ABSTRACT
The primary objective of this study was to evaluate the real-world effectiveness, side effects and challenges associated with the implementing of the groundbreaking BPaL-containing regimen in Thailand. Another aim was to investigate the characteristics and severity of the disease, the presence of abnormal extensive lesions in chest X-Rays and the influence of cavitation on sputum conversion. MATERIAL AND METHOD: The case series study included patients at TB clinic of Central chest institute of Thailand between August 2021-April 2023. All 28 Patients fullfilled the diagnostic criterial for MDR-TB by molecular tests and/or sputum culture. Sputum molecular test, utilizing GeneXpert MRB/XDR or Genotype MTBDRsl assay, was conducted. The 8 Pre-XDR patients who exhibited quinolone resistance and the 2 MDR-TB patients who encountered side effected from quinolone drugs were treated with BPaL regimen, while the remainder received BPaLM regimens. RESULTS: Among the 28 patients, 23 (82.1 %) successfully completed the treatment with favorable outcomes. However, one patient from the BpaL regimen died due to severe destroy lung lesion, and four patients from the BpalM regimen discontinued treatment. The investigation into the correlation between extension lesion, cavitation lesions, and culture conversion unveiled that the group with extension lesions and cavitation ≥4 cm had a diminished probability of achieving sputum culture conversion within 8 weeks in comparison to the group without attributes. The associated risk ratio was 0.56 (95 % CI, 0.14-2.27), p = 0.14. Although the study report minimal side effects, 6 patients (22.2 %) experienced peripheral neuropathy and a notable adverse reaction identified was optic neuritis, affecting 2 cases (7.1 %). SUMMARY: The administration of the BPaL-containing regimen resulted in rapid sputum conversion within 8 weeks and had minimal side effects.
ABSTRACT
BACKGROUND: Standard six months short course regimen for treatment of pulmonary tuberculosis is very effective and is recommended as standard treatment. But this regimen composes of many drugs and causes high adverse drug reactions especially gastrointestinal irritation. Spitted administration of drugs to two times a day may reduce adverse drug reactions. OBJECTIVE: To study adverse drug reactions and outcome of single daily versus split drug (two times a day) administration of standard six month short course regimen in newly diagnosed pulmonary tuberculosis. MATERIAL AND METHOD: Newly diagnosed pulmonary tuberculosis patients of the Central Chest Institute of Thailand were randomized to receive standard six months regimen once daily or two times a day (split drug). Patients were followed-up every two weeks and a questionnaire was used to detect adverse drug reactions. Outcome of treatment was evaluated according to national tuberculosis treatment guideline. RESULTS: 122 pulmonary tuberculosis were eligible for the present study and 61 patients were enrolled to each group of once daily or split drug regimen. Pulmonary tuberculosis patients who received split drug regimen had a higher cure rate but not statistical significance because of lower transfer out rate. Adverse drug reactions were similar in both groups of patients who received once daily and split drug regimen. Although split drug group had lower gastrointestinal adverse drug reactions. CONCLUSION: Split drug regimen has the same cure rate of treatment as single daily regimen and same adverse drug reactions.
