角膜保护剂与平衡盐溶液在增生性糖尿病视网膜病变微创玻璃体手术中对眼表保护作用的比较

Comparison of the protective effect of corneal protectant and balanced salt solution on the ocular surface during minimally invasive vitreous surgery for proliferative diabetic retinopathy

目的比较角膜保护剂羟丙基甲基纤维素(HPMC)与平衡盐溶液(BSS)在增生性糖尿病视网膜病变(PDR)微创玻璃体手术中对角膜上皮的保护效果。方法采用随机对照临床试验设计,纳入2018年9月至2019年1月在徐州市第一人民医院接受微创玻璃体手术的PDR患者50例50眼,采用随机数字表法将患者分为HPMC组和BSS组,每组25眼,所有术眼均接受非接触广角镜下三通道微创玻璃体切割手术,术中根据分组不同分别滴加质量分数2%HPMC和BSS保持眼表湿润。记录是否联合白内障手术、手术时间、2%HPMC或BSS应用次数和术前及术毕角膜上皮水肿分级。术后共随访1个月,分别于术前及术后1 d、3 d、10 d和1个月行角膜荧光素钠染色和泪膜破裂时间(BUT)测定,于术前及术后1个月行基础泪液分泌试验(SⅠt)和眼表疾病指数(OSDI)问卷调查。结果HPMC组平均点眼(5.00±1.56)次,明显少于BSS组的(50.56±17.00)次,差异有统计学意义(t=-13.071,P<0.01)。术毕HPMC组角膜水肿评分为1.0(1.0,1.0)分,低于BSS组的2.0(2.0,2.0)分,差异有统计学意义(Z=-4.909,P<0.01)。各组内术后1 d、3 d、10 d、1个月术眼角膜荧光素钠染色评分总体比较差异均有统计学意义(HPMC组:χ^(2)=36.040,P<0.01;BSS组:χ^(2)=50.892,P<0.01),术后1、3、10 d时HPMC组术眼角膜荧光素钠染色评分均低于相应时间点BSS组,差异均有统计学意义(均P<0.05)。术后1 d、3 d、10 d、1个月HPMC组术眼BUT值分别为(6.15±2.20)、(6.95±2.46)、(6.16±2.11)和(5.81±2.92)s,BSS组分别为(3.89±1.87)、(5.32±2.59)、(5.01±2.12)和(4.97±2.10)s,术后不同时间点2个组间BUT总体比较差异均有统计学意义(F_(分组)=5.240,P<0.05;F时间=2.846,P<0.05)。BSS组术前SⅠt值为(12.24±5.55)mm,明显高于术后1个月的(9.96±4.53)mm,差异有统计学意义(t=3.863,P=0.001);BSS组术后OSDI评分为(51.00±12.04)分,明显高于术前的(47.89±10.95)分,差异有统计学意义(t=-2.111,P<0.05)。结论与BSS相比,PDR微创玻璃体手术中采用2%HPMC对PDR微创玻璃体手术中角膜上皮的保护效果更佳,并且可减少术中使用频率、缩短PDR术眼术后眼表组织的修复时间。

Objective To compare the protective effect of corneal protectant hydroxypropyl methylcellulose(HPMC)and balanced salt solution(BSS)on corneal epithelium in vitreous body surgery for proliferative diabetic retinopathy(PDR).Methods A randomized controlled clinical trial was conducted.Fifty eyes of 50 patients with PDR who underwent minimally invasive vitrectomy in Xuzhou First People's Hospital from September 2018 to January 2019 were enrolled and randomly divided into HPMC group and BSS group,with 25 eyes in each group.All eyes underwent three-channel minimally invasive vitrectomy under non-contact wide-angle lens,and 2%HPMC and BSS were applied to keep the ocular surface moist according to grouping during the operation.The combination of cataract surgery,operation time,application times of 2%HPMC or BSS and the grade of corneal epithelial edema before and after operation were recorded.The patients were followed up for 1 month.Corneal fluorescein sodium staining and tear film break-up time(BUT)test were performed before operation and at 1 day,3 days,10 days and 1 month after operation.SchirmerⅠtest(SⅠt)and ocular surface disease index(OSDI)questionnaire were carried out before operation and at 1 month after operation.The study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of Xuzhou First People's Hospital(No.xyyⅡ[2018]005).Written informed consent was obtained from each patient prior to any medical examination.Results The average frequency of application of eye drops in the HPMC group was(5.00±1.56)times,which was significantly less than(50.56±17.00)times in the BSS group(t=-13.071,P<0.01).The postoperative corneal edema score of the HPMC group was 1.0(1.0,1.0)point,which was lower than 2.0(2.0,2.0)points of BSS group,and the difference was statistically significant(Z=-4.909,P<0.01).There were statistically significant differences in postoperative corneal fluorescein sodium scores among 1 day,3 days,10 days and 1 month in the two groups(HPMC group:χ^(2)=36.040,P<0.01;BSS group:χ^(2)=50.892,P<0.01).The 1-,3-and 10-day postoperative corneal fluorescein sodium scores in the HPMC group were significantly lower than those in the BSS group(all at P<0.05).One-day,3-day,10-day and 1-month postoperative BUT values were(6.15±2.20),(6.95±2.46),(6.16±2.11)and(5.81±2.92)seconds in the HPMC group,respectively,and were(3.89±1.87),(5.32±2.59),(5.01±2.12)and(4.97±2.10)seconds in the BSS group,respectively.There were significant differences in BUT between the two groups at different time points(F group=5.240,P<0.05;F time=2.846,P<0.05).The preoperative and 1-month postoperative SⅠt values in the BSS group were(12.24±5.55)mm and(9.96±4.53)mm,respectively,showing a statistically significant difference(t=3.863,P=0.001).The postoperative OSDI score in the BSS group was(51.00±12.04)points,which was significantly higherly than the preoperative value of(47.89±10.95)points,and the difference was statistically significant(t=-2.111,P<0.05).Conclusions Compared with BSS,2%HPMC in minimally invasive vitreous surgery has better protective effect on corneal epithelium of PDR,reduces the frequency of eye drop use during the surgery and shortens the repair time of ocular surface tissue after surgery.