不同剂量他克莫司滴眼液对角膜结膜炎患者临床疗效及安全性的对比研究

Comparative Study on Clinical Efficacy and Safety of Different Doses of Tacrolimus Eye Drops in the Treatment of Patients with Keratoconjunctivitis

目的:探讨不同剂量他克莫司滴眼液对角膜结膜炎患者的临床疗效及安全性。方法:采用随机、开放的队列研究方法,选取2021年3月至2023年3月就诊于江汉大学附属湖北省第三人民医院门诊的角膜结膜炎患者89例,采用随机数字表法分为低剂量组(n=44)和常规剂量组(n=45)。低剂量组患者给予他克莫司滴眼液1日1次,常规剂量组患者给予他克莫司滴眼液1日2次,所有患者均连续治疗6个月。比较两组患者治疗前,治疗1、3及6个月后的眼部症状评分及眼部体征评分;比较两组患者治疗前、治疗6个月后的炎症指标[C反应蛋白(CRP)、白细胞介素(IL)2和IL-6]水平、视力及眼压;比较两组患者的临床疗效及不良事件发生情况。结果:治疗1、3个月后,常规剂量组患者眼部症状评分、眼部体征评分显著低于低剂量组,差异均有统计学意义(P<0.05);但治疗6个月后,两组患者眼部症状评分、眼部体征评分的差异均无统计学意义(P>0.05)。治疗6个月后,两组患者血清CRP、IL-2和IL-6水平,眼压及最佳矫正视比较,差异均无统计学意义(P>0.05)。常规剂量组、低剂量组患者的临床治疗总有效率分别为91.11%(41/45)、88.64%(39/44),差异无统计学意义(P>0.05);低剂量组患者的不良事件发生率为4.55%(2/44),低于常规剂量组的11.11%(5/45),但差异无统计学意义(P>0.05)。结论:低剂量他克莫司在短期内改善角膜结膜炎患者临床症状及体征的效果不及常规剂量方案,但长期临床治疗效果并未受影响,且应用低剂量他克莫司的不良事件发生率更低,具有一定的临床应用前景。

OBJECTIVE:To probe into clinical efficacy and safety of different doses of tacrolimus eye drops in the treatment of patients with keratoconjunctivitis.METHODS:A randomized,open cohort study was adopted.Totally 89 patients with keratoconjunctivitis admitted into Hubei Third People’s Hospital Affiliated to Jianghan University from Mar.2021 to Mar.2023 were extracted to be divided into low-dose group(n=44)and conventional dose group(n=45)by random number table method.Tacrolimus eye drops were used once a day in the low-dose group and twice a day in the conventional dose group.All patients were treated continuously for 6 months.The scores of ocular symptoms and signs were compared between two groups before treatment,after treatment of 1 month,3 months and 6 months.The inflammation levels[C-reactive protein(CRP),interleukin(IL)-2,IL-6],best corrected vision and intraocular pressure(IOP)were compared between two groups before treatment and after treatment of 6 months.The clinical efficacy and adverse events were compared between two groups.RESULTS:After treatment of 1 month and 3 months,the scores of ocular symptoms and signs in the conventional dose group were significantly lower than those in the low-dose group,with statistically significant differences(P<0.05).After treatment of 6 months,there was no statistically significant difference between two groups in the scores of ocular symptoms and signs(P>0.05).After treatment of 6 months,there was no statistically significant difference in serum CRP,IL-2,IL-6,IOP and best corrected vision between two groups(P>0.05).The total effective rate of conventional dose group and low-dose group was respectively 91.11%(41/45)and 88.64%(39/44),with no statistically significant difference(P>0.05).The incidence of adverse events in the low-dose group was 4.55%(2/44),lower than 11.11%(5/45)in the conventional dose group,the difference was not statistically significant(P>0.05).CONCLUSIONS:The effects of low-dose tacrolimus in improving the clinical symptoms and signs of keratoconjunctivitis in the short term is less than that of conventional dose regimen,yet the long-term clinical efficacy is not affected,and the incidence of adverse events is lower when using low-dose tacrolimus,which has certain clinical application prospects.