UMIN試験ID | UMIN000040351 |
---|---|
受付番号 | R000046045 |
科学的試験名 | Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis |
一般公開日(本登録希望日) | 2020/05/10 |
最終更新日 | 2021/12/20 12:23:37 |
日本語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
英語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
日本語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
英語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
日本語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
英語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
日本語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
英語
Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
日本/Japan |
日本語
Glaucoma
英語
Glaucoma
呼吸器内科学/Pneumology | 眼科学/Ophthalmology |
悪性腫瘍以外/Others
いいえ/NO
日本語
Inhaled corticosteroid (ICS) has been accepted as the first-choice treatment option for stable asthma and asthma chronic obstructive pulmonary disease overlap (ACO)[GINA2020, GINA-GOLD2017]. Corticosteroid, which is directly delivered to the airway via inhaler devices, effectively ameliorates inflammation of the respiratory system. Compared to oral corticosteroids, ICS cause less systemic side effect since small portion of ICS is absorbed into systemic circulation. Nonetheless, some systemic adverse events were recognized including hypothalamic-pituitary-adrenal axis, decreased bone mineral density, and dermal thinning[PMID 10326936]. Attention should be also pay for ocular effects such as cataract and glaucoma. Regarding cataract, two meta-analyses published in 2006 and 2009 consistently revealed that ICS treatment resulted in increased risk of cataract [PMID 19740259, 16671966]. Regarding glaucoma, a large-scale case control study with 9793 patients and 38325 controls by Garbe et al. showed that prolonged administration of high doses of inhaled glucocorticoids increased the risk of ocular hypertension or open-angle glaucoma[PMID: 9042844]. Their report raised a serious concern for physicians who take care of patients with asthma and ACO since glaucoma is a lifelong eye disease that can lead to vision loss if not controlled. However, many subsequent researches did not confirm the link between ICS and glaucoma. Furthermore, no meta-analysis that assessed how ICS impacts on risk of glaucoma and ocular hypertension has been published. This systematic review and meta-analysis aimed to evaluate whether ICS increases the risk of glaucoma and increased intraocular pressure (IOP).
英語
Inhaled corticosteroid (ICS) has been accepted as the first-choice treatment option for stable asthma and asthma chronic obstructive pulmonary disease overlap (ACO)[GINA2020, GINA-GOLD2017]. Corticosteroid, which is directly delivered to the airway via inhaler devices, effectively ameliorates inflammation of the respiratory system. Compared to oral corticosteroids, ICS cause less systemic side effect since small portion of ICS is absorbed into systemic circulation. Nonetheless, some systemic adverse events were recognized including hypothalamic-pituitary-adrenal axis, decreased bone mineral density, and dermal thinning[PMID 10326936]. Attention should be also pay for ocular effects such as cataract and glaucoma. Regarding cataract, two meta-analyses published in 2006 and 2009 consistently revealed that ICS treatment resulted in increased risk of cataract [PMID 19740259, 16671966]. Regarding glaucoma, a large-scale case control study with 9793 patients and 38325 controls by Garbe et al. showed that prolonged administration of high doses of inhaled glucocorticoids increased the risk of ocular hypertension or open-angle glaucoma[PMID: 9042844]. Their report raised a serious concern for physicians who take care of patients with asthma and ACO since glaucoma is a lifelong eye disease that can lead to vision loss if not controlled. However, many subsequent researches did not confirm the link between ICS and glaucoma. Furthermore, no meta-analysis that assessed how ICS impacts on risk of glaucoma and ocular hypertension has been published. This systematic review and meta-analysis aimed to evaluate whether ICS increases the risk of glaucoma and increased intraocular pressure (IOP).
安全性・有効性/Safety,Efficacy
日本語
英語
日本語
The primary outcome was glaucoma frequency in the form of an unadjusted odds ratio (OR) between ICS and non-ICS population.
英語
The primary outcome was glaucoma frequency in the form of an unadjusted odds ratio (OR) between ICS and non-ICS population.
