| Objective: 1.To observe the effect of Shenling Fuzheng capsule combined with HAART on peripheral blood T lymphocyte count in patients with HIV/AIDS in order to understand the status of cellular immune function in patients with HIV/AIDS.2.To observe the effect of Shenling Fuzheng capsule combined with HAART on the expression of immune activation marker HLA-DR in CD4+ and CD8+T cells after 6 months of treatment of HIV/AIDS patients,and to evaluate the clinical efficacy and safety of Shenling Fuzheng capsule combined with HAART in the treatment of HIV/AIDS.Methods: one hundred and ten patients with HIV/AIDS who met the inclusion criteria were randomly divided into two groups: experimental group(n = 55)and control group(n = 55).Among them,the experimental group was treated with Shenling Fuzheng capsule(oral,4 tablets at a time,3 times a day)on the basis of receiving the domestic standard high efficiency combined with antiretroviral therapy(Highly active antiretroviral therapy,HAART),a traditional Chinese medicine for invigorating the spleen and dispelling dampness.The control group will maintain the original HAART treatment regimen,The course of treatment of HIV/AIDS patients in two groups was observed for 6 months.before entering the group and 3 and 6 months after treatment,the patients in the two groups were treated for 6 months,and thepatients in the two groups were observed for 6 months before admission and 3and 6 months after treatment.The basic situation,peripheral blood T lymphocyte count,expression of immune activation marker HLA-DR molecule and clinical drug safety index of the two groups were dynamically tracked and evaluated,including:(1)Peripheral venous blood samples were collected and the effects of Shenling Fuzheng capsule + HAART on CD3+,CD4+,CD8+T lymphocyte count and CD4/CD8 ratio in patients with HIV/AIDS were analyzed by BD FACSCalibur flow cytometry.(2)Peripheral venous blood samples were collected and the expression of immune activation marker HLA-DR on CD4+T and CD8+T lymphocytes in two groups of HIV/AIDS patients was analyzed by BD FACSCalibur flow cytometry.(3)the basic conditions of the two groups of HIV/AIDS patients were recorded,and the safety indexes were detected before treatment and at the end of 3 and 6 months after treatment.SPSS22.0 was used to analyze the indexes of patients in each group,and the results of the study were summarized.Results: a total of 110 patients with HIV/AIDS,55 patients in HAART group and 55 patients in Shenling Fuzheng capsule + HAART group were enrolled in this study.after a 6-month course of treatment,91 patients were finally involved in the experimental analysis.the results were as follows:1.The completion of the case and the basic situation of the patient:(1)the main cause of shedding in the Chinese and western medicine group was poor drug compliance,accounting for 47.37% of the total number of shedding cases,while in the western medicine group,the main cause of shedding was drug side effects,accounting for 15.79% of the total number of shedding cases.The proportion of shedding in the Chinese and western medicine group was higher than that in the western medicine group.(2)both groups of HIV/AIDS patients were mainly middle-aged and elderly,male than female,the possible route of infection was heterosexual transmission.2.Effect of Shenling Fuzheng capsule combined with HAART on immune function of patients with HIV/AIDS:(1)The changes of CD3+T lymphocytes: in the comparison between the two groups,there was no significant difference in CD3+T lymphocyte count between the two groups before treatment and 3 and 6 months after treatment.In the intra-group comparison,the patients in the two groups were treated for6 months,There was no significant difference between before treatment and 3months after treatment(P > 0.05).(2)changes of CD4+T lymphocytes: after 3 and 6 months of treatment,the number of CD4+T lymphocytes in the two groups was significantly higher than that before treatment(P< 0.001),and the comparison between the two groups: at different treatment time points,There was no significant difference between the two groups(P > 0.05).(3)changes of CD8+T lymphocytes: the changes of CD8+T lymphocyte counts in the two groups changed with the passage of time.after 3 and 6months of treatment,the CD8+T lymphocyte counts in the two groups were significantly lower than those before treatment.There was no significant difference between the two groups at different treatment time points(P >0.001),but there was no significant difference between the two groups at different treatment time points(P > 0.001),but there was no significant difference between the two groups at different treatment time points(P >0.05).(4)the change of CD4/CD8 ratio: after 3 and 6 months of treatment,the ratio of CD4/CD8 in the two groups was higher than that before treatment,but there was no significant difference between the two groups at different treatment time points(P > 0.05).3.Changes of expression of immune activation marker HLA-DR on CD4+ and CD8+T lymphocytes and clinical safety analysis after 6 months of treatment in the two groups:(1)after 6 months of treatment,the expression of HLA-DR on CD4+ and CD8+T lymphocytes in both groups was significantly lower than that before treatment(P < 0.001).However,there was no significant difference between the two groups after 6 months of treatment(P> 0.05).(2)the results of safety index suggested that no damage caused by the change of liver and kidney function index was found during the observation period,and no adverse effect caused by the change of blood routine was found.After 3 and 6 months of treatment,some blood routine and liver and kidney function related indexes in the two groups were significantly different from those before treatment(P< 0.05),but both of them were within the normal range.There was no significant difference between the two groups at each time point(P > 0.05).Conclusion: in this study,through the evaluation and analysis of the existing sample size and observation period,the following conclusions are drawn:1.Shenling Fuzheng capsule combined with HAART can increase the CD4+T lymphocyte count of HIV/AIDS patients,increase the CD4/CD8 ratio of HIV/AIDS patients,and improve their immune function.2.Shenling Fuzheng capsule combined with HAART can reduce the level of immune activation in HIV/AIDS patients to a certain extent,which is animportant starting point for traditional Chinese medicine to intervene the immune activation state of acquired immunodeficiency syndrome.3.Shenling Fuzheng capsule combined with HAART showed no obvious side effects in the treatment of HIV/AIDS. |
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