小牛血去蛋白提取物眼用凝胶治疗骨髓移植术后慢性移植物抗宿主病引起的中重度干眼临床疗效评价  

The clinical efficiency of calf blood extract gel on moderate to severe dry eye induced by chronic graft versus host diseases after bone marrow transplantation

作　　者：刘靖[1] 刘祖国[1] 邵毅[1] 陈景尧[1] 李炜[1] 林辉[1] 

机构地区：[1]厦门大学眼科研究所厦门大学附属厦门眼科中心,361005

出　　处：《中华眼科杂志》2013年第1期32-36,共5页Chinese Journal of Ophthalmology

基　　金：国家自然科学基金与香港联合项目（30931160432）;国家自然科学基金（30872810）

摘　　要：目的探讨小牛血去蛋白提取物眼用凝胶对于骨髓移植术后慢性移植物抗宿主病（cGVHDs）引起的干眼的治疗效果。方法采用随机双盲交叉设计研究方法，将2009年9月至2010年12月在厦门大学附属厦门眼科中心眼表疾病专科门诊确诊为骨髓移植术后慢性移植物抗宿主病引起的中重度干眼患者12例（24只眼）随机分为A组（6例12只眼）和B组（6例12只眼）。治疗第一阶段A组接受自家血清治疗，B组接受小牛血去蛋白提取物治疗；待第一阶段治疗洗脱后（停药一个月）第二阶段A组接受小牛血去蛋白提取物治疗，B组接受自家血清治疗。两组均加用0．05％羧甲基纤维素钠滴眼液和0．1％氟甲松龙滴眼液治疗。分别在治疗前，第一阶段治疗后，第二阶段治疗前和第二阶段治疗后的各时间点检测并评定患者干眼主观症状、视力、角膜荧光素染色（FL）、泪膜破裂时间（BUT）及基础泪液分泌试验（SIt），分析不同药物治疗前后症状体征改善情况使用非参数检验，两种药物间和不同给药顺序对症状体征影响的比较采用二阶段交叉设计方差分析。结果眼部症状视疲劳、干涩感、异物、畏光、疼痛、眼红、视力在自家血清（U=22．5，43．2，27．0，17．4，21．5，38．5，23．0，均P〈0．05）和小牛血去蛋白提取物（U=33．0，24．5，29．0，40．5，26．0，36．0，51．0，均P〈0．05）两种药物治疗后均较治疗前有统计学意义，A、13组治疗后FL评分分别为2．00±1．00及3．00±1．50，与治疗前相比差异有统计学意义（U=273．0，135．0；P〈0．01），通过交叉设计方差分析比较视疲劳、干涩感、烧灼感、畏光、疼痛、流泪、眼红、视力、FL、BUT以及SIt在两种药物间（F=1．45，2．43，2．14，1．91，1．63，0．51，1．19，0．68，2．75，0．77，1．23，均P〉0．05）和两种给药顺序间（F=3．17，2．62�Objective To investigate the clinical efficiency of calf blood extract gel on dry eye induced by chronic graft versus host diseases after bone marrow transplantation. Methods It was a two- stage cross-over design double-blind controlled study. Twelve patients （twenty-four eyes） diagnosis dry eye induced by chronic graft versus diseases in Ocular Surface Out-patient Clinic of Xiamen UniverSity Affiliated Xiamen Eye Center 2009 from 2010 to were divide into two groups： group A accepted the treatment ofautologous serum in the first stage and group B accepted the treatment of calf blood extract gel, after one month of elution, group A accepted calf blood extract gel and group B accepted autologous serum. The signs and symptoms with different therapies were recorded at the time of pre and post therapies, which were analyzed by Wilcoxon analysis and two-stage cross-over analysis. Results Ocular dry eye symptoms including visual tiredness, dry and unsmooth sensation, foreign body sensation, photophobia, pain, redness and visual acuity had been improved in both autologous serum therapy（ U = 22. 5, 43.2, 27.0, 17. 4, 21.5, 38.5, 23.0, P 〈0. 05） and calf blood extract gel therapy （ U = 333.0, 24. 5, 29. 0, 40. 5, 26. 0, 36. 0, 51. 0, P 〈 0. 05 ） after two-week treatment. Corneal FL had significantly been improved （ 2. 00± 1.00, 3.00 ± 1.50） （ Group A U = 273.0, Group B U = 135.0,P 〈 0. 01 ）. Ocular dry eye signs and symptoms including visual tiredness, dry and unsmooth sensation, burning sensation, photophobia, pain, tearing, redness, visual acuity, corneal FL, TFBUT and S It hadn＇t significantly improved between two kinds of therapies（F= 1.45, 2.43, 2. 14, 1.91, 1.63, 0.51, 1.19, 0.68, 2.75, 0.77, 1.23, P〉0.05）or between two kinds of offering drug orders（F =3. 17, 2.62, 0.91, 1.42, 0.89, 2. 17, 0.95, 1.54, 3.21,6.72, 1.37, P 〉 0. 05 ） in the two-stage cross-over design. Only foreign body sensation had significantly statistical difference between two kinds of drug （ F = 11.38,

关 键 词：小牛血去蛋白提取物凝胶 骨髓移植 移植物抗宿主病 干眼综合征 治疗结果 

分 类 号：R457.7[医药卫生—治疗学] R779.6[医药卫生—临床医学]