Results:

  • Among the 408 newly diagnosed APL patients, 27 experienced early deathand the early mortality rate was 62%. The median time from diagnosis to death was 8 days (1-29 days). Age, risk stratification, white blood cell (WBC) count, prothrombin time (PT), fibrinogen, fibrinogen degradation products (FDP), D-dimer, high-sensitivity troponin T (hs-cTnT), lactate dehydrogenase (LDH), WBC count peak and its occurrence time, diffuse alveolar hemorrhage (DAH), tumor lysis syndrome (TLS), disseminated intravascular coagulation (DIC), cerebral hemorrhage (ICH), and gastrointestinal bleeding (GIH) were statistically significant between the early death and non-early death groups. Multivariate regression analysis revealed that age ≥ 60 years (P=0.029), WBC count≥ 10×109/L (P=0.012), FDP ≥ 150 mg/L (P=0.038), DAH (P=0.001), and ICH (P<0.001) were independent risk factors for early mortality in newly diagnosed APL patients. The predictive model constructed had an area under the receiver operating characteristic (ROC) curve (AUC) of 0.936, with sensitivity and specificity of 94.8% and 81.0%, respectively.

  • The median follow-up duration for all patients was 52.83 months (0.03-125.70 months). Among them, 7 patients died after induced remission, and 13 patients experienced recurrence, with a median recurrence time of 24.0 months (4.3-37.2 months). The 5-year overall survival (OS) rate for all patients was 91.60%, and the 5-year event-free survival (EFS) rate was 87.90%. For high-risk and medium-low-risk patients, the 5-year OS rates were 81.1% and 95.5%, respectively (P<0.001), and the 5-year EFS rates were 75.67% and 92.48%, respectively (P<0.001). For elderly and young patients, the 5-year OS rates were 75.4% and 93.4%, respectively (P<0.001), and the 5-year EFS rates were 71.62% and 89.70%, respectively (P<0.001). After excluding patients with early death, the 5-year OS rate for the remaining 381 patients was 98.10%. The 5-year OS rates for the high-risk and medium-low-risk groups were 97.80% and 98.20%, respectively (P=0.791), and the 5-year OS rates for elderly and young patients were 90.91% and 98.80%, respectively (P=0.001).

  • In this study of 408 newly diagnosed APL patients, 119 developed critical illness, with a critical illness rate of 29.17% and an early mortality rate of 22.69%. Age ≥60years (P=0.017), D-dimer≥20ug/mL (P=0.045), hs-cTnT≥15pg/mL (P=0.032), NT-proBNP≥2000pg/mL (P=0.012), and WBC count peak (P<0.001) were identified as independent risk factors for severe APL.The predictive model, based on these five indicators, showed strong predictive ability with AUC values of 0.877 (95%CI 0.816-0.938) in the training group and 0.860 (95%CI 0.755-0.966) in the validation group. The calibration curves closely followed the standard curves in both groups, indicating good model fit. DCA curves demonstrated stable net benefits within a wide threshold range (0.08-0.91), providing reliable support for clinical decisions.

Conclusion: The early mortality rate in newly diagnosed APL patients was 6.62%. Risk factors for early death included age ≥60 years, WBC count ≥10×10^9/L, FDP ≥150 mg/L, DAH, and ICH. Risk factors for the development of critically ill newly diagnosed APL patients included age ≥60 years, D-dimer ≥20 µg/mL, hs-cTnT≥15 pg/mL, NT-proBNP≥2000 pg/mL, and peak WBC count. The clinical model for predicting critical APL, constructed based on these five indicators, showed high predictive value and could effectively identify critically ill patients.

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2025
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