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肉毒杆菌神经毒素在眼科中的应用

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发表于 2019-8-21 00:00:03 | 显示全部楼层 |阅读模式

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概要
肉毒杆菌神经毒素(BoNT)是第一种用于治疗眼科疾病和减少皮肤皱纹作为美容剂的生物毒素。适当使用时,会削弱肌肉收缩的力量和/或抑制腺体分泌。肉毒杆菌毒素治疗最常见的部位是上表面,包括眉间,额头,眉毛和侧眦线,或鱼尾纹。通过放松引起皱纹的肌肉,可以通过其使用实现非永久性结果。 BoNT已广泛用于各种眼科疾病。 BoNT的作用是暂时的,但即使在重复注射后通常也保持治疗益处。治疗通常耐受良好。与治疗相关的并发症和副作用是罕见且暂时的。并发症是由于相邻肌群的弱(化学去神经),免疫机制和注射技术引起的。目前的治疗适应症,剂量,并发症和禁忌症用于下列与眼科有关的疾病:美学用途,斜视,眼睑痉挛,面肌痉挛,眼睑退缩,睑内翻,泪腺分泌过多综合征和面瘫。

关键词:肉毒毒素,眼睑痉挛,面肌痉挛,斜视

介绍
导致人类肉毒杆菌病的肉毒杆菌神经毒素(BoNT)由产孢子,厌氧,革兰氏阳性杆菌梭菌肉毒杆菌产生。 BoNT是人类已知的最有效的毒素

鉴定出的第一种生物毒素BoNT于1973年由Scott等人首次应用于治疗斜视(水平肌肉),并于1980年开始用于人类.3 BoNT A型(BoNT-A)获得美国食品和药物管理局(FDA)于1989年治疗斜视,眼睑痉挛和面肌痉挛,后来在2002年用于美容目的的眉间区域.4在土耳其,卫生部批准使用肉毒杆菌毒素(Allergan,Inc.,Irvine) 2001年,加利福尼亚州,美国)和Dysport(Medicis Pharmaceutical Corp.,Scottsdale,AZ,USA)于2002年。

注意到用BoNT治疗眼睑痉挛的患者表现出面部皱纹减少,这加速了用于治疗皱纹的BoNT的研究和实施.5,6 BoNT现在在世界范围内用于美学目的。此外,在应用于神经系统疾病后,注意到毒素的无汗效应,并且BoNT于1994年开始用于治疗多汗症.7

作用机制 - 药理学
肉毒杆菌是革兰氏阳性,厌氧杆菌,具有七种抗原性独特的血清型(A-G)。 由这些血清型产生的神经毒素的分子大小不同,范围为300至900千道尔顿(kDa)(表1)。 BoNT由50kDa轻链和与二硫键连接的100kDa重链组成.8 A,B,E,F和G血清型引起人类肉毒杆菌中毒.9A型是最有效的外毒素,也是BoNT 最常用的商业类型。 BoNT的作用机制是基于阻断突触前神经末梢释放乙酰胆碱。 除乙酰胆碱外,BoNT还抑制其他化学刺激物的释放,如去甲肾上腺素,多巴胺,5-羟色胺,γ-氨基丁酸,甘氨酸和蛋氨酸 - 脑啡肽.8

表格1
肉毒神经毒素产品的比较
t1.jpg

就毒素副作用的发展而言,BoNT的扩散在临床上是重要的。由于它们在注射后快速崩解,因此认为BoNT制剂中使用的各种蛋白质复合物不影响BoNT的扩散。大剂量或高剂量的BoNT给药增加了扩散区域,从而增加了副作用的可能性

用于临床实践的配方
目前有四种商业制剂的BoNT:Botox(Allergan,Inc.,Irvine,CA,USA),Dysport(Medicis Pharmaceutical Corp.,Scottsdale,AZ,USA),Myobloc / Neurobloc(Solstice Neurosciences,Inc.,Louisville,KY) ,美国)和Xeomin / Bocouture(Merz Pharmaceuticals,德国法兰克福)(表1)。 BoNT-A产品之间存在一些差异。 2009年,FDA声明每种BoNT-A产品的效力取决于其制备方法。在临床实践中,建议以1:2.5-3单位(U)的比例应用肉毒杆菌毒素或Dysport .10,11该剂量是根据安全性而不是疗效确定的.12一桶肉毒杆菌相当于1U Xeomin和50-100 U的Myobloc。

