李琴,黎智,張少維,張蝶念,黃毅
23G與20G玻璃體切除術(shù)治療增生型糖尿病視網(wǎng)膜病變的臨床觀察
李琴,黎智,張少維,張蝶念,黃毅
目的 在聯(lián)合術(shù)前眼內(nèi)注射雷珠單抗及術(shù)中眼內(nèi)全視網(wǎng)膜光凝(PRP)基礎(chǔ)上,比較20G與23G玻璃體切除術(shù)治療增生型糖尿病視網(wǎng)膜病變(PDR)的手術(shù)效果。方法 PDR患者88例(98只眼),隨機(jī)分為20G組40例(48只眼)和23G組44例(50只眼)。玻璃體切除術(shù)前1周行眼內(nèi)注射雷珠單抗,術(shù)中行全視網(wǎng)膜光凝,術(shù)后隨訪(fǎng)3個(gè)月。以手術(shù)時(shí)間,術(shù)中出血情況、術(shù)后最佳矯正視力(BCVA)、眼壓、新生血管消退情況、患者滿(mǎn)意度為指標(biāo),比較兩組差異。結(jié)果 20G組與23G組的平均手術(shù)時(shí)間分別為 (85.00±25.00)min,(60.00±19.00)min,23G組較20G組明顯縮短(P<0.05)。兩組術(shù)中增生膜表面再出血的情況相當(dāng),均各有2只眼。 20G 組術(shù)前、術(shù)后 1周、1 個(gè)月、3 個(gè)月的 BCVA(LogMar視力)分別為 1.4±0.02,0.68±0.04,0.54±0.04,0.54±0.03;23G 組的 BCVA 分別為 1.6±0.04,0.61±0.01,0.54±0.02,0.58±0.02。 兩組術(shù)后 BCVA 均較術(shù)前提高(P<0.05),但組間差異無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)。20G組與23G組術(shù)后1周、1個(gè)月、3個(gè)月的眼壓分別為(12.8±1.8)mm Hg 和(12.4±1.2) mm Hg;(15.9±2.2) mm Hg 和(16.5±1.0) mm Hg;(16.9±2.6)mm Hg 和(16.6±2.1)mm Hg(1 mm Hg=0.133 kPa),差異均無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)。兩組術(shù)后1個(gè)月熒光素眼底血管造影(FFA)檢查,新生血管未完全消退者20G組有2只眼,23G組有3只眼。23G組術(shù)中及術(shù)后滿(mǎn)意度好于20G組(P<0.05)。結(jié)論 在聯(lián)合術(shù)前眼內(nèi)注射雷珠單抗及術(shù)中PRP基礎(chǔ)上,20G與23G兩種玻璃體手術(shù)治療PDR均有較好的效果。與20G比較,23G玻璃體手術(shù)的操作時(shí)間更短,患者術(shù)中、術(shù)后的不適感更為輕微,滿(mǎn)意度更好。
23G;20G;玻璃體切除術(shù);增殖期糖尿病視網(wǎng)膜病變
傳統(tǒng)20G玻璃體切除手術(shù)是目前治療增生型糖尿病視網(wǎng)膜病變(proliferative diabetic retinopathy,PDR)的有效方法,配合應(yīng)用血管內(nèi)皮生長(zhǎng)因子(vascular endothelial growth factor,VEGF) 可降低術(shù)中和術(shù)后眼內(nèi)出血的發(fā)生率[1-2],而23G微創(chuàng)玻璃體手術(shù)因?yàn)檩^20G玻璃體手術(shù)具有穿刺口無(wú)需縫合等優(yōu)點(diǎn)也已經(jīng)廣泛應(yīng)用于臨床。為了比較兩種手術(shù)方式在聯(lián)合應(yīng)用抗VEGF藥物時(shí)的治療效果,我們對(duì)一組PDR患者進(jìn)行了對(duì)照觀察,現(xiàn)將結(jié)果報(bào)告如下。
1.1 研究對(duì)象
2014年11月—2015年 8月在我院確診為PDR的患者 88例(98只眼),其中男 42例(50只眼),女 42例(48只眼),年齡 34~68歲。 術(shù)前行視力、眼壓、眼前節(jié)、眼底、三面鏡及眼彩色多普勒超聲檢查等。隨機(jī)分為20G組40例(48只眼)和23G組44 例(50 只眼)。20G 組平均年齡(59.25±7.82)歲,平均眼壓(14.6±5.2) mm Hg(1 mm Hg=0.133 kPa),最佳矯正視力1.4±0.02(LogMAR視力)。23G組平均年齡(61.50±6.12)歲,平均眼壓(13.4±6.1) mm Hg,最佳矯正視力1.6±0.04(LogMAR視力)。兩組患者的性別、年齡、視力、眼壓差異無(wú)統(tǒng)計(jì)學(xué)意義(P>0.05)。納入標(biāo)準(zhǔn):所有患者均符合PDR診斷標(biāo)準(zhǔn)[3],明確糖尿病病史,空腹血糖控制在8 mmol/L以下,餐后2 h血糖在12 mmol/L以下,三面鏡檢查視網(wǎng)膜有增殖性改變或具有視網(wǎng)膜表面新生血管膜伴或不伴牽拉性視網(wǎng)膜脫離,眼底窺不進(jìn),眼彩色多普勒超聲示玻璃體積血伴或不伴牽拉性視網(wǎng)膜脫離。排除標(biāo)準(zhǔn):合并新生血管性青光眼者,孔源性視網(wǎng)膜脫離者,視網(wǎng)膜中央靜脈阻塞引起的玻璃體積血等疾病者。所有患者簽署手術(shù)知情同意書(shū)。
