Chinese Medicine Clinical Studies To Delay The Incidence Of Hiv Infection

Highly active antiretroviral therapy(HAART) is currently recognized as the most effective treatment on AIDS.It can effectively suppress the replication of HIV,but it still has some shortcomings such as time limit,expensive and toxic side effects.With the development of AIDS treatment,traditional Chinese medicine(TCM) has gradually appeared its advantages,which has less side effect and resistance.Once it was found to be infected with HIV,TCM can be used to protect the immune function,and the cost is not expensive.Since 1987,staffs in department of AIDS research of Guang'an men Hospital,China Academy of Chinese Medical Sciences participated in the project of TCM treatment on AIDS in Tanzania organized by the State Administration of TCM,and accumulated many clinical experiences on TCM treatment of AIDS.Ai-ling granule with the function of strengthening Qi,motivating blood and cleating away toxicity,is a proprietary Chinese medicine preparation which was developed in this project.In this study,randomized placebo-controlled experiment on HIV early infected cases is carried out to prove the efficacy and safety of TCM,especially its effect on delaying onset of AIDS,so as to find effective ways of TCM treatment for HIV infected cases.1.ObjectiveHIV early infected cases are treated with TCM in this randomized placebo-controlled study in order to test the efficacy and safety of TCM,and to explore its effect on delaying onset of AIDS.We hope provide an effective and economic TCM preparation for HIV infected people.2.MethodThis is a forward-looking and randomized placebo-controlled study,in which 90 HIV infected cases are intaked and divided into Treatment group,Ai Ling granule group and Placebo control group.30 cases are intaked in each group and observed for 12 months.We visited patients every month.At the 0,3^rd,6^th,9^th,12^th month we observed their clinical symptoms and tested the count of CD₄⁺T lymphocytes,CD₈⁺T lymphocytes,CD₃⁺T lymphocytes,CD₄/CD₈,and CD₄⁺CD₄₅RA;At the 0,6^th,12^th month,we tested the viral load and the safety indicators.3.Results After 12 months' Observation,results in aspect of signs and symptoms:symptoms in Treatment group and Ai Ling granule group were both developed and the total scores were decreased significantly,there were significant statistical differences(P＜0.01);In Placebo control group,total score of symptoms had been reduced to some extend,there was no statistical difference(P＞0.05).Comparison among groups:there were significant statistical differences(P＜0.01) of symptom total score among the 3 groups after treatment, Treatment group and Ai Ling granule group were better than the Placebo control group. Karnovsky Score in Treatment group and Ai Ling granule group were both significantly increased after treatment,and there were significant statistical differences(P＜0.01); Karnovsky Score in the Placebo control group had been increased also,but the difference was not statistically significant(P＞0.05).Comparison among groups:there were significant statistical differences(P＜0.01) of Karnovsky Score among the 3 groups after treatment,Treatment group and Ai Ling granule group were better than the Placebo control group.Results in aspect of immune indicators:there was significant statistical difference (P＜0.01) of CD₄⁺T lymphocyte count at the 3^rd,9^th,12^th month in Treatment group,and CD₄⁺T lymphocyte count was increased significantly at 9^th,12^th month;There was statistical difference(P＜0.01) of CD₄⁺T lymphocyte count at the 6^th month in Ai Ling granule group(P＜0.05),CD₄⁺T lymphocyte count was increased at 9^th,12^th month,but there was no statistical difference(P＞0.05).CD₄⁺T lymphocyte count was decreased from 6^th month in the Placebo control group,there was statistical difference at 9^th month (P＜0.05),and there was significant statistical difference at 12^th month(P＜0.01). Comparison among groups:there were statistical differences of CD₄⁺T lymphocyte count at 6^th month among the 3 groups(P＜0.05),and significant differences at 9^th,2^th month (P＜0.01).CD₄⁺T lymphocyte count were both increased in Treatment group and Ai Ling granule group,and Treatment group was better than Ai Ling granule group.CD₄⁺T lymphocyte count was decreased in the Placebo control group.CD₄⁺CD₄₅RA phenotype ratio analysis of 15 cases in Ai Ling granule revealed the ratio was higher after treatment, though there was no statistical difference(P＞0.05).Results in aspect of viral load:there were both no statistical differences of viral load in different treatment period of Treatment group and Ai Ling granule group(P＞0.05); Viral load in the Placebo control group was significantly increased at 12^th month,there was significantly statistical difference(P＜0.01).Comparison among groups:there were no statistical differences of viral load among the 3 groups(P＞0.05). Safety indicators:there were no significant changes in safety indicators,and no serious adverse events(P＞0.05).4.ConclusionThe symptoms were developed significantly by intervention of TCM on HIV early infected cases,and the CD₄⁺T lymphocyte count and CD₄⁺CD₄₅RA phenotype ratio were both improved to some extend.Viral load could be maintained at a relatively stable level, and TCM treatment on HIV infected cases was safe.TCM can delay onset of AIDS.