Advanced Search

Journal of Traditional Chinese Medicine >

2022 , Vol. 42 >Issue 3: 432 - 438

DOI: https://doi.org/10.19852/j.cnki.jtcm.2022.03.010

Research Article

Efficacy and safety of Mianyi granules (+mianyi+) for reversal of immune nonresponse following antiretroviral therapy of human immunodeficiency virus-1: a randomized, double-blind, multi-center, placebo-controlled trial

  • Ying LIU ,
  • Wen ZOU ,
  • Qingfei XIAN ,
  • Xin DENG ,
  • Fuchun ZHANG ,
  • Li WANG ,
  • Yonghong LI ,
  • Wenhui LUN ,
  • Jian WANG
Expand
  • 1 Traditional Chinese Medicine Center for Acquired Immune Deficiency Syndrome Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China
    2 Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China
    3 Infectious Disease Department of Guangzhou Eighth People’s Hospital, Guangzhou 510060, China
    4 Internal Medicine Department of Traditional Chinese Medicine, Yunnan Provincial Academy of Traditional Chinese Medicine, Kunming 650031, China
    5 Department of Hepatology, Shenyang Sixth People’s Hospital, Shenyang 110006, China
    6 Department of Dermatology, Beijing Ditan Hospital, Beijing 100015, China
Prof. WANG Jian, TCM Center for AIDS Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing 100700, China. 62tiger@163.com,Telephone: + 86-10-64089765

Received date: 2021-09-02

  Accepted date: 2021-11-21

  Online published: 2022-05-20

Supported by

Fun:Supported by the State Major Science & Technology Specific Projects, Prevention and Treatment of Serious Infectious Diseases such as Acquired Immune Deficiency Syndrome and Viral Hepatitis(2017ZX10205501);Fun:Supported by the State Major Science & Technology Specific Projects, Prevention and Treatment of Serious Infectious Diseases such as Acquired Immune Deficiency Syndrome and Viral Hepatitis(2013ZX10005-001);National Nature Science Foundation of China, Mechanism of PD-1 Receptor Mediated Immunosuppression based on the Improvement of Digestive Tract Mucosal Function in HIV/AIDS Patients by Removing Dampness and Detoxification(82174221)

Fold

Abstract

OBJECTIVE: To investigate whether Mianyi granules (+mianyi+) 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.

Key words： HIV-1; immunity; antiretroviral therapy; treatment outcome; safety; Mianyi granules

Cite this article

Ying LIU , Wen ZOU , Qingfei XIAN , Xin DENG , Fuchun ZHANG , Li WANG , Yonghong LI , Wenhui LUN , Jian WANG . Efficacy and safety of Mianyi granules (+mianyi+) for reversal of immune nonresponse following antiretroviral therapy of human immunodeficiency virus-1: a randomized, double-blind, multi-center, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2022 , 42(3) : 432 -438 . DOI: 10.19852/j.cnki.jtcm.2022.03.010

