AIM： To evaluate the long-term efficacy and safety of dexamethasone implants in subjects affected by diabetic macular edema（DME） resistant to anti-vascular endothelial growth factor（VEGF） therapy.METHODS： Thirty...AIM： To evaluate the long-term efficacy and safety of dexamethasone implants in subjects affected by diabetic macular edema（DME） resistant to anti-vascular endothelial growth factor（VEGF） therapy.METHODS： Thirty-two DME patients were enrolled.A700 microgram slow release Intravitreal Dexamethasone Implant（Ozurdex~） was placed in the vitreous cavity.All patients were followed for 18 mo.Best-corrected visual acuity（BCVA） measured with Early Treatment Diabetic Retinopathy Study（ETDRS） and central macular thickness（CMT） exams were carried out at baseline（T0）and after 1（T1）,3（T3）,4（T4）,6（T6）,9（T9）,12（T12）,15（T15）,and 18mo（T18） post injection. RESULTS： Repeated measures ANOVA showed an effect of treatment on ETDRS（P〈0.0001）.Post hoc analyses revealed that ETDRS values were significantly increased at T1,T3,T4,T9,and T15（P 〈0.001） as compared to baseline value（T0）.At T6,T12,and T18,ETDRS values were still statistically higher than baseline（P〈0.001 vs T0）.However,at these time points,we observed a trend to return to baseline conditions.ANOVA also showed an effect of treatment（P 〈0.0001）.CMT decreased significantly at T1,T3,T4,T9,and T15（P〈0.001）.At T6（P〈0.01）,T12 and T18（P〈0.001） CMT was also significantly lower than T0 although a trend to return to the baseline conditions was also observed.CONCLUSION： Our findings demonstrate that Intravitreal Dexamethasone Implant is a good option to improveBCVA and CMT in DME patients resistant to anti-VEGF therapy.Our data also show that the use of drugs administered directly into the vitreous allows achieving appropriate and long-lasting concentration at the site of disease without systemic side effects.展开更多
目的探讨大黄灵脾颗粒联合肾衰方经皮透药治疗慢性肾脏病3~5期(CKD3~5期)患者的临床效果。方法选取2020年1月—2021年12月上海市闵行区中西医结合医院就诊的CKD3~5期患者60例,随机分为对照组和治疗组,各30例。两组均采用一般治疗及常规...目的探讨大黄灵脾颗粒联合肾衰方经皮透药治疗慢性肾脏病3~5期(CKD3~5期)患者的临床效果。方法选取2020年1月—2021年12月上海市闵行区中西医结合医院就诊的CKD3~5期患者60例,随机分为对照组和治疗组,各30例。两组均采用一般治疗及常规西医治疗,所有患者均服用大黄灵脾颗粒,治疗组在此基础上,加用经皮透药疗法于双侧肾俞穴。比较两组疗效及药物不良反应,比较两组血清肌酐(Scr)、尿素氮(BUN)、尿酸(UA)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、24 h尿蛋白定量(24 h Upr)等。结果治疗后两组患者Scr、BUN、24 h Upr均较治疗前下降,差异有统计学意义(P<0.05);治疗组总有效率76.7%(23/30)高于对照组的60.0%(18/30),但差异无统计学意义(P>0.05),治疗组中医证候积分较对照组明显降低(P<0.05)。结论大黄灵脾颗粒联合肾衰方经皮透药治疗可以改善CKD3~5期患者肾功能及中医临床证候,延缓病程的进展。展开更多
AIM： To compare three initial monthly intravitreal ranibizumab（IVR） injections followed by pro re nata（PRN） dosing with one initial monthly IVR injections followed by PRN dosing for macular edema（ME） secondary ...AIM： To compare three initial monthly intravitreal ranibizumab（IVR） injections followed by pro re nata（PRN） dosing with one initial monthly IVR injections followed by PRN dosing for macular edema（ME） secondary to branch retinal vein occlusion（BRVO）.METHODS： Forty-two eyes of 42 patients who had IVR injections for BRVO were retrospectively studied. Eighteen eyes received 1 initial IVR injection（1＋PRN group） and 24 eyes received 3 monthly IVR injections（3＋PRN）. At 1, 3, 6 and 12mo; spectral-domain optical coherence tomography（SD-OCT） was performed. Central macular thickness（CMT）, the integrity of the external limiting membrane（ELM）, the presence of subretinal fluid, cyst size, the presence of inner segment/outer segment（IS/OS） defect were determined.RESULTS： At baseline the mean CMT was 521.3±153.2 μm in the 3＋PRN group while it was 438.1±162.4 μm in 1＋PRN group. At the final visit, mean CMT was 278.3±87.8 μm in the 3＋PRN group and 285.2±74.2 μm in the 1＋PRN group（P=0.079）. The changes in CMT over the entire study period were also comparable in both groups（243±160 μm in the 3＋PRN group, and 152.9±175.3 μm in the 1＋PRN group; P=0.090）. At baseline, best-corrected visual acuity（BCVA） was 