秒词邦

新闻原文：

“每天滴一次，就可以延缓儿童近视”，“效果立竿见影，比OK镜好使”，“睡前滴一滴，半年没涨度数”......过去几年，不少家长将阿托品当作“近视神药”。即便之前还未在中国大陆地区获批上市，阿托品就凭借优秀的疗效和简单的操作方法，常年出现在家长们的代购清单里，疯狂程度堪比另一爆款“减肥神药”司美格鲁肽。

近期，阿托品终于迎来了一个重磅消息。2024年3月，国家药品监督管理局正式批准兴齐眼药的0.01%浓度阿托品用于缓解儿童近视，这意味着国内有了首款正式上市的、作为控制近视的处方药——硫酸阿托品滴眼液。

对于已经近视的孩子来说，这无疑是一个好消息，家长们终于不用再颇费周折地获取这一“近视神药”。然而阿托品顺利上市后，接下来的问题也层出不穷。常被称为“安慰剂”的0.01%浓度的阿托品是否真的有效？低浓度阿托品变得更易获得后，是否存在被滥用的风险？本期《眼健为实》展开聊聊。

1、不少家长一掷千金求购，阿托品代购乱象丛生

早在阿托品滴眼液获批上市之前，有不少儿童已经用上了该药。

为了能更好地控制孩子近视，家长们不惜花费重金，从各种渠道获得阿托品滴眼液。其中，“海外代购”和“院内制剂”就是最常见的两种获取阿托品滴眼液的方式。

海外代购不难理解，主要是去香港、台湾、新加坡等地购买。这些地区的硫酸阿托品滴眼液已经上市，凭借医生处方可以购买到。比如乐托品（Latropine），由中国台湾药企五福化学制药有限公司研发生产，就深受代购喜爱。

但是，海外代购保证不了药品的价格和质量。2022年11月，有网友表示，乐托品的代购价格从最开始的40-60元涨到了108元每盒，“越来越贵，而且越来越不好买了”。相比于价格持续上涨，买到假货则更令人糟心。据半岛都市报报道称，一位女士通过代购购买的阿托品，通过检测后，竟然毫无阿托品成分，就是普通的睫状肌麻痹药。

院内制剂是另一种获得阿托品的常见渠道。在阿托品正式获批之前，兴齐眼药的阿托品曾在部分医院以院内制剂的“身份”面市，并于互联网医院销售。2021年，兴齐眼药仅靠阿托品就获得约2.8亿元的药品收入。但该药于2022年7月22日起暂停网售，仅院内正常销售。

互联网医院暂停网售后，阿托品的代购价曾一度暴涨过6倍。“代购一次，药费298元，跑腿费200元”，有网友在社交媒体上记录自己代购阿托品的经历。

买不到阿托品，有家长开始转化思路，自行配制低浓度阿托品。

在某社交媒体上搜索，自配阿托品的人不在少数。通常是医院给开高浓度阿托品后，家长们回家根据配比单自行配制。然而，毕竟是入眼的东西，自配的阿托品是否能做到无菌，是否会导致孩子出现眼部感染，谁也无法保证。

高价买，买不到就不惜冒着风险自行配置，家长们可谓“无所不用其极”，这也侧面反映了当下青少年的近视防控需求很大。

此次阿托品获批，也意味着其在中国大陆地区顺利“转正”，家长们可以买得更安心、用得更放心。

然而未来就不会有新的问题了么？

2、0.01%阿托品，到底是“神药”还是“安慰剂”？

本次获批上市的阿托品滴眼液为0.01%浓度，但其实，这种浓度的阿托品近视防控效果，一直受到争议。

阿托品根据浓度不同，分为高浓度阿托品（简称“高阿”）和低浓度阿托品（简称“低阿”）两种。

1%浓度的高阿，通常会在儿童散瞳验光的时候用到。在验光之前，医生会往孩子眼睛里滴一种药水，滴完后看东西就会变得很模糊，甚至会有一种口干的感觉，这种药物就是“高阿”。高阿主要作用是麻痹眼内睫状肌、暂时抑制调节力，使得验光度数更准确。

