目的：观察0.05%环孢素滴眼液在翼状胬肉切除联合自体角膜缘干细胞移植术后眼表恢复中的效果。

方法：本研究为前瞻性随机对照研究，选取2023年9月至2024年9月保定市第一中心医院收治的原发性翼状胬肉单眼发病患者104例104眼，采用随机数字表法分为试验组52眼和对照组52眼。所有患者均由同一医师采用翼状胬肉切除联合自体角膜缘干细胞移植术，试验组术后采用妥布霉素地塞米松滴眼液联合0.3%玻璃酸钠滴眼液及0.05%环孢素滴眼液治疗，对照组术后采用妥布霉素地塞米松滴眼液联合0.3%玻璃酸钠滴眼液治疗。比较两组患者术后角膜上皮修复情况； 术前，术后1、3 mo眼表功能\〖角膜荧光素染色(FL)评分、基础泪液分泌试验(SⅠt)、泪膜破裂时间(BUT)\〗； 干眼症状\〖眼表疾病指数(OSDI)评分、标准干眼评估(SPEED)评分\〗； 记录术后并发症及复发情况。

结果：随访期间，共2 例患者失访(试验组与对照组各1例)，失访率为1.9%。最终每组各51 例完成全部随访。两组患者术前一般资料比较无差异(P>0.05)。两组患者术后角膜上皮修复时间、拆线时间比较均无差异(均P>0.05)。术后1 mo，两组患者SⅠt、BUT较术前均降低，且试验组均高于对照组(均P<0.05)； FL评分较术前均升高，且试验组低于对照组(均P<0.05)； 术后3 mo，对照组患者SⅠt、BUT、FL评分与术前比较均无差异(均P>0.05)，试验组SⅠt、BUT较术前均升高，且高于对照组，FL评分较术前降低，且低于对照组(均P<0.05)。术后3 mo，两组患者SⅠt、BUT较术后1 mo均升高，且试验组高于对照组(均P<0.05)； 两组患者FL评分较术后1 mo均降低，且试验组低于对照组(P<0.05)。术后1 mo，两组患者OSDI、SPEED评分较术前均升高，且试验组低于对照组(均P<0.05)； 术后3 mo，试验组 OSDI、SPEED评分恢复至术前水平(均P>0.05)，对照组OSDI、SPEED评分较术前均升高，且高于试验组(均P<0.05)； 术后3 mo，两组患者 OSDI、SPEED评分较术后1 mo均降低，且试验组低于对照组(均P<0.05)。两组术后并发症总发生率比较无差异(P>0.05)。术后6 mo随访统计，试验组无复发，对照组复发率为11.8%(P<0.05)。

结论：翼状胬肉切除联合自体角膜缘干细胞移植术后应用0.05%环孢素滴眼液可促进眼表功能恢复，显著改善干眼症状，有效减少复发发生，且未发现对角膜上皮修复造成影响，无并发症增加，安全性良好。

METHODS:This study is a prospective randomized controlled trial, selecting 104 cases(104 eyes)of primary pterygium with monocular onset admitted to Baoding First Central Hospital from September 2023 to September 2024 as the initial sample. The patients were divided into an experimental group and a control group using a random number table method, with 52 eyes in each group. Both groups underwent pterygium excision and autologous corneal limbal stem cell transplantation performed by the same surgeon. The control group received tobramycin dexamethasone eye drops combined with 0.3% sodium hyaluronate eye drops, while the experimental group was additionally treated with 0.05% cyclosporine eye drops. The corneal epithelial repair status, ocular surface function \〖corneal fluorescein staining(FL)score, Schirmer I test(SIt), break-up time of tear film(BUT)\〗 at preoperative and postoperative time points(1 and 3 mo), and dry eye symptoms \〖ocular surface disease index(OSDI), standard patient evaluation of eye dryness(SPEED)scores\〗. Additionally, the recurrence rate and postoperative complications were recorded.

RESULTS: During the follow-up period, there was 1 case of loss to follow-up in both the experimental group and the control group, with lost to follow-up rate of 1.9%. Finally, 51 cases in each group completed all followed-up. No statistically significant difference was observed in preoperative general characteristics of patients between the two groups(P>0.05), and there was no statistically significant difference in corneal epithelial repair time or suture removal time(all P>0.05). At 1 mo postoperatively, the SIt and BUT decreased in both groups compared to preoperative levels, with the experimental group showing higher values than the control group(all P<0.05). FL scores increased compared to preoperative levels but were lower in the experimental group(all P<0.05). By 3 mo, the SIt, BUT and FL score of the control group were not statistically different from preoperative levels(all P>0.05), whereas the experimental group showed increased SIt and BUT, which were higher than the control group, and reduced FL scores, and decreased FL scores, which was lower than the control group(all P<0.05). At 3 mo postoperatively, both groups showed increased SIt and BUT compared to 1-month values, with the experimental group outperforming the control group(all P<0.05). FL scores decreased in both groups compared to 1-month values, with the experimental group maintaining lower scores(P<0.05). At 1 mo postoperatively, OSDI and SPEED scores were higher than preoperative levels, with the experimental group higher than the control group(all P<0.05); at 3 mo postoperatively, the scores returned to preoperative level(all P>0.05), and the OSDI and SPEED scores of the control group increased and higher than those of the experiment group(all P<0.05); at 3 mo postoperatively, the OSDI and SPEED scores decreased when compared with 1-month preoperative level, and the experiment group was lower than the control group(all P<0.05). There was no difference in the total incidence of postoperative complications between the two groups(P>0.05). According to the statistics of 6 mo follow-up after operation, there was no recurrence in the experimental group, and the recurrence rate was 11.8% in the control group(P<0.05).

CONCLUSION: Adjunctive use of 0.05% cyclosporine eye drops after pterygium excision with limbal stem cell transplantation enhances ocular surface recovery, reduces dry eye symptoms, and lowers recurrence rates without compromising corneal epithelial healing or safety.