University of Pisa, Department of Neurosciences, Pisa, Italy.
Expert Opin Pharmacother. 2012 Nov;13(16):2269-80. doi: 10.1517/14656566.2012.736490.
Depression is a comorbidity affecting quality of life (QoL) in patients with Parkinson's disease (PD) and requires appropriate treatment. This study evaluated the tolerability, safety, and efficacy of duloxetine 60 mg once daily for 12 weeks in PD patients with major depressive disorder (MDD).
Non-comparative, open-label, multi-center study.
Tolerability was evaluated by discontinuation rate (acceptable if ≤ 19%) due to treatment-emergent adverse events (TEAEs) and motor symptoms (UPDRS). Safety measures were TEAEs, the UKU side effect rating scale, vital signs, weight, laboratory tests, and ECG. Efficacy measures included HAMD-17, BDI, CGI-S, PGI-I, and pain VAS. QoL was measured by PDQ-39.
Of the 151 patients enrolled, 8.6% (95% upper CI: 13.3%) discontinued the study due to TEAEs. Worsening in PD-related tremor and rigidity was not observed, activities of daily living significantly improved and UKU subscales progressively decreased. Clinically significant abnormalities in laboratory findings were limited to four cases of hypercholesterolemia and one increase of total bilirubin, CPK, and fasting glucose. Blood pressure, weight, and ECG did not change from baseline. HAMD-17 and PDQ-39 total score and individual domains, BDI, CGI-S, and PGI-I total scores significantly improved.
Duloxetine seems well tolerated and likely effective in the treatment of depression associated with PD, with no detrimental effects in PD signs and symptoms.
抑郁症是帕金森病（PD）患者生活质量（QoL）的合并症，需要进行适当的治疗。本研究评估了度洛西汀 60mg 每日一次治疗 12 周对伴有重性抑郁障碍（MDD）的 PD 患者的耐受性、安全性和疗效。
非对照、开放标签、多中心研究。
因治疗引起的不良事件（TEAE）和运动症状（UPDRS）而导致停药率（可接受率≤19%）评估耐受性。安全性指标为 TEAE、UKU 副作用评定量表、生命体征、体重、实验室检查和心电图。疗效指标包括 HAMD-17、BDI、CGI-S、PGI-I 和疼痛 VAS。QoL 通过 PDQ-39 进行评估。
在纳入的 151 例患者中，有 8.6%（95%置信区间上限：13.3%）因 TEAE 而退出研究。未观察到 PD 相关震颤和僵直恶化，日常生活活动显著改善，UKU 亚量表逐渐降低。实验室检查结果的临床显著异常仅局限于 4 例高胆固醇血症和 1 例总胆红素、CPK 和空腹血糖升高。血压、体重和心电图与基线相比无变化。HAMD-17 和 PDQ-39 总分及各单项、BDI、CGI-S 和 PGI-I 总分均显著改善。
度洛西汀治疗 PD 相关抑郁似乎具有良好的耐受性，且可能有效，对 PD 体征和症状无不良影响。
