title: Effect of Immune No. 2 on the immune reconstitution in patients with HIV/AIDS after highly active antiretroviral treatment: a randomized double blind placebo controlled clinical trial.
abstract: OBJECTIVE
  To observe the Immune No. 2 (2) 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.
authors.affiliation: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Wang
authors.forename: Yong
authors.initials: Y
authors.lastname: Li
authors.forename: Yan-Li
authors.initials: YL
authors.lastname: Tang
authors.forename: Hong-Sheng
authors.initials: HS
authors.lastname: Lin
authors.forename: Xin-Fang
authors.initials: XF
authors.lastname: Wu
authors.forename: Jie
authors.initials: J
authors.lastname: Liu
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology*; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017493:Leukocyte Common Antigens / Q000378:metabolism; D008297:Male; D010919:Placebos; D019562:Viral Load
chemical_list: D004365:Drugs, Chinese Herbal; D010919:Placebos; C588016:immune no. 2; D017493:Leukocyte Common Antigens