他克莫司治疗眼眶炎性假瘤的疗效及安全性研究  

A study on the efficacy and safety of tacrolimus in the treatment of inflammatory pseudotumor of the orbit

作　　者：孙明明 张磊[1] 周欢粉[1] 宋宏鲁 付俊霞 徐歆桐 王永平[1] 魏世辉[1] 徐全刚[1] SUN Mingming;ZHANG Lei;ZHOU Huanfen;SONG Honglu;FU Junxia;XU Xintong;WANG Yongping;WEI Shihui;XU Quangang(Senior Department of Ophthalmology,the Third Medical Center of PLA General Hospital,Beijing 100039,China)

机构地区：[1]解放军总医院第三医学中心眼科医学部,北京100039

出　　处：《中国研究型医院》2021年第6期11-16,共6页Chinese Research Hospitals

基　　金：中国博士后科学基金(2019M653944)。

摘　　要：目的观察口服小剂量他克莫司(FK506)胶囊预防特发性眼眶炎性假瘤(IOIP)复发的有效性及安全性。方法选取2015年1月至2018年10月临床确诊为IOIP的42例患者进行前瞻性研究,随机分为试验组和对照组,试验组采用糖皮质激素结合FK506治疗,对照组采用单纯糖皮质激素治疗,所有患者均进行病历采集、眼科及影像检查。视力检查采用斯内伦(Snellen)视力表,并将结果转换为最小分辨角对数(logMAR)视力记录。随访13~108个月,以末次随访为疗效判定时间点,比较两组IOIP的年复发率(ARR)、矫正视力、复发者与未复发者发病年龄和观察随访后不良反应的发生率。连续变量的比较采用独立样本t检验或Mann-Whitney U检验,分类变量的比较采用χ2检验或Fisher精确检验。结果两组患者治疗后平均矫正视力比较,差异无统计学意义(t=1.934,P>0.05)。平均ARR(0.18±0.39)次/年,试验组平均ARR 0次/年,对照组平均ARR(0.31±0.47)次/年,差异有统计学意义(Z=-2.505,P<0.05)。随访期间8例患者复发,7例为对照组患者,1例为试验组患者停药后复发。复发者与未复发者的发病年龄比较,差异均无统计学意义(Z=-0.500,P>0.05)。试验组患者均未出现不良反应。结论小剂量FK506胶囊治疗IOIP可降低ARR,安全性好。Objective To observe the effectiveness and safety of oral low-dose tacrolimus(FK506)capsules against the recurrence of idiopathic orbital inflammatory pseudotumor(IOIP).Methods Forty-two patients clinically diagnosed with IOIP from January 2015 to October 2018 were selected for a prospective study.These patients were randomly divided into a trial group and a control group.The experimental group was treated with glucocorticoids combined with FK506.The control group was treated with glucocorticoids alone.All patients underwent medical record taking,ophthalmology,and imaging examinations.A Snellen visual acuity chart was used for visual acuity examination and the results were converted to a minimum resolution angular logarithm(logMAR)visual acuity records.The annual recurrence rate(ARR),corrected visual acuity,age at onset of recurrence versus non-recurrence,and the incidence of adverse effects after observation of follow-up was compared between the two groups of IOIP at 13 to 108 months,with the last follow-up visit as the time point for efficacy determination.Independent sample t-test or Mann Whitney U test was used to compare continuous variables,and theχ2 test or Fisher exact test was used for comparison of categorical variables.Results There was no statistically significant difference in mean corrected visual acuity between the two groups after treatment(t=1.934,P>0.05).The mean ARR(0.18±0.39)time/year was 0 time/year in the test group and 0 times/year in the control group(0.31±0.47),with statistically significant differences(Z=-2.505,P<0.05).During follow-up,8 patients relapsed,7 in the control group and 1 in the experimental group after drug discontinuation.There was no significant difference between relapsed and non-relapsed patients on onset age(Z=-0.500,P>0.05).None of the patients in the test group experienced any adverse effects.Conclusion Lose-dose FK506 capsules for IOIP can reduce ARR with good safety.

关 键 词：眼眶疾病 特发性眼眶炎性假瘤 他克莫司 糖皮质激素类 复发 

分 类 号：R777.5[医药卫生—眼科]