| Objective:Aripiprazole is a partial agonist of dopamine D2 receptors, in theory, it can be used to reverse hyperprolactinemia caused by other antipsychotic drugs.The purpose of this study is to explore the efficacy and safety of aripiprazole for reversing hyperprolactinemia caused by risperidone, as well as to determine the optimal dosage aripiprazole.Methods:101 schizophrenic patients of hyperprolactinemia caused by risperidone were randomly divided into three groups after informed consent, which was in combination with aripiprazole with different daily dosage as 5mg,10mg and 15mg for 12 weeks. Serum level of prolactin was measured at baseline and at the end of 4th,8th, 12th week of the combination treatment. All patients were assessed with Positive and Negative Symptoms Rating Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) to evaluate the curative effect and safety.The main analysis method was variance analysis of repeated measurement data.Results:(1) There was no significant difference in serum prolactin level at baseline among the three groups (P>0.05). Serum prolactin levels in each group decreased significantly at the end of the 4th,8th,12th week compared with the baseline (P< 0.001), however, there was no significant difference in serum prolactin level among the three groups at each interview-point (P<0.05). (2) There was no significant difference in total socre and all factor scores of PANSS at the baseline among the three groups (P>0.05). No significant intragroup change in total score and all factor scores of PANSS was observed at the end of the 4th,8th,12th week compared with the baseline (P>0.05). There was no significant intergroup difference in total score and all factor scores of PANSS among the three groups at each interview-point (P>0.05). (3) No serious adverse event was observed in the three groups. Score of TESS in 15mg/d aripiprazole group was significant higher than that in 10mg/d and 5mg/d aripiprazole groups at the end of the 4th,8th,12th week of the combination treatment (P<0.05). There was no significant difference in score of TESS between 10mg/d and 5mg/d aripiprazole group at each interview-point (P>0.05).Conclusion:(1) Combination treatment with ariprazole can effectively reduce the hyperprolactinemia caused by risperidone. (2) Instead of efficacy superiority for treating hyperprolactinmia caused by risperidone,15mg/d aripiprazole increase the side effects. Combination with 5-10 mg/d aripiprazole may be the optimal dose for hyperprolactinmia caused by risperidone. |
