This retrospective cohort study was conducted to explore the effect of traditional Chinese medicine (TCM) therapy on the long-term trends in CD4⁺ T-cell count among patients with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) who were treated with combined antiretroviral therapy (cART) over a 14-year period. A total of 721 individuals were treated with cART alone (cART group), and 307 individuals were treated with both cART and TCM (TCM + cART group). Among all enrolled patients with HIV/AIDS, 99.5% were farmers, 71.1% had more than 6 years of education, and 96.8% were infected with HIV via a paid blood donation. For those patients with HIV/AIDS who had a baseline CD4⁺ T-cell count of <350 cells/mL, the CD4⁺ T-cell count tended to increase to approximately 350 cells/mL more rapidly in the TCM + cART group than in the cART group, but when the baseline CD4⁺ T-cell count was ≥350 cells/mL, there was no difference between the cART and TCM + cART groups. For other patients with HIV/AIDS who had a baseline CD4⁺ T-cell count of 350-500 cells/mL, the CD4⁺ T-cell counts tended to increase slightly, but there was no difference between the two groups. For patients with HIV/AIDS who had a baseline CD4⁺ T-cell count of ≥500 cells/mL, the CD4⁺ T-cell counts tended to be maintained at a particular level, with no difference between the two groups. The results show that the effect of TCM on the CD4⁺ T-cell counts of patients with HIV/AIDS is related to the CD4⁺ T-cell level at the time of initial treatment. TCM can increase the CD4⁺ T-cell count among patients with HIV/AIDS who have a baseline CD4⁺ T-cell count of <350 cells/mL. Sex and age have a slight influence on the therapeutic effect of TCM.

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