Stonecipher Karl, Perry Henry D, Gross Robert H, Kerney Donna L
Southeastern Laser and Refractive Center, Greensboro, NC, USA.
Curr Med Res Opin. 2005 Jul;21(7):1057-63. doi: 10.1185/030079905X50615.
To assess patients' experiences with topical cyclosporine A (tCSA) 0.05% ophthalmic emulsion (Restasis) to treat keratoconjunctivitis sicca (KCS) in a real-world setting.
A total of 4504 ophthalmologists, optometrists and primary care physicians from throughout the United States participated in the study. Individual physicians identified patients from their practice who were appropriate candidates for treatment with tCSA and provided them with free sample medication and study materials. Patients voluntarily enrolled in the program by following the instructions provided in the study materials. Data for this study were obtained from patient surveys that included questions related to patients' experiences using topical cyclosporine A 0.05% ophthalmic emulsion (tCSA). Using automated surveys at baseline, 30-days and 60-days post-medication initiation, patients rated symptom severity, symptom impact on daily activities, and use of artificial tears pre- and post-treatment with study medication. Participants also reported on the rapidity of symptom relief and satisfaction with tCSA.
A total of 5884 patients completed the study. The vast majority (84%) was female; average age was 63 years. Patients who completed the study (n = 5884) achieved significant reductions (p < 0.001) of 30% in symptom severity and 31%-36% in activity impairments relative to baseline. A positive association (p < 0.001) was observed between number of years with dry eye and the average ratings for symptom severity and impact on everyday activities. Onset of relief was noted within 1 week by 32% of patients and within 3 weeks by 73%. More than 60% reported decreased use of artificial tears at both 30 days and 60 days post-treatment initiation.
Results suggest that in a real-world setting tCSA is an effective treatment for patients suffering from KCS. Onset of relief may be more rapid than in previously published reports.
在实际临床环境中评估患者使用0.05%环孢素A（tCSA）眼用乳剂（Restasis）治疗干眼症（KCS）的体验。
来自美国各地的4504名眼科医生、验光师和初级保健医生参与了该研究。个体医生从其诊所中识别出适合使用tCSA治疗的患者，并为他们提供免费的样品药物和研究材料。患者通过遵循研究材料中提供的说明自愿参加该项目。本研究的数据来自患者调查，其中包括与患者使用0.05%环孢素A眼用乳剂（tCSA）的体验相关的问题。在用药开始时、用药后30天和60天通过自动调查，患者对症状严重程度、症状对日常活动的影响以及治疗前和治疗后使用人工泪液的情况进行评分。参与者还报告了症状缓解的速度和对tCSA的满意度。
共有5884名患者完成了研究。绝大多数（84%）为女性；平均年龄为63岁。完成研究的患者（n = 5884）与基线相比，症状严重程度显著降低（p < 0.001）30%，活动障碍降低31%-36%。观察到干眼年限与症状严重程度的平均评分以及对日常活动的影响之间存在正相关（p < 0.001）。32%的患者在1周内注意到缓解开始，73%的患者在3周内注意到缓解开始。超过60%的患者在治疗开始后30天和60天报告人工泪液的使用减少。
结果表明，在实际临床环境中，tCSA对患有KCS的患者是一种有效的治疗方法。缓解开始可能比以前发表的报告更快。
