雷珠单抗治疗不同疾病所致黄斑水肿的疗效观察

目的：探讨玻璃体腔注射雷珠单抗治疗因糖尿病、视网膜静脉阻塞继发黄斑水肿的安全及有效性。方法：选取2013-06/2016-02在北京航天中心医院眼科因糖尿病继发黄斑水肿( DME )和视网膜静脉阻塞继发黄斑水肿( RVO-ME)收治入院,并符合本研究纳入及排除标准的患者35例38眼,其中DME 23眼,RVO-ME 15眼。患眼接受玻璃体腔雷珠单抗(0.5mg/0.05mL)注射治疗,治疗前和治疗后1、3d,1wk、1mo定期门诊回访观察最佳矫正视力( BCVA )、黄斑中心凹厚度( CRT )、眼压。比较雷珠单抗治疗DME及RVO-ME前后的疗效。结果：DME组及RVO-ME组治疗后1、3d,1wk的BCVA均较治疗前提高,差异均有统计学意义(P<0.05),而两组1 mo的BCVA与治疗前相比差异均无统计学意义( P>0.05)。 DME组及RVO-ME组治疗后1、3d,1wk,1mo的CRT均较治疗前明显改善,差异均有统计学意义( P<0.05)。在BCVA及CRT方面比较,雷珠单抗对于RVO-ME及 DME疗效差异无统计学意义( P >0.05)。结论：玻璃体腔注射雷珠单抗对DME及RVO-ME的治疗均安全有效。     

Clinical efficacy of intravitreal corticoid as an adjunctive therapy to anti-VEGF treatment of neovascular age-related macular degeneration: a Meta-analysis

AIM: To evaluate the efficacy and safety of intravitreal corticoid as an adjunctive therapy to anti-vascular endothelial growth factor (VEGF) treatment of neovascular age-related macular degeneration (nvAMD). METHODS: Four databases including PubMed, Embase, Cochrane Library, and the clinicaltrials.gov were comprehensively searched for studies comparing intravitreal corticoid plus anti-VEGF (IVC/IVA) vs anti-VEGF monotherapy (IVA) in patients with nvAMD. GRADE profiler was used to assess the quality of outcomes. Best-corrected visual acuity (BCVA), central macular thickness (CMT) and adverse events including the occurrence of severe elevation of intraocular pressure (IOP) and the progress of cataract were extracted from the eligible studies. Review Manager (RevMan) 5.3 was used to analyze the data. RESULTS: There was no statistic difference of mean change in BCVA at 6 and 12mo between IVC/IVA and IVA group [95% confidence interval (CI): -2.28 to 4.24, P=0.55; 95%CI: -3.01 to 8.70, P=0.34]. No statistic difference was found in the change of CMT between two groups at 6mo time point (95%CI: -17.98 to 16.42, P=0.93) while the CMT reduction in IVC/IVA group was significantly more obvious than IVA group at 12mo time point [mean difference (MD)=-44.08, 95%CI: -80.52 to -7.63, P=0.02]. The risk of occurrence of severe elevation of IOP in the IVC/IVA group was higher than that in the IVA group (95%CI: 1.92 to 9.48; P=0.0004). Cataract progression risk was calculated no statistic difference between two groups (95%CI: 0.74 to 4.66; P=0.18). CONCLUSION: No visual or anatomical benefits are observed in IVC/IVA group at 6mo. At 12mo, the CMT of the IVC/IVA group is significantly lower than that of the IVA group. Risk of severe elevation of IOP is significantly higher when treated by IVC/IVA.     

