Objective: To explore the interventional effects of Fuzheng Kangdu pills combined with highly active antiretroviral therapy(HAART) therapy on oxidative stress in patients with human immunodeficiency virus(HIV) infection stage IIB

and investigate its action mechanism. Method: The 120 patients were randomly divided into blank group

HAART group

and Fuzheng Kangdu pills+HAART group by using the random number table. Complete data were obtained from 94 of these patients

including 30 cases in the blank group

33 cases in HAART group

and 31 cases in Fuzheng Kangdu pills+HAART

patients in all the groups received treatment for 12 months to observe the effects of Fuzheng Kangdu pills+HAART on reactive oxygen species(ROS)

nuclear factor-κB(NF-κB)

and absolute counts of the T lymphocyte subsets in patients with HIV infection stage ⅡB. Result: At 12 months of treatment

ROS and NF-κB levels in Fuzheng Kangdu pills+HAART group were significantly lower than those in blank group and HAART group(P<0.05)

as compared to blank group

both HAART group and Fuzheng Kangdu pills+HAART group could effectively increase the number of patients with viral load<100 copy·mL-1 (P<0.01) and reduce the number of patients with viral load fluctuation(P<0.01)

which however presented no significant differences between the two groups. CD3+ T lymphocytes counts in the Fuzheng Kangdu pills+HAART group were significantly increased as compared with the conditions before treatment

blank group or HAART group(P<0.05

P<0.01). CD4+T lymphocyte counts in HAART group and Fuzheng Kangdu pills+HAART group were significantly increased as compared with the conditions before treatment or blank group(P<0.05)

CD4+T lymphocyte count in Fuzheng Kangdu pills+HAART group showed an increasing tendency as compared with that in HAART group. Conclusion: Fuzheng Kangdu pills combined with HAART therapy could reduce oxidative stress and effectively inhibit NF-κB level elevation in patients with HIV infection stage ⅡB

and meanwhile

it could also effectively increase the number of patients with plasma viral load<100 copy·mL-1

reduce the number of patients with viral load fluctuation

and raise CD3+ and CD4+ T lymphocyte count.