普瑞巴林在治疗中国人群纤维肌痛的疗效和安全性

普瑞巴林在治疗中国人群纤维肌痛的疗效和安全性

贵州医科大学  麻醉与心脏电生理课题组

翻译：刘云琴   编辑：张中伟   审校：曹莹

01 目的

在中国，纤维肌痛（FM）可能未得到充分诊断和治疗，部分原因是缺乏对该疾病的认识和理解，以及可用的治疗方法有限。

02 方法

这项随机、双盲、III期局部注册试验比较了普瑞巴林（300-450 mg/天的灵活剂量）与安慰剂在中国22个中心对根据美国风湿病学会1990年标准诊断为FM的中国成人疼痛的疗效和安全性。患者报告疼痛评分为≥40毫米，在100毫米刻度上（从0“无疼痛”到100“最严重疼痛”）。主要疗效终点是从基线检查到第14周平均疼痛评分（MPS）的变化。次要终点包括睡眠和睡眠干扰的测量，全程监测安全性和耐受性。

03 结果

普瑞巴林的中位剂量为335毫克/天。普瑞巴林组（n=170）与安慰剂组（n=164）相比，从基线检查到第14周，每周MPS显著降低（最小二乘平均差[95%可信区间]：-0.73[-1.10至-0.36]；P=0.0001）。明显更大比例的患者经历过≥30%及≥与安慰剂相比，普瑞巴林组第14周MPS降低50%。普瑞巴林治疗的受试者在睡眠和睡眠干扰方面表现出改善。普瑞巴林的耐受性普遍良好。最常见的不良反应是头晕和嗜睡；普瑞巴林治疗的受试者未发生严重不良事件（SAE）。9名接受安慰剂治疗的受试者出现严重不良事件。

04 结论

普瑞巴林（300-450毫克/天）是一种安全有效的治疗方法，用于减轻中国本土FM患者的疼痛和改善睡眠。

05 原始文献来源

Zhang X , Xu H , Zhang Z , et al. Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects[J]. Journal of Pain Research, 2021, Volume 14:537-548.

英文原文    

Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects

Abstract：

Purpose: Fibromyalgia (FM) may go underdiagnosed and untreated in China in part due to a lack of awareness and understanding of the condition, and limited available treatments.

Patients and Methods: This randomized, double-blind, Phase III local registration trial compared the efficacy and safety of pregabalin (flexibly dosed 300–450 mg/day) versus placebo for the management of pain in Chinese adults diagnosed with FM according to American College of Rheumatology 1990 criteria, across 22 centers within China. Patients reported pain score of ≥40 mm on 100-mm scale (from 0 “no pain” to 100 “worst possible pain”). The primary efficacy endpoint was change from baseline to Week 14 in mean pain score (MPS). Secondary endpoints included measures of sleep and sleep interference. Safety and tolerability were monitored throughout.

Results: Median pregabalin dose was 335 mg/day. A significant reduction from baseline to Week 14 in weekly MPS was seen for patients treated with pregabalin (n=170) versus placebo (n=164) (least-squares mean difference [95% confidence interval]: -0.73 [-1.10 to -0.36]; P=0.0001). Significantly greater proportions of patients experienced ≥30% and ≥50% reductions in MPS at Week 14 with pregabalin versus placebo. Pregabalin-treated subjects demonstrated improvements in measures of sleep and sleep interference. Pregabalin was generally well tolerated. The most common adverse events were dizziness and somno-lence; no serious adverse events (SAEs) occurred in pregabalin-treated subjects. Nine placebo-treated subjects experienced SAEs.

Conclusion: Pregabalin (300–450 mg/day) is a safe and effective treatment for reducing pain and improving sleep in native Chinese subjects with FM.

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