{"title":"对耐药性结核病患者采用含有贝达喹啉和地拉那米的治疗方案的有效性和安全性。","authors":"Oki Nugraha Putra, Yulistiani Yulistiani, Soedarsono Soedarsono, Susi Subay","doi":"10.4103/picr.picr_1_23","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).</p><p><strong>Objective: </strong>The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.</p><p><strong>Methods: </strong>Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.</p><p><strong>Results: </strong>Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (<i>P</i> ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (<i>P</i> < 0.05).</p><p><strong>Conclusion: </strong>DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 2","pages":"89-93"},"PeriodicalIF":0.0000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11101004/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effectiveness and safety of regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis.\",\"authors\":\"Oki Nugraha Putra, Yulistiani Yulistiani, Soedarsono Soedarsono, Susi Subay\",\"doi\":\"10.4103/picr.picr_1_23\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).</p><p><strong>Objective: </strong>The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.</p><p><strong>Methods: </strong>Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.</p><p><strong>Results: </strong>Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (<i>P</i> ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (<i>P</i> < 0.05).</p><p><strong>Conclusion: </strong>DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.</p>\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":\"15 2\",\"pages\":\"89-93\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11101004/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.picr_1_23\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/9/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_1_23","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/9/11 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Effectiveness and safety of regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis.
Background: Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).
Objective: The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.
Methods: Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.
Results: Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (P ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (P < 0.05).
Conclusion: DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.
期刊介绍:
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.