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Adverse drug reactions among children with tuberculosis in China: a multicentre study, 2017-2022
Yiqing Zhou1, Yu Kan2, Ping Liu3
1School of Public Health, Hangzhou Medical College, Hangzhou, China.
Insights
Adverse drug reactions (ADRs) are common in children undergoing tuberculosis (TB) treatment in China, mainly affecting the blood and gastrointestinal systems. Severe TB and specific drug regimens increase the risk, requiring careful monitoring.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Clinical Pharmacy
Background:
- Tuberculosis (TB) treatment is effective but can cause adverse drug reactions (ADRs).
- Understanding ADRs in pediatric TB patients is crucial for optimizing treatment.
- Data on ADRs in Chinese children with TB is limited.
Purpose of the Study:
- To investigate the occurrence, frequency, and risk factors of ADRs in children receiving anti-TB treatment in China.
- To identify specific patient groups at higher risk for ADRs.
Main Methods:
- A multicenter study involving 11 hospitals in China.
- Data collected from 482 pediatric TB patients.
- Multivariable logistic regression used to identify factors associated with ADRs.
Main Results:
- 19% of pediatric TB patients experienced ADRs.
- Most common ADRs included blood system damage (24%) and gastrointestinal reactions (24%).
- Severe TB and use of HRZ(E) + second-line drugs increased the odds of ADRs (OR=2.44 and OR=3.70, respectively).
Conclusions:
- ADRs are prevalent in Chinese pediatric TB patients, primarily affecting the hematological and gastrointestinal systems.
- ADRs are often transient and occur during the intensive treatment phase.
- Severe disease and combination drug regimens necessitate targeted surveillance and optimized pediatric TB therapies.
Objective:
Although tuberculosis (TB) treatment, if adequately taken and adhered to, is highly effective. To investigate the occurrence, frequency and related factors of adverse drug reactions (ADRs) during anti-TB treatment in children in China.
Methods:
We conducted a multicentre study and collected data from 11 representative paediatric specialists and general hospitals offering anti-TB treatment. The outcome of interest was the occurrence of any ADRs. Multivariable logistic regression was performed to explore factors associated with ADRs and to identify groups at high-risk for ADRs.
Results:
In total, 482 patients were enrolled; of whom, 94 (19%) reported an ADR. The most common ADRs were blood system damage (24%) and gastrointestinal reactions (24%). Most ADRs occurred within the intensive treatment period and were of short duration. Children with severe TB or those treated with HRZ(E) + second-line drugs in the intensive phase were at higher odds of developing ADRs (OR = 2.44, 95% CI: 1.36-4.39, p = 0.003; OR = 3.70, 95% CI: 2.01-6.81, p < 0.001, respectively).
Conclusions:
ADRs are prevalent in Chinese paediatric TB patients, predominantly haematological or gastrointestinal, transient during the intensive phase. Severe disease and HRZ(E) + second-line regimens confer elevated risk, necessitating targeted surveillance and optimized paediatric therapies balancing efficacy and safety.
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