清眩润目饮颗粒治疗糖尿病干眼患者的临床研究

Clinical trial of Qingxuan Runmuyin granules in the treatment of dry eye patients with diabetes

目的探讨清眩润目饮颗粒联合玻璃酸钠滴眼液对糖尿病干眼患者临床疗效及眼表炎性因子的影响。方法选取糖尿病干眼的患者作为研究对象,对照组在常规治疗的基础上加用玻璃酸钠滴眼液进行治疗,试验组患者在对照组的基础上加用清眩润目饮颗粒制剂口服。比较2组患者的疗效、干眼评分、泪膜破裂时间、泪液中的炎性因子以及药物不良反应发生情况。结果本研究共入组90例,其中试验组44例,对照组46例。试验组因患者中途退出脱落2例,对照组因患者中途退出原因脱落3例,最终试验组和对照组分别纳入42和43例。治疗后,对照组和试验组的总有效率分别为65.12%和88.10%,差异有统计学意义(P<0.05);治疗1个月,对照组和试验组的干眼症评分分别为6.15±1.58和3.06±0.51,泪膜破裂时间(BUT)评分分别为7.18±1.68和8.06±2.01,基础泪液分泌量(SIT)评分分别为7.18±1.68和8.06±2.01,治疗3个月后,对照组和试验组的干眼症评分分别为4.67±1.26和1.23±0.36,BUT评分分别为8.69±2.06和10.23±2.66;SIT评分分别为8.09±1.35和10.23±1.96。试验组上述指标与对照组组比较,差异均有统计学意义(均P<0.05)。对照组患者总药物不良反应发生率为11.63%(5例/43例),试验组患者总药物不良反应发生率为11.90%(5例/42例),差异无统计学意义(P>0.05)。结论清眩润目饮可以辅助改善糖尿病干眼患者的干眼不适症状,并且相对安全,值得临床推广应用。

Objective To investigate the effects of Qingxuan Runmuyin granule preparation combined with sodium hyaluronate eye drops on clinical efficacy and ocular surface inflammatory factors in diabetic dry eye patients.Methods The patients with diabetic dry eye were selected as the study objects.The control group was treated with sodium hyaluronate eye drops on the basis of conventional treatment,and the treatment group was treated with Qingxuan Runmuyin granule orally on the basis of control group.The efficacy,dry eye score,tear film rupture time,inflammatory factors in tears and the occurrence of adverse drug reactions were compared between the two groups.Results A total of 90 cases were enrolled in this study,including 44 cases in the treatment group and 46 cases in the control group.There were 2 cases of shedding in the treatment group and 3 cases in the control group due to the withdrawal of patients.Finally,42 cases in the treatment group and 43 cases in the control group were included,respectively.After treatment,the total effective rate of the control group and the treatment group was 65.12%and88.10%,respectively,and the difference was statistically significant(P<0.05).After 1 month of treatment,dry eye scores in control group and treatment group were 6.15±1.58 and 3.06±0.51,tear film breakup time(BUT)scores were 7.18±1.68 and 8.06±2.01,and SchirmerⅠtest(SIT)scores were 7.18±1.68 and 8.06±2.01.After 3months of treatment,the dry eye scores of the control group and the treatment group were 4.67±1.26 and1.23±0.36,the tear film BUT scores were 8.69±2.06 and 10.23±2.66;SIT scores were 8.09±1.35 and10.23±1.96,respectively.The above indexes of treatment group were compared with those of control group,and the differences were statistically significant(all P<0.05).The total incidence of adverse drug reactions was 11.63%(5/43)in control group and 11.90%(5/42)in treatment group,with no statistical significance(P>0.05).Conclusion Qingxuan Runmuyin granules can improve the symptoms of dry eye discomfort in diabetic dry eye patients,and it is relatively safe and worthy of clinical application.