目的：评价0.1%他克莫司滴眼液治疗慢性移植物抗宿主病（cGVHD）相关干眼症的疗效，并与单纯人工泪液治疗比较。
方法：前瞻性临床研究。纳入在浙江大学医学院附属第一医院就诊伴有干眼症的慢性移植物抗宿主病患者（cGVHD-DE），随机分为他克莫司（TAC）组和玻璃酸钠（SH）组。收集所有患者的年龄、性别、初步诊断、发病时间，并记录发病前及治疗后2周、治疗后2个月时患者的视力（VA）、眼表疾病指数（OSDI）、角膜荧光素染色（FL）和泪液分泌试验（SⅠt）结果，采用Keratograph 5M测量患者的泪河高度（TMH）、首次非侵入性泪膜破裂时间（NIBUTf），结膜充血程度和睑板腺萎缩程度（睑板腺红外成像）等4个干眼相关的客观指标。比较分析0.1% TAC滴眼液治疗cGVHD-DE的安全性和有效性。数据采用方差分析、Firedman检验、独立样本 t检验，Mann-Whitney检验进行分析。
结果：共纳入21例（42眼），TAC组11例，SH组10例。2组性别构成、年龄差异无统计学意义。治疗前各项干眼相关指标差异无统计学意义。治疗2周后，TAC组OSDI评分（ t=3.99， P=0.003）和双眼NIBUTf（右眼 t=2.30， P=0.044；左眼 t=2.42， P=0.034）以及SH组的OSDI评分（ t=3.20， P=0.011）和右眼NIBUTf（ t=2.46， P=0.036），较治疗前均显著提高。治疗2个月后，TAC组所有参数均较治疗前显著提高（均 P<0.05）。而SH组中，OSDI、FL、TMH、NIBUTf和结膜充血程度较治疗前显著提高（ P<0.05），但泪液分泌功能和睑板腺功能与基线比较无明显改善。治疗2个月后，TAC组与SH组进行比较，除FL外，其余干眼相关参数TAC组均较SH组改善更明显（均 P<0.05）。研究期间TAC组和SH组均未发生明显眼部并发症。
结论：0.1%他克莫司滴眼液治疗cGVHD-DE安全有效，眼表分析仪有助于此类患者病情的评估和随访。
Objective:To evaluate the efficacy of 0.1% Tacrolimus eye drops in the treatment of dry eye (DE) caused by chronic graft-versus-host disease (cGVHD-DE) and compare it with the treatment of lubricating eye drops.
Methods:Prospective clinical study. The chronic graft-versus-host disease (cGVHD) patients with DE from the First Affiliated Hospital, Zhejiang University School of Medicine were included according to the inclusion criteria and categorized randomly into two different groups, Tacrolimus group (TAC) and sodium hyaluronate group (SH). Data were collected at the baseline, 2 weeks and 2 months after the treatments on patients' age, gender, primary diagnosis, time of onset, visual acuity (VA), ocular surface disease index (OSDI), corneal fluorescein staining (FL) and Schirm Ⅰ test (SⅠt). Other four objective DE indicators, including the height of tear meniscus (TMH), the first non-invasive tear break-up time (NIBUTf), the degree of conjunctival injection and the infrared meibography were also obtained and recorded by Keratograph 5M. Data were analyzed by variance analysis, Firedman and t-test, etc.
Results:A total of 21 patients with 42 eyes were included, 11 patients (22 eyes) in the TAC, 10 patients (20 eyes) in SH. There was no significant difference in age, gender, and all clinical indicators at the baseline between the two groups. 2 weeks after the treatments, in TAC group, OSDI score ( t=3.99, P=0.003), NIBUTf in both eyes (right eye: t=2.30, P=0.044; left eye: t=2.42, P=0.034) were significantly improved when compared with the baseline, in SH group, the indicators were OSDI score ( t=3.20, P=0.011) and NIBUTf in right eyes ( t=2.46, P=0.036) that had significant improvement. After 2 months of treatment, all clinical dry eye indicators in the TAC group were significantly improved compared with the baseline ( P<0.05). But in the SH group, the SⅠt and the infrared meibography had no statistically significant difference when compared with the baseline. Comparing the two groups after 2 months of treatment, we found that all indicators in the TAC group were more significantly improved than that in the SH group, except for the FL, in which the difference had no statistical significance ( P<0.05). No adverse ocular effect was found in the study in both groups.
Conclusions:0.1% tacrolimus eye drops are safe and effective in the treatment of cGVHD-DE, and Keratograph 5M is helpful in the evaluation and follow-up of the treatments.
唐旭园,夏建华,吴琴,等. 0.1%他克莫司滴眼液治疗慢性移植物抗宿主病相关干眼症的疗效评价[J]. 中华眼视光学与视觉科学杂志,2020,22(03)：172-179.
DOI:10.3760/cma.j.cn115909-20191222-00339版权归中华医学会所有。
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唐旭园,夏建华,吴琴,等. 0.1%他克莫司滴眼液治疗慢性移植物抗宿主病相关干眼症的疗效评价.中华眼视光学与视觉科学杂志, 2020, 22(3): 172-179. DOI: 10.3760/cma.j.cn115909-20191222-00339.
唐旭园：酝酿和设计实验；实施研究，统计分析，论文撰写。夏建华：病例收集、采集数据。吴琴：采集数据。杜持新：课题指导、论文修改
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