Lunn Michael Pt, Hughes Richard Ac, Wiffen Philip J
Department of Neurology, National Hospital for Neurology and Neurosurgery, Queen Square, London, UK, WC1N 3BG.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD007115. doi: 10.1002/14651858.CD007115.pub2.
Duloxetine is a balanced serotonin and noradrenaline reuptake inhibitor licensed for the treatment of major depressive disorders, urinary stress incontinence and the management of neuropathic pain associated with diabetic peripheral neuropathy. A number of trials have been conducted to investigate the use of duloxetine in neuropathic and nociceptive painful conditions.
To assess the benefits and harms of duloxetine for treating painful neuropathy and different types of chronic pain.
We searched The Cochrane Neuromuscular Group Specialized Register (10 March 2009), The Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2009), MEDLINE (January 1966 to March 2009), EMBASE (January 1980 to March 2009), and www.clinicaltrials.gov to March 2009 and the reference lists of identified publications for trials of duloxetine used for the treatment of painful peripheral neuropathy or chronic pain.
We selected all randomised or quasi-randomised trials of any formulation of duloxetine, used for the treatment of painful peripheral neuropathy or chronic pain in adult participants.
Two authors extracted data independently onto a specially designed proforma and cross checked them.
Six trials were identified including 2220 participants. Three studies included participants with painful diabetic neuropathy and three treated participants with fibromyalgia. Duloxetine at 60 mg daily is effective in treating painful diabetic peripheral neuropathy in the short-term to 12 weeks with a risk ratio (RR) for 50% pain reduction at 12 weeks of 1.65 (95% confidence interval (CI) 1.34 to 2.03), number needed to treat (NNT) 6 (95% CI 5 to 10). Duloxetine at 60 mg daily is also effective in fibromyalgia over 12 weeks (RR 50% reduction in pain 1.57, 95% CI 1.20 to 2.06; NNT 8, 95% CI 5 to 17) and 28 weeks (RR 1.58, 95% CI 1.10 to 2.27). Adverse events were common in both treatment and placebo arms but more common in the treatment arm with a dose dependent effect. Most side effects were minor, but 16% of participants stopped the drug due to side effects. Serious adverse events were rare.
AUTHORS' CONCLUSIONS: There is moderately strong evidence that duloxetine 60 mg and 120 mg daily are efficacious for treating pain in diabetic peripheral neuropathy and fibromyalgia but 20 mg daily is not. Minor side effects are common at therapeutic doses but serious side effects are rare. Direct comparisons of duloxetine with other antidepressants and with other drugs already shown to be efficacious in neuropathic pain would be appropriate and should include unbiased economic analyses.
度洛西汀是一种5-羟色胺和去甲肾上腺素再摄取平衡抑制剂，已获许可用于治疗重度抑郁症、尿失禁以及与糖尿病性周围神经病相关的神经性疼痛。已经进行了多项试验来研究度洛西汀在神经性和伤害性疼痛性疾病中的应用。
评估度洛西汀治疗疼痛性神经病和不同类型慢性疼痛的利弊。
我们检索了Cochrane神经肌肉疾病专业注册库（2009年3月10日）、Cochrane对照试验中心注册库（Cochrane图书馆2009年第3期）、MEDLINE（1966年1月至2009年3月）、EMBASE（1980年1月至2009年3月）以及截至2009年3月的www.clinicaltrials.gov网站，并检索了已识别出版物的参考文献列表，以查找用于治疗疼痛性周围神经病或慢性疼痛的度洛西汀试验。
我们选择了所有使用度洛西汀任何剂型治疗成年参与者疼痛性周围神经病或慢性疼痛的随机或半随机试验。
两位作者独立将数据提取到专门设计的表格上，并进行交叉核对。
共识别出6项试验，包括2220名参与者。3项研究纳入了患有疼痛性糖尿病性神经病的参与者，3项研究治疗了纤维肌痛患者。每日60毫克度洛西汀在短期至12周内有效治疗疼痛性糖尿病性周围神经病，12周时疼痛减轻50%的风险比（RR）为1.65（95%置信区间（CI）1.34至2.03），需治疗人数（NNT）为6（95%CI 5至10）。每日60毫克度洛西汀在12周内对纤维肌痛也有效（疼痛减轻50%的RR为1.57，95%CI 1.20至2.06；NNT为8，95%CI 5至17），在28周时也有效（RR为1.58，95%CI 1.10至2.27）。不良事件在治疗组和安慰剂组中均常见，但在治疗组中更常见，且有剂量依赖性效应。大多数副作用轻微，但16%的参与者因副作用停药。严重不良事件罕见。
有中等强度的证据表明，每日60毫克和120毫克度洛西汀对治疗糖尿病性周围神经病和纤维肌痛中的疼痛有效，但每日20毫克无效。治疗剂量下轻微副作用常见，但严重副作用罕见。将度洛西汀与其他抗抑郁药以及已证明对神经性疼痛有效的其他药物进行直接比较是合适的，并且应包括无偏倚的经济学分析。
