| Study Ⅰ:Objective:To search the literature related to cold and heat syndromes of rheumatoid arthritis(RA)and analyze its bibliometric characteristics.Methods:Keywords of "rheumatoid arthritis" and "cold and heat" were used to search the database of China National Knowledge Infrastructure(CNKI),Wanfang,Cqvip and Pubmed.The literatures for the classification of cold and heat syndromes in RA patients were further screened by reading the abstract and full text.The characteristics of the included literature including the publication year,the diagnostic criteria of western medicine,the classification criteria of TCM syndromes,whether the research has inclusion and exclusion criteria,whether the research approved by the ethics committee,and the included research indicators were analyzed.Results:A total of 25 relevant literatures were included by the search,and 23 of the included literatures were diagnosing RA patients using the RA classification standard developed by ACR in 1987 or(and)the ACR/EULAR in 2009;17 of them used several versions of the TCM syndrome classification criteria to classify the cold and heat syndromes of RA,and other 8 papers did not give a clear TCM syndrome classification criterion;21 papers specifically established patient exclusion criteria based on research characteristics;only 4 papers declared the approval by the ethics committee in the text;Erythrocyte sedimentation rate,C-reactive protein,rheumatoid factor,CD4 positive lymphocytes gene expression,age,disease course,joint swelling,joint tenderness,and 28 joint disease activities were outcome indicators with high frequency.Conclusion:At present,the academic community has not yet reached a unified consensus on the classification criteria of RA cold and heat syndromes.In the future,scientific methods should be used to reach relevant expert consensus.At the same time,clinical studies related to RA cold and heat syndromes should follow relevant regulations that obtain ethical review and approval.Study Ⅱ:Objective:To conduct meta-analysis of the clinical objective indexes of RA cold and heat syndromes,and to further clarify the clinical characteristics of RA cold and heat syndrome patients from the perspective of evidence-based medicine.Methods:The clinical literature related to RA cold and heat syndrome included in the bibliometrics was used to evaluate the quality of the literature based on the Agency for Healthcare Research and Quality’s cross-sectional study quality evaluation items,and the relevant clinical indicators of age,course of disease,28-joint disease activity score,erythrocyte sedimentation rate,C-reactive protein,rheumatoid factor,the general health of the patient based on the visual simulation score,number of white blood cells,number of red blood cells,number of platelets,immunoglobulin A,immunoglobulin M,immunoglobulin G,interleukin-8.Interleukin-10 and tumor necrosis factor-α data were extracted and converted into a unified type,and related data were merged using Review Manager 5.3.Results:A total of 11 clinical studies were included.The Agency for Healthcare Research and Quality’s evaluation of cross-sectional study quality evaluation items showed that 9 papers scored 8 points and 2 papers scored 7 points.Related data were merged using Review Manager 5.3,the results showed that the erythrocyte sedimentation rate[SD(random)=-9.26,95%CI(-12.46,-6.05),P<0.0001],C-reactive protein[SD(Fixed)=-1.80,95%CI(-2.21,-1.40),P<0.0001],28-joint disease activity score[SD(Fixed)=-t.01,95%CI(-1.19,-0.83),P<0.00001],rheumatoid factor[SD(Fixed)=-5.34,95%CI(-10.38,-0.30),P=0.04],the general health of the patient based on the visual simulation score[SD(random)=-9.50,95%CI(-19.11,0.12),P<0.00001],white blood cell count[SD(Fixed)=-0.81,95%CI(-1.25,-0.38),P=0.0002],number of platelet count[SD(Fixed)=-39.23,95%CI(-58.37,-20.09),P<0.0001],The indicators of the heat syndrome group were higher than the cold syndrome group.For immunoglobulin M[SD(Fixed)=73.49,95%CI(20.56,126.42),P=0.007],the cold syndrome group was higher than the heat syndrome group.Conclusion:There are clear differences in clinical objective indicators between patients with RA heat syndrome and patients with cold syndrome,which can provide a basis for the objectivization of RA cold and heat syndrome.Study Ⅲ:Objective:To collect clinical data of RA patients,explore the difference between clinical characteristics of RA cold and heat syndrome,and explore the key factors of RA cold and heat syndrome based on logistic regression,provide a basis for the objective syndrome differentiation of RA cold and heat syndrome.Methods:A total of 134 patients who met the RA diagnostic criteria revised by the American College of Rheumatology/The European League Against Rheumatism in 2009,were divided into a cold syndrome group and a heat syndrome group according to the theory of "syndrome differentiation of cold and heat".The patient’s clinical data of gender,age,course of disease,the number of tenderness of 28 joints,the number of swellings of 28 joints,the number of synovitis of 28 joints under ultrasound,the number of Doppler blood flow signals of 28 joints under ultrasound,the number of bone erosions of 28 joints under ultrasound,28-joint disease activity score,erythrocyte sedimentation rate,C-reactive protein,the general health of the patient based on the visual simulation score,rheumatoid factor,anti-cyclic citrullinated peptide antibody,anti-SSA antibody,anti-keratin antibody,antiperinuclear factor antibody,anti-nuclear antibody titer,white blood cell count,red blood cell count,hemoglobin,platelet count,urine specific gravity,triglycerides,total cholesterol,high-density lipoprotein cholesterol,low-density lipoprotein cholesterol,fatty liver(by ultrasound),blood immunoglobulin A,blood immunoglobulin G,blood immunoglobulin M,complement 3,complement 4,alanine aminotransferase,aspartate aminotransferase,γ-glutamyl transpeptidase,albumin,blood urea nitrogen,blood creatinine were collected.The differences in the above indicators between the 2 groups were compared.The univariate logistic regression analysis was used to select the variable P<0.10.Combined with clinical selection of representative factors,multi-factor logistic regression was further used to clarify the clinical feature factors of RA cold and heat syndromes.Results:Compared with the cold syndrome group,the number of tenderness of 28 joints,the number of swelling of 28 joints,the general health of the patient based on the visual simulation score,rheumatoid factor,the number of synovitis of 28 joints under ultrasound,the number of Doppler blood flow signals of 28 joints under ultrasound,the number of bone erosions of 28 joints under ultrasound,the erythrocyte sedimentation rate,C-reactive protein,blood immunoglobulin A,blood immunoglobulin G,glutamyl transpeptidase,28-joint disease activity score were higher,and the difference was statistically significant(P<0.05);hemoglobin and high-density lipoprotein cholesterol indexes were lower,and the difference was statistically significant(P<0.05).28-joint disease activity score,the number of Doppler blood flow signals of 28 joints under ultrasound,rheumatoid factor,erythrocyte sedimentation rate,the number of tenderness of 28 joints,and the general health of the patient based on the visual simulation score were included in the multi-factor logistic regression.The results showed that 28-joint disease activity score(OR=9.354,95%CI=4.225-20.707),the number of Doppler blood flow signals of 28 joints under ultrasound(OR=1.419,95%CI=0.942-2.137)were independent predictors of RA cold and heat syndrome.With the increase of 28-joint disease activity score and the increase of the number of Doppler blood flow signals of 28 joints under ultrasound in RA patients,the probability of heat syndrome was significantly increased.Conclusion:There are some differences in the clinical indicators of cold and heat syndromes in RA patients.The number of Doppler blood flow signals of 28 joints under ultrasound and the value of the disease activity of 28 joints are independent predictors of cold and heat syndromes. |
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