日本語
英語
その他・メタアナリシス等/Others,meta-analysis etc
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
適用なし/Not applicable |
適用なし/Not applicable |
男女両方/Male and Female
日本語
In a case-control studies, cases should have glaucoma. Glaucoma need not be specified as open-angle, closed-angle, or normal-tension glaucoma.
In a cohort study and an RCT, ICS-treated patients with any respiratory diseases including asthma and ACO may be included. No limitation was set for dosage, frequency, or timing of ICS-treatment.
英語
In a case-control studies, cases should have glaucoma. Glaucoma need not be specified as open-angle, closed-angle, or normal-tension glaucoma.
In a cohort study and an RCT, ICS-treated patients with any respiratory diseases including asthma and ACO may be included. No limitation was set for dosage, frequency, or timing of ICS-treatment.
日本語
None
英語
None
日本語
名 | 信之 |
ミドルネーム | |
姓 | 堀田 |
英語
名 | Nobuyuki |
ミドルネーム | city |
姓 | Horita |
日本語
横浜市立大学
英語
Yokohama City University School of Medicine
日本語
呼吸器内科
英語
Department of Pulmonology
236-0032
日本語
3-9 fukuura kanazawaku
英語
3-9 fukuura kanazawaku
0457872700
horitano@yokohama-cu.ac.jp
日本語
名 | 信之 |
ミドルネーム | |
姓 | 堀田 |
英語
名 | Nobuyuki |
ミドルネーム | |
姓 | Horita |
日本語
横浜市立大学
英語
Yokohama City University School of Medicine
日本語
呼吸器内科
英語
Department of Pulmonology
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9 fukuura kanazawaku yokohama
0457872800
horitano@yokohama-cu.ac.jp
日本語
その他
英語
Yokohama City University School of Medicine
日本語
横浜市立大学
日本語
日本語
英語
日本語
その他
英語
Yokohama City University School of Medicine
日本語
横浜市立大学
日本語
その他/Other
日本語
英語
Japan
日本語
英語
日本語
英語
日本語
IRBなし
英語
not applicable
日本語
IRBなし
英語
not applicable
not applicable
not applicable
いいえ/NO
日本語
英語
日本語
英語
2020 | 年 | 05 | 月 | 10 | 日 |
最終結果が公表されている/Published
31665
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
2021 | 年 | 12 | 月 | 20 | 日 |
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
日本語
英語
Please see:
Allergy Asthma Immunol Res. 2021 May;13(3):435-449. doi: 10.4168/aair.2021.13.3.435.
主たる結果の公表済み/Main results already published
2020 | 年 | 05 | 月 | 10 | 日 |
2020 | 年 | 05 | 月 | 10 | 日 |
2020 | 年 | 05 | 月 | 10 | 日 |
2021 | 年 | 03 | 月 | 31 | 日 |
日本語
See English section
英語
Study search
We willsearch for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection on May 10th, 2020.
Publication type
Case-control studies, cohort studies, and randomized controlled trials will be included when each study provided data to compare glaucoma frequencies between ICS and non-ICS population in the form of odds ratio (OR).
Studies that offered information concerning only the secondary endpoints will be also included.
Non-English language article and conference abstract were allowed.
Treatment
ICS with any type of inhaler device and any type of glucocorticoid will be allowed. If patients in ICS arm are simultaneously administered muscarine antagonist, the patients in non-ICS arm should be also treated with the same muscarine antagonist because muscarine antagonist is a known cause of glaucoma.
Primary outcome
The primary outcome will be glaucoma frequency in the form of an unadjusted odds ratio (OR) between ICS and non-ICS population.
Secondary outcome.
The secondary outcomes includes (i) glaucoma frequency in the form of adjusted odds ratio (OR) between ICS and non-ICS population, (ii) intraocular pressure (IOP) change from the baseline, mmHg mean, difference (MD), (iii) single-measured IOP, mmHg, MD.
Quality assessment
Newcastle-Ottawa Scale (NOS) will be used to assess the risk of bias of each study.
Subgroup analysis
Subgroup analysis based on study designs will be conducted.
2020 | 年 | 05 | 月 | 10 | 日 |
2021 | 年 | 12 | 月 | 20 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046045
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046045
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