To analyze the efficacy and safety of duloxetine and gabapentin in painful diabetic neuropathy (PDN).A randomized, open-label, active control, 12-week trial was conducted. A total of 86 participants were randomized in 1:1 ratio into gabapentin 300 mg and duloxetine 60 mg groups. The primary efficacy objective was comparison of mean change in Visual Analogue Scale (VAS) (0-100 points) scores between duloxetine and gabapentin. The symptom scores and adverse events were assessed as secondary outcomes.Statistically significant (P value<.001) improvement was observed in VAS scores in both duloxetine group and gabapentin group at 12 weeks as compared to baseline. However, no significant difference in VAS scores between duloxetine and gabapentin. Similar improvement in diabetic neuropathy symptoms (DNS), diabetic neuropathy examination (DNE), and neuropathic disability score (NDS) was observed in either group over 12 weeks. There were no significant differences in DNS (P = 0.578), DNE (P = 0.410), and NDS (P = 0.071) scores between the two treatment groups. The overall safety evaluation of both duloxetine and gabapentin were similar. The most common adverse events reported were gastrointestinal.The results indicated that both drugs were effective for the symptomatic relief from PDN and had similar efficacy. Follow-up of patients was only for 12 weeks and therefore the long-term efficacy and safety of the study drugs could not be assessed.背景: 分析度洛西汀和加巴喷丁治疗痛性糖尿病神经病变(PDN)的疗效和安全性。 方法: 采用随机、开放、对照、为期12周的临床试验。86名受试者按1:1比例随机分为加巴喷丁300 mg组和度洛西汀60 mg组。主要疗效目标是比较度洛西汀和加巴喷丁视觉模拟评分(VAS)(0~100分)的平均变化。症状评分和不良事件被评估为次要结果。 结果: 与基线相比，度洛西汀组和加巴喷丁组在12周时的VAS评分均有统计学意义(P<0.001)的改善。但度洛西汀与加巴喷丁在VAS评分上无显著差异。糖尿病神经病变症状(DNS)、糖尿病神经病变检查(DNE)和神经病变残疾评分(NDS)在超过12周后均有相似的改善。两组患者的神经功能缺损评分(P=0.578)、神经功能缺损评分(P=0.410)和神经功能缺损评分(P=0.071)均无显著性差异。度洛西汀和加巴喷丁的总体安全性评价相似。报告的最常见的不良反应是胃肠道反应。 结论: 两种药物均能有效缓解PDN的症状，且疗效相当。患者的随访时间仅为12周，因此无法评估研究药物的长期疗效和安全性。.