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原发性开角型青光眼患者使用奥美沙坦酯异丙酯的 3 年疗效和安全性。

Three-year efficacy and safety of omidenepag isopropyl in patients with normal tension glaucoma.

机构信息

Inouye Eye Hospital, 4-3 Kanda-surugadai, Chiyoda-ku, Tokyo, 101-0062, Japan.

Nishikasai Inouye Eye Hospital, 3-12-14 Nishikasai, Edogawa-ku, Tokyo, 134-0088, Japan.

出版信息

Jpn J Ophthalmol. 2024 May;68(3):206-210. doi: 10.1007/s10384-024-01052-8. Epub 2024 Apr 8.

DOI:10.1007/s10384-024-01052-8
PMID:38587788
Abstract

PURPOSE

To retrospectively evaluate the 3-year efficacy and safety of single-agent omidenepag isopropyl in patients with normal tension glaucoma (NTG).

STUDY DESIGN

Retrospective.

METHODS

One hundred patients (100 eyes) who had newly been administered omidenepag isopropyl were enrolled in this study. Intraocular pressure (IOP) was compared at baseline and 6, 9, 12, 18, 24, 30, and 36 months after administration. The mean deviation values at baseline and 12, 24, and 36 months measured using the Humphrey visual field test (30-2 Swedish Interactive Threshold Algorithm standard) were compared. Adverse reactions and dropouts were assessed.

RESULTS

IOP significantly decreased from 15.5±2.7 mmHg at baseline to 13.8 ±2.3 mmHg after 6 months, 13.9± 2.3 mmHg after 12 months, 13.9±2.3 mmHg after 18 months, 13.8±2.1 mmHg after 24 months, 13.9±2.0 mmHg after 30 months, and 13.6±1.7 mmHg after 36 months (P < 0.0001). There was no significant difference in the mean deviation values at baseline (-3.66±3.49 dB), 12 months (-3.41±3.80 dB), 24 months (-3.13±3.81 dB), and 36 months (-3.06±3.30 dB). Adverse reactions occurred in 11 patients (11.0%), including conjunctival hyperemia in 6 patients. Fifty-two patients (52.0%) were excluded from the analysis because they discontinued treatment either due to IOP measurement by NCT or the use of additional drugs.

CONCLUSION

After the administration of omidenepag isopropyl, IOP in patients with NTG decreased within 3 years, visual fields were maintained, and safety was satisfactory. Thus, omidenepag isopropyl can be used as the first-line treatment for patients with NTG.

摘要

目的

回顾性评估单药异丙基奥米登普用于正常眼压性青光眼(NTG)患者的 3 年疗效和安全性。

研究设计

回顾性。

方法

本研究纳入了 100 例(100 只眼)新接受异丙基奥米登普治疗的患者。比较给药前和给药后 6、9、12、18、24、30 和 36 个月的眼压。使用 Humphrey 视野计(30-2 瑞典交互阈值算法标准)测量的基线和 12、24 和 36 个月的平均偏差值进行比较。评估不良反应和脱落情况。

结果

眼压从基线时的 15.5±2.7mmHg 显著下降至 6 个月时的 13.8±2.3mmHg、12 个月时的 13.9±2.3mmHg、18 个月时的 13.9±2.3mmHg、24 个月时的 13.8±2.1mmHg、30 个月时的 13.9±2.0mmHg 和 36 个月时的 13.6±1.7mmHg(P<0.0001)。基线时(-3.66±3.49dB)、12 个月时(-3.41±3.80dB)、24 个月时(-3.13±3.81dB)和 36 个月时(-3.06±3.30dB)的平均偏差值无显著差异。11 例(11.0%)患者出现不良反应,其中 6 例出现结膜充血。由于眼压测量或使用其他药物,52 例(52.0%)患者被排除在分析之外。

结论

给予异丙基奥米登普后,NTG 患者的眼压在 3 年内下降,视野得到维持,且安全性令人满意。因此,异丙基奥米登普可作为 NTG 患者的一线治疗药物。

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本文引用的文献

1
One-Year Efficacy and Safety of Omidenepag Isopropyl in Patients with Normal-Tension Glaucoma.原发性开角型青光眼患者使用奥美沙坦异丙酯的一年疗效和安全性。
J Ocul Pharmacol Ther. 2022 Jun;38(5):354-358. doi: 10.1089/jop.2021.0122. Epub 2022 May 25.
2
Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan.日本原发性开角型青光眼和高眼压症患者使用依普沙坦异丙酯的上市后观察性研究的中期结果。
Adv Ther. 2022 Mar;39(3):1359-1374. doi: 10.1007/s12325-021-02035-8. Epub 2022 Jan 20.
3
Periocular Adverse Reactions to Omidenepag Isopropyl.
奥米地帕异丙酯的眼周不良反应
Am J Ophthalmol. 2022 May;237:114-121. doi: 10.1016/j.ajo.2021.12.011. Epub 2021 Dec 20.
4
Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study.选择性 EP2 激动剂奥美尼普坦异丙酯治疗开角型青光眼和高眼压症的 12 个月疗效和安全性:RENGE 研究。
Jpn J Ophthalmol. 2021 Nov;65(6):810-819. doi: 10.1007/s10384-021-00868-y. Epub 2021 Sep 8.
5
Recovery of deepening of the upper eyelid sulcus after switching from prostaglandin FP receptor agonists to EP2 receptor agonist: a 3-month prospective analysis.从前列腺素 FP 受体激动剂转换为 EP2 受体激动剂后对上眼睑沟加深的恢复:一项 3 个月的前瞻性分析。
Jpn J Ophthalmol. 2021 Sep;65(5):591-597. doi: 10.1007/s10384-021-00855-3. Epub 2021 Jul 20.
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A Randomized Phase 2 Trial Comparing Omidenepag Isopropyl 0.002% Once and Twice Daily in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension (SPECTRUM-6).一项比较原发性开角型青光眼或高眼压症患者每日一次和两次给予地匹福林异丙酯 0.002%的随机 2 期试验(SPECTRUM-6)。
J Glaucoma. 2021 Jun 1;30(6):473-480. doi: 10.1097/IJG.0000000000001836.
7
Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study.原发性开角型青光眼或高眼压症中对曲伏前列素无应答/低应答患者的异丙基奥马曲班的降眼压作用:FUJI 研究。
Jpn J Ophthalmol. 2020 Jul;64(4):398-406. doi: 10.1007/s10384-020-00748-x. Epub 2020 Jun 22.
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Intraocular pressure and visual field changes in normal-tension glaucoma patients treated using either unoprostone or latanoprost: a prospective comparative study.使用 unoprostone 或拉坦前列素治疗的正常眼压性青光眼患者的眼压和视野变化:一项前瞻性比较研究。
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