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作 者:袁志兰[1] 孙红[1] 王理理[2] 王林农[3] 于浩[4]
机构地区:[1]南京医科大学第一附属医院眼科,中国江苏省南京市1210029 [2]南京军区南京总医院眼科,中国江苏省南京市2210002 [3]南京市第一医院眼科,中国江苏省南京市3210006 [4]南京医科大学统计教研室,中国江苏省南京市210029
出 处:《国际眼科杂志》2006年第5期1066-1068,共3页International Eye Science
摘 要:目的:比较国产酒石酸溴莫尼定滴眼液(brimonidinetar-trateeyedrops)与进口同类药品阿法根滴眼液治疗青光眼和高眼压症的临床疗效及安全性。方法:原发性开角型青光眼或高眼压症患者240例,多中心随机双盲分成试验组(2g/L国产酒石酸溴莫尼定滴眼液)和对照组(阿法根滴眼液)。两组均每日点药2次(08∶00和20∶00),每次1滴。将点第1滴药后2h的眼压及连续点药后1,2,4wk的眼压与基线眼压进行比较研究,同时观察血压、心率等全身及局部副作用。结果:试验组点药前平均眼压为23.74±4.77mmHg,点1滴药后2h平均眼压为19.38±4.51mmHg(下降17.58%),连续点药1wk平均眼压为18.34±4.57mmHg(下降22.19%),2wk平均眼压为18.42±4.32mmHg(下降21.73%),4wk平均眼压为18.56±4.46mmHg(下降21.06%);对照组点药前平均眼压为24.54±5.66mmHg点1滴药后2h平均眼压为20.60±5.70mmHg(下降15.46%),连续点药1wk平均眼压为19.79±6.50mmHg(下降18.82%),2wk平均眼压为19.46±5.05mmHg(下降19.59%),4wk平均眼压为19.73±5.68mmHg(下降18.73%),经统计学处理两组之间降眼压效果无显著性差异。试验组和对照组均无明显的局部和全身不良反应发生。结论:国产2g/L酒石酸溴莫尼定滴眼液与阿法根滴眼液用于治疗原发性开角性青光眼与高眼压症,两者降眼压效果相似,全身和局部副作用小。AIM: To evaluate the ocular hypotensive efficacy and safety of domatic brimonidine tartrate 2g/L compared with Alphagan to treat primary openangle glaucoma (POAG) or ocular hypertension. METHODS: Two hundred and forty patients with POAG or ocular hypertension were randomly divided into two groups: trial group (domatic brimonidine tartrate eye drops 2g/L) and control group (Alphagan). One drop was instilled to patients twice daily (at 8:00 AM and 8:00 PM). Intraocular pressure (IOP) at 2 hours after instilling the first dose, and 1, 2 and 4 weeks after sustained instilling were compared with the baseline. On the other hand, systematic and local adverse effects were also observed. RESULTS: In trial group, the mean IOP was 23.74 + 4.77mmHg at baseline, 19.38 + 4.51mmHg (decreased 17.58%) at 2 hours after instilling the first dose, 18.34+ 4.57mmHg (decreased 22.19%) at i week after sustained instilling, 18.42+ 4.32mmHg (decreased 21.73%) at 2 weeks after sustained instilling, 18.56 + 4.46mmHg (decreased 21.06%) at 4 weeks after sustained instilling, respectively. In control group, the mean IOP was 24.54+ 5.66mmHg, 20.60+ 5.70mmHg (decreased 15.46% ), 19.79+ 6.50mmHg (decreased 18.82%), 19.46+ 5.05mmHg (decreased 19.59%), 19.73+ 5.68mmHg (decreased 18.73% ), respectively. The difference between two groups in ocular hypotensive efficacy was not significant. No systematic and local adverse effects were observed in these two groups. CONCLUSION: Instilling domatic brimonidine tartrate eye drops twice daily shows ocular hypotensive efficacy similar to Alphagan, and a similarly rate of systematic and local adverse effects.
关 键 词:国产酒石酸溴莫尼定滴眼液 阿法根 治疗 青光眼药物
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