Ke Yang, Jing Zhou, Yinghui Wang, Yingshi Piao, Mei Li, Yun Cheng, Xiaohong Chen, Ying Jie
{"title":"岛状眶下神经血管蒂唇唾液腺移植治疗严重干眼病:一项IDEAL 0、1和2a期研究","authors":"Ke Yang, Jing Zhou, Yinghui Wang, Yingshi Piao, Mei Li, Yun Cheng, Xiaohong Chen, Ying Jie","doi":"10.1136/bmjsit-2024-000324","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To address the lack of nerve and blood supply after labial salivary gland transplantation (LSGT) resulting in glandular atrophy. We designed a modified LSGT, called insular infraorbital neurovascular pedicle LSGT, and evaluated the postoperative efficacy.</p><p><strong>Design: </strong>This is a prospective, single-centre, self-contained study.</p><p><strong>Setting: </strong>The research was conducted at Beijing Tongren Hospital, Capital Medical University from July 2019 to March 2024.</p><p><strong>Participants: </strong>Eight patients (nine eyes) with severe dry eye disease (DED) were enrolled in this study.</p><p><strong>Interventions: </strong>All patients underwent insular infraorbital neurovascular pedicle LSGT and were followed up for at least 6 months postoperatively.</p><p><strong>Main outcome measure: </strong>Key evaluation indices were best-corrected visual acuity (BCVA), Ocular Surface Disease Index (OSDI) score, tear break-up time (TBUT), Corneal Fluorescence Staining (CFS) score, and Schirmer I test (SIT).</p><p><strong>Results: </strong>With a mean follow-up of 17.56±11.72 months, BCVA improved in four eyes and stabilized in five. OSDI score decreased from 59.33±14.37 to 26.27±10.14 (p<0.001). SIT improved from 0.00±0.00 mm to 5.44±2.01 mm (p<0.0001). TBUT increased from 0.23±0.48 s to 5.48±4.67 s (p=0.008). CFS scores decreased from 12.56±2.65 to 7.56±3.09 (p<0.001). All glands remained viable with good blood supply, and no serious complications were observed.</p><p><strong>Conclusion: </strong>Insular infraorbital neurovascular pedicle LSGT for severe DED is a feasible and effective treatment, maintaining good secretory capacity and blood supply long-term.</p><p><strong>Trial registration number: </strong>ChiCTR2200056015.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"7 1","pages":"e000324"},"PeriodicalIF":1.6000,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751987/pdf/","citationCount":"0","resultStr":"{\"title\":\"Insular infraorbital neurovascular pedicle labial salivary gland transplantation for the treatment of severe dry eye disease: an IDEAL stage 0, 1 and 2a study.\",\"authors\":\"Ke Yang, Jing Zhou, Yinghui Wang, Yingshi Piao, Mei Li, Yun Cheng, Xiaohong Chen, Ying Jie\",\"doi\":\"10.1136/bmjsit-2024-000324\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>To address the lack of nerve and blood supply after labial salivary gland transplantation (LSGT) resulting in glandular atrophy. We designed a modified LSGT, called insular infraorbital neurovascular pedicle LSGT, and evaluated the postoperative efficacy.</p><p><strong>Design: </strong>This is a prospective, single-centre, self-contained study.</p><p><strong>Setting: </strong>The research was conducted at Beijing Tongren Hospital, Capital Medical University from July 2019 to March 2024.</p><p><strong>Participants: </strong>Eight patients (nine eyes) with severe dry eye disease (DED) were enrolled in this study.</p><p><strong>Interventions: </strong>All patients underwent insular infraorbital neurovascular pedicle LSGT and were followed up for at least 6 months postoperatively.</p><p><strong>Main outcome measure: </strong>Key evaluation indices were best-corrected visual acuity (BCVA), Ocular Surface Disease Index (OSDI) score, tear break-up time (TBUT), Corneal Fluorescence Staining (CFS) score, and Schirmer I test (SIT).</p><p><strong>Results: </strong>With a mean follow-up of 17.56±11.72 months, BCVA improved in four eyes and stabilized in five. OSDI score decreased from 59.33±14.37 to 26.27±10.14 (p<0.001). SIT improved from 0.00±0.00 mm to 5.44±2.01 mm (p<0.0001). TBUT increased from 0.23±0.48 s to 5.48±4.67 s (p=0.008). CFS scores decreased from 12.56±2.65 to 7.56±3.09 (p<0.001). All glands remained viable with good blood supply, and no serious complications were observed.</p><p><strong>Conclusion: </strong>Insular infraorbital neurovascular pedicle LSGT for severe DED is a feasible and effective treatment, maintaining good secretory capacity and blood supply long-term.</p><p><strong>Trial registration number: </strong>ChiCTR2200056015.</p>\",\"PeriodicalId\":33349,\"journal\":{\"name\":\"BMJ Surgery Interventions Health Technologies\",\"volume\":\"7 1\",\"pages\":\"e000324\"},\"PeriodicalIF\":1.6000,\"publicationDate\":\"2025-01-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751987/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Surgery Interventions Health Technologies\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjsit-2024-000324\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Surgery Interventions Health Technologies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/bmjsit-2024-000324","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Insular infraorbital neurovascular pedicle labial salivary gland transplantation for the treatment of severe dry eye disease: an IDEAL stage 0, 1 and 2a study.
Objectives: To address the lack of nerve and blood supply after labial salivary gland transplantation (LSGT) resulting in glandular atrophy. We designed a modified LSGT, called insular infraorbital neurovascular pedicle LSGT, and evaluated the postoperative efficacy.
Design: This is a prospective, single-centre, self-contained study.
Setting: The research was conducted at Beijing Tongren Hospital, Capital Medical University from July 2019 to March 2024.
Participants: Eight patients (nine eyes) with severe dry eye disease (DED) were enrolled in this study.
Interventions: All patients underwent insular infraorbital neurovascular pedicle LSGT and were followed up for at least 6 months postoperatively.
Main outcome measure: Key evaluation indices were best-corrected visual acuity (BCVA), Ocular Surface Disease Index (OSDI) score, tear break-up time (TBUT), Corneal Fluorescence Staining (CFS) score, and Schirmer I test (SIT).
Results: With a mean follow-up of 17.56±11.72 months, BCVA improved in four eyes and stabilized in five. OSDI score decreased from 59.33±14.37 to 26.27±10.14 (p<0.001). SIT improved from 0.00±0.00 mm to 5.44±2.01 mm (p<0.0001). TBUT increased from 0.23±0.48 s to 5.48±4.67 s (p=0.008). CFS scores decreased from 12.56±2.65 to 7.56±3.09 (p<0.001). All glands remained viable with good blood supply, and no serious complications were observed.
Conclusion: Insular infraorbital neurovascular pedicle LSGT for severe DED is a feasible and effective treatment, maintaining good secretory capacity and blood supply long-term.