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三叉神经副交感神经通路刺激治疗干眼症的疗效与安全性:一项系统评价和荟萃分析。

Efficacy and safety of trigeminal parasympathetic pathway stimulation for dry eye: A systematic review and meta-analysis.

作者信息

Hu Jindong, Ju Mohan, Shi Yongjun, Liu Xinquan, Zhu Yongbao

机构信息

Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.

Department of Integrative Medicine, Baoshan Campus of Huashan Hospital, Fudan University, Shanghai, China.

出版信息

Indian J Ophthalmol. 2024 May 1;72(Suppl 3):S381-S392. doi: 10.4103/IJO.IJO_2147_23. Epub 2024 Mar 8.

DOI:10.4103/IJO.IJO_2147_23
PMID:38454841
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC467035/
Abstract

This study aimed to investigate the efficacy and safety of trigeminal parasympathetic pathway (TPP) stimulation in the treatment of dry eye. A comprehensive search for randomized clinical trials was performed in seven databases (MEDLINE, Embase, CENTRAL, etc.) up to 28 February 2023. After screening the suitable studies, the data were extracted and transformed as necessary. Data synthesis and analysis were performed using Review Manager 5.4, and the risk of bias and quality of evidence were evaluated with the recommended tools. Fourteen studies enrolling 1714 patients with two methods (electrical and chemical) of TPP stimulation were included. Overall findings indicate that TPP stimulation was effective in reducing subjective symptom score (standardized mean difference [SMD], -0.45; 95% confidence interval [CI], -0.63 to -0.28), corneal fluorescence staining (mean difference [MD], -0.78; 95% CI, -1.39 to -0.18), goblet cell area (MD, -32.10; 95% CI, -54.58 to -9.62) and perimeter (MD, -5.90; 95% CI, -10.27 to -1.53), and increasing Schirmer's test score (SMD, 0.98; 95% CI, 0.65 to 1.31) and tear film break-up time (SMD, 0.57; 95% CI, 0.19 to 0.95). Compared to inactive or low-activity stimulation controls, it has a higher incidence of adverse events. Therefore, TPP stimulation may be an effective treatment for dry eye, whether electrical or chemical. Adverse events are relatively mild and tolerable. Due to the high heterogeneity and low level of evidence, the current conclusions require to be further verified.

摘要

本研究旨在探讨三叉神经副交感神经通路(TPP)刺激治疗干眼症的疗效和安全性。截至2023年2月28日,在七个数据库(MEDLINE、Embase、CENTRAL等)中对随机临床试验进行了全面检索。筛选出合适的研究后,提取数据并在必要时进行转换。使用Review Manager 5.4进行数据合成和分析,并使用推荐工具评估偏倚风险和证据质量。纳入了14项研究,共1714例采用两种TPP刺激方法(电刺激和化学刺激)的干眼症患者。总体研究结果表明,TPP刺激在降低主观症状评分(标准化均数差[SMD],-0.45;95%置信区间[CI],-0.63至-0.28)、角膜荧光素染色(均数差[MD],-0.78;95%CI,-1.39至-0.18)、杯状细胞面积(MD,-32.10;95%CI,-54.58至-9.62)和周长(MD,-5.90;95%CI,-10.27至-1.53),以及提高泪液分泌试验评分(SMD,0.98;95%CI,0.65至1.31)和泪膜破裂时间(SMD,0.57;95%CI,0.19至0.95)方面有效。与无活性或低活性刺激对照组相比,其不良事件发生率更高。因此,无论电刺激还是化学刺激,TPP刺激可能是治疗干眼症的有效方法。不良事件相对较轻且可耐受。由于异质性高和证据水平低,目前的结论需要进一步验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/73b14873efd2/IJO-72-381-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/a677ac78d801/IJO-72-381-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/9c6717d3dfdc/IJO-72-381-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/5d3cd0999857/IJO-72-381-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/c202476e2405/IJO-72-381-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/73b14873efd2/IJO-72-381-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/a677ac78d801/IJO-72-381-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/9c6717d3dfdc/IJO-72-381-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/5d3cd0999857/IJO-72-381-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/c202476e2405/IJO-72-381-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b82c/467035/73b14873efd2/IJO-72-381-g006.jpg

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本文引用的文献

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Bilateral Effect of OC-01 (Varenicline Solution) Nasal Spray for Treatment of Signs and Symptoms in Individuals with Mild, Moderate, and Severe Dry Eye Disease.OC-01(盐酸伐尼克兰溶液)鼻喷雾剂治疗轻、中、重度干眼患者的体征和症状的双侧效应。
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Does Dry Eye Disease Severity Impact Efficacy of Varenicline Solution Nasal Spray on Sign and Symptom Treatment Outcomes?干眼症严重程度是否影响维替泊芬鼻用溶液治疗体征和症状的疗效?
Optom Vis Sci. 2023 Feb 1;100(2):164-169. doi: 10.1097/OPX.0000000000001986. Epub 2022 Dec 31.
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Effectiveness of Intranasal Tear Neurostimulation for Treatment of Dry Eye Disease: A Meta-Analysis.
鼻内泪神经刺激治疗干眼疾病的有效性:一项荟萃分析。
Ophthalmol Ther. 2023 Feb;12(1):389-400. doi: 10.1007/s40123-022-00616-6. Epub 2022 Nov 28.
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Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials.绝经状态是否会影响使用OC-01(伐尼克兰溶液)鼻喷雾剂治疗干眼症的效果?ONSET-1和ONSET-2临床试验的事后分析。
Ophthalmol Ther. 2023 Feb;12(1):355-364. doi: 10.1007/s40123-022-00607-7. Epub 2022 Nov 18.
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OC-01 (Varenicline Solution) Nasal Spray Demonstrates Consistency of Effect Regardless of Age, Race, Ethnicity, and Artificial Tear Use.OC-01(伐尼克兰溶液)鼻喷雾剂显示,无论年龄、种族、民族和是否使用人工泪液,其效果均具有一致性。
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ONSET-1 Phase 2b Randomized Trial to Evaluate the Safety and Efficacy of OC-01 (Varenicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease.OC-01(盐酸伐仑克林溶液)鼻喷剂治疗干眼疾病体征和症状的 ONSET-1 期 2b 随机临床试验:安全性和疗效评估
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Matching-adjusted indirect comparison of phase 3 clinical trial outcomes of OC-01 (varenicline solution) nasal spray and lifitegrast 5% ophthalmic solution for the treatment of dry eye disease.OC-01(伐尼克兰溶液)鼻喷雾剂与 lifitegrast 5%滴眼液治疗干眼症的 3 期临床试验结局的匹配调整间接比较。
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