0.92±0.60 logarithm of the minimal angle of resolution（logMAR） in the 3＋PRN group, while it was 0.72±0.46 logMAR in the 1＋PRN group. Final BCVA was 0.42±0.55 logMAR in the 3＋PRN group and 0.38±0.50 logMAR in the 1＋PRN group（P=0.979）. Additionally, the BCVA changes from baseline to final visit were not significantly different（-0.50±0.45 logMAR in the 3＋PRN group, and-0.33±0.39 logMAR in the 1＋PRN group; P=0.255）.CONCLUSION： No significant differences in the anatomical or functional results are found between 3＋PRN and 1＋PRN regimens in the patients receiving ranibizumab for ME secondary to BRVO. Intact IS/OS and baseline BCVA are good predictor of the visual gain, while baseline CMT is a good predictor of the anatomical gain.展开更多
Diabetic retinopathy(DR)is the leading cause of vision loss of working-age adults,and diabetic macular edema(DME)is the most frequent cause of vision loss related to diabetes.The Wisconsin Epidemiologic Study of Diabe...Diabetic retinopathy(DR)is the leading cause of vision loss of working-age adults,and diabetic macular edema(DME)is the most frequent cause of vision loss related to diabetes.The Wisconsin Epidemiologic Study of Diabetic Retinopathy found the 14-year incidence of DME in type 1 diabetics to be 26%.Similarly the Diabetes Control and Complications Trial reported that 27% of type 1 diabetic patients develop DME within9 years of onset.The most common type of diabetes,type 2,is strongly associated with obesity and a sedentary lifestyle.An even higher incidence of macular edema has been reported in older patients with type 2diabetes.Within the last 5 years,the use of intravitreal corticosteroids and intravitreal anti-vascular endothelial growth factor(VEGF)agents have come into clinical practice for the management of DME and several recent randomized clinical trials have shown improved effectiveness of ranibizumab compared to focal/grid laser.In this theme issue,we discuss the classification of DR and the treatment options currently available for the treatment of DME including corticosteroids,anti-VEGF agents,combined therapy,enzymatic vitrectomy(vitreolysis),and new therapies.展开更多
We inquired the impact of reduced therapy discontinuation in diabetic macular edema(DME) on physician's revenue considering anti-vascular endothelial growth factor(VEGF) monotherapy and its combination with Navila...We inquired the impact of reduced therapy discontinuation in diabetic macular edema(DME) on physician's revenue considering anti-vascular endothelial growth factor(VEGF) monotherapy and its combination with Navilas treatment. Data were collected on injection frequency, treatment discontinuation and reimbursement fees for DME treatment with anti-VEGF compared to anti-VEGF in combination with navigated laser. Based on these data an economic model was built to compare physicians revenue over a 5y period using either therapy for 4 European countries and the USA. Due to patients' higher therapy adherence, physicians using navigated laser therapy with anti-VEGF generate similar or higher revenues compared to VEGF monotherapy in all analyzed countries. The use of Navilas decreases the patient's injection burden at the same clinical outcome, while the physician's revenue remained stable or increased. Therewith, therapy discontinuation in DME can be reduced using the combination therapy with Navilas.展开更多
