不同浓度局部纳布啡用于控制光折射性角膜切削术后疼痛。

The use of topical nalbuphine in different concentrations to control pain after photorefractive keratectomy.

机构信息

Ophthalmology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

出版信息

Int Ophthalmol. 2022 Jul;42(7):2145-2153. doi: 10.1007/s10792-022-02214-8. Epub 2022 Jan 12.

DOI:10.1007/s10792-022-02214-8

PMID:35020101

Abstract

PURPOSE

This is a randomized controlled study aiming to evaluate the safety and efficacy of two different concentrations of topical nalbuphine hydrochloride, when used to relieve pain in the first days following photorefractive keratectomy (PRK).

METHODS

This is a prospective double blinded randomized clinical trial that included 189 patients who had PRK for correction of low and moderate refractive errors. Patients were randomly assigned to three groups according to the eye drops given to relieve pain in the first three postoperative days; the first group received topical nalbuphine with a concentration of 2 mg/ml (Group A = 64 patients), the second group received topical nalbuphine in a concentration of 1 mg/ml (Group B = 69 patients) and the third group received topical artificial tears only (Group C = 56 patients).The patients were asked to rate their pain daily using a numeric rating scale and to record the number of drops instillation times/day. The time needed for complete epithelial healing, best-corrected visual acuity (BCVA) and spherical equivalent after three months were recorded in each group.

RESULTS

In the first three days, there was a statistically significant difference in pain score among the three groups with lower values in the two topical nalbuphine groups when compared with the control group receiving artificial tears. Moreover, the higher concentration group showed significantly lower pain score and less number of drops used /day in comparison with the lower concentration group.There were no statistically significant differences in epithelial healing time, BCVA and spherical equivalent after three months among the three groups.

CONCLUSION

The use of topical nalbuphine is effective in relieving pain in the first few days following PRK and this pain relief is not associated with any compromise regarding epithelial healing nor refractive outcome. The pain control with 2 mg/ml concentration is significantly higher than that with 1 mg/ml concentration of nalbuphine. Trial registration numberISRCTN21394752 https://doi.org/10.1186/ISRCTN21394752 The trial is retrospectively registered in ISRCTN registry at March 08, 2021.

摘要

目的

本研究旨在评估两种不同浓度的盐酸纳布啡滴眼液用于缓解准分子激光角膜切削术（PRK）后最初几天疼痛的安全性和有效性。

方法

这是一项前瞻性、双盲、随机临床试验，纳入了 189 名接受 PRK 治疗低中度屈光不正的患者。患者根据术后前 3 天使用的滴眼剂分为三组以缓解疼痛；第一组给予 2mg/ml 浓度的盐酸纳布啡滴眼液（A 组=64 例），第二组给予 1mg/ml 浓度的盐酸纳布啡滴眼液（B 组=69 例），第三组仅给予人工泪液（C 组=56 例）。患者每天使用数字评分量表评估疼痛，并记录滴眼次数/天。记录每组完全上皮愈合、最佳矫正视力（BCVA）和术后 3 个月的球镜等效值。

结果

在最初的 3 天内，三组之间的疼痛评分存在统计学差异，与接受人工泪液的对照组相比，两种盐酸纳布啡滴眼液组的疼痛评分较低。此外，与低浓度组相比，高浓度组的疼痛评分和每日滴眼次数均显著降低。三组之间的上皮愈合时间、BCVA 和术后 3 个月的球镜等效值无统计学差异。

结论

在 PRK 术后最初几天使用盐酸纳布啡滴眼剂可有效缓解疼痛，且这种疼痛缓解与上皮愈合或屈光结果无关。2mg/ml 浓度的盐酸纳布啡的止痛效果明显优于 1mg/ml 浓度的盐酸纳布啡。试验注册号 ISRCTN21394752 https://doi.org/10.1186/ISRCTN21394752 该试验于 2021 年 3 月 8 日在 ISRCTN 注册中心进行了回顾性注册。