A 12 month, randomized, double masked study comparing latanoprost with timolol in pigmentary glaucoma
A 12 month, randomized, double masked study comparing latanoprost with timolol in pigmentary glaucoma
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DOI：
10.1016/s0161-6420(99)90115-x
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发表时间：
1999-03-01
期刊：
影响因子：
13.7
通讯作者：
Gallenga, PE
中科院分区：
文献类型：
--
作者：
Mastropasqua, L;Carpineto, P;Gallenga, PE
目的：比较0.005%拉坦前列素每日一次局部应用与0.5%噻吗洛尔每日两次给药治疗色素性青光眼患者12个月的疗效、副作用以及对房水动力学的影响。设计：前瞻性、随机、双盲、临床研究。36名患有双侧色素性青光眼的患者被纳入该研究，这些患者仅用一种以上的镇静药物进行控制。样本人群被随机分为2个年龄和性别匹配的组，每组18名患者。第1组接受0.005%拉坦前列素滴眼液，每天一次和车辆（安慰剂），每天一次;组2被分配到噻吗洛尔0.5%滴眼液，每天两次。主要结果措施：昼夜曲线的眼内压（IOP）进行基线日和治疗后0.5，3，6，12个月。在上午8：00、中午12：00、下午4：00和下午8：00进行IOP测量。在基线日和研究的最后一天使用Schiotz电子眼压计测量流出量（“C”）。使用配对或非配对数据的双尾Student t检验对治疗和基线值之间或拉坦前列素和噻吗洛尔组之间的差异进行统计学评价。逐小时比较昼夜IOP测量值。结果：拉坦前列素和噻吗洛尔均能显著降低眼压（P < 0.001）。6个月和12个月后，拉坦前列素组的IOP降低分别为6.0 +/- 4.5和5.9 +/- 4.6，噻吗洛尔组分别为4.8 +/- 3.0和4.6 +/- 3.1。比较拉坦前列素和噻吗洛尔的平均昼夜测量值，在3、6和12个月时显示统计学显著性差异（P < 0.001）。仅在拉坦前列素治疗组中发现平均“C”与基线相比显著增强（+30%）（P = 0.017）。拉坦前列素治疗眼的平均结膜充血分级为0.3，噻吗洛尔治疗眼为0.2。在18例接受拉坦前列素治疗的患者中，1例患者的双眼观察到虹膜颜色发生显著变化，而接受噻吗洛尔治疗的18例患者中无一例发生虹膜颜色显著变化。在2例接受拉坦前列素治疗的患者中，怀疑周边虹膜基质变暗。在噻吗洛尔组中，心率从基线时的72 +/- 9次/分钟显著降低至12个月时的67 +/- 10次/分钟。虽然进一步的研究可能需要在更大的样本上证实这些数据，并在长期随访中评估虹膜色素沉着增加的副作用，但在色素性青光眼患者中，0.005%拉坦前列素每日一次给药耐受性良好，与0.5%噻吗洛尔每日两次给药相比，降低IOP更有效。
Objective: To compare the efficacy and side effects and the effect on aqueous humor dynamics of 0.005% latanoprost applied topically once daily with 0.5% timolol given twice daily for 12 months to patients with pigmentary glaucoma.Design: Prospective, randomized, double-masked, clinical study.Participants: Thirty-six patients affected with bilateral pigmentary glaucoma controlled with no more than a single hypotensive medication were enrolled in the study.Intervention: The sample population was randomly divided into 2 age- and gender-matched groups each of 18 patients. Group 1 received 0.005% latanoprost eyedrops once daily and the vehicle (placebo) once daily; group 2 was assigned to timolol 0.5% eyedrops twice daily.Main Outcome Measures: Diurnal curves of intraocular pressure (IOP) were performed on the baseline day and after 0.5, 3, 6, and 12 months of treatment. The IOP measurements were performed at 8:00 AM, 12:00 noon, 4:00 PM, and 8:00 PM. Outflow facility ("C") was measured on the baseline day and on the last day of the study with a Schiotz electronic tonometer. A two-tailed Student's t test for paired or unpaired data was used for statistical evaluation of differences between treatment and baseline values or between the latanoprost and timolol group. Diurnal IOP measurements were compared hour by hour. Mean values of the two eyes IOP and "C" were used for analysis.Results: Compared with baseline measurements, both latanoprost and timolol caused a significant (P < 0.001) reduction of IOP at each hour of diurnal curve throughout the duration of therapy. Reduction of IOP was 6.0 +/- 4.5 and 5.9 +/- 4.6 with latanoprost and 4.8 +/- 3.0 and 4.6 +/- 3.1 with timolol after 6 and 12 months, respectively. Comparison of mean diurnal measurements with latanoprost and timolol showed a statistical significant (P < 0.001) difference at 3, 6, and 12 months. Mean "C" was found to be significantly enhanced (+30%) only in the latanoprost-treated group compared with the baseline (P = 0.017). Mean conjunctival hyperemia was graded at 0.3 in latanoprost-treated eyes and 0.2 in timolol-treated eyes. A remarkable change in iris color was observed in both eyes of 1 of the 18 patients treated with latanoprost and none of the 18 patients who received timolol. Darkening of the peripheral iris stroma was suspected in two patients treated with latanoprost. In the timolol group, heart rate was significantly reduced from 72 +/- 9 at baseline to 67 +/- 10 beats per minute at 12 months.Conclusions: Although further studies may need to confirm these data on a larger sample and to evaluate the side effect of increased iris pigmentation on long-term follow-up, in patients with pigmentary glaucoma, 0.005% latanoprost taken once daily was well tolerated and more effective in reducing IOP than 0.5% timolol taken twice daily.