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卤替泼诺眼部凝胶 0.5%:在眼部手术后炎症和疼痛中的应用评价。

Loteprednol etabonate ophthalmic gel 0.5%: a review of its use in post-operative inflammation and pain following ocular surgery.

机构信息

Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand.

出版信息

Drugs. 2013 Jun;73(9):949-58. doi: 10.1007/s40265-013-0073-8.

DOI:10.1007/s40265-013-0073-8
PMID:23740411
Abstract

Loteprednol etabonate ophthalmic gel 0.5% (Lotemax(®)) is approved in the USA for the treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. The new gel formulation of loteprednol etabonate offers some potential advantages over the previously available ophthalmic suspension and ointment formulations of the drug. Because the gel is non-settling, a uniform dose of loteprednol etabonate is delivered without the need to vigorously shake the product. The pH of the gel formulation is close to that of physiological tears and the concentration of preservative is low. In clinical trials, loteprednol etabonate ophthalmic gel 0.5% for 14 days was effective, very well tolerated and safe when used for the treatment of post-operative inflammation and pain following cataract surgery. Relative to vehicle, loteprednol etabonate ophthalmic gel 0.5% effectively reduced postoperative ocular inflammation and ocular pain and had a similar overall tolerability, comfort and safety profile. It is associated with a low risk of inducing clinically significant increases in intraocular pressure. In conclusion, loteprednol etabonate ophthalmic gel 0.5% is an additional formulation option for the short-term treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. It provides uniform dosing of a topical ophthalmic corticosteroid that has been demonstrated to be effective and well-tolerated in the treatment of ocular inflammation.

摘要

0.5% 卤替泼诺酯眼用凝胶(Lotemax(®))在美国被批准用于治疗接受眼部手术后的炎症和疼痛。卤替泼诺酯的新凝胶制剂相对于先前可用的该药物的眼用混悬液和眼膏制剂具有一些潜在优势。由于凝胶不会沉降,因此无需剧烈摇晃产品即可提供均匀剂量的卤替泼诺酯。凝胶制剂的 pH 值接近生理泪液,且防腐剂浓度较低。在临床试验中,使用 0.5% 卤替泼诺酯眼用凝胶治疗白内障手术后的炎症和疼痛,14 天有效,耐受性良好,安全性高。与载体相比,0.5% 卤替泼诺酯眼用凝胶可有效减轻术后眼部炎症和疼痛,且总体耐受性、舒适度和安全性相似。它引起眼内压显著升高的风险较低。总之,0.5% 卤替泼诺酯眼用凝胶是用于治疗接受眼部手术的患者术后炎症和疼痛的另一种短期治疗选择。它提供了一种已被证明在治疗眼部炎症方面有效且耐受性良好的局部眼用皮质类固醇的均匀剂量。

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本文引用的文献

1
Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop.开发一种用于抗炎的0.5%氯替泼诺混悬凝胶制剂,用作眼药水。
Clin Ophthalmol. 2013;7:299-312. doi: 10.2147/OPTH.S40588. Epub 2013 Feb 13.
2
Loteprednol etabonate 0.5% versus prednisolone acetate 1.0% for the treatment of inflammation after cataract surgery.白内障手术后炎症的治疗:洛度沙胺滴眼液 0.5%与醋酸泼尼松龙滴眼液 1.0%的疗效比较。
J Cataract Refract Surg. 2013 Feb;39(2):168-73. doi: 10.1016/j.jcrs.2012.10.039. Epub 2012 Dec 8.
3
Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery.
Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery.
Loteprednol 乙二酸酯(亚微米)眼用凝胶 0.38%:用于眼部手术后炎症和疼痛的综述。
Clin Drug Investig. 2020 Apr;40(4):387-394. doi: 10.1007/s40261-020-00899-2.
白内障手术后眼部炎症和疼痛的治疗中,使用 0.5%洛度沙胺眼用凝胶的疗效和安全性。
J Cataract Refract Surg. 2013 Feb;39(2):158-67. doi: 10.1016/j.jcrs.2012.09.013. Epub 2012 Dec 3.
4
Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial.0.5%氯替泼诺依碳酸酯凝胶用于白内障手术后的疼痛和炎症:一项多中心试验的结果
Clin Ophthalmol. 2012;6:1113-24. doi: 10.2147/OPTH.S32643. Epub 2012 Jul 18.
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Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use.0.5%氯替泼诺妥布酯眼用混悬液:术后抗炎使用的疗效与安全性。
Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
6
Advances in corticosteroid therapy for ocular inflammation: loteprednol etabonate.眼部炎症皮质类固醇治疗的进展:氯替泼诺酯。
Int J Inflam. 2012;2012:789623. doi: 10.1155/2012/789623. Epub 2012 Mar 28.
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A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis.一项多中心、随机、平行分组的临床试验,比较了 loteprednol etabonate 0.5%/tobramycin 0.3%与 dexamethasone 0.1%/tobramycin 0.3%在治疗中国患者的睑缘角膜结膜炎中的安全性和疗效。
Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.
8
Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery.0.5%氯替泼诺依碳酸酯眼膏治疗白内障术后炎症和疼痛的安全性及有效性。
Clin Ophthalmol. 2011;5:177-86. doi: 10.2147/OPTH.S16832. Epub 2011 Feb 10.
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Attenuation of ocular hypertension with the use of topical loteprednol etabonate 0.5% in steroid responders after corneal transplantation.角膜移植术后应用局部 loteprednol etabonate 0.5%治疗类固醇反应性患者的眼压升高。
Cornea. 2009 Dec;28(10):1139-43. doi: 10.1097/ICO.0b013e3181a3c52f.
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Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers.氯替泼诺/妥布霉素与地塞米松/妥布霉素对健康志愿者眼压的影响。
Cornea. 2008 Jan;27(1):50-5. doi: 10.1097/ICO.0b013e31815873c7.