To investigate the risk factors for acute kidney injury (AKI) following the use of amphotericin B deoxycholate and to develop a predictive model to guide clinical monitoring and intervention.

A retrospective analysis was conducted on hospitalized patients who received amphotericin B deoxycholate between January 2014 and September 2024. Patients were divided into a training set and a validation set. Demographic data, laboratory findings, and medication orders were collected. Based on the occurrence of AKI during treatment and within 7 days after discontinuation, patients were classified into an AKI group and a non-AKI group. Univariate analysis was used to screen for potential risk factors, multivariate logistic regression was employed to construct a predictive model, and model performance was evaluated using the area under the receiver operating characteristic curve (AUC) and the Hosmer-Lemeshow test.

The training set included 473 patients, comprising 255 males (53.91%) and 218 females (46.09%), with a median age of 52(35, 62) years. The AKI group consisted of 191 cases (40.38%), and the non-AKI group consisted of 282 cases (59.62%). The validation set included 114 patients, comprising 80 males (70.18%) and 34 females (29.82%), with a median age of 43.5 (31.0, 58.5) years. The AKI group consisted of 42 cases (36.84%), and the non-AKI group consisted of 72 cases (63.16%). Univariate analysis revealed statistically significant differences between the two groups in 23 factors (all P < 0.05), including demographic data (age, admission to intensive care unit (ICU), death, length of hospital stay), laboratory findings (serum creatinine above normal, urea above normal, neutrophil percentage below normal, neutrophil percentage above normal, lymphocyte percentage below normal, serum sodium above normal), concomitant medications (nonsteroidal anti-inflammatory drugs (NSAIDs), antifungal agents, neurological drugs, adrenergic drugs, sodium bicarbonate tablets/injection, diphenhydramine/promethazine injection, NSAIDs⁺ diphenhydramine/promethazine, NSAIDs⁺ corticosteroids, diphenhydramine/promethazine+corticosteroids, NSAIDs⁺ diphenhydramine/prome-thazine+corticosteroids), and comorbidities (diabetes mellitus, kidney disease, cardiac insufficiency)(all P < 0.05). Multivariate analysis identified admission to the ICU (OR=2.128, 95% CI: 1.415-3.201), elevated serum creatinine at admission (OR=1.920, 95% CI: 1.235-2.985), and comorbid cardiac insufficiency (OR=3.394, 95% CI: 1.369-8.417) as risk factors, while prophylactic use of diphenhydramine/promethazine injection (OR=0.182, 95% CI: 0.083-0.399) or sodium bicarbonate tablets/injection (OR=0.512, 95% CI: 0.339-0.773) were protective factors.The prediction model equation is as follows. logit(P)=ln[P/(1-P)]= -0.479+0.755X₁+0.652X₂+1.222X₃-1.702X₄-0.67X₅ (X₁ admitted to the intensive care unit, X₂ admitted to the hospital with higher serum creatinine than the normal value, X₃ complicated with cardiac insufficiency, X₄ combined with diphenhydramine/promethazine injection, X₅ was combined with sodium bicarbonate tablets/injection, X was taken as "1" or "0" according to whether the conditions were met). The AUC of the model was 0.735 (95% CI: 0.691-0.780) in the training set and 0.699 (95% CI: 0.604-0.795) in the validation set. The Hosmer-Lemeshow test yielded a χ² value of 4.048 (P=0.774), indicating good model calibration.

Admission to the ICU, elevated serum creatinine at admission, and comorbid cardiac insufficiency as potential risk factors for AKI, while prophylactic use of diphenhydramine/promethazine or sodium bicarbonate showed a protective association. A predictive model with good discrimina-tion and calibration was developed, which may provide a basis for early identification of high-risk patients and timely adjustment of treatment strategies in clinical practice.

To evaluate the clinical safety of four CD19-targeted and two BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapies.

Adverse drug reaction (ADR) reports for six CAR-T products (Breyanzi, Kymriah, Tecartus, Yescarta, Abecma, Carvykti) from the US FDA Adverse Event Reporting System (FAERS) database between January 2004 and March 2025 were retrieved. The basic characteristics of the reports were analyzed. ADRs were categorized by System Organ Class (SOC) and coded into corresponding preferred term(PT) using MedDRA (Version 27.1). The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to detect association signals between the six drugs and the PT.

A total of 54 833 ADR reports were included in this study: Breyanzi (1511, 2.76%), Kymriah (18 087, 32.99%), Tecartus (4408, 8.04%), Yescarta (23 937, 43.65%), Abecma (2762, 5.04%), and Carvykti (4128, 7.53%). These reports corresponded to 15 210 unique patients, comprising 7136 males (46.92%), 4483 females (29.47%), and 3591 (23.61%) with missing gender information. Regarding age distribution, all patients in the Abecma and Carvykti groups were ≥18 years old, while 22.52% of patients in the Kymriah group were < 18 years old. The proportion of male patients was higher than that of females across all six drug groups. The top seven ADRs by report count were, in order: various nervous system disorders; immune system disorders; general disorders and administration site conditions; various investigations; infections and infestations; various neoplasms; and blood and lymphatic system disorders. The top ten PTs by report count included cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), pyrexia, neurotoxicity, death, hypotension, disease progression, fatigue, platelet count decreased, and malignant neoplasm progression. Among the six CAR-T therapies, the BCMA-targeted Abecma showed the strongest association with CRS [ROR 2412.12(95% CI: 2093.06-2779.83), PRR 891.75(χ²=449 083.34)]. The CD19-targeted Tecartus showed the strongest association with ICANS [ROR 2604.50 (95% CI: 2317.29-2927.30), PRR 1775.36 (χ²=705 195.47)] and neurotoxicity [ROR 762.84(95% CI: 685.77-848.56), PRR 439.88 (χ²=254 246.08)].All drugs except Tecartus were associated with decreased platelet count. Furthermore, both Breyanzi and Kymriah were associated with malignant neoplasm progression.

Clinicians should implement rigorous safety monitoring for patients receiving CAR-T therapy, paying particular attention to the early symptoms of CRS and neurotoxicity, and enhance surveillance for malignant neoplasm progression.

To design a safety management system for antitumor drugs, which can intercept or warn the overdose of medical orders from the prescription source, and ensure the safety of clinical application of antitumor drugs.

The threshold of interception and warning strategy of 88 kinds of antitumor drugs were developed, and the safety management system of antitumor drugs was established to intercept or warn the overdose orders. The interception and warning data from January 2021 to June 2021 in the safety management system of antitumor drugs were extracted and analyzed.

A total of 665 medical orders were intercepted or warned by the safety management system of antitumor drugs, and the majority of the intercepted or warned drugs were oral tablets(74.29%). The intercepted orders were 642 (96.54%), and the warned orders were 23(3.46%). Among the intercepted medical orders, frequency error (64.22%) has the highest proportion, followed by route error (11.73%) and dose error (9.92%). A total of 564 medical orders were intercepted, involving 28 kinds of antitumor drugs. Methotrexate tablets ranked first in overdose quantity, with an average of seven times. Pemetrexed ranked first in overdose multiples, with an average overdose of 1000 times. 78 medical orders were intercepted for over pathway, involving 5 kinds of antitumor drugs.

The safety management system of antitumor drugs can eliminate the error of overdose in prescription and guarantee the safety of antitumor drugs.