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。

AIM: To evaluate and compare the clinical performance of 5 kinds of polyhexamethylene biguanide(PHMB)based multi-purpose solutions(MPS)manufactured in China when used with a commercially available silicone hydrogel contact lens in terms of solution-induced corneal staining(SICS), ocular response(corneal staining and ocular hyperemia), corneal infiltrative events(CIE)and ocular comfort.

METHODS: This was a prospective, open label, randomized, parallel group clinical trial. Totally 162 participants who were at least 18y old were enrolled and randomized into 5 groups of PHMB-based MPS made in China: Complete^® MPS, Hydron^® Aqua-shining moist, Baoshining^TM, Weicon^® Fresh, Weicon^® 2000 MPS(abbreviated as C, H, B, W, and W2). All participants wore balafilcon A contact lenses with monthly disposal(Bausch & Lomb Purevision^®)in conjunction with the designated MPS on a daily wear for 3mo. Clinical visits were at baseline, 2wk, 1 and 3mo. SICS and CIE were reported as first event incidence per 100 Px-months. Ocular response was graded on 0-4 scale in 0.5 steps(0=none, 4=severe)and ocular comfort was assessed via a numeric rating scale(1-10 in 1-point steps, 1=poor, 10=excellent). Ocular comfort and ocular response variables were analysed using linear mixed model. CIE and SICS were analysed using Fisher's exact test and logistic regression.

RESULTS: There were 36(22%)Pxs who dropped out. SICS incidence for each MPS were: H(26.3%),B(20.8%), W(19.4%), W2(13.4%), C(12.8%). The SICS rate of H was significantly different to W2(P = 0.012)and C(P = 0.005). There were no significant differences in ocular response, CIE incidence and ocular comfort between different MPSs(P>0.05). Pxs with SICS had significantly lower comfort during the day and at the end of than those who did not have SICS.

CONCLUSION: Differences in SICS incidence were found between MPSs but not for CIE incidence, ocular response or ocular comfort. SICS in PHMB-based MPS was found to be associated with ocular discomfort.

华柏恩视觉科技有限公司资助