口服与局部应用双氯芬酸预防全视网膜光凝术中疼痛的比较。

Oral versus topical diclofenac for pain prevention during panretinal photocoagulation.

作者信息

Zakrzewski Peter A, O'Donnell Heather L, Lam Wai-Ching

机构信息

Department of Ophthalmology, University of British Columbia, Vancouver, Canada.

出版信息

Ophthalmology. 2009 Jun;116(6):1168-74. doi: 10.1016/j.ophtha.2009.01.022. Epub 2009 Apr 19.

DOI:10.1016/j.ophtha.2009.01.022

PMID:19376588

Abstract

PURPOSE

To investigate the effect of pretreatment oral and topical diclofenac on pain reduction during panretinal laser photocoagulation (PRP) for proliferative diabetic retinopathy (PDR).

DESIGN

Prospective, randomized, double-masked, placebo-controlled clinical trial.

PARTICIPANTS AND CONTROLS

A total of 90 patients with PDR requiring PRP for the first time were assigned randomly to 1 of 3 study groups: oral diclofenac (n = 30), topical diclofenac (n = 31), or placebo (n = 29).

METHODS

Study medications were administrated before the first PRP treatment, and pain levels experienced during and 15 minutes after PRP were recorded on a visual analog scale (VAS). Pain levels during a second PRP session, performed on a later date with no pretreatment medications, also were recorded on a VAS.

MAIN OUTCOME MEASURES

The primary outcome measures were the mean VAS pain scores during the first PRP treatment. Secondary outcome measures were the mean VAS pain scores 15 minutes after the first PRP and during the second PRP, and reported side effects after the first PRP.

RESULTS

Mean VAS pain scores during the first PRP were: oral diclofenac, 25.7+/-19.9; topical diclofenac, 33.8+/-27.9; and placebo, 41.3+/-31.0. The pain score difference between oral diclofenac and placebo was both clinically significant (>or=13) and statistically significant (P = 0.02), whereas differences between oral and topical diclofenac (P = 0.20) and topical diclofenac and placebo (P = 0.33) were not. Multivariate regression analysis for age, gender, and total laser energy demonstrated lower pain levels for both oral diclofenac (P = 0.015) and topical diclofenac (P<0.0001) versus placebo, but no difference between oral and topical diclofenac (P = 0.67). For the first PRP, all 3 groups had lower mean pain scores at 15 minutes after treatment compared with during treatment (P<or=0.0003). Mean pain scores were higher during the second compared with the first PRP for the oral diclofenac (P = 0.02) and placebo (P = 0.05) groups. No significant rate difference for any side effect was found between groups.

CONCLUSIONS

When given in a single dose, oral diclofenac is an effective pretreatment analgesic agent for reducing the pain experienced during PRP for PDR.

FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

摘要

目的

探讨术前口服及局部应用双氯芬酸对增殖性糖尿病视网膜病变（PDR）进行全视网膜激光光凝（PRP）时减轻疼痛的效果。

设计

前瞻性、随机、双盲、安慰剂对照临床试验。

参与者与对照组

90例首次需要进行PRP的PDR患者被随机分配到3个研究组中的1组：口服双氯芬酸组（n = 30）、局部应用双氯芬酸组（n = 31）或安慰剂组（n = 29）。

方法

在首次PRP治疗前给予研究药物，PRP期间及治疗后15分钟的疼痛程度采用视觉模拟评分法（VAS）记录。在之后某天进行的第二次PRP治疗（未进行术前用药）期间的疼痛程度也采用VAS记录。

主要观察指标

主要观察指标为首次PRP治疗期间的平均VAS疼痛评分。次要观察指标为首次PRP治疗后15分钟及第二次PRP治疗期间的平均VAS疼痛评分，以及首次PRP治疗后报告的副作用。

结果

首次PRP治疗期间的平均VAS疼痛评分分别为：口服双氯芬酸组25.7±19.9；局部应用双氯芬酸组33.8±27.9；安慰剂组41.3±31.0。口服双氯芬酸组与安慰剂组之间的疼痛评分差异在临床（≥13）及统计学上均具有显著性（P = 0.02），而口服与局部应用双氯芬酸组之间（P = 0.20）以及局部应用双氯芬酸组与安慰剂组之间（P = 0.33）的差异无显著性。对年龄、性别和总激光能量进行多变量回归分析显示，与安慰剂组相比，口服双氯芬酸组（P = 0.015）和局部应用双氯芬酸组（P<0.0001）的疼痛程度较低，但口服与局部应用双氯芬酸组之间无差异（P = 0.67）。对于首次PRP治疗，所有3组在治疗后15分钟时的平均疼痛评分均低于治疗期间（P≤0.0003）。口服双氯芬酸组（P = 0.02）和安慰剂组（P = 0.05）第二次PRP治疗期间的平均疼痛评分高于首次。各治疗组间任何副作用的发生率均无显著差异。