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1.
目的:探讨康柏西普玻璃体腔注射联合激光光凝治疗糖尿病黄斑水肿的临床疗效及安全性。方法:收取2013年6月至2015年8月间我院收治的糖尿病黄斑水肿患者87例(87眼)作为研究对象,采用随机数字表法将其分为观察组及对照组,观察组43例(43眼)给予康柏西普玻璃体腔注射联合激光光凝治疗,对照组44例(44眼)给予单纯激光光凝治疗。对两组患者治疗前后视力(best corrected visual acuilty,BCVA)、视网膜厚度(central macular thickness,CMT)、临床疗效、并发症以及生活质量进行观察与比较。结果:治疗前两组患者BCVA、CMT均无显著差异,治疗后两组BCVA、CMT均有所提高,同时间点观察组明显高于对照组,差异有统计学意义(P0.05)。观察组治疗后6个月视力提高率为81.40%,对照组为13.64%,观察组远高于对照组,差异有统计学意义(P0.05)。观察组患者共有3例出现一过性眼压升高,对照组共有2例患者出现一过性眼压增高,两组相较无统计学差异(P0.05)。观察组生活质量显著高于对照组,差异有统计学意义(P0.05)。结论:康柏西普玻璃体腔注射联合激光光凝治疗糖尿病黄斑水肿具有良好的疗效及安全性,有利于患者生活质量提高,值得临床推广应用。  相似文献   

2.

Objective

To evaluate if a standardized combination therapy regimen, utilizing 3 monthly ranibizumab injections followed by navigated laser photocoagulation, reduces the number of total ranibizumab injections required for treatment of diabetic macular edema (DME).

Research Design and Methods

A 12-month, prospective comparison of 66 patients with center-involving DME: 34 patients with combination therapy were compared to 32 patients treated with ranibizumab monotherapy. All patients initially received 3 monthly ranibizumab injections (loading phase) and additional injections pro re nata (PRN). Combination therapy patients additionally received navigated laser photocoagulation after the loading phase. Main outcome measures were mean number of injections after the loading phase and change in BCVA from baseline to month 12.

Results

Navigated laser combination therapy and ranibizumab monotherapy similarly improved mean BCVA letter score (+8.41 vs. +6.31 letters, p = 0.258). In the combination group significantly less injections were required after the 3 injection loading phase (0.88±1.23 vs. 3.88±2.32, p< = 0.001). By month 12, 84% of patients in the monotherapy group had required additional ranibizumab injections as compared to 35% in the combination group (p< = 0.001).

Conclusions

Navigated laser combination therapy demonstrated significant visual gains in most patients. Retreatment rate and number of injections were significantly lower compared to ranibizumab monotherapy and compared to the results of conventional laser combination therapy previously reported in pivotal anti-VEGF studies.  相似文献   

3.

Objective

Compare the efficacy of ranibizumab, aflibercept, laser, and sham in the first-line treatment of diabetic macular edema (DME) to inform technology assessments such as those conducted by the UK National Institute for Health and Care Excellence (NICE).

Data sources

MEDLINE, Embase, Cochrane Library, congress abstracts, ClinicalTrials.gov registry and Novartis data on file.

Inclusion criteria

Studies reporting 6- or 12-month results of randomized controlled trials (RCTs) evaluating at least two of ranibizumab 0.5 mg pro re nata, aflibercept 2.0 mg bi-monthly, laser photocoagulation or sham. Study quality was assessed based on likelihood of bias in selection, attrition, detection and performance.

Outcome measure

Improvement in best-corrected visual acuity (BCVA) measured as the proportion of patients gaining ≥10 letters on the Early Treatment Diabetic Retinopathy Study scale. The outcome was chosen following acceptance by NICE of a Markov model with 10-letter health states in the assessment of ranibizumab for DME.

Meta-analysis

Bayesian network meta-analyses with fixed and random effects adjusted for differences in baseline BCVA or central retinal thickness.

Results

The analysis included 1,978 patients from eight RCTs. The random effects model adjusting for baseline BCVA was the best model based on total residual. The efficacy of ranibizumab was numerically, but not statistically, superior to aflibercept (odds ratio [OR] 1.59; 95% credible interval [CrI], 0.61–5.37). Ranibizumab and aflibercept were statistically superior to laser monotherapy with ORs of 5.50 (2.73–13.16) and 3.45 (1.62–6.84) respectively. The probability that ranibizumab is the most efficacious treatment was 73% compared with 14% for aflibercept, 12% for ranibizumab plus laser, and 0% for laser.

