中华实验眼科杂志
中華實驗眼科雜誌
중화실험안과잡지
CHINESE JOURNAL OF EXPERIMENTAL OPHTHALMOLOGY
2011年
6期
559-563
,共5页
王丽丽%张雯%李立婕%金丽英%霍敏
王麗麗%張雯%李立婕%金麗英%霍敏
왕려려%장문%리립첩%금려영%곽민
贝伐单抗%曲安奈德%糖尿病%黄斑水肿%玻璃体注射%眼压
貝伐單抗%麯安奈德%糖尿病%黃斑水腫%玻璃體註射%眼壓
패벌단항%곡안내덕%당뇨병%황반수종%파리체주사%안압
Becacizumab%Triamcinolone acetonide%Diabetes%Macular edema%Intravitreal injection%Intraocular pressure
背景 黄斑水肿是糖尿病最常见的损害视力的原因,玻璃体腔注射贝伐单抗和曲安奈德(TA)的方法已被用于糖尿病黄斑水肿(DME)的治疗,但2种药物的临床效果和安全性的评价和比较是非常必要的.目的 评价和比较玻璃体腔注射贝伐单抗和TA治疗DME的疗效及安全性.方法 收集经OCT及荧光素眼底血管造影(FFA)确诊为DME者98例98眼,按就诊的先后时间分为贝伐单抗组和TA组,每组各49例49眼.贝伐单抗组患眼于角膜缘后4mm处行玻璃体腔注射贝伐单抗0.05ml(1.25mg),TA组玻璃体腔注射TA 0.1ml(4mg).术后4、8、12周观察并比较2组患眼的视力(国际视力表视力)、黄斑中心视网膜厚度(CMT)、眼压及并发症的情况.结果 所有患者均完成临床试验.2组患者的人口基线特征比较差异均无统计学意义(P>0.05).TA组和贝伐单抗组患眼玻璃体注射后各时间点视力与注射前比较均明显提高,差异均有统计学意义(P<0.01),贝伐单抗组在治疗后4～8周时视力最好,注射12周时视力较8周下降,差异有统计学意义(t=-11.579,P<0.05);玻璃体注射前后不同时间2组患眼间的视力比较差异均无统计学意义(P>0.05).玻璃体注射前后不同时间2组患眼间的CMT值比较差异均无统计学意义(P>0.05),但TA组和贝伐单抗组患眼玻璃体注射后各时间点CMT值与注射前比较均明显减少,差异均有统计学意义(P<0.01).TA组患眼玻璃体注射后4、8、12周眼压值均明显高于贝伐单抗组,差异均有统计学意义(P<0.05、P<0.01),TA组患眼玻璃体注射后4、8、12周眼压值均高于注射前基线值(P<0.01),贝伐单抗组4、8、12周眼压值与注射前比较差异无统计学意义(P>0.05).TA组患眼玻璃体注射后眼压升高的发生率14.3%.结论 玻璃体腔注射贝伐单抗治疗DME与TA玻璃体注射相比均能提高视力,减轻黄斑水肿.TA显效时间较贝伐单抗快,但贝伐单抗安全性较好.
揹景 黃斑水腫是糖尿病最常見的損害視力的原因,玻璃體腔註射貝伐單抗和麯安奈德(TA)的方法已被用于糖尿病黃斑水腫(DME)的治療,但2種藥物的臨床效果和安全性的評價和比較是非常必要的.目的 評價和比較玻璃體腔註射貝伐單抗和TA治療DME的療效及安全性.方法 收集經OCT及熒光素眼底血管造影(FFA)確診為DME者98例98眼,按就診的先後時間分為貝伐單抗組和TA組,每組各49例49眼.貝伐單抗組患眼于角膜緣後4mm處行玻璃體腔註射貝伐單抗0.05ml(1.25mg),TA組玻璃體腔註射TA 0.1ml(4mg).術後4、8、12週觀察併比較2組患眼的視力(國際視力錶視力)、黃斑中心視網膜厚度(CMT)、眼壓及併髮癥的情況.結果 所有患者均完成臨床試驗.2組患者的人口基線特徵比較差異均無統計學意義(P>0.05).TA組和貝伐單抗組患眼玻璃體註射後各時間點視力與註射前比較均明顯提高,差異均有統計學意義(P<0.01),貝伐單抗組在治療後4～8週時視力最好,註射12週時視力較8週下降,差異有統計學意義(t=-11.579,P<0.05);玻璃體註射前後不同時間2組患眼間的視力比較差異均無統計學意義(P>0.05).玻璃體註射前後不同時間2組患眼間的CMT值比較差異均無統計學意義(P>0.05),但TA組和貝伐單抗組患眼玻璃體註射後各時間點CMT值與註射前比較均明顯減少,差異均有統計學意義(P<0.01).TA組患眼玻璃體註射後4、8、12週眼壓值均明顯高于貝伐單抗組,差異均有統計學意義(P<0.05、P<0.01),TA組患眼玻璃體註射後4、8、12週眼壓值均高于註射前基線值(P<0.01),貝伐單抗組4、8、12週眼壓值與註射前比較差異無統計學意義(P>0.05).TA組患眼玻璃體註射後眼壓升高的髮生率14.3%.結論 玻璃體腔註射貝伐單抗治療DME與TA玻璃體註射相比均能提高視力,減輕黃斑水腫.TA顯效時間較貝伐單抗快,但貝伐單抗安全性較好.
