Objective: To assess the efficacy and safety of polymyxin B in neutropenic patients with hematologic disorders who had refractory gram-negative bacterial bloodstream infection. Methods: From August 2021 to July 2022, we retrospectively analyzed neutropenic patients with refractory gram-negative bacterial bloodstream infection who were treated with polymyxin B in the Department of Hematology of the First Affiliated Hospital of the Soochow University between August 2021 to July 2022. The cumulative response rate was then computed. Results: The study included 27 neutropenic patients with refractory gram-negative bacterial bloodstream infections. Polymyxin B therapy was effective in 22 of 27 patients. The median time between the onset of fever and the delivery of polymyxin B was 3 days [interquartile range (IQR) : 2-5]. The median duration of polymyxin B treatment was 7 days (IQR: 5-11). Polymyxin B therapy had a median antipyretic time of 37 h (IQR: 32-70). The incidence of acute renal dysfunction was 14.8% (four out of 27 cases), all classified as "injury" according to RIFLE criteria. The incidence of hyperpigmentation was 59.3%. Conclusion: Polymyxin B is a viable treatment option for granulocytopenia patients with refractory gram-negative bacterial bloodstream infections.目的： 观察多黏菌素B治疗粒细胞缺乏（粒缺）伴难治性革兰阴性菌血流感染的疗效和安全性。 方法： 回顾性分析2021年8月至2022年7月在苏州大学附属第一医院血液科收治的粒缺伴难治性革兰阴性菌血流感染的病例，观察多黏菌素B治疗的疗效与安全性。 结果： 共纳入27例粒缺伴难治性革兰阴性菌血流感染的血液病患者，其中22例多黏菌素B治疗有效，首次发热至给予多黏菌素B的中位间隔为3（2，5）d；多黏菌素B的中位用药时间为7（5，11）d，中位退热时间为37（32，70）h。其中4例发生急性肾功能损伤，占14.8%，根据RIFLE标准，均为"损伤（Injury）"级别；色素沉着发生率为59.3%。 结论： 多黏菌素B治疗粒缺伴难治性革兰阴性菌血流感染具有较好的疗效和安全性。. 

[Efficacy and safefy of Polymyxin B treatment for neutropenic patients suffering from refractory Gram-negative bacterial bloodstream infection].

Background Carbapenem-resistant Gram-negative organism (CRO) infection is a critical clinical disease with high mortality rates. The 30-day mortality rate following antibiotic treatment serves as a benchmark for assessing the quality of care. Colistin sulfate is currently considered the last resort therapy against infections caused by CRO. Nevertheless, there is a scarcity of reliable tools for personalized prognosis of CRO infections. This study aimed to develop and validate a nomogram to predict the 30-day all-cause mortality in patients with CRO infection who underwent colistin sulfate treatment. Methods A prediction model was developed and preliminarily validated using CRO-infected patients treated with colistin sulfate at Tongji Hospital in Wuhan, China, who were hospitalized between May 2018 and May 2023, forming the study cohort. Patients admitted to Xianning Central Hospital in Xianning, China, between May 2018 and May 2023 were considered for external validation. Multivariate logistic regression was performed to identify independent predictors and establish a nomogram to predict the occurrence of 30-day all-cause mortality. The receiver operating characteristic (ROC) curve, the area under the ROC curve (AUC), and the calibration curve were used to evaluate model performance. The decision curve analysis (DCA) was used to assess the model clinical utility. Results A total of 170 patients in the study cohort and 65 patients in the external validation cohort were included. Factors such as age, duration of combination therapy, nasogastric tube placement, history of previous surgery, presence of polymicrobial infections, and occurrence of septic shock were independently associated with 30-day all-cause mortality and were used to construct the nomogram. The AUC of the nomogram constructed from the above six factors was 0.888 in the training set. The Hosmer-Lemeshow test showed that the model was a good fit ( p = 0.944). The calibration curve of the nomogram was close to the ideal diagonal line. Furthermore, the decision curve analysis demonstrated significantly better net benefit in the model. The external validation proved the reliability of the prediction nomogram. Conclusion A nomogram was developed and validated to predict the occurrence of 30-day all-cause mortality in patients with CRO infection treated with colistin sulfate. This nomogram offers healthcare providers a precise and efficient means for early prediction, treatment management, and patient notification in cases of CRO infection treated with colistin sulfate. 

