| Objective:The research based on the clinical research platform of traditional Chinese medicine(TCM)treatment of AIDS,a large sample and multi-center epidemiological survey method was used to retrospectively analyze the demographic and clinical data of patients with Immunological Non-Responders(INRs)after Antiretroviral therapy(ART).The population characteristics of INRs,influencing factors of INRs,distribution of TCM syndromes,and related influencing factors of traditional Chinese medicine syndromes were investigated,so as to provide scientific basis for clinical treatment of immune reconstitution.Methods:According to the inclusion criteria and exclusion criteria,data screening was conducted on the clinical research platform.The INRs patients were treated in the outpatient department of each sub-center from January 2014 to December 2021.Patients’ TCM syndrome types,demographic data,physical examination,current medical history,relevant symptoms and signs,immune reconstitution indicators,and laboratory test indicators were collected to establish a database.SPSS23.0 software was used to analyze the relevant data and evaluate the related influencing factors of immune reconstruction and TCM syndromes.Results:1.General data analysis:1017 HIV/AIDS patients were included,who were INRs and distributed in ten provinces and the majority of cases in Guangzhou,Henan,Beijing,Yunnan,and Xinjiang.There were 815 males,accounting for 80.1%of the total,and 202 females,accounting for 19.9%of the total.Their ages ranged from 40 to 60 years old,557 cases,accounting for 54.8%;the marital status was mostly married or cohabiting,accounting for 48.5%;patients with a history of allergies accounted for 5.3%;sexual transmission was the main route of transmission,with homosexual transmission accounting for 12.6%and heterosexual transmission accounting for 28.9%.Normal BMI accounted for 60.9%,thin accounted for 9.6%and overweight accounted for 29.5%.There were 768 cases of first-line antiviral treatment,accounting for 75.5%;5.8%of the patients had HBV infection and 5.6%had HCV infection.There were 646 cases with an average alcohol intake of less than 5g per day,accounting for 63.5%;there were 524 cases of smoking less than 3 cigarettes per day,accounting for 51.5%.The distribution of symptoms and signs such as cough,lassitude,anorexia,chills and cold,fever,sore throat,diarrhea,and other immune reconstruction-related indicators was mainly mild.2.Univariate analysis:There were significant differences in age,ART treatment time,whether transmitted by apheresis plasma,whether drinking alcohol,red blood cell count,CD4+T/CD8+T lymphocyte ratio and INRs group(P<0.05).The results of multiple comparison showed that the age of group C(ART treatment for more than 4 years,CD4+T lymphocyte count<500 μL-1)is greater than group A(ART treatment for more than 1 year and less than 2 years,CD4+T lymphocyte count<200 μL-1),and group A is greater than group B(ART treatment for more than 2 year and less than 4 years,CD4+T lymphocyte count<350 μL-1).The difference in age distribution among the three groups was statistically significant(P<0.05).The transmission rate of patients in group B was 14.5%higher than that in group A(4.4%)(P<0.05).The transmission rate of patients in group C was 15.7%higher than that in group B(14.5%)(P<0.05).In level of "average" alcohol consumption,Group C was 14.9%higher than group A(12.4%)(P<0.05).There were statistical differences in CD4+T lymphocyte level and CD4+T/CD8+T ratio between group A and group B,group A and group C(P<0.05),group B was higher than group A,group C was higher than group A.3.Multivariate analysis:CD4+T lymphocyte count was used as the dependent variable,and the factors with statistically significant results of univariate analysis were used as independent variables,and multiple hierarchical linear regression analysis was included.It was concluded that CD4+T/CD8+T lymphocyte ratio(β=94.239,P<0.001)and ART treatment time(β=3.202,P<0.05)had a positive effect on CD4+T lymphocyte count.4.Distribution of TCM syndromes:Among the 1017 patients with Immunological Non-Responders of HIV/AIDS,there were 681 cases of spleen