Inazaki Hiroshi, Kobayashi Satoshi, Anzai Yoko, Satoh Hisayoshi, Sato Shimpei, Inoue Maiko, Yamane Shin, Kadonosono Kazuaki
Department of Ophthalmology and Microtechnology, Yokohama City University School of Medicine, Yokohama, Japan.
J Glaucoma. 2017 Feb;26(2):96-100. doi: 10.1097/IJG.0000000000000552.
The purpose of the study was to evaluate the intraocular pressure (IOP)-lowering effect and tolerability of ripasudil, a rho-kinase inhibitor, in patients with glaucoma inadequately controlled with maximum medical therapy.
This prospective, noncomparative, interventional case series study included 35 patients with primary open angle glaucoma, in whom the glaucoma was poorly controlled with maximum medical therapy before starting the treatment with ripasudil. Ripasudil was instilled twice a day as adjunctive therapy to the ongoing glaucoma treatment. The primary end point was the degree of IOP reduction after 3 months of treatment, whereas the secondary end points were the percentage of patients reaching the predefined target IOP and the incidence of adverse events.
We examined 35 eyes of 35 patients with primary open angle glaucoma. The IOP reduction (relative percentage IOP reduction) from baseline was -2.8 mm Hg (-15.5%; 95% confidence interval, -1.6 to -3.9 mm Hg; P<0.001) after 3 months of treatment. The predefined target IOP was achieved in 48.5% (17/35) of the patients. The adverse events were conjunctival hyperemia (all patients), allergic conjunctivitis (2 patients), and ophthalmalgia (1 patient).
The addition of ripasudil was effective in lowering the IOP in patients with glaucoma poorly controlled with maximal medical therapy; moreover, the drug was well tolerated. In 48.5% of the patients in whom the predefined target IOP was achieved, this adjunctive therapy helped avoid glaucoma surgery at least in the short term.
本研究旨在评估Rho激酶抑制剂法舒地尔对最大药物治疗后眼压控制不佳的青光眼患者的降眼压效果和耐受性。
这项前瞻性、非对照、干预性病例系列研究纳入了35例原发性开角型青光眼患者,这些患者在开始使用法舒地尔治疗前,最大药物治疗对青光眼的控制效果不佳。法舒地尔作为正在进行的青光眼治疗的辅助治疗,每天滴眼两次。主要终点是治疗3个月后的眼压降低程度,次要终点是达到预定目标眼压的患者百分比和不良事件的发生率。
我们检查了35例原发性开角型青光眼患者的35只眼。治疗3个月后,眼压较基线降低了-2.8 mmHg(-15.5%;95%置信区间为-1.6至-3.9 mmHg;P<0.001)。48.5%(17/35)的患者达到了预定的目标眼压。不良事件包括结膜充血(所有患者)、过敏性结膜炎(2例患者)和眼痛(1例患者)。
对于最大药物治疗后眼压控制不佳的青光眼患者,加用法舒地尔可有效降低眼压;此外,该药物耐受性良好。在48.5%达到预定目标眼压的患者中,这种辅助治疗至少在短期内有助于避免青光眼手术。