To investigate the efficacy and safety of amisulpride combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and concomitant hyperprolactinemia in acute phase.

A total of 72 patients who had poor efficacy and increased prolactin levels after a 8-week treatment of amisulpride were randomly divided into control group and study group, with 36 patients in each group. The patients in the control group continued to be treated with amisulpride （400 - 1 200 mg·d^-1）, while the patients in the study group received aripiprazole （the initial dose was 5 mg·d^-1, which could be increased to 10-30 mg·d^-1） on the basis of amsulpride, for an additional 8 weeks of treatment. The scores of Positive and Negative Syndrome Scale （PANSS） and Treatment Emergent Symptom Scale （TESS） and the levels of serum prolactin were compared between the two groups at the time of enrollment and different time points of treatment.

Two cases were dropped out in each group and 34 cases were completed in each group. The effective rate of the study group was significantly higher than that of the control group at the 2nd, 4th, and 8th weekend of treatment （P<0.05）. At the end of 4 and 8 weeks, the total PANSS score in the study group was significantly lower than that in the control group （P<0.01）, and significantly decreased compared with that at the time of enrollment （P<0.01）. At the end of treatment, the reduction of PANSS total score, positive score, and psychopathology score of the study group were significantly higher than those of the control group （P<0.01）. The prolactin levels in the study group was significantly lower than that in the control group at the 4th and 8th weekend of treatment （P<0.01）, and was also significantly lower than that at the time of enrollment （P<0.01）. The increase of serum prolactin in female patients in the study group was more significant than that in male patients （P<0.01） after 8 weeks of treatment with amisulpride, and the decrease of serum prolactin in female patients was also more significant than that in male patients （P<0.01） after treatment combined with aripiprazole. There were no significant difference in TESS score and incidence rate of adverse reactions between the two groups （P>0.05）.

After combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and elevated serum prolactin, the therapeutic effect can be increased, the serum prolactin level can be reduced, and the benefits are more obvious in female patients, with no significant increase in adverse reactions.