一瓶肉毒杆菌含有100U,一瓶Dysport含有500U,一瓶Xeomin含有50或100U(有两种形式)的BoNT-A。 Mybloc是一种BoNT-B制剂,有3种不同的版本,含有2,500-10,000 U /小瓶。与其他BoNT产品不同,Mybloc不需要稀释,可以直接应用

制备和储存条件
由于肉毒杆菌更优选用于眼科,皮肤病学和美容应用,给药和剂量的讨论将主要集中在该产品上.4,6,10,11 BoNT-A制剂以含有冻干粉末的小瓶的形式分布。将含有100U BoNT-A的Botox小瓶用1-8mL无菌盐水重建。得到的0.1mL肉毒杆菌溶液含有1.25至10U的BoNT-A.13。在临床实践中,最常见的剂量是2.5U / 0.1mL,通过用4mL无菌盐水重建Botox小瓶获得。含有500 U的Dysport小瓶可以用2.5-5 mL盐水(10-20 U / 0.1 mL)重建.14 BoNT非常脆弱,因此在准备使用时必须注意不要使溶液发泡或搅动。制造商建议在4小时内使用BoNT解决方案或重建。制备后不应冷冻BoNT;溶液必须在2-8°C下储存,并在24小时内使用。研究报道,BoNT-A制剂用等渗氯化钠溶液重建并在2-8℃下储存,可安全使用长达2周,临床疗效无明显下降[11,15,16]。

除了保持功效外,保留制剂的无菌性是另一个重要的考虑因素。 Alam等[17]证明单瓶BoNT-A的无菌性不会受到7周内不同时间进行的注射的影响(总共127个小瓶,平均每次使用4.5次)。

效果持续时间
BoNT在24-72小时内开始生效,并在7-14天内达到最大效果。它对自主神经的影响(治疗多汗症,膀胱过度活动症)持续时间明显长(6-9个月),而不是对横纹肌的影响(面部皱纹; 3-4个月).13

给药和麻醉
对于BoNT注射,优选具有30号针头的1mL注射器。注射前,应使用不含酒精的消毒液清洁皮肤并擦干。含有利多卡因和丙胺卡因组合的酰胺衍生物外用乳膏可用于降低疼痛感。皮肤拉紧,露出浅表血管,注射时应避免使用。18

使用领域
BoNT于1989年被FDA批准用于治疗斜视,眼睑痉挛和面肌痉挛,并于2002年获得美学目的.4自2001年土耳其卫生部批准以来,它已在土耳其广泛用于美学目的。除眼科外,BoNT还用于各种医学分支,用于疼痛管理和功能治疗。对于男性和女性而言,使用BoNT治疗由反复肌肉收缩形成的面部皱纹的理想年龄组是40-60岁。在眼科成形术中,BoNT还用于偏斜和眼部疾病,如斜视,眼睑痉挛,面肌痉挛,上睑退缩,睑内翻,泪腺分泌过多,面瘫。

面部皱纹
遗传,年龄,环境因素和面部肌肉的过度都会在皱纹的发展中发挥作用.19,20在运动过程中出现或在休息时不明显的线条称为动态皱纹,而休息期间线条明显的线条则是21,22 Carruthers和Carruthers23指出,用于美容目的的BoNT-A在用于中上层和下层的较低剂量时与上层相比是有效的。 BoNT干扰肌肉收缩并消除线条,没有主要的局部或全身并发症。已知毒素扩散到面部注射部位周围2.5-3cm的区域.24低体积,高浓度的溶液用于减少BoNT在美容应用中的扩散。

额头和Glabellar皱纹
额肌负责前额区域的皱纹。当额肌拉高肌肉时,额头皮肤会出现水平线条。额肌的内侧纤维通常更强,从而形成深皱纹。在额肌最大收缩时标记水平皱纹,然后肌肉注射在6到8个位置,肉毒杆菌毒素剂量为10-15U,Dysport剂量为20-30U。18

