Tag: statistics

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):698-705. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.011.

ABSTRACT

OBJECTIVE: To retrospectively analyze the clinical characteristics of 15 children with B-cell acute lymphoblastic leukemia (B-ALL) treated with blinatumomab, and summarize the efficacy and safety of blinatumomab in the treatment of pediatric B-ALL.

METHODS: Fifteen children who received treatment with blinatumomab from February 2022 to January 2023 were enrolled in this study. One course (28 days) of blinatumomab concurrent with intrathecal chemotherapy was given according to the standard regimen, except for 2 cases who had shortened course of treatment due to hematopoietic stem cell transplantation (HSCT) and did not receive combined intrathecal chemotherapy, and 1 case had a shortened course of treatment due to economic problems. The efficacy and safety of the treatment were evaluated.

RESULTS: In terms of efficacy, for the children who had achieved complete molecular remission (CMR) before treatment, blinatumomab treatment could effectively maintain CMR status; For the children who did not achieve CMR, the CMR rate after one standard course of treatment with blinatumomab reached 66.7%(4/6); For the children with relapsed/refractory ALL (R/R ALL) who had minimal residual disease (MRD), the MRD clearance rate reached 75.0%(3/4). The statistical results of the incidence of adverse events showed that 13.3%(2/15) of the children did not experience any adverse events. The most common adverse events were cytokine release syndrome (CRS) (73.3%, 11/15) and transaminase elevation (26.7%, 4/15); 33.3%(5/15) of the children experienced grade 3 or higher adverse events. All the adverse events were resolved after symptomatic treatment.The level of IgG decreased significantly after 4-7 weeks of treatment with blinatumomab, and gradually recovered after 8 weeks of treatment.

CONCLUSION: Blinatumomab can be used as a safe and effective treatment for inducing deep remission in pediatric R/R-ALL patients and as a bridge therapy for the pediatric ALL patients who are intolerant to chemotherapy.

PMID:40613158 | DOI:10.19746/j.cnki.issn.1009-2137.2025.03.011

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):691-697. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.010.

ABSTRACT

OBJECTIVE: To analyze the gene mutation characteristics and survival time of patients with newly diagnosed acute myeloid leukemia (AML) based on next-generation sequencing(NGS) gene detection.

METHODS: A retrospective analysis was conducted on the clinical data of 92 patients with AML (non APL) admitted to our hospital from January 2018 to May 2022. AML related genes tested were using NGS, the mutation characteristics and survival time of AML patients were analyzed.

RESULTS: Among the 92 patients, 41 were males and 51 were females. A total of 38 types of gene mutations were detected. Six-two patients carried at least one gere mutation, while no gene mutations were detected in 30 patients. In the group with favourable prognosis (n =14), the frequencies of higher gene mutations were NRAS, KIT (21.43%, n =3), KRAS (14.29%, n =2). In the group with intermediate prognosis (n =64), the gene mutation frequencies from high to low were DNMT3A (18.75%, n =12), NPM1 (17.19%, n =11), IDH2, FLT3-ITD, CEBPA (12.50%, n =8), TET2 (10.94%, n =7). In the poor prognosis group (n =14), ASXL1, TP53, EZH2, NRAS had higher gene mutation frequency than others(14.29 %, n =2 ). Statistical analysis revealed that KIT had a relative hotspot of mutations in the intermediate-risk group, and DNMT3A had a relative hotspot of mutations in the high-risk group (P < 0.05). The correlation analysis of genes with high mutation rates in different prognostic groups, such as NRAS, KIT, IDH2, DNMT3A, NPM1, and FLT3-ITD, with prognosis found that KIT was a factor affecting OS (P < 0.05), while no significant differences were observed for the others(P >0.05).

CONCLUSION: The frequency of gene mutations is high in AML patients, 67.4% of the patients carried at least one gene mutation. The mutation frequency varies among different genes in patients with different karyotypes, and there are obvious dominant mutations. KIT and DNMT3A can be used as factors for evaluating the prognosis of AML.

