Hao Y R, Li S Y, Bao J Y, Wang J Y, Li A, Tian L, Jie Y
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Institute of Ophthalmology, Beijing Key Laboratory of Ophthalmology & Visual Sciences, Beijing 100730, China.
Zhonghua Yan Ke Za Zhi. 2024 Feb 11;60(2):127-136. doi: 10.3760/cma.j.cn112142-20231109-00221.
To evaluate the efficacy of 0.05% cyclosporine A eye drops combined with vitamin A palmitate eye gel in the treatment of dry eye associated with meibomian gland dysfunction (MGD). A single-center, prospective, randomized, parallel controlled trial design was used to include patients diagnosed with MGD-associated dry eye. The patients were randomly divided into three groups and administered with medications binocularly for 12 weeks. The CsA+VA group was given 0.05% cyclosporine A eye drops twice a day and vitamin A palmitate eye gel three times a day. The CsA+HA group was given 0.05% cyclosporine A eye drops twice a day and 0.1% sodium hyaluronate eye drops three times a day. The HA group was given 0.1% sodium hyaluronate eye drops 3 times a day. The OSDI score, tear meniscus height, fluorescein tear break-up time, Schirmer Ⅰ test (without anesthesia), tear film lipid layer thickness, meibomian gland morphology and function examination, and corneal fluorescein sodium staining score were evaluated at baseline, 4, 8, and 12 weeks after the initiation of the treatment, respectively. A total of 120 patients with MGD-related dry eye met the enrollment criteria, but 10 patients were lost to follow-up; 110 patients were finally included for observation, including 36 patients in the CsA+VA group, 38 in the CsA+HA group and 36 in the HA group. The OSDI score, tear meniscus height, fluorescein tear break-up time and meibomian gland secretion of the 3 groups were significantly improved. At the 12th week of the treatment, the differences of the CsA+VA group [25.45±15.11, (0.30±0.13) mm, (3.72±1.40) s, (5.03±2.52) points] and the CsA+HA group [26.98±16.89, (0.27±0.10) mm, (4.34±1.76) s, (5.11±2.39) points] from the HA group [24.57±11.26, (0.24±0.06) mm, (3.18±1.11) s, (9.11±3.34) points] were statistically significant (<0.05). Compared with the CsA+HA group [(68.39±26.66) nm], the tear film lipid layer thickness in the CsA+VA group [(72.61±23.65) nm] was significantly increased (<0.05). In the CsA+VA group, the meibomian gland secretion characters and discharge capacity among patients with severe abnormalities [(6.28±2.59) and (5.89±2.77) points at the 12th week of treatment], moderate abnormalities [(4.27±2.02) and (4.64±2.02) points at the 12th week of treatment] and mild abnormalities [(2.80±0.84) and (2.60±0.55) points at the 12th week of treatment] were significantly different (<0.05). 0.05% cyclosporine A combined with vitamin A palmitate can significantly improve the symptoms and signs of patients with MGD-related dry eye, especially the tear film lipid layer thickness and the meibomian gland secretion characters and discharge capacity in severe cases.
评估0.05%环孢素A滴眼液联合维生素A棕榈酸酯眼用凝胶治疗睑板腺功能障碍（MGD）相关性干眼的疗效。采用单中心、前瞻性、随机、平行对照试验设计，纳入诊断为MGD相关性干眼的患者。将患者随机分为三组，双眼给药12周。环孢素A+维生素A组给予0.05%环孢素A滴眼液每日2次和维生素A棕榈酸酯眼用凝胶每日3次。环孢素A+透明质酸钠组给予0.05%环孢素A滴眼液每日2次和0.1%透明质酸钠滴眼液每日3次。透明质酸钠组给予0.1%透明质酸钠滴眼液每日3次。分别在治疗开始时、治疗后4周、8周和12周评估眼表疾病指数（OSDI）评分、泪河高度、荧光素泪膜破裂时间、SchirmerⅠ试验（无麻醉）、泪膜脂质层厚度、睑板腺形态和功能检查以及角膜荧光素钠染色评分。共有120例MGD相关性干眼患者符合纳入标准，但10例患者失访；最终纳入110例患者进行观察，其中环孢素A+维生素A组36例，环孢素A+透明质酸钠组38例，透明质酸钠组36例。三组的OSDI评分、泪河高度、荧光素泪膜破裂时间和睑板腺分泌均有显著改善。治疗第12周时，环孢素A+维生素A组[25.45±15.11，（0.30±0.13）mm,（3.72±1.40）s，（5.03±2.52）分]和环孢素A+透明质酸钠组[26.98±16.89,（0.27±0.10）mm,（4.34±1.76）s，（5.11±2.39）分]与透明质酸钠组[24.57±11.26,（0.24±0.06）mm,（3.18±1.11）s，（9.11±3.34）分]相比差异有统计学意义（<0.05）。与环孢素A+透明质酸钠组[（68.39±26.66）nm]相比，环孢素A+维生素A组的泪膜脂质层厚度[（72.61±23.65）nm]显著增加（<0.05）。在环孢素A+维生素A组中，重度异常患者[治疗第12周时为（6.28±2.59）和（5.89±2.77）分]、中度异常患者[治疗第12周时为（4.27±2.02）和（4.64±2.02）分]和轻度异常患者[治疗第12周时为（2.80±0.84）和（2.60±0.55）分]的睑板腺分泌特征和排出能力有显著差异（<0.05）。0.05%环孢素A联合维生素A棕榈酸酯可显著改善MGD相关性干眼患者的症状和体征，尤其是泪膜脂质层厚度以及重度病例的睑板腺分泌特征和排出能力。
