Adverse Events in Treating Smear-Positive Tuberculosis Patients in China

Abstract

This study aimed to estimate the adverse events (AE) rate during anti-tuberculosis treatment and to explore AE-related risk factors. New and previously treated smear-positive tuberculosis (TB) cases were enrolled from eight regions in China between April 2009 and October 2010. The AE rate was estimated, and AE risk factors during anti-TB treatment were assessed using Cox proportional models. Among 2091 Chinese subjects with anti-TB treatment, 462 (22.1%, 95% confidence interval (CI), 20.3–23.9) patients developed AE, with liver injury and gastrointestinal reactions constituting the most common AE. Specifically, 9.8% (95% CI, 8.5–11.1) and 6.3% (95% CI, 5.3–7.4) developed liver injuries and gastrointestinal reactions, respectively. We found that AE rate differed by regions, TB knowledge score, symptoms score and smoking status. Liver injuries were associated with age, sex and smoking status; gastrointestinal reactions were associated with education level and symptom score. Improving patients’ knowledge on TB could reduce AE rate.

Antituberculosis Drug‐Induced Adverse Events in the Liver, Kidneys, and Blood: Clinical Profiles and Pharmacogenetic Predictors

“…Globally, ADR has been a major contributor toward anti‐TB treatment discontinuation or failure, particularly in developing countries such as China. In the present study, ATD‐ADRs noticeably and substantially impacted anti‐TB treatment, with an incidence of 16.5% and an intervention rate of 10.4%; fortunately, most were reversible after timely interference, findings that were comparable to other studies from China . In our study, ATDH, the most frequent and serious ATD‐ADR, was moderate (10.6%) compared with the data in the literature on hospitalized patients (4.8–36%) because of different definitions used, heterogeneous ethnic origins, various sample sizes, and even potential confounding causes of hepatotoxicity.…”

“…Leukopenia and thrombocytopenia are increasing and unfavorable among Chinese TB patients. Despite the threat that they pose to patients, these events have been overlooked in studies from other regions of China . A recent retrospective study included a relatively smaller sample of patients from northern China .…”

Correlation between lncRNA AC079767.4 variants and liver injury from antituberculosis treatment in West China

“…The liver injury from our research having rate of 12.88% was consistent with those in the Xia et al's [23] and Shu et al's studies [24]. Recently, Zhang et al have profiled the adverse reaction events due to TB treatment in a large TB patient cohort and described that liver dysfunction was the most frequently adverse event with rate of 9.80% and the blood system disorders merely accounted with the proportion of 0.86% [25]. Compared to Zhang et al's results, the markedly higher occurrence rate of both hepatotoxicity (12.88%) and blood system injury (3.51%) in our work were yielded.…”

Home-based Anti-Tuberculosis Treatment Adverse Reactions (HATTAR) study: a protocol for a prospective observational study

“…Based on medication records, symptoms, signs, laboratory test results, relevant investigations and self-recorded diaries, local supervising doctors will be able to judge ADEs preliminarily. Experts from the ADRs monitoring centre will regularly review and verify the judgements and classify all the ADEs into eight categories as follows8 29: (1) liver dysfunction, including elevated transaminase and jaundice; (2) gastrointestinal reactions, including nausea, vomiting and diarrhoea; (3) drug allergy, including pruritus and rash; (4) arthralgia or muscle pain; (5) nervous system disorders, including sleep disorders, dizziness, headache, tinnitus and hearing loss; (6) haematological system disorders, including anaemia and leucopenia; (7) renal impairment, including decline of renal function, positive urine protein and renal failure and (8) cardiac injury, including QT prolongation; (9) others. Finally, the experts will conduct causality assessments based on the WHO-UMC causality assessment system30 and the Roussel Uclaf Causality Assessment Method31 and judge some ADEs as ADRs according to the criteria.…”