Objective To evaluate the effectiveness and safety of TCM syndrome differentiation method combined with western medicine in treating hematological toxicity caused by highly active anti-retroviral therapy（ HAART）.Methods Totally 226 cases of AIDS with HAART-related hematological toxicity were randomized into the treatment group of 149 cases and control group of 77 cases with central randomizing system. Both groups were treated by the former HAART and basic treatment with western medicine. The treatment group was added with Modified Bazhen Decoction and Shenqi-Pill with Ginseng Yangrong Decoction one dose daily according to syndrome differentiation. The treatment lasted for 16 weeks. The symptoms and signs of patients in each group were observed respectively at the begining and the end of 4th

8th

12 th

and 16 th week. Quality of life（ QOL） was observed before and after treatment. The clinical efficacy and safety were evaluated after treatment. Results The total effective rate of the treatment group and control group was 77. 7% and 65. 7% respectively

with a significant difference between groups（ P < 0. 05）. The scores of symptoms were decreased gradually at different time points in both groups

with a statistical significance within each group（ F = 108. 412

P = 0. 000）

but with no statistical significance between groups（ F = 1. 858

P =0. 174）. After treatment

QOL in both groups was significantly improved（ P < 0. 05）

but with no significant difference between groups（ P > 0. 05）. There were no serious adverse events in both groups during the treatment. Conclusion TCM syndrome differentiation combined with western medicine can reduce the hematological toxic and sideeffects of HAART so that to significantly relieve the clinical symptoms and signs and improve QOL.