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超声睫状体成形术治疗青光眼的临床应用研究进展

Research progress on clinical application of ultrasound cycloplasty in the treatment of glaucoma

来源期刊: 眼科学报 | 2024年8月 第39卷 第8期 395-401 发布时间:2024-08-28 收稿时间:2024/10/18 8:49:50 阅读量:379
作者:
关键词:
青光眼超声睫状体成形术高强度聚焦超声
glaucoma ultrasound cycloplasty high-intensity focused ultrasound
DOI:
10.12419/24071504
收稿时间:
2024-07-05 
修订日期:
2024-08-03 
接收日期:
2024-08-20 
青光眼是世界首位不可逆性致盲性眼病,降眼压是唯一被证实有效的干预措施。手术是降低眼压的主要途径,近年来创伤更小、术后炎症反应更轻、并发症更少的微创青光眼手术逐渐在临床得到应用。超声睫状体成形术(ultrasound cycloplasty, UCP)是一种新型微创青光眼治疗技术。本文综述了国内外现有研究,表明UCP在治疗各种类型青光眼中均表现出良好的降眼压效果,但不同类型青光眼疗效存在一定差异。UCP可减少术后局部抗青光眼药物的使用数量,同时显示出较少的并发症和较轻的术后反应。与其他睫状体分泌功能减弱性手术相比,该手术在缓解难治性青光眼患者因高眼压导致的局部疼痛方面尤为有效。青光眼类型、超声探头型号匹配及治疗扇区数量是影响疗效的主要因素,其适应的准确把握及手术参数设计的优化将进一步提高其治疗效果。本文归纳了UCP治疗青光眼的作用原理、手术操作与术后用药、适应证与禁忌证、有效性、安全性及其疗效的影响因素,以期为其临床应用和研究提供参考依据。
Glaucoma is the leading cause of irreversible blindness worldwide. Lowering intraocular pressure (IOP) is the only proven intervention to effectively prevent visual field deterioration and slow the progression of glaucoma. Surgery plays a critical role in reducing IOP, with traditional glaucoma surgeries focusing primarily on classic filtration procedures. In recent years, minimally invasive glaucoma surgeries (MIGS), characterized by less trauma, milder postoperative inflammation, and fewer complications, have been increasingly applied and continuously refined in clinical practice. Ultrasound cycloplasty (UCP) is a novel, minimally invasive technique for glaucoma treatment. This article reviews existing research both domestically and internationally, showing that UCP demonstrates good IOP-lowering effects in various types of glaucoma, though its efficacy varies across different glaucoma types. UCP reduces the need for postoperative anti-glaucoma medications, while also exhibiting fewer complications and milder postoperative reactions. Compared with other ciliary body function-reducing surgeries, UCP is particularly effective in alleviating local pain caused by elevated IOP in patients with refractory glaucoma. The type of Glaucoma, matching of the ultrasound probe model, and the number of treatment sectors are key factors influencing UCP efficacy. Accurate selection of indications and optimization of surgical parameters will further enhance its therapeutic outcomes. This article summarizes the mechanisms, surgical procedures, postoperative medication, indications and contraindications, efficacy, safety, and factors influencing UCP outcomes in glaucoma treatment, aiming to provide a reference for its clinical application and research.

文章亮点

1. 关键发现

 • 本文综述了超声睫状体成形术 (ultrasound cycloplasty, UCP) 在青光眼治疗中的国内外研究进展,详细探讨了 UCP 的作用机制、手术方法及术后用药、适应证与禁忌、有效性、安全性及其疗效的影响因素。同时基于现有研究的不足,提出了UCP 在临床应用中亟待解决的问题以及未来的研究方向。

2. 已知与发现

 • UCP 适应广泛,在不同类型及不同治疗阶段的青光眼患者中均表现出良好的降压效果和安全性,并能减轻难治性青光眼患者因高眼压而引起的局部疼痛。UCP 疗效的影响因素包括青光眼类型、超声探头型号选择、超声暴露时间及治疗扇区数量等。

