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那普啡那滴眼液单次滴眼对玻璃体腔注射相关疼痛的镇痛效果:一项随机临床试验。

Analgesic Effect of a Single Drop of Nepafenac 0.3% on Pain Associated with Intravitreal Injections: A Randomized Clinical Trial.

机构信息

Department of Ophthalmology, Medical School, University of Patras, Patras, Greece.

出版信息

J Ocul Pharmacol Ther. 2019 Apr;35(3):168-173. doi: 10.1089/jop.2018.0113. Epub 2019 Jan 28.

Abstract

PURPOSE

To evaluate the analgesic effect of nepafenac 0.3% in patients undergoing intravitreal injections (IVI) of antivascular endothelial growth factors.

METHODS

This is a single-center, prospective, randomized, blinded, triple-arm, placebo-controlled interventional study. Patients were randomized into 3 Groups. Group 1 (n = 33) received nepafenac 0.1%, Group 2 (n = 32) received nepafenac 0.3%, and Group 3 (n = 31) received placebo 40 min before IVI. Using the short form of the McGill Pain Questionnaire (SF-MPQ), pain intensity was assessed with the visual analog scale (VAS), the Main Component of the SF-MPQ, and the present pain intensity (PPI) scores immediately and 6 h postinjection.

RESULTS

Immediately after IVI, the VAS pain score was statistically significantly lower in patients treated with nepafenac 0.1% and 0.3%, compared with placebo (P < 0.001 and P = 0.001, respectively). The PPI scores were statistically significantly lower when nepafenac 0.1% or 0.3% was instilled compared with placebo (P = 0.01 and P < 0.0001, respectively). The Main Component of the SF-MPQ scores were statistically significantly lower after nepafenac 0.1% and 0.3% administration compared with placebo (P = 0.001 and P < 0.001, respectively). Six hours post-IVI the nepafenac 0.3% demonstrated statistically significantly higher analgesic effect compared with nepafenac 0.1% and placebo as this was indicated by the VAS pain score (P = 0.013 and P < 0.00001, respectively) and by the PPI score (P = 0.01 and P < 0.00001, respectively).

CONCLUSIONS

A single instillation of nepafenac 0.1% or 0.3% before IVI could effectively alleviate the IVI-related pain. The 0.3% formula exerts its analgesic effect more intensively at 6 h after the IVI.

摘要

目的

评估那他霉素 0.3%在接受抗血管内皮生长因子玻璃体腔内注射(IVI)的患者中的镇痛效果。

方法

这是一项单中心、前瞻性、随机、双盲、三臂、安慰剂对照的干预研究。患者随机分为 3 组。第 1 组(n=33)接受那他霉素 0.1%,第 2 组(n=32)接受那他霉素 0.3%,第 3 组(n=31)在 IVI 前 40 分钟接受安慰剂。使用 McGill 疼痛问卷(SF-MPQ)短表,通过视觉模拟评分(VAS)、SF-MPQ 主要成分和即刻及注射后 6 小时的现有疼痛强度(PPI)评分评估疼痛强度。

结果

IVI 后即刻,与安慰剂相比,接受那他霉素 0.1%和 0.3%治疗的患者 VAS 疼痛评分显著降低(P<0.001 和 P=0.001)。与安慰剂相比,给予那他霉素 0.1%或 0.3%时 PPI 评分显著降低(P=0.01 和 P<0.0001)。给予那他霉素 0.1%和 0.3%后,SF-MPQ 主要成分评分显著低于安慰剂(P=0.001 和 P<0.001)。IVI 后 6 小时,与那他霉素 0.1%和安慰剂相比,那他霉素 0.3%显示出统计学上更高的镇痛效果,这表现为 VAS 疼痛评分(P=0.013 和 P<0.00001)和 PPI 评分(P=0.01 和 P<0.00001)。

结论

在 IVI 前单次滴注那他霉素 0.1%或 0.3%可有效缓解 IVI 相关疼痛。0.3%配方在 IVI 后 6 小时发挥更强的镇痛作用。

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