Latest ArticlesTo observe the clinical efficacy and safety of preoperative medication with lidocaine hydrochloride injection ultrasonic atomization combined with low-dose dexmedetomidine hydrochloride injection for fiberoptic bronchoscopy under general anesthesia in patients with pulmonary tuberculosis.
Patients with pulmonary tuberculosis scheduled for general anesthesia fiberoptic bronchoscopy were randomly divided into treatment group and control group. Both groups were given intravenous infusions of fentanyl citrate injection 0.05 mg and 1.5 mg·kg-1 propofol medium and long chain fat emulsion injection for induction of anesthesia. During the procedure, 2-3 mg·kg-1·h-1 propofol medium and long chain fat emulsion injection was used to maintain anesthesia. Control group received no additional treatment, while treatment group received an additional intravenous infusion of 0.2 μg·kg-1 dexmedetomidine hydrochloride injection through micro-pump over 15 min, combined with nebulized inhalation of lidocaine hydrochloride injection 3-4 mL, before induction of anesthesia. The postoperative anesthesia status, recovery quality, inflammation-related indicators and safety were compared between the two groups.
Among the 95 patients with pulmonary tuberculosis who underwent fiberoptic bronchoscopy under general anesthesia, 3 cases dropped out during the treatment and finally 46 cases were included in each group. After treatment, the loss of consciousness time in control group and treatment group were (172.65±36.81) and (146.67±26.46)s, respectively; the recovery time were (18.67±1.06) and (15.50±0.75) min, respectively; the orientation recovery time were (16.63±1.76) and (9.57±1.70) min and the dosage of propofol were (130.21±13.41) and (124.02±15.43) mg, respectively; the Ramsay scores of 10 minutes after awakening were (3.09±0.51) and (2.57±0.62) points, respectively; the Ramsay scores of 20 minutes after awakening were (3.52±0.55) and (3.00±0.67) points, respectively; the levels of death-associated protein kinase 1 (DAPK1) were (88.08±9.85) and (81.88±11.55) ng·L-1, respectively; the levels of NOD-like receptor family pyrin domain-containing 3 (NLRP3) were (78.63±9.35) and (73.96±7.52) ng·L-1, respectively; the levels of interleukin-1β (IL-1β) were (46.02±4.59) and (41.04±6.62) ng·L-1, respectively and the levels of IL-18 were (5.71±1.64) and (4.78±1.23) ng·L-1, respectively. The differences of the above indexes between treatment group and control group were statistically significant (all P<0.05). The main adverse drug reactions of control group were tinnitus, dizziness, nausea, agitation and convulsion; in treatment group were dizziness, nausea, agitation and convulsion, the total incidence of adverse drug reactions in control group was 13.04% (6 cases/46 cases), while that in treatment group was 8.70% (4 cases/46 cases). There was no statistically significant difference between the two groups (P>0.05).
Lidocaine hydrochloride injection combined with low-dose dexmedetomidine hydrochloride injection has significant advantages in patients with pulmonary tuberculosis undergoing fiberoptic bronchoscopy under general anesthesia. It can effectively improve the anesthetic effect and recovery quality of patients, reduce the dosage of propofol and reduce the levels of inflammatory factors with with good safety.
The newly revised The International Council for Harmonizsation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 R(3) sets out internationally accepted principles and standards for conducting clinical trials. The application of innovative technologies in clinical trials, consideration of risk proportionality, and the development of new models are all important drivers for the revision of ICH E6 R(3). The main features of this revision include: alignment with “ICH E8 R(1) General Considerations for Clinical Studies,” restructuring of the document, provision of guidance on data governance, encouragement of risk-proportionate and fit-for-purpose approaches, and the establishment of practical and feasible expectations for sponsors and investigators. The revision also adapts to innovations in clinical trial design, technology, conduct, and data sources; strengthens the protection of minor trial participants; emphasizes transparency in clinical trial registration and results reporting; and updates terminology. The revision of ICH E6 R(3) impacts sponsors, investigators, ethics committees, and service providers, offering guidelines that are both practical and flexible, and continuously responding to the rapid development of the clinical trial ecosystem.
A 76 years old female patient was hospitalized twice for pulmonary infection and bronchiectasis with infection. During her first admission to the respiratory department for pulmonary infection, she received intravenous cefoperazone sodium/sulbactam sodium combined with bronchodilators for 11 days and was discharged following clinical improvement, with no documented adverse drug reactions (ADRs). During her second presentation to the emergency department for bronchiectasis exacerbation, the patient developed cyanosis and profuse sweating 13 minutes after intravenous cefoperazone/sulbactam administration. Despite successful resuscitation and subsequent transfer to the intensive care unit (ICU), emergency physicians failed to recognize this event as a suspected drug hypersensitivity reaction or document it in the medical records. After 11 days of meropenem therapy and symptomatic management in the ICU, she was transferred back to the respiratory department. Respiratory physicians initiated antibiotic de-escalation by readministering cefoperazone/sulbactam, which precipitated respiratory distress, profuse sweating and systemic discomfort within 19 minutes, followed by loss of consciousness and cardiopulmonary arrest. The patient died after 48 hours of unsuccessful resuscitation. This case serves as a reminder that the sensitization period for drugs can persist from several days to several months. The absence of ADRs with previous use does not entirely preclude the risk of subsequent administration. The recognition of hypersensitivity is critical, necessitating enhanced vigilance among healthcare professionals regarding ADRs. The documentation of ADRs and handover procedures during transfers between departments should not be overlooked to ensure medication safety.
