多佐胺/噻吗洛尔固定复方制剂与拉坦前列素对正常眼压性青光眼患者眼压和眼灌注压影响的比较：一项随机交叉临床试验
Comparison of the Effects of Dorzolamide/Timolol Fixed Combination versus Latanoprost on Intraocular Pressure and Ocular Perfusion Pressure in Patients with Normal-Tension Glaucoma: A Randomized, Crossover Clinical Trial.
作者信息
Lee Na Young, Park Hae-Young Lopilly, Park Chan Kee
机构信息
Department of Ophthalmology and Visual Science, College of Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea.
Department of Ophthalmology and Visual Science, College of Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
出版信息
PLoS One. 2016 Jan 12;11(1):e0146680. doi: 10.1371/journal.pone.0146680. eCollection 2016.
BACKGROUD
To assess the noninferiority of a dorzolamide-timolol fixed combination (DTFC) versus latanoprost in terms of intraocular pressure (IOP) and to compare blood pressure (BP), ocular perfusion pressure (OPP) and diastolic ocular perfusion pressure (DOPP) between the latanoprost and DTFC groups in patients with normal-tension glaucoma (NTG).
METHODS
Prospective, interventional, randomized, single-blinded, crossover design study. Patients with newly diagnosed NTG that had not been treated with a glaucoma medication in the most recent 2 months were recruited. In total, 44 patients with NTG were randomly allocated to one of two groups. Patients in group A were treated with DTFC, lubricant, and latanoprost for 4 weeks each, whereas patients in group B were treated with latanoprost, lubricant, and DTFC for 4 weeks each. Patients were examined on day 1 (without medication), week 4 (under medication), week 8 (without medication), and week 12 (under medication). At weeks 4 and 12, diurnal IOP, systolic and diastolic BP, and OPP were measured at 8:00 AM, 10:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM.
RESULTS
Baseline demographic characteristics showed no difference in terms of age, sex, central corneal thickness, spherical equivalent, or stage of glaucoma between the groups. The between-group difference was -0.19 ± 0.18 mmHg (mean ± SE, upper bound of one-sided 95% CI, 0.12). Diurnal IOP showed no difference between the groups with an average IOP reduction of 13.1% using latanoprost and 12.3% using DTFC. Diurnal systolic and diastolic BP were lower in the DTFC group than the latanoprost group; however, the difference between the groups was not statistically significant. Diurnal OPP and DOPP also showed no statistically significant difference between the groups.
CONCLUSIONS
IOP lowering efficacy of DTFC was noninferior to that of latanoprost in newly diagnosed NTG patients. There was no difference in BP, OPP, or DOPP between the latanoprost and DTFC groups. This prospective, randomized, single-blinded, crossover study demonstrated the noninferiority of DTFC versus latanoprost in terms of IOP in patients with NTG.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01175902.
背景
评估多佐胺-噻吗洛尔固定复方制剂（DTFC）与拉坦前列素在降低眼压（IOP）方面的非劣效性，并比较正常眼压性青光眼（NTG）患者中拉坦前列素组与DTFC组之间的血压（BP）、眼灌注压（OPP）和舒张期眼灌注压（DOPP）。
方法
前瞻性、干预性、随机、单盲、交叉设计研究。招募最近2个月内未接受过青光眼药物治疗的新诊断NTG患者。总共44例NTG患者被随机分配到两组中的一组。A组患者分别接受DTFC、润滑剂和拉坦前列素治疗，各治疗4周；而B组患者分别接受拉坦前列素、润滑剂和DTFC治疗，各治疗4周。在第1天（未用药）、第4周（用药中）、第8周（未用药）和第12周（用药中）对患者进行检查。在第4周和第12周，于上午8:00、上午10:00、中午12:00、下午4:00和晚上8:00测量昼夜眼压、收缩压和舒张压以及眼灌注压。
结果
基线人口统计学特征显示，两组在年龄、性别中央角膜厚度、等效球镜度或青光眼分期方面无差异。组间差异为-0.19±0.18 mmHg（均值±标准误，单侧95%CI上限为0.12）。昼夜眼压在两组间无差异，使用拉坦前列素时眼压平均降低13.1%，使用DTFC时眼压平均降低12.3%。DTFC组的昼夜收缩压和舒张压低于拉坦前列素组；然而，两组之间的差异无统计学意义。昼夜眼灌注压和舒张期眼灌注压在两组间也无统计学显著差异。
结论
在新诊断的NTG患者中，DTFC降低眼压的疗效不劣于拉坦前列素。拉坦前列素组与DTFC组在血压、眼灌注压或舒张期眼灌注压方面无差异。这项前瞻性、随机、单盲、交叉研究证明了在NTG患者中DTFC在眼压方面不劣于拉坦前列素。
试验注册
ClinicalTrials.gov NCT01175902。
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