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Impaired response to erythytocytopenics is the cause of ineffective red blood cell production and anemia due to bone marrow growth abnormal syndrome (MDS).
in-body, lenamin (LEN) enhances the signal of erythocyte-producing proteins.
study aims to clarify whether LEN therapy can restore and improve the response of low-risk, non-del (5q) MDS patients, who show anemia and are less likely to be ineffective or benefit from recombined erythymocytopenic therapy, to EPO α.
This is a Phase 3 U.S. intergroup trial that stratells patients into the LEN-EPO alpha or LEN groups based on serum-promoting erythrocyte production concentrations and a history of treatment with previous erythrocyte-promoting cells.
195 assessable patients were randomly grouped during the study process: 99 in the LEN-EPO alpha group and 96 in the LEN group.
after 4 courses of treatment, the primary endpoint rate (28.3%) of the main red line reaction (MER) of the combined drug was significantly higher than that of LEN (11.5%) alone (p-0.004).
of the 136 patients who completed the 16-week study, 38.9 percent in the joint group and 15.6 percent in the single LEN group received MER (p-0.004), respectively.
the recurrence-free rates in the
groups, 18.2% and 20.8% of the patients in the two groups received a mild red line response, and the overall red line response rate reached 46.5% (joint group) and 32.3% (single LEN group), respectively.
patients who did not respond to LEN, 38 patients switched to EPI alpha, of which 10 (26.3%) received MER.
treatment was very long-lasting, with a medium MER duration of 23.8 months, while patients treated with LEN alone had an effective duration of 13 months.
In summary, LEN can restore the sensitivity of growth factor insensitive, low-risk, non-del (5q) MDS patients to recombinative erythrocytogen;