0.05%环孢素滴眼液(Ⅱ)治疗干燥综合征相关中重度干眼的有效性和安全性:随机、双盲、安慰剂对照亚组研究

Efficacy and safety of 0.05%cyclosporine A ophthalmic emulsion in the treatment of moderate to severe dry eye patients with Sjögren's syndrome:a randomized,double-blinded,and placebo-controlled subgroup study

目的评估0.05%环孢素滴眼液(Ⅱ)治疗干燥综合征相关中重度干眼的有效性和安全性。方法随机、双盲、安慰剂平行对照优效试验的亚组研究。确诊干燥综合征且眼部表现为中重度干眼患者随机进入试验组和对照组,分别给予试验药0.05%环孢素滴眼液(Ⅱ)和对照药(溶剂)每天2次,两组同时滴用人工泪液(羟丙甲纤维素滴眼液)每天3次作为基础治疗,用药后第7、28、56、84天以及停药后第14天进行复查。结果共纳入60例患者,其中试验组32例,对照组28例。治疗第84天时,试验组和对照组临床总有效率分别为68.8%和17.9%(P<0.001),试验组在第28天及以后各随访时间点显现统计优效。与研究药物相关的不良事件,试验组和对照组发生率分别为6.3%和3.6%(P>0.05),主要表现为轻中度眼痛。各随访时间点眼部不适感组间比较差异无统计学意义(P>0.05),未发生危及生命或影响视力的严重不良事件。结论0.05%环孢素滴眼液(Ⅱ)每天2次滴眼治疗干燥综合征相关中重度干眼安全有效。

Objective To evaluate the efficacy and safety of 0.05%cyclosporine A ophthalmic emulsion(CsA OE)in the treatment of moderate to severe dry eye patients with Sjögren's syndrome.MethodsThis was a subgroup analysis of a randomized,double-blinded,and placebo-controlled study.Patients with moderate to severe dry eye due to Sjögren's syndrome were randomized to receive twice-daily 0.05%CsA OE(study group)and its vehicle(control group),along with unpreserved hypromellose eye drops three times per day.Patients were followed up at day 7,28,56,84 and 14 days after drug withdrawl.Results A total of 60 patients were randomized with 32 in the study group and 28 in the control group.The overall effective rates of study and control group at day 84 were 68.8%and 17.9%respectively(P<0.001).The study group showed efficacy superiority from day 28.Drug related adverse events(AEs)were recorded in 2(6.3%)and 1(3.6%)patients in the study and control groups respectively(P>0.05)with ocular pain as the most frequently reported AEs,and it was mostly mild to moderate.No difference was found in the occurrence of ocular discomfort between two groups at all follow-up timepoints(P>0.05).There were no detrimental effects on visual acuity or vital signs.Conclusion Twice-daily instillation of 0.05%CsA OE is effective and well tolerated for the treatment of moderate to severe dry eye patients with Sjögren's syndrome.