视网膜分支静脉阻塞相关黄斑水肿不同治疗方案疗效评价

目的 比较单纯玻璃体内注射抗血管内皮生长因子(VEGF)药物和联合应用地塞米松玻璃体内植入剂治疗视网膜分支静脉阻塞(BRVO)相关黄斑水肿(ME)的效果。方法 回顾性分析BRVO相关ME的102例(102眼)患者的临床资料,分为两组,A组为单纯玻璃体内注射抗VEGF药物组(治疗期间接受任何一种抗VEGF药物),B组为玻璃体内注射抗VEGF药物和地塞米松玻璃体内植入剂组(不分先后顺序,治疗期间使用两种药物)。每月随访,共随访6个月及以上,末次注射后,连续3次随访均无视网膜下液,黄斑中心区厚度(CMT)变化≤50μm,且CMT≤250μm为观察终点。比较两组患者玻璃体内注药次数、治疗前及治疗后最佳矫正视力(BCVA)、眼压、CMT。结果 两组患者经治疗后均能有效改善BCVA及降低CMT,A组患者玻璃体内注药次数为(4.59±2.83)次,B组患者玻璃体内注药次数为(3.02±1.62)次,两组比较差异有统计学意义(P=0.00)。治疗前后,A组患者BCVA(logMAR)从0.77±0.47提高到0.48±0.44(P=0.00),B组患者BCVA从0.73±0.45提高到0.42±0.3...     

Effectiveness of intravitreal ranibizumab for diabetic macular edema in vitrectomized versus non-vitrectomized eyes: a Meta-analysis

AIM: To evaluate the effectiveness and safety of intravitreal ranibizumab (IVR) for diabetic macular edema (DME) in vitrectomized versus non-vitrectomized eyes. METHODS: The PubMed, EMBASE, Web of Science, Cochrane, EBSCO were comprehensively searched for studies comparing vitrectomized and non-vitrectomized eyes with DME. Clinical outcomes of best-corrected visual acuity (BCVA), central macular thickness (CMT), the mean number of intravitreal injection and adverse events were extracted and analyzed. RESULTS: Six studies involving 641 eyes were included. Final visual gain significantly improved and CMT significantly reduced in vitrectomized eyes at 6mo and 12mo visits (P<0.05). Although the mean reduction in CMT among non-vitrectomized eyes was significantly greater than in vitrectomized eyes at the 6mo [mean difference (MD)=53.57, 95% confidence interval (CI): 28.03 to 78.72, P<0.0001] and 12mo (MD=49.65, 95%CI: 19.58 to 79.72, P=0.01), no significant difference was detected in improvement in BCVA at either 6mo (MD=0.05, 95%CI: -0.02 to 0.13, P=0.14) or 12mo (MD=0.03, 95%CI: -0.04 to 0.09, P=0.43). Injection number of ranibizumab in non-vitrectomized eyes was significantly less than that in vitrectomized eyes during 6-month period (MD=0.60, 95%CI: 0.16 to 1.04, P=0.008), while there was no statistically significant difference between the two groups during 12mo of follow-up. CONCLUSION: Evidence from current study suggests that IVR was useful for both vitrectomized group and non-vitrectomized group with DME. Although less reduction in macular thickness is found in vitrectomized group, visual improvement between two groups is similar.     

Intravitreal anti-VEGF agents, oral glucocorticoids, and laser photocoagulation combination therapy for macular edema secondary to retinal vein occlusion: preliminary report

AIM: To evaluate the efficacy and safety of combined anti-vascular endothelial growth factor (VEGF) agents, oral glucocorticoid, and laser photocoagulation therapy for macular edema (ME) secondary to retinal vein occlusion (RVO). METHODS: This study included 16 eyes of 16 patients with RVO-associated ME. Patients were initially treated with oral prednisone and an intravitreal anti-VEGF agent. Two weeks later, patients underwent standard laser photocoagulation. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), and retinal vessel oxygenation were examined over 12mo. RESULTS: Patients received 1.43±0.81 anti-VEGF injections. Mean baseline and 12-month logMAR BCVA were 0.96±0.51 (20/178) and 0.31±0.88 (20/40), respectively, in eyes with central retinal vein occlusion (CRVO) (P<0.00), and 1.02±0.45 (20/209) and 0.60±0.49 (20/80), respectively, in eyes with branch retinal vein occlusion (BRVO) (P<0.00). At 12mo, CRT had significantly decreased in eyes with CRVO (P<0.00) and BRVO (P<0.00). Venous oxygen saturation had significantly increased in eyes with CRVO (P<0.00) and BRVO (P<0.00). No examined parameters were significantly different between the 2 RVO groups. No serious adverse effects occurred. CONCLUSION: Anti-VEGF, glucocorticoid, and photocoagulation combination therapy improves visual outcome, prolongs therapeutic effect, and reduces the number of intravitreal injections in eyes with RVO-associated ME.     

