Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: A double-blind placebo-controlled trial

普瑞巴林 医学 安慰剂 麻醉 临床终点 神经病理性疼痛 周围神经病变 神经传导速度 随机对照试验 安慰剂对照研究 糖尿病神经病变 不利影响 内科学 糖尿病 双盲 替代医学 病理 内分泌学
作者
Joseph C. Arezzo,Julio Rosenstock,Linda LaMoreaux,L. Pauer
出处
期刊:BMC Neurology [BioMed Central]
卷期号:8 (1) 被引量:189
标识
DOI:10.1186/1471-2377-8-33
摘要

Recent consensus guidelines recommend pregabalin as a first-tier treatment for painful diabetic peripheral neuropathy (DPN). We evaluated the efficacy of pregabalin 600 mg/d (300 mg dosed BID) versus placebo for relieving DPN-associated neuropathic pain, and assessed its safety using objective measures of nerve conduction (NC). In this randomized, double-blind, placebo-controlled trial, the primary efficacy measure was endpoint mean pain score (MPS) from daily pain diaries (11-point scale). NC velocity and sensory and motor amplitudes were assessed at baseline, endpoint, and end of follow-up (2 weeks post-treatment). At each timepoint, the median-motor, median-sensory, ulnar-sensory, and peroneal-motor nerves were evaluated. Secondary efficacy measures included weekly MPS and proportion of responders (patients achieving ≥50% reduction in MPS from baseline to endpoint). After 1-weeks' dosage escalation, pregabalin-treated patients received 300 mg BID for 12 weeks. Eighty-two patients received pregabalin and 85 placebo. Mean durations were 10 years for diabetes and ~5 years for painful DPN. Pregabalin-treated patients had lower MPS than controls (mean difference, -1.28; p <.001). For all four nerves, 95% CIs for median differences in amplitude and velocity from baseline to endpoint and baseline to follow-up included 0 (ie, no significant difference vs. placebo). Significant pain improvement among pregabalin-treated patients was evident at week 1 and sustained at every weekly timepoint. More pregabalin-treated patients (49%) than controls (23%) were responders (p <.001). Pregabalin 600 mg/d (300 mg BID) effectively reduced pain, was well tolerated, and had no statistically significant or clinically meaningful effect on NC in patients with painful DPN. ClinicalTrials.gov NCT00159679
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
阿朱完成签到,获得积分10
刚刚
牛马研究生完成签到,获得积分20
1秒前
昭昭完成签到,获得积分10
1秒前
4566完成签到,获得积分10
2秒前
所所应助牛马码字员采纳,获得10
6秒前
昭昭发布了新的文献求助10
7秒前
君衡完成签到 ,获得积分10
8秒前
潇湘雪月发布了新的文献求助10
8秒前
10秒前
754完成签到,获得积分10
10秒前
SciGPT应助芒果柠檬采纳,获得10
11秒前
芬栀完成签到,获得积分10
12秒前
烂漫吐司完成签到,获得积分10
13秒前
14秒前
爱蕊咖完成签到 ,获得积分10
14秒前
odanfeonq完成签到,获得积分10
14秒前
遗忘完成签到,获得积分10
15秒前
16秒前
可爱的函函应助昭昭采纳,获得50
17秒前
19秒前
杜景婷完成签到 ,获得积分10
19秒前
卡卡罗特完成签到,获得积分10
19秒前
odanfeonq发布了新的文献求助10
19秒前
23秒前
俄而完成签到 ,获得积分10
23秒前
23秒前
24秒前
科研通AI5应助感动黄豆采纳,获得10
25秒前
酷酷的友灵完成签到,获得积分10
26秒前
量子星尘发布了新的文献求助10
26秒前
27秒前
29秒前
潇湘雪月发布了新的文献求助10
29秒前
30秒前
30秒前
我是老大应助露亮采纳,获得10
33秒前
顾矜应助Bressanone采纳,获得10
33秒前
阳光发布了新的文献求助10
34秒前
半夏发布了新的文献求助10
35秒前
36秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989242
求助须知:如何正确求助?哪些是违规求助? 3531393
关于积分的说明 11253753
捐赠科研通 3270010
什么是DOI,文献DOI怎么找? 1804868
邀请新用户注册赠送积分活动 882084
科研通“疑难数据库(出版商)”最低求助积分说明 809136