Background: Traditional Chinese herbal medicine (TCM) has been used to treat HIV/AIDS for more than 20 years. TCM has shown to improve the quality of life, protect liver function, alleviate clinical symptoms, and slow down the progression of HIV disease. Nevertheless, the exact mechanism of TCM in treating AIDS remains unclear. The following study investigates the clinical efficacy, mechanisms and targets of TCM in the treatment of HIV/AIDS patients. Methods: A prospective, open-label, 4-years long pilot study, which included 207 HIV-1-infected patients ware conducted at the HIV outpatient clinic of the Beijing Youan Hospital, Capital Medical University between January1, 2011, and December 30, 2014. Patients were divided into HAART group, which was treated with tenofovir (TDF)/lamivudine (3TC)/efavirenz (EFV); and TCM-HAART treatment group treated with a combination of HAART and TCM (which consisted of Astragalus, Licorice, Atractylodes, Yam, Medlar, Codonopsis, Salvia).HIV-specific T cell immune function and T cell subtype changes were detected using Elispot and flow cytometry, respectively. Results: Stronger HIV-specific T cell immune function was observed in TCM HAART group compared to HAART group (P<0.01). Naive CD4 T and CD8 T ratio were significantly increased in TCM-HAART group compared to HAART group at 24W and 72W (P<0.05 or P<0.01). In addition, no significant differences in memory CD4 T, memory CD8 T and Treg cells were found between groups. Conclusions: The obtained findings suggest that TCM can improve the immune function of T cells and promote immune reconstitution of the body. Funding: This study was supported by the National Natural Science Foundation of China (81603552); Beijing health system high level talent project (2015-3-100); Beijing Chinese Medicine Science and Technology Development Fund Planning Project (JJ2018-32); Beijing Liver Disease Research Institute Foundation (2018-2-1); Specific prediction and early stage diagnosis of molecular markers about liver cancer screening system and mechanism research platform (2016-2). Declaration of Interest: All authors no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Ethical Approval: The study protocol was approved by the ethics review committee of the Beijing YouAn Hospital, in accordance with the principles of the 2008 Declaration of Helsinki and the China regulatory authorities. Written informed consent was obtained from all participants before any study procedures were performed.
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