P Lobascio, G Tomasicchio, N Cassetta, D F Altomare, G Gallo, A Pezzolla, R Laforgia
{"title":"使用亚甲基蓝和三硝酸甘油为基础的乳膏治疗慢性肛裂：一项来自转诊直肠科单位的II期随机试点试验。","authors":"P Lobascio, G Tomasicchio, N Cassetta, D F Altomare, G Gallo, A Pezzolla, R Laforgia","doi":"10.1007/s10151-024-03029-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Chronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.</p><p><strong>Methods: </strong>A phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.</p><p><strong>Results: </strong>Nine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.</p><p><strong>Conclusion: </strong>Methylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.</p>","PeriodicalId":51192,"journal":{"name":"Techniques in Coloproctology","volume":"29 1","pages":"39"},"PeriodicalIF":2.7000,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The use of a methylene blue and glyceryl trinitrate-based cream for the treatment of chronic anal fissures: a phase II randomized pilot trial from a referral coloproctological unit.\",\"authors\":\"P Lobascio, G Tomasicchio, N Cassetta, D F Altomare, G Gallo, A Pezzolla, R Laforgia\",\"doi\":\"10.1007/s10151-024-03029-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Chronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.</p><p><strong>Methods: </strong>A phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.</p><p><strong>Results: </strong>Nine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.</p><p><strong>Conclusion: </strong>Methylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.</p>\",\"PeriodicalId\":51192,\"journal\":{\"name\":\"Techniques in Coloproctology\",\"volume\":\"29 1\",\"pages\":\"39\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-01-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Techniques in Coloproctology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10151-024-03029-8\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Techniques in Coloproctology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10151-024-03029-8","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
The use of a methylene blue and glyceryl trinitrate-based cream for the treatment of chronic anal fissures: a phase II randomized pilot trial from a referral coloproctological unit.
Background: Chronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.
Methods: A phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.
Results: Nine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.
Conclusion: Methylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.
期刊介绍：
Techniques in Coloproctology is an international journal fully devoted to diagnostic and operative procedures carried out in the management of colorectal diseases. Imaging, clinical physiology, laparoscopy, open abdominal surgery and proctoperineology are the main topics covered by the journal. Reviews, original articles, technical notes and short communications with many detailed illustrations render this publication indispensable for coloproctologists and related specialists. Both surgeons and gastroenterologists are represented on the distinguished Editorial Board, together with pathologists, radiologists and basic scientists from all over the world. The journal is strongly recommended to those who wish to be updated on recent developments in the field, and improve the standards of their work.
Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1965 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the Principles of Laboratory Animal Care (NIH publication no. 86-23 revised 1985) were followed as were applicable national laws (e.g. the current version of the German Law on the Protection of Animals). The Editor-in-Chief reserves the right to reject manuscripts that do not comply with the above-mentioned requirements. Authors will be held responsible for false statements or for failure to fulfill such requirements.
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