OBJECTIVE:To investigate whether Mianyi granules(免疫II颗粒)are effective and safe in reversing immune nonresponse following antiretroviral therapy(ART)in individuals with human immunodeficiency virus(HIV)infection.METHODS:Randomized,double-blind,multi-center,placebo-controlled trial(factorial design)of daily oral Mianyi granules versus placebo for 72 weeks.A total of 361 HIV-positive individuals receiving ART at five Class III Grade I hospitals in China between September 2013 and January 2016 completed the study.The primary endpoints were frequencies of CD3+,CD4+,CD8+,and CD45RA+cells at seven timepoints over the 72 weeks.Secondary endpoints included viral loads,clinical symptoms,and quality of life at 72 weeks.RESULTS:A total of 400 participants were enrolled in the study and randomized,of whom 361 completed the study:189 individuals(140 men and 49 women)in the Mianyi granule group and 172 individuals(135 men and 37 women)in the placebo group.In the intent-to-treat population,CD4+T cell counts increased from(193±71)cells/mm3 at baseline to(288±131)cells/mm3 post-treatment in the Mianyi granule group and from(200±75)cells/mm3 at baseline to(264±124)cells/mm3 post-treatment in the placebo group.Patients treated with Mianyi granule had higher increases in CD4+T cell counts than those treated with placebo(P=0.045).Reversal of immune nonresponse was defined as a CD4+T cell increase of more than 100 cells/mm3.After treatment for 72 weeks,Mianyi granule was effective in reversing immune nonresponse in a higher proportion of individuals(20.2％)compared with placebo(9.7％).CD45RA+cell counts increased from(34±32)cell/mm3 at baseline to(51±61)cells/mm3 post-treatment in the Mianyi granule group and from(37±33)cells/mm3 at baseline to(48±37)cells/mm3 post-treatment in the placebo group.Mianyi granules were more effective than placebo in increasing CD45RA+cell counts.CONCLUSIONS:In ART-treated HIV-positive adults with immune nonresponse,treatment with Mianyi granules for 72 weeks was safe and significantly increased CD4+and CD45RA+cell counts,thereby promoting immune reconstitution.

LIU Ying;ZOU Wen;XIAN Qingfei;DENG Xin;ZHANG Fuchun;WANG Li;LI Yonghong;LUN Wenhui;WANG Jian

Traditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment,China Academy of Chinese Medical Sciences,Beijing 100700,China;Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530011,China;Infectious Disease Department of Guangzhou Eighth People's Hospital,Guangzhou 510060,China;Internal Medicine Department of Traditional Chinese Medicine,Yunnan Provincial Academy of Traditional Chinese Medicine,Kunming 650031,China;Department of Hepatology,Shenyang Sixth People's Hospital,Shenyang 110006,China;Department of Dermatology,Beijing Ditan Hospital,Beijing 100015,China

中医杂志（英文版）

[1]LIU Ying;ZOU Wen;XIAN Qingfei;DENG Xin;ZHANG Fuchun;WANG Li;LI Yonghong;LUN Wenhui;WANG Jian-.Efficacy and safety of Mianyi granules(免疫Ⅱ颗粒)for reversal of immune nonresponse following antiretroviral therapy of human immunodeficiency virus-1:a randomized,double-blind,multi-center,placebo-controlled trial)[J].中医杂志（英文版）,2022(03):432-438

Mianyi,nonresponse,CD45RA+cells,CD45RA+cell

Efficacy,safety,granules,reversal,immune,following,antiretroviral,therapy,human,immunodeficiency,virus,randomized,double,blind,multi,center,placebo,controlled,trial,OBJECTIVE,To,investigate,whether,effective,reversing,ART,individuals,HIV,infection,METHODS,Randomized,factorial,design,daily,oral,versus,weeks,total,positive,receiving,five,Class,III,Grade,hospitals,China,between,September,January,completed,study,primary,endpoints,were,frequencies,CD3+,CD8+,seven,timepoints,over,Secondary,included,loads,clinical,symptoms,quality,life,RESULTS,participants,enrolled,whom,women,group,In,intent,population,CD4+T,counts,increased,from,mm3,baseline,post,treatment,Patients,treated,had,higher,increases,than,those,Reversal,was,defined,more,After,proportion,compared,increasing,CONCLUSIONS,adults,significantly,CD4+and,thereby,promoting,reconstitution

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