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[摘要]
目的:评价免疫抑制剂——他克莫司滴眼液治疗春季卡他性角结膜炎(vernal keratoconjunctivitis,VKC)的治疗效果。
方法:随机双盲试验,安慰剂对照。收集四川大学华西医院眼科16例门诊患者,将16例患者按就诊顺序随机分为治疗组与对照组。治疗组使用他克莫司滴眼液,对照组使用他克莫司滴眼液基础液,观察期为28d。对研究眼眼部体征和自觉症状分别进行单项评分,以治疗前后眼部体征总分变化量为主要疗效指标,主观症状为次要疗效指标。
结果:(1)组内比较:两组症状和体征在用药前后的差异具有统计学意义,治疗组用药后各个时期的自觉症状评分均低于用药前,且随着时间推移,症状评分逐渐降低,差异有统计学意义,对照组用药后不同时期之间的差异无统计学意义。(2)组间比较:两组患者的主观症状和体征在用药前和用药后第一次复查时差异无统计学意义,之后两次复查差异均具有统计学意义。评分变化量(用药前评分-用药后评分)在用药后第一次复查时差异无统计学意义,之后两次复查差异均具有统计学意义。
结论:他克莫司滴眼液能改善VKC患者的体征与症状,对于使用抗过敏滴眼液无明显改善的VKC,具有迅速、优良的改善效果,可应用于临床。
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[Abstract]
AIM: To evaluate the curative effects of tacrolimus on vernal keratoconjunctivitis(VKC).
METHODS: A double-blind, randomized, placebo-controlled trial.Sixteen ambulatory patients from department of ophthalmology in West China Hospital of Sichuan University were randomly divided into drug treatment group and control group. Patients in treatment group were treated with tacrolimus eye drops, and control group with the basic placebo eye drops. Observation period of the trial was 28 days after taking the drops. The signs and symptoms were recorded and marked respectively. Total variation of ocular signs before or after therapy was main therapeutic index but subjective symptoms were the secondary index.
RESULTS: Comparison in groups: there were significant differences on the scores of signs and symptoms before and after medication. After the drug treatment group, consciousness of each period symptom score was lower than before the medication, and over time, symptom score gradually reduced, the difference was statistically significant, but the control group after the medication had no statistically significant differences between different periods. Compared between the groups: There were no significant differences of subjective symptoms and signs before and after medication at the first review, but there were statistically significant differences during the other two reviews. Score variation(scores before or after medication)had no significant differences in the first review but had it in the following two times.
CONCLUSION:Tacrolimus can be used to improve the signs and symptoms of VKC, especially for the severe patients who are nonresponse to the anti-anaphylaxis drops. Tacrolimus can be quick and excellent to improve the effects, so it can be applied into clinic.
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