Backonja M, Beydoun A, Edwards K R, Schwartz S L, Fonseca V, Hes M, LaMoreaux L, Garofalo E
Department of Neurology, University of Wisconsin, Madison 53792, USA.
JAMA. 1998 Dec 2;280(21):1831-6. doi: 10.1001/jama.280.21.1831.
Pain is the most disturbing symptom of diabetic peripheral neuropathy. As many as 45% of patients with diabetes mellitus develop peripheral neuropathies.
To evaluate the effect of gabapentin monotherapy on pain associated with diabetic peripheral neuropathy.
Randomized, double-blind, placebo-controlled, 8-week trial conducted between July 1996 and March 1997.
Outpatient clinics at 20 sites.
The 165 patients enrolled had a 1- to 5-year history of pain attributed to diabetic neuropathy and a minimum 40-mm pain score on the Short-Form McGill Pain Questionnaire visual analogue scale.
Gabapentin (titrated from 900 to 3600 mg/d or maximum tolerated dosage) or placebo.
The primary efficacy measure was daily pain severity as measured on an 11-point Likert scale (0, no pain; 10, worst possible pain). Secondary measures included sleep interference scores, the Short-Form McGill Pain Questionnaire scores, Patient Global Impression of Change and Clinical Global Impression of Change, the Short Form-36 Quality of Life Questionnaire scores, and the Profile of Mood States results.
Eighty-four patients received gabapentin and 70 (83%) completed the study; 81 received placebo and 65 (80%) completed the study. By intent-to-treat analysis, gabapentin-treated patients' mean daily pain score at the study end point (baseline, 6.4; end point, 3.9; n = 82) was significantly lower (P<.001) compared with the placebo-treated patients' end-point score (baseline, 6.5; end point, 5.1; n = 80). All secondary outcome measures of pain were significantly better in the gabapentin group than in the placebo group. Additional statistically significant differences favoring gabapentin treatment were observed in measures of quality of life (Short Form-36 Quality of Life Questionnaire and Profile of Mood States). Adverse events experienced significantly more frequently in the gabapentin group were dizziness (20 [24%] in the gabapentin group vs 4 [4.9%] in the control group; P<.001) and somnolence (19 [23%] in the gabapentin group vs 5 [6%] in the control group; P = .003). Confusion was also more frequent in the gabapentin group (7 [8%] vs 1 [1.2%]; P = .06).
Gabapentin monotherapy appears to be efficacious for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life.
疼痛是糖尿病性周围神经病变最困扰人的症状。多达45%的糖尿病患者会发生周围神经病变。
评估加巴喷丁单药治疗与糖尿病性周围神经病变相关疼痛的效果。
1996年7月至1997年3月进行的随机、双盲、安慰剂对照、为期8周的试验。
20个地点的门诊诊所。
入选的165例患者有1至5年因糖尿病性神经病变导致疼痛的病史，且在简式麦吉尔疼痛问卷视觉模拟量表上的疼痛评分至少为40毫米。
加巴喷丁（从900毫克/天滴定至3600毫克/天或最大耐受剂量）或安慰剂。
主要疗效指标是用11点李克特量表（0，无疼痛；10，可能的最严重疼痛）测量的每日疼痛严重程度。次要指标包括睡眠干扰评分、简式麦吉尔疼痛问卷评分、患者总体变化印象和临床总体变化印象、简短健康调查36项生活质量问卷评分以及情绪状态剖面图结果。
84例患者接受加巴喷丁治疗，70例（83%）完成研究；81例接受安慰剂治疗，65例（80%）完成研究。按意向性分析，加巴喷丁治疗组患者在研究终点时的平均每日疼痛评分（基线为6.4；终点为3.9；n = 82）与安慰剂治疗组患者的终点评分（基线为6.5；终点为5.1；n = 80）相比显著更低（P <.001）。加巴喷丁组所有疼痛的次要结局指标均显著优于安慰剂组。在生活质量指标（简短健康调查36项生活质量问卷和情绪状态剖面图）方面观察到有利于加巴喷丁治疗的其他统计学显著差异。加巴喷丁组更频繁出现的不良事件是头晕（加巴喷丁组20例[24%]，对照组4例[4.9%]；P <.001）和嗜睡（加巴喷丁组19例[23%]，对照组5例[6%]；P =.003）。加巴喷丁组困惑也更常见（7例[8%]对1例[1.2%]；P =.06）。
加巴喷丁单药治疗似乎对治疗与糖尿病性周围神经病变相关的疼痛和睡眠干扰有效，并对情绪和生活质量有积极影响。