Limitations

Three of the eight RCTs included are not yet published. The models did not adjust for all potential effect modifiers.

Conclusion

Ranibizumab was non-significantly superior to aflibercept and both anti-VEGF therapies had statistically superior efficacy to laser.  相似文献   

4.
The aim of the present study was to compare the changes in the levels of 27 aqueous humor cytokines between diabetic patients with macular edema (ME) and diabetic patients without ME. Undiluted aqueous humor samples were obtained from 68 consecutive type 2 diabetic patients without ME and 56 consecutive type 2 diabetic patients with ME. The concentrations of 27 cytokines in the aqueous humor samples were measured using a multiplex bead immunoassay. Compared with diabetic patients without ME, diabetic patients with ME had significantly higher concentrations of IL-1β, IL-6, IL-8, IP-10, MCP-1, and VEGF in the aqueous humor. However, the concentrations of IL-10 and IL-12 were significantly lower in the diabetic patients with ME. The aqueous humor levels of IL-1β, IL-6, IL-8, MCP-1, IP-10, and VEGF were closely correlated with retinal macular thickness, retinal macular volume and the severity of ME. In addition, the aqueous humor levels of IL-10 and IL-12 decreased with increasing the severity of ME. A variety of cytokines associated with inflammation and angiogenesis may contribute to the pathogenesis of diabetic macular edema, and both anti-inflammatory and antiangiogenic agents should be included in the treatment of ME simultaneously.  相似文献   

5.
为了探讨2型糖尿病白内障术后黄斑水肿与房水中细胞因子的关系,本研究选取2016年2月至2017年7月在我院治疗的2型糖尿病白内障患者117例117眼,均行超声乳化白内障摘除术,观察术后4周黄斑水肿发生情况以及房水中多种细胞因子水平。研究结果显示:术后4周,有37眼发生黄斑水肿(观察组),未发生黄斑水肿80眼(对照组);观察组术后4周黄斑区视网膜厚度为(247.28±18.37)μm,明显高于对照组(p<0.05),且明显高于术前水平(p<0.05);观察组术后4周干扰素诱导蛋白-10 (IP-10)、巨噬细胞趋化蛋白(MCP-1)、血管内皮生长因子(VEGF)和细胞因子转化生长因子-β2 (TGF-β2)水平分别为(6.01±0.89) pg/mL、(340.03±45.39) pg/mL、(812.28±40.06) pg/mL和(40.05±10.03) pg/mL,明显高于对照组(p<0.05),且高于术前水平(p<0.05);观察组和对照组手术前后粒细胞-巨噬细胞集落刺激因子(GM-CSF)和碱性成纤维细胞生长因子(b-FGF)比较差异无统计学意义(p>0.05);术后4周IP-10、MCP-1、VEGF和TGF-β2水平与黄斑区视网膜厚度呈正相关(r=0.452, 0.501, 0.466和0.470, p<0.05)。本研究的结果初步说明,房水中IP-10、MCP-1、VEGF和TGF-2水平与2型糖尿病白内障术后黄斑水肿有一定关系,有可能成为黄斑水肿的特异性评价指标,值得进一步研究。  相似文献   

6.

Objective

To evaluate the relative efficacy of ranibizumab (RBZ) monotherapy or combined with laser (RBZ + Laser) versus laser monotherapy for the treatment of diabetic macular edema (DME).

Methods

A comprehensive literature search using PUBMED, ClinicalTrials.gov, and the Cochrane Library to identify randomized controlled trials (RCTs) comparing RBZ or RBZ + Laser to laser monotherapy in patients with DME. Efficacy estimates were determined by comparing weighted mean differences (WMD) in the change of best corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline, and the risk ratios (RR) for the proportions of patients with at least 15 letters change from baseline. Safety analysis estimated the RR of cardiac disorders at 6 to 12 months in RBZ therapy vs. laser monotherapy. Statistical analysis was performed using the RevMan 5.1 software.

