The LAMP Study data over three years: 0.05% atropine leads and minimally rebounds

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研究摘要摘要

纸标题:Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression Study: Continued Versus Washout: Phase 3 Report

作者: Jason C Yam, Xiu Juan Zhang, Yuzhou Zhang, Yu Meng Wang, Shu Min Tang, Fen Fen Li, Ka Wai Kam, Simon T Ko, Benjamin H K Yip, Alvin L Young, Clement C Tham, Li Jia Chen, Chi Pui Pang

作者与Ophthalmolo部门关系gy and Visual Sciences, The Chinese University of Hong Kong, Hong Kong and other: seepubmed listingfor full detail.

Date:October 2021

参考:Ophthalmol 2021; Oct 7:S0161-6420(21)00745-4.

Summary

这项研究将近视进展(LAMP)研究的低浓度阿托品延长至三年。概述所有三项研究的发现:

  1. The one year LAMP study将0.05%,0.025%和0.01%的阿托品与安慰剂组相比。同类数据中的第一个数据显示了浓度依赖性响应。0.025%和0.05%的副作用曲线相似,但0.05%最有效,下一步为0.025%,与安慰剂组相比,在控制轴向伸长率方面有效0.01%。[[Link to Myopia Profile Science analysis这是给予的
  2. 两年灯学习看到,经过安慰剂治疗的儿童都转变为0.05%的阿托品,而其他治疗组仍在继续。在两年的时间里,0.05%的效率最高,只有一年的0.05%治疗的孩子表现出与两年内0.01%的轴向长度相似的轴向长度。在第二年,0.025%和0.01%的治疗效果与第一年的统计学上不同。[[Link to abstract这是给予的
  3. 三年灯学习saw half of the children continue with 0.05%, 0.025% or 0.01% treatment and half ceased, to test for a rebound effect (faster post-treatment progression). Progression was faster in the non-treated groups, and the formerly-0.05% group showed a slightly faster 'rebound' but only by around 0.04mm over one year, considered clinically insignificant. Younger children (6-8 years) were more likely to show greater rebound, but there was no influence of refraction, sex, parental myopia status, outdoor activity or near work activity on progression or the rebound effect in the washout group. Over the whole three years, 0.05% was most effective while 0.025% and 0.01% were not significantly different in total axial length change. The conclusion confirmed 0.05% as most effective over three years.

这对我的练习意味着什么?

阿托品0.05%在控制轴向伸长率的三年内似乎最有效。在LAMP研究的第一年,阿托品0.025%比0.01%更有效,但在第二年相似。在第三年,他们都是相似的。这表明从0.05%开始的临床价值,建议以较低的浓度开始,并期望以后可能会增加浓度。

This study also showed that the rebound effect from ceasing atropine 0.05% was small, labelled 'clinically insignificant' (0.04mm faster progression over one year), while 0.025% and 0.01% groups didn't experience a 'rebound effect'. This indicates there is likely still value in some form of tapering before atropine cessation, if 0.05% concentration has been used.

What do we still need to learn?

The LAMP Study is the only placebo-controlled trial (which it was in the first year) to directly compare these low concentrations of atropine.在三年的时间里,结果表明,在第一年和第二年,0.05%的效果最高,而仅在第一年才发现0.025%的效果更高。了解这些浓度如何在其他患者人口统计中起作用,这将是有价值的,对三年以上的长期治疗策略的进一步定义也将是有价值的,尤其是在年龄较大的儿童中。

抽象的

标题:Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression Study: Continued Versus Washout: Phase 3 Report

作者:Jason C Yam, Xiu Juan Zhang, Yuzhou Zhang, Yu Meng Wang, Shu Min Tang, Fen Fen Li, Ka Wai Kam, Simon T Ko, Benjamin H K Yip, Alvin L Young, Clement C Tham, Li Jia Chen, Chi Pui Pang

目的:(1)比较第三年的持续和停止治疗的疗效,0.05%,0.025%和0.01%的阿托品的疗效。(2)评估3年内持续治疗的功效。(3)在停止治疗后研究反弹现象及其决定因素。

设计:A randomized, double-masked extended trial.

Participants:438名4至12岁的儿童中,总共有350名最初招募到低浓度的阿托品中的肌病进展(LAMP)研究中。

方法:在第三年开始时,每组中的儿童以1:1的比例随机分配,以持续治疗和冲洗亚组。以4个月的间隔测量环半型球形等效(SE)折射和轴向长度(AL)。

主要观察指标:组之间的SE和AL变化。

Results:A total of 326 children completed 3 years of follow-up. During the third year, SE progression and AL elongation were faster in the washout subgroups than in the continued treatment groups across all concentrations: -0.68 ± 0.49 diopters (D) versus -0.28 ± 0.42 D (P < 0.001) and 0.33 ± 0.17 mm versus 0.17 ± 0.14 mm (P < 0.001) for the 0.05%; -0.57 ± 0.38 D versus -0.35 ± 0.37 D (P = 0.004) and 0.29 ± 0.14 mm versus 0.20 ± 0.15 mm (P = 0.001) for the 0.025%; -0.56 ± 0.40 D versus -0.38 ± 0.49 D (P = 0.04) and 0.29 ± 0.15 mm versus 0.24 ± 0.18 mm (P = 0.13) for the 0.01%. Over the 3-year period, SE progressions were -0.73 ± 1.04 D, -1.31 ± 0.92 D, and -1.60 ± 1.32 D (P = 0.001) for the 0.05%, 0.025%, and 0.01% groups in the continued treatment subgroups, respectively, and -1.15 ± 1.13 D, -1.47 ± 0.77 D, and -1.81 ± 1.10 D (P = 0.03), respectively, in the washout subgroup. The respective AL elongations were 0.50 ± 0.40 mm, 0.74 ± 0.41 mm, and 0.89 ± 0.53 mm (P < 0.001) for the continued treatment subgroups and 0.70 ± 0.47 mm, 0.82 ± 0.37 mm, and 0.98 ± 0.48 mm (P = 0.04) for the washout subgroup. The rebound SE progressions during washout were concentration dependent, but their differences were clinically small (P = 0.15). Older age and lower concentration were associated with smaller rebound effects in both SE progression (P < 0.001) and AL elongation (P < 0.001).

Conclusions:在第三年,与洗涤方案相比,持续的阿托品治疗在所有浓度方面都取得了更好的作用。在中国儿童中,0.05%的阿托品在3年中仍然是最佳浓度。在所有3种研究的阿托品浓度中,弹力效应的差异差异在临床上很小。在年龄较大和浓度较低的情况下停止治疗与较小的反弹有关。

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About Kate

Dr Kate Gifford是澳大利亚布里斯班的临床验光师,研究人员,同伴教育者和专业领导者,也是Myopia个人资料的联合创始人。

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