1차 항결핵제 약물이상반응 현황: 단일기관 약물이상사례 보고사례 기반 분석
Adverse Drug Reactions to First-line Anti-tubercular Drugs Based on Individual Case Safety Report in a Single Tertiary Hospital
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Background/Aims: Tuberculosis has incidence and mortality rates that are among the highest for all communicable diseases. Adverse drug reactions (ADRs) to anti-tubercular drugs are common, and have a major impact on treatment maintenance and prognosis. It is important to understand the characteristics of ADRs and establish a suitable management plan. Methods: We retrospectively reviewed patients with ADRs during treatment with first-line antitubercular drugs such as isoniazid, rifampicin, ethambutol, and pyrazinamide from 2009 to 2018. Age, sex, and total treatment period, and the onset, severity, seriousness, and system organ class of ADRs, were analyzed to understand the characteristics of first-line anti-tubercular drug-related ADRs. Results: A total of 1,606 of 5,482 patients (29.3%) experienced ADRs after administration of first-line anti-tubercular drugs. The incidence of ADRs related to isoniazid, rifampicin, ethambutol, and pyrazinamide was 22.2%, 21.3%, 24.5%, and 29.6%, respectively. A total of 2,098 ADR reports were made (mean of 1.3 ± 0.6 per patient). The rates of mild, moderate, and severe ADRs were 32.4%, 61.1%, and 6.5%, respectively. There were 127 reports (6.1%) of serious ADRs. Skin and appendage disorders were most frequently reported (27.5%), followed by gastrointestinal disorders (17.5%), and liver and biliary system disorders (13.1%). The total treatment period was longer in patients who experienced ADRs (224.0 ± 3.1 days vs. 247.0 ± 4.7 days, p = 0.009). Conclusions: The incidence of ADRs to first-line anti-tuberculosis drugs was 29.3%, and 6.5% were severe ADRS. ADRs prolonged the overall treatment duration, indicating the importance of their detection and management.
Abstract
Background/Aims: Tuberculosis has incidence and mortality rates that are among the highest for all communicable diseases. Adverse drug reactions (ADRs) to anti-tubercular drugs are common, and have a major impact on treatment maintenance and prognosis. It is important to understand the characteristics of ADRs and establish a suitable management plan. Methods: We retrospectively reviewed patients with ADRs during treatment with first-line antitubercular drugs such as isoniazid, rifampicin, ethambutol, and pyrazinamide from 2009 to 2018. Age, sex, and total treatment period, and the onset, severity, seriousness, and system organ class of ADRs, were analyzed to understand the characteristics of first-line anti-tubercular drug-related ADRs. Results: A total of 1,606 of 5,482 patients (29.3%) experienced ADRs after administration of first-line anti-tubercular drugs. The incidence of ADRs related to isoniazid, rifampicin, ethambutol, and pyrazinamide was 22.2%, 21.3%, 24.5%, and 29.6%, respectively. A total of 2,098 ADR reports were made (mean of 1.3 ± 0.6 per patient). The rates of mild, moderate, and severe ADRs were 32.4%, 61.1%, and 6.5%, respectively. There were 127 reports (6.1%) of serious ADRs. Skin and appendage disorders were most frequently reported (27.5%), followed by gastrointestinal disorders (17.5%), and liver and biliary system disorders (13.1%). The total treatment period was longer in patients who experienced ADRs (224.0 ± 3.1 days vs. 247.0 ± 4.7 days, p = 0.009). Conclusions: The incidence of ADRs to first-line anti-tuberculosis drugs was 29.3%, and 6.5% were severe ADRS. ADRs prolonged the overall treatment duration, indicating the importance of their detection and management.
참고문헌 (23)
- "Global tuberculosis report" (2019)[URL]
- "National tuberculosis program guideline" (2020)[URL]
- Korea Centers for Disease Control & Prevention, "Korean Guidelines for Tuberculosis", Joint Committee for the Revision of Korean Guidelines for Tuberculosis and Korea Centers for Disease Control &Prevention, ~ (2020)
- Gholami K, "Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients", Pharm Pract(Granada), 4, pp.134~138 (2006)
- 김상훈, "단기 항결핵 화학요법에 의한 약물 이상반응의 유병률", 대한내과학회지, 73(5), pp.496~502 (2007), 대한내과학회
- Ormerod LP, "Frequency and type of reactions to antituberculosis drugs : observations in routine treatment", Tuber Lung Dis, 77, pp.37~42 (1996)
- Yee D, "Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis", Am J Respir Crit Care Med, 167, pp.1472~1477 (2003)
- Singh A, "Prevalence of adverse drug reaction with first-line drugs among patients treated for pulmonary tuberculosis", Clinical Epidemiology and Global Health, 3(Suppl 1), pp.S80~S90 (2015)
- Shean K, "Drug-associated adverse events and their relationship with outcomes in patients receiving treatment for extensively drug-resistant tuberculosis in South Africa", PLoS One, 8, pp.e63057~ (2013)
- Huang YS, "Recent progress in genetic variation and risk of antituberculosis drug-induced liver injury", J Chin Med Assoc, 77, pp.169~173 (2014)
- Chamorro JG, "Sex, ethnicity, and slow acetylator profile are the major causes of hepatotoxicity induced by antituberculosis drugs", J Gastroenterol Hepatol, 28, pp.323~328 (2013)
- Goldman JL, "Pediatric pharmacovigilance : enhancing adverse drug reaction reporting in a tertiary care children's hospital", Ther Innov Regul Sci, 47, pp.566~571 (2013)
- "Glossary of pharmacovigilance terms" (2020)[URL]
- "The use of the WHO-UMC system for standardised case causality assessment" (2020)[URL]
- "WHO-ART" (2009)[URL]
- Prasad R, "Adverse drug reactions in tuberculosis and management", Indian J Tuberc, 66, pp.520~532 (2019)
- Breen RA, "Adverse events and treatment interruption in tuberculosis patients with and without HIV co-infection", Thorax, 61, pp.791~794 (2006)
- Forget EJ, "Adverse reactions to first-line antituberculosis drugs", Expert Opin Drug Saf, 5, pp.231~249 (2006)
- Schaberg T, "Risk factors for side-effects of isoniazid, rifampin and pyrazinamide in patients hospitalized for pulmonary tuberculosis", Eur Respir J, 9, pp.2026~2030 (1996)
- "Clinical trial of six-month and four-month regimens of chemotherapy in the treatment of pulmonary tuberculosis", Am Rev Respir Dis., 119, pp.579~585 (1979)
- Castro AT, "Incidence and risk factors of major toxicity associated to first-line antituberculosis drugs for latent and active tuberculosis during a period of 10 years", Rev Port Pneumol., 21, pp.144~150 (2015)
- 황영훈, "1차 및 2차 항결핵제에 의한 DRESS (drug reaction with eosinophilia and systemic symptom) 증후군 1예와 문헌고찰", Allergy Asthma & Respiratory Disease, 5(2), pp.111~116 (2017), 대한 소아알레르기 호흡기학회[DOI]
- Siripassorn K, "Successful drug desensitization in patients with delayed-type allergic reactions to anti-tuberculosis drugs", Int J Infect Dis, 68, pp.61~68 (2018)