度洛西汀和加巴喷丁治疗糖尿病性神经病变的疗效与安全性评估：一项系统评价和荟萃分析
Evaluating the efficacy and safety of duloxetine and gabapentin in managing diabetic neuropathy: A systematic review and meta-analysis.
作者信息
Attar Ahmed A, Halabi Mumen H, Barnawi Ehab T, Sindi Gadi K, Altayeb Ammar A, Fadel Fadel T, Alsubhi Lama H, Alsamiri Ghadah Y, Alsabban Ahmad S
机构信息
College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.
Department of Neuroscience, Ministry of the National Guard-Health Affairs, Jeddah, Saudi Arabia.
出版信息
Br J Pain. 2025 Aug 6:20494637251365690. doi: 10.1177/20494637251365690.
BACKGROUND AND OBJECTIVE
Painful diabetic neuropathy (PDN) is a common complication of diabetes, characterized by significant pain and functional impairment. Gabapentin and duloxetine are standard treatments. This study compared their efficacy in alleviating pain, improving clinical global impression of change (CGIC), reducing sleep interference, enhancing response rates, and assessing safety.
METHODS
A systematic review and meta-analysis was conducted following PRISMA guidelines. A search of Embase, Medline, ScienceDirect, Scopus, Web of Science, and Cochrane databases through May 2024 identified randomized controlled trials comparing gabapentin and duloxetine for PDN. Risk of bias was assessed using the Cochrane RoB2 tool. Data on pain, CGIC, sleep interference, responder rates, and adverse events were analyzed using a random-effects model, with results presented as standardized mean differences and risk ratios with 95% confidence intervals.
RESULTS
Six RCTs with 526 patients (44% female) were included. There was no significant difference between duloxetine and gabapentin in relieving pain (SMD = -0.16, 95% CI [-0.36, 0.03], = .10, I = 66%). No significant differences were observed in the overall effect of CGIC (MD = 0.01, 95% CI [-0.07, 0.09], = .79, I = 0%), or sleep interference (MD = -0.07, 95% CI [-0.36, 0.23], = .67, I = 39%); However, duloxetine showed superiority at week 1 for CGIC (MD = 0.56, 95% CI [0.18, 0.94], = .003), and week 8 for sleep interference (MD = -0.40, 95% CI [-0.79, -0.01], = .04, I = 0%), while gabapentin was superior at week 1 in sleep interference (MD = 0.75, 95% CI [0.11, 1.39], = .02). No significant differences were observed in responder rates or adverse events.
CONCLUSION
Gabapentin and duloxetine are effective for PDN, with distinct advantage at different time points. Personalized treatment is recommended, and future research should assess long-term efficacy in diverse populations.
背景与目的
痛性糖尿病神经病变（PDN）是糖尿病常见的并发症，其特征为显著疼痛和功能障碍。加巴喷丁和度洛西汀是标准治疗药物。本研究比较了它们在缓解疼痛、改善临床总体变化印象（CGIC）、减少睡眠干扰、提高缓解率及评估安全性方面的疗效。
方法
按照PRISMA指南进行系统评价和荟萃分析。检索截至2024年5月的Embase、Medline、ScienceDirect、Scopus、科学网和Cochrane数据库，以确定比较加巴喷丁和度洛西汀治疗PDN的随机对照试验。使用Cochrane RoB2工具评估偏倚风险。采用随机效应模型分析疼痛、CGIC、睡眠干扰、缓解率及不良事件的数据，结果以标准化均数差和风险比及95%置信区间表示。
结果
纳入6项随机对照试验，共526例患者（44%为女性）。度洛西汀和加巴喷丁在缓解疼痛方面无显著差异（标准化均数差=-0.16，95%置信区间[-0.36, 0.03]，P=.10，I²=66%）。在CGIC的总体效果（均数差=0.01，95%置信区间[-0.07, 0.09]，P=.79，I²=0%）或睡眠干扰方面（均数差=-0.07，95%置信区间[-0.36, 0.23]，P=.67，I²=39%）未观察到显著差异；然而，度洛西汀在第1周时CGIC方面表现更优（均数差=0.56，95%置信区间[0.18, 0.94]，P=.003），在第8周时睡眠干扰方面更优（均数差=-0.40，95%置信区间[-0.79, -0.01]，P=.04，I²=0%），而加巴喷丁在第1周时睡眠干扰方面更优（均数差=0.75，95%置信区间[0.11, 1.39]，P=.02）。在缓解率或不良事件方面未观察到显著差异。
结论
加巴喷丁和度洛西汀对PDN均有效，在不同时间点有不同优势。建议进行个体化治疗，未来研究应评估不同人群的长期疗效。
Zotero 插件