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
刚刚
guangshuang完成签到 ,获得积分10
1秒前
量子星尘发布了新的文献求助10
1秒前
小明完成签到,获得积分10
1秒前
einuo发布了新的文献求助10
1秒前
SYLH应助111采纳,获得10
2秒前
hh发布了新的文献求助10
5秒前
羊羊完成签到,获得积分10
5秒前
卡卡罗特先森完成签到 ,获得积分10
6秒前
朽木完成签到 ,获得积分10
8秒前
8秒前
fanyueyue应助111采纳,获得10
10秒前
10秒前
10秒前
kcmat发布了新的文献求助10
11秒前
hh完成签到,获得积分10
12秒前
Philadelphus发布了新的文献求助10
13秒前
einuo完成签到,获得积分10
13秒前
AKYDXS完成签到,获得积分10
16秒前
昏睡的蟠桃应助Llllll采纳,获得200
16秒前
科研通AI2S应助hao采纳,获得10
16秒前
17秒前
17秒前
香蕉觅云应助阿湫采纳,获得10
18秒前
星辰大海应助星辰采纳,获得10
18秒前
阿卡宁完成签到,获得积分10
18秒前
lzw完成签到 ,获得积分10
18秒前
沉静烧仙草完成签到,获得积分20
19秒前
烟花应助嘉嘉琦采纳,获得10
19秒前
隐形曼青应助科研通管家采纳,获得10
19秒前
Hello应助科研通管家采纳,获得10
20秒前
Ava应助科研通管家采纳,获得10
20秒前
上官若男应助科研通管家采纳,获得10
20秒前
20秒前
赘婿应助科研通管家采纳,获得10
20秒前
烟花应助科研通管家采纳,获得10
20秒前
FashionBoy应助科研通管家采纳,获得10
20秒前
英俊的铭应助科研通管家采纳,获得10
20秒前
在水一方应助科研通管家采纳,获得10
20秒前
accepted应助科研通管家采纳,获得10
20秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
Research on Disturbance Rejection Control Algorithm for Aerial Operation Robots 500
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 4038524
求助须知:如何正确求助?哪些是违规求助? 3576221
关于积分的说明 11374737
捐赠科研通 3305912
什么是DOI,文献DOI怎么找? 1819354
邀请新用户注册赠送积分活动 892688
科研通“疑难数据库(出版商)”最低求助积分说明 815048