今日の臨床サポート

非感染性結膜炎(アレルギー性結膜疾患、春季カタル、巨大乳頭結膜炎を含む)

著者: 高村悦子 東京女子医科大学 医学部眼科学講座

監修: 沖波聡 倉敷中央病院眼科

著者校正済:2021/10/27
現在監修レビュー中
患者向け説明資料

概要・推奨   

  1. アレルギー性結膜疾患の確定診断には結膜擦過物の好酸球の検出が必要である(推奨度2)。
  1. アレルギー性結膜疾患の迅速診断には、涙液総IgE検査が有用である(推奨度2)。
  1. アレルギー性結膜疾患の治療には、効果および安全性から抗アレルギー点眼薬を選択する(推奨度1)。
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
高村悦子 : 講演料(参天製薬)[2021年]
監修:沖波聡 : 特に申告事項無し[2021年]

改訂のポイント:
  1. アレルギー性結膜疾患診療ガイドラインの改訂に基づき、診断基準、治療の記載の改定を行った。

病態・疫学・診察

疾患情報  
  1. アレルギー性結膜疾患とは、Ⅰ型アレルギーが関与する結膜の炎症性疾患で、発症時期、臨床所見の違いにより、アレルギー性結膜炎(季節性、通年性)、春季カタル、アトピー性角結膜炎、巨大乳頭結膜炎に分類される。
  1. 季節性アレルギー性結膜炎はスギ花粉症が代表的疾患であり、花粉の飛散期に眼瘙痒感、充血、流涙などの症状が出現する。
  1. 通年性アレルギー性結膜炎は、主にダニ、ハウスダストがアレルゲンであり、慢性の経過をとる。
  1. 春季カタルはアトピー体質の学童、特に男児に好発する。結膜の増殖性変化や角膜障害を特徴とし、激しい眼瘙痒感、眼痛、視力低下を自覚する。
  1. アトピー性角結膜炎は、顔面にアトピー性皮膚炎を伴う患者に起こる慢性の角結膜炎である。
  1. 巨大乳頭結膜炎は、コンタクトレンズなどの機械的刺激が関与する。
  1. 症状の改善のためには、点眼薬を中心とした薬物治療に加え、セルフケアも必要である
問診・診察のポイント  
  1. 結膜炎の主要症状について確認する。(眼瘙痒感、流涙、充血、眼脂の有無、眼脂の性状など)

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文献 

著者: Etsuko Takamura, Keiko Nomura, Hiroshi Fujishima, Kazumi Fukagawa, Yoshiyuki Satake, Yuka Fukada, Mitsuru Sawa, Eiji Uchida
雑誌名: Allergol Int. 2006 Jun;55(2):157-65. doi: 10.2332/allergolint.55.157.
Abstract/Text BACKGROUND: This study was conducted to investigate the efficacy and safety of 0.025% levocabastine hydrochloride in Japanese subjects with seasonal allergic conjunctivitis and its duration of action using the conjunctival allergen challenge (CAC) test.
METHODS: Twenty-four asymptomatic subjects were randomized to instill 0.025% levocabastine ophthalmic suspension in one eye and vehicle in the other eye 10 minutes before the CAC test. Signs and symptoms of allergic conjunctivitis were scored 10, 15, and 25 minutes after the CAC test. The duration of drug effects was also evaluated by allergen rechallenge 4 hours after levocabastine administration. The itching score for each eye as the primary efficacy endpoint was assessed 15 minutes after the CAC test using a 5-point scale.
RESULTS: The mean itching score in the levocabastine-treated group was 0.08 +/- 0.06, which was significantly lower than the mean score of 1.98 +/- 0.16 in the vehicle group (P < 0.0001). The redness and chemosis of the conjunctiva were also improved significantly compared with the vehicle group. Levocabastine showed prolonged efficacy in inhibiting itching (0.42 +/- 0.12 vs 0.94 +/- 0.17, P < 0.0002) and redness (1.04 +/- 0.18 vs 1.42 +/- 0.22, P < 0.01) of the conjunctiva upon the rechallenge test. No significant topical or systemic adverse safety findings were observed in the levocabastine group.
CONCLUSIONS: The results indicate that 0.025% levocabastine ophthalmic suspension is effective and safe in the treatment of allergic conjunctivitis with a duration of action of at least 4 h.

