Skljarevski Vladimir, Zhang Shuyu, Iyengar Smriti, D'Souza Deborah, Alaka Karla, Chappell Amy, Wernicke Joachim
Lilly Research Laboratories, Indianapolis, IN 46285, USA.
Curr Drug ther. 2011 Nov;6(4):296-303. doi: 10.2174/157488511798109592.
The primary objective of this study is to review the efficacy of duloxetine in treating chronic pain using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations for clinical significance across chronic pain states. These include pain intensity, patient ratings of overall improvement, physical functioning, and mental functioning. This review comprised the side-by-side analyses of 12 double-blind, placebo-controlled trials of duloxetine in patients with chronic pain (diabetic peripheral neuropathic pain, fibromyalgia, chronic pain due to osteoarthritis, and chronic low back pain). Patients received duloxetine (60 to 120 mg/day) or placebo. Average pain reduction was assessed over 3 months as the primary efficacy outcome. Other measures used were physical function and Patient Global Impression of Improvement. In 10 of the 12 studies, statistically significant greater pain reduction was observed for duloxetine- compared with placebo-treated patients. The response rates based on average pain reduction, improvement of physical function, and global impression were comparable across all 4 chronic pain states. Compared with patients on placebo, significantly more patients treated with duloxetine reported a moderately important pain reduction (≥30% reduction) in 9 of the 12 studies, a minimally important improvement in physical function in 8 of the 12 studies, and a moderately important to substantial improvement in Patient Global Impression of Improvement rating in 11 of the 12 studies. The analyses reported here show that duloxetine is efficacious in treating chronic pain as demonstrated by significant improvement in pain intensity, physical functioning, and patient ratings of overall improvement.
本研究的主要目的是利用临床试验中方法、测量和疼痛评估倡议（IMMPACT）针对慢性疼痛状态临床意义的建议，回顾度洛西汀治疗慢性疼痛的疗效。这些指标包括疼痛强度、患者对总体改善的评分、身体功能和心理功能。本综述对12项度洛西汀治疗慢性疼痛患者（糖尿病性周围神经病理性疼痛、纤维肌痛、骨关节炎所致慢性疼痛和慢性下腰痛）的双盲、安慰剂对照试验进行了并列分析。患者接受度洛西汀（60至120毫克/天）或安慰剂治疗。将3个月内的平均疼痛减轻情况作为主要疗效指标进行评估。使用的其他指标包括身体功能和患者总体改善印象。在12项研究中的10项中，与安慰剂治疗的患者相比，度洛西汀治疗的患者疼痛减轻具有统计学意义。基于平均疼痛减轻、身体功能改善和总体印象的缓解率在所有4种慢性疼痛状态中相当。与接受安慰剂治疗的患者相比，在12项研究中的9项中，接受度洛西汀治疗的患者报告疼痛有中度显著减轻（减轻≥30%）的人数明显更多；在12项研究中的8项中，身体功能有最小显著改善；在12项研究中的11项中，患者总体改善印象评分有中度显著至大幅改善。此处报告的分析表明，度洛西汀在治疗慢性疼痛方面有效，疼痛强度、身体功能以及患者对总体改善的评分均有显著改善。
