Home-based Anti-Tuberculosis Treatment Adverse Reactions (HATTAR) study: a protocol for a prospective observational study
Open Access
- 30 March 2019
- Vol. 9 (3), e027321
- https://doi.org/10.1136/bmjopen-2018-027321
Abstract
IntroductionTuberculosis (TB) continues to be an important public health problem throughout much of the world. Drug treatment is the only effective treatment method, but adverse drug events (ADEs) and adverse drug reactions (ADRs) can affect medication adherence. As the number of drug-resistant TB patients and the number of anti-TB drugs have increased, it is necessary to explore the risk factors for ADEs/ADRs to reduce their occurrence. This study aims to build a home-based anti-TB treatment cohort and to recognise the incidences, prognosis and risk factors of anti-TB drug-induced ADEs/ADRs in real-world experiences.Methods and analysisThis study is a multicentre, prospective observational cohort study. The study population will consist of 3200 newly diagnosed TB patients between January 2019 and December 2020. After initiating the anti-TB treatment, all patients will be followed up until finishing treatment unless they withdraw, and we will record personal drug use and signs and/or symptoms of discomfort. Patients will receive scheduled laboratory tests in designated hospitals every 2 weeks during the first 2 months, and the residual blood sample after conducting the laboratory tests will be preserved. The ADEs/ADRs will be placed into eight categories: liver dysfunction, gastrointestinal reactions, drug allergy, arthralgia or muscle pain, nervous system disorders, haematological system disorders, renal impairment and others.Ethics and disseminationThis study protocol has been approved by the ethics committees of Nanjing Medical University. All patients will give written informed consent before enrollment. The findings of the study will be published in peer-reviewed journals and will be presented at national and international conferences.Funding Information
- Key Research and Development Plan of Zhenjiang
- Priority Academic Program Development of Jiangsu Higher Education Institutions
- National Natural Science Foundation of China
This publication has 48 references indexed in Scilit:
- Adverse Reactions Due to Directly Observed Treatment Strategy Therapy in Chinese Tuberculosis Patients: A Prospective StudyPLOS ONE, 2013
- Long Noncoding RNA HOTAIR Is a Prognostic Marker for Esophageal Squamous Cell Carcinoma Progression and SurvivalPLOS ONE, 2013
- CYP2E1,GSTM1andGSTT1genetic polymorphisms and susceptibility to antituberculosis drug-induced hepatotoxicity: a nested case-control studyJournal of Clinical Pharmacy & Therapeutics, 2012
- Sample Size and Statistical Power Calculation in Genetic Association StudiesGenomics & Informatics, 2012
- Incidence, Clinical Features and Impact on Anti-Tuberculosis Treatment of Anti-Tuberculosis Drug Induced Liver Injury (ATLI) in ChinaPLOS ONE, 2011
- Drogas antituberculose: interações medicamentosas, efeitos adversos e utilização em situações especiais - parte 1: fármacos de primeira linhaJornal Brasileiro de Pneumologia, 2010
- Design of the Anti-tuberculosis Drugs induced Adverse Reactions in China National Tuberculosis Prevention and Control Scheme Study (ADACS)BMC Public Health, 2010
- Antituberculosis drug‐induced hepatotoxicity: Concise up‐to‐date reviewJournal of Gastroenterology and Hepatology, 2007
- Predisposition of antituberculosis drug induced hepatotoxicity by cytochrome P450 2E1 genotype and haplotype in pediatric patients.Journal of Gastroenterology and Hepatology, 2006
- Criteria of drug-induced liver disorders: Report of an International Consensus MeetingJournal of Hepatology, 1990