中华眼底病杂志
中華眼底病雜誌
중화안저병잡지
CHINESE JOURNAL OF OCULAR FUNDUS DISEASES
2011年
6期
510-514
,共5页
脉络膜新生血管化/治疗%抗体,单克隆/治疗应用%Ranibizumab
脈絡膜新生血管化/治療%抗體,單剋隆/治療應用%Ranibizumab
맥락막신생혈관화/치료%항체,단극륭/치료응용%Ranibizumab
Choroidal neovascularization/therapy%Antibodies,monoclonal/therapeutic use%Ranibizumab
目的 观察玻璃体腔注射抗血管内皮生长因子(VEGF)单克隆抗体ranibizumab(商品名Lucentis)治疗特发性脉络膜新生血管(ICNV)的临床疗效和安全性.方法 经临床检查确诊的ICNV患者54例54只眼纳入研究.其中,男性24例24只眼,女性30例30只眼；年龄21～49岁,平均年龄(32.57±7.06)岁；病程6 d～3个月.采用Snellen视力表行最佳矫正视力(BCVA)、早期糖尿病视网膜病变治疗研究(EDTRS)视力表行EDTRS视力检查,同时行间接检眼镜、荧光素眼底血管造影(FFA)、光相干断层扫描(OCT)等检查.患眼治疗前BCVA眼前手动～0.6,EDTRS视力平均字母数为(32.00±16.41)个.黄斑中心视网膜厚度(CRT)平均值为(337.31±76.91) μm.玻璃体腔注射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg).治疗后平均随访时间(15.56±6.54)个月.首次治疗后第1个月随访检查时如发现CNV病灶扩大或有新发CNV病灶,则行再次注射治疗.对比分析治疗前后BCVA、ETDRS视力、CRT及CNV病灶渗漏变化情况.结果 首次治疗后1个月,ETDRS视力平均字母数为(48.81±16.96)个,较治疗前平均字母数增加16.81个字母,差异有统计学意义(t=-11.991,P＜0.01).视力增加＞15个字母者25只眼,占46.30％;视力减少≥1个字母者2只眼,占3.70％.OCT检查显示,CRT平均值为(227.67±91.41)μm,与治疗前CRT平均值比较,差异有统计学意义(t=12.021,P＜0.01).末次随访检查时,患眼注射次数1～4次,平均注射次数(1.59±0.71)次.ETDRS视力平均字母数为(49.20±16.60)个,较治疗前平均字母数增加17.20个字母,差异有统计学意义(t=-11.390,P＜0.01).视力增加＞15个字母者27只眼,占50.00％;视力减少≥1个字母者3只眼,占5.56％.OCT检查显示,CRT平均值为(227.69±89.30) μm,与治疗前CRT平均值比较,差异有统计学意义(t=10.872,P＜0.01).CNV渗漏完全停止者35只眼,占64.81％;渗漏范围减少者11只眼,占20.37％;渗漏无明显变化或范围扩大者6只眼,占11.11％;出现新病灶者2只眼,占3.70％.随访中未见与注射及药物有关的眼部及全身不良反应.结论 玻璃体腔注射ranibizumab治疗ICNV安全有效,可提高患眼视力,减轻黄斑水肿；其远期疗效及安全性还有待进一步观察.
目的 觀察玻璃體腔註射抗血管內皮生長因子(VEGF)單剋隆抗體ranibizumab(商品名Lucentis)治療特髮性脈絡膜新生血管(ICNV)的臨床療效和安全性.方法 經臨床檢查確診的ICNV患者54例54隻眼納入研究.其中,男性24例24隻眼,女性30例30隻眼；年齡21～49歲,平均年齡(32.57±7.06)歲；病程6 d～3箇月.採用Snellen視力錶行最佳矯正視力(BCVA)、早期糖尿病視網膜病變治療研究(EDTRS)視力錶行EDTRS視力檢查,同時行間接檢眼鏡、熒光素眼底血管造影(FFA)、光相榦斷層掃描(OCT)等檢查.患眼治療前BCVA眼前手動～0.6,EDTRS視力平均字母數為(32.00±16.41)箇.黃斑中心視網膜厚度(CRT)平均值為(337.31±76.91) μm.玻璃體腔註射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg).治療後平均隨訪時間(15.56±6.54)箇月.首次治療後第1箇月隨訪檢查時如髮現CNV病竈擴大或有新髮CNV病竈,則行再次註射治療.對比分析治療前後BCVA、ETDRS視力、CRT及CNV病竈滲漏變化情況.結果 首次治療後1箇月,ETDRS視力平均字母數為(48.81±16.96)箇,較治療前平均字母數增加16.81箇字母,差異有統計學意義(t=-11.991,P＜0.01).視力增加＞15箇字母者25隻眼,佔46.30％;視力減少≥1箇字母者2隻眼,佔3.70％.OCT檢查顯示,CRT平均值為(227.67±91.41)μm,與治療前CRT平均值比較,差異有統計學意義(t=12.021,P＜0.01).末次隨訪檢查時,患眼註射次數1～4次,平均註射次數(1.59±0.71)次.ETDRS視力平均字母數為(49.20±16.60)箇,較治療前平均字母數增加17.20箇字母,差異有統計學意義(t=-11.390,P＜0.01).視力增加＞15箇字母者27隻眼,佔50.00％;視力減少≥1箇字母者3隻眼,佔5.56％.OCT檢查顯示,CRT平均值為(227.69±89.30) μm,與治療前CRT平均值比較,差異有統計學意義(t=10.872,P＜0.01).CNV滲漏完全停止者35隻眼,佔64.81％;滲漏範圍減少者11隻眼,佔20.37％;滲漏無明顯變化或範圍擴大者6隻眼,佔11.11％;齣現新病竈者2隻眼,佔3.70％.隨訪中未見與註射及藥物有關的眼部及全身不良反應.結論 玻璃體腔註射ranibizumab治療ICNV安全有效,可提高患眼視力,減輕黃斑水腫；其遠期療效及安全性還有待進一步觀察.