PMID 17075252  Allergol Int. 2006 Jun;55(2):157-65. doi: 10.2332/aller・・・
著者: Hiroshi Fujishima, Yuichi Ohashi, Etsuko Takamura
雑誌名: Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi: 10.1016/j.anai.2014.07.007. Epub 2014 Aug 20.
Abstract/Text BACKGROUND: Epinastine hydrochloride is a selective histamine H1 receptor antagonist that also inhibits IgE receptor-mediated histamine release from mast cells.
OBJECTIVE: To show the superiority of epinastine 0.05% ophthalmic solution (epinastine) to placebo ophthalmic solution (placebo) and noninferiority to olopatadine 0.1% ophthalmic solution (olopatadine) for cedar pollen antigen-induced ocular itching and conjunctival hyperemia.
METHODS: The study was conducted in ophthalmologically asymptomatic adult volunteers with seasonal allergic conjunctivitis using a conjunctival allergen challenge test. Subjects were randomized into 3 groups (n = 87) to evaluate superiority to placebo (visits 4 to 6) and 2 groups (n = 86) to evaluate noninferiority to olopatadine (visit 7). At each visit, a single administration of the study medication was instilled at 15 minutes (visit 4), 4 hours (visit 5), 8 hours (visit 6), and 4 hours (visit 7) before the conjunctival allergen challenge test. Ocular itching and conjunctival hyperemia of allergic conjunctivitis were assessed after the conjunctival allergen challenge test.
RESULTS: For the primary end point, epinastine showed superiority to placebo for the inhibition of ocular itching and conjunctival hyperemia induced at 4 hours after the dose (equivalent to 4-times-daily dosing). For the secondary end points, epinastine significantly inhibited itching and conjunctival hyperemia induced at 15 minutes and 8 hours after the dose (equivalent to 2-times-daily dosing) compared with placebo. In addition, epinastine demonstrated noninferiority to olopatadine for ocular itching and conjunctival hyperemia. No adverse drug reactions or serious adverse events were reported throughout the study, indicating that epinastine has a good safety profile.
CONCLUSION: Epinastine is effective and safe for the treatment of allergic conjunctivitis.
TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT01363700.

Copyright © 2014 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
PMID 25163405  Ann Allergy Asthma Immunol. 2014 Oct;113(4):476-81. doi・・・
著者: Hiroshi Fujishima, Kazumi Fukagawa, Yoji Takano, Shigeki Okamoto, Yayoi Nakagawa, Eiichi Uchio, Norihiko Yokoi, Atsuki Fukushima, Etsuko Takamura
雑誌名: Allergol Int. 2006 Sep;55(3):301-3. doi: 10.2332/allergolint.55.301.
Abstract/Text BACKGROUND: We investigated the early efficacy of topical levocabastine, an H(1) histamine-receptor antagonist, in improving the clinical symptoms of allergic conjunctivitis.
METHODS: Thirty-six patients with allergic conjunctivitis were enrolled. One drop of levocabastine was instilled in one eye and one drop of artificial tears in the contralateral eye. Clinical examinations were performed before, and 15 and 30 minutes after instillation. Symptoms of itching and signs of injection were assessed at each time point.
RESULTS: Both levocabastine and artificial tears resulted in a statistically significant reduction in ocular itching. However, levocabastine was significantly more effective.
CONCLUSIONS: Although artificial tears had a positive effect in reducing symptoms of allergic conjunctivitis, by the washing out of allergens, levocabastine was more effective than artificial tears in controlling acute symptoms of allergic conjunctivitis, demonstrating that the selective H1 histamine-receptor antagonist action of levocabastine is rapidly effective in a clinical setting.

PMID 17075271  Allergol Int. 2006 Sep;55(3):301-3. doi: 10.2332/allerg・・・
著者: J M Lewis, T Priddy, J Judd, M O Gordon, M A Kass, A E Kolker, B Becker
雑誌名: Am J Ophthalmol. 1988 Nov 15;106(5):607-12.
Abstract/Text In a retrospective study we reviewed the records of 788 subjects who had been corticosteroid tested with 0.1% dexamethasone four times daily to one eye for six weeks. All subjects had normal kinetic visual fields and optic nerve heads in both eyes at the time of testing and were followed up for a minimum of five years. Some subjects had normal baseline intraocular pressures whereas others were considered to have ocular hypertension. Of 276 individuals who were high corticosteroid responders (intraocular pressure greater than 31 mm Hg during dexamethasone administration), 36 (13.0%) developed glaucomatous visual field loss during the follow-up period. Only nine of 261 individuals (3.4%) who were intermediate responders (intraocular pressure 20 to 31 mm Hg during dexamethasone administration) and none of 251 individuals who were low responders (intraocular pressure less than 20 mm Hg during dexamethasone administration) developed glaucomatous visual field loss. However, the ability of the intraocular pressure response to dexamethasone to predict the development of glaucomatous visual field loss was not as good as the predictive power of a multivariate model that included patient age, race, baseline intraocular pressure, baseline outflow facility, baseline cup/disk ratio, and systemic hypertension.