Development and validation of a prognostic nomogram to predict 30-day all-cause mortality in patients with CRO infection treated with colistin sulfate

Abstract Background Mitoxantrone hydrochloride liposome (Lipo-MIT) exhibits encouraging efficacy in treating multiple hematologic malignancies. This study evaluated the real-world efficacy and safety of Lipo-MIT-containing regimens in the treatment of acute myeloid leukemia (AML). Methods This noninterventional, ambispective cohort study was conducted at 42 centers in China. Patients with newly diagnosed or relapsed/refractory AML who received Lipo-MIT-containing regimens were included. The primary endpoint was the composite complete remission (CRc) rate. Results Between January 2022 and December 2023, 117 patients with newly diagnosed AML and 122 patients with relapsed/refractory AML were included. The CRc and objective response rates were 84.6% (95% confidence interval [CI], 76.8-90.6) and 91.5% (95% CI, 84.8-95.8), respectively, in the newly diagnosed AML, and 45.1% (95% CI, 36.1-54.3) and 55.7% (95% CI, 46.5-64.7), respectively, in relapsed/refractory AML. The 2-year-event-free survival and overall survival rates for newly diagnosed AML were 67.0% (95% CI, 54.4-76.8) and 77.8% (95% CI, 63.8-86.9), respectively, while the rates for relapsed/refractory AML were 23.9% (95% CI, 12.5-37.3) and 56.9% (95% CI, 39.6-70.9), respectively. Univariate and multivariate analyses suggested age and the number of prior failed induction therapy cycles as independent prognostic factors for CRc in relapsed/refractory AML (all P &amp;lt; .05). Treatment-related adverse events (AEs) were reported in 216 patients (90.4%). Thrombocytopenia (64.4%), leukopenia (63.6%), and neutropenia (60.7%) were the most common AEs of grade 3-4. No treatment-related deaths occurred. Conclusions Lipo-MIT-containing regimens were effective and well-tolerated in AML under real-world circumstances. Trial Registration ID ChiCTR2200067172 

Real-world effectiveness of mitoxantrone hydrochloride liposome containing regimens in acute myeloid leukemia

Purpose Gram-negative bloodstream infection (GNBI) poses a serious threat to critically ill patients. This retrospective study aimed to uncover drug resistance of pathogens and the GNBI effect on in-hospital death and distinguish death risk factors in a medical intensive care unit (ICU). Patients and Methods A retrospective study of all GNBI patients in the medical ICU of the Third Xiangya Hospital over 9 nine years was conducted. Blood samples were performed by a BACTEC 9240 system, MALDI-TOF MS, Bruker and Vitek-2 system. Logistic regression was used for analyzing risk factors for death. Results Seventy-five episodes of GNBI developed in 68 (1.4%) out of 4954 patients over a span of 9 years. The most frequently isolated bacterium was Klebsiella pneumoniae, with the lungs as the predominant source of GNBI. The resistance rate of Gram-negative bacteria to polymyxin B was 11.6% after excluding those intrinsically resistant non-fermentative bacteria. All Enterobacter spp. were susceptible to ceftazidime/avibactam. Thirty-three (48.5%) patients underwent inappropriate empirical antibiotic treatment and 48 (70.6%) patients died during the hospitalization. Multivariate logistic regression analysis identified that lymphocyte count at GNBI onset ≤0.5×109/L, invasive mechanical ventilation, and septic shock were related to in-hospital death. Body mass index ≥23 and appropriate empirical antibiotic use after GNBI were negatively associated with in-hospital death. Conclusion GNBI was a frequent complication among patients in the medical ICU. This study underscored the presence of diverse factors that either heightened or attenuated the risk of in-hospital death.