AIM： To appraise the effect of treatment for diabetic macular edema（DME） in proliferative stage with sufficient panrentinal photocoagulation（PRP） therapy and intravitreal injections（IV） Conbercept and posterior...AIM： To appraise the effect of treatment for diabetic macular edema（DME） in proliferative stage with sufficient panrentinal photocoagulation（PRP） therapy and intravitreal injections（IV） Conbercept and posterior subtenon＇s triamcinolone acetonide（STTA） sequential therapy.METHODS： This prospective clinical randomized controlled trial of cross-over design was conducted in three phases. The participants included cases of DME in proliferative stage. They were divided into two groups and treated with PRP before enrollment. Group A were treated with IVConbercept 0.5 mg for one month in the 1^st phase. Group B were treated with STTA 40 mg（twice per two weeks）. The interventions were exchanged in the second phase（2mo） between the two groups. In the third phase（3-6mo） no other treatment was given. Best corrected visual acuity（BCVA）, central macular thickness（CMT） measured by OCT and complications were compared.RESULTS： After phase I： in Group A, BCVA improved from 0.201±0.17 to 0.37±0.24（F=5.88, P=0.004）. CMT changed from 449±155.10 to 304.1±84.70 μm（F=14.9, P〈0.01）. In Group B, BCVA changed from 0.195±0.19 to 0.26±0.20（F=0.76, P=0.41） while CMT changed from 463.82±152.92 to 366.00±115.40 μm（F=3.70, P〈0.03）. The improvement of BCVA was better in Group A（P〈0.05）. After phase II： in Group A, BCVA raised to 0.47±0.27（F=0.26, P〈0.01）, CMT reduced to 260.67±62.97 μm（F=-188.3, P〈0.01）; in Group B, BCVA raised to 0.51±0.26（F=0.31, P〈0.01）, CMT reduced to 261.93±50.15 μm（F=-201.9, P〈0.01）. But there were no difference between two groups（P〉0.05）. After phase III： in Group A, BCVA maintained 0.42±0.25（F=0.22, P=0.001）, CMT maintained 267.8±58.34 μm,（F=-0.27, P〈0.01）; in Group B, BCVA was 0.47±0.25（F=-0.27, P〈0.01）, CMT was 272.71±49.16 μm（F=-191.1, P〈0.01）. No serious complications happened in all phases.CONCLUSION： PRP＋Conbercept is better than PRP＋STTA in DME with proliferative stage but PRP＋Conbercept＋STTA sequential therapy may be a wiser choice for persistent effectiveness on anatomical as well as functional status.展开更多
AIM： To compare the therapeutic effect and safety of laser photocoagulation along with intravitreal ranibizumab（IVR） versus laser therapy in treatment of diabetic macular edema（DME）.METHODS： Pertinent publicatio...AIM： To compare the therapeutic effect and safety of laser photocoagulation along with intravitreal ranibizumab（IVR） versus laser therapy in treatment of diabetic macular edema（DME）.METHODS： Pertinent publications were identified through comprehensive searches of Pub Med, EMBASE, Web of Science, Cochrane Library, and Clinical Trials.gov to identify randomized clinical trials（RCTs） comparing IVR＋laser to laser monotherapy in patients with DME. Therapeutic effect estimates were determined by weighted mean differences（WMD） of change from baseline in best corrected visual acuity（BCVA） and central retinal thickness（CRT） at 6, 12, or 24 mo after initial treatment, and the risk ratios（RR） for the proportions of patients with at least 10 letters of improvement or reduction at 12 mo. Data regarding major ocular and nonocular adverse events（AEs） were collected and analyzed. The Review Manager 5.3.5 was used.RESULTS： Six RCTs involving 2069 patients with DME were selected for this Meta-analysis. The results showed that IVR＋laser significantly improved BCVA compared with laser at 6mo（WMD： 6.57; 95% CI： 4.37-8.77; P〈0.00001）, 12mo（WMD： 5.46; 95% CI： 4.35-6.58; P〈0.00001）, and 24mo（WMD： 3.42; 95% CI： 0.84-5.99; P=0.009） in patients with DME. IVR＋laser was superior to laser in reducing CRT at 12 mo from baseline with statistical significance（WMD：-63.46; 95% CI：-101.19 to-25.73; P=0.001）. The pooled RR results showed that the proportions of patients with at least 10 letters of improvement or reduction were in favor of IVR＋laser arms compared with laser（RR： 2.13; 95% CI： 1.77-2.57; P〈0.00001 and RR： 0.37; 95% CI： 0.22-0.62; P=0.0002, respectively）. As for AEs, the pooled results showed that a significantly higher proportion ofpatients suffering from conjunctival hemorrhage（study eye） and diabetic retinal edema（fellow eye） in IVR＋laser group compared to laser group（RR： 3.29; 95% CI： 1.53-7.09; P=0.002 and RR： 3.02; 95% CI： 1.24-7.32; P=0.01, respectively）. The incidence of other ocular and nonocular AEs considered in this Meta-analysis had no statistical difference between IVR＋laser and laser alone.CONCLUSION： The results of our analysis show that IVR＋laser has better availability in functional（improving BCVA） and anatomic（reducing CRT） outcomes than laser monotherapy for the treatment of DME. However, the patients who received the treatment of IVR＋laser may get a higher risk of suffering from conjunctival hemorrhage（study eye） and diabetic retinal edema（fellow eye）.展开更多
AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants(Ozurdex?/DEX) in patients with diabetic macular edema(DME) either na?ve or nonna?ve to anti-VEGF therapies who switched to DEX implant...AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants(Ozurdex?/DEX) in patients with diabetic macular edema(DME) either na?ve or nonna?ve 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 na?ve 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 6 mo. 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 na?ve before receiving DEX implant, was collected.RESULTS: Improvement in mean BCVA was observed from 1-4 mo after injection with a decreased effect at month 6 as expected, with better outcomes in na?ve compared to non-na?ve 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 2 mo after DEX therapy. The mean number of injections of the overall population during the 6 mo 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 na?ve patients.展开更多
文摘AIM： To evaluate the long-term efficacy and safety of dexamethasone implants in subjects affected by diabetic macular edema（DME） resistant to anti-vascular endothelial growth factor（VEGF） therapy.METHODS： Thirty-two DME patients were enrolled.A700 microgram slow release Intravitreal Dexamethasone Implant（Ozurdex~） was placed in the vitreous cavity.All patients were followed for 18 mo.Best-corrected visual acuity（BCVA） measured with Early Treatment Diabetic Retinopathy Study（ETDRS） and central macular thickness（CMT） exams were carried out at baseline（T0）and after 1（T1）,3（T3）,4（T4）,6（T6）,9（T9）,12（T12）,15（T15）,and 18mo（T18） post injection. RESULTS： Repeated measures ANOVA showed an effect of treatment on ETDRS（P〈0.0001）.Post hoc analyses revealed that ETDRS values were significantly increased at T1,T3,T4,T9,and T15（P 〈0.001） as compared to baseline value（T0）.At T6,T12,and T18,ETDRS values were still statistically higher than baseline（P〈0.001 vs T0）.However,at these time points,we observed a trend to return to baseline conditions.ANOVA also showed an effect of treatment（P 〈0.0001）.CMT decreased significantly at T1,T3,T4,T9,and T15（P〈0.001）.At T6（P〈0.01）,T12 and T18（P〈0.001） CMT was also significantly lower than T0 although a trend to return to the baseline conditions was also observed.CONCLUSION： Our findings demonstrate that Intravitreal Dexamethasone Implant is a good option to improveBCVA and CMT in DME patients resistant to anti-VEGF therapy.Our data also show that the use of drugs administered directly into the vitreous allows achieving appropriate and long-lasting concentration at the site of disease without systemic side effects.
文摘目的探讨大黄灵脾颗粒联合肾衰方经皮透药治疗慢性肾脏病3~5期(CKD3~5期)患者的临床效果。方法选取2020年1月—2021年12月上海市闵行区中西医结合医院就诊的CKD3~5期患者60例,随机分为对照组和治疗组,各30例。两组均采用一般治疗及常规西医治疗,所有患者均服用大黄灵脾颗粒,治疗组在此基础上,加用经皮透药疗法于双侧肾俞穴。比较两组疗效及药物不良反应,比较两组血清肌酐(Scr)、尿素氮(BUN)、尿酸(UA)、丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、24 h尿蛋白定量(24 h Upr)等。结果治疗后两组患者Scr、BUN、24 h Upr均较治疗前下降,差异有统计学意义(P<0.05);治疗组总有效率76.7%(23/30)高于对照组的60.0%(18/30),但差异无统计学意义(P>0.05),治疗组中医证候积分较对照组明显降低(P<0.05)。结论大黄灵脾颗粒联合肾衰方经皮透药治疗可以改善CKD3~5期患者肾功能及中医临床证候,延缓病程的进展。
