度洛西汀治疗脑卒中后中枢性疼痛的疗效：一项随机双盲安慰剂对照试验。

Efficacy of Duloxetine in Patients with Central Post-stroke Pain: A Randomized Double Blind Placebo Controlled Trial.

机构信息

Department of Neurology, Institute of Medical Science, Banaras Hindu University, Varanasi, Uttar Pradesh, India.

出版信息

Pain Med. 2023 Jun 1;24(6):610-617. doi: 10.1093/pm/pnac182.

DOI:10.1093/pm/pnac182

PMID:36409018

Abstract

OBJECTIVE

Central post-stroke pain (CPSP) refers to neuropathic pain in areas of the body corresponding to stroke lesions. Duloxetine, a serotonin-norepinephrine reuptake inhibitor, is safe and effective against neuropathic pain. In this randomized double-blind placebo-controlled study, we studied the effect of duloxetine in CPSP patients.

METHODS

Consecutive patients satisfying the inclusion criteria were enrolled in the study and were randomized in a simple 1:1 randomization to duloxetine and placebo groups. Baseline demographic, clinical and imaging data were obtained. Prespecified primary outcome was comparison of change in pain intensity from baseline to 4 weeks, as assessed on Numeric Rating Scale (NRS) in both groups. Prespecified secondary outcomes were comparison of change in average pain severity from baseline to 4 weeks as measured on Short-form McGill Pain Questionnaire-2 (SFMPQ-2) score and Pain Disability Index (PDI) score and comparison of Patient Global Impression of Change (PGIC) score at the end of 4 weeks of treatment in both groups. Duloxetine at doses of 30 mg and similarly appearing placebo tablets were given and the dose was doubled if there was no response at the end of 2 weeks. Response to treatment was defined as ≥2 points reduction of NRS pain score.

RESULTS

In total, 82 patients were enrolled in the study, 41 in each group. There was a significant difference in reduction in NRS score between duloxetine and placebo group from baseline (6.51 ± 1.03 vs 6.37 ± 1.41) to 4 weeks (3.02 ± 1.70 vs 4.40 ± 1.77, P = .02 for difference in reduction between groups). SFMPQ-2 score (P = .032) and Pain Disability Index score (P = .005) also differ significantly from baseline to 4 weeks between the two groups. PGIC score at the end of 4 weeks was significantly different between the two groups (5.15 ± 1.54 vs 3.89 ± 1.51; P < .001). Responder rate (defined as % of patients with ≥ 2 points reduction on NRS pain score from baseline to end of 4 weeks), on post hoc analysis was found to be significantly higher in duloxetine group (80.5%) than placebo group (43.9%) (P = .042).

CONCLUSIONS

Duloxetine can be an effective treatment option for patients with moderate to severe central post-stroke pain.

摘要

目的

中枢性卒中后疼痛（CPSP）是指与中风病变部位相对应的身体区域的神经性疼痛。度洛西汀是一种 5-羟色胺和去甲肾上腺素再摄取抑制剂，对神经性疼痛安全有效。在这项随机双盲安慰剂对照研究中，我们研究了度洛西汀对 CPSP 患者的影响。

方法

符合纳入标准的连续患者被纳入研究，并按照简单的 1:1 随机分组，分为度洛西汀组和安慰剂组。记录基线人口统计学、临床和影像学数据。预设的主要结局是比较两组患者从基线到 4 周时疼痛强度的变化，采用数字评分量表（NRS）评估。预设的次要结局是比较两组患者从基线到 4 周时平均疼痛严重程度的变化，采用简短麦吉尔疼痛问卷-2（SFMPQ-2）评分和疼痛残疾指数（PDI）评分进行比较，以及两组患者在治疗 4 周时患者总体印象变化（PGIC）评分的比较。给予度洛西汀 30mg 剂量和外观相似的安慰剂片，如果在 2 周后没有反应，则将剂量加倍。治疗反应定义为 NRS 疼痛评分至少降低 2 分。

结果

共有 82 名患者入组，每组 41 名。从基线（6.51±1.03 比 6.37±1.41）到 4 周（3.02±1.70 比 4.40±1.77，P=0.02），度洛西汀组与安慰剂组的 NRS 评分降低有显著差异。SFMPQ-2 评分（P=0.032）和疼痛残疾指数评分（P=0.005）也在两组之间从基线到 4 周时有显著差异。两组患者在 4 周结束时的 PGIC 评分也有显著差异（5.15±1.54 比 3.89±1.51；P<0.001）。在事后分析中，发现度洛西汀组的应答率（定义为 NRS 疼痛评分从基线到 4 周结束时至少降低 2 分的患者百分比）显著高于安慰剂组（80.5%比 43.9%；P=0.042）。