1989年，中国台湾首次有学者报道：近视孩子长期使用高阿，能明显抑制眼球前后径（即眼轴）的增长，从而减慢近视度数的加深，这无疑是阿托品在临床使用上的“意外之喜”。

然而，研究人员们也发现，阿托品浓度越高，副作用会更加明显。在使用高阿时，孩子会出现畏光、眼压升高、视力模糊等不良反应，甚至会出现青光眼、急性角膜炎等问题。而且停药后会出现近视反弹性增长，且浓度越高，反弹效果越明显。

因此，科学界也一直在探索用于近视控制的最佳浓度。

2016年，著名的新加坡ATOM2实验证明，与0.5%、0.1%阿托品相比，0.01%阿托品滴眼液在5年内能更有效地减缓近视进展，且副作用更小，推荐为6～12岁进展性近视的一线治疗方案。

2022年，我国《低浓度阿托品滴眼液在儿童青少年近视防控中的应用专家共识（2022）》发布，进一步表明：0.01%浓度阿托品适用年龄为4岁至青春期的近视人群。

目前，多国指南共识均推荐0.01%浓度的阿托品作为儿童近视防控的药物。

然而，近几年关于低阿最著名的研究——香港中文大学进行的一项有关低浓度阿托品防治近视研究(LAMP)，却提出了新的最佳浓度，即0.05%。

研究团队招募了438名年龄在4-12岁之间的儿童，他们双眼均患有最少100度近视并于过去一年增加50度以上，并给这些儿童分别使用0.05%、0.025%、0.01%浓度的阿托品或安慰剂。在3年的研究中发现，0.05%的阿托品是延缓近视的最佳浓度，且近视反弹率很小。

此后，也有越来越多的文献指出，尽管0.01%的阿托品是最安全的浓度，但遗憾的是，这个浓度的控制效果也是最弱的。

2023年，香港中文大学眼科团队在《JAMA》发表重磅研究称，在4-9岁的非近视儿童中，0.05%浓度阿托品对近视预防有效果，而0.01%浓度阿托品对近视预防的效果与安慰剂组无显著差异。

同样也是在2023年， 国际知名期刊JAMA Ophthalmology发表的论文指出，0.01%阿托品滴眼液对减缓美国儿童近视进展及眼轴增长无效。

这一系列的研究，直接将0.01%阿托品的效果推到舆论的风口浪尖上，导致0.01%阿托品或成了“安慰剂”。

对此，行业内多位眼科专家表示，0.01%浓度是一个兼顾药效和安全性的折中选项，率先获批的药品都倾向于低浓度、高安全性。但也有专家指出，控制青少年近视进展的最佳阿托品浓度，应该是“疗效”与“副作用”之间的最佳平衡。如果儿童近视进展较快，应当在可以承受的副作用下，追求更高浓度的疗效。

对于0.01%和0.05%浓度的阿托品，究竟哪种获益更佳，未来还需要更多的临床研究来证实。

3、阿托品不是神药，并非人人可用

相比于0.01%阿托品使用效果不佳而言，超适应症使用，甚至滥用，则可能成为低阿上市后面临的最大问题。

目前，兴齐眼药的阿托品滴眼液一盒30支，一支0.4ml，单盒价格为298元，全年使用费用大约在3500元左右，如果按照连续使用3年来计算，花费大约在10500元。这相比于动辄要花费9000-15000元/年的OK镜、离焦软镜，拥有较高的性价比。而且它的使用方法也很简单，只需要睡前在眼中滴入，再按压内眼角即可。

由于操作方便、性价比高、易获得的特点，低浓度阿托品势必会迎来更多近视儿童家长的青睐。

但是既然是处方药，肯定是有使用范围的。本次获批的兴齐眼药0.01%阿托品适应症为：100度至400度的近视、散光不超150度，适应群体为6岁至12岁儿童。

根据我国“低阿使用专家共识”，该药的适用年龄为4-16岁，如果大于16岁但近视进展仍然比较快者，可以延长使用到25岁，但3岁以下禁用。共识也指出，近视大于50度，近视每年发展超过50度，才推荐使用。

