese medicine(TCM)syndrome types of patients with knee osteoarthritis(KOA),and provide evidence-based medicine evidence for the standardization of TCM syndrome differentiation and treatment administration of KOA.2.To explore the correlation between clinical staging protocols in guideline for TCM diagnosis and treatment of knee osteoarthritis(2020 Edition)and factors such as TCM evidence and imaging,in order to provide a basis for identifying the superior aspects of TCM in the treatment of KOA and formulating staging treatment protocols.Methods1.A study on the Chinese medical evidence of osteoarthritis of the knee based on cluster analysis1.1 Develop clinical questionnaireThree clinical questionnaires were developed by clinical experts through a"brainstorming" process with reference to the relevant statements of KOA symptoms in authoritative publications such as Diagnostics of TCM,Internal Medicine of TCM,Standard for Diagnosis and Treatment of Diseases and Syndromes of TCM,Guiding Principles for Clinical Research of New Drugs of TCM and Guidelines for Diagnosis and Treatment of Common Diseases in Orthopedics and Traumatology of TCM.The "Case record form for osteoarthritis of the knee"(Appendix 1)includes three aspects of the patient’s general profile(age,sex,height,weight),structured case entries(chief complaint,trigger,past history,personal history)and imaging Kellgren-Lawrence classification,with a total of 53 specific entries;"Staging elements of osteoarthritis of the knee recording form"(Appendix 2)containing the core symptoms relevant to the staging determination,with a total of 23 specific entries;The"Record of elements of Chinese medicine evidence for osteoarthritis of the knee"(Appendix 3)includes two major aspects of local symptoms(skin condition of the knee,pain,movement,morphology)and overall symptoms(four diagnoses:looking,smelling,asking and cutting),with a total of 232 specific entries.1.2 Data collectionA total of 180 confirmed KOA cases,60 in each of the clinical phases of exacerbation,remission and recovery,were enrolled in the hospital outpatient or inpatient setting between September 2020 and December 2020.2 highly trained clinical information collectors were instructed by senior clinicians to interpret and complete the patient record forms in real time,and to take photographs of the tongue and imaging images for preservation.The data from the quality control audited cases were entered into EXCEL 2016 to form a data summary table.The information in the questionnaire needed to be quantified and recorded as 1 for symptom presence and 0 for absence.1.3 Data filtering and statisticsThe data related to the general condition of the patients and the elements of TCM evidence were screened and extracted,and the SPSS 22.0 statistical software was applied to cluster the patients.After deleting the symptoms with a frequency of<10%(i.e.the frequency of occurrence<18)and the symptoms with no discriminatory significance,the R-type cluster analysis method in systematic clustering was used.2.Correlation study of clinical staging of KOAInformation on clinical stage,gender,age,side,duration of illness,body mass index,imaging K-L classification and TCM syndromes were extracted from the data summary table and the differences between the different stages were analysed using SPSS 22.0 statistical software.The distribution of gender and TCM evidence type between different staging periods was tested by chi-square test,and those with differences between groups were combined with Cramer’s V test and Post hoc testing;the distribution of age,disease duration and body mass index were compared by one-way ANOVA;the distribution of K-L grading was compared by Kruskal-Wallis H test.The difference was considered statistically significant at P<0.05.Results1.A study on the Chinese medical evidence of osteoarthritis of the knee based on cluster analysisThe study included 180 patients,with a male to female ratio of 1:2.91.The ratio of the affected side was 1:1.02;The age ranged from 42 to 80 years old,with a median of 65 years old;The course of disease ranged from 0.25 to 360 months,with a median of 36 months;Body mass index(BMI)was 24.51±3.18;According to K-L classification,there were 3 cases(1.67%)in grade 0,29 cases(16.11%)in grade I,60 cases(33.33%)in grade II,66 cases(36.67%)in grade III and 22 cases(12.22%)in grade Ⅳ.Cluster analysis showed that KOA could be classified into five types:cold dampness syndrome,dampness heat syndrome,qi stagnation and blood stasis syndrome,liver and kidney deficiency syndrome,Qi and blood deficiency syndrome,which was more in line with clinical practice.According to this TCM classification standard,46 cases(25.56%)of cold dampness obstruction syndrome,38 cases(21.11%)of liver and kidney deficiency syndrome,37 cases(20.56%)of qi stagnation and blood stasis syndrome,34 cases(18.89%)of Qi and blood deficiency syndrome and 25 cases(13.89%)of dampness heat obstruction syndrome were included.2.Correlation study of clinical staging of KOA.Sixty cases in each of the phases of exacerbation,remission and recovery were included in this study..The general condition of the patients was the same as that of the previous study.