PMID:40613157 | DOI:10.19746/j.cnki.issn.1009-2137.2025.03.010

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):682-690. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.009.

ABSTRACT

OBJECTIVE: To retrospectively analyze the clinical characteristics, co-mutated genes in newly diagnosed acute myeloid leukemia (AML) patients with NRAS and KRAS gene mutations, and the impact of NRAS and KRAS mutations on prognosis.

METHODS: The clinical data and next-generation sequencing results of 80 newly diagnosed AML patients treated at our hospital from December 2018 to December 2023 were collected. The clinical characteristics, co-mutated genes of NRAS and KRAS , and the impact of NRAS and KRAS mutations on prognosis in newly diagnosed AML patients were analyzed.

RESULTS: Among 80 newly diagnosed AML patients, NRAS mutations were detected in 20 cases(25.0%), and KRAS mutations were detected in 9 cases(11.3%). NRAS mutations predominantly occurred at codons 12 and 13 of exon 2, as well as codon 61 of exon 3, while KRAS mutations were most commonly occurred at codons 12 and 13 of exon 2, all of which were missense mutations. There were no statistically significant differences observed in terms of age, sex, white blood cell count(WBC), hemoglobin(Hb), platelet count(PLT), bone marrow blasts, first induction chemotherapy regimen, CR1/CRi1 rates, chromosome karyotype, 2022 ELN risk classification and allogeneic hematopoietic stem cell transplantation(allo-HSCT) among the NRAS mutation group, KRAS mutation group and NRAS/KRAS wild-type group (P >0.05). KRAS mutations were significantly correlated with PTPN11 mutations (r =0.344), whereas no genes significantly associated with NRAS mutations were found. Survival analysis showed that compared to the NRAS/KRAS wild-type group, patients with NRAS mutation had a relatively higher 5-year overall survival (OS) rate and relapse-free survival (RFS) rate, though the differences were not statistically significant (P =0.097, P =0.249). Compared to the NRAS/KRAS wild-type group, patients with KRAS mutation had a lower 5-year OS rate and RFS rate, with no significant differences observed (P =0.275, P =0.442). There was no significant difference in the 5-year RFS rate between the KRAS mutation group and NRAS mutation group (P =0.157), but the 5-year OS rate of patients with KRAS mutation was significantly lower than that of patients with NRAS mutation (P =0.037).

CONCLUSION: In newly diagnosed AML patients, KRAS mutation was significantly correlated with PTPN11 mutation. Compared to patients with NRAS/KRAS wild-type, those with NRAS mutation showed a more favorable prognosis, while patients with KRAS mutation showed a poorer prognosis; however, these differences did not reach statistical significance. Notably, the prognosis of AML patients with KRAS mutation was significantly inferior compared to those with NRAS mutation.

PMID:40613156 | DOI:10.19746/j.cnki.issn.1009-2137.2025.03.009

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):672-681. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.008.

ABSTRACT

OBJECTIVE: To retrospectively analyze the clinical data of newly diagnosed acute myeloid leukemia (AML) patients treated with venetoclax combined with azacitidine (Ven/Aza) or standard “3+7” regimen and similar regimens, collect real-world study data, compare the treatment response and adverse events between the two regimens, as well as perform survival analysis.

METHODS: To retrospectively analyze the efficacy, survival, and adverse reactions of newly diagnosed AML patients treated with Ven/Aza (24 cases) and “3+7” regimens (117 cases ) in our hospital from September 2009 to March 2023, as well as factors influencing outcomes. A propensity score matching (PSM) was performed on age and Eastern Cooperative Oncology Group performance status (ECOG PS) to obtain a 1:1 matched cohort of 20 pairs, and the efficacy and survival before and after the matching were compared.