但实际上，在阿托品还未获批上市前，部分家长就已经开始不合理地使用阿托品了。

比如，有家长会给3岁以内的孩子使用，或者孩子本没有近视，只是远视储备消失，家长出于焦虑就开始拿阿托品当作预防近视使用。有一些孩子，一年近视度数进展不超过50度，其实只需要观察即可，但家长仍然会给孩子使用阿托品。

阿托品正式上市后，这种情况会不会愈演愈烈，我们不得而知。但必须强调的是，即使是低浓度阿托品，也容易导致眼压升高，如果有家族遗传的眼压较高的患儿，还有可能会诱发青光眼。如孩子本身是过敏体质，可能出现结膜充血、皮肤瘙痒、发烧等过敏反应。如果需要使用，也要经过医生评估指导后用，切不可盲目乱用。

此外，儿童在使用阿托品期间，应该做好定期观察，最好每3个月到医院复查一次，以确保安全以及评估效果。

最后，近视的防控主要不是靠药物，而是增加户外活动时间和健康的用眼习惯。“户外时间不够，阿托品来补”的想法的确本末倒置，真正应该做到的是，不用阿托品，增加户外时间。

【参考文献】

[1]Wei-Han, Chua, and, et al. Atropine for the Treatment of Childhood Myopia[J]. Ophthalmology, 2006.

[2] Tong L , Xiao L H , Koh A , et al. Atropine for the Treatment of Childhood Myopia: Effect on Myopia Progression after Cessation of Atropine[J]. Ophthalmology, 2009, 116(3):572-579.

[3]Audrey, Chia, Wei-Han, et al. Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2)[J]. Ophthalmology, 2012.

[4]中华医学会眼科学分会眼视光学组,中国医师协会眼科医师分会眼视光专业委员会. 低浓度阿托品滴眼液在儿童青少年近视防控中的应用专家共识（2022）[J]. 中华眼视光学与视觉科学杂志,2022,24(6):401-409.

[5] Yam JC, Jiang Y, Tang SM, et al. Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019;126(1):113-124.

[6] Yam JC, Li FF, Zhang X, et al. Two-Year Clinical Trial of the Low-Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report. Ophthalmology. 2020;127(7):910-919.

[7] Yam JC, Zhang XJ, Zhang Y, et al. Three-Year Clinical Trial of Low-Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report. Ophthalmology. 2022;129(3):308-321.

[8]“近视神药”来了？https://news.inewsweek.cn/society/2024-03-19/21497.shtml

[9]半岛调查｜网红阿托品滴眼液代购乱象丛生，“近视神药”并非真“神药”https://baijiahao.baidu.com/s?id=1718048065280255695&wfr=spider&for=pc

[10]儿童“近视神药”无效争议？陶勇教授：“不可依一家之言”https://www.xiaohongshu.com/explore/63f04e53000000000800cc73?note_flow_source=baidu

新闻译文：

"Dropping once a day can delay children's myopia", "The effect is immediate and better than OK lenses", "Dropping one drop before bedtime does not increase the degree for six months" In the past few years, many parents have regarded atropine as a "miracle cure for myopia". Even though it has not been approved for listing in Chinese Mainland before, atropine has always appeared in parents' purchase lists with its excellent efficacy and simple operation methods, and its craziness is comparable to another popular "weight loss magic drug" Smeglutide.

Recently, atropine has finally received a heavyweight news. In March 2024, the National Medical Products Administration officially approved the use of 0.01% concentration atropine in Xingqi Eye drops to alleviate myopia in children. This means that the first prescription drug officially launched in China for controlling myopia - atropine sulfate eye drops.

For children who are already nearsighted, this is undoubtedly good news, as parents no longer have to struggle to obtain this "miracle cure for myopia". However, after the smooth launch of atropine, the following problems also emerged one after another. Is the 0.01% concentration of atropine, often referred to as "placebo," really effective? Is there a risk of abuse when low concentration atropine becomes easier to obtain? In this issue of "Eye Health as Reality", we will discuss it.

1. Many parents are spending a lot of money to make purchases, and there is a chaotic situation of atropine purchasing agents

Many children had already used atropine eye drops before they were approved for marketing.

