Department of Ophthalmology, Taipei Medical University Hospital, Taipei, Taiwan; Department of Ophthalmology, Taipei Medical University, Taipei, Taiwan; Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan.
Clin Ther. 2010 Jan;32(1):44-52. doi: 10.1016/j.clinthera.2010.01.024.
Most marketed artificial tears are substitutes for the aqueous layers of the tear film; therefore, frequent instillation of artificial tears is necessary. Newer gel-, cellulose-, and mineral oil-based formulations have been designed to overcome the disadvantages of current aqueous tear substitutes by offering prolonged retention times.
The aim of this study was to compare the efficacy, safety, and local tolerance of artificial tears containing carbomer-based lipids or hydroxypropyl (HP)-guar gel in patients with dry eye syndrome.
A 4-week, prospective, randomized, parallel-group, comparative, noninferiority study was conducted at the Taipei Medical University Hospital (Taipei, Taiwan) in patients with dry eye syndrome who were randomly assigned to 1 of 2 treatment groups: the carbomer-based lipid-containing (CBLC) gel group and the HP-guar gel group. The primary end point was global assessment of study treatment by the patients at weeks 2 and 4. All patients met the diagnostic criteria of impaired tear function and ocular surface abnormalities. Outcomes measured at baseline and 2 and 4 weeks included Schirmer's test values, tear breakup time (TBUT), and a patient subjective assessment of symptoms. Safety and tolerability were assessed by clinically significant changes in terms of incidence of adverse events and conducted by unmasked investigators.
A total of 30 Taiwanese patients with dry eye syndrome were included and randomly assigned to the 2 treatment groups: the mean (SD) age was 40.37 (14.96) years in the CBLC gel group and 49.49 (12.20) years in the HP-guar gel group. At baseline, the mean (SD) Schirmer's test value was 4.53 (2.28) mm in the right eye and 5.13 (2.42) mm in the left eye in the CBLC gel group; 4.40 (2.16) mm in the right eye and 4.20 (1.78) mm in the left eye for the HP-guar gel group. The mean (SD) for both eyes was 4.83 (2.36) mm in the CBLC gel group and 4.30 (2.08) mm in the HP-guar gel group. There was no statistically significant difference between Schirmer's scores at baseline. Patients in both treatment groups experienced an improvement from baseline in symptoms and signs, Schirmer's test value, and TBUT at 2 and 4 weeks after treatment. The Schirmer's test score increased to a mean of 8.20 (4.49) mm in the right eye and 9.33 (4.94) mm in the left eye in the CBLC gel group after 2 weeks, and increased to 10.07 (5.56) mm in the right eye and 10.86 (5.58) mm in the left eye after 4 weeks. The increases in Schirmer's test score and TBUT were also observed in the HP-guar gel group. The Schirmer's test score increased to 5.13 (2.18) mm in the right eye and 5.60 (2.74) mm in the left eye after 2 weeks, and increased to 6.93 (3.37) mm in the right eye and 6.53 (3.16) mm in the left eye after 4 weeks. The increase in Schirmer's test values in both eyes was significantly greater at 2 and 4 weeks in the CBLC gel group than that in the HP-guar gel artificial tear group (all, P < 0.05). Subjective patient assessment was better with the CBLC group (excellent and good reported by 26.6% and 73.4%, respectively, of the CBLC gel group vs 13.4% and 33.4% of the HP-guar gel group at 4 weeks; both, P = 0.004).
Both artificial tear formulations were effective in relieving dry eye syndrome in these patients. The tolerance of CBLC gel artificial tears was comparable to that of HP-guar gel artificial tears.
大多数市售人工泪液是泪膜水层的替代品；因此，需要频繁滴注人工泪液。新型凝胶、纤维素和矿物油基配方旨在通过提供更长的保留时间来克服当前水性泪液替代品的缺点。
本研究旨在比较含有卡波姆脂质或羟丙基（HP）-瓜尔胶的人工泪液在干眼症患者中的疗效、安全性和局部耐受性。
在台北医学大学附属医院（中国台湾台北）进行了一项为期 4 周的前瞻性、随机、平行组、比较、非劣效性研究，纳入了干眼症综合征患者，并将其随机分配至 2 种治疗组之一：含卡波姆脂质的（CBLC）凝胶组和 HP-瓜尔胶凝胶组。主要终点是患者在第 2 周和第 4 周时对研究治疗的总体评估。所有患者均符合泪液功能受损和眼表面异常的诊断标准。在基线和第 2 周和第 4 周测量的结局包括 Schirmer 测试值、泪膜破裂时间（TBUT）和患者对症状的主观评估。安全性和耐受性通过发生不良事件的临床显著变化进行评估，并由未设盲的研究者进行评估。
共纳入 30 例中国台湾干眼症综合征患者，并随机分配至 2 种治疗组：CBLC 凝胶组的平均（SD）年龄为 40.37（14.96）岁，HP-瓜尔胶凝胶组为 49.49（12.20）岁。在基线时，CBLC 凝胶组右眼的平均（SD）Schirmer 测试值为 4.53（2.28）mm，左眼为 5.13（2.42）mm；右眼为 4.40（2.16）mm，左眼为 4.20（1.78）mm。右眼和左眼的平均值分别为 4.83（2.36）mm和 4.30（2.08）mm。两组患者在基线时的 Schirmer 评分均无统计学差异。两组患者在治疗后第 2 周和第 4 周时，症状和体征、Schirmer 测试值和 TBUT 均有所改善。在 CBLC 凝胶组中，右眼的 Schirmer 测试评分增加至 8.20（4.49）mm，左眼增加至 9.33（4.94）mm，治疗 4 周后右眼增加至 10.07（5.56）mm，左眼增加至 10.86（5.58）mm。HP-瓜尔胶凝胶组也观察到 Schirmer 测试评分和 TBUT 的增加。在 HP-瓜尔胶凝胶组中，右眼的 Schirmer 测试评分增加至 5.13（2.18）mm，左眼增加至 5.60（2.74）mm，治疗 4 周后右眼增加至 6.93（3.37）mm，左眼增加至 6.53（3.16）mm。治疗 2 周和 4 周后，CBLC 凝胶组双眼的 Schirmer 测试值增加均显著大于 HP-瓜尔胶人工泪液组（均 P < 0.05）。CBLC 组的主观患者评估更好（CBLC 凝胶组 26.6%和 73.4%的患者报告为极好和良好，4 周时的 HP-瓜尔胶凝胶组分别为 13.4%和 33.4%；均 P = 0.004）。
两种人工泪液配方均能有效缓解干眼症患者的症状。CBLC 凝胶人工泪液的耐受性与 HP-瓜尔胶人工泪液相当。
