治疗的主要目的在于改善高血压和高血糖,确保在发生视力减退之前阻止致盲性疾病的发生,因为阻止视力丢失比逆转更容易。 应建议患者咨询他们的医生,以获得合理的血压和血糖控制。 尽管控制好血压和血糖可减缓视网膜病变的发生和进展,[24]The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.http://www.nejm.org/doi/full/10.1056/NEJM199309303291401#t=articlehttp://www.ncbi.nlm.nih.gov/pubmed/8366922?tool=bestpractice.com[25]UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998 Sep 12;352(9131):837-53.http://www.ncbi.nlm.nih.gov/pubmed/9742976?tool=bestpractice.com[26]UK Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998 Sep 12;317(7160):703-13.http://www.bmj.com/content/317/7160/703.fullhttp://www.ncbi.nlm.nih.gov/pubmed/9732337?tool=bestpractice.com 一旦存在威胁视力的疾病,就需要眼科治疗。通常包括黄斑激光治疗、玻璃体内治疗、广泛视网膜光凝术、玻璃体切除术或联合治疗。[52]Early Treatment Diabetic Retinopathy Study Research Group. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. ETDRS report number 2. Ophthalmology. 1987 Jul;94(7):761-74.http://www.ncbi.nlm.nih.gov/pubmed/3658348?tool=bestpractice.com[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com[47]Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS report number 8. Ophthalmology. 1981 Jul;88(7):583-600.http://www.ncbi.nlm.nih.gov/pubmed/7196564?tool=bestpractice.com[61]Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized clinical trial. Diabetic Retinopathy Vitrectomy Study report 2. Arch Ophthalmol. 1985 Nov;103(11):1644-52.http://www.ncbi.nlm.nih.gov/pubmed/2865943?tool=bestpractice.com[62]Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial: Diabetic Retinopathy Vitrectomy Study report 3. Ophthalmology. 1988 Oct;95(10):1307-20.http://www.ncbi.nlm.nih.gov/pubmed/2465517?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。 黄斑水肿可被定义为临床显著性或非临床显著性两种,仅前者需要治疗。
会诊医生转诊的标准如下。[51]Public Health England. Diabetic eye screening: commission and provide. April 2017 [internet publication].https://www.gov.uk/government/collections/diabetic-eye-screening-commission-and-provide
增殖性糖尿病视网膜病变 (PDR):需要紧急转诊。
重度非增殖性糖尿病视网膜病变 (NPDR):需要常规转诊。
黄斑水肿:需要常规转诊。
无临床意义的黄斑水肿的非重度 NPDR(无 DR 或轻度至中度 NPDR)仅需要观察。 非重度 NPDR 伴有累及黄斑中央的临床严重黄斑水肿需要玻璃体内抗血管生长因子 (VEGF) 治疗。[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com [ ]How do anti-vascular endothelial growth factors compare with one another for people with diabetic macular edema?https://cochranelibrary.com/cca/doi/10.1002/cca.1794/full显示答案VEGF 抗体治疗包括单克隆抗体雷珠单抗、贝伐单抗和融合蛋白阿柏西普。 对于未累及黄斑中央的水肿部分,应当考虑黄斑激光治疗。[52]Early Treatment Diabetic Retinopathy Study Research Group. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. ETDRS report number 2. Ophthalmology. 1987 Jul;94(7):761-74.http://www.ncbi.nlm.nih.gov/pubmed/3658348?tool=bestpractice.com[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com[65]Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12):1796-806.http://www.ncbi.nlm.nih.gov/pubmed/2866759?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于患有轻度至中度非增殖性糖尿病性视网膜病变和黄斑水肿的患者,黄斑激光治疗可减少其 2 至 3 年内的视力丧失。[65]Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12):1796-806.http://www.ncbi.nlm.nih.gov/pubmed/2866759?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。