3. 意义与改变

 • UCP 是一种能够有效降低眼压的微创青光眼手术。进一步细化适应选择和优化手术参数设计,将有助于 UCP 疗效的提升。

       青光眼是一组以病理性眼压升高为主要危险因素的,以青光眼性神经纤维萎缩和视野缺损为主要特征的全球首位不可逆性致盲眼病。根据世界青光眼协会调查显示,2013年全球40~80岁青光眼患者约有6430万,预计2040年将增加至1.118亿[1]。《中国青光眼指南(2020)》指出,中国青光眼患者约占全球青光眼患者总数的四分之一,是世界范围内青光眼相关视觉损害最为严重的国家之一[2]。与青光眼相关的危险因素包括高龄、高度近视、种族、青光眼家族史和眼压升高[3]。其中降低眼压是唯一被证明能有效延缓青光眼视神经萎缩进展和视野恶化的手段,因此青光眼的治疗策略主要以降低眼压为主[4]
       在青光眼的临床治疗中,通常先使用降眼压滴眼液,当药物治疗不足以控制病情时,则考虑行激光或手术治疗。传统的小梁切除术由于其较好的控制眼压效果,长期以来一直被视为青光眼手术的“金标准”。但由于手术创口相对较大,相应并发症风险较高[4]。目前抗青光眼手术趋向于向更微创、更安全有效和更易操作的方向发展。其中创伤更小、术后炎症反应更轻、并发症更少的睫状体分泌功能减弱术,在近几年不断发展优化并应用于临床,当中即包括超声睫状体成形术(ultrasound cycloplasty, UCP)。
       2010年,Aptel等[5]描述了一种新的高强度聚焦超声(high-intensity focused ultrasound, HIFU)系统,使用微型换能器发出的HIFU产生热效应使得睫状体产生凝固性坏死。而后有公司研制出相应设备EyeOP1,能够执行自动化、计算机辅助和非操作者依赖的HIFU凝固过程,这种手术即为UCP。据报道,这种超声治疗可显著降低眼压(30%~40%),且未见严重的并发症或不良反应,其最初主要用于治疗难治性青光眼[6-7],目前临床应用已进一步扩大适应证,积极探索对于初治及原发性青光眼的疗效[8],也取得了较好的效果,为青光眼的治疗提供了新选择。本文就UCP治疗青光眼的作用原理、手术方法、适应证和禁忌证、有效性、安全性及疗效的影响因素等方面进行综述,以期为其临床治疗和研究提供参考依据。

1 UCP的作用原理

       截至目前,探讨UCP降低IOP作用原理的动物实验和临床研究发现,UCP主要通过破坏睫状突上皮减少房水产生,以及增加葡萄膜巩膜通路房水流出两种机制降低眼压。

1.1 减少房水产生

       HIFU可使组织温度迅速升高至80 ℃,且能量沉积和组织加热并不依赖于组织内色素含量,使睫状突上皮细胞凝固性坏死的同时保留血-房水屏障。既往动物实验表明[9],光学显微镜下治疗区域睫状突基质水肿、血管充血,并出现凝固性坏死。其中以睫状突远端受影响最为严重,出现双层上皮细胞坏死脱落,而其炎症反应则有限,仅出现少量炎症细胞。电子显微镜下发现,在单个微型换能器超声作用下,病理改变局限于8~12个相邻的睫状突。数周后睫状体开始退化、萎缩而相邻未治疗区域的睫状突上皮细胞未受影响。在一项UCP治疗青光眼患者的初步研究中,使用超声生物显微镜(ultrasound biomicroscopy, UBM)检查提示睫状体出现囊性退化,并伴有多个囊腔[10]。此外Mastropasqua等[11]发现,睫状突上皮的破坏程度与治疗剂量有关。

1.2 增加葡萄膜巩膜通路的房水流出

       Aptel等[9]使用新西兰兔行UCP治疗发现,光学显微镜下治疗区域巩膜和睫状体之间、巩膜和脉络膜之间以及睫状体基底部内部有数个较大的液体间隙,这个特征一直持续至术后6个月,可能是组织收缩或组织微结构的改变导致。而其在临床研究中对接受UCP手术的患者眼前节进行UBM成像,发现在12只眼中有8只出现了脉络膜上腔液体间隙[10]。而Mastropasqua等[12]则使用眼前节光学相干断层扫描观察了44例接受UCP手术的难治性青光眼患者,发现巩膜内原有的低反射空间(hyporeflective space, HS)变宽并产生了新的HS。HS即为与周围巩膜相比反射率较低的基质内腔。他们推测HS的形成可能是热诱导巩膜纤维分层的结果,HS的增加很可能促进房水经由葡萄膜-巩膜途径的外流。此外,他们使用活体共聚焦显微镜观察到超声穿透部位结膜微囊体增多,提出假设认为微囊体可能是房水通过巩膜并最终穿过结膜的标志。Roquancourt等[13]也在UCP术后患者的UBM检查中观察到了葡萄膜-巩膜途径的增宽。