文摘AIM： To compare three initial monthly intravitreal ranibizumab（IVR） injections followed by pro re nata（PRN） dosing with one initial monthly IVR injections followed by PRN dosing for macular edema（ME） secondary to branch retinal vein occlusion（BRVO）.METHODS： Forty-two eyes of 42 patients who had IVR injections for BRVO were retrospectively studied. Eighteen eyes received 1 initial IVR injection（1＋PRN group） and 24 eyes received 3 monthly IVR injections（3＋PRN）. At 1, 3, 6 and 12mo; spectral-domain optical coherence tomography（SD-OCT） was performed. Central macular thickness（CMT）, the integrity of the external limiting membrane（ELM）, the presence of subretinal fluid, cyst size, the presence of inner segment/outer segment（IS/OS） defect were determined.RESULTS： At baseline the mean CMT was 521.3±153.2 μm in the 3＋PRN group while it was 438.1±162.4 μm in 1＋PRN group. At the final visit, mean CMT was 278.3±87.8 μm in the 3＋PRN group and 285.2±74.2 μm in the 1＋PRN group（P=0.079）. The changes in CMT over the entire study period were also comparable in both groups（243±160 μm in the 3＋PRN group, and 152.9±175.3 μm in the 1＋PRN group; P=0.090）. At baseline, best-corrected visual acuity（BCVA） was 0.92±0.60 logarithm of the minimal angle of resolution（logMAR） in the 3＋PRN group, while it was 0.72±0.46 logMAR in the 1＋PRN group. Final BCVA was 0.42±0.55 logMAR in the 3＋PRN group and 0.38±0.50 logMAR in the 1＋PRN group（P=0.979）. Additionally, the BCVA changes from baseline to final visit were not significantly different（-0.50±0.45 logMAR in the 3＋PRN group, and-0.33±0.39 logMAR in the 1＋PRN group; P=0.255）.CONCLUSION： No significant differences in the anatomical or functional results are found between 3＋PRN and 1＋PRN regimens in the patients receiving ranibizumab for ME secondary to BRVO. Intact IS/OS and baseline BCVA are good predictor of the visual gain, while baseline CMT is a good predictor of the anatomical gain.
文摘Diabetic retinopathy(DR)is the leading cause of vision loss of working-age adults,and diabetic macular edema(DME)is the most frequent cause of vision loss related to diabetes.The Wisconsin Epidemiologic Study of Diabetic Retinopathy found the 14-year incidence of DME in type 1 diabetics to be 26%.Similarly the Diabetes Control and Complications Trial reported that 27% of type 1 diabetic patients develop DME within9 years of onset.The most common type of diabetes,type 2,is strongly associated with obesity and a sedentary lifestyle.An even higher incidence of macular edema has been reported in older patients with type 2diabetes.Within the last 5 years,the use of intravitreal corticosteroids and intravitreal anti-vascular endothelial growth factor(VEGF)agents have come into clinical practice for the management of DME and several recent randomized clinical trials have shown improved effectiveness of ranibizumab compared to focal/grid laser.In this theme issue,we discuss the classification of DR and the treatment options currently available for the treatment of DME including corticosteroids,anti-VEGF agents,combined therapy,enzymatic vitrectomy(vitreolysis),and new therapies.
文摘We inquired the impact of reduced therapy discontinuation in diabetic macular edema(DME) on physician's revenue considering anti-vascular endothelial growth factor(VEGF) monotherapy and its combination with Navilas treatment. Data were collected on injection frequency, treatment discontinuation and reimbursement fees for DME treatment with anti-VEGF compared to anti-VEGF in combination with navigated laser. Based on these data an economic model was built to compare physicians revenue over a 5y period using either therapy for 4 European countries and the USA. Due to patients' higher therapy adherence, physicians using navigated laser therapy with anti-VEGF generate similar or higher revenues compared to VEGF monotherapy in all analyzed countries. The use of Navilas decreases the patient's injection burden at the same clinical outcome, while the physician's revenue remained stable or increased. Therewith, therapy discontinuation in DME can be reduced using the combination therapy with Navilas.