BoNT的第一个整形应用是眉间皱纹。有两条肌肉负责眉间皱纹:肌肉收缩向肌肉内侧边缘向下收缩并在眉间引起水平线条,而皱眉肌纤维肌肉拉向肌肉内侧末端,从而形成垂直线条根据从许多使用不同剂量的研究中获得的临床发现,以剂量为20 U Botox26,27或50 U Dysport,以V形图案进行5次注射至眉间区域.28,29,30男性的BoNT-A剂量通常较高,因为它们的肌肉质量较厚。在一项安慰剂对照,双盲,随机研究肉毒杆菌毒素的研究中,男性患者需要至少40 U的初始剂量来治疗眉间皱纹.31

眉毛重新定位
肌肉位置由额肌(提升),眼轮匝肌,压迫性上颌骨,皱眉肌和提肌(压迫体)的平衡决定.25,32

建议在3个点的眼轮匝肌上颞肌内肌肉注射,总剂量约为10-15 U肉毒杆菌或30-40 U Dysport。18对眼轮匝肌进行肉毒杆菌注射(7-10 U),据报道,眉毛压迫肌中的一个在眉毛中部瞳孔区域引起约1 mm的高度,在外侧眦区域引起约5 mm .33三点注射约6-10 U剂量已经确定对于颞上眼轮匝肌的肉毒杆菌有效地抬起眉毛.33,34注射给予肌肉的外侧三分之一和距离眼眶骨边缘1cm,以避免眶内扩散。 BoNT扩散到周围组织可导致复视(外直肌),眼睑下垂(提肌睑肌)和眉毛过度抬高(额外额肌).35

眶周皱纹(Crow’s脚)
由于眼轮匝肌在微笑时的作用,乌鸦的脚是从外眦向外辐射的皱纹.20 BoNT注射在距离眼眶侧缘1 cm处进行,以防止BoNT扩散到外直肌.36

研究已经确定,12U的Botox37剂量或30-36U的Dysport38,39剂量分为3次注射是有效的。将BoNT注射到眼眶外侧缘以上太远可导致眼睑上睑下垂,而注射太远可导致颧肌麻痹和唇不对称(眼睑下垂).40眼轮匝肌过度麻痹可导致闭眼减弱.24

斜视
BoNT首次应用于人类眼科手术,由Alan Scott作为斜视手术的替代方案.3他的目的是通过减弱收缩的拮抗肌来减少偏差。 BoNT特别适用于复杂病例,如应避免全身麻醉的患者,麻痹性斜视或术后连续性斜视的患者,偏差小于40屈光度的患者,活动性甲状腺眼眶病变患者,循环内斜视患者,以及经历过多次手术的患者斜视手术.41

尽管通常使用肌电图来促进将BoNT准确注射到目标肌肉中42,但也可以通过直接观察肌肉的开放方法进行注射(图1)。肉毒杆菌的平均剂量为每个肌肉1-3U。高剂量(特别是> 10 U)时并发症的发生率增加.41据报道,BoNT-A可减少超过50%的患者眼部偏差43,44,45,并在婴儿和儿童中产生令人满意的长期效果.46 ,47

1.jpg
图1
在右眼中,从鼻象限制备基于穹窿的结膜瓣以暴露内直肌,然后使用30号针(来自BaşarE。)从肌肉插入约10mm处施用肌内注射肉毒杆菌神经毒素。存档)
BoNT-A注射可用作儿科内斜视斜视手术的替代方案.48图2显示了在作者的诊所接受BoNT-A(肉毒杆菌毒素)注射治疗的婴儿内斜视患者。可以看出,肉毒杆菌注射后患者的内斜视得到了解决。 Tengtrisorn等[49]将BoNT-A给予各向异性儿童(平均年龄26.8个月),发现平均偏离角从第一次注射前40.4棱镜屈光度的基线下降到第二次注射前的24.5棱镜屈光度。他们报告说,BoNT-A给药在约73%的患者中取得了成功的结果。 Ruiz等[50]观察到BoNT-A注射后18个月以上患者的成功,但报告18岁以下患者失败。相比之下,Campos等[51]发现,与7个月以上的患者相比,BoNT治疗在7个月以下的婴儿内斜视患者中更为成功。在一系列29例急性单侧第六神经麻痹患者中,76%的患者在直肌外侧麻痹发作后平均40天内注射BoNT治疗内直肌.52 In Yabaş等[53]的病例对照研究包括22例急性第六脑神经麻痹患者,14例患者在同侧拮抗肌中接受BoNT注射,8例接受闭塞治疗。尽管两组显示出相当的治愈率,但BoNT组表现出更快速的症状改善。对于慢性第六脑神经麻痹,转位手术和BoNT注射到内直肌可被认为是一种安全有效的治疗选择.54,55

