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Most patients with acute myeloid leukemia (AML) in old age have poor prognostication, and even if the patient receives the treatment of the normylation agent, it is difficult to achieve satisfactory clinical results.
previous Phase 1b study, Venetolax combined azacine had a good effect on older AML patients.
Recently, researchers recruited previously untreated AML patients to conduct Phase III studies, in which patients aged 75 years or older were randomly given Venetura (400mg) or placebo once a day on the basis of standard Azathroside therapy (subderrone or intravenous injections, 75 mg per square metre of surface area, 1 cycle every 28 days, 1-7 days per cycle).
end point of the study is total survival.
431 patients, with an average age of 76, included 286 in the Vinetola group and 145 in the placebo group.
the 20.5-month mid-follow-up, the total survival of the Vinetola group was 14.7 months and that of the control group was 9.6 months (death risk ratio was 0.661). the total remission rate in the
Venetola group was higher than in the control group (36.7% vs 17.9%), and the compound remission rate (complete or complete remission accompanied by incomplete hematological recovery) was higher than in the control group (66.4% vs 28.3%). the occurrence of major adverse events (including nausea) in the total survival difference of
was 44%, in the control group it was 35%, the rate of plateboard reduction at level 3 or higher was 45% and 38% respectively, the occurrence of neural granulocytic reduction was 42% and 28%, and the rate of febrile neural cell reduction was 42% and 19%, respectively.
85 percent of patients in the Venetura group had an infection, compared with 67 percent in the control group, 83 percent in the Vinetura group and 73 percent in the placebo group.
studies have concluded that Vinetola combined azadenosine can effectively prolong the survival of elderly patients with acute myeloid leukemia aged 75 years and older.
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