Raskin Joel, Smith Timothy R, Wong Kar, Pritchett Yili Lu, D'Souza Deborah N, Iyengar Smriti, Wernicke J F
Lilly Research Laboratories, Toronto, Canada.
J Palliat Med. 2006 Feb;9(1):29-40. doi: 10.1089/jpm.2006.9.29.
Duloxetine hydrochloride is a dual reuptake inhibitor of both serotonin and norepinephrine. In the present open-label study, the safety of duloxetine at a fixed-dose of 60 mg twice daily (BID) for up to 52 weeks was evaluated and compared to routine care in the therapy of patients diagnosed with diabetic peripheral neuropathic pain (DPNP).
Patients who completed a 13-week, double-blind, duloxetine and placebo acute therapy period were rerandomly assigned in a 2:1 ratio to therapy with duloxetine 60 mg BID (N=161) or routine care (N=76) for an additional 52 weeks. Routine care consisted primarily of gabapentin, amitriptyline, and venlafaxine. The study included male or female outpatients 18 years of age or older with a diagnosis of DPNP caused by type 1 or type 2 diabetes.
A higher percentage of routine care-treated patients experienced 1 or more serious adverse events. No statistically significant therapy-group difference was observed in the overall incidence of treatment-emergent adverse events (TEAEs). The TEAEs reported by 10% or more of duloxetine 60 mg BID-treated patients were nausea, and by the routine care-treated patients were peripheral edema, pain in the extremity, somnolence, and dizziness. Duloxetine did not appear to adversely affect glycemic control, lipid profiles, nerve function, or the course of DPNP. There were no statistically significant therapy-group differences observed in the 36-item Short-Form Health Survey subscales or in the EuroQol 5-Dimension Questionnaire.
In this study, duloxetine was safe and well tolerated compared to routine care in the long-term management of patients with DPNP.
盐酸度洛西汀是一种5-羟色胺和去甲肾上腺素的双重再摄取抑制剂。在本开放性研究中，评估了每天两次固定剂量60毫克度洛西汀长达52周的安全性，并与诊断为糖尿病性周围神经病变性疼痛（DPNP）患者治疗中的常规护理进行了比较。
完成了为期13周的度洛西汀和安慰剂双盲急性治疗期的患者，以2:1的比例重新随机分配，接受每天两次60毫克度洛西汀治疗（N = 161）或常规护理（N = 76），持续52周。常规护理主要包括加巴喷丁、阿米替林和文拉法辛。该研究纳入了年龄在18岁及以上、诊断为1型或2型糖尿病所致DPNP的男性或女性门诊患者。
接受常规护理治疗的患者中，经历1种或更多严重不良事件的比例更高。在治疗中出现的不良事件（TEAE）的总体发生率方面，未观察到治疗组之间有统计学显著差异。每天两次60毫克度洛西汀治疗的患者中，10%或更多患者报告的TEAE为恶心，而常规护理治疗的患者报告的TEAE为外周水肿、肢体疼痛、嗜睡和头晕。度洛西汀似乎未对血糖控制、血脂水平、神经功能或DPNP病程产生不利影响。在36项简短健康调查子量表或欧洲五维健康量表问卷中，未观察到治疗组之间有统计学显著差异。
在本研究中，与DPNP患者的长期管理常规护理相比，度洛西汀安全且耐受性良好。
