Antiretroviral Therapy combined with Shenling Guben Granules for the treatment of HIV infection with immune reconstitution deficiency:a randomized,double-blind,placebo-controlled study  

作　　者：Hongqi Zhang Chong Ma Wen Zou Huijun Guo Xin Li Xinghua Tan Yuqi Yang Jianping Ma Quansheng Feng Shuiqing Liu Yaokai Chen Jian Wangb Jipeng Dong Ying Liu 

机构地区：[1]Experimental Research Center,China Academy of Chinese Medical Sciences,Beijing,China [2]Research Center of AIDS Treatment With Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing,China [3]Wang Jing Hospital of China Academy of Chinese Medical Sciences,Beijing,China [4]The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Henan,China [5]Infection Center,Beijing Ditan Hospital,Captial Medical University,Beijing,China [6]Guangzhou Eighth People’s Hospital,Guangdong,China [7]Yunnan Institute of Traditional Chinese Medicine,Yunnan,China [8]Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine,Xinjiang,China [9]Chengdu University of Traditional Chinese Medicine,Chengdu,China [10]Guiyang Public Health Clinical Center,Guizhou,China [11]Chongqing Public Health Medical Center,Chongqing,China

出　　处：《Guideline and Standard in Chinese Medicine》2024年第4期228-235,共8页中医规范与标准(英文)

基　　金：Supported by the State Major Science&Technology Specific Projects(2017ZX10205501);National Nature Science Foundation of China(82174221).

摘　　要：Background:Even with long-term complete suppression of the virus through antiretroviral therapy(ART),people infected with HIV cannot attain optimal immune reconstitution.This phenomenon is called immune reconstitution deficiency,there are no effective therapeutic interventions for immune reconstitution deficiency in modern medicine.Objective:To evaluate the efficacy and safety of ART with Shenling Guben Granules Traditional Chinese medicine in boosting immunological reconstitution compared with ART alone.Methods:This was a randomized,double-blind,placebo-controlled,multicenter clinical trial evaluating the efficacy and safety of ART combined with Chinese medicine.The individuals aged 18–65 years with poor immune reconstitution following ART were included in this trial.The primary outcome was a change in the absolute value of CD4^(+)T lymphocytes after 72 weeks of combined ART and Chinese medicine administration.Secondary outcomes included changes in CD4^(+)T lymphocyte functional subpopulations,activated T lymphocyte subpopulations,CD4^(+)T lymphocyte proliferation,and T lymphocyte apoptosis from baseline to after 72 weeks.We also evaluated efficacy at 24-and 48-week intervals to better understand the dynamics of the trial drug’s efficacy.Results:There was a significant increase in CD4^(+)cell counts in groups treated with the Shenling Guben Granules after 24,48,and 72 weeks of treatment(P<0.05),and the difference in CD4^(+)cell counts at 24 weeks of treatment was statistically significant(P=0.010).After 48 and 72 weeks of therapy,the CD4^(+)CD38^(+)cell counts in the Shenling Guben Granules group were significantly higher than in the control group(P<0.05).In the subgroup analysis of CD4^(+)cell counts≥200 cells/mm^(3),the CD4^(+)cell counts in the treatment group were higher than the control group after treatment for 24,48,and 72 weeks(P<0.05).Discussion:CD4 cell counts in HIV/AIDS patients with immunological reconstitution insufficiency can be improved to a certain extent using Shenling Guben Granules.The

关 键 词：AIDS HIV immune reconstitution traditional Chinese medicine shenling guben granules safety 

分 类 号：R73[医药卫生—肿瘤]