Drug intelligence / Profile preview

qinbudan

Development stage
Phase 2
Modality
Small Molecules
Administration
Oral
01

Overview

Qinbudan is a traditional Chinese medicine that has been used to treat pulmonary tuberculosis (PTB) in China since the 1960s. Based on the search results, I can provide the following information about this medication. ## Overview Qinbudan is available as a tablet formulation (QBDT) and has been studied as an adjunct therapy for retreatment of pulmonary tuberculosis. Clinical studies have shown that Qinbudan promotes sputum-culture negative conversion and lesion absorption in tuberculosis patients[1]. ## Clinical Evidence A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in China to evaluate the efficacy and safety of Qinbudan tablet as an adjunct therapy for retreatment of pulmonary tuberculosis. The study enrolled patients who had received previous anti-TB treatment from April 2011 to March 2013[1]. In this trial: - The treatment group received an anti-TB regimen plus Qinbudan tablet - The control group received an anti-TB regimen plus placebo - The anti-TB treatment included isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin for 2 months, followed by isoniazid, rifampicin, ethambutol for 6 months The primary outcome measured was sputum-culture conversion using the MGIT 960 liquid medium method. Secondary outcomes included lung lesion absorption and cavity closure[1]. ## Safety Profile The safety analysis from the clinical trial showed that Qinbudan has a favorable safety profile: - The rates of adverse events and treatment-related adverse reactions were similar between the Qinbudan and placebo groups - In the placebo group, there were 84 cases (67.2%) of adverse events, while there were 76 cases (60.3%) in the treatment group - The adverse reactions mainly included abnormalities in laboratory parameters - No significant differences in adverse events and adverse reaction rates were observed between the two groups[1] Qinbudan represents an example of traditional Chinese medicine being evaluated through modern clinical trial methodology for its potential benefits in treating tuberculosis, particularly in cases where retreatment is necessary.

Brand names
Qinbudan tabletQBDT

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