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 the...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 falling 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）. Conclusion： 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.展开更多
基金Supported by Chinese Ministry of Science and Technology(No. 2008ZX10005-004)
文摘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 falling 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）. Conclusion： 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.