1.2 手術(shù)方法
為保證手術(shù)質(zhì)量及可比性,所有手術(shù)均由同一術(shù)者完成。術(shù)前1周內(nèi)行玻璃體腔內(nèi)注射雷珠單抗,點(diǎn)0.3%左氧氟沙星眼水3 d,嚴(yán)格無(wú)菌操作條件下玻璃體腔內(nèi)注射雷珠單抗0.5 mg,之后繼用抗生素眼水點(diǎn)眼,觀察眼壓及眼部情況至玻璃體切除手術(shù)當(dāng)天。兩組患者分別用20G和23G博士倫玻璃體切割機(jī)配套套包行三通道密閉式玻璃體切除術(shù) (有白內(nèi)障的患者行透明角膜緣切口白內(nèi)障超聲乳化吸除術(shù),手術(shù)后根據(jù)眼底情況有選擇地植入人工晶狀體),術(shù)中切除前后段玻璃體,纖維增殖膜給予小心剝除,難以剝除者給予保留,視網(wǎng)膜新生血管膜出血者及時(shí)眼內(nèi)電凝止血,氣液交換后行全視網(wǎng)膜光凝。根據(jù)眼底情況選擇C3F8填充或硅油填充。手術(shù)結(jié)束后,切口有滲漏的用7-0可吸收縫線(xiàn)縫合1針。手術(shù)時(shí)間記錄為:消毒鋪單開(kāi)始到患者手術(shù)結(jié)束包扎患眼,并除去做白內(nèi)障的手術(shù)時(shí)間。
1.3 觀察指標(biāo)
觀察指標(biāo)包括:術(shù)后1周、1個(gè)月、3個(gè)月時(shí)的最佳矯正視力(BCVA)及眼壓;手術(shù)時(shí)間;術(shù)中再次出血的幾率;術(shù)后新生血管消退情況;患者滿(mǎn)意度?;颊邼M(mǎn)意度采用問(wèn)卷的形式對(duì)患者在術(shù)中及術(shù)后感受進(jìn)行調(diào)查,問(wèn)卷的內(nèi)容主要針對(duì)患者對(duì)自我病情的了解,醫(yī)師與患者溝通,在手術(shù)中的疼痛及耐受程度,和術(shù)后效果,舒適度等。滿(mǎn)分為5分,很滿(mǎn)意-滿(mǎn)意:4~5分,比較滿(mǎn)意:3~2分,不滿(mǎn)意:1分,很不滿(mǎn)意:0分。
1.4 統(tǒng)計(jì)學(xué)方法
應(yīng)用SPSS 17.0軟件對(duì)數(shù)據(jù)進(jìn)行統(tǒng)計(jì)學(xué)分析。計(jì)量資料以xˉ±s表示,治療前后組內(nèi)比較采用重復(fù)測(cè)量方差分析模型中的LSD法,同一時(shí)間點(diǎn)組間比較采用兩獨(dú)立樣本t檢驗(yàn);等級(jí)資料組間比較采用Mann-Whitney U檢驗(yàn)。P<0.05為差異有統(tǒng)計(jì)學(xué)意義。
2.1 玻璃體腔注射雷珠單抗情況
兩組患者接受玻璃體腔注射雷珠單抗后眼壓均在正常范圍內(nèi),均未出現(xiàn)手術(shù)并發(fā)癥,如晶狀體損傷、眼內(nèi)新鮮出血、眼壓升高、眼內(nèi)炎、葡萄膜炎、醫(yī)源性視網(wǎng)膜脫離及心腦血管意外等。虹膜新生血管在注藥后的3~5 d消退,視網(wǎng)膜、視盤(pán)周?chē)律苣ひ苍跀?shù)天后逐漸消退。
2.2 術(shù)后BCVA(LogMAR視力)
20G組術(shù)后1周、1個(gè)月、3個(gè)月的BCVA分別為 0.68±0.04, 0.54±0.04, 0.54±0.03;23G 組的 BCVA 分別為 0.61±0.01,0.54±0.02, 0.58±0.02。兩組術(shù)后各時(shí)間平均BCVA均較術(shù)前提高(P<0.05),術(shù)后各時(shí)間的組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(術(shù)后1周,t=2.542,P=0.265; 術(shù)后 1 個(gè)月,t=1.975,P=0.318;術(shù)后 3 個(gè)月,t=1.890,P=0.326)。
2.3 術(shù)后眼壓
