目的：观察0.05%环孢素滴眼液(Ⅱ)联合玻璃酸钠滴眼液治疗2型糖尿病合并中重度干眼的临床疗效。方法：选取2024年1月至2024年9月于徐州医科大学附属医院内分泌科及眼科就诊的2型糖尿病合并中重度干眼患者120例120眼为研究对象，采用随机数字法分为联合组[采用0.05%环孢素滴眼液(Ⅱ)联合玻璃酸钠滴眼液治疗]和对照组(采用玻璃酸钠滴眼液治疗)，各60例60眼。分别在基线，治疗1、2、3 mo进行眼表疾病指数(OSDI)评分、非接触式泪河高度(NITMH)、首次非侵入式泪膜破裂时间(NIBUTf)、睑板腺缺失评分、脂质层厚度分级、结膜等级、角膜荧光素钠染色评分(FL)等检查； 并观察3 mo后泪液中炎症因子变化，采用角膜共聚焦显微镜(IVCM)分析角膜基底下神经丛(SBN)中角膜神经纤维形态及密度改变。结果：治疗1、2、3 mo后两组患者NITMH、NIBUTf均较基线时升高(均P<0.05)，且联合组升高幅度大于对照组(均P<0.05)； OSDI评分、FL较基线降低(均P<0.05)，且联合组降低幅度大于对照组(均P<0.05)； 两组患者睑板腺缺失评分与基线相比无明显改善(均P>0.05)； 治疗3 mo后两组患者泪液中炎症因子IL-6、MMP-9较基线时降低(均P<0.001)，且联合组下降幅度大于对照组(均P<0.001)； 治疗3 mo后联合组分支神经数量、角膜神经密度较基线时升高，神经弯曲度评分、树突状细胞(DC)密度较基线时降低(均P<0.001)，对照组较基线比较无明显变化(均P>0.05)。结论：0.05%环孢素滴眼液(Ⅱ)联合玻璃酸钠滴眼液治疗2型糖尿病合并中重度干眼效果显著，能有效控制眼表炎症，改善角膜神经形态与数量，且无严重并发症出现。

AIM:To evaluate the clinical efficacy of 0.05% cyclosporine eye drops(Ⅱ)combined with sodium hyaluronate eye drops in treating patients with type 2 diabetes mellitus(T2DM)and moderate-to-severe dry eye.METHODS:A total of 120 T2DM patients(120 eyes)with moderate-to-severe dry eye, treated at the endocrinology and ophthalmology departments at the Affiliated Hospital of Xuzhou Medical University from January 2024 to September 2024, were enrolled in the study. The patients were randomly divided into two groups: combination group [0.05% cyclosporine eye drops(Ⅱ)+ sodium hyaluronate eye drops] and control group(sodium hyaluronate eye drops alone), with 60 cases(60 eyes)in each group. Assessments were conducted at baseline and at 1, 2, and 3 mo post-treatment, including the ocular surface disease index(OSDI), non-contact tear meniscus height(NITMH), first non-invasive tear breakup time(NIBUTf), meibomian gland loss score, lipid layer thickness grade, conjunctival hyperemia grade, and corneal fluorescein staining(FL)score. At 3 mo after treatment, changes in tear inflammatory factors were observed, and corneal subbasal nerve plexus(SBN)morphology/density were analyzed using in vivo confocal microscopy(IVCM).RESULTS:At 1, 2, and 3 mo post-treatment, both groups showed statistically significant increases in NITMH and NIBUTf compared to baseline(all P<0.05), with greater improvement observed in the combination group(both P<0.05). OSDI and FL scores significantly decreased from baseline(all P<0.05), with more pronounced reductions in the combination group(both P<0.05). Meibomian gland loss scores showed no significant improvement in either group(all P>0.05). At 3 mo after treatment, tear levels of interleukin 6(IL-6)and matrix metalloproteinase-9(MMP-9)significantly decreased in both groups(all P<0.001), with a greater reduction noted in the combination group(both P<0.001). The combination group displayed increased corneal nerve branch density and nerve fiber density, along with decreased nerve tortuosity and dendritic cell(DC)density compared to baseline(all P<0.001), while the control group did not show significant changes(all P>0.05).CONCLUSION: The combination of 0.05% cyclosporine eye drops(Ⅱ)and sodium hyaluronate eye drops significantly improves clinical outcomes in T2DM patients with moderate-to-severe dry eye. This treatment effectively alleviates ocular surface inflammation, restores corneal nerve morphology and density, and demonstrates a favorable safety profile.

徐州医科大学附属医院临床研究专项(No.LCZX202408)