摘要
目的观察中药明视方颗粒控制儿童心阳不足证低度近视的有效性和安全性。方法采用多中心、随机、双盲安慰剂对照的研究方法,将就诊于8家分中心的290例心阳不足证低度近视患儿随机分为治疗组和对照组各145例,治疗组给予宣教+配镜+中药明视方颗粒,对照组给予宣教+配镜+明视方安慰剂颗粒。明视方及安慰剂颗粒均口服,每次1袋(3 g),每日2次,口服4周休息2周为1个疗程,共治疗4个疗程(共24周)。分别在治疗前、治疗第12周、治疗第24周、36周随访时、48周随访时观察等效球镜、最佳裸眼远视力、眼轴、角膜曲率K1、调节幅度、中医证候评分、等效球镜进展量,并于治疗第24周判定近视进展控制率,治疗前后分别进行安全性指标检测。结果48周随访时治疗组等效球镜进展量低于对照组(P<0.05)。治疗组近视进展控制率(57.60%,72/125)高于对照组(44.63%,54/121)(P<0.05)。治疗组36周随访时最佳裸眼远视力高于对照组(P<0.05);两组各观察时点等效球镜与治疗前比较均明显降低(P<0.05),48周随访时治疗组高于对照组(P<0.05);两组眼轴治疗及随访各观察时点与治疗前比较均明显升高(P<0.05),治疗组眼轴增长量在治疗第24周及48周随访时均低于对照组(P<0.05);治疗组角膜曲率K1治疗第24周较治疗前明显降低(P<0.05);治疗组调节幅度在36周及48周随访时均较治疗前明显提高(P<0.05)。两组患儿在治疗第12周、第24周及36周、48周随访时面色淡白/晦滞、苔白脉细、神疲乏力评分及中医证候总积分均较治疗前明显降低(P<0.05);治疗第24周及36周随访时视物模糊评分均较治疗前明显降低(P<0.05);48周随访时治疗组视物模糊评分较治疗前明显降低(P<0.05)。治疗组36周随访时神疲乏力评分高于对照组,48周随访时视物模糊评分低于对照组(P<0.05)。两组治疗过程均未发现不良反应,治疗前后安全性指标未见明显异常�
Objective To observe the effectiveness and safety of the Chinese herbal medicine Mingshi Granules(明视方颗粒)for low myopia in children with heart yang insufficiency.Methods A multicentre,prospective,doubleblind randomised controlled study was conducted,in which 290 children with low myopia from 8 centres were ran⁃domly divided into 145 cases in the treatment group and 145 cases in the control group,and the treatment group was given education,dispensing glasses,and Chinese herbal medicine Mingshi Granules,while the control group was given education,dispensing glasses,and granules placebo.Both Mingshi Granules and placebo granules were taken orally,1 bag each time,twice daily,4 weeks of oral intake and 2 weeks of rest as 1 course of treatment,a total of 4 courses of treatment(24 weeks).Equivalent spherical lenses,best naked-eye distance visual acuity,ocular axis,corneal cur⁃vature K1,adjustment amplitude,traditional Chinese medicine(TCM)symptom scores,calculate the amount of pro⁃gression of equivalent spherical lenses,were observed at the 12th and the 24th week of treatment,at the 36th week and 48th week of follow-up,resectively,the control rate of myopia progression was evaluated at the 24th week,and safety indexes were observed before treatment.Results The amount of progression of equivalent spherical lenses was lower in the treatment group than in the control group at the 48-week follow-up(P<0.05).The control rate of myopia progression at 24 weeks after treatment in the treatment group was higher(57.60%,72/125)than that in the control group(44.63%,54/121)(P<0.05).The best naked-eye distance visual acuity at 36-week follow-up in the treatment group was higher than that in the control group(P<0.05).Equivalent spherical lenses were significantly lower in both groups at all observation time points compared with pre-treatment(P<0.05),and were higher in the treatment group than in the control group at the 48-week follow-up(P<0.05).The ocular axes of both groups were significantly higher at each observation
作者
王健全
侯昕玥
亢泽峰
杨迎新
刘新泉
沈志华
俞晓艺
姚靖
梁凤鸣
张风梅
喻京生
王宁利
宋曼
孙宏睿
晏鑫
WANG Jianquan;HOU Xinyue;KANG Zefeng;YANG Yingxin;LIU Xinquan;SHEN Zhihua;YUXiaoyi;YAO Jing;LIANG Fengming;ZHANG Fengmei;YU Jingsheng;WANG Ningli;SONG Man;SUN Hongrui;YAN Xin(Eye Hospital,China Academy of Chinese Medical Sciences,Beijing,100040;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University;Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine;Shenzhen Traditional Chinese Medicine Hospital;The First Affiliated Hospital of Guangzhou University of Chinese Medicine;First Affiliated Hospital,Heilongjiang University of Chinese Medicine;First Teaching Hospital of Tianjin University of Tradi-tional Chinese Medicine;Henan Province Hospital of Traditional Chinese Medicine;The First Hospital of Hunan University of Chinese Medicine;Beijing Tongren Hospital,Capital Medical University;Fuzhou Hospital of Traditional Chinese Medi-cine,Fujian University of Traditional Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2024年第6期587-593,共7页
Journal of Traditional Chinese Medicine
基金
中国中医科学院中央级公益性科研院所基本科研业务费(中医药循证医学项目)
国家重点研发计划(2022YFC3502500)
国家中医药管理局中医药传承与创新“百千万”人才工程(岐黄工程)岐黄学者
福建省卫生健康委员会第三批柔性引进医疗卫生高层次人才团队(闽卫人函〔2023〕1480)。
关键词
低度近视
儿童
明视方
精筋失衡
心阳不足证
low myopia
children
Mingshi Formula(明视方)
imbalance of essence and sinew
heart yang insuffi⁃ciency syndrome