PMID 3189477  Am J Ophthalmol. 1988 Nov 15;106(5):607-12.
著者: M Ohji, S Kinoshita, E Ohmi, Y Kuwayama
雑誌名: Am J Ophthalmol. 1991 Oct 15;112(4):450-4.
Abstract/Text We examined intraocular pressures of patients with strabismus whose eyes were instilled with corticosteroid eyedrops after a strabismus operation. Group A consisted of 11 children under 10 years of age whose eyes were instilled with 0.1% dexamethasone; Group B consisted of nine patients 10 years old or older whose eyes were instilled with 0.1% dexamethasone; and Group C consisted of 13 children under 10 years of age whose eyes were instilled with 0.1% fluorometholone. In Group A, four patients had intraocular pressures greater than 30 mm Hg, five had intraocular pressures from 21 to 30 mm Hg, and two had intraocular pressures under 21 mm Hg one or two weeks postoperatively. The intraocular pressure decreased to less than 21 mm Hg one week after discontinuation of dexamethasone treatment in all nine patients. No patients in Groups B or C had intraocular pressures greater than 20 mm Hg. Our results suggest that marked ocular hypertensive response to 0.1% dexamethasone treatment occurs frequently in children under 10 years of age.

PMID 1928249  Am J Ophthalmol. 1991 Oct 15;112(4):450-4.
著者: J F Elliott, Y Lin, S B Mizel, R C Bleackley, D G Harnish, V Paetkau
雑誌名: Science. 1984 Dec 21;226(4681):1439-41.
Abstract/Text Cyclosporin A blocked production of the lymphokine interleukin 2 by activated T lymphocytes. In a human and a murine cell line this inhibition reflected an absence of interleukin 2 messenger RNA. Under conditions in which these cells are normally stimulated to secrete high levels of interleukin 2, they failed to do so in the presence of cyclosporin A. In both cell lines this failure was accompanied by an absence of interleukin 2 messenger accumulation.

PMID 6334364  Science. 1984 Dec 21;226(4681):1439-41.
著者: Daisuke Shii, Tomoko Oda, Katsuhiko Shinomiya, Osamu Katsuta, Masatsugu Nakamura
雑誌名: J Ocul Pharmacol Ther. 2009 Aug;25(4):321-8. doi: 10.1089/jop.2009.0009.
Abstract/Text PURPOSE: The effects of cyclosporine A eye drops on the early-phase reaction were investigated in a type-I allergic conjunctivitis model.
METHODS: Mice were actively sensitized with ragweed (RW) absorbed on aluminium hydroxide gel and challenged with RW for 10 days (single challenge model) or 10-14 days (repetitive challenge model) after the first sensitization. For the evaluation of itching, ovalbumin was used as an antigen instead of RW. The effects of cyclosporine A eye drops on increased vascular permeability, mast cell degranulation, and itching were evaluated and compared with those of other anti-allergic eye drops.
RESULTS: In the single challenge model, cyclosporine A eye drops significantly inhibited the increase in vascular permeability and histological evaluations showed suppressed degranulation of mast cells. Disodium cromoglycate (DSCG) eye drops showed only a slight tendency to inhibit the increase in both pathophysiological parameters. Ketotifen or betamethasone eye drops significantly inhibited the increase in vascular permeability. The order of potency in the single challenge model was ketotifen > cyclosporine A > betamethasone. In the repetitive challenge model, cyclosporine A eye drops significantly inhibited the increase in vascular permeability and DSCG eye drops showed only slight inhibition. Ketotifen or betamethasone significantly inhibited the increase in vascular permeability. The order of potency in the repetitive challenge model was cyclosporine A > betamethasone > ketotifen. The effect of cyclosporine A eye drops on the itch-scratch response was studied. Cyclosporine A and DSCG significantly reduced the itch-scratch response in the single and repetitive challenge models; the effect of cyclosporine A in the repetitive challenge model was more potent than in the single challenge model.
CONCLUSIONS: Those results suggest that administration of cyclosporine A eye drops inhibit the early-phase reaction in type-I allergic conjunctivitis, which may be mediated by the suppression of mast cell degranulation. This action of cyclosporine A eye drops may be involved in the therapeutic effect of cyclosporine A on allergic conjunctivitis.