RESULTS: The median age of patients in the Ven/Aza group was 69 years, while that in the “3+7” group was 56 years (P <0.001). Objective remission rate (ORR) was 62.5% in Ven/Aza group and 74.8% in “3+7” group (P >0.05). The median overall survival (OS) in the Ven/Aza group was 522 days, while that in the “3+7” group was 1 002 days (P >0.05). After controlling the two variables of age and ECOG PS, a PSM cohort of 20 pairs was obtained, in which the ORR was 65% in Ven/Aza group and 60% in “3+7” group (P >0.05). The median OS was 522 days and 629 days, and median progression-free survival (PFS) was 531 days and 198 days between the two groups, respectively. There were no statistically significant differences in OS and PFS between the two groups (both P >0.05). Additionally, the incidence of adverse events in the Ven/Aza group was significantly reduced.

CONCLUSION: The overall cohort shows that the “3+7” regimen has advantages in efficacy and survival, but Ven/Aza regimen is relatively safer. After performing PSM on age and ECOG PS, the Ven/Aza group showed improved efficacy, and a longer median PFS compared to “3+7” group.

PMID:40613155 | DOI:10.19746/j.cnki.issn.1009-2137.2025.03.008

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2025 Jun;33(3):660-665. doi: 10.19746/j.cnki.issn.1009-2137.2025.03.006.

ABSTRACT

OBJECTIVE: To investigate the short-term efficacy and safety of low-dose venetoclax combined with CHG (cytarabine+homoharringtonine+G-CSF) priming regimen in patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy.

METHODS: The data of 14 patients with AML or high-risk MDS admitted to the department of hematology/oncology of the First Hospital of Tsinghua University and 2 cooperative institutions from July 2022 to August 2023 were retrospectively analyzed. All the patients were treated with low-dose venetoclax combined with CHG priming regimen and the early induction (one course) efficacy and adverse reactions were observed.

RESULTS: Among the 14 patients, 10 were males and 4 were females, with a median age of 69.5 (46-83) years. After 1 cycle of induction chemotherapy, the complete remission (CR) rate was 64.3% (9/14) and overall response rate (ORR) was 78.6% (11/14). Among the 10 patients with adverse prognosis according to cytogenetics and molecular genetics, the CR rate was 50.0% (5/10), and ORR was 70.0% (7/10). In 7 patients with TP53 mutation, the CR rate was 42.9% (3/7) and ORR was 71.4% (5/7). In the 6 patients with complex karyotype, CR rate was 33.3% (2/6) and ORR was 66.7% (4/6). While the CR rate and ORR of 8 non-complex karyotype patients were both 87.5% (7/8), and the difference in CR rate between patients with complex karyotype and non-complex karyotype was statistically significant ( P < 0.05). The adverse reactions of chemotherapy were tolerable, without early treatment-related deaths.

CONCLUSION: Low-dose venetoclax combined with CHG priming regimen can be used as an effective treatment for AML and high-risk MDS patients who are ineligible for intensive chemotherapy, and it is safe and worthy of clinical application.

PMID:40613153 | DOI:10.19746/j.cnki.issn.1009-2137.2025.03.006

J Gynecol Oncol. 2025 Jun 21. doi: 10.3802/jgo.2026.37.e2. Online ahead of print.

ABSTRACT

OBJECTIVE: Cervical cancer (CCa) significantly affects female fertility and quality of life. This study aimed to construct and validate a random survival forest (RSF) model to identify the factors that affect the overall survival (OS) in patients with CCa in China and compare its performance with that of the Cox proportional hazards model (Cox model).

METHODS: Data on CCa patients were collected from Chongqing University Cancer Hospital. The performance and discrimination ability of the models were evaluated via the C-index, integrated Brier score (IBS), accuracy, sensitivity, specificity, and area under the receiver operating characteristic curve (AUC). The Kaplan-Meier (K-M) survival curve was used to analyze the difference in OS between patients with high and low risk predicted by RSF model.

RESULTS: A total of 3,982 patients were included in this study. Comparing to Cox model, the RSF model ranked important variables and identified radiotherapy (RT) as an important treatment measure. A comprehensive analysis of the evaluation indices confirmed that the RSF model outperformed the Cox model (IBS: 0.152 vs. 0.162, C-index: 0.863 vs. 0.764). The RSF model metrics for the validation cohort (VC) were as follows: 1-, 3-, and 5-year AUC (0.908, 0.884, and 0.869), sensitivity (0.746), specificity (0.825), and accuracy (0.808). The OS of low-risk patients predicted by RSF was greater than that of high-risk patients.

