Otsubo Tempei, Watanabe Yoshinori, Hongo Seiji, Inoue Mikichika, Akimoto Kimiko, Murakami Ken, Takahashi Ryutaro, Kikuchi Toshiaki
Department of Psychiatry, Tokyo Women's Medical University Medical Center East, Tokyo, Japan.
Himorogi Psychiatric Institute, Tokyo, Japan.
Neuropsychiatr Dis Treat. 2018 Apr 6;14:955-966. doi: 10.2147/NDT.S152985. eCollection 2018.
To assess the effectiveness and safety of switching the antidepressant formulation from immediate-release (IR) to controlled-release (CR) paroxetine in patients with major depressive disorder (MDD).
A total of 113 outpatients with MDD diagnosed according to the , Fourth Edition, Text Revision, and treated with a stable dose of IR paroxetine for at least 6 months were enrolled. Patients were then switched to CR paroxetine for 8 weeks. Effectiveness was evaluated by scores on the Himorogi Self-Rating Depression/Anxiety Scales (HSDS/HSAS) and the Clinical Global Impression - Severity (CGI-S). Safety was evaluated based on the reported adverse drug reactions (ADRs). Medication satisfaction and preference were assessed based on questionnaire responses using Likert-type scales.
The overall patient HSDS/HSAS scores significantly improved after switching from IR to CR paroxetine (<0.001). Furthermore, CR paroxetine was superior to IR paroxetine (<0.001) according to the results of the CGI-S evaluation. ADRs were experienced by 14 (12.4%) patients, including dry mouth, nausea/vomiting, somnolence/drowsiness, and wakefulness/arousal during sleep. Satisfaction and preference for paroxetine improved after switching to the CR formulation (<0.001; chi-square test).
These results suggest that switching the treatment from IR to CR paroxetine could improve depressive symptoms and decrease ADRs. However, these results may have been caused by the psychological effect of drug switching. Hence, future studies with blinded evaluation methods are required to confirm and expand our findings.
评估将重度抑郁症（MDD）患者的抗抑郁药物剂型从速释（IR）帕罗西汀转换为控释（CR）帕罗西汀的有效性和安全性。
共纳入113例根据《精神疾病诊断与统计手册》第四版修订版诊断为MDD且用稳定剂量的IR帕罗西汀治疗至少6个月的门诊患者。然后将患者换用CR帕罗西汀治疗8周。通过日高自我评定抑郁/焦虑量表（HSDS/HSAS）评分和临床总体印象 - 严重程度（CGI-S）评估有效性。根据报告的药物不良反应（ADR）评估安全性。使用李克特量表根据问卷回答评估用药满意度和偏好。
从IR帕罗西汀转换为CR帕罗西汀后，患者总体HSDS/HSAS评分显著改善（<0.001）。此外，根据CGI-S评估结果，CR帕罗西汀优于IR帕罗西汀（<0.001）。14例（12.4%）患者出现ADR，包括口干、恶心/呕吐、嗜睡/困倦以及睡眠期间觉醒/兴奋。换用CR剂型后，对帕罗西汀的满意度和偏好有所改善（<0.001；卡方检验）。
这些结果表明，将治疗从IR帕罗西汀转换为CR帕罗西汀可改善抑郁症状并减少ADR。然而，这些结果可能是由药物转换的心理效应引起的。因此，需要未来采用盲法评估方法的研究来证实和扩展我们的发现。