20G組與23G組術(shù)后1周、1個(gè)月、3個(gè)月的眼壓分別為 (12.8±1.8) mm Hg 和(12.4±1.2) mm Hg;(15.9±2.2) mm Hg 和(16.5±1.0) mm Hg;(16.9±2.6)mm Hg和(16.6±2.1)mm Hg。 兩組各時(shí)間眼壓差異均無(wú)統(tǒng)計(jì)學(xué)意義 (t=1.873,P=0.070;t=2.012,P=0.060;t=1.945,P=0.060)。
2.4 手術(shù)時(shí)間
20G組與23G組的平均手術(shù)時(shí)間分別為(85.00±25.00) min,(60.00n±19.00) min,23G 組較20G 組明顯縮短(t=4.783,P=0.023),差異原因主要在于23G手術(shù)傷口無(wú)需縫合,并減少了反復(fù)進(jìn)出穿刺口的手術(shù)步驟。
2.5 術(shù)中再次出血的情況
20G組和23G組各有2只眼術(shù)中視網(wǎng)膜血管或增生膜表面反復(fù)出血,術(shù)中電凝止血,待出血穩(wěn)定后給予視網(wǎng)膜光凝和玻璃體內(nèi)填充,防止術(shù)后再出血。
2.6 術(shù)后新生血管消退情況
兩組術(shù)后1個(gè)月行熒光素眼底血管造影(FFA)檢查,新生血管未完全消退的20G組有2只眼,23G組有3只眼,予再次光凝。術(shù)后3個(gè)月復(fù)查見(jiàn)視網(wǎng)膜新生血管完全消退。
2.7 術(shù)中及術(shù)后滿(mǎn)意度
23G組因總體手術(shù)時(shí)間縮短,患者術(shù)中未感不適,術(shù)后有輕微疼痛及眼內(nèi)異物感,20G組總體患者手術(shù)時(shí)間較長(zhǎng),術(shù)中有感胸悶不適,眼痛,術(shù)后感眼脹痛磨卡不適較23G組多。從問(wèn)卷評(píng)分上看,20G組48只眼,滿(mǎn)意26只眼(54.2%),比較滿(mǎn)意16只眼(33.3%),不滿(mǎn)意 6只眼(12.5%);23G 組 50只眼,滿(mǎn)意 40只眼 (80.0%),比較滿(mǎn)意 9只眼(18.0%),不滿(mǎn)意1只眼 (2.0%),23G組好于 20G組,組間差異有統(tǒng)計(jì)學(xué)意義(Z=-2.840,P=0.005)。
PDR是導(dǎo)致糖尿病患者失明的主要原因,玻璃體手術(shù)是治療PDR的有效方法。PDR患者視網(wǎng)膜及其增殖膜內(nèi)大量的新生血管容易引起玻璃體切除術(shù)中出血,遮擋手術(shù)視野,術(shù)中需要反復(fù)進(jìn)行電凝操作,增加醫(yī)源性視網(wǎng)膜損傷的可能性并延長(zhǎng)手術(shù)時(shí)間。術(shù)前應(yīng)用抗VEGF藥物可以使新生血管萎縮,最大限度的減少術(shù)中出血,減少眼內(nèi)電凝次數(shù)和手術(shù)時(shí)間,從而提高手術(shù)效率。術(shù)中全視網(wǎng)膜光凝(panretinal photocoagulation,PRP)可進(jìn)一步減少新生血管的生長(zhǎng)。我們因此將術(shù)前玻璃體腔內(nèi)注射雷珠單抗、術(shù)中PRP作為兩組玻璃體手術(shù)患者共同的處置方法。結(jié)果發(fā)現(xiàn)虹膜新生血管在注藥后的3~5 d消退,視網(wǎng)膜、視盤(pán)周?chē)律苣ひ苍跀?shù)天后逐漸消退。術(shù)后1個(gè)月FFA檢查顯示,20G組視網(wǎng)膜新生血管未完全消退者2只眼,23G組有3只眼,這可能與患者術(shù)中與視網(wǎng)膜致密粘連的增殖膜未完全切除有關(guān)。
手術(shù)后兩組的BCVA均較術(shù)前明顯提高(P<0.05),術(shù)后隨訪(fǎng)各時(shí)點(diǎn)的視力水平接近,說(shuō)明兩組手術(shù)效果相當(dāng)。有文獻(xiàn)報(bào)道認(rèn)為兩種手術(shù)方式的手術(shù)成功率和術(shù)后視力恢復(fù)方面沒(méi)有明顯不同[5-6],我們的觀察結(jié)果與其相符。Park等[7]認(rèn)為23G玻璃體切除術(shù)與20G在PDR中有相同的作用,僅在手術(shù)操作時(shí)間和術(shù)后低眼壓發(fā)生率上有差別。20G玻璃體手術(shù)需要剪開(kāi)球結(jié)膜,電凝止血,鞏膜切口較大,術(shù)后鞏膜和結(jié)膜需分層縫合,這些手術(shù)操作步驟均導(dǎo)致手術(shù)時(shí)間延長(zhǎng),增加患者痛苦,而23G玻璃體手術(shù)不需切開(kāi)結(jié)膜,減少了止血步驟,結(jié)膜和鞏膜切口不需縫合或僅需縫合1針即可,明顯縮短手術(shù)時(shí)間,患者配合度較高。