In order to better control their children's myopia, parents are willing to spend a lot of money to obtain atropine eye drops from various channels. Among them, "overseas purchasing" and "in hospital preparations" are the two most common ways to obtain atropine eye drops.

Overseas purchasing is not difficult to understand, mainly buying from places such as Hong Kong, Taiwan, and Singapore. Atropine sulfate eye drops have been launched in these regions and can be purchased with a doctor's prescription. For example, Latropine, developed and produced by Wufu Chemical Pharmaceutical Co., Ltd., a pharmaceutical enterprise in Taiwan, China, is deeply loved by purchasing agents.

However, overseas purchasing cannot guarantee the price and quality of drugs. In November 2022, some netizens reported that the purchasing price of Letuopin had increased from the initial 40-60 yuan to 108 yuan per box, "becoming increasingly expensive and difficult to buy.". Compared to the continuous rise in prices, buying counterfeit goods is even more frustrating. according to the Peninsula Metropolis Daily, a woman purchased atropine through purchasing agents and found no atropine content after testing, which is a common ciliary muscle paralysis drug.

Intrahospital preparations are another common channel for obtaining atropine. Before the official approval of atropine, the atropine of Xingqi Eye medicine was marketed in some hospitals as a hospital preparation and sold in Internet hospitals. In 2021, Xingqi Eye Medicine earned approximately 280 million yuan in drug revenue solely from atropine. But the drug will be temporarily suspended from online sales starting from July 22, 2022, and will only be sold normally in hospitals.

Internet hospitals suspended online after-sales service, and the purchase price of atropine once soared six times. A netizen recorded their experience of purchasing atropine on social media, stating that it costs 298 yuan for medication and 200 yuan for running errands.

Unable to buy atropine, some parents have started to change their mindset and prepare low concentration atropine themselves.

There are many people who self prepare atropine when searching on a certain social media platform. Usually, after the hospital prescribes high concentration atropine, parents go home and prepare their own according to the prescription. However, after all, it is something that enters the eyes, and no one can guarantee whether self formulated atropine can be sterile or whether it will cause eye infections in children.

Buying at a high price, if not available, parents are willing to take risks and configure their own products. This reflects the high demand for myopia prevention and control among teenagers today.

The approval of atropine this time also means that it has become a regular person in Chinese Mainland, and parents can buy and use atropine with more confidence.

But will there be no new problems in the future?

2. 0.01% atropine, is it a "miracle drug" or a "placebo"?

The atropine eye drops approved for marketing this time have a concentration of 0.01%, but in fact, the myopia prevention and control effect of this concentration of atropine has been controversial.

Atropine is divided into two types based on its concentration: high concentration atropine (referred to as "high atropine") and low concentration atropine (referred to as "low atropine").

A high concentration of 1% is usually used in children's dilated pupils for optometry. Before optometry, doctors will drop a medication into the child's eyes. After the medication is applied, the vision will become blurry, and there may even be a feeling of dry mouth. This medication is called "Gao Ah". The main function of Gao A is to paralyze the ciliary muscle in the eye, temporarily suppress the regulatory force, and make the refractive index more accurate.

In 1989, for the first time in Taiwan, China, China, a scholar reported that long-term use of Gao'a by myopic children could significantly inhibit the growth of the anterior and posterior eye diameter (i.e. eye axis), thus slowing down the deepening of myopia, which was undoubtedly a "surprise" in the clinical use of atropine.

However, researchers also found that the higher the concentration of atropine, the more pronounced the side effects. When using Gao A, children may experience adverse reactions such as photophobia, elevated intraocular pressure, blurred vision, and even problems such as glaucoma and acute keratitis. Moreover, after discontinuing the medication, there will be an increase in myopic rebound elasticity, and the higher the concentration, the more significant the rebound effect.

Therefore, the scientific community has also been exploring the optimal concentration for myopia control.

In 2016, the famous Singapore ATOM2 experiment proved that compared to 0.5% and 0.1% atropine, 0.01% atropine eye drops can more effectively slow down the progression of myopia within 5 years with fewer side effects. It is recommended as a first-line treatment for progressive myopia between the ages of 6 and 12.