(1)The gender distribution of patients in each stage:the ratio of male and female was 1:3 in attack stage and rehabilitation stage,1:2.75 in remission stage,and the difference was not statistically significant(χ2=0.058,P=0.971).(2)The age distribution of patients in each stage:65.00(59.00,68.75)years old in attack stage,66.00(59.25,70.00)years old in remission stage and 65.00(55.50,70.75)years old in rehabilitation stage,and the difference was not statistically significant(F=0.053,P=0.949).(3)The course of disease in each stage:29.50(12.00,60.00)months in attack stage,36.00(12.001,13.75)months in remission stage and 36.00(12.00,57.00)months in rehabilitation stage,and the difference was not statistically significant(F=0.870,P=0.421).(4)The BMI of patients in each stage:24.90±2.88 in the attack stage,24.41±3.51 in the remission stage and 24.23±3.13 in the rehabilitation stage,and the difference was not statistically significant(F=0.723,P=0.487).(5)The distribution of Kellgren-Lawrence staging in each stage:in the exacerbation phase from grade 0 to grade Ⅳ in the order of 1 case(1.67%),10 cases(16.67%),19 cases(31.67%),22 cases(36.67%),8 cases(13.33%);in the remission phase in the order of 0 cases(0%),5 cases(8.33%),20 cases(33.33%),29 cases(48.33%),6 cases(10.00%);the recovery period was 2 cases(3.33%),14 cases(23.33%),21 cases(35.00%),15 cases(25.00%)and 8 cases(13.33%)in that order..There was no significant difference(H=4.817,P=0.090),(6)The distribution of Qi stagnation and blood stasis syndrome,cold dampness syndrome,dampness heat syndrome,liver and kidney deficiency and Qi and blood weakness in the exacerbation period was 26 cases(43.33%),17 cases(28.33%),16 cases(26.67%),0 cases(0%),and 1 case(1.67%)in that order;in the remission period was 11 cases(18.33%),18 cases(30.00%),6 cases(10.00%),and 15 cases(25.00%),10 cases(16.67%);in the recovery period in the order of 0 cases(0%),11 cases(18.33%),3 cases(5.00%),23 cases(38.33%),23 cases(38.33%).The differences were statistically significant(χ2=83.726,P<0.001).There was a moderate correlation between the clinical stage and Syndrome types of TCM(Cramer’s V=0.482,P<0.001).In the attack stage,qi stagnation and blood stasis syndrome(ASR=5.3)and dampness heat syndrome(ASR=3.5)were more likely to appear,but liver and kidney deficiency syndrome(ASR=-4.9)and Qi blood deficiency syndrome(ASR=-4.2)were less likely to appear;There was no tendency of TCM syndrome type in remission stage;In the convalescent stage,the syndrome of liver and kidney deficiency(ASR=4.0)and Qi and blood deficiency(ASR=4.7)were more likely to appear,but the syndrome of qi stagnation and blood stasis(ASR=-4.8)was less likely to appear.Conclusions:1.Through cluster analysis,this study objectively summed up five TCM syndrome types of knee osteoarthritis,which were cold dampness syndrome,dampness heat syndrome,qi stagnation and blood stasis syndrome,liver and kidney deficiency syndrome and Qi and blood deficiency syndrome,which provided evidence-based medicine reference for the standardization of clinical syndrome differentiation and treatment of knee osteoarthritis.2.There were no differences in the distribution of patients in the three clinical stages of KOA:exacerbation,remission and recovery,in terms of gender,ageand body mass index,or in the disease duration and imaging K-L classification,but there was a moderate correlation with the TCM classification.In the attack stage,qi stagnation and blood stasis syndrome and dampness heat syndrome were more likely to appear,but liver and kidney deficiency syndrome and Qi blood deficiency syndrome were less likely to appear;There was no tendency of TCM syndrome type in remission stage;In the convalescent stage,the syndrome of liver and kidney deficiency and Qi and blood deficiency were more likely to appear,but the syndrome of qi stagnation and blood stasis was less likely to appear. |
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