Early Effectiveness of Bedaquiline Containing Regimen in Treatment of Multidrug-resistant and Extensively Drug-resistant Pulmonary Tuberculosis: An One-arm Observational Study of 24 Weeks

Chunhong YU; Yanhong ZHAO; Xing LIU; Lingjun SHEN; Weixian LI; Haiwen LI; Hao FAN

doi:10.12259/j.issn.2095-610X.S20221113

Volume 43 Issue 11

Nov. 2022

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Chunhong YU, Yanhong ZHAO, Xing LIU, Lingjun SHEN, Weixian LI, Haiwen LI, Hao FAN. Early Effectiveness of Bedaquiline Containing Regimen in Treatment of Multidrug-resistant and Extensively Drug-resistant Pulmonary Tuberculosis: An One-arm Observational Study of 24 Weeks[J]. Journal of Kunming Medical University, 2022, 43(11): 99-106. doi: 10.12259/j.issn.2095-610X.S20221113

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Chunhong YU, Yanhong ZHAO, Xing LIU, Lingjun SHEN, Weixian LI, Haiwen LI, Hao FAN. Early Effectiveness of Bedaquiline Containing Regimen in Treatment of Multidrug-resistant and Extensively Drug-resistant Pulmonary Tuberculosis: An One-arm Observational Study of 24 Weeks[J]. Journal of Kunming Medical University, 2022, 43(11): 99-106. doi: 10.12259/j.issn.2095-610X.S20221113

Citation:

Chunhong YU, Yanhong ZHAO, Xing LIU, Lingjun SHEN, Weixian LI, Haiwen LI, Hao FAN. Early Effectiveness of Bedaquiline Containing Regimen in Treatment of Multidrug-resistant and Extensively Drug-resistant Pulmonary Tuberculosis: An One-arm Observational Study of 24 Weeks[J]. Journal of Kunming Medical University, 2022, 43(11): 99-106. doi: 10.12259/j.issn.2095-610X.S20221113

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Early Effectiveness of Bedaquiline Containing Regimen in Treatment of Multidrug-resistant and Extensively Drug-resistant Pulmonary Tuberculosis: An One-arm Observational Study of 24 Weeks

doi: 10.12259/j.issn.2095-610X.S20221113

1.
School of Pharmacy，Dali University，Dali Yunnan 671000
2.
Dept. of Pharmacy，Kunming Third People’s Hospital /Yunnan Clinical Center for Infectious Disease， Kunming Yunnan 650041，China

Received Date: 2022-07-14
Publish Date: 2022-11-25

Abstract

Abstract

Objective To evaluate the efficacy of a bedaquiline-containing regimen in the treatment of multidrug-resistant/extensively drug-resistant tuberculosis, and to explore the adverse reactions, so as to provide a reference for safe and rational drug use in clinical practice. Methods The clinical data of 62 patients with multi-drug resistant/extensively drug-resistant tuberculosis treated with a bedaquiline-containing regimen from October 2019 to October 2021 in the Third People’s Hospital of Kunming were retrospectively analyzed to evaluate the efficacy and safety of bedaquiline-containing regimen. Background Drug composition, number and days of sputum negative conversion, lesion absorption, cavity closure, and distribution of adverse events were counted, and their correlation was analyzed. QTcF values （corrected for heart rate, QT interval values calculated using the Fridericia formula） were recorded before and after medication, and changes from baseline at each monitoring point were compared and analyzed. Results All 62 patients were followed up for 24 weeks, and there were no deaths, lost to follow-up or withdrawal cases; At the end of 24 weeks of treatment, the sputum smear-negative conversion rate was 93.5% （58/62）, the sputum culture negative conversion rate was 85.4% （53/62）, the lesion absorption rate was 87.1% （54/62）, and the cavity closure rate was 92.3% （36/39） in 39 patients with cavities. There were a total of 217 adverse events, 203 （93.5%） were mild to moderate （grade 1 to 2） adverse events and 14 （6.5%） were serious （grade 3 to 5） adverse events. A total of 22 discontinuations were performed during treatment. Bedaquiline-related adverse events were 11 discontinuations, mainly manifested as QTc prolongation in 9 （41.0%） and hepatotoxicity in 2 （9.1%）. Statistical calculation results showed that abnormal liver function was negatively correlated with sputum negative conversion time （z = -0.293, P < 0.01）; QTc interval prolongation was negatively correlated with sputum negative conversion time （ z = -0.544, P < 0.01）. Sixty-two patients were compared between the mean QTcF value at each monitoring site and the baseline QTcF value, and the QTcF value gradually increased with the extension of the course of treatment, and the differences at weeks 4, 8, 12, 16, and 24 were statistically significant. Conclusions Bedaquiline-containing regimens achieve a high rate of sputum negative conversion at 24 weeks in the treatment of multidrug-resistant/extensively drug-resistant tuberculosis and can promote the absorption of imaging lesions in patients. Although the incidence of adverse drug reactions is high, they are generally controllable and tolerable to most patients. Special attention should be paid to QTc prolongation and liver injury during medication.
- Bedaquiline,
- Tuberculosis,
- Multidrug-resistant pulmonary tuberculosis,
- Extensively drug-resistant tuberculosis,
- Retrospective study

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References

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