地塞米松玻璃体腔植入剂治疗非动脉炎性前部缺血性视神经病变

目的:探究地塞米松玻璃体腔植入剂(DEX)治疗非动脉炎性前部缺血性视神经病变(NAION)的效果和安全性,以及不同病程的应答反应。方法:回顾性研究。纳入2018-01/2020-12在郑州大学第一附属医院诊断为NAION的患者70例70眼,根据治疗方式不同分为两组,常规治疗组35例35眼仅接受常规注射用甲泼尼龙琥珀酸钠冲击、改善微循环和营养神经治疗,联合治疗组35例35眼接受常规治疗联合DEX治疗。比较两组患者以及不同病程的患者治疗前和治疗后3mo最佳矫正视力(BCVA)、平均视野缺损(MD)、模式标准差(PSD)、视盘视网膜神经纤维层平均厚度(RNFL)和眼压。结果:两组患者治疗后3mo BCVA和MD较治疗前均改善(P<0.05),联合治疗组治疗前后PSD无差异(P>0.05),常规治疗组较治疗前恶化(P<0.05)。联合治疗组治疗后3mo BCVA和MD及PSD较常规治疗组改善(P<0.05),联合治疗组治疗后3mo总有效率较常规治疗组高(P<0.05),两组治疗后3mo RNFL平均厚度无差异(P>0.05)。在病程≤15d患者中,联合治疗组...     

Fixed bimonthly aflibercept in naïve and switched neovascular age-related macular degeneration patients: one year outcomes

AIM: To determine real life clinical outcomes in poorly responsive and treatment-naïve neovascular age related macular degeneration (nvAMD) patients using bimonthly fixed dosing aflibercept regimen. METHODS: This was a retrospective study of 165 eyes with nvAMD started on aflibercept at Southampton Eye Unit between June 2013 and June 2014. Patients were either switched from pro re nata (PRN) ranibizumab/bevacizumab due to poor response (107 eyes), or treatment-naïve (58 eyes). Patients initially received 3-monthly intravitreal aflibercept injections followed by 2-monthly fixed doses. Clinic visits were scheduled at month 0, 4, 10 and 12. Mean change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline were assessed using the Wilcoxon signed-rank test. The proportion of patients maintaining BCVA (<15 letters loss) at 12mo was also evaluated. RESULTS: Mean BCVA change at month 12 was +3.29 and +4.67 letters in the switched and naïve aflibercept groups respectively (P<0.01). BCVA was maintained in 95.3% of switched and 96.6% of naïve patients. CRT at month 12 showed a decrease of -6.16 µm in the switched group and -35.36 µm in the naïve group (P<0.01). Patients previously treated with ranibizumab/bevacizumab had on average received 7.4 ranibizumab/bevacizumab injections over 12.6mo, attending 10 clinic visits. The fixed dosing aflibercept regimen required an average of 7.1 injections (naïve group), 7.5 injections (switched group) and 4 clinic visits per year. CONCLUSION: Fixed bimonthly aflibercept is effective in both treatment-naïve and poorly responsive nvAMD patients. Adopting a fixed dosing regimen can reduce patient burden without compromising on outcomes.     

阿柏西普治疗糖尿病性黄斑水肿患者多焦视网膜电图明视负反应变化

目的:观察糖尿病性黄斑水肿(DME)患者接受阿柏西普治疗前后多焦视网膜电图(mf-ERG)明视负反应(PhNR)的变化。方法:回顾性队列研究。收集2019-05/2022-06在武汉大学附属爱尔眼科医院(武汉爱尔眼科医院)就诊的DME患者37例37眼,每月注射阿柏西普0.05mL,连续注射3mo。并选取排除相关眼部疾病的体检正常者20例20眼作为对照组。比较两组参与研究者治疗前后mf-ERG的PhNR振幅,最佳矫正视力(BCVA)(LogMAR)、中央视网膜厚度(CRT)、黄斑区毛细血管丛血管密度(CPVD)。结果:治疗前DME患者mf-ERG PhNR振幅(201.69±80.92nV)明显低于正常对照组(398.87±77.92nV)(P<0.01)。治疗后6mo DME患者mf-ERG的PhNR平均振幅与治疗前明显升高(P=0.036),但在治疗后6mo时仍明显低于正常对照组(P=0.031)。治疗后6mo DME患者BCVA(LogMAR)从0.64±1.33提高到0.37±1.39(P=0.021),CPVD较治疗前明显增加(P=0.029)。治疗后6mo DME患者m...     

