可变剂量普瑞巴林对难治性痛性糖尿病周围神经病的疗效评估  

Efficacy evaluation on flexible dozes of Pregabalin for treatment of peripheral neuropathy in refractory painful diabetics

作　　者：金艺仪 沈沸[2] 张瑛[2] 周礼清 潘静 

机构地区：[1]上海市花木社区卫生服务中心,上海201204 [2]上海交通大学医学院附属仁济医院,上海200127

出　　处：《上海预防医学》2015年第3期162-165,共4页Shanghai Journal of Preventive Medicine

摘　　要：[目的]评估可变剂量普瑞巴林治疗难治性痛性糖尿病周围神经病的疗效与耐受性。[方法]采用前瞻、开放、非随机对照设计。对48例难治性痛性糖尿病周围神经病患者，予以普瑞巴林150～300 mg／d治疗4周。应用数字等级评分（ NRS）评价基线、第2周、第4周时疼痛强度及疼痛对睡眠的干扰，应用汉密尔顿抑郁量表（ HAMD－17）、汉密尔顿焦虑量表（ HAMA）和患者总体印象改变（ PGIC）评定情绪及总体疗效。[结果]46例患者完成4周研究，研究终点普瑞巴林平均剂量为（262．5±57．9）mg／d。治疗后疼痛评分由治疗前的6．2±1．0下降至4．3±1．4（第2周）、3．0±1．6（第4周）（P值均＜0．01），睡眠干扰评分由治疗前的5．1±1．4下降至3．3±1．4（第2周）、2．1±1．5（第4周）（P值均＜0．01）。 HAMD－17、HAMA评分均明显改善（P值均＜0．01）。26例（56．5％）患者PGIC为“极为好转”或“明显好转”。无严重不良事件，仅2例（4．2％）患者因头晕、嗜睡退出研究。[结论]普瑞巴林150～300 mg／d能有效改善难治性痛性糖尿病周围神经病患者的疼痛、睡眠状况及焦虑、抑郁情绪，且耐受性良好。Objective ] To evaluate the efficacy and tolerability of a flexible-dose pregabalin regimen in patients with refractory painful diabetic peripheral neuropathy . [ Methods] A prospective, open, non-randomized design was adopted .A series of 48 patients with refractory painful diabetic peripheral neuropathy received pregabalin 150 to 300 mg/d for 4 weeks.Pain intensity and sleep interference score were measured using numerical rating scale at baseline and at 2 and 4 weeks after therapy.Secondary meas-ures for assessment of mood and overall efficacy included 17-item Hamilton depression scale （ HAMD -17）, Hamilton anxiety scale （ HAMA） and patient global impression of change （ PGIC）.Adverse events were recorded . [ Results] The 46 patients completed the 4 weeks study .The mean dose of pregabalin was （262.5 ±57.9）mg/d at endpoint.The mean pain score decreased from 6.2 ±1.0 at baseline to 4.3 ± 1.4 at 2 weeks and 3.0 ±1.6 at 4 weeks （ P all〈0.01）.The mean sleep interference score was 5.1 ±1.4, 3.3 ±1.4, 2.1 ±1.5 respectively （P all〈0.01）.Also, significant improvements were noted in the HAMD and HAMA score （P〈0.01）.And among them, 26 patients （56.5%） reported“very much improved” or“much improved” in PGIC.Pregabalin was generally well tolerated without severe side effects reported and only 2 patients （ 4 .2%） discontinued the study because of their dizziness , somnolence . [ Conclusion] Pregabalin 150 to 300 mg/d can effectively improve pain , sleep, anxiety/depression in patients with refractory painful diabetic peripheral neuropathy , and it was well-tolerated.

关 键 词：痛性糖尿病周围神经病 普瑞巴林 难治性 

分 类 号：R587.2[医药卫生—内分泌]