玻璃体内注射 VEGF 抗体治疗的主要不良反应是感染,发生率约 0.05% 至 0.1% 。[66]Cheung CS, Wong AW, Lui A, et al. Incidence of endophthalmitis and use of antibiotic prophylaxis after intravitreal injections. Ophthalmology. 2012 Aug;119(8):1609-14.http://www.ncbi.nlm.nih.gov/pubmed/22480743?tool=bestpractice.com 黄斑激光治疗的不良反应包括近中心视力丧失、可见盲点和偶尔的脉络膜新生血管形成或中央凹损伤。
患有重度 NPDR/非高危型 PDR 和非临床有意义黄斑水肿的患眼可用广泛视网膜光凝术治疗。[67]Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology. 1991 May;98(5 Suppl):766-85.http://www.ncbi.nlm.nih.gov/pubmed/2062512?tool=bestpractice.com 然而,在治疗的患者中会出现更多的早期视力减退,并且治疗往往用于具有全身性疾病或眼部疾病进展危险因素的患者。
重度 NPDR/非高风险 PDR 伴有累及黄斑中央的临床显著的黄斑水肿需要玻璃体内抗 VEGF 药物治疗。[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。 VEGF 抗体治疗包括单克隆抗体雷珠单抗、贝伐单抗和融合蛋白阿柏西普。 对于未累及黄斑中央的水肿部分,应当考虑黄斑激光治疗。[52]Early Treatment Diabetic Retinopathy Study Research Group. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. ETDRS report number 2. Ophthalmology. 1987 Jul;94(7):761-74.http://www.ncbi.nlm.nih.gov/pubmed/3658348?tool=bestpractice.com[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com[65]Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12):1796-806.http://www.ncbi.nlm.nih.gov/pubmed/2866759?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于患有轻度至中度非增殖性糖尿病性视网膜病变和黄斑水肿的患者,黄斑激光治疗可减少其 2 至 3 年内的视力丧失。[65]Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12):1796-806.http://www.ncbi.nlm.nih.gov/pubmed/2866759?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。 可以考虑全视网膜光凝术。[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com[68]Patz A, Schatz H, Berkow JW, et al. Macular edema: an overlooked complication of diabetic retinopathy. Trans Am Acad Ophthalmol Otolaryngol. 1973 Jan-Feb;77(1):OP34-42.http://www.ncbi.nlm.nih.gov/pubmed/4738180?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于患有中度至重度非增殖性糖尿病视网膜病变和黄斑水肿的患者,全视网膜光凝术可有效降低重度视力丧失的风险。[68]Patz A, Schatz H, Berkow JW, et al. Macular edema: an overlooked complication of diabetic retinopathy. Trans Am Acad Ophthalmol Otolaryngol. 1973 Jan-Feb;77(1):OP34-42.http://www.ncbi.nlm.nih.gov/pubmed/4738180?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。 经全视网膜光凝术治疗的重度 NPDR/低风险 PDR 患者可能出现早期视力丧失,[67]Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology. 1991 May;98(5 Suppl):766-85.http://www.ncbi.nlm.nih.gov/pubmed/2062512?tool=bestpractice.com 同时进行玻璃体内抗 VEGF 治疗可能缓解。接受玻璃体内抗 VEGF 治疗的糖尿病黄斑水肿患者可能不需要全视网膜光凝术,因为抗 VEGF 治疗会抑制新生血管形成。[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com[69]Writing Committee for the Diabetic Retinopathy Clinical Research Network. Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy. JAMA. 2015 Nov 24;314(20):2137-46.http://www.ncbi.nlm.nih.gov/pubmed/26565927?tool=bestpractice.com
广泛视网膜光凝术的不良反应包括黄斑水肿、视野受限(在一些情况下,严重到足以导致丢失驾驶许可)、目眩以及夜视丧失。
对于存在视力减退高风险的 PDR 而无临床有意义黄斑水肿或者无黄斑水肿的患眼,应行广泛视网膜光凝术作为急救方法。[47]Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS report number 8. Ophthalmology. 1981 Jul;88(7):583-600.http://www.ncbi.nlm.nih.gov/pubmed/7196564?tool=bestpractice.com[67]Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology. 1991 May;98(5 Suppl):766-85.http://www.ncbi.nlm.nih.gov/pubmed/2062512?tool=bestpractice.com[70]Hercules BL, Gayed II, Lucas SB, et al. Peripheral retinal ablation in the treatment of proliferative diabetic retinopathy: a three-year interim report of a randomised, controlled study using the argon laser. Br J Ophthalmol. 