消旋山莨菪碱(0.05%)防治近视的临床观察  

Clinical observation of 0.05% racanisodamine in myopia prevention and treatment

作　　者：李涛[1] 周晓东[1] 陈志[2] 赵婧[2] 

机构地区：[1]复旦大学附属金山医院眼科,上海201508 [2]复旦大学附属眼耳鼻喉科医院眼科,上海200031

出　　处：《中国眼耳鼻喉科杂志》2013年第1期27-30,共4页Chinese Journal of Ophthalmology and Otorhinolaryngology

基　　金：上海市金山区卫生局基金项目(2011-06)

摘　　要：目的探讨非选择性M受体阻滞剂消旋山莨菪碱对儿童近视的防治作用。方法复旦大学附属眼耳鼻喉科医院视光中心门诊的近视儿童中选择合理期待并签署知情同意书的93名学龄儿童,符合以下条件:①6～14岁;②球镜范围为-0.50～-6.00DS,散光≤1.50DC;③双眼屈光间质清;④排除眼部器质性疾病。受试儿童分为药物干预组(n=50)和对照组(n=43)。①药物干预组儿童滴用0.05%消旋山莨菪碱滴眼液,每晚睡前使用1次,共1年;②对照组儿童不给予任何药物。药物干预组平均年龄为(9.94±1.97)岁,对照组为(10.64±1.52)岁;药物干预组平均等效球镜和眼轴长度分别为(-2.14±1.60)D和(24.23±0.80)mm,对照组为(-2.28±0.78)D和(24.59±0.72)mm。两组间年龄、等效球镜差异均无统计学意义(P=0.06,P=0.46),眼轴差异有统计学意义(P=0.001)。随访期为1年,每半年1次,予以主觉验光和IOLMaster测量眼轴长度。两组儿童不同时间点等效球镜和眼轴长度采用独立样本t检验进行统计学分析。结果 6个月、12个月时,药物干预组平均等效球镜分别为(-2.60±1.69)D、(-3.35±1.40)D,对照组分别为(-2.64±0.82)D、(-3.09±0.90)D,两组间差异均无统计学意义(P=0.99,P=0.17)。药物干预组平均等效球镜分别增加(-0.47±0.75)D、(-0.42±1.16)D,对照组分别增加(-0.33±0.37)D、(-0.45±0.35)D,两组间差异无统计学意义(P=0.11,P=0.79)。6个月、12个月时,药物干预组平均眼轴长度为(24.52±0.80)mm、(24.97±0.76)mm,对照组分别为(24.75±0.72)mm、(24.88±0.74)mm,两组间差异均无统计学意义(P=0.06,P=0.55)。药物干预组平均眼轴长度分别增加(0.30±0.34)mm、(0.25±0.14)mm,对照组分别增加(0.17±0.10)mm、(0.12±0.09)mm,两组间差异均有统计学意义(P<0.001,P<0.001)。结论 0.05%消旋山莨菪碱对儿童近视进展和眼轴延长的控制作用不明显;0.05%消旋山莨菪碱在部分儿童中的潜在有效性有待进一步探讨。Objective To investigate the effect of non-selective muscarinic receptor antagonist, racanisodamine, on myopia prevention and treatment in children. Methods Ninety-three school age children with reasonable expectation and written informed consent signed were recruited at the optometry center of Fudan University Eye and ENT Hospital. Inclusion criteria were ： （±aged from 6 to 14 years ; （±）spherical refractive error was from -6.00 to 4）. 50 diopter （ D）, and astigmatism was no more than 1.50 DC ; （±）clear visual pathways in both eyes ; @free from eye diseases. Participants were divided into 2 groups： treatment group （n =50） and control group （n =43）. Children in the treatment group were administrated with 0.05% racanisodamine drops on a nightly basis for one year. Children in the control group did not receive any treatment. The average age was （9.94± 1.97） years for the treatment group and （ 10.64 ± 1.52） years for the control group. The mean baseline spherical equivalent （SE） and axial length （AL） were （-2. 14 ± 1.60） D and （24.23 ± O. 80） mm for the treatment group, and （ -2.28 ± 0.78 ） D and （24.59 ± 0. 72 ） mm for the control group, respectively. There were no statistical differences in age and SE （P = 0.06 ,P = 0.46）, whereas statistical difference in AL （P = 0.001 ） between two groups. Subjects were followed up at the six months and one year. Participants underwent subjective refraction and AL measurements using IOL Master. Independent t test was performed to compare the SE and AL between groups at various follow-up time points. Results Mean SE was （ -2.60 ±1.69） D and （ -3.35 ± 1.40） D for the treatment group, and （-2.64 ± 0.82）D and （-3.09 ± 0.90）D for the control group at month 6 and 12, respectively. The differences between groups were not statistically significant （P = 0.99, P = 0.17 ）. The mean increases in SE at month 6 and 12 were （4）. 47 ± 0.75 ） D and （ -0.42 ± 1.16） D for the treatment

关 键 词：消旋山莨菪碱 近视 眼轴长度 儿童 

分 类 号：R778.11[医药卫生—眼科]