{"title":"印度孟买耐药肺外结核病患者同时接受贝达喹啉和地拉那米德治疗的情况","authors":"Himani Mongia , Fatima Mamnoon , Arunima Silsarma , Raman Mahajan , Alpa Dalal , Miriam Arago Galindo , Aparna Iyer , Pramila Singh , Homa Mansoor , Mrinalini Das , Mabel Morales , Hannah Spencer , Petros Isaakidis","doi":"10.1016/j.jctube.2024.100433","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>World Health Organization suggests concurrent bedaquiline-delamanid (BDQ-DLM) as part of individualised regimens for eligible patients with pulmonary drug-resistant tuberculosis (DR-TB); however, data for patients with drug-resistant extrapulmonary tuberculosis (EPTB) is extremely limited. This study documents the treatment outcomes and adverse events associated with concurrent BDQ-DLM-based regimens in patients with drug-resistant EPTB at a Médecins Sans Frontières clinic in Mumbai, India.</p></div><div><h3>Methods</h3><p>Retrospective cohort study based on routinely collected programmatic data. Individualised regimens were based on drug-susceptibility testing and previous drug exposure. Drug-resistant EPTB patients initiated on regimens containing concurrent BDQ and DLM from April 2016 to October 2019 were included.<!--> <!-->Patients who completed treatment were followed up at 12 months.</p></div><div><h3>Results</h3><p>Of 17 patients, median age was 23 years (IQR = 21–30 years) and 12/17 (71 %) were female. Pre-extensively drug-resistant tuberculosis and extensively drug-resistant TB was reported in 13/17 (76.4 %) and 2/17 (11.7 %) patients respectively. Microbiological reports were unavailable for two patients with central nervous system TB. Lymph node TB was the commonest form of EPTB in 9/17 (53 %) of patients. Median duration of treatment was 18.9 months. At least one grade three or four severe adverse event (SAE) was reported by 13/17 (76.4 %) patients. Thirteen (76.4 %) patients had favourable outcomes. None of the patients relapsed or died in the one-year period of post-treatment follow-up.</p></div><div><h3>Conclusion</h3><p>Concurrent BDQ-DLM-based regimens in drug-resistant EPTB were effective and associated with manageable adverse events.</p></div>","PeriodicalId":37942,"journal":{"name":"Journal of Clinical Tuberculosis and Other Mycobacterial Diseases","volume":"35 ","pages":"Article 100433"},"PeriodicalIF":1.9000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2405579424000202/pdfft?md5=54d6378eb9485a2cb8a83469dfa82d39&pid=1-s2.0-S2405579424000202-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Concomitant bedaquiline and delamanid therapy in patients with drug-resistant extra-pulmonary tuberculosis in Mumbai, India\",\"authors\":\"Himani Mongia , Fatima Mamnoon , Arunima Silsarma , Raman Mahajan , Alpa Dalal , Miriam Arago Galindo , Aparna Iyer , Pramila Singh , Homa Mansoor , Mrinalini Das , Mabel Morales , Hannah Spencer , Petros Isaakidis\",\"doi\":\"10.1016/j.jctube.2024.100433\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>World Health Organization suggests concurrent bedaquiline-delamanid (BDQ-DLM) as part of individualised regimens for eligible patients with pulmonary drug-resistant tuberculosis (DR-TB); however, data for patients with drug-resistant extrapulmonary tuberculosis (EPTB) is extremely limited. This study documents the treatment outcomes and adverse events associated with concurrent BDQ-DLM-based regimens in patients with drug-resistant EPTB at a Médecins Sans Frontières clinic in Mumbai, India.</p></div><div><h3>Methods</h3><p>Retrospective cohort study based on routinely collected programmatic data. Individualised regimens were based on drug-susceptibility testing and previous drug exposure. Drug-resistant EPTB patients initiated on regimens containing concurrent BDQ and DLM from April 2016 to October 2019 were included.<!--> <!-->Patients who completed treatment were followed up at 12 months.</p></div><div><h3>Results</h3><p>Of 17 patients, median age was 23 years (IQR = 21–30 years) and 12/17 (71 %) were female. Pre-extensively drug-resistant tuberculosis and extensively drug-resistant TB was reported in 13/17 (76.4 %) and 2/17 (11.7 %) patients respectively. Microbiological reports were unavailable for two patients with central nervous system TB. Lymph node TB was the commonest form of EPTB in 9/17 (53 %) of patients. Median duration of treatment was 18.9 months. At least one grade three or four severe adverse event (SAE) was reported by 13/17 (76.4 %) patients. Thirteen (76.4 %) patients had favourable outcomes. None of the patients relapsed or died in the one-year period of post-treatment follow-up.</p></div><div><h3>Conclusion</h3><p>Concurrent BDQ-DLM-based regimens in drug-resistant EPTB were effective and associated with manageable adverse events.</p></div>\",\"PeriodicalId\":37942,\"journal\":{\"name\":\"Journal of Clinical Tuberculosis and Other Mycobacterial Diseases\",\"volume\":\"35 \",\"pages\":\"Article 100433\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2405579424000202/pdfft?md5=54d6378eb9485a2cb8a83469dfa82d39&pid=1-s2.0-S2405579424000202-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Tuberculosis and Other Mycobacterial Diseases\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2405579424000202\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Tuberculosis and Other Mycobacterial Diseases","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2405579424000202","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Concomitant bedaquiline and delamanid therapy in patients with drug-resistant extra-pulmonary tuberculosis in Mumbai, India
Background
World Health Organization suggests concurrent bedaquiline-delamanid (BDQ-DLM) as part of individualised regimens for eligible patients with pulmonary drug-resistant tuberculosis (DR-TB); however, data for patients with drug-resistant extrapulmonary tuberculosis (EPTB) is extremely limited. This study documents the treatment outcomes and adverse events associated with concurrent BDQ-DLM-based regimens in patients with drug-resistant EPTB at a Médecins Sans Frontières clinic in Mumbai, India.
Methods
Retrospective cohort study based on routinely collected programmatic data. Individualised regimens were based on drug-susceptibility testing and previous drug exposure. Drug-resistant EPTB patients initiated on regimens containing concurrent BDQ and DLM from April 2016 to October 2019 were included. Patients who completed treatment were followed up at 12 months.
Results
Of 17 patients, median age was 23 years (IQR = 21–30 years) and 12/17 (71 %) were female. Pre-extensively drug-resistant tuberculosis and extensively drug-resistant TB was reported in 13/17 (76.4 %) and 2/17 (11.7 %) patients respectively. Microbiological reports were unavailable for two patients with central nervous system TB. Lymph node TB was the commonest form of EPTB in 9/17 (53 %) of patients. Median duration of treatment was 18.9 months. At least one grade three or four severe adverse event (SAE) was reported by 13/17 (76.4 %) patients. Thirteen (76.4 %) patients had favourable outcomes. None of the patients relapsed or died in the one-year period of post-treatment follow-up.
Conclusion
Concurrent BDQ-DLM-based regimens in drug-resistant EPTB were effective and associated with manageable adverse events.
期刊介绍：
Journal of Clinical Tuberculosis and Mycobacterial Diseases aims to provide a forum for clinically relevant articles on all aspects of tuberculosis and other mycobacterial infections, including (but not limited to) epidemiology, clinical investigation, transmission, diagnosis, treatment, drug-resistance and public policy, and encourages the submission of clinical studies, thematic reviews and case reports. Journal of Clinical Tuberculosis and Mycobacterial Diseases is an Open Access publication.
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