PMID 19650707  J Ocul Pharmacol Ther. 2009 Aug;25(4):321-8. doi: 10.10・・・
著者: Nobuyuki Ebihara, Yuichi Ohashi, Eiichi Uchio, Shigeki Okamoto, Naoki Kumagai, Jun Shoji, Etsuko Takamura, Yayoi Nakagawa, Kenichi Nanba, Atsuki Fukushima, Hiroshi Fujishima
雑誌名: J Ocul Pharmacol Ther. 2009 Aug;25(4):365-72. doi: 10.1089/jop.2008.0103.
Abstract/Text PURPOSE: To evaluate the effectiveness and safety of a novel cyclosporine 0.1% aqueous ophthalmic solution in a large population with vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
METHODS: A prospective observational postmarketing study was initiated in Japan. A total of 594 patients with VKC or AKC were started on this drug within 1 year after market launch (January 2006) and completed a 6-month follow-up. These patients were observed clinically, and subjective ocular symptoms (itching, discharge, tearing, photophobia, foreign body sensation, and pain), objective signs (hyperemia, swelling, follicle, papillae, and giant papillae for the tarsal conjunctiva; hyperemia and edema for the bulbar conjunctiva; Trantas dots and swelling for the limbus; and corneal involvement), and adverse events were recorded.
RESULTS: All scores for symptoms and signs significantly decreased from Month 1 through Month 6 of treatment in both VKC and AKC. Median total symptom scores at baseline, Month 1, and Month 6 were 6, 2, and 1, respectively, for VKC, and 7, 3, and 2, respectively, for AKC. Similarly, median total sign scores were 12, 7, and 5, respectively, for VKC, and 14, 10, and 7, respectively, for AKC. The percentage of patients able to complete topical cyclosporine 0.1% therapy within 6 months due to alleviation of symptoms was higher for VKC (44.4%) than for AKC (21.9%). In both VKC and AKC, approximately 30% of steroid users were able to discontinue topical steroids. Adverse drug reactions (ADRs) were found in 12.0% of patients, and the most common ADR was eye irritation (4.4%). Infectious corneal complications were observed in five AKC patients, including two cases of bacterial corneal ulcer and three cases of herpetic keratitis; all of these patients were concomitantly using topical steroids.
CONCLUSIONS: Topical cyclosporine 0.1% is an effective and safe treatment for VKC and AKC.

PMID 19441889  J Ocul Pharmacol Ther. 2009 Aug;25(4):365-72. doi: 10.1・・・
著者: T Kino, H Hatanaka, S Miyata, N Inamura, M Nishiyama, T Yajima, T Goto, M Okuhara, M Kohsaka, H Aoki
雑誌名: J Antibiot (Tokyo). 1987 Sep;40(9):1256-65.
Abstract/Text The immuno-pharmacological profile of a novel immunosuppressive agent, FK-506 produced by a streptomycete, is presented here. We proceeded to test the effect of the agent on various in vitro immune systems. It showed that mixed lymphocyte reaction, cytotoxic T cell generation, the production of T cell-derived soluble mediators such as interleukin 2 (IL-2), interleukin 3 and gamma-interferon and the expression of the IL-2 receptor were suppressed by this agent. The IC50 values of FK-506 and ciclosporin (CS) in all tests were approximately 0.1 nM and 10 nM, respectively. Therefore, the novel agent, FK-506 suppressed in vitro immune systems at about hundred times lower concentration than CS.