1977 Sep;61(9):555-63.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1043048/pdf/brjopthal00237-0004.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/336079?tool=bestpractice.com[71]Ferris F. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc. 1996;94:505-37.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1312110/pdf/taos00005-0523.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/8981711?tool=bestpractice.com 它使这些患者的重度视力丧失(视力 5/200 或更差)速率减半。[47]Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS report number 8. Ophthalmology. 1981 Jul;88(7):583-600.http://www.ncbi.nlm.nih.gov/pubmed/7196564?tool=bestpractice.com[67]Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology. 1991 May;98(5 Suppl):766-85.http://www.ncbi.nlm.nih.gov/pubmed/2062512?tool=bestpractice.com[70]Hercules BL, Gayed II, Lucas SB, et al. Peripheral retinal ablation in the treatment of proliferative diabetic retinopathy: a three-year interim report of a randomised, controlled study using the argon laser. Br J Ophthalmol. 1977 Sep;61(9):555-63.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1043048/pdf/brjopthal00237-0004.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/336079?tool=bestpractice.com[71]Ferris F. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc. 1996;94:505-37.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1312110/pdf/taos00005-0523.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/8981711?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于患有增殖性糖尿病视网膜病变的患者,全视网膜光凝术可在 3 至 5 年内有效降低重度视力丧失的风险。[70]Hercules BL, Gayed II, Lucas SB, et al. Peripheral retinal ablation in the treatment of proliferative diabetic retinopathy: a three-year interim report of a randomised, controlled study using the argon laser. Br J Ophthalmol. 1977 Sep;61(9):555-63.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1043048/pdf/brjopthal00237-0004.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/336079?tool=bestpractice.com[71]Ferris F. Early photocoagulation in patients with either type I or type II diabetes. Trans Am Ophthalmol Soc. 1996;94:505-37.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1312110/pdf/taos00005-0523.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/8981711?tool=bestpractice.com[47]Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS report number 8. Ophthalmology. 1981 Jul;88(7):583-600.http://www.ncbi.nlm.nih.gov/pubmed/7196564?tool=bestpractice.com[67]Early Treatment Diabetic Retinopathy Study Research Group. Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Ophthalmology. 1991 May;98(5 Suppl):766-85.http://www.ncbi.nlm.nih.gov/pubmed/2062512?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。
