Murakami Masato, Osada Kenichi, Ichibayashi Hisao, Mizuno Hiromichi, Ochiai Toshimitsu, Ishida Mitsuhiro, Alev Levent, Nishioka Kusuki
a Department of Psychosomatic Medicine , Nihon University School of Medicine , Tokyo , Japan.
b Department of Neuropsychiatry , St. Marianna University School of Medicine , Kawasaki , Japan.
Mod Rheumatol. 2017 Jul;27(4):688-695. doi: 10.1080/14397595.2016.1245237. Epub 2016 Oct 31.
We aimed to evaluate the long-term safety and efficacy of duloxetine 60 mg in Japanese patients with fibromyalgia enrolled from a preceding randomized, placebo-controlled, phase III duloxetine trial.
This was a long-term, open-label extension study. Patients received oral duloxetine once daily at a dose of 20 mg for 1 week, followed by 40 mg for 1 week, and then 60 mg for 48 weeks. The primary outcome was the frequency of adverse events (AEs) and adverse drug reactions (ADRs) of duloxetine. Efficacy and health outcomes were assessed.
In total, 149 patients were enrolled from the preceding study. The median length of treatment was 364.0 days. The incidence of AEs and ADRs was 92.6 and 63.8%, respectively. ADRs occurring at an incidence of ≥5% were somnolence, constipation, nausea, weight increase, thirst, and malaise. The proportion of patients with mild, moderate, and severe AEs was 80.5, 10.1, and 2.0%. There were no serious treatment-related AEs in this study. The Brief Pain Inventory average pain score improved at all time-points compared with baseline (mean change ± standard deviation at Week 50 was -1.31 ± 1.70).
Duloxetine was safe and effective in the long-term treatment of Japanese patients with fibromyalgia.
我们旨在评估度洛西汀60mg对在前一项随机、安慰剂对照的度洛西汀III期试验中入组的日本纤维肌痛患者的长期安全性和疗效。
这是一项长期、开放标签的延申研究。患者每日口服一次度洛西汀，起始剂量为20mg，服用1周，随后40mg服用1周，然后60mg服用48周。主要结局是度洛西汀的不良事件（AE）和药物不良反应（ADR）的发生频率。对疗效和健康结局进行评估。
共有149例患者来自前一项研究。治疗的中位时长为364.0天。AE和ADR的发生率分别为92.6%和63.8%。发生率≥5%的ADR有嗜睡、便秘、恶心、体重增加、口渴和不适。轻度、中度和重度AE患者的比例分别为80.5%、10.1%和2.0%。本研究中无严重的治疗相关AE。与基线相比，简明疼痛量表平均疼痛评分在所有时间点均有所改善（第50周时的平均变化±标准差为-1.31±1.70）。
度洛西汀对日本纤维肌痛患者的长期治疗安全有效。
