进口角膜保护剂与国产角膜保护黏弹剂对眼科手术患者角膜上皮的保护作用和安全性的对比分析

Comparative analysis of the protective effect and safety of imported corneal protectors and domestic corneal protective viscoelastic agents on the corneal epithelium of patients undergoing ophthalmic surgery

目的对比分析进口角膜保护剂与国产角膜保护黏弹剂对眼科手术患者角膜上皮的保护作用和安全性。方法选取2021年1月至7月在山东第一医科大学附属眼科医院拟行单眼白内障手术或眼底手术的患者52例(52眼)为研究对象。采用随机数字法将患者分为试验组和对照组,每组各26眼。试验组使用国产角膜保护黏弹剂,对照组使用波兰产角膜保护剂。主要保护作用评价指标为光学清晰度保持成功率,次要保护作用评价指标包括产品在术前、术后的保护剂眼表覆盖厚度、光学清晰度保持时间及光学清晰度评分。术前和术后对患者行泪膜破裂时间(TBUT)、泪液分泌试验(SIt)检查以及角膜荧光素钠染色(CFS)评分,并对产品安全性进行评价。结果试验组和对照组的光学清晰度保持成功率分别为100.00%、96.15%,率差为3.85%(95%可信区间为-3.55%~11.24%)。两组患者术前和术后保护剂眼表覆盖厚度比较差异均无统计学意义(均为P>0.05)。两组患者光学清晰度保持时间、光学清晰度评分差异均无统计学意义(均为P>0.05)。两组患者术后1 d、7 d的TBUT及术后7 d的SIt,差异均无统计学意义(均为P>0.05);试验组患者术后1 d的CFS评分高于对照组,差异有统计学意义(P<0.05),两组患者术后7 d的CFS评分,差异无统计学意义(P>0.05)。试验组和对照组不良事件发生率分别为34.62%(9/26)和26.92%(7/26),差异无统计学意义(P=0.349)。结论国产角膜保护黏弹剂在防止术中因角膜干燥而导致的角膜上皮损伤方面安全有效,与已上市的进口角膜保护剂疗效相当。

Objective To compare and analyze the protective effect and safety of imported corneal protectors and domestic corneal protective viscoelastic agents on the corneal epithelium of patients undergoing ophthalmic surgery.Methods Totally 52 patients(52 eyes) who underwent monocular cataract surgery or fundus surgery at the Eye Hospital of Shandong First Medical University from January to July 2021 were selected in this study. They were randomly divided into the test group and the control group, with 26 eyes in each group. Patients in the test group used domestic corneal protective viscoelastic agents, while patients in the control group used Polish corneal protectors. In terms of the protective effect, the primary evaluation indicator was the success rate of optical clarity maintenance, and the secondary evaluation indicators included the thickness of the product’s preoperative and postoperative ocular surface coverage, optical clarity retention time, and optical clarity score. Tear break-up time(TBUT), Schirmer’s I test(SIt), and corneal fluorescein staining(CFS) were performed on patients before and after surgery, and the safety of the products was evaluated.Results The success rate of optical clarity maintenance in the test and control groups were 100.00% and 96.15%, respectively, with a difference of 3.85 %(95% CI:-3.55% to 11.24%). There was no significant difference in the ocular surface covering thickness before and after surgery between the two groups(all P>0.05). The differences in the optical clarity retention time and optical clarity score between the two groups were insignificant(all P>0.05). TBUT at day 1 and 7 postoperatively and SIt on day 7 postoperatively showed no significant statistical difference between the two groups(all P>0.05). The CFS scores of patients in the test group were higher than those in the control group at 1 d after surgery, and the difference was statistically significant(P<0.05), while there was no statistically significant difference between the CFS scores of the two groups on day 7 postoperatively(P>0.05). The incidence of adverse events in the test and control groups was 34.62%(9/26) and 26.92 %(7/26), respectively, with no statistically significant difference(P=0.349).Conclusion Domestic corneal protective viscoelastic agents are safe and effective in preventing intraoperative corneal epithelial damage due to corneal dryness and can be comparable to the imported corneal protectors in efficacy.