玻璃酸钠联合重组人表皮生长因子治疗白内障术后干眼症患者的临床研究

Clinical trial of sodium hyaluronate combined with recombinant human epidermal growth factor in the treatment of patients with dry eye after cataract operation

目的评价玻璃酸钠联合重组人表皮生长因子(rhEGF)治疗白内障术后干眼症患者的疗效。方法将白内障术后干眼症患者分为试验组和对照组,对照组给予玻璃酸钠滴眼液,每次1滴,tid,滴眼至结膜囊内,治疗4周;试验组在对照组治疗的基础上给予rhEGF滴眼液治疗,每次1~2滴,tid,滴眼至结膜囊内,治疗4周。对比2组患者临床疗效,治疗4周时干眼症状,以及治疗前及治疗4周后的泪膜破裂时间(BUT)、基础泪液分泌试验(SⅠT)、角膜荧光素染色(CFS)评分、睑板腺分泌物评分(MGYSS)、泪液炎症因子的含量,并进行安全性评价。结果对照组和试验组分别纳入39和41例。试验组、对照组总有效率分别为95.12%和79.49%,在统计学上差异有统计学意义(P<0.05)。治疗4周后,试验组和对照组干眼症状评分分别为(1.42±0.18)和(2.31±0.26)分,BUT分别为(11.89±1.26)和(10.46±1.27)s,SⅠT分别为(10.12±1.35)和(8.45±0.87)mm,CFS评分分别为(0.83±0.11)和(1.94±0.25)分,MGYSS评分分别为(10.85±1.17)和(12.43±1.56)分,泪液白细胞介素(IL)-1β分别为(35.26±3.53)和(74.12±7.55)ng·L^(-1),IL-6分别为(8.35±0.86)和(12.41±12.56)pg·mL^(-1),试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组药物不良反应发生率分别为12.20%和10.26%,在统计学上差异无统计学意义(P>0.05)。结论玻璃酸钠与rhEGF联合可明显改善白内障术后干眼症状,提高泪膜稳定性,减轻泪液炎症因子,保护睑板腺完整度。

Objective To evaluate the effect of sodium hyaluronate combined with recombinant human epidermal growth factor(rhEGF)in the treatment of dry eye after cataract surgery.MethodssPatients with dry eye after cataract surgery were divided into treatment group and control group.The control group was treated with sodium hyaluronate eye drops via dropping into the conjunctival sac,a drop per dose,tid,for 4 weeks.On this basis,the treatment group was treated with rhEGF eye drops via dropping into the conjunctival sac,1-2 drops per dose,tid,for 4 weeks.The two groups were compared on overall clinical efficacy,dry eye symptoms before treatment and after 4 weeks of treatment.Tear-film breakup time(BUT),basic tear secretion test(schirmert Iest,SIT),corneal fluorescein staining(CFS)score,meibomian gland yield secretion score(MGYSS),and the levels of tear inflammatory factors were compared between two groups before treatment and after 4 weeks of treatment.The safety was evaluated.Results Finally,41 cases and 39 cases were included in the treatment group and the control group,respectively.After treatment,the total effective rates in the treatment group and the control group were 95.12%and 79.49%,with statistically significant difference(P<0.05).After 4 weeks of treatment,dry eye symptom scores of the treatment group and control group were 1.42±0.18 and 2.31±0.26;BUT were(11.89±1.26)and(10.46±1.27)s;SIT were(10.12±1.35)and(8.45±0.87)mm;CFS scores were 0.83±0.11 and 1.94±0.25;MGYSS scores were 10.85±1.17 and 12.43±1.56;interleukin-1βlevels in tears were(35.26±3.53)and(74.12±7.55)ng·L^(-1);interleukin-6 levels were(8.35±0.86)and(12.41±12.56)pg·mL^(-1).Compared with the control group,the above indexes in the treatment group were statistically significant(all P<0.05).The incidence rates of adverse drug reactions in the treatment group and the control group were 12.20%and 10.26%,without statistically significant difference between the groups(P>0.05).Conclusion Sodium hyaluronate combined with rhEGF can significantly improve dry eye symptoms after cataract surgery,enhance the stability of tear film,reduce tear inflammatory factors,and protect the integrity of meibomian gland.