배경 황반수종시당뇨병최상견적손해시력적원인,파리체강주사패벌단항화곡안내덕(TA)적방법이피용우당뇨병황반수종(DME)적치료,단2충약물적림상효과화안전성적평개화비교시비상필요적.목적 평개화비교파리체강주사패벌단항화TA치료DME적료효급안전성.방법 수집경OCT급형광소안저혈관조영(FFA)학진위DME자98례98안,안취진적선후시간분위패벌단항조화TA조,매조각49례49안.패벌단항조환안우각막연후4mm처행파리체강주사패벌단항0.05ml(1.25mg),TA조파리체강주사TA 0.1ml(4mg).술후4、8、12주관찰병비교2조환안적시력(국제시력표시력)、황반중심시망막후도(CMT)、안압급병발증적정황.결과 소유환자균완성림상시험.2조환자적인구기선특정비교차이균무통계학의의(P>0.05).TA조화패벌단항조환안파리체주사후각시간점시력여주사전비교균명현제고,차이균유통계학의의(P<0.01),패벌단항조재치료후4～8주시시력최호,주사12주시시력교8주하강,차이유통계학의의(t=-11.579,P<0.05);파리체주사전후불동시간2조환안간적시력비교차이균무통계학의의(P>0.05).파리체주사전후불동시간2조환안간적CMT치비교차이균무통계학의의(P>0.05),단TA조화패벌단항조환안파리체주사후각시간점CMT치여주사전비교균명현감소,차이균유통계학의의(P<0.01).TA조환안파리체주사후4、8、12주안압치균명현고우패벌단항조,차이균유통계학의의(P<0.05、P<0.01),TA조환안파리체주사후4、8、12주안압치균고우주사전기선치(P<0.01),패벌단항조4、8、12주안압치여주사전비교차이무통계학의의(P>0.05).TA조환안파리체주사후안압승고적발생솔14.3%.결론 파리체강주사패벌단항치료DME여TA파리체주사상비균능제고시력,감경황반수종.TA현효시간교패벌단항쾌,단패벌단항안전성교호.
Background Diabetic macular edema is the primary complication of diabetes.Becacizumab and triamcinolone acetonide(TA) have been intravitreally used to treat diabetic macular edema,but it is necessary to compare and evaluate their efficacy and safety.Objective The aim of this trial was to discuss and compare the safety and efficacy of intravitreal injection of becacizumab and TA for diabetic macular edema.Methods A case-controlled study was designed.In this pilot clinical trial,total 98 eyes of 98 patients determined as diabetic macular edema by optical coherence tomography(OCT) and fluorescine funds angiography(FFA) were assigned to becacizumab group and TA group according to the visiting time.Becacizumab of 0.05ml(1.25mg) was injected into vitreous via 4mm posterior to limbus in becacizumab group and TA of 0.1ml(4mg) was used at the same way.The visual acuity,central macular thickness(CMT) and intraocular pressure(IOP) were examined before and 4,8,12 weeks after injection.The complication after injection was compared between these two groups.This study was approved by Ethic Committee of Xi'an Central Hospital.Written informed consent was obtained from each patient prior to this protocol.Results All of the patients finished the medical procedure and follow-up.No significant differences were found in the demographic characteristics between two groups(P＞0.05).The vision was obviously improved in both becacizumab group and TA group in 4,8,12 weeks after injection in comparison with before injection(P＜0.01),but no evident differences were seen in vision at various time points between two groups (P＞0.05).The CMT values were reduced after injection compared with before injection in both two groups(P＜0.01),however,there was no any difference was found in CMT value between becacizumab group and TA group whatever before and after injection(P＞0.05).In 4,8,12 weeks after intravitreous injection,the IOPs were elevated in TA group compared with becacizumab group(P＜0.05,P＜0.01),and the IOP was higher after injection than that before injection in TA group(P＜0.01).The incidence of increased IOP after intravitreal injection of TA was 14.3%.No complication was observed in becacizumab group during the follow-up duration.Conclusion Both becacizumab and TA can treat diabetic macular edema by intravitreal administration.Intravitreal injection of TA may be the more favorable therapy for diabetic macular edema in comparison with becacizumab.However,this outcome indicate that IOP should be monitored during the follow-up period.