高风险 PDR 伴有累及黄斑中央的严重黄斑水肿 (clinically significant macular oedema, CSMO) 应当接受广泛视网膜光凝术和玻璃体内抗 VEGF 治疗。[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。 VEGF 抗体治疗包括单克隆抗体雷珠单抗、贝伐单抗和融合蛋白阿柏西普。 对于未累及黄斑中央的水肿部分,应当考虑黄斑激光治疗。[52]Early Treatment Diabetic Retinopathy Study Research Group. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. ETDRS report number 2. Ophthalmology. 1987 Jul;94(7):761-74.http://www.ncbi.nlm.nih.gov/pubmed/3658348?tool=bestpractice.com[58]Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy for Diabetic Macular Edema. Ophthalmology. 2011 Apr;118(4):615-25.http://www.ncbi.nlm.nih.gov/pubmed/21459215?tool=bestpractice.com[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com[60]Do DV, Nguyen QD, Boyer D, et al; da Vinci Study Group. One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema. Ophthalmology. 2012 Aug;119(8):1658-65.http://www.ncbi.nlm.nih.gov/pubmed/22537617?tool=bestpractice.com[65]Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12):1796-806.http://www.ncbi.nlm.nih.gov/pubmed/2866759?tool=bestpractice.com证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射雷珠单抗可快速且持续提高患者视敏度。[59]Nguyen QD, Brown DM, Marcus DM, et al. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012 Apr;119(4):789-801.http://www.aaojournal.org/article/S0161-6420%2811%2901242-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/22330964?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于黄斑水肿累及黄斑中央的糖尿病患者,玻璃体内注射阿柏西普 (aflibercept) 可快速且持续提高患者视敏度。[63]Heier JS, Korobelnik JF, Brown DM. et al. Intravitreal aflibercept for diabetic macular edema: 148-week results from the VISTA and VIVID studies. Ophthalmology. 2016 Nov;123(11):2376-85.http://www.ncbi.nlm.nih.gov/pubmed/27651226?tool=bestpractice.com[64]Sivaprasad S, Prevost AT, Vasconcelos JC, et al. Clinical efficacy of intravitreal aflibercept versus panretinal photocoagulation for best corrected visual acuity in patients with proliferative diabetic retinopathy at 52 weeks (CLARITY): a multicentre, single-blinded, randomised, controlled, phase 2b, non-inferiority trial. Lancet. 2017 Jun 3;389(10085):2193-203.https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31193-5/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/28494920?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。证据 A视敏度:有高质量的证据表明,对于患有轻度至中度非增殖性糖尿病性视网膜病变和黄斑水肿的患者,黄斑激光治疗可减少其 2 至 3 年内的视力丧失。[65]Early Treatment Diabetic Retinopathy Study Research Group. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study report number 1. Arch Ophthalmol. 1985 Dec;103(12):1796-806.http://www.ncbi.nlm.nih.gov/pubmed/2866759?tool=bestpractice.com系统评价或者受试者>200名的随机对照临床试验(RCT)。
广泛视网膜光凝术被视为虹膜新生血管形成患者的紧急治疗方法,尽管仅有中度的支持证据。[72]Jacobson DR, Murphy RP, Rosenthal AR. The treatment of angle neovascularization with panretinal photocoagulation. Ophthalmology. 1979 Jul;86(7):1270-7.http://www.ncbi.nlm.nih.gov/pubmed/95786?tool=bestpractice.com玻璃体内抗 VEGF 治疗可在短期内有效抑制虹膜新生血管形成。[73]Wakabayashi T, Oshima Y, Sakaguchi H, et al. Intravitreal bevacizumab to treat iris neovascularization and neovascular glaucoma secondary to ischemic retinal diseases in 41 consecutive cases. Ophthalmology. 2008 Sep;115(9):1571-80, 1580.e1-3.http://www.ncbi.nlm.nih.gov/pubmed/18440643?tool=bestpractice.com
