*仅供医学专业人士阅读参考
硫酸阿托品滴眼液上市为何如此曲折？
撰文丨柚子
3月11日，国家药监局官网发布药品批准证明文件送达信息显示，沈阳兴齐眼药的硫酸阿托品滴眼液已通过批准上市。
图1：国家药品监督管理局官网
根据兴齐眼药官网信息显示
[1]，此次获批的0.01%硫酸阿托品滴眼液可用于延缓球镜度数为-1.00D~-4.00D
（散光≤1.50D、屈光参差≤1.50D）
的 6~12 岁儿童的近视进展。
在近几十年里，近视已成为青少年视力损伤的最常见因素。我国的近视率不容小觑，国家卫健委调查显示，截至2020年，我国儿童青少年总体近视率为52.7%，其中6岁儿童为14.3%，小学生为35.6%，初中生为71.1%，高中生为80.5%。
研究表明，近视儿童年龄越小，成年高度近视风险越大，因此，找到能有效控制近视增长的手段不仅受到临床关注，也是众多家长关心的问题。低浓度阿托品用于控制近视进展在近年来成为视光学中药物控制近视研究的热点。
阿托品滴眼液“超说明书”用药由来已久
阿托品在眼科的使用广泛，常用于散瞳检查验光，可以缓解睫状肌痉挛，在后续的研究中逐渐发现了其有控制近视增长的作用。硫酸阿托品滴眼液早在亚洲新加坡、日本、印度、中国香港和中国台湾等地区用于防控近视已近20年。
阿托品滴眼液的近视控制效果呈现浓度依赖效应，高浓度阿托品滴眼液对近视的控制效果可高达60%~96%，但高浓度阿托品滴眼液存在严重畏光、近视力下降等不良反应以及停药后反弹效应。因此，一直未有正式的药品获批进入临床，在用于减缓近视进展上，阿托品滴眼液属于超说明书用药。
直至2016年开展的亚洲人群的系列随机对照临床试验
（ATOM1、ATOM2）
提示
[2]，0.01%阿托品滴眼液具有延缓近视进展效果，且和较高浓度阿托品滴眼液相比具有最小不良反应以及停药后最小反弹效应。
2021年，澳大利亚治疗用品管理局
(TGA)
批准Aspen公司的0.01%硫酸阿托品滴眼液，用于减缓儿童和青少年近视的发展。该药可作为一种减缓近视进展的治疗方案用于近视每年进展≥-1.0 D屈光度的4
~14岁儿童。这也是全球首款明确用于缓解近视的滴眼液。
我国2022年发布的《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》也指出
[3]：0.01%阿托品滴眼液具有良好的延缓近视进展效果，和更高浓度阿托品滴眼液相比不良反应最小、反弹效应最低，因此可能是现阶段延缓儿童青少年近视进展的合理浓度。
历经8年临床验证，院内制剂终于转正
在我国，阿托品滴眼液早期以院内制剂的形式在临床得到广泛使用。
2019年，兴齐眼药通过旗下的兴齐眼科医院，将低浓度阿托品滴眼液作为该院的院内制剂上市，后续又通过互联网医疗方式实现了线上的低浓度阿托品处方的开具以及销售，引发了一批阿托品网络求购潮。随后又有多家医院的同类院内制剂获批上市。
不过从2016年开始，兴齐眼药就已经与新加坡国立眼科中心
（SNEC）
签署合作协议，在SNEC国内独家授权的硫酸阿托品滴眼液处方及5年临床试验数据的基础上，开展硫酸阿托品滴眼液III期临床试验。
2022年12月，兴齐眼药公布了硫酸阿托品滴眼液1年的III期临床试验的总结报告
[4]，研究共纳入 406 例 6~12 岁儿童受试者，用药观察为期 1 年，停药后 0.5 年的随访观察。研究结果显示，试验组对比安慰剂组在主要疗效指标上有统计学意义的显著性差异，试验组优于安慰剂组；且安全性良好，患者使用依从性好。
图2 兴齐眼药证券公告
此次获批的0.01%硫酸阿托品滴眼液，是国内首款上市的延缓儿童近视进展低浓度硫酸阿托品滴眼液，对降低儿童青少年群体近视率有重要意义。也从院内制剂转正，给了近视患儿更多的选择。
阿托品滴眼液能否预防近视？
关于阿托品滴眼液能否预防近视也是争议不断。2023年2月，香港中文大学一项随机对照双盲研究
[5]比较了0.01%和0.05%两种浓度的阿托品在未近视的儿童中对近视的预防作用。研究结果显示，安慰剂和0.01%阿托品组，近视的发生率并没有统计意义上的显著区别；0.05%阿托品滴眼液可降低近视发生率和快速近视漂移的受试者百分比。
而在同年6月，郑州大学第一附属医院眼科专家团队发布在
European Journal of Pediatrics的一项前瞻性、随机双盲、空白对照、交叉试验证明
[6]，0.01%阿托品滴眼液在近视前期儿童中的使用可有效预防近视发生及快速近视漂移。
这两项研究的随访时间暂时都不长，从目前国内外的临床试验，在针对阿托品滴眼液预防近视的研究还相对较少，还需要更多的循证证据，并评估其长期安全性。值得注意的是，儿童青少年近视防控并不只有使用药物控制这一种单一手段，光学矫正、增加户外活动、养成良好的用眼习惯也是不可忽略的。
参考文献：
[1]http://www.sinqi.com/html/SYXQ/202403/948631948631026924.html
[2]Chia A, Lu QS, Tan D. Five-year clinical trial on atropine for the treatment of myopia 2: myopia control with atropine 0.01% eyedrops. Ophthalmology, 2016, 123(2): 391-399.
[3]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.
[4]https://static.cninfo.com.cn/finalpage/2022-12-15/1215365273.PDF
[5]Yam JC, Zhang XJ, Zhang Y, et al. Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children: The LAMP2 Randomized Clinical Trial. JAMA. 2023;329(6):472–481.