Short-term results of intravitreal bevacizumab for macular edema with retinal vein obstruction and diabetic macular edema.

OBJECTIVE: The aim of this study was to identify the short-term effect, safety, and durability of intravitreally injected bevacizumab in patients with macular edema (ME) caused by retinal vein obstruction (RVO) and diabetic macular edema (DME). METHODS: We retrospectively evaluated 39 eyes of 36 patients, 14 with ME caused by RVO and 25 with DME, who received intravitreal bevacizumab (1.25 mg) and were followed up for at least 3 months. Monthly assessments examined safety, best corrected visual acuity with an ETDRS chart (logMAR), and central retinal thickness (CRT) using optical coherence tomography. RESULTS: No significant ocular or systemic side-effects were observed. The follow-up period was 5.4 +/- 1.1 months (mean +/- standard deviation). During follow-up, the mean number of injections was 1.4 +/- 0.5. The baseline mean logMAR was 0.91 +/- 0.51, and the mean CRT was 552.6 +/- 186.7 microm. At 1, 2, and 3 months, the mean logMAR was 0.67 +/- 0.46 (paired t test, P < 0.001), 0.66 +/- 0.46 (P < 0.001), and 0.69 +/- 0.45 (P < 0.001), respectively, and the mean CRT was 323.1 +/- 151.9 mum (P < 0.001), 324.6 +/- 136.9 mum (P < 0.001), and 382.5 +/- 130.4 microm (P < 0.001), respectively. Fourteen (14) of 34 eyes with more than 3 months of follow-up required a second injection at a mean 3.4 +/- 1.0 months after the initial injection. For both ME caused RVO and DME patients, a bevacizumab administration improved logMAR and CRT at each time point through to 6 months, except for logMAR in DME at 1 week (P = 0.081), 5 months (P = 0.130) and 6 months (P = 0.759). CONCLUSIONS: An intravitreal bevacizumab injection for ME caused by RVO and DME was safe and effective for improving visual acuity and reducing CRT.     

Factors influencing improvement of visual field after trans-sphenoidal resection of pituitary macroadenomas: a retrospective cohort study

AIM: To investigate the influencing factors of visual field improvement after trans-sphenoidal resection of pituitary macroadenomas. METHODS: This retrospective cohort study included 201 patients (366 eyes) with visual field defect induced by pituitary macroadenomas. All of them were treated with trans-sphenoidal surgery. Ophthalmologic evaluation, best-corrected visual acuity (BCVA), and visual field examination were performed before and 3mo after surgery. BCVA, visual field defect index mean deviation (MD), duration of symptoms, age, sex, and volume of tumors were compared. Expression of vascular endothelial growth factor (VEGF) and Ki-67 of tumor tissue were detected by immunohistochemical technique. RESULTS: The mean age of patients was 44.23±1.29y. Ninety-three patients were female and 108 were male. The mean tumor volume was 14.36±6.23 cm3. The mean duration of preoperative symptoms was 11.50±0.88mo. Mean preoperative MD was -17.50±0.82 dB. Mean Preoperative visual acuity was 0.64±0.04. Postoperative visual field improved in 270 (73.77%) eyes, unchanged in 96 (26.23%) eyes. Multivariate logistic regression displayed that the factors independently influencing visual field improvement were young age (OR=1.71, 95%CI: 1.325-2.387, P=0.013), low preoperative MD absolute value (OR=1.277, 95%CI: 1.205-1.355, P<0.001), small volume of tumor (OR=1.458, 95%CI: 1.060-4.289, P<0.001), low expression of VEGF in tumor tissue (OR=1.554, 95%CI: 1.089-2.457, P=0.022), and low expression of Ki-67 in tumor tissue (OR=1.552, 95%CI: 1.161-2.847, P=0.026). CONCLUSION: After pituitary macroadenomas trans-sphenoidal resection, the independent influencing factors of the visual fields recovery were low preoperative MD absolute value, young age, small volume of tumor, and expression levels of VEGF/ Ki-67.     