In 2022, the expert Consensus on the application of Low Concentration Atropine Eye Drops in the Prevention and Control of Myopia in Children and Adolescents (2022) was released in China, further indicating that 0.01% concentration of Atropine is suitable for myopic individuals aged 4 to adolescence.

At present, consensus in multiple guidelines recommends atropine at a concentration of 0.01% as a medication for the prevention and control of myopia in children.

However, in recent years, a study on the prevention and treatment of myopia with low concentration atropine (LAMP) conducted by the Chinese University of Hong Kong, the most famous research on low concentration atropine, has proposed a new optimal concentration of 0.05%.

The research team recruited 438 children between the ages of 4 and 12, all of whom had at least 100 degree myopia in both eyes and had increased by more than 50 degrees in the past year. These children were given atropine or placebo at concentrations of 0.05%, 0.025%, and 0.01%, respectively. In a 3-year study, it was found that 0.05% atropine is the optimal concentration for delaying myopia, and the myopia rebound rate is very small.

Subsequently, more and more literature has pointed out that although 0.01% atropine is the safest concentration, unfortunately, the control effect of this concentration is also the weakest.

In 2023, the ophthalmology team of The Chinese University of Hong Kong published a heavyweight study in JAMA stating that in non myopic children aged 4-9, a 0.05% concentration of atropine is effective in preventing myopia, while a 0.01% concentration of atropine has no significant difference in preventing myopia compared to the placebo group.

In 2023, an internationally renowned journal JAMA Ophthalmology published a paper stating that 0.01% atropine eye drops are ineffective in slowing down the progression of myopia and axial growth in American children.

This series of studies directly pushed the effect of 0.01% atropine to the forefront of public opinion, leading to 0.01% atropine becoming a placebo.

Several ophthalmologists in the industry have stated that a concentration of 0.01% is a compromise between efficacy and safety, and the first approved drugs tend to have low concentrations and high safety. But some experts also point out that the optimal concentration of atropine to control the progression of myopia in adolescents should be the best balance between "efficacy" and "side effects". If children's myopia progresses rapidly, they should pursue higher concentrations of therapeutic effects under tolerable side effects.

More clinical studies are needed in the future to confirm which benefits are better for atropine at concentrations of 0.01% and 0.05%.

3. Atropine is not a miracle drug, not everyone can use it

Compared to the poor effectiveness of using 0.01% atropine, the use beyond indications, and even abuse, may become the biggest problem faced by low-grade atropine after its launch.

At present, a box of 30 atropine eye drops, each 0.4ml, for Xingqi Eye Medicine is priced at 298 yuan per box. The annual usage cost is approximately 3500 yuan. If calculated based on continuous use for 3 years, the cost is approximately 10500 yuan. Compared to OK lenses and defocus soft lenses that often cost 9000 to 15000 yuan per year, this has a higher cost performance ratio. And its usage is also very simple, just drop it into your eyes before going to bed and press the inner corner of your eye.

Due to its convenient operation, high cost-effectiveness, and easy availability, low concentration atropine is bound to be favored by more parents of myopic children.

But since it is a prescription drug, there must be a scope of use. The approved Xingqi eye medicine with 0.01% atropine is suitable for children aged 6 to 12 years old, with myopia and astigmatism not exceeding 150 degrees ranging from 100 to 400 degrees.

According to the consensus of experts on low myopia use in China, the age of application for this medication is 4-16 years old. If the age is over 16 but the progression of myopia is still relatively fast, it can be extended to 25 years old, but it is prohibited for those under 3 years old. The consensus also points out that myopia is recommended only when it exceeds 50 degrees and develops over 50 degrees annually.

However, in reality, some parents had already started using atropine unreasonably before it was approved for sale.

For example, some parents may use atropine as a preventive measure for children under 3 years old, or if the child does not have nearsightedness but their hyperopia reserves disappear, parents may start using atropine due to anxiety. Some children, whose myopia progression does not exceed 50 degrees in a year, only need to be observed, but parents still give their children atropine.

