摘要目的 观察不同时间玻璃体腔注射雷珠单抗辅助玻璃体切割手术治疗增生型糖尿病视网膜病变(PDR)的疗效.方法 前瞻性、随机平行对照性研究.临床确诊为PDR的97例患者97只眼纳入研究.采用字母随机分组方式,将患者分为手术前注药组、手术中注药组和未注药组,分别为30例30只眼、32例32只眼、35例35只眼.3组患眼最佳矫正视力(BCVA) (F=0.18)及玻璃体积血分级(x2=1.39)比较,差异均无统计学意义(P＞0.05).所有患眼均进行标准的经睫状体平坦部23G玻璃体切割手术.手术前注药组、手术中注药组患眼分别于手术前3～7 d、手术结束时行玻璃体腔注射10 mg/ml的雷珠单抗0.05 ml(含雷珠单抗0.5 mg)治疗;未注药组患眼除玻璃体切割手术外不注射任何药物.手术后1周,1、3、6、9、12个月,所有患眼行BCVA、眼底彩色照相、光相干断层扫描(OCT)检查.观察BCVA、玻璃体再积血(RVH)发生率及黄斑中心凹厚度(CFT).以手术后1周～1个月发生RVH视为早期RVH;手术后1个月以上发生RVH视为晚期RVH.结果 手术后1个月,手术前注药组、手术中注药组和未注药组患眼平均BCVA均较手术前有不同程度提高.手术3个月后,手术前注药组和手术中注药组患眼平均BCVA基本趋于稳定,未注药组3只眼平均BCVA有所下降.3组患眼手术后1、3、12个月平均BCVA比较,差异均无统计学意义(F=1.42、1.17、0.26,P＞0.05).手术前注药组、手术中注药组和未注药组患眼手术后早期RVH发生率分别为16.7％、9.4％、28.6％.3组患眼早期RVH发生率比较,差异有统计学意义(x2=5.12,P＜0.05).手术中注药组患眼手术后早期RVH发生率低于手术前注药组和未注药组,差异均有统计学意义(x2 =4.04、4.93,P＜0.05).手术前注药组、手术中注药组和未注药组患眼手术后晚期RVH发生率分别为13.3％、9.4％、14.3％.3组患眼手术后晚期RVH发生率比较,差异无统计学意义(x2=0.47,P＞0.05).手术前注药组、手术中注药组和未注药组患眼手术后1个月平均CFT较手术后1周均有不同程度下降.3组患眼平均CFT下降程度比较,差异有统计学意义(F=59.50,P＜0.05).手术前注药组和手术中注药组患眼平均CFT下降程度比较,差异无统计学意义(t=0.23,P＞0.05).手术后3、6、9、12个月,3组患眼平均CFT均有不同程度的增厚.3组患眼平均CFT比较,差异均无统计学意义(F=2.92、2.86、3.07、3.12,P＞0.05).结论 玻璃体腔注射雷珠单抗有助于降低PDR患眼玻璃体切割手术后RVH发生率,降低CFT增厚度,改善BCVA.手术结束时给药的效果略优于手术前给药.

abstractsObjective To assess the clinical efficacy of vitrectomy with intravitreal ranibizumab (IVR) at different injection time for proliferative diabeticretinopathy (PDR).Methods This was a prospective,comparative,and randomized study.Ninety-seven eyes of 97 patients were enrolled and randomly assigned to three different treatment groups:30 eyes (30 patients) in the preoperative IVR group,32 eyes (32 patients) in the intraoperative IVR group and 35 eyes (35 patients) in the no IVR injection group.The best corrected visual acuity (BCVA) (F=0.18) and the grading of vitreous hemorrhage (x2 =1.39) before surgery did not differ significantly among the 3 groups,respectively (P ＞ 0.05).All eyes enrolled underwent conventional 23-gauge pars plana vitrectomy (PPV).The preoperative IVR group received intravitreal 0.5 mg/0.05 ml ranibizumab injection 3 to 7 days before PPV,intraoperative IVR group received intravitreal 0.5 mg/0.05 ml ranibizumab injection at the end of PPV and non-drug injection group received PPV only.Postoperative BCVA,fundus color photography,optical coherence tomography examination was performed in all eyes at 1 week and 1,3,6,9,12 months after surgery.Early RVH was defined as RVH occurred within 1 week to 1 month postoperatively;while late RVH was defined as RVH occurred 1 month later after the operation.Results The mean BCVA were all improved among the 3 groups compared with the preoperative vision at 1 month after operation.At the beginning of 3 months after surgery,the average BCVA of the preoperative injection group and the intraoperative injection group tended to stable;while 3 eyes in the non-drug injection group began to decreased.There was no significant difference in average BCVA at 1,3 and 12 months of follow-up periods among the 3 groups (F=1.42,1.17,0.26;P＞0.05).The incidences of early RVH were 16.7％,9.4％,28.6％ in the preoperative injection group,intraoperative injection group,and non-drug injection group,respectively (x2 =5.12,P＜0.05).The incidence of early RVH in the intraoperative injection group reduced compared to preoperative injection group and non-drug injection group (x2 =4.04,4.93;P＜0.05).The incidences of late RVH were 13.3％,9.4％,14.3％ in preoperative injection group,intraoperative injection group,and non-drug injection group,respectively (x2 =0.47,P＞0.05).The average centeral foveal thickness (CFT) decreased among the 3 groups in different degrees at 1 month when compared with that of 1 week after operation and the decreasing was statistically significant (F=59.50,P＜0.05).A subgroup pairwise analysis showed no significant difference of decreasing CFT in preoperative injection group compared with that of intraoperative injection group (t=0.23,P＞0.05).The average CFT of the 3 groups had different degrees of thickening at 3,6,9,12 months after surgery,and the increasingof CFT among the 3 groups were not differ significantly (F=2.92,2.86,3.07,3.12;P＞0.05).Conclusions The adjunctive use of IVR can reduce the incidence of early postoperative RVH in vitrectomy for PDR,decrease in macular thickness and obtain favorable visual recovery.The effect of preoperative IVR injection was slightly better than that of the intraoperative IVR injection.