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目的:针对搭配市售硅水凝胶隐形眼镜使用的5种中国产含聚六亚甲基双胍(polyhexamethylene biguanide,PHMB)多功能护理液,通过护理液相关角膜染色、眼部反应(角膜染色、眼部充血)、角膜浸润、眼部舒适度来评估和比较其临床表现。方法:前瞻性、开放、随机、平行对照临床试验。选取18岁以上受试者162名,并随机分为5组,分别使用5种中国产含PHMB多功能护理液:全能多功能护理液,海昌水感觉润护理液,保视宁护理液,卫康新视护理液及卫康2 000多功能护理液(分别缩写为C,H,B,W,和W2)。所有受试者都配戴月抛型硅水凝胶隐形眼镜(博士伦纯视)3mo,并每日使用指定的多功能护理液。在配戴前,配戴后2wk,1和3mo进行随访。统计每百人每月护理液相关角膜染色及角膜浸润事件。眼部反应分0-4级,最小梯度为0.5(0=无反应,4=严重反应);眼部舒适度通过数字量表评定(分1-10级,最小梯度为1,1=差,10=优)。眼部舒适度和眼部反应采用线性混合模型进行分析。角膜浸润及护理液相关角膜点染通过Fisher确切概率法和logistic回归分析进行分析。结果:有36名(22%)受试者中途退出试验。每组护理液相关角膜染色发生率为:H组26.3%,B组20.8%,W组19.4%,W2组13.4%,C组12.8%,其中H组的发生率分别与W2组(P=0.012)、C组(P=0.005)的差异有统计学意义。不同组间眼部反应、角膜浸润及眼部舒适度的差异均无统计学意义(P>0.05)。存在护理液相关角膜染色的受试者在白天及结束时相比于不存在护理液相关角膜点染的受试者舒适度明显较低。结论:对于不同的护理液,护理液相关角膜染色发生率存在差异,但角膜浸润、眼部反应及眼部舒适度不存在差异。PHMB多功能护理液引发的角膜染色与眼部舒适度相关。
OBJECTIVE: To investigate the effects of five kinds of multi-functional Chinese-made polyhexamethylene biguanide (PHMB) multifunctional care solution, which are used in commercial contact lenses of silicone hydrogel, through corneal staining of nursing fluid, ocular reaction (corneal staining, Eye congestion, corneal infiltration, eye comfort to assess and compare their clinical manifestations. Methods: Prospective, open, randomized, parallel controlled clinical trials. 162 subjects over the age of 18 were selected and randomly divided into five groups, respectively, using five kinds of Chinese-made PHMB-containing multi-functional care solution: multi-functional care solution, water Changchang feel feeling care solution, Wei Kang as Nursing Solutions and Weikang 2 000 multi-functional care solutions (abbreviated as C, H, B, W, and W2). All subjects were fitted with monthly disposable Silicone Hydrogel Contact Lenses (Bausch & Lomb Eye) for 3 months and daily with the indicated multi-purpose care solution. Before wearing, wearing 2wk, 1 and 3mo follow-up. Statistical per 100 people care solution-related corneal staining and corneal infiltration events. The eye response was rated 0-4, with a minimum gradient of 0.5 (0 = no response, 4 = severe response); eye comfort was assessed by a digital scale (grades 1-10 with a minimum gradient of 1, 1 = 10 = excellent). Eye comfort and eye response were analyzed using a linear mixed model. Corneal infiltration and fluid-associated corneal staining were analyzed by Fisher’s exact test and logistic regression analysis. RESULTS: Thirty-six (22%) subjects dropped out of the trial. The incidence of corneal staining of each care solution was 26.3% in H group, 20.8% in B group, 19.4% in W group, 13.4% in W2 group and 12.8% in C group, and the incidence of H group was significantly higher than that in W2 group (P = 0.012 ), C group (P = 0.005), the difference was statistically significant. There was no significant difference in ocular response, corneal infiltration and eye comfort between different groups (P> 0.05). Subjects with nursing fluid associated corneal staining were significantly less comfortable at daytime and at the end of the day than subjects without associated fluid corneal spotting. CONCLUSIONS: There is a difference in the incidence of corneal staining associated with different care solutions, but there is no difference in corneal infiltration, eye response, and eye comfort. Corneal staining caused by PHMB Multi-Care solution is associated with eye comfort.