Pflugfelder Stephen C, Maskin Steven L, Anderson Bruce, Chodosh James, Holland Edward J, De Paiva Cintia S, Bartels Stephen P, Micuda Teresa, Proskin Howard M, Vogel Roger
Baylor College of Medicine, Houston, Texas, USA.
Am J Ophthalmol. 2004 Sep;138(3):444-57. doi: 10.1016/j.ajo.2004.04.052.
To evaluate loteprednol etabonate ophthalmic 0.5% suspension, versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance.
Randomized, double-masked, placebo-controlled clinical trial.
Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were randomly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks. Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued. Symptoms were scored using a visual analog scale (VAS) of 1 to 100. Corneal fluorescein staining was scored 0 to 4 in five areas. Conjunctival injection was graded 0 to 3 in the inferior bulbar, nasal bulbar, and inferior tarsal areas. Lid margin injection was graded 0 to 3. Safety was assessed by funduscopy, lens examination, biomicroscopy, visual acuity, and Goldmann tonometry, and by monitoring adverse events and changes in symptoms.
In subsets of patients with at least moderate clinical inflammation, there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy. The differences did not reach statistical significance at 4 weeks, although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group. Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported.
The use of topical loteprednol etabonate 0.5% 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component.
评估0.5%氯替泼诺依碳酸酯眼用混悬液与安慰剂相比，对泪液清除延迟患者干眼症炎症成分的治疗效果。
随机、双盲、安慰剂对照临床试验。
64例患有干眼症且泪液清除延迟的患者被随机分配，每天4次接受氯替泼诺或赋形剂治疗，为期4周。在治疗的第2周和第4周以及停药后2周对患者进行评估。症状使用1至100的视觉模拟量表（VAS）评分。角膜荧光素染色在五个区域的评分为0至4分。结膜充血在球结膜下、鼻侧球结膜和睑板下区域的分级为0至3级。睑缘充血分级为0至3级。通过眼底镜检查、晶状体检查、生物显微镜检查、视力和Goldmann眼压测量法，以及监测不良事件和症状变化来评估安全性。
在至少有中度临床炎症的患者亚组中，治疗2周后，氯替泼诺治疗组与赋形剂治疗组之间存在显著差异。尽管与赋形剂治疗组相比，氯替泼诺治疗的患者保持了改善，但在4周时差异未达到统计学意义。安全性评估显示，两种治疗的耐受性均良好，报告的不良事件频率和类型相似。
对于患有至少中度炎症成分的干眼症患者，每天4次使用0.5%的局部用氯替泼诺依碳酸酯可能有益。
