Objective: To evaluate the effectiveness and safety of intravitreal dexamethasone implant (IDI) in diabetic macular edema (DME) patients with and without prior vitrectomy. Methods: 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 t-test, Mann-Whitney U-test, χ2 test or Fisher's exact test, and generalized estimating equations. Results: 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 (Z=-2.10, P=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 (Z=-2.24, P=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 P<0.05). In the vitrectomy group, CMT before and 15 days after injection were 487 (438, 661) μm and 389 (340, 553) μm, respectively (Z=-3.45, P<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 (Z=-4.07, P<0.001). There were no statistically significant differences in BCVA and CMT between the two groups at all follow-up time points (all P>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 (P=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 (P=0.529). No severe ocular or systemic complications were observed in any patients. Conclusions: 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.
目的： 评价地塞米松玻璃体内植入剂（IDI）对接受与未接受玻璃体切除术的糖尿病性黄斑水肿（DME）患者的疗效与安全性。 方法： 回顾性队列研究。收集2018年3月至2020年8月于北京爱尔英智眼科医院确诊为DME且采用IDI治疗患者的临床和随访资料，根据既往是否行玻璃体切除术，将患者分为手术组和未手术组。记录患者注射IDI前和注射IDI后15 d以及1、2、3、6个月时的最佳矫正视力（BCVA）、眼压、黄斑中心视网膜厚度（CMT），眼部和全身并发症的发生情况，以及DME复发和再治疗的时间，比较2个组注射前后各指标的变化差异。采用t检验、Mann-Whitney U检验、χ2检验或Fisher精确概率检验以及广义估计方程进行统计分析。 结果： 共纳入患者36例（41只眼），其中男性24例，女性12例；年龄（57.2±11.9）岁；手术组19例（21只眼），未手术组17例（20只眼）。与注射前相比，注射IDI后15 d起手术组患眼BCVA较注射前提高，分别为1.00（0.52，1.31）和 0.61（0.30，1.00）（Z=-2.10，P=0.036）；未手术组患眼于注射后1个月BCVA较注射前提高，分别为0.76（0.60，1.35）和 0.52（0.10，0.70）（Z=-2.24，P=0.025）。与注射前相比，注射IDI后15 d起之后每个随访时点2个组患眼CMT均较注射前降低（均P<0.05），手术组注射前和注射后15 d分别为487（438，661）和389（340，553）μm（Z=-3.45，P<0.001）；未手术组注射前和注射后15 d分别为486（410，641）和323（290，396）μm（Z=-4.07，P<0.001）。在所有随访的时点2个组BCVA和CMT差异均无统计学意义（均P>0.05）。手术组复发时间为3.0（3.0，4.0）个月，未手术组为5.0（4.0，5.0）个月，2个组复发时间差异无统计学意义（P=0.675）。手术组与未手术组4只眼（19.0%）和3只眼（15.0%）出现高眼压，差异无统计学意义（P=0.529）。所有患者均未出现严重眼部并发症或全身不适。 结论： 玻璃体内注射IDI对接受与未接受玻璃体切除术的DME患者均安全有效，且疗效相似，但在行玻璃体切除术后患者中起效更快，注射IDI后半年内DME的复发情况无明显差别。.