Treatment of Dry Eye With Intracanalicular Injection of Hydroxybutyl Chitosan: A Prospective Randomized Clinical Trial.
Treatment of Dry Eye With Intracanalicular Injection of Hydroxybutyl Chitosan: A Prospective Randomized Clinical Trial.
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DOI：
10.3389/fmed.2021.769448
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发表时间：
2021
影响因子：
3.9
通讯作者：
Gong L
中科院分区：
文献类型：
--
作者：
Lin T;Wang W;Lu Y;Gong L
背景：目前市场上的点状/管内塞子都是在临床使用之前设计的，用于治疗干眼病(DED)。为了提供一种个性化的泪道引流系统闭塞方法，减少并发症，我们开发了一种“液体堵塞”策略，即通过腔内注射羟丁基壳聚糖(HBC)溶液，这是一种温度敏感的相变生物材料。本研究通过与VisiPlug可吸收管内塞子的比较，评价了HBC塞子治疗干眼症的有效性和安全性。方法：采用单中心、随机、对照临床试验。50名DED患者被随机分成1：1接受HBC注射治疗或VisiPlug治疗。分别于治疗前0天、治疗前1周、4周和12周进行眼表疾病指数(OSDI)问卷调查、泪液破裂时间(TBUT)、角膜荧光染色(CFS)、泪液半月板高度(TMH)和酚红线试验。结果：两组患者的年龄、性别和DED相关特征基本平衡。两种封堵法均能缓解DED的症状和体征。OSDI、酚红线试验和泪液半月板高度较治疗前有显著改善(P<；0.05)，而角膜荧光染色和泪液破裂时间无明显改善(P>；0.05)。在第1周和第4周，HBC注射组和VisiPlug组之间差异无统计学意义(P>；0.05)。12周时，在维持酚红线试验(Hbc：206.9±47.95μm，VisiPlug：242.59±60.30μm，P=0.009)和撕裂半月板高度(Hbc：206.9±47.95 mm，VisiPlug：242.59±60.30 mm，P=0.041)方面，HBC注射剂不如VisiPlug注射剂有效。两组眼部不良事件发生率均相对较低。结论：与VisiPlug相比，HBC注射剂具有相似的疗效和安全性。血管内注射HBC液是治疗DED的一种有前途的个体化治疗方法。临床试验注册：本研究在中国临床试验注册中心注册(https://www.chictr.org.cn/enindex.aspx)，号：ChiCTR1800016603)。
Background: Punctal/intracanalicular plugs on the market nowadays are all designed before clinical use in treating dry eye disease (DED). To provide an individualized lacrimal drainage system occlusion method and reduce the complications, we developed a “liquid plug” strategy by intracanalicular injection of hydroxybutyl chitosan (HBC) solution, a thermosensitive, phase-changing biomaterial. This study evaluated the efficacy and safety of the HBC plug in treating dry eye disease by comparing it with the VisiPlug absorbable intracanalicular plug. Methods: A monocenter, randomized, controlled clinical trial was performed. Fifty patients with DED were randomized 1:1 to undergo either the HBC injection treatment or the VisiPlug treatment. Ocular Surface Disease Index (OSDI) questionnaire, tear break-up time (TBUT), corneal fluorescence staining (CFS), tear meniscus height (TMH), and phenol red thread test were evaluated at Day 0 (baseline, before treatment) and Weeks 1, 4, and 12. Results: The two groups had a balanced baseline of age, gender, and DED-related characteristics. Both occlusion methods could relieve the symptoms and signs of DED. Significant improvement was found in OSDI, phenol red thread test, and tear meniscus height (P < 0.05 compared to baseline) but not in corneal fluorescence staining and tear break-up time (P > 0.05). There is no statistically significant difference between HBC injection and VisiPlug at Weeks 1 and 4 (P > 0.05). However, at week 12, the HBC injection was not as effective as the VisiPlug in maintaining phenol red thread test (HBC: 5.35 ± 3.22 mm, VisiPlug: 8.59 ± 4.35 mm, P = 0.009) and tear meniscus height (HBC: 206.9 ± 47.95 μm, VisiPlug: 242.59 ± 60.30 μm, P = 0.041). The numbers of ocular adverse events were relatively low in both groups. Conclusions: The HBC injection showed similar efficacy and safety compared to VisiPlug. The intracanalicular injection of HBC solution proves to be a promising, individualizing method to treat DED. Clinical Trial Registration: This study is registered with the Chinese Clinical Trial Registry (https://www.chictr.org.cn/enindex.aspx), Identifier: ChiCTR1800016603.