목적 관찰파리체강주사항혈관내피생장인자(VEGF)단극륭항체ranibizumab(상품명Lucentis)치료특발성맥락막신생혈관(ICNV)적림상료효화안전성.방법 경림상검사학진적ICNV환자54례54지안납입연구.기중,남성24례24지안,녀성30례30지안；년령21～49세,평균년령(32.57±7.06)세；병정6 d～3개월.채용Snellen시력표행최가교정시력(BCVA)、조기당뇨병시망막병변치료연구(EDTRS)시력표행EDTRS시력검사,동시행간접검안경、형광소안저혈관조영(FFA)、광상간단층소묘(OCT)등검사.환안치료전BCVA안전수동～0.6,EDTRS시력평균자모수위(32.00±16.41)개.황반중심시망막후도(CRT)평균치위(337.31±76.91) μm.파리체강주사10 mg/ml적ranibizumab 0.05 ml(함ranibizumab 0.5 mg).치료후평균수방시간(15.56±6.54)개월.수차치료후제1개월수방검사시여발현CNV병조확대혹유신발CNV병조,칙행재차주사치료.대비분석치료전후BCVA、ETDRS시력、CRT급CNV병조삼루변화정황.결과 수차치료후1개월,ETDRS시력평균자모수위(48.81±16.96)개,교치료전평균자모수증가16.81개자모,차이유통계학의의(t=-11.991,P＜0.01).시력증가＞15개자모자25지안,점46.30％;시력감소≥1개자모자2지안,점3.70％.OCT검사현시,CRT평균치위(227.67±91.41)μm,여치료전CRT평균치비교,차이유통계학의의(t=12.021,P＜0.01).말차수방검사시,환안주사차수1～4차,평균주사차수(1.59±0.71)차.ETDRS시력평균자모수위(49.20±16.60)개,교치료전평균자모수증가17.20개자모,차이유통계학의의(t=-11.390,P＜0.01).시력증가＞15개자모자27지안,점50.00％;시력감소≥1개자모자3지안,점5.56％.OCT검사현시,CRT평균치위(227.69±89.30) μm,여치료전CRT평균치비교,차이유통계학의의(t=10.872,P＜0.01).CNV삼루완전정지자35지안,점64.81％;삼루범위감소자11지안,점20.37％;삼루무명현변화혹범위확대자6지안,점11.11％;출현신병조자2지안,점3.70％.수방중미견여주사급약물유관적안부급전신불량반응.결론 파리체강주사ranibizumab치료ICNV안전유효,가제고환안시력,감경황반수종；기원기료효급안전성환유대진일보관찰.
Objective To observe the efficacy and safety of intravitreal injection of ranibizumab (Lucentis) to treat idiopathic choroidal neovascularization (ICNV).Methods Fifty-four eyes from 54 patients with ICNV were included in this study.There were 24 males and 30 females.The patients aged from 21 to 49 years with a mean age of 32.57 ± 7.06 years,The course of disease ranged from 6 days to 3 months with an average of 1.07±0.65 months.The examinations of best corrected visual acuity (BCVA)included Snellen chart and ETDRS visual acuity of ETDRS chart.Indirect ophthalmoscopy,fundus fluorescein angiography (FFA) and optic coherence tomography (OCT) were performed.The BCVA was hand motion - 0.6.The average score of ETDRS chart was 32.00± 16.41,and the average CRT (337.31±76.91) μm before treatment.All of the patients received an initial intravitreal injection of ranibizumab (0.5 mg,0.05 ml) and repeated treatments after the one-month follow-up if needed.The average follow-up period was 15.56±6.54 months.The changes of BCVA,ETDRS visual acuity,CRT and leakage of CNV before and after treatment were observed.Results One month after first injection,the mean number of ETDRS chart letters increased 16.81 to 48.81 ± 16.96 with a significant difference (t=- 11.991,P＜0.01),in which 25 eyes increased more than 15 (46.30 ％),while 2 eyes decreased more than 1 (3.70％).The mean CRT was (227.67± 91.41) μm,which significantly decreased compared with before treatment (t=12.021,P＜0.01).At the end of the follow-up period the number of repetitive intravitreal injections of ranibizumab was 1 - 4 times,with the mean of (1.59±0.71) times/eye.The mean number of ETDRS chart letters increased 17.20 to 49.20 ± 16.60 with a significant difference (t =-11.390,P＜0.01),in which 27 eyes increased more than 15 (50.00％),while 3 eyes decreased more than 1 (5.56％).The mean CRT was (227.69± 89.30) μm,which significantly decreased compared with before treatment (t =10.872,P＜0.01).There was complete CNV closure in 35 eyes (64.81 ％),partial closure in 11 eyes ( 20.37 ％),no change or expansion in 6 eyes (11.11 ％),and new CNV in 2 eyes (3.70％).No ocular or systemic adverse events were found after intravitreal injection of ranibizumab during the follow-up duration.Conclusions Intravitreal injection of ranibizumab is safe and effective for idiopathic choroidal neovascularization.It may improve the visual acuity and macular edema.However,long-term efficacy and safety remain to be further studied.
