Murat Terzi, Elif Merve Helvacı, Sedat Şen, Cavit Boz, Vedat Çilingir, Aylin Akçalı, Yeşim Beckmann, Cihat Uzunköprü, Recai Türkoğlu, Nur Yüceyar, Hüsnü Efendi, Sena Destan Bünül, Meral Seferoğlu, Dilcan Kotan, Sibel Güler, Belgin Petek Balcı, Bilgin Öztürk, Semra Mungan, Nilüfer Kale İçen, Sami Ömerhoca, Şükran Yurtoğulları, Serhan Sevim, Şule Aydın Türkoğlu, Mustafa Çam, Mehmet Fatih Yetkin, Tahir Kurtuluş Yoldaş, Ali Özhan Sıvacı, Şeyda Figül Gökçe, Esra Gürsoy, Aysun Ünal, Nuray Bilge, Kadriye Ağan, Münire Kılınç Toprak, Belgin Koçer, Gökçe Sezer, Yüksel Terzi
{"title":"508例多发性硬化症患者芬戈莫治疗的临床、人口学特征及2年疗效和安全性数据","authors":"Murat Terzi, Elif Merve Helvacı, Sedat Şen, Cavit Boz, Vedat Çilingir, Aylin Akçalı, Yeşim Beckmann, Cihat Uzunköprü, Recai Türkoğlu, Nur Yüceyar, Hüsnü Efendi, Sena Destan Bünül, Meral Seferoğlu, Dilcan Kotan, Sibel Güler, Belgin Petek Balcı, Bilgin Öztürk, Semra Mungan, Nilüfer Kale İçen, Sami Ömerhoca, Şükran Yurtoğulları, Serhan Sevim, Şule Aydın Türkoğlu, Mustafa Çam, Mehmet Fatih Yetkin, Tahir Kurtuluş Yoldaş, Ali Özhan Sıvacı, Şeyda Figül Gökçe, Esra Gürsoy, Aysun Ünal, Nuray Bilge, Kadriye Ağan, Münire Kılınç Toprak, Belgin Koçer, Gökçe Sezer, Yüksel Terzi","doi":"10.29399/npa.28081","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Fingolimod is the first oral immunomodulatory treatment used as secondary care therapy in the treatment of multiple sclerosis for the last 10 years. The objective of our study is to reveal the experiences of the first generic fingolimod active ingredient treatment in different centers across Turkey.</p><p><strong>Method: </strong>The first generic fingolimod efficacy and safety data of patients followed-up in 29 different clinical multiple sclerosis units in Turkey were analyzed retrospectively. Data regarding efficacy and safety of the patients were transferred to the data system both before the treatment and on the 6th, 12<sup>th</sup> and 24<sup>th</sup> month following the treatment. The data were analyzed using the IBM SPSS 20.00. P value of <0.05 was considered to be statistically significant.</p><p><strong>Results: </strong>A total of 508 multiple sclerosis patients, 331 of whom were women, were included in the study. Upon comparing the Expanded Disability Status values before and after the treatment, a significant decrease was observed, especially at month 6 and thereafter. Since bradycardia occurred in 11 of the patients (2.3%), the first dose had to be longer than 6 hours. During the observation of the first dose, no issues that could prevent the use of the drug occured. Side effects were seen in 49 (10.3%) patients during the course of fingolimod treatment. Respectively, the most frequent side effects were bradycardia, hypotension, headache, dizziness and tachycardia.</p><p><strong>Conclusion: </strong>The observed results regarding efficacy and safety were similar to clinical trial data in the literature and real life data in terms of the first equivalent with fingolimod active ingredient.</p>","PeriodicalId":51142,"journal":{"name":"Noropsikiyatri Arsivi-Archives of Neuropsychiatry","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9999220/pdf/archneuro-60-23.pdf","citationCount":"1","resultStr":"{\"title\":\"Clinical and Demographic Characteristics and Two-Year Efficacy and Safety Data of 508 Multiple Sclerosis Patients with Fingolimod Treatment.\",\"authors\":\"Murat Terzi, Elif Merve Helvacı, Sedat Şen, Cavit Boz, Vedat Çilingir, Aylin Akçalı, Yeşim Beckmann, Cihat Uzunköprü, Recai Türkoğlu, Nur Yüceyar, Hüsnü Efendi, Sena Destan Bünül, Meral Seferoğlu, Dilcan Kotan, Sibel Güler, Belgin Petek Balcı, Bilgin Öztürk, Semra Mungan, Nilüfer Kale İçen, Sami Ömerhoca, Şükran Yurtoğulları, Serhan Sevim, Şule Aydın Türkoğlu, Mustafa Çam, Mehmet Fatih Yetkin, Tahir Kurtuluş Yoldaş, Ali Özhan Sıvacı, Şeyda Figül Gökçe, Esra Gürsoy, Aysun Ünal, Nuray Bilge, Kadriye Ağan, Münire Kılınç Toprak, Belgin Koçer, Gökçe Sezer, Yüksel Terzi\",\"doi\":\"10.29399/npa.28081\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Fingolimod is the first oral immunomodulatory treatment used as secondary care therapy in the treatment of multiple sclerosis for the last 10 years. The objective of our study is to reveal the experiences of the first generic fingolimod active ingredient treatment in different centers across Turkey.