Effect Of Yiqi Pei Yuan On T-cell Subsets Of HIV/AIDS Patients With Incomplete Immune Reconstitution After HAART

ObjectiveHighly activeanti-retroviral therapy(HAART)is supposed to inhibit virus replication of HIV/AIDS patientseffectively,improve CD4+ T lymphocytes and restore the patients' immune function to a certain extent.But even in the case of viral suppression,there is still a small part(15~30%)of patients with HIV/AIDS can not achieve moderate immune reconstitution.Therefore,the present study aims to explore Yiqi Peiyuan on T-cell subsets of HIV/AIDS Patients with Incomplete Immune Reconstitution after HAART and safety of combination of Traditional Chinese medicines(TCM)and Western medicines through observing the changes of immunological indexeses before and after treatment.MethodsA randomized,double-blind,placebo-controlled approach was designed,80 cases of HIV/AIDS patients that met the inclusion criteria were randomly divided into treatment group and control group,35 cases in treatment group,35 cases in control group.Treatment group were treated by TCM Granule combined with HAART and control group were treated by HAART combined with placebo.The change of CD3+?CD4+?CD8+?CD45RA+?CD45R0+ counts,effective rate of immune reconstitution and changes of immune reconstitution disease involvedindexes and safety indexeswere compared between the two groups at five time points(before treating,3,6,9,12 months).Results1.Changes of CD3+ T lymphocytes:The number of CD3 cells in the experimental group showed an upward trend,the CD3 cell count increased significantly(P<0.05)after 12,15 and 18 months compared with pre-treatment,and there was no significant difference in the rest of the time;In the control group,the number of CD3 cells increased significantly after treatment in December and 18 months(P<0.05).There was no significant difference between the two groups after treatment in the change CD3 cell count(P>0.05).2.Changes of CD4+ T lymphocytes:CD4 cell count was higher than that before treatment after 9,12,15 and 18 months treatment,the difference was statistically significant(P<0.05);In the control group,CD4 cell count was higher than pre-treatment after treatment for 12,15,and 18 months,the difference was statistically significant(P<0.05).After 18 months of treatment,the increase of CD4 cell count in the experimental group was higher than that in the control group,the difference was statistically significant P=0.045).3.Change situation of CD8+ T lymphocytes:There was no significant difference between the two groups at each time point after treatment compared with baseline CD8+ cell count,There was no significant difference between the groups in the change of CD8+ cell count at each time point.4.Change situation of CD45RA+ T lymphocytes:CD45RA cell count was significantly increased in experimental group after treatment for 12,15 and 18 months(P<0.05),In the control group,the number of CD45RA cells was significantly increased at each time point after treatment for 12 months(P<0.05).There was no significant difference between the two groups in the change of CD45RA cell count in evey time point.5.Difference before and after treament in CD45RO+ T lymphocytes:After 12,15 and 18 months treatment,the CD45RO cell count was significantly elevated(P<0.01),CD45RO cell count in the control group was also enhancedat the three time points after 12 months treatment.There were no significant differences in the the change CD45RO cell count between the six monitoring sites in the two groups(P>0.05).6.Immune reconstitution efficiency:There was no significant difference between the two groups in the efficiency of immune reconstitution in the first 5 time points.The effective rate of immune reconstitution of treated group was53.33%(16/30),which was significantly higher than 28.57%(10/35)of control at the points of 18 month,the differences were statistically significant(P=0.039).7.Safeness index assessment:Safety quotas for instance,blood routine,urine routine,liver and kidney function were in the normal value of certain fluctuations in both groups before and after treatment,but there was no significant difference between the groups in the changes of indexes.ConclusionYiqipeiyuan Combined with western medicine antiviral therapy can enhanceCD4 cell count of patients with poor immune reconstitution in HIV/AIDS and improve effective rate of immune reconstitution.The combined application show good security.