Results

Seven RCTs were selected for this meta-analysis, including 1749 patients (394 patients in the RBZ group, 642 patients in the RBZ + Laser group, and 713 patients in the laser group). RBZ and RBZ + Laser were superior to laser monotherapy in the mean change of BCVA and CMT from baseline (WMD = 5.65, 95% confidence interval (CI), 4.44–6.87, P<0.00001; WMD  = 5.02, 95% CI, 3.83–6.20, P<0.00001, and WMD  = −57.91, 95% CI, −77.62 to −38.20, P<0.00001; WMD  = −56.63, 95% CI, −104.81 to −8.44, P = 0.02, respectively). The pooled RR comparing the proportions of patients with at least 15 letters improvement or deterioration were also in favor of RBZ and RBZ + Laser (RR = 2.94, 95% CI, 1.82–4.77, P<0.00001; RR = 2.04, 95% CI, 1.50–2.78, P<0.00001, and RR = 0.21, 95% CI, 0.06–0.71, P = 0.01; RR = 0.52, 95% CI, 0.29–0.95, P = 0.03, respectively). There were no significant differences between RBZ and RBZ + Laser for any of the parameters. There were no difference in the safety profile between RBZ and laser.

Conclusion

RBZ and RBZ + Laser had better visual and anatomic outcomes than laser monotherapy in the treatment of DME. RBZ + Laser seemed to be equivalent to RBZ.  相似文献   

7.

Purpose

To develop EdgeSelect, a semi-automatic method for the segmentation of retinal layers in spectral domain optical coherence tomography images, and to compare the segmentation results with a manual method.

Methods

SD-OCT (Heidelberg Spectralis) scans of 28 eyes (24 patients with diabetic macular edema and 4 normal subjects) were imported into a customized MATLAB application, and were manually segmented by three graders at the layers corresponding to the inner limiting membrane (ILM), the inner segment/ellipsoid interface (ISe), the retinal/retinal pigment epithelium interface (RPE), and the Bruch''s membrane (BM). The scans were then segmented independently by the same graders using EdgeSelect, a semi-automated method allowing the graders to guide/correct the layer segmentation interactively. The inter-grader reproducibility and agreement in locating the layer positions between the manual and EdgeSelect methods were assessed and compared using the Wilcoxon signed rank test.

Results

The inter-grader reproducibility using the EdgeSelect method for retinal layers varied from 0.15 to 1.21 µm, smaller than those using the manual method (3.36–6.43 µm). The Wilcoxon test indicated the EdgeSelect method had significantly better reproducibility than the manual method. The agreement between the manual and EdgeSelect methods in locating retinal layers ranged from 0.08 to 1.32 µm. There were small differences between the two methods in locating the ILM (p = 0.012) and BM layers (p<0.001), but these were statistically indistinguishable in locating the ISe (p = 0.896) and RPE layers (p = 0.771).

Conclusions

The EdgeSelect method resulted in better reproducibility and good agreement with a manual method in a set of eyes of normal subjects and with retinal disease, suggesting that this approach is feasible for OCT image analysis in clinical trials.  相似文献   

8.
目的:探讨雷珠单抗联合视网膜激光光凝术对视网膜分支静脉阻塞(BRVO)继发黄斑水肿患者视网膜电图P1波及生活质量的影响.方法:选取2017年1月~2019年8月期间我院收治的BRVO继发黄斑水肿患者60例,根据随机数字表法分为对照组(n=30)和研究组(n=30),对照组患者予以雷珠单抗治疗,研究组则在对照组的基础上联...  相似文献   

9.
目的:探讨糖尿病性黄斑水肿的三维光学相干断层扫描技术(3D-OCT)与多焦视网膜电图(m ERG)检查结果的相关性。方法:随机选择糖尿病性黄斑水肿患者40人60只眼,经荧光造影检查示黄斑部有持续性的荧光渗漏、囊样水肿,3D-OCT示黄斑中心凹厚度大于170um,对黄斑中心凹旁上、下、鼻、颞约750um处视网膜神经上皮层处厚度进行OCT自带软件的分析测量。随机选择18人35只年龄相配的正常眼为对照组以同样方法行3D-OCT黄斑旁四个方位的神经上皮厚度测量。两组用同种方法行常规黄斑部m ERG检查。所有数据应用SPSS13.0统计软件进行处理,分析3D-OCT与m ERG在影像学方面的相关性。结果:两组被检查者检查结果经统计学处理后对比发现:被检查者黄斑中央5°、10°区域N1、P1波反应密度绝对值与黄斑中心凹神经上皮层厚度具有显著的相关性(P0.05)。结论:糖尿病性黄斑水肿的神经上皮厚度的改变与黄斑区m ERG的改变具有显著相关性,主要表现为黄斑中央5°和10°区域m ERG各波反应密度的改变,且有神经上皮厚度增加的越大,m ERG各波反应密度的降低的幅度也随之变大的趋势。  相似文献   

