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普瑞巴林治疗创伤后外周神经病理性疼痛的疗效:一项随机对照试验的荟萃分析。

Pregabalin in patients with post-traumatic peripheral neuropathic pain: A meta-analysis of randomized controlled trials.

机构信息

Bohlool Hospital, Gonabad University of Medical Sciences, Gonabad, Iran.

Nursing Care Research Center, Semnan University of Medical Sciences, Semnan, Iran.

出版信息

Pain Pract. 2023 Jul;23(6):595-602. doi: 10.1111/papr.13221. Epub 2023 Mar 21.

Abstract

OBJECTIVE

The aim of the study was to investigate the safety and efficacy of pregabalin versus placebo in post-traumatic peripheral neuropathic pain (PTNP).

METHODS

PubMed, Cochrane Library, Web of Science, and Google Scholar were searched for relevant evidence up to January 2022. The Cochran tool was used to assess the quality of randomized clinical trials (RCTs). Data analysis was performed using Comprehensive Meta-Analysis software.

RESULTS

Three RCTs involving 821 patients were included in the meta-analysis. A significant difference was observed between pregabalin and placebo in terms of the pain score (the standardized mean difference [SMD] = -0.14, 95% CI: 0.28 to -0.006, p = 0.04) and sleep interference (MD = -0.25, 95% CI: -0.39 to -0.11, p = 0.00). There was also a significant difference between pregabalin and placebo regarding somnolence (risk ratio [RR] = 2.78; 95% CI: 1.64-4.71, p = 0.00), dizziness (RR = 4.13; 95% CI: 2.71-6.28, p = 0.00), and disturbance in attention (RR: 2.97; 95% CI: 1.02-8.65, p = 0.04). However, no significant difference was observed between pregabalin and placebo in terms of headache (RR = 1.20; 95% CI: 0.70-2.06, p = 0.50), fatigue (RR = 1.42; 95% CI: 0.82-2.47, p = 0.20), nausea (RR = 1.52; 95% CI: 0.88-2.62, p = 0.13), constipation (RR = 1.84; 95% CI: 0.78-4.29, p = 0.15), and discontinuation (RR = 1.52; 95% CI: 0.45-5.06, p = 0.49).

CONCLUSION

Compared with placebo, pregabalin showed better efficacy in reducing PTNP and improving sleep interference. However, it was associated with higher adverse events. Further RCTs are needed to confirm these findings.

摘要

目的

本研究旨在探讨普瑞巴林治疗创伤后周围神经病理性疼痛(PTNP)的安全性和有效性。

方法

检索 2022 年 1 月前 PubMed、Cochrane 图书馆、Web of Science 和 Google Scholar 上的相关证据。使用 Cochrane 工具评估随机对照试验(RCT)的质量。采用 Comprehensive Meta-Analysis 软件进行数据分析。

结果

纳入 3 项 RCT 共 821 例患者的 meta 分析结果显示,普瑞巴林组与安慰剂组疼痛评分[标准化均数差(SMD)=-0.14,95%CI:0.28 至 -0.006,p=0.04]和睡眠干扰[MD=-0.25,95%CI:-0.39 至 -0.11,p=0.00]差异均有统计学意义。普瑞巴林组较安慰剂组更易发生嗜睡[风险比(RR)=2.78;95%CI:1.64-4.71,p=0.00]、头晕(RR=4.13;95%CI:2.71-6.28,p=0.00)和注意力障碍(RR:2.97;95%CI:1.02-8.65,p=0.04)。但两组头痛[RR=1.20;95%CI:0.70-2.06,p=0.50]、疲劳[RR=1.42;95%CI:0.82-2.47,p=0.20]、恶心[RR=1.52;95%CI:0.88-2.62,p=0.13]、便秘[RR=1.84;95%CI:0.78-4.29,p=0.15]和停药[RR=1.52;95%CI:0.45-5.06,p=0.49]差异无统计学意义。

结论

与安慰剂相比,普瑞巴林治疗 PTNP 可更有效减轻疼痛和改善睡眠干扰,但不良反应发生率更高。需要进一步的 RCT 来证实这些发现。

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