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【Diabetes Care】Pregabalin治疗痛性糖尿病周围神经病
Findings from seven randomized, controlled trials across a range of doses
ABSTRACT
OBJECTIVE—To evaluate the efficacy, safety, and tolerability of pregabalin across the effective dosing range, to determine differences in the efficacy of three times daily (TID) versus twice daily (BID) dosage schedules, and to use time-to-event analysis to determine the time to onset of a sustained therapeutic effect using data from seven trials of pregabalin in painful diabetic peripheral neuropathy (DPN).
RESEARCH DESIGN AND METHODS—Data were pooled across seven double-blind, randomized, placebo-controlled trials using pregabalin to treat painful DPN with dosages of 150, 300, and 600 mg/day administered TID or BID. Only one trial included all three of these dosages, and TID dosing was used in four. All studies shared fundamental selection criteria, and treatment durations ranged from 5 to 13 weeks.
RESULTS—Pooled analysis showed that pregabalin significantly reduced pain and pain-related sleep interference associated with DPN (150, 300, and 600 mg/day administered TID vs. placebo, all P 0.007). Only the 600 mg/day dosage showed efficacy when administered BID (P 0.001). Pain and sleep interference reductions associated with pregabalin appear to be positively correlated with dosage; the greatest effect was observed in patients treated with 600 mg/day. Kaplan-Meier analysis revealed that the median time to onset of a sustained (30% at end point) 1-point improvement was 4 days in patients treated with pregabalin at 600 mg/day, 5 days in patients treated with pregabalin at 300 mg/day, 13 days in patients treated with pregabalin at 150 mg/day, and 60 days in patients receiving placebo. The most common treatment-emergent adverse events were dizziness, somnolence, and peripheral edema.
CONCLUSIONS—Treatment with pregabalin across its effective dosing range is associated with significant, dose-related improvement in pain in patients with DPN.
1448.rar (296.64k) 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Efficacy, Safety, and Tolerability of Pregabalin Treatment for Painful Diabetic Peripheral Neuropathy
普瑞巴林治疗痛性糖尿病周围神经病变的有效性、安全性和，耐受性
Findings from seven randomized, controlled trials across a range of doses
一定剂量范围内7个随机对照试验的结果
ABSTRACT
摘要
OBJECTIVE—To evaluate the efficacy, safety, and tolerability of pregabalin across the effective dosing range, to determine differences in the efficacy of three times daily (TID) versus twice daily (BID) dosage schedules, and to use time-to-event analysis to determine the time to onset of a sustained therapeutic effect using data from seven trials of pregabalin in painful diabetic peripheral neuropathy (DPN).
研究目的——利用这七个用普瑞巴林治疗痛性糖尿病周围神经病(DPN)的试验数据，评价有效剂量范围内普瑞巴林的有效性、安全性和耐受性，确定一日三次(TID)和一日两次(TID)服药效果的不同，利用事件发生时间分析来确定稳定疗效开始的时间。
RESEARCH DESIGN AND METHODS—Data were pooled across seven double-blind, randomized, placebo-controlled trials using pregabalin to treat painful DPN with dosages of 150, 300, and 600 mg/day administered TID or BID. Only one trial included all three of these dosages, and TID dosing was used in four. All studies shared fundamental selection criteria, and treatment durations ranged from 5 to 13 weeks.
研究设计和方法——汇集这七个用普瑞巴林治疗痛性DPN的双盲随机安慰剂对照试验的数据，药物剂量为150, 300, and 600 毫克/天，TID或BID给药。只有一个试验包括了三种剂量，四个试验是TID给药。所有研究有共同的基本选择标准，治疗时间从5周到14周。
RESULTS—Pooled analysis showed that pregabalin significantly reduced pain and pain-related sleep interference associated with DPN (150, 300, and 600 mg/day administered TID vs. placebo, all P 0.007). Only the 600 mg/day dosage showed efficacy when administered BID (P 0.001). Pain and sleep interference reductions associated with pregabalin appear to be positively correlated with dosage; the greatest effect was observed in patients treated with 600 mg/day. Kaplan-Meier analysis revealed that the median time to onset of a sustained (30% at end point) 1-point improvement was 4 days in patients treated with pregabalin at 600 mg/day, [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-09-07 05:14
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