10.
目的:探讨激光联合康柏西普治疗糖尿病视网膜病变伴黄斑水肿的临床效果及可能机制。方法:选取2017年1月至2017年12月我院收治的糖尿病视网膜病变伴黄斑水肿患者92例作为研究对象,随机分为观察组46例(46眼)及对照组46例(46眼)。对照组患者实施激光治疗,观察组在注射康柏西普1周后再进行激光治疗。比较两组患者治疗后的临床疗效,治疗前后最佳矫正视力(BCVA)、黄斑中心厚度(CMT)、血管内皮生长因子(VEGF)、胰岛素样生长因子-1(IGF-1)及红细胞生成素(EPO)水平的变化。结果:治疗后,观察组的总有效率为91.30%,显著高于对照组(69.57%,P0.05);两组患者的BCVA均较治疗前明显提高(P0.05),CMT均低于治疗前(P0.05),但观察组BCVA较对照组更高(P0.05);CMT较对照组更低(P0.05)。治疗后,两组患者的VEGF、IGF-1、EPO均较治疗前明显降低,且观察组的VEGF、IGF-1、EPO均显著低于对照组(P0.05)。结论:激光联合康柏西普治疗糖尿病视网膜病变伴黄斑水肿的临床疗效显著优于单用激光治疗,并可有效改善VEGF、IGF-1、EPO水平,这可能对抑制血管新生产生积极作用。  相似文献   

11.
目的:研究康柏西普联合全视网膜光凝(panretinal photocoagulation,PRP)治疗糖尿病黄斑水肿(diabetic macular edema, DME)的疗效及安全性。方法:回顾性分析2016年4月到2018年4月本院接诊的DME患者238例,按照治疗方式的不同将其分成观察组及对照组。对照组采用PRP治疗,观察组则采用抗血管内皮生长因子(vascular endothelial growth factor, VEGF)药物康柏西普联合PRP实施治疗。比较两组患者治疗后的临床效果、手术前后视力和黄斑中心凹厚度的变化及预后情况。结果:治疗后,观察组的治疗效率为94.96%,较对照组(84.87%)显著升高(P0.05)。观察组术后视力明显高于手术前(P0.05),且显著高于对照组(P0.05);观察组术后黄斑中心凹厚度明显小于术前(P0.05),且显著小于对照组。观察组并发症发生率(3.36%)明显低于对照组(10.92%,P0.05)。结论:康柏西普联合PRP治疗DME患者的效果显著优于单用PRP治疗,且安全性更高。  相似文献   

12.
PurposeTo evaluate interobserver agreement for the detection of spectral-domain optical coherence tomography (SDOCT) features of diabetic macular edema (DME).MethodCross-sectional study in which 2 retinal specialists evaluated SDOCT scans from eyes receiving treatment for DME. Scans from 50 eyes with DME of 39 patients were graded for features of DME including intra-retinal fluid (IRF), diffuse retinal oedema (DRE), hyper-reflective foci (HRF), subretinal fluid (SRF), macular fluid and vitreomacular traction (VMT). Features were graded as present or absent at zones involving the fovea, 1mm from the fovea and the whole scan of 49 line scans. Analysis was performed using cross-tabulations for percentage concordance and kappa values (κ).ResultsIn the 2950 line scans analysed, there was an increase in percentage concordance for DRE and HRF when moving from a foveal line scan, 1mm zone and then to a whole scan analysis (88% vs 94% vs 96%) and (88% vs 94% vs 94%) respectively with κ ranging from substantial to almost perfect. Percentage concordance for SRF was 96% at all 3 regions analysed, whilst IRF was 96% at fovea and 98% at higher number of line-scans analysed. Concordance for MF was 100% at fovea and 98% at 1mm zone and whole scan with almost perfect and substantial κ respectively. κ agreement was substantial for VMT at all regions analysed.ConclusionWe report a high level of interobserver agreement in the detection of SDOCT features of DME. This finding is important as detection of macular fluid is used to guide retreatment with anti-angiogenic agents.  相似文献   

13.

