玻璃体腔注射雷珠单抗与光动力疗法联合玻璃体腔注射雷珠单抗治疗特发性脉络膜新生血管的疗效比较

Intravitreal ranibizumab injection combined with or without photodynamic therapy for idiopathic choroidal neovascularization., a comparative efficacy study

目的比较单纯玻璃体腔注射雷珠单抗（ranibizumab。商品名I。ucentis）与光动力疗法（PDT）联合玻璃体腔注射雷珠单抗治疗特发性脉络膜新生血管（ICNV）的临床疗效及安全性。方法随机对照临床前瞻性研究。经最佳矫正视力（BCVA）、全视网膜镜眼底检查、眼底血管造影及光相干断层扫描（OCT）检查确诊的ICNV患者27例27只眼纳入研究。采用随机数表对患者随机分为2组。其中，单纯玻璃体腔注射雷珠单抗组（单纯药物注射治疗组）13例13只眼；PDT治疗1周后玻璃体腔注射雷珠单抗组（联合治疗组）14例14只跟。单纯药物注射治疗组行玻璃体腔注射雷珠单抗0．5mg；联合治疗组参照PDT治疗老年性黄斑变性研究制定的标准先行PDT治疗，1周后行玻璃体腔注射雷珠单抗0．5mg。治疗后1、2、3、6、12个月，采用治疗前相同的设备和方法检查BCVA、脉络膜新生血管（CNV）渗漏以及视网膜厚度的变化。其中，BCVA转换为最小分辨角对数（IogMAR）视力。CNV未完全闭合仍有渗漏者，则再次行玻璃体腔注射雷珠单抗治疗。2次玻璃体腔注射雷珠单抗治疗之间的最短间隔时间为1个月。结果2组患者治疗后视力较治疗前均有明显提高。治疗后12个月，单纯药物注射治疗组患者平均logMAR视力为0．22±0．11，联合治疗组患者平均IogMAR视力为0．21±0．12；2组患者平均logMAR视力比较，差异无统计学意义（t=0．187，P=0．853）。眼底血管造影检查结果显示，单纯药物注射治疗组患者中10例CNV完全闭合，占77．92％；3例CNV部分闭合，轻微荧光渗漏，占23．08％。联合治疗组患者中12例CNV完全闭合，占85．71％；2例CNV部分闭合，轻微荧光渗漏，占14．29％。OCT检查结果显示，2组患者治疗后CNV强反射区域缩小，视网膜下积液吸收，黄斑区视网膜厚度下降。单纯药物注射治疗组患者黄斑区平均视网膜厚度为（167．96±10．69）μm，联合治疗组患者黄斑区平均视网膜厚度为（171．64±11．30）μm；2组患者平均视网膜厚度比较，差异无统计学意义（t=-0．887，P=0．389）。单纯药物注射治疗组患者接受玻璃体腔注射的平均次数为（2．4±1．0）次；联合治疗组患者接受玻璃体腔注射的平均次数为（1.5±0．7）次。两组患者接受玻璃体腔注射的平均次数比较，差异有统计学意义（t=2．821，P=0．009）。治疗及随访过程中，单纯药物注射治疗组患者中1例出现结膜下出血，其余患者未发现其他眼部及全身不良反应。结论单纯玻璃体腔注射雷珠单抗或PDT联合玻璃体腔注射雷珠单抗均能减轻CNV渗漏，降低视网膜厚度，改善ICNV患者视力，无严重的眼部和全身不良反应。PDT联合玻璃体腔注射雷珠单抗治疗可减少玻璃体腔注射的次数。

Objective To compare the clinic therapeutic effect of intravitreal ranibizumab injection versus photodynamic therapy （PDT） combined with intravitreal ranibizumab injection for idiopathic choroidal neovascularizatio （ICNV）, and to investigate the clinical effect and safety of treatment. Methods A randomized controlled clinical prospective study was performed for 27 patients （27 eyes） diagnosed as ICNV. Fourteen patients were assigned to receive PDT and intravitreal ranibizumab injection （combinationgroup, n = 14）; the control group was treated with only intravitreal ranibizumab injection （single group, n= 13）. The combination group was treated with an intravitreal injection of ranibizumab （0.5 mg/0.05 ml） 1 week after PDT. The best-corrected visual acuity （BCVA） （logMAR）, examination of the ocular fundus, fluorescence fundus angiography （FFA）, indocyanine green angiography （ICGA） and optical coherence tomography （OCT） were performed respectively at 1, 2, 3, 6 and 12 months after treatment. If ehoroidal neovascularization （CNV） was only partially regressed or the leakage went on during follow-up, those patients were re injected with ranibizumab. Results After 12 months, the average vision is 0.22±0.11 in single group, and 0.21 ±0.12 in combination group, and the differences were not significant （t=0. 187, P=0. 853）. In single group FFA and ICGA showed completely closed CNV in 10 eyes （77.92%）, and almost closed CNV in 3 eyes （23.08%） with obvious reduction of fluorescence leakage. In combination group FFA and ICGA showed completely closed CNV in 12 eyes （85.. 71%）, and almost closed CNV in 2 eyes （14.29%） with obvious reduction of fluorescence leakage; OCT showed the subretinal fluid absorption and reduction of CNV. The average macular retinal thickness （MRT） in single groups is （167.96±10.69） m, and in combination groups is （171.64±11.30） m. In single and combination groups MRT decreased significantly at the final follow up, but no significant differences in both groups （t= -0. 887, P=0. 389）. The average number of intravitreal injection was （1.5±0.7） in combination group and （2.4±1.0） in single group （t= 2. 821, P= 0. 009）. There were no ocular or systemic adverse events observed except for one patient with subconjunctival hemorrhage in the single group. Conclusions Intravitreal ranihizumab injection and PDT combined with intravitreal bevacizumab injection are both effective and safe for the patients with ICNV. The combined therapy can induce CNV regression, fundus hemorrhage and exudation absorption more effectively, and have less recurred CNV and side effects.