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ENGLISH ABSTRACT
HA-Mg引流片兔眼前房植入对眼压控制的有效性和安全性
朱小敏
罗王杜
林怡
蔡明铭
陈毅
谢琳
王勇
李翔骥
作者及单位信息
·
DOI： 10.3760/cma.j.cn115989-20230301-00071
Efficacy and safety of HA-Mg drainage plate implantation in anterior chamber for intraocular pressure control in rabbit eyes
Zhu Xiaomin
Luo Wangdu
Lin Yi
Cai Mingming
Chen Yi
Xie Lin
Wang Yong
Li Xiangji
Authors Info & Affiliations
Zhu Xiaomin
Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
Luo Wangdu
Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
Lin Yi
Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
Cai Mingming
Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
Chen Yi
School of Materials Science and Engineering, National Engineering and Technology Research Center for Magnesium Alloy Materials, Chongqing 400045, China
Xie Lin
Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
Wang Yong
School of Materials Science and Engineering, National Engineering and Technology Research Center for Magnesium Alloy Materials, Chongqing 400045, China
Li Xiangji
Department of Ophthalmology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
·
DOI： 10.3760/cma.j.cn115989-20230301-00071
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摘要

目的评估羟基磷灰石涂层镁基(HA-Mg)青光眼引流片植入兔眼后的安全性和有效性。

方法使用配对比较法将12只SPF级3～4月龄新西兰白兔随机分为HA-Mg引流片植入组和小梁切除术组，每组6只，均取右眼进行相应操作；12只左眼均不行任何操作，作为正常对照组。术后1、3、5个月，采用裂隙灯显微镜及前置镜观察术后各组眼部情况；采用超声生物显微镜检查引流片于前房与结膜下间隙固定情况。术后5个月，采用角膜内皮细胞计数仪测量HA-Mg引流片植入组角膜内皮细胞数量；术前和术后每周采用Tonopen眼压计测量眼压，连续监测21周；采用锥虫蓝前房注入法验证房水引流通道通畅性；采用苏木精－伊红染色法评估HA-Mg引流片完全降解后房水引流通道与周围组织情况。

结果术后实验兔均未出现全身及眼部异常或不良反应，6枚HA-Mg引流片均于术后约4个月完全降解，4枚引流片位置固定良好，2枚引流片出现少量旋转移位，无引流片落入前房；术后5个月，HA-Mg引流片植入组和正常对照组角膜内皮细胞数量分别为(2 535.2±274.4)和(2 521.0±175.8)个，差异无统计学意义( t＝0.073， P＝0.857)。手术前后不同时间点各组眼压总体比较，差异均有统计学意义( F 组别＝26.409， P<0.001； F 时间＝7.843， P<0.001)，其中小梁切除术组和正常对照组术后不同时间点眼压均高于HA-Mg引流片植入组，HA-Mg引流片植入组术后不同时间点眼压均低于术前，差异均有统计学意义(均 P<0.05)。引流通道通畅性实验发现，HA-Mg引流片植入术后5个月，蓝色染色剂仍可从前房引流到结膜下。术后6个月引流片已完全降解，巩膜层间可见线状房水引流通道及虹膜前粘连，各组织均未见明显炎性细胞浸润。

结论HA-Mg引流片植入兔眼后可有效降低眼压，安全性较好。

青光眼;青光眼引流装置;青光眼外引流手术;羟基磷灰石涂层镁基
ABSTRACT

ObjectiveTo evaluate the safety and efficacy of hydroxyapatite-magnesium (HA-Mg) glaucoma drainage plate after implantation in rabbit eyes.

MethodsTwelve New Zealand white rabbits were randomly assigned to HA-Mg drainage implant group and trabeculectomy group using the paired comparison method, with 6 rabbits in each group.The right eyes of rabbits were taken as the experimental eyes, and the left eyes of rabbits were taken as a normal control group.HA-Mg drainage implant group underwent implantation of the HA-Mg drainage plate and the trabeculectomy group underwent trabeculectomy.At 1, 3, and 5 months after surgery, the ocular condition was observed by slit-lamp examination with auxiliary lenses and the fixation of the drainage plate in the anterior chamber and subconjunctiva was measured by ultrasound biomicroscopy.At 5 months after surgery, corneal endothelial cell counts were performed with a corneal endothelial cell counter.The intraocular pressure (IOP) was continuously measured weekly for 21 weeks preoperatively and postoperatively.The flow patency of aqueous humor drainage channel was identified by the injection of trypan blue in anterior chamber.The aqueous humor drainage channels and surrounding tissues were evaluated by hematoxylin-eosin (HE) staining after HA-Mg drainage plate was completely degraded.This study was in accordance with China Animal Welfare Law and the ARVO Statement on the use of animals for ophthalmic research, and animal experiments were conducted in accordance with the Regulations on the Administration of Experimental Animals issued by the National Science Council.The study protocol was reviewed and approved by the Ethics Committee of The Third Affiliated Hospital of Chongqing Medical University (No.Kelun Pre-Examination [2021]14).