[6]Wang W, Zhang F, Yu S, Ma N, Huang C, Wang M, Wei L, Zhang J, Fu A. Prevention of myopia shift and myopia onset using 0.01% atropine in premyopic children - a prospective, randomized, double-masked, and crossover trial. Eur J Pediatr. 2023 Jun;182(6):2597-2606.
本文来源：医学界眼科频道
责任：向宇
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rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px) and (prefers-color-scheme:dark){body:not(.pages_skin_pc) .wx-root:not([data-weui-theme=light]),body:not(.pages_skin_pc) body:not([data-weui-theme=light]){--appmsgExtra-BG: #121212}}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]).my_comment_empty_data{background-color:#111}}body,.wx-root{--weui-BG-6: rgba(0, 0, 0, .05);--weui-ACTIVE-MASK: rgba(0, 0, 0, .05)}body,.wx-root{--weui-REDORANGE: #ff6146;--weui-BG-0: #ededed;--weui-BG-1: #f7f7f7;--weui-BG-2: #fff;--weui-BG-3: #f7f7f7;--weui-BG-4: #4c4c4c;--weui-BG-5: #fff;--weui-FG-0: rgba(0, 0, 0, .9);--weui-FG-HALF: rgba(0, 0, 0, .9);--weui-FG-1: rgba(0, 0, 0, .55);--weui-FG-2: rgba(0, 0, 0, .3);--weui-FG-3: rgba(0, 0, 0, .1);--weui-FG-4: rgba(0, 0, 0, .15);--weui-FG-5: rgba(0, 0, 0, .05);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #fa9d3b;--weui-YELLOW: #ffc300;--weui-GREEN: #91d300;--weui-LIGHTGREEN: #95ec69;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1485ee;--weui-PURPLE: #6467f0;--weui-WHITE: #fff;--weui-LINK: #576b95;--weui-TEXTGREEN: #06ae56;--weui-FG: #000;--weui-BG: #fff;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: #fa9d3b;--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: #06ae56;--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: #10aeff;--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(0, 0, 0, .5);--weui-TAG-BACKGROUND-BLACK: rgba(0, 0, 0, .05)}body,.wx-root{--weui-BG-0: #ededed;--weui-BG-1: #f7f7f7;--weui-BG-2: #fff;--weui-BG-3: #f7f7f7;--weui-BG-4: #4c4c4c;--weui-BG-5: #fff;--weui-FG-0: rgba(0, 0, 0, .9);--weui-FG-HALF: rgba(0, 0, 0, .9);--weui-FG-1: rgba(0, 0, 0, .55);--weui-FG-2: rgba(0, 0, 0, .3);--weui-FG-3: rgba(0, 0, 0, .1);--weui-FG-4: rgba(0, 0, 0, .15);--weui-FG-5: rgba(0, 0, 0, .05);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #fa9d3b;--weui-YELLOW: #ffc300;--weui-GREEN: #91d300;--weui-LIGHTGREEN: #95ec69;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1485ee;--weui-PURPLE: #6467f0;--weui-WHITE: #fff;--weui-LINK: #576b95;--weui-TEXTGREEN: #06ae56;--weui-FG: #000;--weui-BG: #fff;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: #fa9d3b;--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: #06ae56;--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: #10aeff;--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(0, 0, 0, .5);--weui-TAG-BACKGROUND-BLACK: rgba(0, 0, 0, .05)}.wx-root,body{--weui-BTN-ACTIVE-MASK: rgba(0, 0, 0, .1)}.wx-root,body{--weui-BTN-DEFAULT-ACTIVE-BG: #e6e6e6}.wx-root,body{--weui-DIALOG-LINE-COLOR: rgba(0, 0, 0, .1)}.wx-root,body{--weui-BG-COLOR-ACTIVE: #ececec}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BTN-ACTIVE-MASK: rgba(255, 255, 255, .1)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BTN-DEFAULT-ACTIVE-BG: rgba(255, 255, 255, .126)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-DIALOG-LINE-COLOR: rgba(255, 255, 255, .1)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--APPMSGCARD-BG: #1E1E1E}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--APPMSGCARD-LINE-BG: rgba(255, 255, 255, .07)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BG-COLOR-ACTIVE: #373737}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BG-6: rgba(255, 255, 255, .1);--weui-ACTIVE-MASK: rgba(255, 255, 255, .1)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-REDORANGE: #ff6146;--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .8);--weui-FG-HALF: rgba(255, 255, 255, .6);--weui-FG-1: rgba(255, 255, 255, .5);--weui-FG-2: rgba(255, 255, 255, .3);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--discussInput-BG: rgba(255, 255, 255, .03)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--nickName-FG: #959595}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .8);--weui-FG-HALF: rgba(255, 255, 255, .6);--weui-FG-1: rgba(255, 255, 255, .5);--weui-FG-2: rgba(255, 255, 255, .3);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media(prefers-color-scheme:dark){.wx-root:not([data-weui-theme=light]),body:not([data-weui-theme=light]){--appmsgExtra-BG: #121212}}.rich_media_content p{clear:both;min-height:1em}td p{margin:0;padding:0}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]) .rich_media_content img:not(.wx_img_placeholder){filter:brightness(.8)}}@media screen and (min-width:1024px){body:not(.pages_skin_pc) :root{--appmsgPageGap: 20px;--appmsgPageBottomGap: 40px}}:root{--articleFontsize: 17px}:root{--sab: env(safe-area-inset-bottom)}:root{--wxBorderAvatarRatio: 3}:root{--discussPageGap: 20px}:root{--immersive-safe-bottom: env(safe-area-inset-bottom)}:root{--appmsgPageGap: 20px;--appmsgPageBottomGap: 40px}
div.autoTypeSetting24psection > p,div.autoTypeSetting24psection > section{margin-bottom: 24px;}