</p><p><strong>Method: </strong>The first generic fingolimod efficacy and safety data of patients followed-up in 29 different clinical multiple sclerosis units in Turkey were analyzed retrospectively. Data regarding efficacy and safety of the patients were transferred to the data system both before the treatment and on the 6th, 12<sup>th</sup> and 24<sup>th</sup> month following the treatment. The data were analyzed using the IBM SPSS 20.00. P value of <0.05 was considered to be statistically significant.</p><p><strong>Results: </strong>A total of 508 multiple sclerosis patients, 331 of whom were women, were included in the study. Upon comparing the Expanded Disability Status values before and after the treatment, a significant decrease was observed, especially at month 6 and thereafter. Since bradycardia occurred in 11 of the patients (2.3%), the first dose had to be longer than 6 hours. During the observation of the first dose, no issues that could prevent the use of the drug occured. Side effects were seen in 49 (10.3%) patients during the course of fingolimod treatment. Respectively, the most frequent side effects were bradycardia, hypotension, headache, dizziness and tachycardia.</p><p><strong>Conclusion: </strong>The observed results regarding efficacy and safety were similar to clinical trial data in the literature and real life data in terms of the first equivalent with fingolimod active ingredient.</p>\",\"PeriodicalId\":51142,\"journal\":{\"name\":\"Noropsikiyatri Arsivi-Archives of Neuropsychiatry\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9999220/pdf/archneuro-60-23.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Noropsikiyatri Arsivi-Archives of Neuropsychiatry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.29399/npa.28081\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Noropsikiyatri Arsivi-Archives of Neuropsychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.29399/npa.28081","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Clinical and Demographic Characteristics and Two-Year Efficacy and Safety Data of 508 Multiple Sclerosis Patients with Fingolimod Treatment.
Introduction: Fingolimod is the first oral immunomodulatory treatment used as secondary care therapy in the treatment of multiple sclerosis for the last 10 years. The objective of our study is to reveal the experiences of the first generic fingolimod active ingredient treatment in different centers across Turkey.
Method: The first generic fingolimod efficacy and safety data of patients followed-up in 29 different clinical multiple sclerosis units in Turkey were analyzed retrospectively. Data regarding efficacy and safety of the patients were transferred to the data system both before the treatment and on the 6th, 12th and 24th month following the treatment. The data were analyzed using the IBM SPSS 20.00. P value of <0.05 was considered to be statistically significant.
Results: A total of 508 multiple sclerosis patients, 331 of whom were women, were included in the study. Upon comparing the Expanded Disability Status values before and after the treatment, a significant decrease was observed, especially at month 6 and thereafter. Since bradycardia occurred in 11 of the patients (2.3%), the first dose had to be longer than 6 hours. During the observation of the first dose, no issues that could prevent the use of the drug occured. Side effects were seen in 49 (10.3%) patients during the course of fingolimod treatment. Respectively, the most frequent side effects were bradycardia, hypotension, headache, dizziness and tachycardia.
Conclusion: The observed results regarding efficacy and safety were similar to clinical trial data in the literature and real life data in terms of the first equivalent with fingolimod active ingredient.
期刊介绍：
Archives of Neuropsychiatry (Arch Neuropsychiatry) is the official journal of the Turkish Neuropsychiatric Society. It is published quarterly, and four editions annually constitute a volume.
Archives of Neuropsychiatry is a peer reviewed scientific journal that publishes articles on psychiatry, neurology, and behavioural sciences. Both clinical and basic science contributions are welcomed. Submissions that address topics in the interface of neurology and psychiatry are encouraged. The content covers original research articles, reviews, letters to the editor, and case reports.
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