关键词: Clinical Trial Glaucoma Intraocular pressure

Mesh : Humans Trabeculectomy / methods Male Intraocular Pressure / drug effects Prospective Studies Female Glaucoma, Open-Angle / surgery drug therapy Isoquinolines / therapeutic use administration & dosage Aged Sulfonamides / therapeutic use administration & dosage Mitomycin / therapeutic use administration & dosage Middle Aged rho-Associated Kinases / antagonists & inhibitors Treatment Outcome Alkylating Agents / administration & dosage therapeutic use

来  源:   DOI:10.1136/bmjophth-2023-001449   PDF(Pubmed)

Abstract:
BACKGROUND: To investigate if there are improvements in trabeculectomy outcomes supporting filtration bleb formation caused by Rho-associated protein kinase (ROCK) inhibitors.
METHODS: This prospective, multicentre, randomised, open-label clinical study examined open-angle glaucoma patients who underwent trabeculectomy or trabeculectomy combined with cataract surgery followed by 3-month postoperative ripasudil treatments. After randomly allocating patients to ripasudil-ROCK inhibitor (ripasudil) or without ripasudil (non-ripasudil) groups. Mean intraocular pressure (IOP) changes, success rate, and number of eyedrops were compared for both groups.
RESULTS: A total of 17 and 15 subjects dropped out in the ripasudil group and non-ripasudil group, respectively. At baseline, the mean IOP was 16.8±5.0 mm Hg in the ripasudil group (38 patients) and 16.2±4.4 in the non-ripasudil group (52 patients). The IOP decreased to 11.4±3.2 mm Hg, 10.9±3.9 mm Hg and 10.6±3.5 mm Hg at 12, 24 and 36 months in the ripasudil group, while it decreased to 11.2±4.1 mm Hg, 10.5±3.1 mm Hg and 10.9±3.2 mm Hg at 12, 24 and 36 months in the non-ripasudil group, respectively. There was a significant decrease in the number of IOP-lowering medications after trabeculectomy in the ripasudil group versus the non-ripasudil group at 24 (p=0.010) and 36 months (p=0.016). There was no statistically significant difference between the groups for the 3-year cumulative probability of success.
CONCLUSIONS: Although ripasudil application did not increase the primary trabeculectomy success rate, it did reduce IOP-lowering medications after trabeculectomy with mitomycin C.
摘要:
背景:研究支持Rho相关蛋白激酶(ROCK)抑制剂引起的滤过泡形成的小梁切除术结果是否有改善。
方法:这种前瞻性,多中心,随机化,开放标签临床研究检查了接受小梁切除术或小梁切除术联合白内障手术的开角型青光眼患者,随后接受术后3个月的rapasudil治疗.在将患者随机分配至利帕舒地尔-ROCK抑制剂(利帕舒地尔)或不使用利帕舒地尔(非利帕舒地尔)组之后。平均眼内压(IOP)变化,成功率,比较两组的滴眼液数量。
结果:在利帕舒地尔组和非利帕舒地尔组共有17和15名受试者退出,分别。在基线,利帕舒地尔组(38例)和非利帕舒地尔组(52例)的平均IOP为16.8±5.0mmHg.眼压下降至11.4±3.2mmHg,利帕舒地尔组在12、24和36个月时分别为10.9±3.9mmHg和10.6±3.5mmHg,下降到11.2±4.1mmHg,在12、24和36个月时,非利帕舒地尔组10.5±3.1mmHg和10.9±3.2mmHg,分别。在24个月(p=0.010)和36个月(p=0.016),里帕苏地尔组与非里帕苏地尔组相比,小梁切除术后降低IOP的药物数量显着减少。两组之间的3年累积成功概率没有统计学上的显着差异。
结论:尽管使用里帕舒地尔并没有增加原发性小梁切除术的成功率,丝裂霉素C小梁切除术后,它确实减少了降低IOP的药物。
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