雷珠单抗辅助玻璃体视网膜手术治疗增生型糖尿病视网膜病变
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摘要
目的观察雷珠单抗辅助玻璃体视网膜手术(vitreoretinal surgery,VRS)治疗Ⅴ期增生型糖尿病视网膜病变(proliferative diabetic retinopathy,PDR)的疗效。方法将PDR(Ⅴ期)患者随机分为治疗组(42例42眼)和对照组(42例42眼),治疗组患者行VRS手术前3～5 d辅助应用雷珠单抗,对照组患者仅行VRS。观察两组患者术中出血率、手术时间、医源性裂孔及眼内填充物等术中情况和术后1个月、3个月、6个月最佳矫正视力、黄斑中心凹视网膜厚度及并发症等情况。结果治疗组和对照组患者手术时间分别为(78.07±8.58)min和(127.79±12.21)min,术中患者出血率、医源性裂孔发生率、硅油填充率治疗组分别为9.52%、2.38%、33.33%,对照组分别为40.48%、16.67%、69.05%,两组比较差异均有统计学意义(均为P<0.05)。术后1个月、3个月、6个月,治疗组的有效率分别为90.48%、76.19%、57.14%,对照组的有效率分别为61.90%、52.38%、47.62%;治疗组和对照组患者的黄斑中心凹视网膜厚度分别为(255.55±13.80)μm、(247.19±13.48)μm、(276.69±20.78)μm和(292.88±20.50)μm、(271.26±25.96)μm、(282.45±18.70)μm。术后1个月、3个月治疗组患者的有效率、黄斑中心凹视网膜厚度及并发症的发生均明显低于对照组,差异均有统计学意义(均为P<0.05)。术后3个月治疗组患者的无菌性眼内炎症和视网膜再增殖发生率均低于对照组,差异均有统计学意义(均为P<0.05);两组患者玻璃体再出血和新生血管再生长发生率差异均无统计学意义(均为P>0.05)。术后6个月治疗组患者的有效率、黄斑中心凹视网膜厚度及并发症发生率和对照组比较差异均无统计学意义(均为P> 0.05)。结论雷珠单抗辅助VRS,能显著减少PDR患者术中的出血,缩短手术时间、降低医源性裂孔发生率和硅油填充率,有助于PDR患者术后近期视功能的恢复,提高了PDR患者的近期临床治疗效果。
Objective To study the effect of intravitreal ranibizumab assisted vitreoretinal surgery(VRS) to treat proliferative diabetic retinopathy(PDR).Methods The monocular PDR patients(Ⅴ-stage) were randomly divided into treatment group(42 patients 42 eyes) and control group(42 patients 42 eyes).Patients in the treatment group were treated with ranibizumab 3 to 5 days before VRS,and only VRS was performed in the control group.The intraoperative blood loss rate,operation time,iatrogenic hiatus and intraocular filler were observed in the two groups,and the best corrected visual acuity,foveal retinal thickness and complications at 1 month,3 months,and 6 months after surgery were observed in all patients.Results The operation time of the treatment group and the control group were(78.07±8.58)min and(127.79±12.21)min,respectively.The bleeding rate,the incidence of iatrogenic hiatus and the filling rate of silicone oil in the treatment group were 9.52%,2.38%,and 33.33%,respectively,and the control group was 40.48%,16.67%,and 69.05%,respectively.The difference between the two groups was statistically significant(all P<0.05).At 1 month,3 months,and 6 months after operation,the effective rate of the treatment group was 90.48%,76.19%,and 57.14%,respectively,and the effective rate of the control group was 61.90%,52.38%,47.62%;the foveal retinal thickness was(255.55±13.80)μm,(247.19±13.48)μm and(276.69±20.78)μm in the treatment group and(292.88 ± 20.50)μm,(271.26±25.96)μm,and(282.45±18.70)μm in the control group.The effective rate,foveal retinal thickness and complications of the treatment group were significantly lower than those of the control group at 1 month and 3 months after operation,and the differences were statistically significant(all P<0.05).The incidence of aseptic intraocular inflammation and retinal re-proliferation in the treatment group was lower than that in the control group at 3 months after operation,and the difference was statistically significant(all P<0.05).There was no significant difference in the incidence of vitreous rebleeding and neovascularization between the two groups(all P>0.05).There was no significant difference in the effective rate,the foveal retinal thickness and complication rate between the treatment group and the control group at 6 months after operation(all P>0.05).Conclusion Ranibizumab assisted VRS can reduce the intraoperative bleeding of PDR patients,shorten the operation time,reduce the incidence of iatrogenic perforation and silicone oil filling rate,which is conducive to the recovery of short-term visual function of PDR patients after surgery and improve the short-term clinical treatment effect.
