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Inactivated Mycobacterium phlei is a heat-inactivated, nonpathogenic mycobacterial preparation that functions as an immunomodulating agent. [1] Its active component is the heat-killed Mycobacterium phlei bacterium, whose cell wall components have immunoregulatory effects. The drug modulates T-cell responses, including CD4+CD25+ regulatory T cells, Th17 cells, and γδT cells, and regulates cytokines such as IL-4, IL-10, IL-17, and IFN-γ. [11, 18] It has been approved in China as a general immunomodulator for the auxiliary treatment of tuberculosis. [16, 19] It is also being investigated for the treatment of asthma, where it is administered via aerosol inhalation to reduce airway inflammation and hyperresponsiveness. [5, 8] A specific formulation, a cell wall-nucleic acid complex known as MCNA, has been studied for bladder cancer, particularly in cases unresponsive to BCG, where it is thought to induce apoptosis in cancer cells. [2, 3, 4] A homeopathic product containing a diluted form of Mycobacterium phlei is marketed separately.
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