We don't know if this situation will worsen after the official launch of atropine. However, it must be emphasized that even low concentrations of atropine can easily lead to elevated intraocular pressure. If there are children with familial inheritance of high intraocular pressure, it may also induce glaucoma. If the child has an allergic constitution, they may experience allergic reactions such as conjunctival congestion, skin itching, and fever. If it needs to be used, it should also be evaluated and guided by a doctor before use, and should not be used blindly.

In addition, children should undergo regular observation during the use of atropine, and it is best to have a follow-up visit to the hospital every 3 months to ensure safety and evaluate the effectiveness.

Finally, the prevention and control of myopia mainly rely not on medication, but on increasing outdoor activity time and healthy eye habits. The idea of "not having enough outdoor time, atropine to make up for it" is indeed putting the cart before the horse. What should be truly achieved is to increase outdoor time without atropine.

[Reference]

[1] Wei Han, Chua, and, et al. Atropine for the Treatment of Child Myopia [J] Ophthalmology, 2006.

[2] Tong L, Xiao L H, Koh A, et al. Atropine for the Treatment of Child Myopia: Effect on Myopia Progression after Cessation of Atropine [J] Ophthalmology, 2009, 116 (3): 572-579

[3] Audrey, Chia, Wei Han, et al. Atropine for the Treatment of Child Myopia: Safety and Efficiency of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2) [J] Ophthalmology, 2012.

[4] The Ophthalmic Optics Group of the Ophthalmology Branch of the Chinese Medical association and the Ophthalmology professional Committee of the Ophthalmology Branch of the Chinese Medical Association Expert consensus on the application of low concentration atropine eye drops in the prevention and control of myopia in children and adolescents (2022) [J] Chinese Journal of Optometry and Visual Science, 2022-24 (6): 401-409

[5] Yam JC, Jiang Y, Tang SM, et al. Low Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double Blind, Placebo Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019; 126 (1): 113-124

[6] Yam JC, Li FF, Zhang X, et al. Two Year Clinical Trial of the Low Concentration Atropine for Myopia Progression (LAMP) Study: Phase 2 Report Ophthalmology. 2020; 127 (7): 910-919

[7] Yam JC, Zhang XJ, Zhang Y, et al. Three Year Clinical Trial of Low Concentration Atropine for Myopia Progression (LAMP) Study: Continued Versus Washout: Phase 3 Report Ophthalmology. 2022; 129 (3): 308-321

[8] Is the myopia elixir here? https://news.inewsweek.cn/society/2024-03-19/21497.shtml

[9] Peninsula survey | Online Celebrity Atropine Eye Drops Purchase Chaos abounds, "Myopia God Drug" is not a true "God Drug" https://baijiahao.baidu.com/s?id=1718048065280255695&wfr=spider&for=pc

[10] Controversy over the Ineffectiveness of Children's Myopia Medicine? professor Tao Yong: "You cannot follow the words of one family." https://www.xiaohongshu.com/explore/63f04e53000000000800cc73?note_flow_source=baidu

句子分析1：

 If calculated based on continuous use for 3 years, the cost is approximately 10500 yuan.

句子成分分析：

If calculated [based on continuous use] [for 3 years], || the cost is [approximately] 10500 yuan.

句子语法结构详解：

* if 为连词，引导条件状语从句。句子有省略。
* calculated 为过去分词。
* the 开头为陈述句。
* is 为系动词作谓语，采用一般现在时。
* the 为定冠词。

相关语法知识:
   省略句
   状语从句
   过去分词
   系动词
   时态

句子相关词汇解释：

Phrase:

Vocabulary:

句子语法错误检查：

(未发现错误)

句子相关学习点：

 cost, spend, take 的区别

句子分析2：

 they should pursue higher concentrations of therapeutic effects under tolerable side effects.

句子成分分析：

they should pursue higher concentrations (of therapeutic effects) [under tolerable side effects].

句子语法结构详解：

(higher 为 high 的比较级形式)

* pursue 为谓语。
* should 为情态动词。they 为人称代词主格。

相关语法知识:
   形容词的比较级和最高级
   人称代词 | 情态动词

句子相关词汇解释：

Phrase:

Vocabulary:

句子语法错误检查：

(未发现错误)

句子相关学习点：

 below 和 under 的区别

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