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| Effect of Immune No. 2 (免疫2号方) on the Immune Reconstitution in Patients with HIV/AIDS after Highly Active Antiretroviral Treatment: A Randomized Double Blind Placebo Controlled Clinical Trial |
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| KeyWord:HIV/AIDS, immune reconstitution, Immune No. 2 |
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| Abstract: |
| Objective: To observe the Immune No. 2 (免疫2号方) on the immune reconstitution in patients with human immunodeficiency virus or acquired immune deficiency syndrome (HIV/AIDS) after highly active antiretroviral therapy (HAART). Methods: A randomized, double-blind, placebo-controlled clinical trial was designed. 233 patients failing immune reconstitution after HAART were randomly divided into treatment group (116 cases) and control group (117 cases), respectively using Immune No. 2 plus HAART and placebo combined with HAART for 6 months. CD4, CD45RA, CD45RO cell numbers, as well as the symptoms, signs and integral improvement rates were observed in order to evaluate the immune reconstitution efficiency. Results: after the intervention for 1 month, the effective rate of the treatment group (18.97%, 22/116) was significantly higher than that of the control group (9.40%, 11/117) (P=0.02); 3 months after treatment, the effective rate of the treatment group (27.59%, 32/116) was no difference from that of the control group (22.22%, 26/117) (P=0.31); 6 months after treatment, the effective rate of the treatment group (34.48%, 40/116) was significantly superior to the control group (21.37%, 25/117) (P=0.02). CD4, CD45RA, CD45RO count of the treatment group was significantly higher than that of the control group (P<0.05). The total score of symptoms and signs in the treatment group was significantly lowered compared with the control group (P=0.02), and the improvement of fatigue, muscle and joint pain, pruritus and shortness of breath in the treatment group was better than the control group (P<0.05). Conclusions: Immune No. 2 can effectively improve the numbers of CD4 cells and its subgroups, as well as the main clinical symptoms and signs of patients after HAART, thereby promoting the immune reconstitution. |
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