PMID 2445722  J Antibiot (Tokyo). 1987 Sep;40(9):1256-65.
著者: Yuichi Ohashi, Nobuyuki Ebihara, Hiroshi Fujishima, Atsuki Fukushima, Naoki Kumagai, Yayoi Nakagawa, Kenichi Namba, Shigeki Okamoto, Jun Shoji, Etsuko Takamura, Kunihiko Hayashi
雑誌名: J Ocul Pharmacol Ther. 2010 Apr;26(2):165-74. doi: 10.1089/jop.2009.0087.
Abstract/Text AIMS: To examine the efficacy of tacrolimus ophthalmic suspension 0.1% in treating severe allergic conjunctivitis.
METHODS: This was a multicenter, randomized, double-masked, placebo-controlled clinical trial. Fifty-six patients with severe allergic conjunctivitis in whom topical antiallergic agents and corticosteroids had been ineffective were randomized to tacrolimus or placebo treatment. Patients were treated either with tacrolimus or placebo twice-daily for 4 weeks. Severity of objective signs in palpebral and bulbar conjunctiva, limbus, and corneal involvement was assessed using 4 grades. Seven subjective symptoms were evaluated by visual analog scale (VAS) assessment. The primary efficacy endpoint was change in the total score of objective signs at the end of treatment. The secondary efficacy endpoints included change in the score for each objective sign and change in the VAS for each subjective symptom. Safety was assessed based on the severity and the incidence of adverse events.
RESULTS: Mean change from baseline in total score for objective signs was significantly greater in the tacrolimus (-5.6 + or - 5.1) than in the placebo group (-0.1 + or - 4.5; P < 0.001). Tacrolimus significantly improved giant papillae (P = 0.001) and corneal involvement (P = 0.005). Five subjective symptoms (itching, discharge, hyperemia, lacrimation, and foreign body sensation) were significantly better in the tacrolimus than in the placebo group. The most frequent treatment-related adverse event in the tacrolimus group was mild ocular irritation upon topical instillation, which was well-tolerated.
CONCLUSION: Tacrolimus ophthalmic suspension 0.1% is effective in treating severe allergic conjunctivitis.

PMID 20307214  J Ocul Pharmacol Ther. 2010 Apr;26(2):165-74. doi: 10.1・・・
著者: Dai Miyazaki, Atsuki Fukushima, Yuichi Ohashi, Nobuyuki Ebihara, Eiichi Uchio, Shigeki Okamoto, Jun Shoji, Etsuko Takamura, Yayoi Nakagawa, Kenichi Namba, Hiroshi Fujishima
雑誌名: Ophthalmology. 2017 Mar;124(3):287-294. doi: 10.1016/j.ophtha.2016.11.002. Epub 2016 Dec 22.
Abstract/Text PURPOSE: To evaluate the effects of 0.1% topical tacrolimus alone or in combination with steroids for the treatment of shield ulcers and corneal epitheliopathy in patients with refractory allergic ocular diseases.
DESIGN: Open cohort study.
PARTICIPANTS: Patients with refractory allergic conjunctivitis epitheliopathy, shield ulcers, or corneal plaques (N = 791).
METHODS: The 791 patients were treated with topical tacrolimus alone or in combination with topical or oral steroids. The effectiveness of the treatments was determined by a corneal epitheliopathy score during the 3-month follow-up period. The clinical signs were rated on a 4-grade scale. Corneal epitheliopathy with no corneal staining was graded as 0, and shield ulcers or plaques were graded as 3, the highest grade. The effects of tacrolimus with and without topical steroids on the epitheliopathy scores were assessed after adjustments for the severity of the clinical signs and characteristics.
MAIN OUTCOME MEASURES: Changes in the corneal epitheliopathy score.
RESULTS: Adjusted mean epitheliopathy score at the baseline was 1.73 (95% confidence interval [CI], 1.65-1.81) for patients treated with tacrolimus alone, and this was significantly reduced by -0.93 at 1 month. The reduction of the score by topical and oral steroids was -0.02 for fluorometholone, 0.02 for betamethasone, and -0.02 for oral steroids, and these reductions were not significant compared with the reduction effect of topical tacrolimus alone at -0.93. The 238 patients with shield ulcer (score 3) were analyzed with adjustments, and the mean epitheliopathy score at 1 month was reduced to 1.38 with tacrolimus alone (95% CI, 1.24-1.51), 1.41 (95% CI, 1.26-1.56) with adjuvant fluorometholone, and 1.46 (95% CI, 1.32-1.61) with adjuvant betamethasone. No significant difference was observed in the adjunctive topical steroids. The presence of severe palpebral conjunctival symptoms, including giant papillae, was a significant resisting factor for topical tacrolimus.
CONCLUSIONS: The significant effects of topical tacrolimus alone on shield ulcers and corneal epitheliopathy suggest that it may be used without the need for steroids.

Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
PMID 28017421  Ophthalmology. 2017 Mar;124(3):287-294. doi: 10.1016/j.・・・

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