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[摘要]
目的:评价雷珠单抗玻璃体腔注射联合577nm激光黄斑格栅光凝(MGP)治疗重度糖尿病黄斑水肿(DME)的临床疗效。
方法:将38例53眼重度DME患者随机分为联合治疗组(20例28眼)和单纯注药组(18例25眼)。所有病例均接受每月1次,连续3次的雷珠单抗玻璃体腔注射(初始治疗),此后每月复查,根据病情需要可给予再次玻璃体腔注射(PRN治疗)。联合治疗组患者第3次注射后1mo内给予577nm激光MGP治疗。随访12mo,观察两组患者ETDRS视力及黄斑中心视网膜厚度(CMT)变化,并比较初始治疗后两组患者的注射次数及重复治疗率。
结果:治疗后3、6、9、12mo平均BCVA与基线相比,联合治疗组分别提高7.6±7.9、7.2±6.1、8.3±6.6、7.9±7.1,单纯注药组分别提高8.5±5.8、7.5±6.4、8.4±8.1、6.5±6.3; 平均CMT与基线比较,联合治疗组分别降低131±162、108±131、115±129、126±157μm,单纯注药组分别降低129±117、96±117、104±135、101±112μm,两组结果无统计学差异(P>0.05)。初始治疗后,联合治疗组患者平均再注药0.87±1.35次,单纯注药组平均再注药2.96±2.07次,差异有显著统计学意义(t=1.714,P<0.01); 联合治疗组中43%患者需进行重复注射,而单纯注药组患者重复注射率为84%,两组结果有显著统计学差异(t=1.385,P<0.01)。
结论:577nm激光MGP联合雷珠单抗玻璃体腔注射可有效改善DME,提高患者视力,与单纯雷珠单抗注射相比,可明显减少注射次数及重复治疗率。
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[Abstract]
AIM: To evaluate the effect of a combination therapy regimen, utilizing 3 monthly ranibizumab injections followed by 577nm laser macular grid photocoagulation(MGP)for treatment of severe diabetic macular edema(DME).
METHODS: Thirty-eight patients(53 eyes)with severe DME were divided into combination therapy group(20 patients, 28 eyes)and ranibizumab monotherapy group(18 patients, 25 eyes)randomly. All patients initially received 3 monthly ranibizumab injections(loading phase)and additional injections pro re nata(PRN). Patients in combination therapy group additionally received 577nm laser MGP during the first month after the loading phase. Change in best corrected visual acuity(BCVA)and central macular thickness(CMT)from baseline to 12mo as well as the mean number of injections after the loading phase were compared between the two groups.
RESULTS: Change in BCVA from baseline in combination therapy group and ranibizumab monotherapy group at 3, 6, 9 and 12mo were 7.6±7.9 letters vs 8.5±5.8 letters, 7.2±6.1 letters vs 7.5±6.4 letters, 8.3±6.6 letters vs 8.4±8.1 letters, 7.9±7.1 letters vs 6.5±6.3 letters respectively. Change in CMT at 3, 6, 9 and 12mo were 131± 162μm, 108± 131μm, 115± 129μm, 126± 157μm in combination therapy group as well as 129±117μm, 96±117μm, 104±135μm, 101±112μm in monotherapy group. The difference between the two groups was not statistically significant. In combination therapy group, significantly less injection was required after the loading phase(0.87±1.35 vs 2.96±2.07,t=1.714, P<0.01). By 12mo, 43% of patients in the combination therapy group had need for additional ranibizumab injections as compared to 84% in monotherapy group(t=1.385,P<0.01).
CONCLUSION: The 577nm laser MGP combined with ranibizumab injection demonstrated markedly visual gains and CMT decrease in DME patients. Retreatment rate and number of injections were significantly lower in combination therapy group compared to ranibizumab monotherapy group.
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