Gram-Negative Bloodstream Infections in a Medical Intensive Care Unit: Epidemiology, Antibiotic Susceptibilities, and Risk Factors for in-Hospital Death

Background Genetic neurodevelopmental disorders (g-NDDs), a complex group of idiopathic syndromes with a heterogeneous genetic etiology, are defined as global developmental delay/intellectual disability (GDD/ID) with other common neurodevelopmental comorbidity (NDC), such as autism spectrum disorder (ASD). Although significant progress has been made in trio-based whole-exome sequencing (trio-WES) that enable the detection of exon-level variants, the diagnostic efficacy of using trio-WES for g-NDDs is still not satisfactory. Therefore, exploring key phenotypic variables for forecasting the diagnostic probability of trio-WES is extremely necessary to implement personalized diagnosis for children with g-NDDs. Methods A total of 265 g-NDDs children who received trio-WES at Sun Yat-sen Memorial Hospital between Sep 2016 and Dec 2022 were enrolled and clustered temporally into training and internal validation sets [163 cases (Oct 2016 ~ Dec 2022) and 102 cases (Sep 2016 ~ Sep 2018), respectively]. A total of 97 g-NDDs children who underwent trio-WES at Weierkang Children’s Rehabilitation Center between Jan 2023 and Dec 2023 were enrolled and served as an independent external validation set. Univariate and multivariate logistic regression were conducted in the training set to screen out independent diagnosis-related phenotypic signifiers and establish an alignment diagram model. The model was further validated in internal and external validation sets. Results Through univariate and multivariate analyses, independent diagnosis-related predictive signifiers, including GDD/ID severity, NDC complexity, ASD, and head circumference abnormality, were identified in the training cohort and used to construct a model. The model showed good discrimination power with an area under the ROC curves (AUC) in the training set of 0.821 (95% CI: 0.756–0.886), yielding a F1 score of 0.76. The model also showed powerful prediction in both the internal (AUC: 0.905 with 95% CI: 0.842–0.968 and F1 score: 0.77) and external validation sets (AUC: 0.919 with 95% CI: 0.858–0.979 and F1 score: 0.79). Conclusion We found the potential linear relationship between trio-WES-diagnostic rates and the phenotypic enrichments in g-NDDs patients for the first time, indicating the possibility of applying a logistic regression model based on phenotypic features to predict the personalized diagnostic rates of using trio-WES in children with g-NDDs. 

pdf/establishment-and-validation-of-a-phenotype-driven-fkkz89o0eb4v.pdf

Establishment and validation of a phenotype-driven predictive model for the diagnostic efficacy of trio-based whole exome sequencing (trio-WES) in children with genetic neurodevelopmental disorders (g-NDDs)

7039 Background: Acute myeloid leukemia (AML) is highly heterogeneous, and more than half of patients (pts) will experience refractory or relapse, with poor prognosis. Currently, chemotherapy and hematopoietic stem cell transplantation (HSCT) are the main treatments for AML. Mitoxantrone is a synthetic anthracenedione anti-cancer drug that is effective in lymphoma, leukemia, and other solid tumors. Mitoxantrone hydrochloride liposome (PLM60) is the first approved mitoxantrone nano-drug, which has shown favorable pharmacokinetic characteristics and significantly prolong the survival time of animals compared with the same dose of mitoxantrone (Li 2008). However, there is still a lack of systematic reports about the real-world application of PLM60 in AML. Methods: We performed a multicenter retrospective analysis of 82 pts with newly diagnosed AML and relapsed/refractory (R/R) AML, who received at least one cycle of PLM60 regimen between January 2022 and November 2022. Pts aged 18 years and above with confirmed diagnosis of AML according to the 2016-revised WHO criteria were eligible for inclusion, except acute promyelocytic leukemia (APL). The median dose of PLM60 in the regimen was 20.0 (range 10.3–31.6) mg/m2. Efficacy was assessed by composite complete remission (CRc) rate and overall response rate (ORR), and logistic regression analysis was performed to analyze factors affecting the curative effect. Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results: 82 pts were enrolled with a median age of 50.5 (range 20-83) years. There were 71 cases of de novo AML and 11 cases of secondary AML. Targeted sequencing was performed on 86.6% of pts (71/82). FLT3 was the most commonly mutated gene found in 22.5% (16/71), followed by ASXL1 mutated in 12.7%, NPM1 in 11.3%, and TP53 in 11.3%. 4.9% (4/82) of pts underwent HSCT. Among the 25 newly diagnosed pts, CRc rate was 72.0% (18/25) and ORR was 92.0% (23/25). Among the 57 R/R pts, CRc rate was 24.6% (14/57) and ORR was 40.4% (23/57). The courses of induction failure ( OR= 16.617, P= 0.026), and the duration of the first complete remission (CR1) ( OR= 20.647, P= 0.007) were independent influencing factors of the efficacy. Common grade 3/4 AEs included decreased neutrophil count (84.1%), thrombocytopenia (76.8%), anemia (73.2%), febrile neutropenia (47.6%), pulmonary infection (11.0%) and upper respiratory tract infection (2.4%). The overall safety was acceptable and controllable. Conclusions: The PLM60 regimen had an encouraging efficacy and showed a manageable safety profile with the most adverse events being hematologic toxicities.

