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Title: [Efficacy of 0.05% cyclosporine A combined with vitamin A palmitate in the treatment of meibomian gland dysfunction-related dry eye].
Author: Hao YR, Li SY, Bao JY, Wang JY, Li A, Tian L, Jie Y.
Journal: Zhonghua Yan Ke Za Zhi; 2024 Feb 11; 60(2):127-136. PubMed ID: 38296318.
Abstract:
Objective: 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). Methods: 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. Results: 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 (P<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 (P<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 (P<0.05). Conclusion: 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. 目的： 评价0.05%环孢素A联合维生素A棕榈酸酯治疗睑板腺功能障碍（MGD）相关干眼的疗效。 方法： 单中心、前瞻性、随机平行对照试验。纳入2022年7至11月在首都医科大学附属北京同仁医院北京同仁眼科中心确诊为MGD相关干眼患者，采用随机数字表法随机分为CsA+VA组（0.05%环孢素A滴眼液双眼点药，每日2次；维生素A棕榈酸酯眼用凝胶双眼点药，每日3次）、CsA+HA组（0.05%环孢素A滴眼液双眼点药，每日2次；0.1%玻璃酸钠滴眼液双眼点药，每日3次）、HA组（0.1%玻璃酸钠滴眼液双眼点药，每日3次）3个组治疗12周，分别记录并比较治疗前（基线）以及治疗后第4、8、12周的眼表疾病指数（OSDI）、泪河高度、荧光素泪膜破裂时间、Schirmer Ⅰ试验结果（无麻醉）、泪膜脂质层厚度、睑板腺形态、睑板腺分泌物排出能力和性状评分、角膜荧光素染色评分。采用单因素方差分析、单因素重复测量方差分析、两因素重复测量方差分析、Bonferroni检验等进行统计学分析。 结果： 共收集120例（120只眼）符合标准的MGD相关干眼患者，失访10例（10只眼），最终纳入研究患者110例（110只眼），年龄为22~73岁，男性22例（22只眼），女性88例（88只眼）；其中CsA+VA组38例（38只眼），CsA+HA组36例（36只眼），HA组36例（36只眼）。3个组OSDI、泪河高度、荧光素泪膜破裂时间和睑板腺分泌物性状评分治疗后均有明显改善，其中治疗第12周，CsA+VA组［25.45±15.11，（0.30±0.13）mm，（3.72±1.40）s，（5.03±2.52）分］和CsA+HA组［26.98±16.89，（0.27±0.10）mm，（4.34±1.76）s，（5.11±2.39）分］与HA组［24.57±11.26，（0.24±0.06）mm，（3.18±1.11）s，（9.11±3.34）分］相比，差异均有统计学意义（均P<0.05）；CsA+VA组的泪膜脂质层厚度［（72.61±23.65）nm］明显高于CsA+HA组［（68.39±26.66）nm］（P<0.05）。在CsA+VA组中，睑板腺分泌物性状和排出能力重度异常者［治疗第12周，（6.28±2.59）和（5.89±2.77）分］、中度异常者［治疗第12周，（4.27±2.02）和（4.64±2.02）分］和轻度异常者［治疗第12周，（2.80±0.84）和（2.60±0.55）分］的睑板腺分泌物性状评分和排出能力评分比较，差异均有统计学意义（均P<0.05）。 结论： 0.05%环孢素A联合维生素A棕榈酸酯可明显改善MGD相关干眼患者的症状和体征，尤其可明显改善泪膜脂质层厚度和重度患者的睑板腺分泌物性状和排出能力。.

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