CsA滴眼液治疗穿透角膜移植术后排斥反应的随机、双盲、多中心临床研究  

The randomized,double blindness,multi-center clinical trail for CsA on rejection following PRK

作　　者：张月琴[1] 陈家琪[2] 邹留河[3] 史伟云[4] 王丽娅[1] 王印其[1] 贺燚[1] 赵东卿[1] 李家臣[1] 祝磊[1] 黄挺[2] 金涛[3] 潘志强[3] 赵靖[4] 姚家琳[5] 李玉凤[5] 

机构地区：[1]河南省眼科研究所河南省角膜病重点实验室,郑州450003 [2]中山大学中山眼科中心,广州510060 [3]首都医科大学附属北京同仁医院眼科,北京100730 [4]山东省眼科研究所,济南266071 [5]华北制药集团新药研究开发有限责任公司,石家庄050015

出　　处：《眼科研究》2009年第5期407-411,共5页Chinese Ophthalmic Research

摘　　要：目的评估1%环孢素A(CsA)滴眼液防治穿透角膜移植术后排斥反应的价值和安全性。方法对240例穿透角膜移植术后患者采用1%CsA滴眼液进行多中心、随机、双盲、安慰剂对照临床研究。实验组与对照组各120例。实验组滴用1%CsA滴眼液,对照组滴用安慰剂,2组每日滴眼4次,每次2滴,共180d。同时2组患者术后均滴用0.1%地塞米松滴眼液,每日4次,2周后改为每日3次,30d后每日2次,60d后每日1次,直至试验完成。出现植片排斥反应时,按常规排斥反应标准进行治疗处理,受试者定期随访180d。进行裂隙灯眼前节检查、眼压测定、记录视力的变化、角膜透明度、生命体征和不良事件等。结果试验组完成试验119例,对照组111例。试验结束后,试验组发生排斥反应7例,对照组17例,发生率为试验组5.89%、对照组14.17%,2组间差异有统计学意义(P=0.025)。随访期发生不良事件试验组4例,对照组5例。试验组眼压升高1例、对照组6例。结论1%CsA滴眼液对于防治角膜移植术后的排斥反应是有效和安全的。Objective The majority cause of penetrating keratoplasty（PRK） failure was proved to be the graft rejection. Application of cyclosporin A （CsA） , a immunosurpress drug, have been thought to associate with a severe adverse action during its systemic administration for treating graft rejection. Present study was to evaluate the clinical value and safety of 1% cyclosporin A （CsA） drops in prevention and treatment of the graft rejection following PRK. Methods A multi-center,randomized, double blindness and control clinical trial of 1% CsA drops in prevention and treatment of the graft rejection was curried out in 240 patients with graft rejection after PRK. In 120 subjects of experimental group, 1% CsA drops was used topically 4 times per day for 180 days,and the placebo was used at the same way in the control group（ 120 patients）. 0. 1% dexamethasone drops was simultenously used in both groups. The subjects were clinically examined and followed-up for 180 days. The intraocular pressure, visual acuity, corneal transparency, manifestations under the slit-limp and adverse effects were assessed during the follow-up. Written informed consent was obtained from all patients before initiation of any medication. This trail was approved by the Ethic Committee of this hospital. Results The lossing subjects were 1 and 9 in 1% CsA group and placebo group respectively during the trail. No significant differences were found in the demography of subjects between 1% CsA group and placebo group （ P 〉 0. 05）. There were remarkble difference in the score of symptom and sign between these two groups （ P 〉 0. 05 ）. The acute rejection rate in 1% CsA group and placebo group was 7 cases （5.89%） and 17 cases （14. 17% ） respectively, indicating a obvious increase in placebo group compared with 1% CsA group （ P = 0. 025 1 ）. A similar result of graft rejection was seen in two groups （P 〉 0. 05）. After administration of 1% CsA drops and placebo, the score of symptom and sign showed an insignificant

关 键 词：穿透角膜移植 移植排斥反应 环孢素A 安慰剂 随机 双盲 多中心 

分 类 号：R779.65[医药卫生—眼科] R988.1[医药卫生—临床医学]