2.jpg
图2
肉毒杆菌前后神经毒素-A注射液(来自BaşarE。档案)
BoNT注射也可用作外斜视患者手术的替代方案。 Sener和Sanac56对25名内斜视患者(平均1.6次注射)和45名外斜视患者(平均1.6次注射)给予BoNT,两组的偏差角约为38个棱镜屈光度。他们报道,在32%的内斜视患者和22%的外斜视患者中,偏差角减小至小于10个棱镜屈光度。超过10U的BoNT-A剂量与上睑下垂和垂直偏差的发生率增加有关。在另一项研究中,1.25-5 U BoNT-A用于预防12名感觉斜视患者的肌肉收缩,平均偏差为34棱镜屈光度,平均矫正效果为73%.57

由于过度矫正导致的残余偏差和连续偏差是可能影响斜视手术结果的潜在并发症。在这些情况下可以应用各种治疗方法,包括闭塞,棱镜矫正,直视治疗和眼镜。 Dawson等[58]对外斜视手术后连续性内斜视患者进行了评估,结果发现36例融合电位患者BoNT-A注射导致可接受的偏差矫正,复视的消退和高质量立体视觉的发展。

大约80%的婴儿内斜视患者出现分离的垂直偏差。 BoNT-A注射同时给予54名患有婴儿内斜视的患者的内直肌,伴随解离的垂直偏差按年龄分为2组(组1 <18个月;组2> 18个月)。在超过18个月的组中完成了水平偏差和离解垂直偏差的完全校正

还有报道称BoNT管理在垂直偏差方面的好处。 Ozkan等[59]观察到,在坚持综合征的情况下给予下直肌的BoNT-A减少了对二次手术的需求。测定BoNT注射到下直肌和上直肌,以改善甲状腺眼病的垂直偏差.60

除了斜视外,BoNT还应用于眼球震颤。对多个水平直肌或眼球后区域进行施用。在某些情况下,球后&#8203;&#8203;注射BoNT会导致眼球震颤显著减少[44],尽管使用这种方法也观察到不利的结果.61球后注射中使用的剂量通常高于(20-30 U)用于肌内注射的剂量。直肌。报告的副作用包括上睑下垂,复视,下直肌麻痹和全眼肌麻痹.41 Carruthers62将BoNT-A应用于4例先天性眼球震颤患者的水平直肌,并观察其中3例可接受的眼球震颤矫正和视力改善。半数患者每3-4个月接受一次BoNT注射,以维持其视力。没有患者发生球后出血,眼睑下垂或球形穿孔。

良性必需的眼睑痉挛
必要的眼睑痉挛是一种局灶性颅肌张力障碍,涉及眼睑和前额肌肉。其特征在于眼轮匝肌的频繁,不随意的收缩,导致眼睛的强力闭合。由于无意识的眼睛闭合,必要的眼睑痉挛可导致功能性失明。反过来,这可能会对患者的个人生活和职业生活产生重大影响.63眼睑痉挛在女性中更为常见.64除了女性症状严重程度和频率增加外,症状与性别无显著差异.65 BoNT自20世纪80年代以来,已经成功地用于治疗眼睑痉挛.4,66,67,68,69,70,71,72,73将BoNT注入皮肤下方的眼轮匝肌。注射部位通常是上眼睑和下眼睑中唇上眼肌的内侧和外侧方面,以降低上睑下垂的风险(图3)。每只眼睛的平均剂量为12.5-25 U肉毒杆菌毒素或50-100 U Dysport.4有些作者表示,长期重复注射BoNT需要增加剂量,14,71,74,而其他报告能够用相同的剂量维持疗效.67,75,76