Analysis of short-term efficacy and safety of mitoxantrone hydrochloride liposome regimen therapy in adult acute myeloid leukemia.

Objectives Gram-negative bacteria (GNB) bloodstream infections (BSIs) are the most widespread and serious complications in hospitalized patients with hematological diseases. The emergence and prevalence of carbapenem-resistant (CR) pathogens has developed into a considerable challenge in clinical practice. Currently, nomograms have been extensively applied in the field of medicine to facilitate clinical diagnosis and treatment. The purpose of this study was to explore risk indicators predicting mortality and carbapenem resistance in hematological (HM) patients with GNB BSI and to construct two nomograms to achieve personalized prediction. Methods A single-center retrospective case-control study enrolled 244 hospitalized HM patients with GNB-BSI from January 2015 to December 2019. The least absolute shrinkage and selection operator (LASSO) regression analysis and multivariate logistic regression analysis were conducted to select potential characteristic predictors of plotting nomograms. Subsequently, to evaluate the prediction performance of the models, the prediction models were internally validated using the bootstrap approach (resampling = 1000) and 10-fold cross validation. Results Of all 244 eligible patients with BSI attributed to GNB in this study, 77 (31.6%) were resistant to carbapenems. The rate of carbapenem resistance exhibited a growing tendency year by year, from 20.4% in 2015 to 42.6% in 2019 (p = 0.004). The carbapenem resistance nomogram constructed with the parameters of hypoproteinemia, duration of neutropenia ≥ 6 days, previous exposure to carbapenems, and previous exposure to cephalosporin/β-lactamase inhibitors indicated a favorable discrimination ability with a modified concordance index (C-index) of 0.788 and 0.781 in both the bootstrapping and 10-fold cross validation procedures. The 28-day all-cause mortality was 28.3% (68/240). The prognosis nomogram plotted with the variables of hypoproteinemia, septic shock, isolation of CR-GNB, and the incomplete remission status of underlying diseases showed a superior discriminative ability of poorer clinical prognosis. The modified C-index of the prognosis nomogram was 0.873 with bootstrapping and 0.887 with 10-fold cross validation. The decision curve analysis (DCA) for two nomogram models both demonstrated better clinical practicality. Conclusions For clinicians, nomogram models were effective individualized risk prediction tools to facilitate the early identification of HM patients with GNB BSI at high risk of mortality and carbapenem resistance.

/pdf/development-and-validation-of-nomograms-for-predicting-the-2tk8prje.pdf

Development and validation of nomograms for predicting the risk probability of carbapenem resistance and 28-day all-cause mortality in gram-negative bacteremia among patients with hematological diseases

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Analysis of short-term efficacy and safety of mitoxantrone hydrochloride liposome regimen therapy in adult acute myeloid leukemia.

Development and validation of nomograms for predicting the risk probability of carbapenem resistance and 28-day all-cause mortality in gram-negative bacteremia among patients with hematological diseases