本研究顯示傳統(tǒng)20G組手術(shù)中,需做鞏膜切口,縫線(xiàn)固定灌注針頭,顯微器械反復(fù)進(jìn)出穿刺口,術(shù)后需縫線(xiàn)縫合切口,手術(shù)時(shí)間延長(zhǎng),患者術(shù)中感胸悶不適者較多,術(shù)后眼痛磨澀感者多見(jiàn),而23G組經(jīng)結(jié)膜直接穿刺,切口無(wú)需縫合,節(jié)省手術(shù)時(shí)間,術(shù)后恢復(fù)較快,患者術(shù)中未感不適,術(shù)后僅有輕微不適,舒適度高,手術(shù)中配合度較好。23G玻璃體切割頭可以更精細(xì)的處理黏稠的玻璃體對(duì)視網(wǎng)膜表面的牽拉,可以更貼近視網(wǎng)膜表面的增殖膜進(jìn)行切除,獨(dú)立完成分離、切除的操作,減少了眼內(nèi)鑷及眼內(nèi)剪的使用,進(jìn)一步縮短了手術(shù)時(shí)間。本研究中兩組患者未見(jiàn)術(shù)后高眼壓或低眼壓出現(xiàn),各時(shí)間點(diǎn)的組間差異也不明顯(P>0.05),可能與操作對(duì)切口處?kù)柲び绊戄^小,傷口閉合情況良好,或是多次操作后行鞏膜縫合,切口仍可以閉合好有關(guān)。Issa等[8]觀察了PDR 170只眼,發(fā)現(xiàn)23G微創(chuàng)玻璃體手術(shù)的醫(yī)源性視網(wǎng)膜裂孔發(fā)生率較20G低,差異有統(tǒng)計(jì)學(xué)意義。23G鞏膜穿刺口小,外徑僅為0.72 mm,不用剪開(kāi)結(jié)膜后再手術(shù)縫合,切口處有套管保護(hù),手術(shù)器械進(jìn)出眼內(nèi)方便,不易損傷眼內(nèi)組織;術(shù)后無(wú)縫線(xiàn)刺激術(shù)后患者自覺(jué)癥狀輕微,舒適度明顯提高。20G患者術(shù)后眼部紅腫及疼痛等自覺(jué)癥狀明顯,而且持續(xù)時(shí)間長(zhǎng),滿(mǎn)意度較23G組低。由于雷珠單抗價(jià)格較昂貴,不屬于醫(yī)保報(bào)銷(xiāo)范疇,不是所有PDR患者都有條件術(shù)前使用,因此樣本量不夠大,今后我們會(huì)加大樣本量進(jìn)一步研究。
綜上所述,在聯(lián)合術(shù)前眼內(nèi)注射雷珠單抗及術(shù)中PRP基礎(chǔ)上,20G與23G兩種玻璃體手術(shù)治療PDR均有較好的術(shù)后效果。兩種術(shù)式的差異主要體現(xiàn)在,23G玻璃體手術(shù)的操作時(shí)間更短,患者在術(shù)中、術(shù)后不適感更為輕微,從而可以為患者提供更好治療體驗(yàn)。
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Clinical observation on treatment of proliferative diabetic retinopathy with 23G and 20G vitrectomy
LI Qin,LI Zhi,ZHANG Shaowei,et al.Xiangyang Central Hospital Affiliated to Hubei University of Arts and Science,Xiangyang 441021,China
OBJECTIVE To explore the clinical efficacy of 20G and 23G vitrectomy on proliferative diabetic retinopathy(PDR)in addition to intravitreal injection with Lucentis before operation and panretinal photocoagulation(PRP)during the procedure.METHODS The clinical data of 88 patients(98 eyes)diagnosed as proliferative diabetic retinopathy who underwent vitrectomy between November 2014 and August 2015 in ophthalmology department of our hospital were analyzed retrospectively.Eighty eight cases were randomly divided into 2 groups as 40 cases(48 eyes)in 20G group and 44 cases(50 eyes)in 23G group.All cases were given intravitreal injection of Lucentis 1 week before operation and panretinal photocoagulation