Latest ArticlesTo investigate the relationship between intravenous polymyxin B (PMB) exposure and clinical outcome in septic patients, and to explore the pharmacokinetic target.
This single-center observational study enrolled septic patients who received PMB therapy between July 2021 and July 2025. Primary outcome was the clinical success rate. Secondary outcomes included 28-day all-cause mortality, 90-day survival time, bacterial clearance, 28-day ventilator/ICU/hospital-free days and incidence of PMB-related acute kidney injury (AKI). The AUCss, 0-12 h and Css, avg were analyzed for associations with outcomes, and cut-off value was determined by receiver-operating characteristic (ROC) curves. Subgroup analysis was conducted among patients receiving continuous renal replacement therapy (CRRT).
Of 82 septic patients, clinical success rate was 37.8%. The AUCss, 0-12 h cut-off value was 27.10 mg·h-1·L-1 (Css, avg 2.26 mg·L-1). AUCss, 0-12 h > 27.10 mg·h-1·L-1 was associated with longer 90-day survival time (ETR=1.92, P=0.039). In the CRRT subgroup, increased loading dose was associated with longer 90-day survival time (ETR=1.38, P=0.015). The incidence of PMB-related AKI was 40.54% (15/37).. Patients with AKI had higher AUCss, 0-12 h (43.51 vs. 27.23 mg·h-1·L-1, P=0.006).
PMB exposure is associated with clinical efficacy in septic patients. Maintaining an AUCss, 0-12 h > 27.10 mg·h-1·L-1 (Css, avg of 2.26 mg·L-1) enhances clinical success. Higher AUCss, 0-12 h is an independent risk factor for PMB-related AKI. Therapeutic drug monitoring is recommended to ensure efficacy and safety.
To analyze the rationality and safety of clinical use of PD-1 inhibitors as novel antitumor drugs, providing guidance for their standardized and safe clinical application.
This study randomly selected inpatient medical records from April to June 2024 (before clinical pharmacist intervention) as the control group, and records from July 2024 to June 2025 (after intervention) as the intervention group. The rationality and safety of PD-1 inhibitor use were analyzed, with each 3-month period constituting a cycle. Results from each cycle were compared with those of the preceding cycle. Statistical analysis was performed to compare the rationality and safety of PD-1 inhibitor use between the first, second, third, and fourth intervention cycles and the pre-intervention cycle.
Post-intervention improvements were observed in prescription qualified rate, proportion of off-label use rate, and number of adverse drug reaction reports for PD-1 inhibitors. For prescription compliance and expanded clinical use indicators, the differences between the first, second, third, and fourth intervention cycles versus the pre-intervention cycle showed statistical significance (P<0.05).
Clinical pharmacist intervention enhances the rationality and standardization of PD-1 inhibitor use in clinical practice, facilitates timely identification of new or severe adverse reactions, and enables appropriate treatment measures, thereby reducing patient mortality, prolonging survival time, and reducing patients'medical costs.
To study the efficacy of PD-1 monoclonal antibody in treating microsatellite instability-high (MSI-H) colorectal cancer with different Kras gene point mutations.
Clinical data of patients with confirmed MSI-H colorectal cancer combined with Kras mutations were collected. Patients were divided into four groups based on different Kras mutation types: A146T, G12C, G12D, and G12V. Treatment efficacy was evaluated using the RECIST 1.1 criteria. Event-free survival (EFS) was calculated with the first administration of PD-1 monoclonal antibody as the starting point for survival time. The detection results of tumor markers (CEA, CA19-9, and CA72-4) were compared before and after treatment. The incidence of adverse reactions during treatment across groups was statistically analyzed.
The ORR (overall response rate) was highest in the G12V group (33.33%), followed by the G12D group (25.00%), the G12C group (20.00%), and the A146T group (12.50%). The DCR (disease control rate) was highest in the A146T group (100%), followed by the G12D group (91.66%), the G12V group (86.66%), the G12C group (70.00%), no statistically significant differences in ORR and DCR were observed among all groups (P>0.05). The average EFS duration was 19.25±12.19 months in the G12V group, 17.60±10.46 months in the A146T group, 15.36±9.32 months in the G12C group, and 12.15±7.36 months in the G12D group, with no significant differences among the groups (P>0.05). The median EFS duration was 15.12 months in the G12V group, 12.76 months in the A146T group, 10.65 months in the G12C group, and 10.20 months in the G12D group. In the G12V group, the levels of CEA and CA19-9 decreased significantly after treatment (P<0.05). During treatment, patients experienced immune-related adverse reactions such as rash, thyroid dysfunction, elevated transaminases, immune-related pneumonia, colitis, and peripheral neuritis, but no statistically significant differences in the incidence rates were found among the groups (P>0.05).
