Abstract：Objective：To observe the clinical effect and the safety of modified Chaihu Shugan powder for drug-induced hyperprolactinemia in female patients with schizophrenia. Methods：A total of 116 cases of female schizophrenic patients with drug-induced hyperprolactinemia were selected and divided into the control group and the treatment group according to the random number table method，with 58 cases in each group. Both groups were given oral administration of amisulpiride；the control group was treated with bromocriptine mesylate tablets， and the treatment group was additionally treated with modified Chaihu Shugan powder based on the treatment of the control group. Both groups were treated for eight weeks. The changes in levels of serum prolactin(PRL)，basal body temperatures，natural killer(NK) cell activity and T lymphocyte subsets including CD3+，CD4+ and CD8+ before and after treatment and the clinical effects in the two groups were compared. The drug safety was evaluated. Results：The total clinical effective rate was 89.66% in the treatment group，significantly higher than that of 75.86% in the control group， the difference being significant(P＜0.05). After treatment for two， four and eight weeks，the PRL levels in serum in the two groups were decreased when compared with those before treatment(P＜0.05)， and the PRL levels in serum in the treatment group at the same time points were lower than those in the control group(P＜ 0.05). Before treatment， there was no significant difference being found in the comparison of basal body temperatures between the two groups(P＞0.05). After treatment，the improvement of basal body temperature in the treatment group was better than that in the control group(P＜0.05). Before treatment， there was no significant difference being found in the comparison of NK cell activity and levels of T lymphocyte subsets between the two groups(P＞0.05). After treatment，the NK cell activity and CD3+ levels in the two groups were increased when compared with those before treatment(P＜0.05)，and the CD4 + levels in the two groups were decreased(P＜0.05)，and the improvement of the above three indexes in the treatment group was more significant than that in the control group(P＜0.05)；the CD8+ levels in the two groups were increased when compared with those before treatment(P＜0.05)，but there was no significance in the difference(P＞0.05). The incidence of adverse reactions was 13.78% in the treatment group and 15.51% in the control group，there being no significance in the difference(P＞0.05). Conclusion： Modified Chaihu Shugan powder for drug- induced hyperprolactinemia in female patients with schizophrenia can effectively improve serum PRL levels，basal body temperatures and immune function，with relatively few adverse reactions.