Effects of Shenling Guben Granules on Quality of Life of and Immune Function in HIV Patients Classified as Immunological Non-responders
10.13422/j.cnki.syfjx.20250991
- VernacularTitle:参灵固本颗粒对艾滋病免疫重建不全患者生存质量和免疫功能的影响
- Author:
Jianing KE
1
;
Wenbo GAO
1
;
Ying LIU
2
Author Information
1. Institute of Basic Theory for Chinese Medicine，China Academy of Chinese Medical Sciences， Beijing 100700，China
2. Research Center of AIDS Treatment with Traditional Chinese Medicine， China Academy of Chinese Medical Sciences，Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
Shenling Guben granules;
HIV immunological nonresponders;
World Health Organization Quality of Life Questionnaire for HIV brief version（WHOQOL-HIV BREF）;
immune function
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(18):135-142
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the effects of Shenling Guben Granules on quality of life and immune function in patients with HIV classified as immunological non-responders （INRs）. MethodsA prospective， multicenter， randomized， double-blind， controlled trial was conducted from August 21， 2018， to January 6， 2021， across eight hospitals in China. A total of 300 INR patients， diagnosed with spleen-kidney yang deficiency or lung-spleen Qi deficiency syndromes， were enrolled and randomly assigned to either the observation group or the control group， with 150 patients in each group. The control group received antiretroviral therapy （ART） combined with placebo， while the observation group received ART combined with Shenling Guben Granules. After 72 consecutive weeks of treatment， the World Health Organization Quality of Life for HIV brief version （WHOQOL-HIV BREF） was used to assess quality of life before and after treatment in both groups. Immune indicators （CD4+ and CD8+ T cell counts）， complete blood count， liver and renal function， and adverse events during treatment were also evaluated to assess safety. ResultsA total of 279 patients were included in the final analysis （140 in the observation group and 139 in the control group）. After treatment， CD4+ T cell counts in the observation group increased significantly compared to baseline （P< 0.05）， whereas the control group showed an upward trend without statistical significance. Compared with the control group after treatment， the observation group showed a significantly greater increase in CD4+ levels （P<0.05）. There were no significant differences in the total score or domain scores of quality of life （physical， psychological， independence， social relationships， environment， and spirituality）， or in CD8+ T cell counts， before and after treatment in either group. The incidence of adverse events during treatment was 10% （14/140） in the observation group and 10.07% （14/139） in the control group， with no statistically significant difference between the two groups. ConclusionAlthough Shenling Guben Granules did not significantly improve quality of life in INR patients， they significantly increased CD4+ cell counts and demonstrated good safety， providing scientific evidence to support their use as a treatment option for INR patients.
