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高渗盐水(5%)与安慰剂治疗超声乳化术后无并发症性角膜水肿的安全性和有效性:一项随机、双盲研究。

Safety and efficacy of hypertonic saline solution (5%) versus placebo in the treatment of postoperative corneal edema after uneventful phacoemulsification: a randomized double-blind study.

机构信息

Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.

出版信息

Int Ophthalmol. 2020 Sep;40(9):2139-2150. doi: 10.1007/s10792-020-01395-4. Epub 2020 May 5.

DOI:10.1007/s10792-020-01395-4
PMID:32372161
Abstract

PURPOSE

To evaluate safety and efficacy of hypertonic saline solution administration after uneventful cataract surgery.

DESIGN

Prospective double-blind randomized study METHODS: In total, 183 eyes of 183 patients undergoing phacoemulsification were randomly allocated into two equal groups. Treatment group (TG) subjects received single-dose hypertonic (NaCl 5%) solution 4 times daily for 14 days, while placebo group (PG) received single dose of normal saline solution (0.9%) at the same frequency in addition to ordinary postoperative treatment. All patients underwent assessment of central corneal thickness (CCT), endothelial cell density (ECD), best-corrected visual acuity (BCVA), clinical staging of postoperative corneal edema and questionnaire regarding the procedure success and impact on patient's life. Measurements were taken at baseline and 1, 4, 9 and 30 days following surgery.

RESULTS

CCT increased by 134.67 ± 94.51 μm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58). Corneal edema showed a significant recession in TG compared to PG on day 4, in terms of both pachymetry (10.73% vs 7.39%, p = 0.004), BCVA (BCVA = 0.64 ± 0.24 [logMAR = 0.25 ± 0.3], BCVA = 0.56 ± 0.23 [logMAR = 0.33 ± 0.3], p = 0.04) and clinical staging (p = 0.02). Similar results were recorded on postoperative day 9 in subjects demonstrating marked corneal edema on the first postoperative day. Endothelial cell loss showed no statistically significant difference between study groups (p = 0.48). No adverse events were recorded in relation to treatment. More patients in the TG (92.4% vs 57.1% in the PG) reported a subjectively clear vision 1 week postoperatively (p = 0.04).

CONCLUSION

The use of 5% hypertonic saline solution is found to be a safe and effective adjunct in the management of postoperative corneal edema after uneventful phacoemulsification, achieving rapid corneal clearance and expediting a good visual outcome, especially in cases with marked postoperative edema.

摘要

目的

评估白内障手术后无并发症患者使用高渗盐水的安全性和疗效。

设计

前瞻性双盲随机研究。

方法

183 例(183 只眼)白内障超声乳化术患者随机分为两组,每组 91 例。治疗组(TG)术后每日 4 次给予单剂量高渗盐水(5%NaCl)溶液,持续 14 天,而安慰剂组(PG)在相同频率下给予单剂量生理盐水(0.9%)溶液,此外还接受普通术后治疗。所有患者均接受中央角膜厚度(CCT)、内皮细胞密度(ECD)、最佳矫正视力(BCVA)、术后角膜水肿的临床分期以及关于手术成功率和对患者生活影响的问卷调查。在基线和术后第 1、4、9 和 30 天进行测量。

结果

术后第 1 天 CCT 增加 134.67 ± 94.51 μm(25.1 ± 19.4%),两组间无差异(p = 0.58)。与 PG 组相比,TG 组在第 4 天的角膜水肿消退更为明显,在角膜厚度(10.73%比 7.39%,p = 0.004)、BCVA(BCVA = 0.64 ± 0.24 [logMAR = 0.25 ± 0.3],BCVA = 0.56 ± 0.23 [logMAR = 0.33 ± 0.3],p = 0.04)和临床分期(p = 0.02)方面均存在显著差异。在术后第 1 天有明显角膜水肿的患者中,在第 9 天也记录到了类似的结果。两组间的内皮细胞丢失无统计学显著差异(p = 0.48)。与治疗相关的不良事件均无记录。TG 组中有更多的患者(92.4%比 PG 组的 57.1%)在术后 1 周时报告视力明显改善(p = 0.04)。

结论

在白内障超声乳化术后无并发症患者中,使用 5%高渗盐水溶液是一种安全有效的辅助治疗方法,可快速清除角膜水肿,促进良好的视力恢复,特别是在术后水肿明显的情况下。

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