Precancerous lesions of gastric cancer (PLGC) are considered as a high-risk factor for the development of gastric cancer. Existing studies have confirmed that hypoxia inducible factor-1α (HIF-1α) plays a key role in the progression of PLGC. HIF-1α promotes the malignant transformation of PLGC by regulating various cellular processes, including angiogenesis, aerobic glycolysis, autophagy, cell proliferation, and apoptosis. Traditional Chinese medicine (TCM) has been shown to modulate the HIF-1α signaling pathway and inhibit these pathological processes, thereby intervening in the development of PLGC. This review will focus on the mechanisms by which HIF-1α mediates PLGC and summarize the potential applications of TCM in the prevention and treatment of PLGC, aiming to provide a clear molecular framework for TCM intervention in PLGC and offer theoretical support and research directions for the development of innovative HIF-1α-targeted Chinese medicines.
The treatment of posterior segment diseases has always been a challenge in the field of ophthalmology. How to overcome obstacles in drug delivery and improve the bioavailability of drugs in the posterior segment of the eye is one of the most challenging aspects in the field of drug research. The innovation of drug delivery routes and dosage forms, as well as breakthroughs in drug development, have brought new hope for the delivery of drugs in the posterior segment of the eye. This article reviews three aspects of innovative drug delivery routes for subretinal drug delivery, suprachoroidal drug delivery, and vitreous cavity implantation, innovative drug delivery form design for nano-formulations and exosomal formulations, and innovative drug development for intraocular injections, topical drops, and oral drugs, with the aim of providing new strategies for the treatment of diseases of the posterior segment of the eye.
To establish and validate a highly sensitive and selective high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the determination of lurasidone, which was used subsequently to clinical lurasidone blood drug concentration monitoring.
Tadalafil was used as internal standard. Following a deproteinization procedure, lurasidone and the internal standard (tadalafil) were isostatically eluted using a mobile phase composed of methanol and 0.1% aqueous formic acid (50：50, v/v) at a flow rate of 0.70 mL·min-1. The chromatographic separation was achieved within 4.0 min on an Agilent ZORBAX Eclipse plus C8(4.6 mm×100.0 mm，3.5 μm). Quantification was performed using a triple-quadrupole mass spectrometer operating in positive electrospray ionization (ESI) mode with multiple reaction monitoring (MRM). The method was validated for selectivity, linearity (calibration curve), precision and accuracy, matrix effect, extraction recovesise, stability and dilutive integrity. The concentrations of 14 clinical samples were measured after this method was validated.
The calibration curve for lurasidone in human plasma demonstrated linearity over the concentration range of 0.50-500.00 ng·mL-1. The precision data (both intra- and inter-day) for the three QC levels ranged from 2.87% to 10.03%. Accuracy (relative error) was within±15% of the nominal values. The plasma samples maintained stability for 28 h at room temperature, for 85 days at -20 ℃ and through five freeze-thaw cycles. The measured concentrations of clinical samples were within the range of the standard curve, with concentrations ranging from 2.63 to 21.17 ng·mL-1.
The validated method is proved to be convenient, accurate, and sensitive for the quantification of lurasidone in human plasma. The method is proved to be suitable for the monitoring of plasma concentration and pharmacokinetics study of lurasidone.
The clinical isolation rate of carbapenem-resistant Acinetobacter baumannii (CRAB) has been increasing year by year, yet effective antimicrobial agents against this pathogen remain severely limited. Sulbactam-durlobactam, a novel β-lactam combination agent, has demonstrated promising in vitro antibacterial activity against CRAB. In May 2023, the U.S. Food and Drug Administration approved its use for patients aged 18 and older to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex, providing a new therapeutic option. This article reviews the mechanism of action, pharmacokinetics, pharmacodynamics, and clinical studies of sulbactam-durlobactam based on literature, aiming to offer insights for clinical practice.
To investigate the influence of augmented renal clearance (ARC) on the steady-state serum concentration and pharmacodynamics of meropenem in patients with severe infections and to analyze the linear relationship between them.
A retrospective analysis was conducted on the inpatients who received meropenem treatment and underwent therapeutic drug monitoring (TDM) at the Fifth Medical Center of the General Hospital of the PLA from June 2021 to September 2024. Serum drug concentration data were collected, and pharmacokinetic parameters were calculated using a one-compartment model. The steady-state serum concentrations and pharmacodynamic parameters were compared between patients with normal renal function and those with ARC. Multiple linear regression analysis was performed to explore the factors influencing meropenem serum concentrations and pharmacodynamic parameters.
