摘要
目的 评估强脉冲光联合 0.05%环孢素滴眼液治疗中重度睑板腺功能障碍(MGD)相关干眼的临床效果.方法 前瞻性随机对照研究.连续纳入 2022 年 3 月至 2022 年 8 月于苏州理想眼科医院就诊的经眼表综合分析仪检查睑板腺缺失比例达 1/3 以上的中重度MGD相关干眼 60 例(120 只眼).采用随机数字表法将研究对象分为 3 组,每组 20 例(40 只眼):A组(玻璃酸钠滴眼液)、B组(玻璃酸钠滴眼液+强脉冲光)、C组(玻璃酸钠滴眼液+强脉冲光+0.05%环孢素滴眼液).于治疗前、治疗后 1 个月、3 个月进行眼表疾病指数量表(OSDI)评分,测定泪河高度(TMH)、非侵入性首次泪膜破裂时间(NIF-BUT)、眼红指数、泪膜脂质层厚度(LLT)、泪液分泌试验(SⅠt)、睑板腺分泌物排出能力和性状评分,并计算睑板腺丢失率,评估并比较 3 种疗法的有效性和安全性.结果 随访期末,最终纳入A组17 例(失访3 例)、B组18 例(失访2 例)、C组17 例(失访3 例)患者.A组治疗后 1 和 3 个月眼红指数为 1.97±0.46 和 1.88±0.54,较治疗前的 2.21±0.81 改善;治疗后 3 个月睑板腺分泌物排出能力评分为(2.17±0.39)分,较治疗前的(2.01±0.51)分增加(均P<0.05),其他指标治疗前后比较差异无统计学意义(均P>0.05).B组治疗后 1 个月OSDI评分为(24.07±5.36)分、NIF-BUT为(4.87±0.92)s、眼红指数为 2.03±0.38、LLT为(54.38±12.18)nm、睑板腺分泌物性状评分为(1.83±0.45)分,均优于治疗前的(37.27±7.35)分、(4.12±0.72)s、2.61±0.69、(49.91±13.84)nm、(2.24±0.37)分,且治疗后 3 个月改善更为明显,TMH及睑板腺分泌物排出能力评分在治疗后 3 个月分别为(0.21±0.04)nm及(2.11±0.33)分,优于治疗前的(0.19±0.05)nm及(2.24±0.37)分(均P<0.05),其他指标治疗前后比较差异无统计学意义(均P>0.05).C组治疗后 1 个月,OSDI评分为(24.87±6.41)分、NIF-BUT为(4.84±1.01)s、TMH为(0.22±0.04)nm、眼红指数为 2.09±0.29、LLT为(55.14±9.05)nm、睑板腺分泌物排出能力评分为(2.06±0.42)分及睑板腺分泌物性状评分为(1.85±0.36)分,均明显优于治疗前的(40.44±7.66)分、(3.71±0.96)s、(0.21±0.04)nm、2.44±0.56、(47.14±10.91)nm、(2.26±0.46)分及(2.06±0.55)分,且治疗后 3 个月改善更为明显(均P<0.05).SⅠt在治疗后 3 个月为(7.03±0.97)mm,较治疗前的(5.76±1.48)mm改善(P<0.05).治疗后 1 个月组间比较,TMH、眼红指数、SⅠt、LLT、睑板腺丢失率、睑板腺分泌物排出能力评分及睑板腺分泌物性状评分差异均无统计学意义(均 P>0.05),B组和 C 组 OSDI 评分及 NIF-BUT 较 A 组改善(P<0.05).治疗后 3 个月,B组和C组OSDI评分、NIF-BUT、LLT、睑板腺分泌物排出能力评分及睑板腺分泌物性状评分较A组改善(P<0.05).C组TMH及SⅠt较A组和B组增加(P<0.001),眼红指数及睑板腺丢失率三组间比较差异无统计学意义(P>0.05).结论 强脉冲光联合 0.05%环孢素滴眼液能够改善中重度MGD相关干眼患者的症状和体征,改善睑板腺功能.
