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长效注射用利培酮在双相情感障碍12个月维持治疗中的有效性

Usefulness of long-acting injectable risperidone during 12-month maintenance therapy of bipolar disorder.

作者信息

Han Changsu, Lee Moon-Soo, Pae Chi-Un, Ko Young-Hoon, Patkar Ashwin A, Jung In-Kwa

机构信息

Department of Psychiatry, Korea University, College of Medicine, Seoul, South Korea.

出版信息

Prog Neuropsychopharmacol Biol Psychiatry. 2007 Aug 15;31(6):1219-23. doi: 10.1016/j.pnpbp.2007.04.017. Epub 2007 May 1.

Abstract

This study aimed to assess the safety, tolerability, efficacy, and compliance of a risperidone long-acting injection (RLAI) formulation for the maintenance treatment of stabilized bipolar patients. A prospective, open-label trial of RLAI was conducted for 12 months. Stable bipolar patients (n=11) were switched from their existing oral antipsychotic agents to RLAI, and injections were given every 2 weeks. The assessments were performed at baseline and at 6 and 12 months of treatment by using the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Severity of Illness (CGI-S) scale, 17-item Hamilton Rating Scale for Depression (HAM-D), Brief Psychiatric Rating Scale (BPRS), and Extrapyramidal Symptom Rating Scale (ESRS). The satisfaction levels of subjects were evaluated at the end of the study period using a 10-point visual analog scale. Ten patients (90.9%) completed the trial, and no significant changes were seen in the YMRS, HAM-D, and BPRS scores throughout the study. CGI-S and ESRS scores were significantly decreased from the baseline to the post-12-month treatment score. Relapses were not reported by any of the participants. This result indicates that RLAI may be beneficial in the maintenance therapy of stable bipolar patients; however, an adequately powered, randomized, placebo-controlled trial is necessary to draw a definite conclusion about the role of RLAI in the maintenance treatment of bipolar patients.

摘要

本研究旨在评估利培酮长效注射剂(RLAI)用于稳定期双相情感障碍患者维持治疗的安全性、耐受性、疗效和依从性。对RLAI进行了一项为期12个月的前瞻性开放标签试验。11名稳定期双相情感障碍患者从现有的口服抗精神病药物换用RLAI,每2周注射一次。在基线以及治疗6个月和12个月时,使用杨氏躁狂评定量表(YMRS)、临床总体印象-疾病严重程度(CGI-S)量表、17项汉密尔顿抑郁评定量表(HAM-D)、简明精神病评定量表(BPRS)和锥体外系症状评定量表(ESRS)进行评估。在研究期结束时,使用10分视觉模拟量表评估受试者的满意度。10名患者(90.9%)完成了试验,在整个研究过程中,YMRS、HAM-D和BPRS评分未见显著变化。CGI-S和ESRS评分从基线到治疗12个月后显著降低。所有参与者均未报告复发情况。该结果表明,RLAI可能对稳定期双相情感障碍患者的维持治疗有益;然而,需要进行一项有足够样本量的随机安慰剂对照试验,以明确RLAI在双相情感障碍患者维持治疗中的作用。

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