目的：比较白内障患者术前局部应用0.1%双氯芬酸与0.1%奈帕芬胺的疼痛度和抗炎疗效。

方法：该前瞻性随机临床试验于2017/06-08在Dr. Yap眼科医院进行。共56例患者诊断为老年性白内障并接受超声乳化术，未出现并发症。受试者按术前应用滴眼剂分为两组(双氯芬酸组和奈帕芬胺组)。炎症特征(第1，7和14d随访)如疼痛度、结膜充血、眼睑痉挛、房水闪辉和细胞水平为主要结果，而角膜内皮细胞密度和形态为次要观察结果。

结果：术后1d(分别为P=0.284， 效应量=0.29， 95% CI=-0.09～0.31； P=0.254， 效应量=0.31， 95% CI=-0.13～0.49)和7d(P=1.000 和 P=0.556， 效应量=0.18， 95% CI=-0.08～0.16)，两组间结膜充血和眼睑痉挛水平无统计学差异。奈帕芬胺组疼痛指数(术中及术后1、4d)显著低于双氯芬酸组(分别为P=0.006， 效应量=0.77， 95% CI=0.24～1.34； P=0.045， 效应量=0.39， 95% CI=-0.10～0.62； P=0.014， 效应量=0.69， 95% CI=-0.06～0.50)。术后1d奈帕芬胺组房水闪辉和细胞水平较低(P=0.029， 效应量=0.59， 95% CI=0.02～0.36)。两组间角膜内皮密度降低无统计学差异，而术后7d奈帕芬胺组六角形细胞比例减少较多(P=0.042， 效应量=-0.55， 95% CI=-2.33 ～ -0.03)。

结论：与双氯芬酸组相比，奈帕芬胺组疼痛度和房水闪辉细胞值较低。

METHODS: This research was designed as prospective randomized clinical trial and conducted in June to August 2017 at Dr. Yap Eye Hospital. There were 56 subjects underwent phacoemulsification operation(single operator)and diagnosed as senile cataract and no adverse events were found. Subjects were divided into 2 groups according to preoperative eye drop medication, namely Diclofenac group and Nepafenac group. Participants and phaco-surgeon were blind regarding to the treatment. Inflammation parameters(at 1, 7 and 14d follow up)such as pain, conjunctiva hyperemic, blepharospasm, flare and cell in anterior chamber level as the primary outcome, whereas density and morphology of corneal endothelial cells as the secondary outcome.

RESULTS: There were no statistically difference in conjunctiva hyperemic and blepharospasm level between 2 groups at 1d(P=0.284, effect size=0.29, 95% CI=-0.09 to 0.31; P=0.254, effect size=0.31, 95% CI=-0.13 to 0.49, respectively)and 7d(P=1.000 and P=0.556, effect size=0.18, 95% CI=-0.08 to 0.16, respectively)postoperatively. The pain scores(during surgery, 1d and 14d postoperative)in Nepafenac group was statistically lower than Diclofenac group(P=0.006, effect size=0.77, 95% CI=0.24 to 1.34; P=0.045, effect size=0.39, 95% CI=-0.10 to 0.62; and P=0.014, effect size=0.69, 95% CI=-0.06 to 0.50, respectively). The degree of flare and cell in Nepafenac group was lower at the 1d after phacoemulsification(P=0.029, effect size=0.59, 95% CI=0.02 to 0.36). Reduction of corneal endothelial density between 2 groups were not statistically significant, however the reduction of hexagonal cell percentage at 7d after phacoemulsification was lower than Nepafenac group(P=0.042, effect size=-0.55, 95% CI=-2.33 to -0.03).

CONCLUSION: The pain and flare-cell levels in Nepafenac group was lower when compared with Diclofenac group.