地塞米松玻璃体植入剂应用进展

地塞米松玻璃体植入剂(DEX)是一种装载0.7mg地塞米松的可生物降解的缓释植入物,其适应证主要有视网膜静脉阻塞继发黄斑水肿(RVO-ME)、糖尿病黄斑水肿(DME)和非感染性葡萄膜炎(NIU)。DEX的应用中不良事件主要有眼压升高和白内障,也正因此DEX在RVO-ME、DME的治疗中属于二线用药,多在抗血管内皮生长因子(VEGF)治疗无应答时使用,但DEX在人工晶状体眼或不愿频繁注药的患者中能发挥出其特定的优势。近来很多研究证实了DEX治疗NIU的有效性和安全性,但其在NIU治疗中的地位尚不明确。本文综述了DEX相关的重大临床试验结果,分析其应用进展和安全性。     

阿柏西普治疗视网膜静脉阻塞继发黄斑水肿的短期疗效

目的：探讨玻璃体腔注射阿柏西普治疗视网膜静脉阻塞(RVO)继发黄斑水肿的短期临床疗效。

方法：收集2019-05/10在我院门诊确诊为RVO继发黄斑水肿的患者24例24眼,均接受玻璃体腔注射阿柏西普治疗,分别于治疗前、治疗后1wk,1mo行视力和光学相干断层扫描血管成像(OCTA)黄斑区3mm×3mm范围检查,获得BCVA(LogMAR)、黄斑中心凹厚度(CMT)、黄斑区浅层毛细血管丛(SCP)血管密度、深层毛细血管丛(DCP)血管密度及中心凹无血管区(FAZ)面积、周长及非圆指数(AI)、拱环周围300μm(FD-300)范围血管密度。

结果：本组患者患眼治疗后1wk,1mo BCVA(0.44±0.29、0.34±0.27)均较治疗前(0.70±0.35)明显改善(均P<0.01),但治疗后1wk与1mo BCVA无差异(P=0.260); 治疗后1wk,1mo CMT(305.71±78.65、255.33±60.23μm)均较治疗前(542.42±189.02μm)明显下降(均P<0.001),但治疗后1wk与1mo CMT无差异(P=0.161); 治疗前后SCP、DCP及FD-300血管密度无明显差异(均P>0.05),提示治疗前后浅层、深层视网膜毛细血管丛及FAZ周围血管密度均无明显改变; 治疗后1wk,1mo FAZ面积、周长均较治疗前增加,非圆指数较治疗前降低(均P<0.05)。

结论：玻璃体腔内注射阿柏西普治疗RVO继发黄斑水肿能够减轻黄斑水肿,改善视力,同时使FAZ形态更趋于规整,且未加重黄斑缺血。     

Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

Purpose

To compare dexamethasone (DEX) intravitreal implant effect in non-vitrectomized (non-PPV) vs vitrectomized (PPV) eyes with macular edema (ME) secondary to non-infectious uveitis.

Methods

Medical records of patients with uveitic ME treated with DEX-intravitreal implant were reviewed. Main outcome measures were changes in central retinal thickness (CRT), best corrected visual acuity (BCVA), intraocular pressure (IOP), vitreous haze and adverse events. Statistical analysis was performed by Longitudinal Linear model using the General Estimating Equation methodology.

Results

Forty-two eyes of 32 patients were included. Median follow-up time was 18 months (interquartile range (IQR): 12–24). Median CRT showed its maximum decrease at the first month in non-PPV and PPV eyes without statistically significant differences between both groups (P=NS). Median Snellen BCVA, converted to logarithm (LogMAR), showed its maximum improvement at third month in both groups without statistically significant differences between them (P=NS). Median IOP was higher in non-PPV eyes than in PPV eyes from third (P=0.025) to 12th month (P=0.013). Vitreous haze score improved in both groups since first month and showed no differences (P=0.706). Reinjection was performed in 45.2% of eyes at a median time of 5 months IQR: (5–6). Ocular hypertension (47.6%) was the most common adverse event.