3.jpg
图3
肉毒杆菌神经毒素注射点治疗眼睑痉挛58
局部副作用可能包括瘀斑,血肿,外翻,睑内翻,面部敏感性丧失,溢泪,干眼症,眼球松,畏光,复视,眼睑下垂,唇下垂和鼻涕。据报道,恶心,疲劳和全身性瘙痒的系统性副作用[71,77,78]。在局部副作用中,复视最能扰乱生活质量。 Wutthiphan等[79]报道了250例大型系列中1.7%的复视。上睑下垂是最常见的并发症之一。 Price和O'Day80在他们的病例系列中有12%观察到眼睑下垂。

面肌痉挛
面肌痉挛是由面神经支配的面部肌肉的单侧,重复性强直或阵挛性收缩。它通常在五到六年开始,是单方面的。与眼睑痉挛相反,面部痉挛在睡眠期间持续存在。它与过度的感觉刺激无关。很少,这种情况可能表现为双侧

它通过25-35 U Botox71,81或47-92 U Dysport82,83,84注射治疗。在长期随访BoNT-A注射治疗面肌痉挛的研究中,Ababneh等[71]报道平均注射后效果持续1年后为14.1周,10年后达到18.1周。 Gill和Kraft85确定前10次注射对平均12.4周有效,并声称这个平均持续时间在接下来的10次注射中保持稳定。 Akdemir等[86]指出BoNT注射后面部痉挛(平均随访90.3个月)和持续时间延长(前5次注射后16.1周,最后5次注射后18.9周)在眼睑痉挛患者中的作用持续时间没有变化(平均随访51.8个月)。

上眼睑退缩
BoNT可用于临时矫正上眼睑退缩。已经观察到眼睑裂隙高度的临时改善,通过结膜注射在恰好位于上睑板边缘上方的2.5-10U肉毒杆菌剂量进入提肌 - Müller肌肉复合体.87,88,89 Salour等人报道了单个剂量为20U的Dysport在中央上睑板边缘经皮注射到提肌腱膜和Müller肌肉是一种安全有效的治疗方法。上睑下垂和复视可能是轻微的并发症。

先天性和后天性睑内翻
BoNT注射降低了眼轮匝肌的前囊和中隔纤维的张力,从而提供其向内折叠的临时校正。将BoNT-A(肉毒杆菌毒素)以5U剂量皮下注射到下眼睑边缘下约3-4mm的3个点中。

泪腺高分泌
味觉(味觉相关)流泪(鳄鱼眼泪综合征)是一种自主神经衰弱,导致过度产生泪液。对于有创伤性面神经麻痹病史的患者,第七或第九脑神经的传出纤维通常是特发性或继发于泪腺的异常神经再支配。一小部分患者可能需要治疗。 BoNT-A注射已被证明是有效的.92 2.5 U BoNT-A(肉毒杆菌毒素)的结膜下注射直接应用于泪腺的睑叶。效果持续时间为6个月93,94

面瘫
在面部麻痹的情况下,可以通过使用BoNT-A注射到上睑提肌来诱导眼睑下垂,而不是用于保护面部麻痹情况下的眼睑或金重植入物来防止角膜损伤。由于提肌上睑肌与上直肌接近,Naik等[95]建议使用针头长度为标准25 mm针头的一半,以防止斜视和贝尔反射减弱。 Yucel和Arturk96在眶顶中线附近注射7.5 U BoNT-A(肉毒杆菌毒素),观察平均效果持续10周。

并发症和副作用
适当使用时,治疗通常是安全的并且患者可以很好地耐受。由于BoNT-A的作用通常在12周内开始消退,其副作用的持续时间有限.97这些自限性副作用,特别是重复注射时常见,约占3%,包括头痛,水肿瘀伤,轻微疼痛与注射和流感样症状有关.98,99注射前两周停止患者使用抗凝药物(阿司匹林,维生素E,非甾体类抗炎药)可以减少瘀伤和出血等副作用。另外,治疗区域在注射后不应按摩长达两小时,以加速注射的BoNT的吸收并减少其向周围组织的扩散。应该警告患者这些问题.24