Abstract
Objective To evaluate the clinical efficacy of intense pulsed light(IPL)combined with 0.05% cyclosporine eye drops in the treatment of dry eye associated with moderate to severe meibomian gland dysfunction(MGD).Methods This was a prospective randomized controlled study.A total of 120 eyes of 60 cases with dry eye associated with moderate to severe MGD whose loss rate of the meibomian gland was more than 1/3 in Lixiang Eye Hospital of Soochow from Mar.2022 to Aug.2022 were selected as the research subjects.The patients were divided into three groups by means of random number table methods,with 20 cases(40 eyes)in each group:group A(sodium hyaluronate eye drops),group B(sodium hyaluronate eye drops+IPL),and group C(sodium hyaluronate eye drops+IPL+0.05% cyclosporine eye drops).Before treatment and at 1 month and 3 months after treatment,ocular surface disease index(OSDI)score,tear meniscus height(TMH),non-invasive first tear film break-up time(NIF-BUT),hyperemia index,tear film lipid layer thickness(LLT),Schirmer I test(SⅠt),meibomian gland morphology and function examination were measured,and the loss rate of meibomian gland was calculated to assess and compare the effectiveness and safety of the three therapies.Results At the end of the follow-up period,17 patients(3 cases missed)in group A,18 patients(2 cases missed)in group B,and 17 patients(3 cases missed)in group C were included.The results showed that the hyperemia index of group A at 1 and 3 months after treatment was 1.97±0.46 and 1.88±0.54,which improved compared to the 2.21±0.81 before treatment.The meibomian gland excretion score at 3 months after treatment was(2.17±0.39)points,which increased compared to the(2.01±0.51)points before treatment(all P<0.05).There was no statistically significant difference in other indicators(all P>0.05).At one month after treatment,the OSDI score of group B[(24.07±5.36)points],NIF-BUT[(4.87±0.92)s],hyperemia index(2.03±0.38),LLT[(54.38±12.18)nm],and meibomian gland secretion score[(1.83±0.45)points]were better than those before treatment[(37.27±7.35)points,(4.12±0.72)s,2.61±0.69,(49.91±13.84)nm,and(2.24±0.37)points].The improvement was more obvious at 3 months after treatment.TMH[(0.21±0.04)nm]and meibomian gland excretion score[(2.11±0.33)points]at 3 months after treatment were better than those before treatment[(0.19±0.05)nm and(2.24±0.37)points](all P<0.05).The other indicators were not statistically significant(all P>0.05).At one month after treatment in group C,OSDI score[(24.87±6.41)points],NIF-BUT[(4.84±1.01)s],TMH[(0.22±0.04)nm],hyperemia index(2.09±0.29),LLT[(55.14±9.05)nm],meibomian gland excretion score[(2.06±0.42)points],and meibomian gland secretion score[(1.85±0.36)points]were significantly better than those before treatment[(40.44±7.66)points,(3.71±0.96)s,(0.21±0.04)nm,2.44±0.56,(47.14±10.91)nm,and(2.26±0.46)points and(2.06±0.55)points],and the improvement was more significant at 3 months after treatment(all P<0.05).At 3 months after treatment,SⅠt was(7.03±0.97)mm,which improved compared to the(5.76±1.48)mm before treatment(P<0.05).Inter-group comparison showed that at 1 month after treatment,TMH,hyperemia index,SⅠt,LLT,the loss rate of meibomian gland,meibomian gland excretion score and meibomian gland secretion score had no statistically significant difference(all P>0.05).The OSDI score and NIF-BUT of group B and group C improved compared to those of group A(P<0.05).At 3 months after treatment,the OSDI score,NIF-BUT,LLT,meibomian gland excretion score and meibomian gland secretion score in group B and group C improved significantly compared to those in group A(P<0.05).The TMH and SⅠt of group C increased significantly compared to those of group A and group B(P<0.001),while there was no significant difference in hyperemia index and the loss rate of meibomian gland among the three groups(P>0.05).Conclusion IPL combined with 0.05% cyclosporine eye drops can improve the subjective symptoms and meibomian gland function of patients with moderate to severe MGD-related dry eye disease.