CONCLUSION: The RSF model demonstrated excellent discrimination, calibrated predictions, and stratified risk for CCa patients. Furthermore, it outperformed the Cox model in predicting risks, thus enabling the delivery of personalised treatment and follow-up strategies.

PMID:40613112 | DOI:10.3802/jgo.2026.37.e2

Clin Chem Lab Med. 2025 Jul 7. doi: 10.1515/cclm-2025-0539. Online ahead of print.

ABSTRACT

OBJECTIVES: Frequent blood sampling in vulnerable patient groups, such as prematurely born infants, can lead to significant blood loss and increased transfusion needs. Current pre-analytical technology requires comparably large blood volumes and leads to discarding of cells. This study investigates a device prototype enabling in-line sampling where cell-reduced plasma for clinical chemistry analyses is generated through acoustophoresis.

METHODS: Blood samples were collected from healthy adult donors in lithium-heparin tubes without gel. Plasma separated via acoustophoresis was compared with centrifuged plasma (2000 g × 10 min) for cell counts (n=14), cell-free hemoglobin (n=21), and 12 routine clinical chemistry analyte tests (n=21). Wilcoxon signed-rank tests and Bland Altman analysis were used for statistical comparison.

RESULTS: Both acoustophoresis (AF) and centrifugation (CEN) generated cell-reduced plasma with<0.01 % of cells remaining after separation. However, compared to CEN plasma, more cells (median count per μL 642 vs. 205, p<0.01) and platelets (median count per μL 20,477 vs. 1,537, p<0.0001) remained in AF plasma. Cell-free hemoglobin (fHb) in AF plasma samples (range 0.0-0.2 g/L) was lower (p<0.01) than in CEN plasma samples (range 0.1-0.3 g/L). Statistically significant relative mean differences in test results ranging from 0.84 % (95 % CI 0.48-1.19) for sodium to 10.50 % (95 % CI 5.02-15.99) for AST were found.

CONCLUSIONS: This proof-of-concept study demonstrates that acoustophoresis has the potential to produce sufficiently cell-free plasma for several commonly performed clinical chemistry analyses. Further studies should assess pathological samples, platelet activation, and improve the design for more efficient removal of platelets.

PMID:40613108 | DOI:10.1515/cclm-2025-0539

J Health Popul Nutr. 2025 Jul 3;44(1):232. doi: 10.1186/s41043-025-00876-5.

ABSTRACT

BACKGROUND: Uganda experiences high maternal mortality ratios, with suboptimal utilization of maternal health services like antenatal care (ANC), especially in rural areas. Community Health Workers (CHWs), known as Village Health Teams (VHTs), have shown the potential to enhance maternal and child health (MCH) outcomes in Uganda by educating pregnant women in the community. However, their training models need to be refined to boost their performance.

OBJECTIVE: We evaluated the effectiveness of a contextually tailored educational intervention delivered by VHTs on the knowledge, attitudes, and antenatal care attendance of pregnant women in Eastern Uganda.

METHODS: We performed a quasi-experimental study using a pre-post-intervention evaluation conducted over six months in Eastern Uganda. We included pregnant women in their first trimester who consented to participate and excluded those in later trimesters. We performed multistage sampling with villages randomly selected and participants enrolled by trained VHTs. The VHTs were trained using a Maternal Newborn Child Health curriculum developed by a multidisciplinary team of healthcare professionals. The VHTs delivered educational sessions to the participants during home visits throughout their pregnancy. Data was collected on pregnant women’s knowledge, attitudes, and antenatal care attendance before and after the intervention. A score of ≥ 75% was considered sufficient knowledge. The Chi-square test was used to test the difference in the proportional change in knowledge and attitude of pregnant women. A paired two-sample t-test assessed changes in ANC attendance pre- and post-intervention. A p < 0.05 was considered statistically significant.