Conclusions

DEX-intravitreal implant for uveitic ME has similar long-term safety profile and good response measured in terms of CRT decrease, BCVA, and vitreous haze improvement in both groups. Non-PPV eyes following DEX-intravitreal implant showed higher IOP increase than PPV eyes, showing the need for close IOP monitoring.     

Comparison of topical nepafenac 0.1% with intravitreal dexamethasone implant for the treatment of Irvine-Gass syndrome

AIM: To compare safety and efficacy of intravitreal dexamethasone (IVD) implant with topical nepafenac (TN) 0.1% in previously untreated Irvine-Gass syndrome (IGS) in clinical practice. METHODS: This was a retrospective study of 62 eyes with IGS after phacoemulsification with posterior chamber intraocular lens (IOL) implantation. None of the patients used treatment before IVD or TN. Best-corrected visual acuity (BCVA) with Early Treatment Diabetic Retinopathy Study chart (ETDRS), slit-lamp, intraocular pressure (IOP) measurement, fundus examination, spectral-domain optical coherence tomography (OCT) and fundus florescein angiography were performed to all subjects at baseline, 1, 3 and 6mo. RESULTS: The mean BCVA of the IVD group was 49.3±6.8, and the mean BCVA of the TN group was 32.9±7.3 ETDRS letters in post-treatment month 6. The mean central macular thickness (CRT) of IVD group was 266.6±53.5 µm and the mean CRT of TN group was 364.9±56.3 µm in post-treatment month 6. Baseline BCVA has correlation with final BCVA in TN group however there was no correlation between baseline BCVA and final BCVA in IVD group. CONCLUSION: IVD is found to be better than TN in controlling pseudophakic macular edema and improving visual acuity. IVD group also has significantly lower CRT however IOP is not significantly different between two groups in post-treatment month 6.     

Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes

AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex®/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs). METHODS: This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected. RESULTS: Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported. CONCLUSION: This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.     

血栓通离子导入联合康柏西普玻璃体腔注射治疗视网膜静脉阻塞合并黄斑水肿

目的：研究血栓通离子导入联合康柏西普玻璃体腔注射治疗视网膜静脉阻塞(RVO)合并黄斑水肿(ME)的临床效果及安全性。

方法：前瞻性研究。将2017-06/2019-06我院106例106眼RVO合并ME患者采用随机数字表法均分为观察组和对照组各53例53眼,均给予玻璃体腔注射康柏西普进行治疗; 观察组另加用血栓通注射液离子导入进行干预,用药时间3mo,两组均随访1a并根据病情进行补充治疗,观察并比较两组治疗前后最佳矫正视力(BCVA)、黄斑区中央视网膜厚度(CRT)、补充治疗情况、房水血管内皮生长因子(VEGF)水平及药物不良反应。

结果：两组治疗后BCVA明显改善(P<0.05),CRT明显降低(P<0.05),且观察组治疗3、6、12mo BCVA高于对照组,CRT低于对照组(P<0.05); 两组治疗后黄斑总容积和房水VEGF水平均明显降低(P<0.05),且观察组治疗1、3、6、12mo黄斑总容积和VEGF水平低于对照组(均P<0.05); 观察组康柏西普、曲安奈德注射次数和激光光凝患者占比均低于对照组(P<0.05); 观察组治疗期间发生眼压升高1眼、结膜下出血3眼,对照组发生结膜下出血2眼、眼内炎1眼,两组比较无差异(P>0.05)。

结论：血栓通离子导入联合康柏西普玻璃体腔注射治疗RVO合并ME可有效抑制VEGF表达,减轻ME并改善患眼视力,疗效和安全性均值得肯定。     

Sub-threshold micro-pulse diode laser treatment in diabetic macular edema: A Meta-analysis of randomized controlled trials

