| Highly active antiretroviral therapy(HAART) dramatically changed the course of HIV infection.Currently,this therapy in China involves the use of agents from at least two distinct classes of antivirals:a non-nucleoside reverse transcriptase inhibitor(NNRTI) in combination with NRTIs.Although these agents are highly efficacious in delaying the onset of AIDS,their clinical utility is limited by viral resistance,nonadherence to therapy, and drug toxicity.The treasure of Traditional Chinese Medicine have affluent experience and theories in the field anti-viral.From 1987,professors of China Academy of Chinese Medical Sciences commenced to research in treating AIDS with Traditional Chinese Medicine in Tanzania.The effect and safety of AILING granule was proved in Tanzania.1 ObjectiveThis prospective,randomized,single-blind,parallel-group study compared the efficacy and safety of AILING granule puls HAART(treatment group) with HAART puls placebo(control group) with HIV/AIDS patients for 24 months.2 MethodA total of 60 patients living with HIV were enrolled and divided randomly into two groups, HAART(AZT+3TC+NVP) puls AILING granule(treatment group) and HAART (AZT+3TC +NVP) pals placebo(control group),all the patients'symptoms and signs were investigated,and at the same time detecting immune function(CD4+T cells counts,CD8+T cells counts,CD4/CD8,CD4+CD45RA),viral load at baseline,the 3rd month,the 6th month,the 9th month,the 12th month,the 18th month and the 24th month,and testing dendritic cells at baseline,the 3rd month,the 6th month,the 9th month,and investigating salty by blood regular test,urine regular test,liver function,renal function,blood sugar, cholesterol,triglyceride,X ray and ECG at baseline,the9thand 24th month.3 ResultsIt showed that there were differences between two groups in accumulated scores of symptoms and signs at the 9th and 12th month(P<0.05),and significant differences at the 24th month(P<0.01 ).The treatment group was better than the control group in Karnovsky Score after the treatment(P<0.05).There were differences between two groups in CD4+T counts at the 9th and 12th month(P<0.05),the results showed the treatment group was better than the control group.The changes of the CD8 counts,CD4+CD45RA,the ratio of CD4/CD8 were similar in both groups(P>0.05 ).The percent of MDC and PDC and also were similar in both groups(P>0.05).The function of MDC was higher for patients treated with AILING granule at the 9th month(P<0.05).The function of PDC was statistically significant higher for patients treated with AILING granule(P<0.01).There were no difference between two groups in viral load(P>0.05).4 ConclusionAiling Granule puls HAART has the better effect of improving immune function(boosting CD4+ cell counts),relieving symptoms,and keeping viral load stabilization for the AIDS patients than HAART only.The compliance of patients was preferably.The antiretrovirus treatment combined with TCM is better safety than only HAART. |