Objective To study the effect of intravitreal ranibizumab assisted vitreoretinal surgery(VRS) to treat proliferative diabetic retinopathy(PDR).Methods The monocular PDR patients(Ⅴ-stage) were randomly divided into treatment group(42 patients 42 eyes) and control group(42 patients 42 eyes).Patients in the treatment group were treated with ranibizumab 3 to 5 days before VRS,and only VRS was performed in the control group.The intraoperative blood loss rate,operation time,iatrogenic hiatus and intraocular filler were observed in the two groups,and the best corrected visual acuity,foveal retinal thickness and complications at 1 month,3 months,and 6 months after surgery were observed in all patients.Results The operation time of the treatment group and the control group were(78.07±8.58)min and(127.79±12.21)min,respectively.The bleeding rate,the incidence of iatrogenic hiatus and the filling rate of silicone oil in the treatment group were 9.52%,2.38%,and 33.33%,respectively,and the control group was 40.48%,16.67%,and 69.05%,respectively.The difference between the two groups was statistically significant(all P<0.05).At 1 month,3 months,and 6 months after operation,the effective rate of the treatment group was 90.48%,76.19%,and 57.14%,respectively,and the effective rate of the control group was 61.90%,52.38%,47.62%;the foveal retinal thickness was(255.55±13.80)μm,(247.19±13.48)μm and(276.69±20.78)μm in the treatment group and(292.88 ± 20.50)μm,(271.26±25.96)μm,and(282.45±18.70)μm in the control group.The effective rate,foveal retinal thickness and complications of the treatment group were significantly lower than those of the control group at 1 month and 3 months after operation,and the differences were statistically significant(all P<0.05).The incidence of aseptic intraocular inflammation and retinal re-proliferation in the treatment group was lower than that in the control group at 3 months after operation,and the difference was statistically significant(all P<0.05).There was no significant difference in the incidence of vitreous rebleeding and neovascularization between the two groups(all P>0.05).There was no significant difference in the effective rate,the foveal retinal thickness and complication rate between the treatment group and the control group at 6 months after operation(all P>0.05).Conclusion Ranibizumab assisted VRS can reduce the intraoperative bleeding of PDR patients,shorten the operation time,reduce the incidence of iatrogenic perforation and silicone oil filling rate,which is conducive to the recovery of short-term visual function of PDR patients after surgery and improve the short-term clinical treatment effect.
引文
[1] WONG T Y,SUN J,KAWASAKI R,RUAMVIBOONSUK P,GUPTA N,CHARLESLANS- SINGH V,et al.Guidelines on diabetic eye care:the international council of ophthalmology recommendations for screening,follow-up,referral,and treatment based on resource settings[J].Ophthalmology,2018,125(10):1608-1622.
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[3] ELMAN K D,WELCH R A,FRANK R N,GOYERT G L,SOKOL R J.Diabetic retinopathy in pregnancy:a review[J].Clin Exp Ophthalmol,2016,44(4):321-334.
[4] YANG X,XU J,WANG R,MEI Y,LEI H,LIU J,et al.A randomizedized controlled trial of conbercept pretreatment before vitrectomy in proliferative diabetic retinopathy[J].J Ophthalmol,2016,2016:2473234.
[5] Ophthalmological society of Chinese medical association,fundus ophthalmology group.Clinical diagnosis and treatment guide for diabetic retinopathy in China (2014)[J].Chin J Ophthalmol,2014,50(11):851-865.中华医学会眼科学会眼底病学组.我国糖尿病视网膜病变临床诊疗指南(2014年)[J].中华眼科杂志,2014,50(11):851-865.
[6] ZHAO X Y,XIA S,WANG E Q,CHEN Y X.Efficacy of intravitreal injection of bevacizumab in vitrectomy for patients with proliferative vitreoretinopathy retinal detachment:a meta-analysis of prospective studies[J].Retina,2018,38(11):462-470.
[7] CUI J L,CHEN H,LU H,DONG FT,WEI D M,JIAO Y,et al.Efficacy and safety of intravitreal conbercept,ranibizumab,and triamcinolone on 23-gauge vitrectomy for patients with proliferative diabetic retinopathy[J].J Ophthalmol,2018,2018:4927259.
[8] MUKKAMALA L,BHAGAT N,ZARBIN MA.Practical lessons from protocol I for the management of diabetic macular edema[J].Dev Ophthalmol,2017,60(1):91-108.
[9] LIU J W,LI C L,YU H Q.Vitrectomy of proliferative diabetic retinopathy with intravitreal injection of leizhu monoclonal antibody[J].Rec Adv Ophthalmol,2016,36 (3):265-267.刘建伟,李聪伶,于海群.雷珠单抗玻璃体内注射对增生型糖尿病视网膜病变玻璃体切割术效果的影响[J].眼科新进展,2016,36(3):265-267.
[10] LI C Y,ZHU A T.Choice of the operative opportunity for diabetic retinopathy complicated with vitreous hemorrhage[J].J Xinxiang Med Univ,2018,35(8):731-734.李春艳,朱安泰.糖尿病视网膜病变并发玻璃体积血手术时机选择[J].新乡医学院学报,2018,35(8):731-734.