PDR 患者不适合广泛视网膜光凝术(联合或不联合黄斑激光治疗),因为混浊的玻璃体出血阻碍眼底的观察,应转诊进行玻璃体切除术。 研究显示与延期的玻璃体切除术相比,早期玻璃体切除术对近期严重的玻璃体出血更有效,特别对于患有 1 型糖尿病且糖尿病病程<20 年的患者和患有重度 PDR 的患者。[61]Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized clinical trial. Diabetic Retinopathy Vitrectomy Study report 2. Arch Ophthalmol. 1985 Nov;103(11):1644-52.http://www.ncbi.nlm.nih.gov/pubmed/2865943?tool=bestpractice.com[62]Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial: Diabetic Retinopathy Vitrectomy Study report 3. Ophthalmology. 1988 Oct;95(10):1307-20.http://www.ncbi.nlm.nih.gov/pubmed/2465517?tool=bestpractice.com[74]Diabetic Retinopathy Vitrectomy Study Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64.http://www.ncbi.nlm.nih.gov/pubmed/2196036?tool=bestpractice.com证据 B视敏度:有中等质量证据表明,与延期玻璃体切除术相比,早期玻璃体切除术对于近期严重玻璃体出血(特别是对于 1 型糖尿病病程<20 年的患者)和重度增殖性糖尿病视网膜病变患者均有效。[74]Diabetic Retinopathy Vitrectomy Study Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64.http://www.ncbi.nlm.nih.gov/pubmed/2196036?tool=bestpractice.com[61]Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized clinical trial. Diabetic Retinopathy Vitrectomy Study report 2. Arch Ophthalmol. 1985 Nov;103(11):1644-52.http://www.ncbi.nlm.nih.gov/pubmed/2865943?tool=bestpractice.com[62]Diabetic Retinopathy Vitrectomy Study Research Group. Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial: Diabetic Retinopathy Vitrectomy Study report 3. Ophthalmology. 1988 Oct;95(10):1307-20.http://www.ncbi.nlm.nih.gov/pubmed/2465517?tool=bestpractice.com受试者<200名的随机对照临床试验(RCT)、受试者>200名且方法学存在缺陷的随机对照临床试验(RCT)、方法学存在缺陷的系统评价或者高质量的观察性(队列)研究。
黄斑牵拉性视网膜脱离 (traction retinal detachment, TRD)[75]Rice TA, Michels RG, Rice EF. Vitrectomy for diabetic traction retinal detachment involving the macula. Am J Ophthalmol. 1983 Jan;95(1):22-33.http://www.ncbi.nlm.nih.gov/pubmed/6185000?tool=bestpractice.com 或牵拉性孔源性视网膜脱离 (traction-rhegmatogenous retinal detachment, TRRD) 患者[76]Thompson JT, de Bustros S, Michels RG, Rice TA. Results and prognostic factors in vitrectomy for diabetic traction-rhegmatogenous retinal detachment. Arch Ophthalmol. 1987 Apr;105(4):503-7.http://www.ncbi.nlm.nih.gov/pubmed/2436604?tool=bestpractice.com 也可从玻璃体切除术中获益,只要黄斑功能未因慢性脱离或缺血而受到严重损害。
同样对于因后部玻璃体变厚牵拉而导致的黄斑病变患者也是有利的。[77]Harbour JW, Smiddy WE, Flynn HW Jr, et al. Vitrectomy for diabetic macular edema associated with a thickened and taut posterior hyaloid membrane. Am J Ophthalmol. 1996 Apr;121(4):405-13.http://www.ncbi.nlm.nih.gov/pubmed/8604734?tool=bestpractice.com
玻璃体切除术的副作用包括白内障、穿刺部位新生血管形成、虹膜新生血管形成、玻璃体腔出血、视网膜裂孔形成以及眼内炎。
对玻璃体内注射抗 VEGF 治疗无效的糖尿病黄斑水肿可能对玻璃体内注射皮质类固醇治疗有反应。 对糖尿病黄斑水肿的眼内注射缓释的地塞米松药物(大部分患眼之前已接受其他治疗),可获得比安慰剂组更好的视力,其中 23% 患者的视力较基线提高15~letter 。 术后大约 60% 患者因白内障需手术,30% 因眼内压升高需要治疗,这些并发症使此治疗成为二线治疗手段。[78]Boyer DS, Yoon YH, Belfort R Jr, et al; Ozurdex MEAD Study Group. Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014 Oct;121(10):1904-14.http://www.aaojournal.org/article/S0161-6420%2814%2900378-9/fulltexthttp://www.ncbi.nlm.nih.gov/pubmed/24907062?tool=bestpractice.com
有些形式的视网膜病变很难治疗。 这些包括黄斑缺血、慢性黄斑水肿、慢性黄斑脱离和由新生血管性青光眼引起的晚期视神经萎缩。 如果两只眼均受累,这些患者应进行低视力评估并提供与视功能障碍有关的所有社会福利。
使用此内容应接受我们的免责声明。
BMJ临床实践的持续改进离不开您的帮助和反馈。如果您发现任何功能问题和内容错误,或您对BMJ临床实践有任何疑问或建议,请您扫描右侧二维码并根据页面指导填写您的反馈和联系信息*。一旦您的建议在我们核实后被采纳,您将会收到一份小礼品。
如果您有紧急问题需要我们帮助,请您联系我们。
邮箱:bmjchina.support@bmj.com
电话:+86 10 64100686-612
*您的联系信息仅会用于我们与您确认反馈信息和礼品事宜。
BMJ临床实践官方反馈平台