2 UCP手术操作与术后用药

       术前须完成详细的眼科评估,包括眼压、最佳矫正视力、裂隙灯检查、UBM和光学生物测量仪(IOL Master)等,以获取睫状体位置、形态信息以及解剖学参数如眼轴长度(axial length, AL)和角膜白到白距离(white-to-white, WTW)。另外还需完成常规的眼部检查如眼底检查、光学相干断层扫描检查、视野检查等。术前通过形态学检查适配相应型号(11、12和13 mm)的超声治疗探头,实现HIFU对目标区域的精准损伤[14]
       进入手术室后,常规消毒麻醉,麻醉可采用球后注射、球周注射或全身麻醉,保证在缓解患者疼痛的同时获得良好的患眼制动,确保治疗过程中探头稳定居中。治疗开始之前,输入患者基本信息包括姓名、出生年月和术前眼压等,并设置治疗相关参数如治疗扇区数。其中可定量化选择固定的6、8、10三种治疗扇区模式,在此基础上,可自行调整为其他10以下数量的治疗扇区模式。治疗扇区数量的选择与术前眼压、疾病种类以及患眼的临床特征等有关。依据术前眼压的考量一般为:术前眼压30 mmHg(1 mmHg=0.133 kPa)以下,选择6扇区(约覆盖40%睫状体总面积)超声治疗;术前眼压30~40 mmHg,8扇区(约覆盖55%睫状体总面积);术前眼压40 mmHg以上,10扇区(约覆盖75%睫状体总面积) [15]。8和10扇区模式都是基于6扇区模式完成后顺时针旋转超声探头实现。完成上述步骤后,手术开始。首先将定位环放置在术眼上,确保瞳孔位置位于中心,踩下脚踏的负压键启动负压抽吸使其附着牢固,避免定位环倾斜。然后将治疗探头置于定位环中,注入生理盐水或平衡盐溶液填充定位环和治疗探头之间的空隙,防止超声能量在空气中快速衰减,并帮助冷却治疗过程产生的热量。最后踩下脚踏的治疗踏板启动治疗程序直至治疗完成。术后常规使用类固醇或非甾体抗炎药和抗生素,使用频率和持续时间视患眼具体病情而定,随后再根据眼部情况逐渐减量[16]。而在抗青光眼药物的使用方面,尚存争议。一些研究选择术后继续维持术前降眼压眼药水,随后主要依据眼压情况再调整用药[17];也有研究选择术后先停用降眼压药物,当术后眼压再次≥21 mmHg时再次用药[18]

3 UCP适应证及禁忌证

       在早期的临床应用中,UCP主要用于各种类型的难治性青光眼,以及进展期、晚期和绝对期患者[19],通常是其他青光眼治疗方法均失败的最后手段。其中包括原发性开角型青光眼、原发性闭角型青光眼、新生血管性青光眼、剥脱性青光眼、葡萄膜炎性青光眼、外伤性青光眼以及其他继发性青光眼[20-21]。随着临床应用经验的积累,也有研究者观察到UCP对于未经手术治疗的青光眼[8]和早、中期青光眼患者[22]的治疗取得了不错的效果,其安全性也得到了验证。UCP的禁忌证主要包括影响定位环和探头居中和稳定的情况,如滤过性手术后滤过泡、引流管的过度隆起、睑裂过小、眼外伤或化学伤导致眼表结构改变;或无适配探头如WTW<10 mm或者>13 mm、眼部肿瘤和感染、巩膜病变,以及严重的视网膜脱离和(或)脉络膜脱离等[23]

