The patients enrolled had a clinical diagnosis of dry eye, were judged by the investigator to be good candidates for cyclosporine therapy, and were 18 years of age or older. There were no statistically significant differences between treatment groups in their demographic characteristics. The patients had a mean age of about 67 years, nearly threefourths were female, and the majority (81%) were Caucasian.
人选的患者都是临床诊断的干眼症,研究人员确认可以接受环孢霉素A治疗,所有患者年龄不低于18岁。两组在人口特征方面无明显统计学差异。患者平均年龄67岁,约3/4患者是女性,多数是高加索人(81%)。
Subjective ocular comfort was self-rated by the patients using a 4-point scale (1=mild discomfort, 4=severe discomfort). Both groups showed a statistically significant reduction in the mean ocular comfort score by 2 weeks and further improvement at 6 weeks. However, the improvement was greater in the combination group compared with cyclosporine monotherapy at week 2 (-0.67 versus -0.89, respectively) and week 6 (-2.55 wersus -1.53, respectively), and the difference in improvement at 2 weeks was statistically significant favoring cyclosporine / ketorolac. “Consistent with these data, patient phone calls and office visits were fewer in patients using ketorolac compared with those using cyclosporine alone.” Said Dr. Schechter.
自觉眼部舒适度由患者用4分分级法自我评分(1=轻度不适,4=重度不适)。2周随访时,两组的平均眼部舒适度评分都有明显下降,而且到6周时改善更多。但联合用药组的效果要好于环孢霉素A单独治疗组,2周时分别是-0.67和-0.89,6周时分别是-2.55和-1.53,环孢霉素A/酮咯酸组在2周时的效果最明显。“和这些治疗相对应的是,加用酮咯酸的患者电话询问以及前来就诊的次数,也少于单独应用环孢霉素A的患者。”Dr. Schechter称。
Objective corneal staining evaluations showed early, statistically significant improvements from baseline with both cyclosporine monotherapy (-1.07) and combination treatment (-1.39) and greater benefit with each regimen at study conclusion (cyclosporine -1.27; cyclosporine/ketorolac -1.74). The difference between treatment protocols achieved statistical significance at 6 weeks.
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