Dang Yalong, Mu Yalin, Li Lin, Mu Yahui, Liu Shujing, Zhang Chun, Zhu Yu, Xu Yimin
Department of Ophthalmology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, People's Republic of China.
Department of Ophthalmology, Yellow River Hospital, Henan University of Science and Technology, Sanmenxia, Henan Province, People's Republic of China.
Drug Des Devel Ther. 2014 Sep 18;8:1441-9. doi: 10.2147/DDDT.S66611. eCollection 2014.
Our objective was to investigate the efficacy and safety of dexa methasone (DEX) implant for the treatment of pseudophakic cystoid macular edema (PCME) in diabetic patients.
This was a prospective, non-randomized, interventional case series of 43 participants. Eighteen patients were enrolled in the DEX implant group and 25 were enrolled in an intravitreal triamcinolone acetonide (IVTA) group.
The primary efficacy measurement was the percentage of patients who gained improvements of more than ten letters in best corrected visual acuity (BCVA) during 6 months of follow-up. Other efficacy measurements included change in BCVA, change in central macular thickness (CMT), and number of retreatments. The primary safety evaluation was the percentage of patients with intraocular hypertension and variation in intraocular pressure (IOP) during 6 months of follow-up. Other adverse events, such as conjunctival hemorrhage, eye pain, secondary infection, endophthalmitis, noninfectious inflammation, retinal detachment, and implant migration, were also recorded during follow-up.
At month 1, we observed that the percentage of patients gaining improvement of more than ten letters was similar in both groups (P = 0.625). As patients in the IVTA group were retreated several times, this effect persisted throughout the study (P = 0.941 at month 2, P = 0.553 at month 3, P = 0.856 at month 6). Variations in CMT were noticed at week 1 and reached their maximum at month 1. No significant difference was found between the two groups (P = 0.831 at week 1, P = 0.783 at month 1). At month 1, the variation in IOP reached its maximum in the DEX implant group and then decreased slightly. However, in the IVTA group, it increased continuously throughout the study. Conjunctival hemorrhage and eye pain were found in both groups, but both were rated as mild in severity, and no significant difference was found (P = 0.184, P = 0.766, respectively).
Both IVTA and DEX implants could effectively restore visual function and recover morphological change in diabetic patients with PCME for at least 6 months, but repeated intravitreal injection was required in the IVTA group. DEX implant is well tolerated. We suggest that intravitreal injection of DEX implant is a promising new therapeutic option for diabetic patients with PCME.
我们的目的是研究地塞米松（DEX）植入物治疗糖尿病患者人工晶状体眼黄斑囊样水肿（PCME）的疗效和安全性。
这是一项针对43名参与者的前瞻性、非随机、干预性病例系列研究。18名患者被纳入DEX植入物组，25名患者被纳入玻璃体内注射曲安奈德（IVTA）组。
主要疗效指标是在6个月随访期间最佳矫正视力（BCVA）提高超过10行的患者百分比。其他疗效指标包括BCVA的变化、中心黄斑厚度（CMT）的变化以及再次治疗的次数。主要安全性评估是随访6个月期间发生高眼压的患者百分比和眼压（IOP）的变化。随访期间还记录了其他不良事件，如结膜出血、眼痛、继发感染、眼内炎、非感染性炎症、视网膜脱离和植入物移位。
在第1个月时，我们观察到两组中视力提高超过10行的患者百分比相似（P = 0.625）。由于IVTA组的患者多次接受再次治疗，这种效果在整个研究过程中持续存在（第2个月时P = 0.941，第3个月时P = 0.553，第6个月时P = 0.856）。在第１周时注意到CMT有变化，并在第1个月时达到最大值。两组之间未发现显著差异（第1周时P = 0.831，第1个月时P = 0.783）。在第1个月时，DEX植入物组的IOP变化达到最大值，然后略有下降。然而，在IVTA组中，IOP在整个研究过程中持续升高。两组均发现结膜出血和眼痛，但严重程度均为轻度，且未发现显著差异（分别为P = 0.184，P = 0.766）。
IVTA和DEX植入物均可有效恢复糖尿病性PCME患者的视觉功能并使形态学改变恢复至少6个月，但IVTA组需要重复进行玻璃体内注射。DEX植入物耐受性良好。我们认为玻璃体内注射DEX植入物是糖尿病性PCME患者一种有前景的新治疗选择。
