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玻璃体内地塞米松植入物在有或无既往玻璃体切割术的糖尿病性黄斑水肿患者中的疗效和安全性:一项回顾性队列研究

[Efficacy and safety of intravitreal dexamethasone implant in diabetic macular edema patients with and without prior vitrectomy: a retrospective cohort study].

作者信息

Li L Y, Li J, Li Y, Zhang W, Wang D Y, Wang W L, Liang B Y, Gu W

机构信息

Beijing Aier Intech Eye Hospital, Aier School of Ophthalmology, Central South University, Beijing 100021, China.

出版信息

Zhonghua Yan Ke Za Zhi. 2023 May 11;59(5):398-403. doi: 10.3760/cma.j.cn112142-20220722-00355.

Abstract

To evaluate the effectiveness and safety of intravitreal dexamethasone implant (IDI) in diabetic macular edema (DME) patients with and without prior vitrectomy. A retrospective cohort study was conducted on DME patients who received IDI treatment at the Aier Eye Hospital, Beijing from March 2018 to August 2020. Patients were divided into two groups according to whether they had undergone vitrectomy or not. Clinical and follow-up data, including best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), occurrence of ocular and systemic complications, and time to DME recurrence and retreatment, were collected before and after IDI injection at 15 days, 1, 2, 3, and 6 months. Statistical analyses were performed using -test, Mann-Whitney -test, test or Fisher's exact test, and generalized estimating equations. Thirty-six patients (41 eyes) were included, with 19 patients (21 eyes) in the vitrectomy group and 17 patients (20 eyes) in the non-vitrectomy group. Compared with baseline, BCVA of eyes in the vitrectomy group was significantly improved at 15 days after IDI injection, with values of 1.00 (0.52, 1.31) and 0.61 (0.30, 1.00), respectively (=-2.10, =0.036); BCVA of eyes in the non-vitrectomy group was significantly improved at 1 month after IDI injection, with values of 0.76 (0.60, 1.35) and 0.52 (0.10, 0.70), respectively (=-2.24, =0.025). Compared with baseline, CMT of eyes in both groups was significantly reduced at all follow-up time points after 15 days of IDI injection (all <0.05). In the vitrectomy group, CMT before and 15 days after injection were 487 (438, 661) μm and 389 (340, 553) μm, respectively (=-3.45, <0.001); in the non-vitrectomy group, CMT before and 15 days after injection were 486 (410, 641) μm and 323 (290, 396) μm, respectively (=-4.07, <0.001). There were no statistically significant differences in BCVA and CMT between the two groups at all follow-up time points (all >0.05). The time to DME recurrence was 3.0 (3.0, 4.0) months in the vitrectomy group and 5.0 (4.0, 5.0) months in the non-vitrectomy group, with no significant difference between the two groups (=0.675). Four eyes (19.0%) in the vitrectomy group and three eyes (15.0%) in the non-vitrectomy group had high IOP, with no significant difference (=0.529). No severe ocular or systemic complications were observed in any patients. IDI treatment is safe and effective in DME patients with and without prior vitrectomy, with similar efficacy, but with faster onset of action in patients with prior vitrectomy. There was no significant difference in DME recurrence within 6 months after IDI injection between the two groups.

摘要

评估玻璃体内注射地塞米松植入物(IDI)在有或无玻璃体切割术史的糖尿病性黄斑水肿(DME)患者中的有效性和安全性。对2018年3月至2020年8月在北京爱尔眼科医院接受IDI治疗的DME患者进行回顾性队列研究。根据患者是否接受过玻璃体切割术将其分为两组。收集IDI注射前及注射后15天、1、2、3和6个月的临床及随访数据,包括最佳矫正视力(BCVA)、眼压(IOP)、中心黄斑厚度(CMT)、眼部和全身并发症的发生情况以及DME复发和再次治疗的时间。采用t检验、Mann-Whitney U检验、χ²检验或Fisher精确检验以及广义估计方程进行统计分析。共纳入36例患者(41只眼),其中玻璃体切割术组19例(21只眼),非玻璃体切割术组17例(20只眼)。与基线相比,玻璃体切割术组患者在IDI注射后15天BCVA显著改善,分别为1.00(0.52,1.31)和0.61(0.30,1.00)(t=-2.10,P=0.036);非玻璃体切割术组患者在IDI注射后1个月BCVA显著改善,分别为0.76(0.60,1.35)和0.52(0.10,0.70)(t=-2.24,P=0.025)。与基线相比,两组患者在IDI注射15天后的所有随访时间点CMT均显著降低(均P<0.05)。玻璃体切割术组注射前及注射后15天的CMT分别为487(438,661)μm和389(340,553)μm(t=-3.45,P<0.001);非玻璃体切割术组注射前及注射后15天的CMT分别为486(410,641)μm和323(290,396)μm(t=-4.07,P<0.001)。两组在所有随访时间点的BCVA和CMT均无统计学显著差异(均P>0.05)。玻璃体切割术组DME复发时间为3.0(3.0,4.0)个月,非玻璃体切割术组为5.0(4.0,5.0)个月,两组间无显著差异(P=0.675)。玻璃体切割术组4只眼(19.0%)和非玻璃体切割术组3只眼(15.0%)出现高眼压,无显著差异(P=0.529)。所有患者均未观察到严重的眼部或全身并发症。IDI治疗在有或无玻璃体切割术史的DME患者中均安全有效,疗效相似,但有玻璃体切割术史的患者起效更快。两组在IDI注射后6个月内DME复发情况无显著差异。

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