Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement.

Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement.
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DOI:
10.1136/bjophthalmol-2013-304453
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发表时间:
2014-08
期刊:
The British journal of ophthalmology
影响因子:
--
通讯作者:
Miyazaki D
Miyazaki D
中科院分区:
其他
文献类型:
--
作者:
Fukushima A;Ohashi Y;Ebihara N;Uchio E;Okamoto S;Kumagai N;Shoji J;Takamura E;Nakagawa Y;Namba K;Fujishima H;Miyazaki D

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本研究的目的是观察外用0.1%他克莫司治疗伴有增生性病变和/或角膜受累的难治性过敏性结膜炎的疗效。这项前瞻性观察研究包括1436例对常规抗过敏药物和/或局部类固醇和/或局部环孢素反应差的难治性过敏性结膜炎患者。在研究期间,所有患者每天服用两次他克莫司眼药水。对10个临床体征和6个临床症状进行四级评分。主要终点是在最后一次观察或治疗6个 月后从基线开始的临床体征和症状评分的变化。治疗1个 月后,症状和体征总积分显著降低(p<0.001)。使用他克莫司滴眼液也可以减少巨大的乳头和角膜病变(p<0.001)。事实证明,这种药物对局部环孢素治疗反应不佳的患者有效。在所有使用局部类固醇的患者中,约有50%的患者已断奶。最常见的不良反应是一过性烧灼感(3.20%)。他克莫司滴眼液对治疗伴有增生性病变和/或角膜受累的难治性过敏性结膜炎非常有效,并可减少或取代局部类固醇的使用。最低000008640。
The objective of this study was to investigate the efficacy of topical 0.1% tacrolimus in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement. This prospective observational study included 1436 patients with refractory allergic conjunctivitis whose condition had responded poorly to conventional antiallergic drugs and/or topical steroids and/or topical cyclosporine. All patients received tacrolimus eye drops twice daily during the study period. Ten clinical signs and six clinical symptoms were rated on a four-grade scale. The primary endpoint was the change from baseline in total clinical signs and symptoms score at the last observation or following 6 months of treatment. Total signs and symptoms score significantly decreased after 1 month of treatment (p<0.001). Giant papillae and corneal lesions were also reduced by tacrolimus eye drop use (p<0.001). The drug proved effective in patients whose condition did not respond well to topical cyclosporine therapy. About 50% of all patients using topical steroids were weaned. The most common adverse reaction was a transient burning sensation (3.20%). Tacrolimus eye drops are highly effective in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement, and may reduce or replace topical steroid use. UMIN 000008640.
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