RESULTS: 228 participants were included, with a mean age of 27 ± 5.90 years and gravidity of 2.92 ± 1.47. There was a 60.7% increase in the proportion of participants with sufficient MCH knowledge after the intervention (19.6-80.3%, p < 0.001). Attitudes toward healthy MCH behaviors also improved. The proportion agreeing that attending eight or more ANC visits is crucial increased by 10.6% (88.1-98.7%, p < 0.001). Recognition of health facilities as the best place for ANC increased by 9.7% (89.9-99.6%, p < 0.001). The average number of ANC visits significantly increased from 1.22 to 6.38 (p < 0.001).

CONCLUSION: Contextually tailored education delivered by trained VHTs significantly improved maternal health knowledge, attitudes, and ANC attendance among pregnant women in rural Uganda.

PMID:40611361 | DOI:10.1186/s41043-025-00876-5

J Health Popul Nutr. 2025 Jul 3;44(1):226. doi: 10.1186/s41043-025-00977-1.

ABSTRACT

Exclusive breastfeeding (EBF) can significantly reduce infant morbidity and mortality. However, evidence suggests that most health professionals fail to practice EBF. This research assessed factors that affect the practice of EBF among 320 randomly selected nursing mothers who are nurses and midwives in major hospitals. A cross-sectional study in four public hospitals in Tamale Metropolis, Ghana, involved 320 female nurses and midwives. Data was collected through a pretested questionnaire, and STATA version 17 was used for statistical analysis. Predictors of EBF were discovered using binary logistic regression models with statistical significance set at p < 0.05. A slight majority (53.1%) of the nurses and midwives reported practising EBF. Notably, over half (52.5%) of the participants demonstrated poor knowledge regarding EBF, despite a strong positive attitude towards it (81.6%). In conclusion, while the attitude towards EBF is generally positive among participants, there are significant gaps in knowledge. Determinants of the practice of EBF were income, living arrangement, parity, child’s age, complications after delivery, and knowledge level. The Ghana Health Service should mandate enhanced EBF training for nurses and midwives and this training should cover practical skills, address knowledge gaps, and be regularly updated and continuous professional development credits could be tied to successful completion.

PMID:40611359 | DOI:10.1186/s41043-025-00977-1

Cardiooncology. 2025 Jul 3;11(1):63. doi: 10.1186/s40959-025-00358-x.

ABSTRACT

Cardiovascular adverse events (CVAE) are clinically relevant side effects during treatment with the proteasome inhibitor carfilzomib. We investigated the predictive value of cardiac biomarkers for onset of CVAE in patients with newly diagnosed high-risk multiple myeloma treated with isatuximab, carfilzomib, lenalidomide, and dexamethasone in the GMMG-CONCEPT study (NCT03104842). Patients included in this prospective, multicenter correlative study were eligible if a serum sample before treatment initiation and at ≥ 1 later study time point were available. N-terminal pro-b-type natriuretic peptide (NT-proBNP) and high-sensitive Troponin I (hsTropI) were measured using immunoassays. Time-to-event analyses were performed using Kaplan-Meier estimators and log-rank test was used for statistical analysis. Among 126 patients included in this study, 40 reported incident CVAE. No significant differences were observed for age, sex, cardiovascular risk factors and cardiovascular comorbidities between patients who experienced CVAE compared to patients without CVAE. NT-proBNP levels were elevated at baseline in 96 (76%) patients. Neither baseline levels nor change in NT-proBNP level during early induction cycles were predictive for the occurrence of CVAE. In contrast, elevation of hsTropI above the 99th percentile was rare. Patients with hsTropI level ≥ 2.9 ng/L, corresponding to the lower limit of quantification, showed a higher risk for CVAE compared to patients with hsTropI < 2.9 ng/L at baseline (p = 0.0023). In conclusion, in patients with newly diagnosed high-risk multiple myeloma undergoing carfilzomib-based quadruplet treatment, low hsTropI pretreatment levels are of high negative predictive value for the occurrence of CVAE whereas elevated NT-proBNP levels are very common before treatment initiation.

PMID:40611354 | DOI:10.1186/s40959-025-00358-x