PD-1 monoclonal antibody showed better efficacy in patients with MSI-H colorectal cancer combined with Kras G12V mutation.
To investigate the efficacy and safety of first-line osimertinib in the treatment of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), and to analyze the influencing factors of progression-free survival (PFS).
The clinical data of patients with EGFR-mutated NSCLC who received first-line osimertinib monotherapy only from January 2019 to December 2022 were collected retrospectively. The primary endpoint was PFS. Survival analysis was performed using the Kaplan-Meier method, and univariate and multivariate Cox regression models were used to analyze the influencing factors of PFS. Meanwhile, the occurrence of adverse events (AEs) was described.
A total of 74 patients were included, with a median PFS of 16.3 months (95%CI=13.2-20.3 months). Subgroup analysis showed that the median PFS of patients with stage ⅢA/ⅣA was significantly longer than that of patients with stage ⅣB (25.1 months vs. 15.0 months, P=0.035). The median PFS of patients with prognostic nutritional index (PNI)≥39.4 was significantly longer than that of patients with PNI <39.4 (17.2 months vs. 10.7 months, P=0.030). Multivariate Cox regression analysis showed that disease stage and PNI were independent influencing factors of PFS. Common AEs included rash, oral ulcer, diarrhea, decreased white blood cell count, and paronychia, mostly grades 1-2.
First-line osimertinib shows favorable efficacy with manageable safety in patients with EGFR-mutated NSCLC. Baseline disease stage and PNI are independent factors for disease progression in NSCLC patients receiving first-line osimertinib.
Inhalation therapy is one of the common treatment methods in respiratory department, and it is clinically commonly used for the treatment of asthma, laryngitis, chronic obstructive pulmonary disease and other diseases. Special populations have attracted widespread attention because of their pathophysiological characteristics or inappropriate use methods, which may lead to improper drug selection or reduced drug effectiveness, and in severe cases, it will endanger patients' lives. According to the physiological characteristics of special populations, the pharmacological characteristics of inhaled drugs are analyzed, and the problems related to the standardized use and rational use of drugs in special populations were summarized, so as to provide a theoretical basis for clinical pharmacists to monitor the use of drugs in special groups of patients undergoing inhalation therapy.
To evaluate the inhibitory effect of JP-1366 for injection on gastric acid secretion and its therapeutic effect on hemorrhagic gastric ulcer.
The histamine-induced gastric acid secretion model in rats was used, and the animals were given JP-1366 for injection by a single intravenous injection to evaluate the inhibitory effect of the test substance on gastric acid secretion in these rats. In the water-immersion restraint-induced hemorrhagic gastric ulcer rat model and aspirin-induced hemorrhagic gastric ulcer rat model, animals were given a single intravenous injection of JP-1366 for injection. The therapeutic effect of the test substance on hemorrhagic gastric ulcer in rats was evaluated by detecting the pH value of gastric juice, gastric bleeding spots, area of hemorrhagic lesions, and inhibition rate on hemorrhagic lesions.
In the histamine induced rat gastric acid secretion model, JP-1366 for injection at different doses significantly increased the pH of gastric juice in the model rats, reduce the volume, concentration, and total acidity of gastric juice, and exhibit a dose-response relationship in terms of acid inhibition. The acid inhibition effect is better than that of omeprazole sodium. In the water immersion restraint induced and aspirin induced rat hemorrhagic gastric ulcer model, injection of JP-1366 can increase the pH of gastric juice, inhibit bleeding in the gastric glands and ameliorate mucosal erosion of gastric tissues at different doses. The ulcer inhibition rate shows a good dose-response, and the effect of improving gastric hemorrhagic lesions in the model rats is better than that of omeprazole sodium. At the same dose (1 mg·kg-1), the degree of improvement in gastric hemorrhagic lesions by injection of JP-1366 and fumarate vonosine is basically equivalent.
JP-1366 for injection treats hemorrhagic gastric ulcers by inhibiting gastric acid secretion, and its effects in inhibiting gastric acid and improving gastric hemorrhagic lesions are superior to those of omeprazole sodium. At the same dose, the improvement of bleeding lesions is equivalent to that of vonoprazan fumarate.
In view of the limitations of amikacin intravenous administration, including poor permeability in lung tissue and significant toxic and side effects, this study adopted the reverse-phase evaporation method to prepare and optimize the formulation and process of amikacin liposomes, and systematically evaluated their physical and chemical properties, in order to provide experimental basis for lung targeted delivery.
Amikacin liposomes were prepared by the reverse-phase evaporation method using dipalmitoylphosphatidylcholine (DPPC) and cholesterol as lipid materials. The encapsulation efficiency was determined by ultrafiltration centrifugation-HPLC. Based on the single factor investigation, the formulation and process parameters were optimized by the Box-Behnken response surface method with encapsulation efficiency as the evaluation index, and their encapsulation efficiency, morphology, particle size, polydispersity index (PDI), Zeta potential and in vitro release behavior were studied.
