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普瑞巴林用于带状疱疹后神经痛患者的长期疗效和安全性:一项为期52周的开放标签、灵活剂量研究结果

[Long-term efficacy and safety of pregabalin in patients with postherpetic neuralgia: results of a 52-week, open-label, flexible-dose study].

作者信息

Ogawa Setsuro, Suzuki Makoto, Arakawa Akio, Yoshiyama Tamotsu, Suzuki Misaki

机构信息

Surugadai Nihon University Hospital/Nihon University School of Medicine, Tokyo 101-8309.

出版信息

Masui. 2010 Aug;59(8):961-70.

PMID:20715519
Abstract

BACKGROUND

The efficacy of pregabalin was demonstrated in a randomized double-blind placebo-controlled 13-week trial in 371 Japanese patients with postherpetic neuralgia (PHN). In this study, we evaluated the long-term efficacy and safety of pregabalin for relief of PHN.

METHODS

126 patients were enrolled from the preceding double-blind study into the 52-week open-label study. Patients were given pregabalin 150 to 600 mg x day(-1). Pain intensity was measured using the Short-Form McGill Pain Questionnaire (SF-MPQ: total score, visual analogue scale and present pain intensity).

RESULTS

The efficacy parameter SF-MPQ showed a decrease over the treatment-term. The changes of visual analogue scale and present pain intensity at the endpoint were -28.3 mm and -1.1 score, respectively. The commonly reported adverse events were dizziness, somnolence, peripheral edema and weight gain, and most of them were mild to moderate in intensity. No new adverse events were observed due to long-term pregabalin administration.

CONCLUSIONS

These results suggest that long-term treatment of pregabalin may be beneficial in patients with PHN.

摘要

背景

在一项针对371名日本带状疱疹后神经痛(PHN)患者的随机双盲安慰剂对照13周试验中,已证明普瑞巴林的疗效。在本研究中,我们评估了普瑞巴林缓解PHN的长期疗效和安全性。

方法

126名患者从前一项双盲研究入选到这项为期52周的开放标签研究中。患者服用普瑞巴林150至600毫克/天。使用简化麦吉尔疼痛问卷(SF-MPQ:总分、视觉模拟量表和当前疼痛强度)测量疼痛强度。

结果

疗效参数SF-MPQ在治疗期间呈下降趋势。终点时视觉模拟量表和当前疼痛强度的变化分别为-28.3毫米和-1.1分。常见的不良事件为头晕、嗜睡、外周水肿和体重增加,且大多数为轻至中度。长期服用普瑞巴林未观察到新的不良事件。

结论

这些结果表明,普瑞巴林长期治疗可能对PHN患者有益。

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