在治疗眉间线或眶周皱纹时可能会出现上睑下垂。 Carruthers等[100]观察了5.4%的病例。建议增加浓度并减少BoNT-A注射量,以防止不必要的扩散到其他肌肉.4上睑下垂是常见的并发症之一。这是由于毒素扩散或意外注入眶隔所引起的。上睑下垂发生率平均为13%.101如果上睑下垂严重到足以干扰视力,使用0.5%的阿普拉定滴眼液来增强Müller肌肉功能可能有利于提肌功能的恢复。根据对1003名患者的荟萃分析,最常见的并发症是眼睑下垂(3.4%),其次是干眼症(2.3%),头痛(1.6%)和眉毛上睑下垂(0.6%).102眼睑上睑下垂经常发生注射到眉间线后,提肌的损伤会侵入眼眶隔膜。上睑下垂早在注射后48小时和最多2周出现,可持续2至12周。为避免眶内扩散造成的眼睑下垂,应用高位,低容量BoNT注射剂,距眼眶骨边缘1 cm处或横向眼角部横向1.5 cm以上.103复视是一种罕见的并发症,通常发生由于下斜肌麻痹。干眼症和溢泪是BoNT给药的其他常见并发症。由于闭眼反射的破坏,可能发生由角膜暴露引起的视力模糊。有罕见报道急性闭角型青光眼104,105和由于全球穿透引起的视网膜撕裂106与BoNT注射相关。迄今为止,报道的副作用包括注射期间疼痛,局部水肿,红斑,瘀斑,交替肌肉无力,流感样症状和高成本。在1989年至2003年期间,几乎所有与向美国食品和药物管理局报告的BoNT注射相关的严重并发症都是使用较高剂量的治疗应用的结果(治疗比例:美容目的为33:1)。在253例严重并发症的病例中,报告了28例死亡,其中没有一例与BoNT用于美容目的有关.107

包含在制剂中的蛋白质可引起针对BoNT注射的抗体反应。目前使用的BoNT试剂(自1998年以来)具有低蛋白质负荷,因此很少引起过敏反应。然而,由于高剂量BoNT的治疗用途,可能发生过敏反应。在向美国食品和药物管理局报告的1437例与BoNT相关的不良事件中,17例治疗用药和29例美容用药均出现非严重过敏性皮疹,11例治疗用户和2例美容用户发生严重过敏反应/皮疹.107减少剂量BoNT和增加注射之间的间隔可以降低抗体产生的风险。关于医疗事故,美国食品和药物管理局已经向美国食品和药物管理局报告了BoNT注射用于美容目的后毒素扩散到周围组织的副作用,但没有报告永久性的严重副作用.107

禁忌
怀孕(C类)和母乳喂养的母亲不应使用BoNT(尚不知道BoNT是否传给母乳); 12岁以下的儿童;对制剂的任何成分极为敏感的个体;或患有凝血病或神经肌肉疾病(重症肌无力,Lambert-Eaton综合征,多发性硬化症等)的患者.24,108

皮肤不应该用酒精清洁。因为它们减少了乙酰胆碱的释放,所以毒素的作用通过氨基糖苷类,环孢菌素,D-青霉胺,奎尼丁,琥珀胆碱,硫酸镁和林可酰胺而增加,而氨基喹诺酮类通过阻断其细胞摄取来降低其作用.24,108因此,详细的医学必须在申请BoNT之前采取历史。

结论
平均寿命比以往任何时候都长,化学去神剂BoNT在减少眼睛和脸部周围老化的迹象方面非常有效。除了用于眼部成形术之外,BoNT还在眼科学中用于眼睑和泪腺系统疾病。此外,BoNT已经在医学中占据了一席之地,作为斜视手术的有力化学替代品,特别是在小儿内斜视和大多数类型的麻痹性斜视中,可以像手术一样有效而不改变肌肉解剖结构。

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