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

• Published in: 中国结合医学杂志：英文版 2013 (5), p.340-346
• Main Author: 王阶 李勇 汤艳莉 林洪生 吴欣芳 刘杰
• Format: Article
• Language: English
• Subjects: 临床试验; 人类免疫缺陷病毒; 患者; 治疗; 艾滋病毒; 逆转录病毒; 随机; 高活性
• ISSN: 1672-0415; 1993-0402

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.