玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab辅助微创玻璃体视网膜手术治疗严重增生型糖尿病视网膜病变的临床观察

Microincision vitrectomy surgery and intravitreal injection of ranibizumab to treat severe proliferative diabetic retinopathy

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（χ^2=4.63、4.56，P＜0.05），手术后3个月之间差异无统计学意义（χ^2=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logMAR BCVA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（χ^2=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（χ^2=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（χ^2=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。

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 （χ^2=4.63, P〈0.05） and 1 month（χ^2=4.56, P〈0.05）, but was not statistically significant for 3 months （χ^2=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 （χ^2=0.97）, neovascular glaucoma （χ^2=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.