and kidney yang deficiency syndrome,accounting for 67.0%,135 cases of Qi and Yin deficiency syndrome,accounting for 13.3%;104 cases of damp-heat intrinsic syndrome,accounting for10.2%;67 cases of lung and spleen deficiency syndrome,accounting for 6.6%and 30 cases of qi deficiency and blood stasis syndrome,accounting for 2.9%.In terms of regional distribution,the spleen kidney yang deficiency syndrome is more common in Henan,followed by Chongqing;The deficiency of both lungs and spleen is more common in Henan and Guangzhou,followed by Yunnan;Syndrome of dampness and heat accumulation is more common in Yunnan,Xinjiang,Sichuan,and Guizhou,followed by Beijing and Guangzhou.5.Analysis of related factors of TCM syndromes:Through comparative analysis between syndromes showed that age,gender,BMI,CD4+T lymphocyte,CD8+T lymphocyte levels were significantly different from the five syndromes of spleen and kidney yang deficiency syndrome,lung and spleen deficiency syndrome,damp heat syndrome,qi deficiency and blood stasis syndrome,and qi and yin deficiency syndrome in INRs patients(P<0.05).There is a significant difference between the symptoms of colds,fever,sore throat,diarrhea,and non infectious rash and the three traditional Chinese medicine syndromes of spleen and kidney yang deficiency,lung and spleen deficiency,and dampness heat accumulation(P<0.05).There is a significant difference between different TCM syndromes and INRs groups(P<0.001).In the analysis of traditional Chinese medicine syndromes,there are more males(815 cases,80.14%)than females(202 cases,19.86%),and most patients aged 40-60(557 cases,54.77%).Most patients’ BMI within the normal range,there is no significant difference among different syndromes within the normal BMI category;In the category of leanness,the proportion of lung and spleen deficiency syndrome is higher than that of dampness heat internal accumulation syndrome,and the proportion of qi deficiency and blood stasis syndrome is higher than that of dampness heat internal accumulation syndrome(P<0.05).In the category of overweight,the proportion of spleen and kidney yang deficiency,dampness heat accumulation,and qi yin deficiency is higher than that of qi deficiency and blood stasis,and the difference is statistically significant(P<0.05).The probability of colds and fever in spleen kidney yang deficiency syndrome and lung spleen deficiency syndrome is higher than that in dampness heat internal accumulation syndrome(P<0.05);The probability of throat pain,diarrhea,and non infectious rash in spleen and kidney yang deficiency syndrome is higher than that in damp heat internal accumulation syndrome(P<0.05).Compared with the syndrome of spleen and kidney yang deficiency,lung and spleen deficiency,and dampness heat internal accumulation,symptoms such as colds,diarrhea,sore throat,fever,and non infectious rash are more likely to occur according to their distribution frequency;At the CD4 and CD8 count levels,the frequency of syndrome distribution is:Qi deficiency and blood stasis syndrome is the most common,followed by dampness heat internal accumulation syndrome,spleen and kidney yang deficiency syndrome,lung and spleen deficiency syndrome,and Qi and yin deficiency syndrome;The spleen kidney yang deficiency syndrome and the dampness heat internal accumulation syndrome are more prone to severe immune reconstitution dysfunction compared to the qi yin deficiency syndrome.Conclusions:1.CD4/CD8 ratio and ART treatment time are independent influencing factors for immune reconstitution,with a positive correlation with CD4+T lymphocyte count levels.2.In terms of the distribution of traditional Chinese medicine syndromes,spleen and kidney yang deficiency syndrome is the most common,followed by qi yin deficiency syndrome,dampness heat accumulation syndrome,lung spleen deficiency syndrome,and qi deficiency and blood stasis syndrome.3.Age,gender(female),high BMI,low BMI,CD4+T lymphocyte,CD8+T lymphocyte levels,whether suffering from a colds,fever,sore throat,diarrhea,non-infectious rash,and the severity of poor immune reconstitution are the influencing factors of traditional Chinese medicine syndromes in INRs. |