Background

To investigate changes in macular morphology and function after an intravitreal dexamethasone implant for diabetic macular edema (DME).

Methods

Twenty-seven eyes in 27 treatment-naive patients affected by DME were treated with intravitreal Ozurdex® injections (IVOI) and followed up 12 months to evaluate morphological and functional changes by means of best-corrected visual acuity (BCVA), microperimetry (MP1), multifocal electroretinography (mfERG), pattern electroretinography (PERG) and spectral domain optical coherence tomography (SD-OCT).

Results

Both BCVA and retinal sensitivity improved significantly at one month after the IVOI (p = 0.031 and p<0.0001, respectively). After five months, the improvement of BCVA remained statistically significant compared with baseline values (p = 0.022); retinal sensitivity improvement was statistically significant for up to four months after the IVOI (p = 0.059). Moreover, central macular thickness significantly decreased for up to four months. Interestingly, PERG and mfERG values did not change significantly for up to four months post-IVOI, but then began to worsen.

Conclusions

In eyes with DME, intravitreal dexamethasone implant determined morphological and functional improvement as soon as one month and for up to four months after the treatment.  相似文献   

14.

Purpose

To evaluate how the monitoring and treatment for diabetic macular edema (DME) has changed in a national sample.

Design

Retrospective cohort study.

Methods

Setting: Administrative medical claims data from a large, national U.S. insurer. Study population: Beneficiaries of a U.S. insurance company. Observation procedures: All incident cases of DME were found. Those in years 2002/3, 2006 and 2010 were followed for a 2-year observation period and those from 2009, 2010 and 2011 for a 1-year observation period. Main Outcome Measures: Types and frequencies of treatment were tallied and compared over each of the cohorts.

Results

Two-year cohorts had 233, 251 and 756 patients in 2002/3, 2006 and 2010 respectively. One-year cohorts had 1002, 1119 and 1382 patients in 2009, 2010 and 2011, respectively. Both percentage of patients receiving therapy and number of treatments given increased across the 2-year cohorts for both focal laser and anti-vascular endothelial growth factor (anti-VEGF) (p<0.001). The highest use of anti-VEGF agents in any of the cohorts was in the 2011 1-year group that only averaged 3.78 injections. Focal laser was used 2.5x as frequently as anti-VEGF injections in the most recent cohorts with only a high of 14.0% of DME patients receiving anti-VEGF therapy in any of the cohorts.

Conclusion

Regardless of treatment modality (laser or injection) DME patients received vastly fewer treatments than patients in randomized control trials. Despite the proven superior visual outcomes of anti-VEGF agents over focal laser in DME, focal laser was still used more frequently.  相似文献   

15.
摘要 目的:研究四妙勇安汤辅助全视网膜激光光凝术(Panretinal laser photocoagulation, PRP)对糖尿病视网膜病变(diabetic retinopathy, DR)患者的疗效及对血糖指标和尿白蛋白排泄率(urinary albumin excretion rate, UAER)的影响。方法:选取2018年6月至2020年2月期间陕西中医药大学附属医院(我院)收治DR患者50例85眼,采用随机数字表法分为对照组和观察组,其中对照组25例43眼,观察组25例42眼。对照组给予PRP治疗,观察组在对照组的基础上给予四妙勇安汤,连续服用28 d后评价两组患者的疗效及安全性,并检测两组患者治疗前后的最佳矫正视力(best corrected visual acuity, BVCA)、平均视野缺损(mean visual field defect, MD)、黄斑中心厚度(central macular thickness, CMT)、血糖相关指标及UAER。结果:治疗后,观察组总有效率(95.24 %)高于对照组(81.39 %,P<0.05)。治疗后1个月和3个月时两组的BVCA显著升高,CMT均显著降低(P<0.05),且观察组均优于对照组(P<0.05);治疗后1个月和3个月时两组的BVCA和CMT对比也存在差异(P<0.05)。与治疗前对比,两组治疗1个月MD值均降低,治疗3个月升高(P<0.05),且观察组治疗后1个月和3个月时的MD均高于对照组(P<0.05)。治疗后观察组患者的空腹血糖(fasting blood glucose, FBG)、空腹胰岛素(fasting insulin,FINS)、糖化血红蛋白(HbA1c)和UAER与治疗前相比显著降低(P<0.05)。两组患者研究期间的未见明显的不良反应。结论:四妙勇安汤联合PRP治疗DR疗效显著,患者BVCA、MD和CMT均得以改善,FBG、HbA1c、FINS水平和UAER均显著降低,且联合应用未见明显不良反应发生,值得临床推广。  相似文献   

