消旋山莨菪碱(0.05%)防治近视的临床观察李涛;周晓东;陈志;赵婧【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～-6.00 DS,散光≤1.50 DC;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IOL Master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: ①aged from 6 to 14 years; ②spherical refractive error was from -6.00 to -0. 50 diopter ( D ), and astigmatism was no more than 1. 50 DC; ?clear visual pathways in both eyes; (4)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 ) y ears for the control group. The mean baseline spherical equivalent ( SE ) and axial length ( AL ) were ( -2. 14 ± 1. 60 ) D and ( 24.23 ±0. 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 thetreatment 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 ( -0.47 ± 0. 75 )D and ( -0. 42 ± 1. 16 )D for the treatment group, and ( -0. 33 ± 0. 37 )D and ( -0. 45 ± 0. 35 )D for the control group, respectively. The differences between groups were not statistically significant(P =0. 11, P =0.79 ). Mean ALs were ( 24. 52 ±0.80 )mm and ( 24. 97 ±0.76 )mm for the treatment group, and ( 24. 75 ±0.72 )rnmm and ( 24. 88 ±0.74 )mm for the control group in month 6 and 12, respectively. The differences between groups were not statistically significant P =0.06,P =0. 55 ). Mean increases in AL were ( 0. 30 ±0. 34 )mm and ( 0. 25 ±0. 14 )mm for the treatment group, and ( 0. 17 ± 0. 10 )mm and ( 0. 12 ± 0. 09 )mm for the control group, respectively. The differences between groups were statistically significant ( P <0. 001 ,P <0.001 ). Conclusions 0. 05% racanisodamine has no effect on reducing the progression of myopia and elongation of AL in children. The potential efficacy of 0. 05% racanisodamine in some children needs further exploration.【期刊名称】《中国眼耳鼻喉科杂志》【年(卷),期】2013(013)001【总页数】4页(P27-30)【关键词】消旋山莨菪碱;近视;眼轴长度;儿童【作者】李涛;周晓东;陈志;赵婧【作者单位】复旦大学附属眼耳鼻喉科医院眼科,上海,200031【正文语种】中文近视是全球最常见的眼科疾病，目前世界卫生组织(WHO)已把近视在内的屈光不正列入亟待解决的致盲性眼病之一，可见近视问题绝不容忽视。

有研究［1］报告:西方儿童近视患病率不足5%，而亚洲7岁儿童却已达29%;我国是近视患病总人数最多的国家之一，约4.3亿，占总人口比例的33%左右。