during the operation.Patients were followed up for three months after the procedure for indexes including duration of operation,rebleeding in operation,intraocular pressure(IOP),improvement of postoperative neovascular,best corrected visual acuity(BCVA)and patient satisfaction.Results between two groups were compared.RESULTS The operation duration of 20G group was 85.00±25.00 min while that of 23G group was 60.00±19.00 min which meant difference between two groups was of statistical significance(P<0.05).Two cases of retinal vessel rebleeding or retinal proliferative membrane rebleeding happened respectively in both groups.By comparison,there was no significant difference in the rebleeding rate (P>0.05).BCVA(LogMar)in 20G and 23G group were 0.68±0.04 and 0.61±0.01 respectively.The results were not statistically different(P>0.05).However,compared with counterparts before operation,results of both group were markedly improved(P<0.05).Average intraocular pressure(IOP)of two groups 1 week,1 month,3 months after treatment were 12.8±1.8mmHg and 12.4±1.2mmHg,15.9±2.2mmHg and 16.5±1.0mmHg,16.9±2.6mmHg and 16.6±2.1mmHg respectively.There was no significant difference in postoperative average IOP between two groups(P>0.05).Patients of both groups were examined by fluorescence fundus angiography(FFA)1 month after the operation.It showed that neovascular in 2 eyes of 20G group and 3 eyes of 23Gg group were not eliminated.The results had no statistical difference between two groups(P<0.05).In addition,patients of 23G group were more satisfied during the procedure and after it than these in 20G group.CONCLUSIONS On basis of intravitreal injection with Lucentis(IVR)before operation and panretinal photocoagulation(PRP),both 20G and 23G vitrectomy
favorable effects.However,the latter was of less procedure duration and discomfort during and after the surgery thus it yield more satisfied response of patients.
23G;20G;vitrectomy;proliferative diabetic retinopathy
10.13444/j.cnki.zgzyykzz.2017.04.010
湖北文理學(xué)院襄陽(yáng)市中心醫(yī)院眼科,湖北襄陽(yáng)441021
黎智,E-mail:1103945483@qq.com
R774.1
B
1002-4379(2017)04-0250-04