国产拉坦前列素滴眼液对POAG和高眼压症的降眼压疗效及安全性多中心研究

背景 拟前列腺素滴眼液是治疗青光眼,尤其是开角型青光眼的一线药物,但价格较高.国产的类似药物拉坦前列素滴眼液已应用于临床,但大样本、多中心的疗效和安全性评价鲜有报道. 目的 采用多中心观察性研究方法评价国产拉坦前列素滴眼液治疗原发性开角型青光眼（POAG）和高眼压症的临床疗效及安全性.方法 采用多中心观察性研究方法,按照统一的纳入标准和排除标准在中国5个地区25家医院纳入确诊的POAG及高眼压症患者576例837眼,其中POAG患者524例755眼,高眼压症患者52例82眼.本研究经广州军区武汉总医院伦理委员会批准实施,所有患者均知情同意并签署知情同意书.患者每晚用0.05 g/L国产拉坦前列素滴眼液点眼1次,用药3个月,主要观察指标为眼压控制情况,次要观察指标为视力、血压、脉搏、眼部症状和体征,采用用药前后自身对照的方法评价药物的疗效及安全性.结果 患者用药后1、2、3个月的眼压分别为（19.66±5.46）、（19.59±7.86）和（19.35±5.03）mmHg（1 mmHg=0.133 kPa）,均较用药前的（28.36±7.86） mmHg明显下降,各时间点眼压值的总体差异有统计学意义（F=748.325,P=0.000）,其中治疗后各时间点的眼压值均明显低于治疗前,差异均有统计学意义（P＜0.001）;用药后1、2、3个月眼压的平均下降幅度分别为（30.43±7.18）％、（30.19±8.72）％和（30.71±9.90）％.治疗后1、2、3个月显效率分别为95.70％、91.76％和88.05％.用药后3个月出现结膜持续充血者占13％,但不妨碍继续用药,未发现与药物相关的全身及其他眼部不良反应.结论 国产拉坦前列素滴眼液可有效降低眼压,安全性好,为治疗开角型青光眼及高眼压症提供了新的选择.

Multicenter trial of therapeutic efficacy and safety of domestic latanoprost on primary open angle glaucoma and ocular hypertension

Background Prostaglandin eye drops is front-line medicines of lowing intraocular pressure for primary open angle glaucoma （POAG）,but its price is higher for long-term application.Domestic latanoprost drops has been applied in clinic.However,its trial of lowing intraocular pressure effect and safety from sizable sample and multi-center is lack.Objective This study was to observe the efficacy and safety of domestic latanoprost for POAG and ocular hypertension.Methods This prospective,multicenter trial was conducted at 25 hospitals in 5 territories of China,and 837 eyes of 576 patients with POAG and ocular hypertension were recruited in the hospitals based on the uniform criteria.Domestic latanoprost drops was topically used once per day at night for 3 months.Intraocular pressure （IOP） was measured 1 month and 2 months,3 months to assess the efficacy of drug,and vision acuity,blood pressure,pulse,ocular symptoms and signs were observed to evaluate the safety of the drug.This study approved by the Ethics Committee of Wuhan General Hospital of Guangzhou Military Command,and all patients were informed consent and signed informed consent.Results IOP was （28.36±7.86）,（19.66±5.46）,（19.59±7.86） and （19.35 ± 5.03） mmHg in pretreatment and posttreatment 1 month,2 months and 3 months,respectively,showing a significant difference among various time points （F =748.325,P =0.000）,and the IOPs were markedly lower in posttreatment than those in pretreatment （all at P＜0.001）.The falling range of IOP was （30.43 ±7.18）％,（30.19 ± 8.72）％,（30.71±9.90） ％ in posttreatment 1 month,2 months and 3 months,respectively.The efficiency was 95.70％,91.76％ and 88.05％ in 1 month,2 months and 3 months.Conjunctival hyperemia was observed in 13％ eyes at the end of following-up.No drug-related systemic and other ocular adverse reactions were found.Conclusions Domestic latanoprost drops can low IOP effectively without serious adverse reaction in POAG and ocular hypertensive patients.