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、B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=3.17,2.62,0.91,1.42,0.89,2.17,0.95,1.54,3.21,6.72,1.37,均P＞0.05)无统计学意义,两种药物间异物感评分差异有统计学意义(F=11.38,P＜0.05),两种给药顺序间异物感评分差异无统计学意义(F=2.62,P＞0.05).结论 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中,在缓解眼部症状、促进角膜上皮修复方面与自家血清的效果相同.
目的 探討小牛血去蛋白提取物眼用凝膠對于骨髓移植術後慢性移植物抗宿主病(cGVHDs)引起的榦眼的治療效果.方法 採用隨機雙盲交扠設計研究方法,將2009年9月至2010年12月在廈門大學附屬廈門眼科中心眼錶疾病專科門診確診為骨髓移植術後慢性移植物抗宿主病引起的中重度榦眼患者12例(24隻眼)隨機分為A組(6例12隻眼)和B組(6例12隻眼).治療第一階段A組接受自傢血清治療,B組接受小牛血去蛋白提取物治療；待第一階段治療洗脫後(停藥一箇月)第二階段A組接受小牛血去蛋白提取物治療,B組接受自傢血清治療.兩組均加用0.05％羧甲基纖維素鈉滴眼液和0.1％氟甲鬆龍滴眼液治療.分彆在治療前,第一階段治療後,第二階段治療前和第二階段治療後的各時間點檢測併評定患者榦眼主觀癥狀、視力、角膜熒光素染色(FL)、淚膜破裂時間(BUT)及基礎淚液分泌試驗(SⅠt),分析不同藥物治療前後癥狀體徵改善情況使用非參數檢驗,兩種藥物間和不同給藥順序對癥狀體徵影響的比較採用二階段交扠設計方差分析.結果 眼部癥狀視疲勞、榦澀感、異物、畏光、疼痛、眼紅、視力在自傢血清(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)兩種藥物治療後均較治療前有統計學意義,A、B組治療後FL評分分彆為2.00±1.00及3.00±1.50,與治療前相比差異有統計學意義(U=273.0,135.0；P＜0.01),通過交扠設計方差分析比較視疲勞、榦澀感、燒灼感、畏光、疼痛、流淚、眼紅、視力、FL、BUT以及SⅠt在兩種藥物間(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)和兩種給藥順序間(F=3.17,2.62,0.91,1.42,0.89,2.17,0.95,1.54,3.21,6.72,1.37,均P＞0.05)無統計學意義,兩種藥物間異物感評分差異有統計學意義(F=11.38,P＜0.05),兩種給藥順序間異物感評分差異無統計學意義(F=2.62,P＞0.05).結論 小牛血去蛋白提取物眼用凝膠治療骨髓移植術後慢性移植物抗宿主病引起的中重度榦眼中,在緩解眼部癥狀、促進角膜上皮脩複方麵與自傢血清的效果相同.
목적 탐토소우혈거단백제취물안용응효대우골수이식술후만성이식물항숙주병(cGVHDs)인기적간안적치료효과.방법 채용수궤쌍맹교차설계연구방법,장2009년9월지2010년12월재하문대학부속하문안과중심안표질병전과문진학진위골수이식술후만성이식물항숙주병인기적중중도간안환자12례(24지안)수궤분위A조(6례12지안)화B조(6례12지안).치료제일계단A조접수자가혈청치료,B조접수소우혈거단백제취물치료；대제일계단치료세탈후(정약일개월)제이계단A조접수소우혈거단백제취물치료,B조접수자가혈청치료.량조균가용0.05％최갑기섬유소납적안액화0.1％불갑송룡적안액치료.분별재치료전,제일계단치료후,제이계단치료전화제이계단치료후적각시간점검측병평정환자간안주관증상、시력、각막형광소염색(FL)、루막파렬시간(BUT)급기출루액분비시험(SⅠt),분석불동약물치료전후증상체정개선정황사용비삼수검험,량충약물간화불동급약순서대증상체정영향적비교채용이계단교차설계방차분석.결과 안부증상시피로、간삽감、이물、외광、동통、안홍、시력재자가혈청(U=22.5,43.2,27.0,17.4,21.5,38.5,23.0,균P＜0.05)화소우혈거단백제취물(U=33.0,24.5,29.0,40.5,26.0,36.0,51.0,균P ＜0.05)량충약물치료후균교치료전유통계학의의,A、B조치료후FL평분분별위2.00±1.00급3.00±1.50,여치료전상비차이유통계학의의(U=273.0,135.0；P＜0.01),통과교차설계방차분석비교시피로、간삽감、소작감、외광、동통、류루、안홍、시력、FL、BUT이급SⅠt재량충약물간(F=1.45,2.43,2.14,1.91,1.63,0.51,1.19,0.68,2.75,0.77,1.23,균P＞0.05)화량충급약순서간(F=3.17,2.62,0.91,1.42,0.89,2.17,0.95,1.54,3.21,6.72,1.37,균P＞0.05)무통계학의의,량충약물간이물감평분차이유통계학의의(F=11.38,P＜0.05),량충급약순서간이물감평분차이무통계학의의(F=2.62,P＞0.05).결론 소우혈거단백제취물안용응효치료골수이식술후만성이식물항숙주병인기적중중도간안중,재완해안부증상、촉진각막상피수복방면여자가혈청적효과상동.
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 of autologous 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 5.0,P ＜ 0.01).Ocular dry eye signs and symptoms including visual tiredness,dry and unsmooth sensation,burning sensation,photophobia,pain,tearing,reduess,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,P ＜ 0.05),while without significant statistical difference between two kinds of offering drug orders (F =2.62,P ＞ 0.05).Conclusion Calf blood extract gel can be consider as a alternative for the treatment of dry eye induced by cGVHDs,because of its functions on releasing ocular dry eye symptoms and promoting corneal epithelial cells repair.
