目的:评估0.1%奈帕芬胺与0.09%溴芬酸滴眼液控制钕钇铝石榴石(YAG)激光周边虹膜切开术(LPI)后炎症的安全性和有效性。
方法:单屏蔽,单中心,随机对照试验。
方法:接受双侧LPI的原发性闭角(PACS)和原发性闭角(PAC)患者的一百六十只眼。
方法:患者以1:1的比例随机分配,在钕YAGLPI后每天三次接受0.1%奈帕芬酸滴眼液或每天两次接受0.09%溴芬酸滴眼液,持续2周。LPI后2周由蒙面研究者进行评估。在基线和LPI后2周进行青光眼症状量表(GSS)问卷调查。LPI后2周,根据Likert量表评估研究药物的主观舒适度评分。在双侧PACS或PAC患者中,分析了右眼,和不对称疾病(即,当一只眼睛有PACS而另一只眼睛有PAC时),对患有PAC的眼睛进行了分析。
方法:主要结局(终点)是未控制的炎症,定义为LPI后1周内有症状的炎症,2周前房细胞的存在,或停药后反弹炎症。次要结果是根据GSS和Likert量表,患者报告的研究药物舒适度。
结果:在LPI后2周,奈帕芬胺组的7例患者(6例PACS和1例PAC)和溴芬酸组的2例PACS患者达到了主要终点,药物组之间无差异(P=0.09)。LPI燃烧后,聪明,并且刺痛在溴芬酸组中更为常见(P=0.01),在Likert量表上也有较高的舒适度评分(P=0.004)。重复LPI的需求相当(奈帕芬胺组的10.0%与溴芬酸组为15.4%;P=0.22)。多变量分析显示,更多的激光射击与需要重复LPI(优势比,1.05;95%置信区间,1.00-1.10;P=0.04)。
结论:在用PACS和PAC进行LPI治疗后,局部用0.09%溴芬酸控制炎症的效果不劣于0.1%奈帕芬胺。Nepafenac可能与患者报告的较高舒适度相关。
OBJECTIVE: To assess the safety and efficacy of 0.1% nepafenac versus 0.09% bromfenac eye drops in controlling inflammation after neodymium yttrium-aluminum-garnet (YAG) laser peripheral iridotomy (LPI).
METHODS: Single-masked, single-center, randomized controlled
trial.
METHODS: One hundred and sixty eyes of patients with primary angle-closure suspect (PACS) and primary angle closure (PAC) undergoing bilateral LPI.
METHODS: Patients were randomized in a 1:1 ratio to receive 0.1% nepafenac thrice daily or 0.09% bromfenac eye drops twice daily for 2 weeks after neodymium YAG LPI. Assessment was performed by masked investigators at 2 weeks after LPI. A Glaucoma Symptom Scale (GSS) questionnaire was administered both at baseline and 2 weeks after LPI. Subjective comfort scores to the
study medications were assessed on the basis of a Likert scale at 2 weeks after LPI. In patients with bilateral PACS or PAC, the right eye was analyzed, and in asymmetrical disease (i.e., when one eye had PACS and the other eye had PAC), the eye with PAC was analyzed.
METHODS: The primary outcome (end point) was uncontrolled inflammation, defined as symptomatic inflammation within 1 week after LPI, the presence of anterior chamber cells at 2 weeks, or rebound inflammation after medication discontinuation. The secondary outcome was patient-reported comfort levels with
study medications based on the GSS and Likert scale.
RESULTS: At 2 weeks after LPI, 7 patients (6 with PACS and 1 with PAC) in the nepafenac group and 2 patients with PACS in the bromfenac group achieved the primary end point, without a difference between the medication groups (P = 0.09). Post-LPI burning, smarting, and stinging was more common in the bromfenac group (P = 0.01), which also had a higher comfort score on the Likert scale (P = 0.004). The need for repeat LPI was comparable (10.0% in the nepafenac group vs. 15.4% in the bromfenac group; P = 0.22). A multivariate analysis revealed that a greater number of laser shots was associated with the need for repeat LPI (odds ratio, 1.05; 95% confidence interval, 1.00-1.10; P = 0.04).
CONCLUSIONS: Topical 0.09% bromfenac is noninferior to 0.1% nepafenac in controlling inflammation after LPI in eyes with PACS and PAC. Nepafenac may be associated with higher patient-reported comfort.