AIM: To examine possible differences in clinical outcomes between sub-threshold micro-pulse diode laser photocoagulation (SDM) and traditional modified Early Treatment Diabetic Retinopathy Study (mETDRS) treatment protocol in diabetic macular edema (DME). METHODS: A comprehensive literature search using the Cochrane Collaboration methodology to identify RCTs comparing SDM with mETDRS for DME. The participants were type I or type II diabetes mellitus with clinically significant macular edema treated by SDM from previously reported randomized controlled trials (RCTs). The primary outcome measures were the changes in the best corrected visual acuity (BCVA) and the central macular thickness (CMT) as measured by optical coherence tomography (OCT). The secondary outcomes were the contrast sensitivity and the damages of the retina. RESULTS: Seven studies were identified and analyzed for comparing SDM (215 eyes) with mETDRS (210 eyes) for DME. There were no statistical differences in the BCVA after treatment between the SDM and mETDRS based on the follow-up: 3mo (MD, -0.02; 95% CI, -0.12 to 0.09; P=0.77), 6mo (MD, -0.02; 95% CI, -0.12 to 0.09; P=0.75), 12mo (MD, -0.05; 95% CI, -0.17 to 0.07; P=0.40). Likewise, there were no statistical differences in the CMT after treatment between the SDM and mETDRS in 3mo (MD, -9.92; 95% CI, -28.69 to 8.85; P=0.30), 6mo (MD, -11.37; 95% CI, -29.65 to 6.91; P=0.22), 12mo (MD, 8.44; 95% CI, -29.89 to 46.77; P=0.67). Three RCTs suggested that SDM laser results in good preservation of contrast sensitivity as mETDRS, in two different follow-up evaluations: 3mo (MD, 0.05; 95% CI, 0 to 0.09; P=0.04) and 6mo (MD, 0.02; 95% CI, -0.10 to 0.14; P=0.78). Two RCTs showed that the SDM laser treatment did less retinal damage than that mETDRS did (OR, 0.05; 95% CI, 0.02 to 0.13; P<0.01). CONCLUSION: SDM laser photocoagulation shows an equally good effect on visual acuity, contrast sensitivity, and reduction of DME as compared to conventional mETDRS protocol with less retinal damage.     

抗血管内皮生长因子单克隆抗体ranibizumab治疗渗出型老年性黄斑变性的一年疗效观察

目的 观察连续12个月玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab(商品名Lucentis)治疗渗出型老年性黄斑变性(AMD)的临床疗效和安全性.方法 前瞻、无对照、开放性研究.经荧光素眼底血管造影(FFA)和吲哚青绿血管造影(ICGA)检查确诊的22例渗出型AMD患者22只眼纳入研究.患者中,男性18例,女性4例;年龄46～79岁,平均年龄(68.2±9.3)岁.采用国际标准视力表行最佳矫正视力(BCVA)和光相干断层扫描(OCT)检查,非接触眼压计测量眼压.为便于统计分析,视力换算为最小分辨角对数视力(logMAR).患眼BCVA 0.01～0.9,平均BCVA 0.26±0.22,平均logMAR0.76±0.44;黄斑中心视网膜厚度(CRT) 182～559 μm,平均CRT值为(302.62±90.18)μm.眼压均正常.玻璃体腔注射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg),每一个月1次,连续12个月.每次治疗后1h和治疗后1d行眼压检查.每一个月均采用首次治疗前的方法和设备行视力、眼压、眼底、OCT检查;3个月行FFA、ICGA检查.22例患者中,完成了12个月随访者13例.13例患者平均logMAR 0.74±0.37,平均CRT值为(305.77±99.69) μm,平均眼压为(12.07±3.93) mm Hg(1 mm Hg=0.133 kPa).采用配对t检验对比分析治疗过程中视力、CRT变化.结果 所有患眼治疗后1个月,平均logMAR为0.52±0.32,与首次治疗前平均logMAR比较,差异有统计学意义(t=4.518,P＜0.05);治疗后3个月,平均logMAR为0.37±0.27,与首次治疗前比较,差异有统计学意义(t=6.237,P＜0.05).完成12个月随访的13只眼,治疗后1、3、12个月平均logMAR分别为0.51±0.34、0.35±0.26、0.34±0.30,与首次治疗前平均logMAR比较,差异均有统计学意义(t=3.443,5.438,4.756;P＜0.05).治疗后1、3个月平均CRT值分别为(228.85±54.93)、(231.00±38.94) μm,与首次治疗前平均CRT值比较,差异有统计学意义(t=2.914,3.199;P＜0.05);治疗后12个月平均CRT值为(262.92±70.48)μm,与首次治疗前平均CRT值比较,差异无统计学意义(t=1.408,P＞0.05).前3次治疗视力提高最快,6只眼视力从0.1～＜0.5提高到0.5及以上;随访第1个月时CRT降低幅度最大.玻璃体注射ranibizumab后1h眼压升高,1d后降至治疗前水平.随访中未见眼内感染等与玻璃体腔注射相关的并发症.结论 每一个月玻璃体腔注射1次ranibizumab可以提高患眼视力,减轻黄斑水肿;无与治疗相关的不良反应发生.     

