Raskin Joel, Pritchett Yili L, Wang Fujun, D'Souza Deborah N, Waninger Amy L, Iyengar Smriti, Wernicke Joachim F
Lilly Research Laboratories, Eli Lilly Canada, Toronto, Ontario, Canada.
Pain Med. 2005 Sep-Oct;6(5):346-56. doi: 10.1111/j.1526-4637.2005.00061.x.
Assess efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, on the reduction of pain severity, in patients with diabetic peripheral neuropathic pain (DPNP).
This was a multicenter, parallel, double-blind, randomized, placebo-controlled trial that enrolled 348 patients with pain due to peripheral neuropathy caused by type 1 or type 2 diabetes mellitus. Patients (N = 116 per group) were randomly assigned to receive duloxetine 60 mg once daily (QD), duloxetine 60 mg twice daily (BID), or placebo, for 12 weeks. The primary outcome measure was the weekly mean score of 24-hour average pain severity evaluated on an 11-point Likert scale. Secondary outcome measures and safety were evaluated.
Compared with placebo-treated patients, both duloxetine-treated groups improved significantly more (P < 0.001) on the 24-hour average pain score. Duloxetine demonstrated superiority to placebo in all secondary analyses of the primary efficacy measure. A significant treatment effect for duloxetine was observed in most secondary measures for pain. Discontinuations due to adverse events were more frequent in the duloxetine 60 mg BID- (12.1%) versus the placebo- (2.6%) treated group. Duloxetine showed no adverse effects on diabetic control, and both doses were safely administered and well tolerated.
In this clinical trial, duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the management of DPNP.
评估选择性5-羟色胺与去甲肾上腺素再摄取抑制剂度洛西汀降低糖尿病性周围神经病变性疼痛（DPNP）患者疼痛严重程度的疗效及安全性。
这是一项多中心、平行、双盲、随机、安慰剂对照试验，纳入348例由1型或2型糖尿病引起的周围神经病变性疼痛患者。患者（每组N = 116）被随机分配接受每日一次60毫克度洛西汀（QD）、每日两次60毫克度洛西汀（BID）或安慰剂，为期12周。主要结局指标是采用11点李克特量表评估的24小时平均疼痛严重程度的每周平均分。对次要结局指标及安全性进行评估。
与接受安慰剂治疗的患者相比，两个度洛西汀治疗组24小时平均疼痛评分改善更为显著（P < 0.001）。在主要疗效指标的所有次要分析中，度洛西汀均显示优于安慰剂。在大多数疼痛次要指标中观察到度洛西汀有显著治疗效果。每日两次服用60毫克度洛西汀的治疗组（12.1%）因不良事件停药的频率高于安慰剂治疗组（2.6%）。度洛西汀对糖尿病控制无不良影响，两种剂量给药均安全且耐受性良好。
在本临床试验中，每日一次60毫克度洛西汀和每日两次60毫克度洛西汀治疗DPNP有效且安全。
