阿立哌唑治疗利培酮所致高催乳素血症女性患者的量效关系

Dose-effect relationship of aripiprazole on hyperprolactinemia induced by risperidone in female patients

目的:评估不同剂量阿立哌唑治疗利培酮所致女性精神分裂症患者高催乳素血症的疗效及安全性。方法:61例利培酮所致高催乳素血症女性精神分裂症患者,随机分至阿立哌唑5 mg组(n=16)、10 mg组(n=15)、20 mg组(n=15)和安慰剂组(n=15),维持原有利培酮剂量不变,随访8周。于基线及第2,4和8周末检测血清催乳素(PRL)水平,于基线及8周末评定阳性和阴性症状量表(PANSS)、Barnes静坐不能评定量表(BAS)、Simpson-Angus量表(SAS)及UKU副作用评定量表(UKU)。结果:第8周末,各阿立哌唑剂量组PRL水平均较治疗前显著下降(P<0.01),而安慰剂组治疗前后PRL水平无统计学差异。第8周末,阿立哌唑10 mg组和20 mg组PRL下降率、正常率均显著高于阿立哌唑5 mg组和安慰剂组(P<0.01),而阿立哌唑10 mg组与20 mg组之间无统计学显著差异。研究终点,4组PANSS,CGI-S,SAS和BAS评分及不良反应发生率均无显著性差异。结论:阿立哌唑可有效治疗利培酮所致女性精神分裂症患者的高催乳素血症,最佳治疗剂量为10 mg·d-1。

Objective： To evaluate the efficacy and safety of different doses of aripiprazole on hyperprolactinemia caused by risperidone in female patients with schizophrenia. Methods： Sixty-one female schizophrenic patients with hyperprolactinemia induced by risperidone were randomly divided into aripiprazole 5 mg group（ n =16）,10 mg group（ n = 15）,20 mg group（ n = 15） and placebo group（ n = 15） added on to fixed dose risperidone treatment for 8 weeks. Serum prolactin levels（ PRL） were measured at baseline,2,4 and 8 weeks. The Positive and Negative Syndrome Scale（ PANSS）,the Barnes Akathisia Scale（ BAS）,Simpson Angus Scale（ SAS） and the UKU Side Effects Rating Scale（ UKU） were assessed at baseline and week 8. Results： PRL levels in the three aripiprazole groups were significantly reduced at the end of the study compared with the baseline（ P〈0. 01）,while there was no significant difference between pre- and post-treatment in the placebo group. At week 8,the decline rate and the normal ratio of PRL levels were significantly higher in the 10 mg and 20 mg groups than those in the5 mg and placebo groups（ P〈0. 01）,but no significant difference was observed between the 10 mg and 20 mg groups. The PANSS,SAS and BAS scores and the incidence of side effects did not differ among all the treatment groups at the end point. Conclusion： Aripiprazole may be effective for treating risperidone-induced hyperprolactinemiain female patients with schizophrenia,and the optimum dose for aripiprazole appears to be 10 mg·d^- 1.