The optimum prescription process parameters were as follows: the phospholipid-to-cholesterol ratio was 4, the phospholipid concentration was 53.79 mg·mL-1, the ratio of lipid to drug was 3.78, the amount of organic solvent (chloroform) was 24.4 mL, the ultrasonic frequency was 40 times, and the rotary evaporation pressure was 600 mbar. The average encapsulation efficiency of the liposomes was (50.40 ± 0.89)%, the average particle size was (218.37 ± 2.47) nm, the PDI was (0.24 ± 0.01), and the Zeta potential was (-0.684 ± 0.21) mV. The in vitro release showed an obvious sustained release effect, with a cumulative release rate of 52.99% at 48 h, which was consistent with the Higuchi model.
The optimized preparation process of amikacin liposomes has good stability and reproducibility. The product has uniform particle size, stable morphology and sustained-release property. It has the potential advantages of achieving pulmonary targeted delivery, improving local efficacy and reducing toxic and side effects, thus laying a foundation for subsequent pharmacodynamics and safety studies.
To investigate the elements of quality difference in Campsis flos based on multi-index content, and to comprehensively evaluate the quality of Campsis flos from different producing areas based on multi-index content.
Eighteen batches of Campsis flos were collected from Jiangsu, Zhejiang and other producing areas. The contents of verbascoside, isoacteoside, apigenin, luteolin, quercetin, rhamnocitrin, maslinic acid, hederagenin, oleanolic acid, ursolic acid, water-soluble extract, total ash and acid-insoluble ash in Campsis flos were used as quality evaluation indexes, the differences from different producing areas were analyzed and characterized by statistical methods. 13 quality evaluation indexes were statistically analyzed by two mathematical models of chemometrics and grey relational analysis (GRA), and the ranking information of the quality of Campsis flos from different producing areas was obtained.
There were some fluctuations in the contents of 13 indexes in Campsis flos from different producing areas, and the established multi-index quantitative method was accurate and feasible. The results of quality evaluation model showed that 18 batches of Campsis flos were divided into three groups according to the origins. Oleanolic acid, ursolic acid, quercetin and verbascoside were the main factors affecting the quality of Campsis flos. The quality of Campsis flos from Jiangsu was better.
There are differences in the content of multiple indexes in Campsis flos from different origin. The established quality evaluation method can distinguish Campsis flos from different origins, and specifically identify the different components, so as to provide reference for the quality evaluation of Campsis flos (including those from different producing areas).
To establish an ultra-performance liquid chromatography-diode array detector (UPLC-DAD) method for the simultaneous determination of 5-hydroxymethylfurfural, morroniside, chlorogenic acid, loganin, paeoniflorin, 4, 5-O-dicaffeoylquinic acid, benzoylpaeoniflorin, and paeonol in Qiju Dihuang condensed pills.
Separation was performed on a Waters ACQUITY HSS T3 C18 column (2.1 mm × 100 mm, 1.8 μm) using a gradient elution program consisting of methanol, acetonitrile, and 0.3% phosphoric acid. Detection wavelengths were set at 230 nm (paeoniflorin, benzoylpaeoniflorin), 240 nm (morroniside, loganin), 274 nm (paeonol), 284 nm (5-hydroxymethylfurfural), 325 nm (chlorogenic acid), and 330 nm (4, 5-O-dicaffeoylquinic acid). The column temperature was maintained at 35 ℃, with a flow rate of 0.3 mL·min -1 and an injection volume of 1 μL.
The calibration curves for 5-hydroxymethylfurfural, morroniside, chlorogenic acid, loganin, paeoniflorin, 4, 5-O-dicaffeoylquinic acid, benzoylpaeoniflorin, and paeonol exhibited good linearity within concentration ranges of 4.69-234.53 (r = 0.999 3), 2.43-121.52 (r=0.999 8), 1.12-56.09 (r = 0.999 9), 2.81-140.33 (r = 0.999 9), 2.55-127.64 (r = 0.999 8), 1.17-58.60 (r = 0.999 8), 2.22-110.75 (r=0.999 5), and 4.93-246.25 μg·mL-1 (r = 0.999 9), respectively. The average recoveries were 99.67%, 99.30%, 97.64%, 99.88%, 99.90%, 102.60%, 99.65%, 100.59% with corresponding RSDs of 0.97%, 1.36%, 0.75%, 1.03%, 1.72%, 0.64%, 1.01% and 1.00%.
The developed method is rapid, accurate, sensitive, efficient, and reproducible, making it suitable for the determination of multi-index components, quality control and quality evaluation of Qiju Dihuang condensed pill.