基金Supported by the Health and Family Planning Commission of Sichuan Province(No:17PJ536)
文摘AIM： To appraise the effect of treatment for diabetic macular edema（DME） in proliferative stage with sufficient panrentinal photocoagulation（PRP） therapy and intravitreal injections（IV） Conbercept and posterior subtenon＇s triamcinolone acetonide（STTA） sequential therapy.METHODS： This prospective clinical randomized controlled trial of cross-over design was conducted in three phases. The participants included cases of DME in proliferative stage. They were divided into two groups and treated with PRP before enrollment. Group A were treated with IVConbercept 0.5 mg for one month in the 1^st phase. Group B were treated with STTA 40 mg（twice per two weeks）. The interventions were exchanged in the second phase（2mo） between the two groups. In the third phase（3-6mo） no other treatment was given. Best corrected visual acuity（BCVA）, central macular thickness（CMT） measured by OCT and complications were compared.RESULTS： After phase I： in Group A, BCVA improved from 0.201±0.17 to 0.37±0.24（F=5.88, P=0.004）. CMT changed from 449±155.10 to 304.1±84.70 μm（F=14.9, P〈0.01）. In Group B, BCVA changed from 0.195±0.19 to 0.26±0.20（F=0.76, P=0.41） while CMT changed from 463.82±152.92 to 366.00±115.40 μm（F=3.70, P〈0.03）. The improvement of BCVA was better in Group A（P〈0.05）. After phase II： in Group A, BCVA raised to 0.47±0.27（F=0.26, P〈0.01）, CMT reduced to 260.67±62.97 μm（F=-188.3, P〈0.01）; in Group B, BCVA raised to 0.51±0.26（F=0.31, P〈0.01）, CMT reduced to 261.93±50.15 μm（F=-201.9, P〈0.01）. But there were no difference between two groups（P〉0.05）. After phase III： in Group A, BCVA maintained 0.42±0.25（F=0.22, P=0.001）, CMT maintained 267.8±58.34 μm,（F=-0.27, P〈0.01）; in Group B, BCVA was 0.47±0.25（F=-0.27, P〈0.01）, CMT was 272.71±49.16 μm（F=-191.1, P〈0.01）. No serious complications happened in all phases.CONCLUSION： PRP＋Conbercept is better than PRP＋STTA in DME with proliferative stage but PRP＋Conbercept＋STTA sequential therapy may be a wiser choice for persistent effectiveness on anatomical as well as functional status.
基金Supported by the National Natural Science Foundation of China(No.81570851)
文摘AIM： To compare the therapeutic effect and safety of laser photocoagulation along with intravitreal ranibizumab（IVR） versus laser therapy in treatment of diabetic macular edema（DME）.METHODS： Pertinent publications were identified through comprehensive searches of Pub Med, EMBASE, Web of Science, Cochrane Library, and Clinical Trials.gov to identify randomized clinical trials（RCTs） comparing IVR＋laser to laser monotherapy in patients with DME. Therapeutic effect estimates were determined by weighted mean differences（WMD） of change from baseline in best corrected visual acuity（BCVA） and central retinal thickness（CRT） at 6, 12, or 24 mo after initial treatment, and the risk ratios（RR） for the proportions of patients with at least 10 letters of improvement or reduction at 12 mo. Data regarding major ocular and nonocular adverse events（AEs） were collected and analyzed. The Review Manager 5.3.5 was used.RESULTS： Six RCTs involving 2069 patients with DME were selected for this Meta-analysis. The results showed that IVR＋laser significantly improved BCVA compared with laser at 6mo（WMD： 6.57; 95% CI： 4.37-8.77; P〈0.00001）, 12mo（WMD： 5.46; 95% CI： 4.35-6.58; P〈0.00001）, and 24mo（WMD： 3.42; 95% CI： 0.84-5.99; P=0.009） in patients with DME. IVR＋laser was superior to laser in reducing CRT at 12 mo from baseline with statistical significance（WMD：-63.46; 95% CI：-101.19 to-25.73; P=0.001）. The pooled RR results showed that the proportions of patients with at least 10 letters of improvement or reduction were in favor of IVR＋laser arms compared with laser（RR： 2.13; 95% CI： 1.77-2.57; P〈0.00001 and RR： 0.37; 95% CI： 0.22-0.62; P=0.0002, respectively）. As for AEs, the pooled results showed that a significantly higher proportion ofpatients suffering from conjunctival hemorrhage（study eye） and diabetic retinal edema（fellow eye） in IVR＋laser group compared to laser group（RR： 3.29; 95% CI： 1.53-7.09; P=0.002 and RR： 3.02; 95% CI： 1.24-7.32; P=0.01, respectively）. The incidence of other ocular and nonocular AEs considered in this Meta-analysis had no statistical difference between IVR＋laser and laser alone.CONCLUSION： The results of our analysis show that IVR＋laser has better availability in functional（improving BCVA） and anatomic（reducing CRT） outcomes than laser monotherapy for the treatment of DME. However, the patients who received the treatment of IVR＋laser may get a higher risk of suffering from conjunctival hemorrhage（study eye） and diabetic retinal edema（fellow eye）.
文摘AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants(Ozurdex?/DEX) in patients with diabetic macular edema(DME) either na?ve or nonna?ve 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 na?ve 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 6 mo. 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 na?ve before receiving DEX implant, was collected.RESULTS: Improvement in mean BCVA was observed from 1-4 mo after injection with a decreased effect at month 6 as expected, with better outcomes in na?ve compared to non-na?ve 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 2 mo after DEX therapy. The mean number of injections of the overall population during the 6 mo 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 na?ve patients.
