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使用30号或32号针头对视网膜病变患者进行玻璃体内注射雷珠单抗后的反流、眼压变化及疼痛:一项随机临床试验

Reflux, Intraocular Pressure Variation and Pain Following Intravitreal Ranibizumab Injections Using 30-Gauge or 32-Gauge Needles for Patients With Retinal Pathologies: A Randomized Clinical Trial.

作者信息

Alshahrani Saeed T, Rubin Uriel, Gupta Vasudha, Gonder Tom, Sharma Sanjay

机构信息

Ophthalmology Department, King Fahad Medical City, Riyadh, SAU.

Ophthalmology, Queens University, Kingston, CAN.

出版信息

Cureus. 2021 Apr 6;13(4):e14320. doi: 10.7759/cureus.14320.

Abstract

PURPOSE

To compare reflux, intraocular pressure (IOP) variation and pain following intravitreal (IV) injections using 30-gauge and 32-gauge needles in patients with retinal pathologies in Saudi Arabia.

METHODS

A double-blind randomized clinical trial was conducted in 2018. Participants were randomized to receive IV injections of Ranibizumab using 30-gauge (Gr) or 32-gauge (Gr) needles. The amount of reflux of injected material, IOP before (IOP) and five minutes after injection (IOP) were measured. The patient-perceived pain score was assessed using a visual analogue score (VAS). Outcome variables were compared.

RESULTS

The study sample was comprised of 86 eyes (86 patients) in each group. Gender (P=0.76), laterality (P=0.55) and age (P=1.0) were not different between groups. The reflux in Gr [34.9% (95% confidence interval {CI}, 24.8; 45.0)] was significantly higher compared to Gr [22.1% (95% CI, 13.3; 30.9)] (P=0.007). The median pain score was 1 in both Gr [interquartile range (IQR) 1.0: 3.0] and Gr (IQR 0.0; 2.0) (P=0.04). Among 56 eyes without reflux in Gr, the IOP and IOP were 13.6±2.7 mmHg and 16.4±5.0 mmHg, respectively. Among 67 eyes without reflux in Gr, the IOP and IOP2 were 13.6±2.9 mmHg and 17.0±5.2 mmHg, respectively. The change in percentage in IOP in Gr and Gr was not significantly different (Mann Whiney P=0.3).

CONCLUSIONS

IV injection given by 30-gauge needle compared to 32-gauge needle resulted in greater patient-perceived pain and more reflux of injected material from the injection site. An increase in IOP was not associated with the gauge of the needle used for IV injection.

摘要

目的

比较在沙特阿拉伯患有视网膜病变的患者中,使用30号和32号针头进行玻璃体内(IV)注射后的反流、眼压(IOP)变化及疼痛情况。

方法

2018年进行了一项双盲随机临床试验。参与者被随机分配接受使用30号(Gr)或32号(Gr)针头进行的雷珠单抗玻璃体内注射。测量注射材料的反流情况、注射前(IOP)和注射后五分钟(IOP)的眼压。使用视觉模拟评分(VAS)评估患者感知的疼痛评分。比较结果变量。

结果

每组研究样本包括86只眼(86名患者)。两组之间的性别(P = 0.76)、眼别(P = 0.55)和年龄(P = 1.0)无差异。30号组的反流率[34.9%(95%置信区间{CI},24.8;45.0)]显著高于32号组[22.1%(95%CI,13.3;30.9)](P =  0.007)。30号组和32号组的中位疼痛评分均为1分(30号组四分位间距(IQR)1.0:3.0;32号组IQR 0.0;2.0)(P = 0.04)。在30号组56只无反流的眼中,注射前眼压和注射后眼压分别为13.6±2.7 mmHg和16.4±5.0 mmHg。在32号组67只无反流的眼中,注射前眼压和注射后眼压分别为13.6±2.9 mmHg和17.0±5.2 mmHg。30号组和32号组眼压的百分比变化无显著差异(Mann - Whiney P = 0.3)。

结论

与32号针头相比,使用30号针头进行玻璃体内注射会使患者感知的疼痛更剧烈,且注射部位的注射材料反流更多。眼压升高与用于玻璃体内注射的针头规格无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af8f/8101509/d13f8f2ed626/cureus-0013-00000014320-i01.jpg

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