地塞米松玻璃体内植入剂联合抗VEGF药物治疗视网膜静脉阻塞

目的：比较地塞米松玻璃体内植入剂联合抗VEGF药物与抗VEGF药物单药治疗视网膜静脉阻塞继发黄斑水肿(RVO-ME)的疗效和安全性。

方法：选取2019-06/2020-12在厦门大学附属厦门眼科中心确诊为视网膜中央静脉阻塞(CRVO)或视网膜分支静脉阻塞(BRVO)继发黄斑水肿的患者133例133眼,其中CRVO-ME患者48眼,BRVO-ME患者85眼。将纳入患者随机分组,其中单药治疗组66眼接受每月注射康柏西普1次,连续3mo,之后每月复诊; 联合治疗组67眼接受地塞米松玻璃体内植入剂注射1次,1wk后注射康柏西普1次,之后每月复诊。随访6mo,观察两组患者最佳矫正视力(BCVA)和中央视网膜厚度(CRT)改善情况,记录康柏西普注射次数及与玻璃体腔注射治疗相关的眼部及全身不良事件发生情况。

结果：治疗后1、2、3、6mo,两组患者BCVA和CRT均较治疗前显著改善,但两组间BCVA和CRT改善程度均无差异(P>0.05)。首次玻璃体腔注射至治疗6mo时,单药治疗组和联合治疗组康柏西普玻璃体腔注射次数分别为3.56±0.12、2.96±0.17次,联合治疗组注射次数显著低于单药治疗组(P=0.004)。随访期间,联合治疗组高眼压和白内障发生率均高于单药治疗组。

结论：地塞米松玻璃体内植入剂联合抗VEGF药物是治疗RVO-ME的有效方法,可显著改善视力,降低CRT,该治疗方案可在减少抗VEGF药物注射次数的同时达到与抗VEGF药物单药治疗相似的疗效,但需要监控眼压变化及白内障进展情况。     

康柏西普与雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿的Meta分析

目的:系统比较康柏西普和雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿(RVO-ME)的疗效和安全性,为临床指导用药提供依据。方法:全网综合检索关于玻璃体腔内注射康柏西普和雷珠单抗治疗RVO-ME的临床随机对照试验文献,对纳入文献进行风险评估,并提取相关数据指标。采用RevMan 5.3软件进行数据分析,并采用Egger检验评价发表偏倚。结果:本研究纳入文献14篇,共计1 350眼。康柏西普组和雷珠单抗组患者最佳矫正视力(BCVA)在治疗后2wk,2、3、6mo无明显差异,但在治疗后1wk[WMD=-0.03,95%CI(-0.05,-0.02),P<0.0001]和1mo[WMD=-0.03,95%CI(-0.04,-0.01),P=0.001]康柏西普组患者BCVA相比雷珠单抗组较好。两组患者黄斑中心凹视网膜厚度(CMT)在治疗后1、2wk,1、2、3mo无明显差异,但在治疗后6mo[WMD=-28.77,95%CI(-54.23,-3.31),P=0.03]康柏西普组患者黄斑水肿减轻程度相比雷珠单抗组更明显。玻璃体腔内注射康柏西普和雷珠单抗产生的不良反应情况无差异[OR=0.95,95%CI(0.57,1.57),P=0.84],但康柏西普的平均注射次数较少。结论:康柏西普和雷珠单抗均可改善BCVA,降低CMT,二者在后期视力改善方面无差异,但康柏西普在改善CMT方面更具优势,且注射次数少,费用低。