中华眼底病杂志
中華眼底病雜誌
중화안저병잡지
CHINESE JOURNAL OF OCULAR FUNDUS DISEASES
2014年
2期
136-140
,共5页
王德功%陈松%王昀%林莉%宫丽%段红涛
王德功%陳鬆%王昀%林莉%宮麗%段紅濤
왕덕공%진송%왕윤%림리%궁려%단홍도
糖尿病视网膜病变/外科学%玻璃体切除术%糖尿病视网膜病变/药物疗法%抗体,单克隆/治疗应用
糖尿病視網膜病變/外科學%玻璃體切除術%糖尿病視網膜病變/藥物療法%抗體,單剋隆/治療應用
당뇨병시망막병변/외과학%파리체절제술%당뇨병시망막병변/약물요법%항체,단극륭/치료응용
Diabetic retinopathy/ surgery%Vitrectomy%Diabetic retinopathy/drug therapy%Antibodies,monoclonal/therapeutic use
目的 观察玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab(IVR)辅助微创玻璃体视网膜手术(VRS)治疗严重增生型糖尿病视网膜病变(PDR)的临床效果.方法 回顾性非随机临床对照研究.临床确诊为严重PDR的60例患者70只眼纳入研究.依据手术前是否行IVR治疗将患者分为IVR组和对照组.IVR组31例35只眼,对照组29例35只眼.IVR组于手术前3~4 d玻璃体腔注射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg),然后行23G微创VRS.对照组直接行23G微创VRS.手术后随访3~12个月,平均随访时间(4.5±1.8)个月.对比分析两组患者最小分辨角对数(logMAR)最佳矫正视力(BCVA)、眼压、黄斑中心凹视网膜厚度(CRT)和视网膜复位及手术后并发症的发生情况.结果 IVR组患者均未发生与注射及药物相关的局部及全身不良反应.手术后1周,1、3个月,IVR组玻璃体积血(VH)发生率分别为8.6%、0.0%、0.0%,对照组VH发生率分别为28.6%、17.1%、8.6%.两组手术后各时间点VH发生率比较,手术后1周及1个月之间差异有统计学意义(x2=4.63、4.56,P<0.05),手术后3个月之间差异无统计学意义(x2=0.24,P>0.05).IVR组、对照组手术后平均logMAR BCVA分别为0.81±0.40、1.05±0.42,均较手术前提高.IVR组、对照组手术前后平均logMARBCVA比较,差异有统计学意义(t=12.78、4.39,P<0.05).IVR组手术后平均logMAR BCVA较对照组提高,两组手术后平均logMAR BCVA比较,差异有统计学意义(t=-2.36,P<0.05).IVR组、对照组手术后平均CRT分别为(297.6±79.8)、(347.6±85.0)μm,两组平均CRT比较,差异有统计学意义(t=-2.53,P<0.05).IVR组、对照组手术后视网膜复位率分别为97.1%、94.3%,两组视网膜复位率比较,差异无统计学意义(x2 =0.35,P>0.05).IVR组、对照组一过性高眼压发生率分别为14.3% 、34.3%,两组间一过性高眼压发生率比较,差异有统计学意义(x2 =4.79,P<0.05).IVR组、对照组视网膜前膜、新生血管性青光眼等并发症发生情况比较,差异也无统计学意义(x2 =0.97、0.51,P>0.05).结论 IVR辅助23G微创VRS治疗严重PDR能提高患者视力,降低手术后VH发生率,减小CRT.
目的 觀察玻璃體腔註射抗血管內皮生長因子單剋隆抗體ranibizumab(IVR)輔助微創玻璃體視網膜手術(VRS)治療嚴重增生型糖尿病視網膜病變(PDR)的臨床效果.方法 迴顧性非隨機臨床對照研究.臨床確診為嚴重PDR的60例患者70隻眼納入研究.依據手術前是否行IVR治療將患者分為IVR組和對照組.IVR組31例35隻眼,對照組29例35隻眼.IVR組于手術前3~4 d玻璃體腔註射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg),然後行23G微創VRS.對照組直接行23G微創VRS.手術後隨訪3~12箇月,平均隨訪時間(4.5±1.8)箇月.對比分析兩組患者最小分辨角對數(logMAR)最佳矯正視力(BCVA)、眼壓、黃斑中心凹視網膜厚度(CRT)和視網膜複位及手術後併髮癥的髮生情況.結果 IVR組患者均未髮生與註射及藥物相關的跼部及全身不良反應.手術後1週,1、3箇月,IVR組玻璃體積血(VH)髮生率分彆為8.6%、0.0%、0.0%,對照組VH髮生率分彆為28.6%、17.1%、8.6%.兩組手術後各時間點VH髮生率比較,手術後1週及1箇月之間差異有統計學意義(x2=4.63、4.56,P<0.05),手術後3箇月之間差異無統計學意義(x2=0.24,P>0.05).IVR組、對照組手術後平均logMAR BCVA分彆為0.81±0.40、1.05±0.42,均較手術前提高.IVR組、對照組手術前後平均logMARBCVA比較,差異有統計學意義(t=12.78、4.39,P<0.05).IVR組手術後平均logMAR BCVA較對照組提高,兩組手術後平均logMAR BCVA比較,差異有統計學意義(t=-2.36,P<0.05).IVR組、對照組手術後平均CRT分彆為(297.6±79.8)、(347.6±85.0)μm,兩組平均CRT比較,差異有統計學意義(t=-2.53,P<0.05).IVR組、對照組手術後視網膜複位率分彆為97.1%、94.3%,兩組視網膜複位率比較,差異無統計學意義(x2 =0.35,P>0.05).IVR組、對照組一過性高眼壓髮生率分彆為14.3% 、34.3%,兩組間一過性高眼壓髮生率比較,差異有統計學意義(x2 =4.79,P<0.05).IVR組、對照組視網膜前膜、新生血管性青光眼等併髮癥髮生情況比較,差異也無統計學意義(x2 =0.97、0.51,P>0.05).結論 IVR輔助23G微創VRS治療嚴重PDR能提高患者視力,降低手術後VH髮生率,減小CRT.