4 UCP有效性和安全性评价

       在早期的临床观察中,UCP在既往接受过抗青光眼手术的难治性青光眼患者中显示了良好的降压效果。末次随访中,眼压下降幅度为20.1%~40.8%[10]。术后1天、7天、1个月、3个月、6个月及12个月的降压幅度分别为15.2%[12]~39.0%[24]、16.2%[10]~49.0%[7]、22.8%[10]~43.0%[7]、20.2%~44.5%[10]、23.5%~37.6%[10]和20.1%[10]~46.0%[25]。近期Faisal等[26]对接受UCP治疗的70例难治性青光眼进行了为期2年随访,末次随访眼压平均降幅为29.99%。另外,一些研究者发现UCP也可减少使用局部抗青光眼的药物数量,Melamed等[7]的研究表明,20例难治性青光眼经UCP治疗后,术后12个月局部抗青光眼药物的使用数量从术前的4.6种减少至4.0种。
       随后,在对既往无抗青光眼手术史患眼的临床研究中,UCP也显示出良好的疗效。Aptel等[8]在对30例未经手术治疗的开角型青光眼进行观察发现,UCP术后眼压下降的平均幅度分别为术后1天29%、术后7天39%、术后1个月19%、术后3个月31%、术后6个月28%和术后1年30%。Torky等[27]对62例无抗青光眼手术史的患者进行UCP治疗后,术后12个月的条件成功率为77.4%(条件成功定义为眼压较术前下降≥30%,眼压>5 mmHg,无论是否使用降眼压药),眼压下降幅度为42.3%,抗青光眼药物使用数量由术前3.2种减少至术后2.1种。Faisal等[28]对88例选用UCP作为初治手段的青光眼患者进行了为期2年的随访,术后2年的完全成功率为52.6%(完全成功定义为眼压较术前降低≥20%,6 mmHg<眼压<21 mmHg,不使用降眼压药物且无威胁视力的并发症),眼压降幅为30.14%,抗青光眼药物使用数量由术前3.3种减少至术后1.7种。
       近年来,随着UCP研究的深入,其是否具有长期降低眼压效果引起了关注。Rouland等[29]的一项对104例难治性青光眼UCP术后3年随访的研究显示[29],手术成功率为55%(手术成功定义为眼压较术前降低≥20%和眼压>5 mmHg,无需其他手术干预),眼压下降幅度为33%,局部使用抗青光眼数量术前3.0种降至术后2.8种。Bolek等[30]的研究表明,41例青光眼患者接受UCP治疗后3年,条件成功率为64%(条件成功定义为眼压下降>20%且无需再次治疗),眼压降幅为28%,局部使用抗青光眼数量术前3.9种降至术后3.2种。上述研究均提示UCP治疗可能具有长期降低眼压的作用,但仍然需要更大样本量的临床研究来验证这一结论。
       虽然UCP在治疗各种类型青光眼中均表现出良好的降眼压效果,但由于青光眼类型不同、分期不同其疗效可能仍然存在差异。Giannaccare等[24]、杨从从等[31]的研究均表明UCP对闭角型青光眼的降眼压效果最明显,开角型青光眼次之,而继发性青光眼,主要是新生血管性青光眼的降眼压效果最差。在青光眼分期中,Aptel等[8]认为相对于晚期青光眼患者,UCP可能更适用于高眼压症、早期或中度青光眼患者的治疗。
       UCP对比其他破坏睫状体手术,例如应用较为广泛的睫状体激光凝固术而言,在降低眼压效果和减少抗青光眼药物数量方面差异并无统计学意义。但经UCP治疗后患者疼痛缓解效果较明显,并发症也相对较少[32-33]。此外,UCP也展现了良好的治疗可重复性[34]。关于重复治疗的时机,一项关于UCP术后眼内炎症反应的研究发现,术后3个月房水闪辉值基本恢复至术前水平[18],因此建议将3个月作为UCP重复治疗时间窗。
       截至目前发表的研究中,UCP显示出良好的安全性。大多数并发症均较轻微和短暂。常见的术后并发症为结膜充血、结膜下出血、结膜水肿、前房炎症、暂时性视力改变、浅层点状角膜炎、浅表角膜溃疡、角膜水肿和瞳孔散大等[27, 35]。UCP术后一般痛感轻微甚至较术前的疼痛显著减轻。Hu等[36]的研究表明,61例终末期青光眼患者眼压难以控制而引起的局部疼痛在经UCP 治疗后,术后3个月平均疼痛评分从术前的1.0显著减少至0.1。崔晴晴等[37]在其28例难治性青光眼UCP的疗效研究中也发现了相似的结果,平均疼痛评分由术前2.0下降至术后6个月1.0。