ResultsNo systemic or ocular side effects were observed in the experimental animals after surgery.All 6 HA-Mg drainage plates were completely degraded about 4 months postoperatively, among which 4 plates were well-fixed and 2 plates had a minimal rotation, and no plate moved into the anterior chamber.At 5 months after surgery, the number of corneal endothelial cells in the HA-Mg drainage implant group and normal control group was 2 535.2±274.4 and 2 521.0±175.8, respectively, and there was no statistical significance between them ( t=0.073, P=0.857).There were statistically significant differences in IOP among the three groups at different time points before and after surgery ( F group=26.409, P<0.001; F time=7.843, P<0.001), in which the IOP in trabeculectomy group and normal control group at different time points after surgery was higher than that in HA-Mg drainage implant group, and the IOP in HA-Mg drainage implant group at different time points after surgery was lower than that before surgery (all at P<0.05).The patency test revealed that the trypan blue could still drain from the anterior chamber to the subconjunctiva 5 months after HA-Mg drainage plate implantation.The scleral linear aqueous humor drainage channel and anterior synechia were observed after drainage plate completely degraded 6 months postoperatively, and no obvious inflammatory cell infiltration was seen.

ConclusionsAfter implantation of HA-Mg drainage plate in rabbit eyes, the intraocular pressure can be effectively lowered and the safety is good.

Glaucoma;Glaucoma drainage device;Glaucoma external drainage surgery;Hydroxyapatite-magnesium
Li Xiangji, Email: nc.defudabe.umqc.latipsohijgnaixil

Zhu Xiaomin and Luo Wangdu contributed equally to this article

Copyright by Chinese Medical Association
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引用本文

朱小敏,罗王杜,林怡,等. HA-Mg引流片兔眼前房植入对眼压控制的有效性和安全性[J]. 中华实验眼科杂志,2024,42(06)：503-510.

DOI:10.3760/cma.j.cn115989-20230301-00071

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青光眼是一种以视野缺损、视神经萎缩为主的特征性视神经疾病，是全球不可逆盲的重要原因 [ 1 , 2 ]。2010年，全世界约有6 050万原发性开角型青光眼和原发性闭角型青光眼患者；2020年，这一数字达到约7 960万；到2040年，全球青光眼患者将达到1.11亿 [ 3 ]。外引流手术目前仍是治疗青光眼主要的手术方式 [ 4 ]，除小梁切除术外，各类型的青光眼引流阀或引流装置在临床工作中也得到广泛应用，如Ahmed引流阀、Ex-Press引流钉、XEN引流管、Preserflo MicroShunt引流管等。然而，目前已应用于临床的青光眼引流装置均由不可降解材料制成，如硅胶、不锈钢、明胶、阳离子聚合材料等。不可降解的引流装置如同异物永远存在于Tenon囊下，所引起的炎症刺激可能是引起引流通道阻塞、引流装置瘢痕包裹的主要危险因素 [ 5 , 6 , 7 , 8 , 9 ]。另一方面，传统青光眼外引流装置因引流管径恒定，手术早期房水引流容易过畅，因此低眼压、浅前房等术后并发症常见 [ 10 ]；而手术后期因瘢痕化等原因，房水引流量减少，眼压再次升高，易导致手术失败。本课题组在前期研究中通过体内外实验筛选出了一种羟基磷灰石涂层镁基(hydroxyapatite-magnesium，HA-Mg)材料，该材料具有较好的生物相容性，较低的毒性，并具有一定的抗瘢痕作用 [ 11 ]。研究团队根据前期研究结果和HA涂层表面结构特点，设计了一款非中空管状的可生物降解青光眼引流片，引流片植入术后早期利用表面涂层间隙引流房水，中后期通过引流片不断降解扩大引流通道，以增加房水引流量。本研究拟观察HA-Mg引流片通过结膜下途径植入新西兰白兔前房内的安全性和控制眼压的有效性。
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备注信息
A
李翔骥，Email： nc.defudabe.umqc.latipsohijgnaixil
B

朱小敏和罗王杜对本文有同等贡献

C

朱小敏：设计实验、实施研究、文章撰写；罗王杜：实施研究、数据收集、文章修改；林怡：实验数据分析与统计；蔡明铭：实施研究；陈毅：引流片制造；谢琳：参与实验设计、实验指导与监督；王勇：材料与实验设计；李翔骥：实验设计与实施、引流片设计、对文章知识性内容的审阅和智力性内容的修改及定稿

D
所有作者均声明不存在利益冲突
E
重庆市自然科学基金 (CSTB2022NSCQ-MSX0077)
重庆医科大学附属第三医院院内孵化项目 (KY19031)
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