목적 관찰파리체강주사항혈관내피생장인자단극륭항체ranibizumab(IVR)보조미창파리체시망막수술(VRS)치료엄중증생형당뇨병시망막병변(PDR)적림상효과.방법 회고성비수궤림상대조연구.림상학진위엄중PDR적60례환자70지안납입연구.의거수술전시부행IVR치료장환자분위IVR조화대조조.IVR조31례35지안,대조조29례35지안.IVR조우수술전3~4 d파리체강주사10 mg/ml적ranibizumab 0.05 ml(함ranibizumab 0.5 mg),연후행23G미창VRS.대조조직접행23G미창VRS.수술후수방3~12개월,평균수방시간(4.5±1.8)개월.대비분석량조환자최소분변각대수(logMAR)최가교정시력(BCVA)、안압、황반중심요시망막후도(CRT)화시망막복위급수술후병발증적발생정황.결과 IVR조환자균미발생여주사급약물상관적국부급전신불량반응.수술후1주,1、3개월,IVR조파리체적혈(VH)발생솔분별위8.6%、0.0%、0.0%,대조조VH발생솔분별위28.6%、17.1%、8.6%.량조수술후각시간점VH발생솔비교,수술후1주급1개월지간차이유통계학의의(x2=4.63、4.56,P<0.05),수술후3개월지간차이무통계학의의(x2=0.24,P>0.05).IVR조、대조조수술후평균logMAR BCVA분별위0.81±0.40、1.05±0.42,균교수술전제고.IVR조、대조조수술전후평균logMARBCVA비교,차이유통계학의의(t=12.78、4.39,P<0.05).IVR조수술후평균logMAR BCVA교대조조제고,량조수술후평균logMAR BCVA비교,차이유통계학의의(t=-2.36,P<0.05).IVR조、대조조수술후평균CRT분별위(297.6±79.8)、(347.6±85.0)μm,량조평균CRT비교,차이유통계학의의(t=-2.53,P<0.05).IVR조、대조조수술후시망막복위솔분별위97.1%、94.3%,량조시망막복위솔비교,차이무통계학의의(x2 =0.35,P>0.05).IVR조、대조조일과성고안압발생솔분별위14.3% 、34.3%,량조간일과성고안압발생솔비교,차이유통계학의의(x2 =4.79,P<0.05).IVR조、대조조시망막전막、신생혈관성청광안등병발증발생정황비교,차이야무통계학의의(x2 =0.97、0.51,P>0.05).결론 IVR보조23G미창VRS치료엄중PDR능제고환자시력,강저수술후VH발생솔,감소CRT.
Objective To observe the clinical effect of microincision vitreoretinal surgery (VRS) assisted with intravitreal injection of ranibizumab (IVR) in severe proliferative diabetic retinopathy (PDR) treatment.Methods This is a prospective non-randomized controlled clinical study.A total of 60 patients (70 eyes) with severe PDR diagnosed were enrolled and divided into IVR group (31 patients,35 eyes) and control group (29 patients,35 eyes).IVR group patients received an intravitreal injection of 0.05 ml ranibizumab solution (10 mg/ml) first,and 3 or 4 days later they received 23G microincision VRS.Control group patients only received 23G microincision VRS.The follow up time was 3 to 12 months with an average of (4.5± 1.8) months.The logarithm of the minimal angle of resolution (logMAR) best corrected visual acuity (BCVA),intraocular pressure,the central retinal thickness (CRT) and retinal reattachment,and the incidence of postoperative complications were comparatively analyzed.Results There was no topical and systemic adverse reactions associated with the drug after injection in IVR group.The incidence of post-operative vitreous hemorrhage (VH) in IVR group and control group was 8.6% and 28.6% at 1 week after surgery,0.0% and 17.1% at 1 month after surgery,0.0% and 8.6% at 3 month after surgery respectively.The differences were statistically significant for 1 week (x2 =4.63,P<0.05) and 1 month (x2 =4.56,P<0.05),but was not statistically significant for 3 months (x2 =0.24,P>0.05).The mean post-operative logMAR BCVA of IVR group (0.81 ± 0.40) and control group (1.05-±-0.42) have all improved than their pre-operative BCVA,the difference was statistically significant (t=12.78,4.39; P< 0.05).The mean logMAR BCVA of IVR group is higher than BCVA of control group,the difference was statistically significant (t=-2.36,P<0.05).The average post-operative CRT in IVR group [(297.6±79.8) μm] was thinner than that of control group [(347.6±85.0) μm],the difference was statistically significant (t=-2.53,P<0.05).The incidence of a transient high intraocular pressure in IVR group (14.3%) was lower than that in control group (34.3%),the difference was statistically significant (t=4.79,P<0.05).The incidence of retinal reattachment (t =0.35),epiretinal membrane (x2 =0.97),neovascular glaucoma (x2 =0.51) was no difference between these two groups (P>0.05).Conclusion The minimally invasive VRS assisted by IVR treatment for severe PDR can effectively prevent postoperative VH,reduce CRT and improve visual acuity.