Objective To observe the effect of Mianyi No.2 Formu la（formula 2 for immune reconstitution） on the immune reconstitution and relief of symptoms and s igns for human immunodeficiency virus/acquired immune deficiency syndrome（HIV/A IDS） patients with infufficient immune reconstitution after highly active antiretroviral treatment（HAART）.Methods Totally 253 HIV/AIDS patien ts with insufficient immune reconstitution after HAART for above one year were randomized into treatment group（126 cases） and the control group（127 cases）.There were 116 cases in the treat ment group and 117 cases in the control group completed the follow-up.Both gro ups were given HAART combined treatment including Zidovudine 300mg

Lamivudine 150mg and Nevirapine 200mg

twice each day.Mianyi No.2 Formula and placebo was added in the treatment group and the control group respectively.Six months later

the cluster of diff erentiation 4（CD4） counts

the effective rate of immune reconstitution and the scores and relief rates of symptoms and signs were observed in both gro ups before and after the treatment.Results The effecti ve rate of immune reconst itution was 34.48% and 21.37% in the treatment group and the control group respe ctively

with significant difference（P<0.05）.Comparing in gro up

CD4 counts were significantly increased in both groups after 3 mont hs or 6 months of treatment（P<0.05 or P<0.01）.Comparing with the control group at the same time point

CD4 counts increased more significantly in the treatment group after 6 months of treatment（P<0.05）.The symptoms and sig ns we re relieved in both groups after 6 months of treatment.The treatment group was superior to the control group in relieving fatigue

muscle joint pain

itching a nd shortness of breath（P<0.05）.Conclusion Mianyi No.2 Formula could increase CD4 counts

improve the effective rate of immune reconstitution and rel ieve symptoms and signs.