目的 评估质量分数0.3％玻璃酸钠滴眼液治疗轻中度干眼的临床疗效. 方法 采用前瞻性、多中心、自身对照临床试验方法,连续纳入2015年1月至2017年6月在厦门大学眼科研究所、复旦大学附属眼耳鼻喉科医院、中山大学中山眼科中心、中南大学湘雅医院、温州医科大学附属眼视光医院、首都医科大学附属北京同仁医院6个临床研究中心确诊为轻中度干眼并完成随访的患者200例200眼的临床资料.所有患者给予0.3％玻璃酸钠滴眼液点眼.分别于治疗前和治疗后14d、28 d进行干眼症状总评分、角膜荧光素钠染色、泪膜破裂时间(BUT)、基础泪液分泌试验(SⅠt)、球结膜充血程度、睑缘改变、睑板腺分泌能力和睑板腺分泌物性质等指标评估,在治疗前和治疗后28 d行结膜印迹细胞学检查,并在用药后14d和28 d进行药物刺激性观察.结果 患者治疗前后干眼症状总评分、BUT、SⅠt、球结膜充血程度总体比较,差异均有统计学意义(F=108.969、27.598、16.838、36.750,均P＜0.01).与治疗前比较,治疗后14d和28 d患者干眼症状总评分和球结膜充血程度评分降低,全角膜荧光素钠染色点数减少,差异均有统计学意义(均P＜0.01).与治疗后14d比较,治疗后28 d干眼症状总评分、球结膜充血程度评分均明显降低,全角膜荧光素钠染色点数明显减少;治疗后14d和28 d,患者BUT较治疗前明显延长,SⅠt值较治疗前明显增大;治疗后28 d BUT较治疗后14 d明显延长,但治疗后28dSⅠt与治疗后14 d无明显变化.患者治疗前后睑缘改变、睑板腺分泌能力和睑板腺分泌物性质评分总体比较,差异均无统计学意义(H=0.255、2.356、0.294,均P＞0.05).治疗后28 d,患者结膜印迹细胞染色分级为1.08±0.74,明显小于治疗前的1.53±0.76,差异有统计学意义(t=5.979,P＜0.01).治疗后28 d,患者球结膜杯状细胞数量明显多于治疗前,差异有统计学意义(U=1 806.500,P＜0.01).治疗后14 d,70％患者表示药物无刺激性,所有患者均未出现难以忍受的、影响日常生活的刺激,耐受性良好.结论 0.3％玻璃酸钠滴眼液能改善轻中度干眼的症状和体征,且具有良好的舒适性,临床上可广泛用于轻中度干眼的治疗.“,”Objective To evaluate the efficacy of 0.3％ sodium hyaluronate ophthalmic solution in mild-to-moderate dry eye patients.Methods A prospective,multicenter,and self-controlled clinical trial was performed on 200 patients who were diagnosed as mild-to-moderate dry eye from January 2015 to June 2017 in Eye Institute of Xiamen University,Eye & ENT Hospital of Fudan University,Zhongshan Ophthalmic Center,Xiangya Hospital Central South University,Eye Hospital of Wenzhou Medical University,and Beijing Tongren Hospital,Capital Medical University.The study protocol was approved by the Ethics Committees of Eye Institute of Xiamen University,written informed consent was obtained from each patient prior to any medical examination.All patients were treated with 0.3％ sodium hyaluronate ophthalmic solution 6 times per day (one drop each time) for 28 days.Corneal fluorescein sodium staining,tear film break-up time (BUT),Schirmer Ⅰ test (S Ⅰ t),degree of conjunctival hyperemia,eyelid margin,meibomian gland secretion,secretory capacity of meibomian gland and subjective symptoms were assessed at baseline,on the 14th day and 28th day after treatment.Bulbar impression cytology was evaluated at baseline and on the 28th day after treatment.Irritation of 0.3％ sodium hyaluronate ophthalmic solution was estimated on the 14th day and 28th day after treatment.Results The total score of subjective symptoms,BUT,S Ⅰ t,degree of conjunctival hyperemia were significantly different among different treatment time points (F =108.969,27.598,16.838,36.750;all at P＜0.01).Compared with before treatment,the total score of subjective symptoms was significantly decreased,the degree of conjunctival hyperemia and the total corneal fluorescein sodium staining point number were significant decreased on the 14th day and 28th day after treatment.The total score of subjective symptoms,degree of conjunctival hyperemia and total corneal fluorescein sodium staining point number on the 28th day after treatment were significant lower than those on the 14th day after treatment.Compared with before treatment,the BUT was significantly longer and the S Ⅰ t scores were significantly increased on the 14th day and 28th day after treatment.The BUT on the 28th day after treatment was significantly longer than that on the 14th day after treatment;no significant difference in S Ⅰ t was observed between the 28th day and the 14th day after treatment.The scores of palpebral margin change,meibomian gland secretory ability and secretion characteristics were not significantly different among different treatment time points(H=0.255,2.356,0.294;all at P＞0.05).The impression cytology grade on the 28th day after treatment was 1.08±0.74,which was significantly lower than 1.53 ±0.76 before treatment (t =5.979,P＜ 0.01).The number of goblet cells on the 28th day after treatment was significantly higher than that before treatment (U =1 806.500,P＜ 0.01).On the 14th day after treatment,70％ of the patients indicated that the drug was non-irritating,and no patient had intolerable irritation affecting daily lives.All patients had good tolerance to this drug.Conclusions The use of 0.3％ sodium hyaluronate eye drops can improve the symptoms and signs of mild to moderate dry eye,which can be widely used for mild-to-moderate dry eye patients in clinic.