阿立哌唑治疗利培酮所致高催乳素血症的双盲对照研究

Adjunctive treatment of risperidone-induced hyperprolactinemia with aripiprazole: a randomized,double-blind,placebo-controlled study

目的:探讨阿立哌唑治疗利培酮所致高催乳素血症的有效性和安全性。方法:116例利培酮所致高催乳素血症的精神分裂症患者,随机分为研究组(59例)和对照组(57例)。维持原有利培酮治疗不变,研究组合并用阿立哌唑20 mg·d-1,对照组合并安慰剂治疗。于基线及治疗2,4,8周末检测血清催乳素水平,于基线及治疗8周末评定阳性与阴性症状量表(PANSS)、临床总体印象量表(疾病严重程度)(CGI-S)、UKU副作用评定量表(UKU)。结果:研究组在8周末催乳素水平(20.98±16.34)μg·L-1较基线(90.93±50.91)μg·L-1明显下降,差异有统计学意义(P<0.001),而对照组治疗前后催乳素水平差异无统计学意义(P>0.05);8周末,研究组催乳素水平下降率为(76.47±15.48)%,正常率为74.58%,显著高于对照组[(3.90±20.70)%,0](P均<0.001);两组治疗前后PANSS、CGI-S评分以及不良反应发生率均无显著性差异(P>0.05)。结论:阿立哌唑可有效治疗利培酮所致的高催乳素血症,且不良发应少。

Objective： To explore the efficacy and safety of adjunctive treatment with aripiprazole in hyperprolactinemia induced by risperidone. Methods： One hundred and sixteent schizophrenic patients with risperidone- induced hyperprolactinemia were randomly assigned to research group （n=59） and control group （n=57）,and received 20 mg？d-1 aripiprazole or placebo for adjunctive treatment respectively. Serum prolactin levels were measured at 0, 2, 4 and 8 weeks and the Positive and Negative Syndrome Scale （PANSS）, Clinical Global Impressions Scale for severity symptom scale （CGI-S）, and UKU Side Effects Rating Scale （UKU） were assessed at baseline and the end of 8 weeks. Results： Serum prolactin levels at the end of 8 weeks（20.98±16.34 μg？L-1）were significantly reduced compared with baseline（90.93±50.91 μg？L-1） in the research group （P〈0.001）, however, there was no significant difference between pre- and post-treatment in the control group（P〉0.05）.At the end of 8 weeks,the decline rate and the normal ratio of serum prolactin levels were significantly higher in the research group [（76.47±15.48）%, 74.58%] than that in the control group [（3.90±20.70）%,0] （both P〈0.001）. There were no significant changes in the total scores of PANSS and CGI-S and the incidence of side effects at the end point（P〉0.05）. Conclusion： Adjunctive aripiprazole treatment may be effective for treating risperidone-induced hyperprolactinemia and associated symptoms, with little adverse effects.