5 UCP疗效影响因素

       目前在国内外临床研究中,UCP在治疗各种类型青光眼中均表现出良好的降眼压效果,但青光眼的类型和分期可导致UCP的降压效果有所差异。如前所述,以闭角型青光眼的降压效果最为显著,优于开角型青光眼和继发性青光眼,但具体机制尚需进一步研究。而中国青光眼患者中闭角型青光眼比例较高[38],提示UCP在中国青光眼治疗中很可能有较好的应用前景。
       正确选择超声探头型号是将HIFU准确定位于睫状体的最重要的步骤之一,显著影响UCP的治疗效果。郑绍阳等[23]研究纳入了中国1 281例2 000只青光眼患眼使用UCP治疗的探头分布情况显示,在现有探头计算方法下12 mm探头的使用数量最多,13 mm探头次之,11 mm最少,仅有0.95%的患者无适合的探头型号。他们的另一项关于探头计算方法评价的研究表明,常用且较为方便的公式法与准确但操作要求较高的UBM图像拟合法的一致性为62.86%[39],提示如果用公式法即使用AL和WTW来计算中国青光眼患者的探头模型,还是有37.14%的结果可能不够准确,建议纳入更多种族人群数据以及更多不同方位的UBM图像以增加公式法计算精度,并采用图像处理工具,增加模型法的检测便捷性。此外,该研究还发现继发性青光眼和原发性开角型青光眼中,两种方法的一致性较好,优于原发性闭角型青光眼,而急性闭角型青光眼的一致性最差,考虑睫状体前旋的位置会影响公式法的计算。
       超声探头暴露时间和治疗扇区数也是影响UCP疗效的重要因素。第一代探头的每个扇区的超声暴露时间(即HIFU 作用于睫状体的时间)为4 s或6 s,而目前第二代探头每个扇区超声暴露时间则固定为8s,每个扇区之间的治疗间隔为20 s[11]。Mastropasqua等[12]发现超声暴露时间设置为6 s比4 s的眼压降幅更大,认为超声暴露时间的延长可以进一步诱导巩膜结膜结构的改变,从而加强房水引流,有效降低眼压。Giannaccare等[24]研究对比4、6、8 s的超声暴露时长的疗效,发现在该时间范围内,随着超声暴露时间延长,在确保安全性的同时降压效果越好;而Deb-Joardar等[40]则用8 s和10 s时长对比,发现两组降压效果比较差异无统计学意义,但治疗10 s前房炎症反应更重。目前第2代探头应用较为广泛,超声暴露时间固定为8 s,相比于第1代探头具有更好的降压效果[11, 35]。而关于治疗扇区数,Hu等[36]对比6扇区和8扇区治疗效果,发现8扇区的降眼压效果早期优于6扇区,但在术后3个月两组降眼压效果比较差异无统计学意义。
       UCP治疗结束后,由于睫状体的补偿性分泌或者前房炎症也可引发眼压波动,故术后需酌情应用抗炎药及抗青光眼药物。

6 小结

       UCP是一种新型微创手术,国内外研究中均证实其能够实现高精度的睫状体功能减弱,同时显示出良好的安全性,并发症较少且术后不良反应轻微。UCP适应证广泛,可以用于各种类型青光眼的治疗,此外由于其创伤更小可实现重复治疗,有效性和安全性均良好。但目前关于UCP治疗青光眼的研究仍存在一定不足:1)关于UCP有效性的评价标准不一,青光眼类型、分期,以及手术成功的标准等观察指标缺乏统一量化,制约了各项研究数据的整合及比较;2)关于UCP术后降眼压药物用药方案尚未统一。虽然目前研究显示UCP可以减少降眼压药的用量,但术后立即停药,可能会引起眼压的波动,仍需要相关研究来评估术后降眼压药物应用模式和停药时机;3)尚缺乏评估UCP疗效影响因素的研究,例如探头计算方法改进的前瞻性研究,借此提高UCP的预测性和治疗效果;4)目前国内UCP治疗的临床研究样本量相对较少、随访时间较短,且缺乏国内青光眼患者进行重复治疗的报道。未来多中心、大样本、长期随访的临床研究还有待进一步开展以进一步证实UCP的临床疗效。

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