国产与进口拉坦前列素滴眼液降眼压作用的短期效果比较

The short-term lowering intraocular pressure effect of domestic latanoprost and Xalatan in patients with primary open angle glaucoma or ocular hypertension

目的比较国产与进口拉坦前列素滴眼液的短期降眼压效果。设计随机、开放、平行对照的临床研究。研究对象原发性开角型青光眼患者和高眼压症患者42例。方法对上述患者按所用药物的不同依随机表法分为A、B两组。A组28例(28眼),滴用国产拉坦前列素滴眼液(特力洁),B组14例(14眼),滴用进口拉坦前列素滴眼液(适利达),均为每日1次,每次1滴,共28天。受试者于入组当日及用药后第28天8:00、11:00、14:00、16:00测眼压,第7、14、21天则于8:00测眼压。眼压测量采用Goldmann压平眼压计,测量3次取平均值。裂隙灯显微镜观察角膜、虹膜、晶状体情况。主要指标眼压值。结果 A组用药前眼压为(23.99±1.51)mm Hg,用药后1～4周眼压分别为(18.04±1.27)mm Hg、(17.75±1.43)mm Hg、(17.63±1.50)mm Hg、(17.49±1.47)mm Hg,用药后眼压明显下降,与用药前相比差异有统计学意义(F=105.72,P=0.000)。B组用药前眼压为(24.37±1.55)mm Hg,用药后1～4周眼压分别为(17.91±1.35)mm Hg、(17.71±1.39)mm Hg、(17.55±1.34)mm Hg、(17.44±1.17)mm Hg,与用药前相比,用药后眼压明显下降,差异有统计学意义(F=67.85 P=0.000)。A、B两组用药前眼压比较无显著性差异(P=0.43),用药后1～4周两组眼压比较无显著性差异(P值分别为0.76、0.93、0.86、0.89)。入组当日8:00、11:00、14:00、16:00 A、B两组眼压之间的比较无显著性差异(P值分别为0.46、0.44、0.50、0.31),用药后28天8:00、11:00、14:00、16:00 A、B两组眼压之间的比较无显著性差异(P值分别为0.89、0.85、0.94、0.98)。用药28天时两组患者角膜、虹膜、晶状体均无异常改变。结论本文的小样本、短期研究显示,国产拉坦前列素与进口拉坦前列素均能有效降低原发性开角型青光眼及高眼压症患者的眼压,两者之间的降眼压效果无显著差异。

Objective To investigate the short-term lowering intraocular pressure（IOP） effect between domestic latanoprost eye drops and Xalatan eye drops.Design A randomized,open,parallel control study.Participants Primary open angle glaucoma patients（POAG） and ocular hypertension（OHT） patients.Method Forty-two patients with POAG or OHT were randomly divided into two groups： Group A,28 eyes of 28 patients,received domestic latanoprost eye drops.Group B,14 eyes of 14 patients,received Xalatan eye drops.The IOP was measured at 8：00,11：00,14：00,16：00 at the first day the 28th day after the eye drops was given.The IOP was measured at 8：00 at the 7th,14th and 21th day.The IOP was measured three times with Goldmann tonometer and an average value was obtained.Cornea,iris and lens were observed with slit lamp.Main Outcome Measures IOP.Results The baseline IOP in group A was 23.99± 1.54 mmHg.The IOP was 18.04±1.27 mmHg,17.75±1.43 mmHg,17.63±1.50 mmHg,17.49±1.47 mmHg after 1,2,3 and 4 weeks respectively.Significant difference was found between baseline IOP and IOP at any time point after eye drops used（F=105.72,P=0.000）.The baseline IOP in group B was 24.37±1.55 mmHg.The IOP was 17.91±1.35 mmHg,17.71±1.39 mmHg,17.55±1.34 mmHg,17.44± 1.17 mmHg after 1,2,3 and 4 weeks respectively.Significant difference was found between baseline IOP and IOP at any time point after eye drops used（F=67.85,P=0.000）.No significant difference was found between baseline IOP in group A and in group B（P=0.43）.No significant difference was found at any time point between group A and group B after 1,2,3 and 4 weeks（P= 0.76,0.93,0.86,0.89 respectively）.No significant difference was found between group A and group B in IOP at the time point 8：00,11：00,14：00,16：00 be-fore eye drops instilling（P= 0.46,0.44,0.50,0.31）.And also no significant difference was found between group A and group B in IOP at the time point 8：00,11：00,14：00,16：00 after eye drops instilling（P= 0.89,0.85,0.94,0.98）.No abnormality was found in cornea,iris and lens at 28 days after medication in both groups.Conclusion This smalll sample and short-term study shows both the domestic latanoprost and Xalatan eye drops can effectively lower IOP in POAG and OHT patients,and no significant difference was found between them.