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[摘要]
目的:探讨0.5g/L环孢素A滴眼液对中重度干眼患者眼部症状及体征评分的影响。
方法:中重度干眼症患者80例160眼依据随机双盲试验原则将其分为两组:观察组40例80眼,采用10g/L羧甲基纤维素钠和0.5g/L环孢素A滴眼液治疗,对照组40例80眼,采用10g/L羧甲基纤维素钠滴眼液治疗,比较两组患者眼部症状和体征评分变化。
结果:观察组治疗总有效率95.0%,显著高于对照组(85.0%),差异有统计学意义(P<0.05); 观察组和对照组患者未治疗时症状积分分别为36.1±4.4、36.4±4.5分,经治疗后,观察组1、3mo时症状积分下降至25.2±3.2、11.09±3.9分,对照组下降至29.4±4.1、22.05±3.1分,治疗前后差异具有统计学意义(P<0.05),但观察组治疗1、3mo的症状积分显著低于对照组,差异有统计学意义(P<0.05); 治疗前,两组患者泪膜破裂时间(BUT)、泪液分泌试验(SⅠt)、角膜荧光素染色(FL)和生活质量(OSDI)评分之间无统计学差异(P>0.05); 经治疗后,观察组四项指标均显著下降(P<0.05),对照组仅FL和OSDI评分显著下降,差异有统计学意义(P<0.05); 观察组治疗后四项指标均显著高于对照组,差异具有统计学意义(P<0.05); 观察组在用药14~28d时3眼出现刺痛感,对照组2眼刺痛感,1眼结膜充血,继续用药时2d后全部消失。
结论:0.5g/L环孢素A滴眼液能够有效缓解中重度干眼患者症状和体征,促进泪液分泌,改善患者眼表环境,治疗效果良好。
[Key word]
[Abstract]
AIM:To investigate the effect of 0.5g/L cyclosporine A for symptom and sign scores in patients with moderate to severe dry eye.
METHODS:Eighty patients(160 eyes)with moderate to severe dry eye were divided into two groups by double-blind and random principles:40 patients(80 eyes)in observation group were treated with 10g/L sodium carboxymethyl cellulose and 0.5g/L cyclosporine A eye drops, 40 patients(80 eyes)in the control group were treated with 10g/L sodium carboxymethyl cellulose eye drops. The changes of ocular sign and symptom scores were compared between the two groups.
RESULTS:The total effective rate of observation group was 95.0%, which was significantly higher than that of control group(85.0%, P<0.05). Symptom scores before treatment in observation group and the control group were 36.1±4.4 and 36.4±4.5 points, respectively; symptom scores at 1 and 3mo after treatment were 25.2±3.2, 11.09±3.9 points in observation group, 29.4±4.1, 22.05±3.1 points in control group. The differences of the two groups before and after treatment were statistically significantly(P<0.05). The scores of observation group at 1 and 3mo after treatment were lower than those of control group(P<0.05). Before treatment, break-up time(BUT), Schirmer I test(SⅠt), fluorescein staining(FL)and ocular surface disease index(OSDI)scores had no significant differences between the two groups(P>0.05). After treatment, the four parameters of observation group were improved significantly(P<0.05), while only FL and OSDI of control group were improved(P<0.05). The four parameters of observation group were higher than those of control group(P<0.05).Three eyes in observation group felt tingling during 14-28d of the drug using, 2 eyes in control group felt tingling and one eye in control group had conjunctival congestion. All the symptoms disappeared after 2d without stopping the drugs.
CONCLUSION:The 0.5g/L cyclosporine A eye drops can effectively relieve the symptoms and signs of moderate to severe dry eye, promote tear secretion, and improve ocular surface environment. The treatment effect is good.
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