Prolactin related symptoms during risperidone maintenance treatment: results from a prospective, multicenter study of schizophrenia

BMC Psychiatry

Research Article

Xin Ma¹  Fang Dong²  Zhimin Wang²  Chuanyue Wang²  Xianbin Li²  Qijing Bo² 

[1] Beijing Key Laboratory of Mental Disorders, Department of Psychiatry, Beijing Anding Hospital, Capital Medical University, No.5 Ankang Lane, Dewai Avenue, 100088, Xicheng District, Beijing, China;Beijing Key Laboratory of Mental Disorders, Department of Psychiatry, Beijing Anding Hospital, Capital Medical University, No.5 Ankang Lane, Dewai Avenue, 100088, Xicheng District, Beijing, China;Center of Schizophrenia, Beijing Institute for Brain Disorders, Laboratory of Brain Disorders (Capital Medical University), Ministry of Science and Technology, 100088, Beijing, China;

关键词: Side effects;    Prolactin related symptoms;    Schizophrenia;    Maintenance treatment;    Antipsychotics;    Risperidone;    Generalized linear mixed model (GLMM);   

DOI  :  10.1186/s12888-016-1103-3

 received in 2016-07-06, accepted in 2016-11-01,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThis study aimed to investigate prolactin related symptoms (PRS) in individuals with schizophrenia during risperidone maintenance treatment for one year, as well as to identify the risk factors for PRS.MethodsIn a multicenter, randomized, controlled, longitudinal study, clinically stabilized schizophrenia patients (N = 374) were randomized to a no-dose-reduction group (N = 129) and 4-week (N = 125) and 26-week (N = 120) reduction groups, in which the original dose was followed by a 50 % reduction over 8 weeks and subsequently maintained. PRS were assessed via a scale of prolactin related adverse events, which included 16 items: menstrual cycle, menstrual period, menstrual volume, menstrual irregularities, amenorrhea, dysmenorrhea, postpartum lactation, gynecomastia, breast tenderness, sexual dysfunction, decreased sexual desire, erectile dysfunction, ejaculatory dysfunction, impotence, increased body hair, and acne. The occurrence of PRS was assessed at baseline and monthly for six months, followed by every two months. A mixed model was used.ResultsPRS at baseline were reported in 18.4, 15.0, and 14.0 % of the 4-week, 26-week, and no-dose-reduction groups, respectively. Female gender, younger age at onset, and the Positive and Negative Syndrome Scale (PANSS) total scores at entry predicted the development of PRS. The mixed model indicated that PRS were more severe in females and at a high dose. In the 237 patients who remained in the study after one year, the incidence of PRS decreased to 9.6, 11.1, and 7.6 % in the 4-week, 26-week, and no-dose-reduction groups, respectively.ConclusionThese findings indicate that the PRS severity was alleviated during the one year treatment period because of the dose reduction. Attention should focus on the side effects of hyperprolactinemia during long-term treatment, especially with a high dose, females, younger age at onset, and more severe patients.Trial registrationClinicalTrials.gov identifier: NCT00848432. Registered February 19, 2009.

【 授权许可】

CC BY   
© The Author(s). 2016