[11] EL RAMI H,BARHAM R,SUN J K,SILVA P S.Evidence-based treatment of diabetic retinopathy[J].Semin Ophthalmol,2017,32(1):67-74.
[12] YANG K Z,SUN P F,CHEN M P.Vitrectomy combined with rezhumab vitreous injection in the treatment of proliferative diabetic retinopathy[J].J Mudanjiang Med Coll,2018,39(1):27-29.杨凯转,孙攀锋,陈梦平.玻璃体切除术联合雷珠单抗玻璃体注射治疗增殖性糖尿病视网膜病变[J].牡丹江医学院学报,2018,39(1):27-29.
[13] ZHANG X,WU C H,ZHOU L J,DAI R P.Observation of optic disc neovascularization using OCT angiography in proliferative diabetic retinopathy after intravitreal conbercept injections[J].Nature,2018,8(1):3972.
[14] AHUJA S,SAXENA S,MEYER C H,GILHOTRA J S,AKDUMAN L.Central subfield thickness and cube average thickness as bioimaging biomarkers for ellipsoid zone disruption in diabetic retinopathy[J].Int J Ret Vit,2018,4(1):41.
[2] SOLOMON S D,CHEW E,DUH E J,SOBRIN L,SUN J K,VANDERBEEK B L,et al.Diabetic retinopathy:a position statement by the american diabetes association[J].Diabetes Care,2017,40(3):412-418.
[3] ELMAN K D,WELCH R A,FRANK R N,GOYERT G L,SOKOL R J.Diabetic retinopathy in pregnancy:a review[J].Clin Exp Ophthalmol,2016,44(4):321-334.
[4] YANG X,XU J,WANG R,MEI Y,LEI H,LIU J,et al.A randomizedized controlled trial of conbercept pretreatment before vitrectomy in proliferative diabetic retinopathy[J].J Ophthalmol,2016,2016:2473234.
[5] Ophthalmological society of Chinese medical association,fundus ophthalmology group.Clinical diagnosis and treatment guide for diabetic retinopathy in China (2014)[J].Chin J Ophthalmol,2014,50(11):851-865.中华医学会眼科学会眼底病学组.我国糖尿病视网膜病变临床诊疗指南(2014年)[J].中华眼科杂志,2014,50(11):851-865.
[6] ZHAO X Y,XIA S,WANG E Q,CHEN Y X.Efficacy of intravitreal injection of bevacizumab in vitrectomy for patients with proliferative vitreoretinopathy retinal detachment:a meta-analysis of prospective studies[J].Retina,2018,38(11):462-470.
[7] CUI J L,CHEN H,LU H,DONG FT,WEI D M,JIAO Y,et al.Efficacy and safety of intravitreal conbercept,ranibizumab,and triamcinolone on 23-gauge vitrectomy for patients with proliferative diabetic retinopathy[J].J Ophthalmol,2018,2018:4927259.
[8] MUKKAMALA L,BHAGAT N,ZARBIN MA.Practical lessons from protocol I for the management of diabetic macular edema[J].Dev Ophthalmol,2017,60(1):91-108.
[9] LIU J W,LI C L,YU H Q.Vitrectomy of proliferative diabetic retinopathy with intravitreal injection of leizhu monoclonal antibody[J].Rec Adv Ophthalmol,2016,36 (3):265-267.刘建伟,李聪伶,于海群.雷珠单抗玻璃体内注射对增生型糖尿病视网膜病变玻璃体切割术效果的影响[J].眼科新进展,2016,36(3):265-267.
[10] LI C Y,ZHU A T.Choice of the operative opportunity for diabetic retinopathy complicated with vitreous hemorrhage[J].J Xinxiang Med Univ,2018,35(8):731-734.李春艳,朱安泰.糖尿病视网膜病变并发玻璃体积血手术时机选择[J].新乡医学院学报,2018,35(8):731-734.
[11] EL RAMI H,BARHAM R,SUN J K,SILVA P S.Evidence-based treatment of diabetic retinopathy[J].Semin Ophthalmol,2017,32(1):67-74.
[12] YANG K Z,SUN P F,CHEN M P.Vitrectomy combined with rezhumab vitreous injection in the treatment of proliferative diabetic retinopathy[J].J Mudanjiang Med Coll,2018,39(1):27-29.杨凯转,孙攀锋,陈梦平.玻璃体切除术联合雷珠单抗玻璃体注射治疗增殖性糖尿病视网膜病变[J].牡丹江医学院学报,2018,39(1):27-29.
[13] ZHANG X,WU C H,ZHOU L J,DAI R P.Observation of optic disc neovascularization using OCT angiography in proliferative diabetic retinopathy after intravitreal conbercept injections[J].Nature,2018,8(1):3972.
[14] AHUJA S,SAXENA S,MEYER C H,GILHOTRA J S,AKDUMAN L.Central subfield thickness and cube average thickness as bioimaging biomarkers for ellipsoid zone disruption in diabetic retinopathy[J].Int J Ret Vit,2018,4(1):41.