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口服止痛合剂在糖尿病视网膜病变全视网膜光凝治疗中的疗效:一项随机临床试验

The efficacy of oral pain relief cocktail during pan-retinal photocoagulation for diabetic retinopathy: a randomized clinical trial.

作者信息

Johari Mohammadkarim, Safniyat Sarah, Badie Mohammadreza, Amini Abdulrahim, Sanie-Jahromi Fatemeh

机构信息

Poostchi Ophthalmology Research Center, Department of Ophthalmology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

Department of Ophthalmology, School of Medicine, Hormozgan University of medical sciences, Bandar Abbas, Iran.

出版信息

Int J Retina Vitreous. 2023 Feb 2;9(1):10. doi: 10.1186/s40942-022-00438-5.

DOI:10.1186/s40942-022-00438-5
PMID:36732865
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9894512/
Abstract

PURPOSE

to evaluate the pain-relieving effect of analgesic combinations during pan-retinal photocoagulation (PRP) in patients with non-proliferative diabetic retinopathy (NPDR).

METHODS

This study was a randomized, double-blind, placebo-controlled trial. Patients with severe NPDR without previous history of PRP were included in the study. Both eyes of the patients were treated with a pan-retinal photocoagulation procedure. The retina was divided into four quadrants and the treatment plan for patients submitted to PRP was divided into four sessions. Different oral medications were given to patients 1 hour before the procedure. Capsules containing a combination of analgesic drugs (including 325 mg acetaminophen, 200 mg ibuprofen, and 40 mg caffeine, referred to as N), pregabalin capsules (75 mg, referred to as P), a combination of N capsules and P capsules (referred to as NP), and the placebo were used in each session. Each patient scored the pain sensation immediately after the procedure using a visual analog scale (VAS).

RESULT

60 eyes of 30 patients were studied. The mean value of VAS in patients receiving the placebo was 3.3 ± 1.822 units, while this scale was 3.067 ± 1.507, 3.5 ± 1.479, and 3.5 ± 1.77 in the N, P, and NP consumed patients, respectively. There was no significant difference in VAS levels and the patient's vital signs between different sessions (P = 0.512).

CONCLUSION

No evidence of the pain-relieving effect of N, P or NP was found during PRP.

TRIAL REGISTRATION

IRCT20200915048724N1. Registered 20 October 2020, https://www.irct.ir/trial/51345.

摘要

目的

评估非增殖性糖尿病视网膜病变(NPDR)患者在全视网膜光凝(PRP)期间联合使用镇痛药的止痛效果。

方法

本研究为随机、双盲、安慰剂对照试验。纳入无PRP既往史的重度NPDR患者。患者的双眼均接受全视网膜光凝治疗。视网膜被分为四个象限,接受PRP治疗的患者的治疗方案分为四个疗程。在治疗前1小时给患者服用不同的口服药物。每个疗程使用含有镇痛药组合(包括325毫克对乙酰氨基酚、200毫克布洛芬和40毫克咖啡因,称为N)的胶囊、普瑞巴林胶囊(75毫克,称为P)、N胶囊和P胶囊的组合(称为NP)以及安慰剂。每位患者在治疗后立即使用视觉模拟量表(VAS)对疼痛感觉进行评分。

结果

研究了30例患者的60只眼。接受安慰剂的患者VAS平均值为3.3±1.822单位,而服用N、P和NP的患者该量表分别为3.067±1.507、3.5±1.479和3.5±1.77。不同疗程之间VAS水平和患者生命体征无显著差异(P = 0.512)。

结论

在PRP期间未发现N、P或NP有止痛效果的证据。

试验注册

IRCT20200915048724N1。于2020年10月20日注册,https://www.irct.ir/trial/51345。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/b0d68bb7c0da/40942_2022_438_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/0e6e08718dab/40942_2022_438_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/4b307ab02fb6/40942_2022_438_Fig2_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/b0d68bb7c0da/40942_2022_438_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/0e6e08718dab/40942_2022_438_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/4b307ab02fb6/40942_2022_438_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/df32c88834e0/40942_2022_438_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/769c0ac099d6/40942_2022_438_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/92d9/9896685/b0d68bb7c0da/40942_2022_438_Fig5_HTML.jpg

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