When meropenem was administered at a dose of 1.0 g three times daily, the blood concentrations in patients with ARC at 3 hours and 0.5 hours before the last administration were (4.78±2.34) mg·L-1 and (2.44±1.60) mg·L-1, respectively. In contrast, the corresponding concentrations in patients with normal renal function were (14.08±10.45) mg·L-1 and (8.40±7.07) mg·L-1, respectively. The blood concentrations of meropenem were significantly lower in ARC patients compared to those with normal renal function (P<0.05). For the pharmacodynamic target of f%T>4MIC≥40%, the target attainment rates in ARC patients were 81.25%, 25.00%, 0.00%, and 0.00% at MIC values of 1, 2, 4, and 8 μg·mL-1, respectively. In comparison, the rates in patients with normal renal function were 92.31%, 76.92%, 53.85%, and 7.69%, respectively, indicating significantly lower target attainment in the ARC group. Multiple linear regression analysis revealed that creatinine clearance rate and serum albumin level significantly influenced both the plasma concentration and pharmacodynamic target attainment of meropenem.
ARC significantly reduces the steady-state serum concentration of meropenem and the rate of achieving pharmacodynamic targets, leading to the failure of anti-infective therapy. For patients with severe infections and ARC, attention should be paid to the effects of creatinine clearance, serum albumin on serum drug concentrations and therapeutic efficacy. TDM should be performed to adjust the dosing regimen in a timely manner.
Diabetic kidney disease (DKD) is a clinical syndrome in which diabetes leads to microvascular lesions and then glomerulosclerosis. In the progression of DKD, the hypoxia inducible factor-1α (HIF-1α) signaling pathway is involved in the occurrence, development and pathological formation of DKD. Related studies have shown that the HIF-1α pathway is the most critical pathway for the treatment of DKD with traditional Chinese medicine. Among them, Chinese medicine monomers, Chinese medicine compounds, and Chinese patent medicines play a role in preventing interstitial fibrosis and glomerulosclerosis by regulating the HIF-1α pathway. Its mechanism is closely related to inflammation, oxidative stress, cell apoptosis, and ferroptosis. This article reviews the existing research results on the treatment of DKD with the intervention of traditional Chinese medicine in the HIF-1α pathway in recent years, in order to provide a theoretical basis for the prevention and treatment of DKD and the development of new drugs.
To investigate the effects of gastrodin (GAS) on diabetes-induced cardiomyopathy (DCM) and its underlying mechanisms.
Fifty C57BL/6J mice were divided into control group (n=10, normal diet) and high-fat high-sucrose (HFD) group [n=40, HFD diet combined with intraperitoneal streptozotocin (STZ) injection to establish the DCM model]. Successfully modeled HFD mice were randomly assigned to the model group, GAS low-dose group (50 mg·kg-1, qd), GAS high-dose group (100 mg·kg-1 qd), and positive control metformin group (250 mg·kg-1，qd). The control and model groups were administered saline via gavage, while the other three groups received their respective drugs via gavage for three consecutive months. Cardiac ultrasound was used to measure left ventricular ejection fraction (LVEF), left ventricular fractional shortening (LVFS), left ventricular end-systolic volume (LVESV), and left ventricular internal diameter at end-systole (LVIDs). Serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were quantified using assay kits. Cardiac tissue levels of malondialdehyde (MDA) and glutathione (GSH) were measured. Protein expression was analyzed via Western blotting.
The LVEF of the model group and high-dose group were (62.54±3.24)% and (80.20±3.29)%, respectively, and the LVFS were (25.87±4.75)% and (42.97±4.75)%, respectively LVESVs were (55.00±4.08) and (23.75±4.79) μL, LVIDs were (2.63±0.16) and (1.67±0.21) mm, TG was (1.17±0.18) and (0.51±0.09) mmol·L-1, TC was (5.58±0.76) and (1.93±0.58) mmol·L-1, HDL-C was (1.69±0.50) and (4.86±0.48) mmol·L-1, LDL-C was (3.84±0.70) and (1.17±0.65) mmol·L-1, respectively. The MDA content was (6.10±0.38) and (3.02±0.16) nmol· mgprot-1, the GSH content was (20.90±10.30) and (39.49±15.70) μmol·gprot-1, the relative expression levels of oxidative stress protein Kelch like ECH associated protein 1 (Keap1) were 1.75±0.22 and 1.07±0.03, the relative expression levels of nuclear factor-E2-related factor 2 (Nrf2) were 0.51±0.09 and 0.96±0.13, and the relative expression levels of peroxidase-1 (PRDX-1) were 0.43±0.08 and 0.93±0.18, respectively, and the relative expression levels of heme oxygenase-1 (HO-1) were 0.42±0.08 and 0.94±0.14, respectively. Compared with the model group, the above indicators in the high-dose group showed statistically significant differences (P<0.01，P<001).
GAS can improve the myocardial function of DCM mice, and its mechanism of action may be related to the inhibition of oxidative stress and the regulation of the Keap1/Nrf2 signaling pathway.
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