16.
17.
A clinical and metabolic study of 32 patients treated with glibenclamide for a period of about one year confirmed that the drug is a potent stimulator of insulin release in maturity onset diabetes, and glibenclamide continued to have this action after a period of eight months. The drug is effective in doses as low as 2·5 mg., and the maximum effective dose is about 15 mg. No significant side-effects were found during the period of the study, in particular there was no alcohol flushing. The metabolic investigations have shown that the drug has some actions which are as yet unexplained.  相似文献   

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摘要 目的:探究改良眼底激光光凝联合康柏西普治疗增殖性糖尿病视网膜病变(PDR)的效果及对视力水平、黄斑区血流密度的影响。方法:回顾性分析2019.06-2022.06于我院接受改良眼底激光光凝治疗的62例(124眼)PDR患者临床资料,纳入对照组,回顾性分析同期于我院接受改良眼底激光光凝联合康柏西普治疗的62例(124眼)PDR患者临床资料,纳入试验组。比较治疗前和治疗后3个月两组患者视力水平[最佳矫正视力(BCVA)、视野指数(VFI)、视野平均缺损(MD)]、视网膜中央动脉血流动力学[峰值血流速度(PSV)、平均血流速度(MV)、搏动指数(PI)、阻力指数(RI)]、黄斑区血流密度[浅层毛细血管丛(SCP)、深层毛细血管丛(DCP)]、生活质量[低视力者生存质量量表(CLVQOL)]差异,记录3个月内两组患者并发症(黄斑水肿、高眼压、视网膜出血)发生情况。结果:治疗后3个月,两组患者BCVA、PSV、MV、SCP、DCP、CLVQOL较治疗前升高,试验组高于对照组(P均<0.05);而VFI、MD、PI、RI水平降低,试验组低于对照组(P均<0.05);两组患者术后并发症无显著性差异(P>0.05)。结论:改良眼底激光光凝治疗联合康柏西普治疗可增强PDR患者视力功能,改善患者视网膜中央动脉血流动力学及黄斑区血流密度,提高生活质量。  相似文献   

20.
摘要 目的:研究玻璃体腔内抗血管内皮生长因子(VEGF)抗体治疗不同光学相干层析成像技术(OCT)分型下的糖尿病黄斑水肿临床疗效。方法:选取2019年1月到2021年3月在我院进行治疗的糖尿病黄斑水肿患者60例,根据OCT检测分为分弥漫性黄斑水肿(DRT)组、囊样黄斑水肿(CME)组和浆液性视网膜脱离(SRD)组,每组20例。所有患者均接受玻璃体腔内注射抗VEGF抗体治疗,比较三组患者临床治疗疗效、黄斑水肿形态、最佳矫正视力(BCVA)、黄斑中心凹厚度(CMT)以及不良反应发生率。结果:(1)DRT、CME和SRD组患者临床治疗有效率分别为85.0 %、75.0 %和50.0 %,治疗后黄斑水肿消退率分别为55.0 %、25.0 %和10.0 %,且组间比较差异显著(P<0.05);(2)三组患者治疗前BCVA和CMT均无差异(P>0.05),治疗后三组患者BCVA和CMT均降低(P<0.05),并且治疗后DRT和CME组患者BCVA和CMT均低于SRD组(P<0.05);(3)DRT、CME和SRD组患者治疗期间不良反应发生率分别为10.0 %、10.0 %和25.0 %,但三组患者治疗期间不良反应发生率比较无差异(P>0.05)。结论:不同OCT分型的糖尿病黄斑水肿经玻璃体腔抗VEGF抗体治疗后临床疗效不同,其中DRT患者临床治疗疗效最好,而SRD患者疗效最差。  相似文献   

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