References

1 Julie CG, Hans JH, Jan G, et al. Incomplete immune recovery in HIV infection: mechanisms, relevance for clinical care, and possible solutions. Clin Dev Immunol 2012; 2012:670957.
2 Kelley CF, Kitchen CM, Hunt PW, et al. Incomplete peripheral CD4 + cell count restoration in HIV-infected patients receiving long-term antiretroviral treatment. Clin Infect Dis 2009; 48:787-94.
3 Nakanjako D, Kiragga A, Ibrahim F, et al. Sub-optimal CD4 reconstitution despite viral suppression in an urban cohort on antiretroviral therapy (ART) in sub-Saharan Africa: frequency and clinical significance. AIDS Res Ther 2008; 5:23.
4 Negredo E, Massanella M, Puig J et al. Nadir CD4 T cell count as predictor and high CD4 T cell intrinsic apoptosis as final mechanism of poor CD4 T cell recovery in virologically suppressed HIVinfected patients: clinical implications. Clin Infect Dis 2010; 50:1300-8.
5 Wu XF, Wang J, Li Y. Intervention of Immune 1 combined HAART on immune function in patients with HIV/AIDS reconstruction. Zhong Guo Zhong Yao Za Zhi 2013; 38:2453-7.
6 Wang J, Li Y, Tang YL, et al. Effect of immune No. 2 on the immune reconstitution in patients with HIV/AIDS after highly active antiretroviral treatment: a randomized double blind placebo controlled clinical trial. Zhong Guo Jie He Yi Xue Za Zhi 2013; 19:340-6.
7 Li T, Xie J, Li Y, et al. Tripterygium wilfordii Hook F extract in cART-treated HIV patients with poor immune response: a pilot study to assess its immunomodulatory effects and safety. HIV Clin Trials 2015; 16:49-56.
8 Shao BP. Clinical research report on the efficacy and safety of Tangcao Tablets in the treatment of HIV/AIDS. Compilation of Papers of the 6th Annual Academic Conference of the AIDS Prevention and Treatment Branch of the Chinese Society of Traditional Chinese Medicine; 2008 Dec; Anhui, China. 2008; 11:179-90.
9 Wu H, Zhao M, Li XW, et al. Clinical observation of the efficacy and safety of Aifukang capsule in patients with HIV infections and AIDS. Zhong Guo Ai Zi Bing Xing Bing 2012; 18:434-7.
10 Wang J, Lin HSH, Li Y, et al. Effect of Mianyi No. 2 formula on the symptoms and signs of HIV/AIDS Patients with insufficient immune reconstitution. Zhong Yi Za Zhi 2012; 53:923-6.
11 Hughes MD, Pocock SJ. Interim monitoring of clinical trials. In: Finkelstein DM, Schoenfeld DA, eds. AIDS Clinical Trials. Hoboken. NJ: Wiley&Sons, 1995: 177-96.
12 The ministry of health standard professional committee of infectious diseases, China (2012) the diagnostic criteria of AIDS and HIV infected, Beijing, China. Zhong Guo Ai Zi Bing Xing Bing 2012; 18:354-6.
13 Department of Health and Human Services (2003) Safety reporting requirements for human drug and biological products; Proposed rule. Food and Drug; Administration Federal Register 68.
14 Chen H, Liu X, Su YX, et al. Notch signaling pathway mediates the immunomodulatory mechanism of Yangfei Huoxue decoction alleviating bleomycin-induced pulmonary fibrosis in rats. J Tradit Chin Med 2020; 40:204-11.
15 Wang J, Lin HS, Liu MY, Li Y. lmmune reconstitution of acquired immune deficiency syndrome. Chin J Integr Med 2010; 16:557-564.
16 Kaufmann GR, Perrin L, Pantaleo G, et al. CD4+ T-lymphocyte recovery in individuals with advanced HIV-1 infection receiving potent antiretroviral therapy for 4 years: the Swiss HIV cohort study. Arch Intern Med 2003; 163:2187-95.
17 Wang J, Huang SJ. Clinical research on the combination of TCM and Western Medicine on AIDS. Beijing: People's Medical Publishing House, 2007: 75-6.
18 Sun J, Wu NP, Feng TT, et al. Effect of long term highly active antiretroviral therapy on abnormal immune activation and immune reconstruction in HIV-1 infected individuals. Zhejiang Da Xue Xue Bao (Yi Xue Ban) 2010; 39:618-22.
19 Herbeuval JP, Boasso A, Grivel JC, et al. TNF-related apoptosis-inducing ligand (TRAIL) in HIV-1-infected patients and its in vitro production by antigen-presenting cells. Blood 2005; 105:2458-64.
20 Goicoechea M, Smith DM, Liu L, et al. Determinants of CD4+ T cell recovery during suppressive antiretroviral therapy: association of immune activation, T cell maturation markers, and cellular HIV-1 DNA. J Infect Dis 2006; 194:29-37.
21 Tao Z, Huang Xj, Liu Y, et al. Efficacy of integrated Traditional Chinese Medicine and anti-retroviral therapy on immunological nonresponse in patients with human immunodeficiency virus/acquired immunodeficiency syndrome: a Meta-analysis of randomized controlled trials. J Tradit Chin Med 2021; 41:669-76.
22 Liu ZB, Wang X, Liu HJ. Treatment of acquired immunodeficiency syndrome with Chinese medicine in China: opportunity, advancement and challenges. Chin J Integr Med 2013; 19:563-7.
Options
Outlines

/

〈 〉