Most ReadTo study the efficacy and safety of allisartan isoproxil tablet combined with indapamide tablet in the treatment of patients with mild to moderate essential hypertension and coronary heart disease.
Patients with mild to moderate essential hypertension and coronary heart disease were divided into treatment group and control group using the cohort method. The control group was given oral indapamide tablets 2.5 mg once a day based on the conventional treatment regimen. The treatment group was given allisartan isoproxil tablets 240 mg once a day in addition to the control group’s regimen for a total of 12 weeks. The clinical efficacy, 24-hour blood pressure variability, cardiac function, vascular endothelial function and safety evaluation of the two groups were compared.
A total of 105 patients were enrolled, including 54 patients in treatment group and 51 patients in control group. After treatment, the total clinical effective rate of the treatment group was 90.74% (49 cases/54 cases), and that of control group was 72.55% (37 cases/51 cases), which was significantly higher in treatment group than in control group (P<0.05). After treatment, the daytime (d) systolic blood pressure variability (SBPV) levels in treatment group and control group were (11.32±2.13) and (12.48±2.26) mmHg, respectively; the nighttime (n) SBPV levels were (10.03±1.79) and (10.82±2.10) mmHg, respectively; the d diastolic blood pressure variability (DBPV) levels were (8.66±1.51) and (9.36±1.57) mmHg, respectively; the nDBPV levels were (8.05±1.32) and (8.68±1.62) mmHg, respectively; the 24 h SBPV levels were (10.85±2.20) and (11.96±2.05) mmHg, respectively; the 24 h DBPV levels were (9.67±1.93) and (10.66±1.92) mmHg, respectively; the brain natriuretic peptide (BNP) levels were (83.47±10.53) and (89.41±13.19) ng·L-1, respectively; the endothelin-1 (ET-1) levels were (55.44±9.27) and (60.36±10.86) ng·L-1, respectively; and the Apelin levels were (36.44±6.41) and (34.22±4.37) ng·mL-1, respectively. The above metrics showed significant differences between the two groups (P<0.05，P<0.01). The adverse drug reactions in treatment group included diarrhea, fever, fatigue, palpitations, soreness in both knee joints, cough, insomnia, decreased appetite and orthostatic hypotension. The adverse drug reactions in control group included diarrhea, headache, decreased appetite, insomnia and orthostatic hypotension. The total incidence of adverse drug reactions in treatment group was 22.22% (12 cases /54 cases), and that in control group was 17.65% (9 cases /51 cases). There was no statistically significant difference (P>0.05).
The application of allisartan isoproxil combined with indapamide in treatment of patients with mild to moderate essential hypertension and coronary heart disease can achieve significant therapeutic effects, regulate 24-hour blood pressure variability, improve cardiac function, vascular endothelial function, and quality of life, also demonstrate 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.
To observe the clinical efficacy and safety of finerenone tablets combined with dapagliflozin tablets in the treatment of elderly diabetic nephropathy (DN).
Elderly patients with DN in hospital were divided into treatment group and control group. The patients in control group were treated with oral dapagliflozin tablets once a day in the morning, with a dose of 5 mg each time, while the patients in the treatment group were combined with finerenone tablets on the basis of control group, and adjusted according to the estimated glomerular filtration rate (eGFR) levels of patients. Serum creatinine (SCr), blood urea nitrogen (BUN), 24 h urine protein quantification, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-cRP), total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and clinical efficacy were compared between groups of patients, and the safety was evaluated.
A total 90 patients were enrolced; 45 in treatment group and 45 in control group. After treatment, the SCr levels in treatment group and control group were (127.63±10.28) and (140.27±11.95) μmol·L-1, BUN levels were (11.45±3.57) and (18.62±3.29) mmol·L-1, 24 h urine protein quantification levels were (99.28±11.42) and (117.92±12.00) mg·24 h-1, IL-6 levels were (12.32±2.15) and (16.41±3.50) ng·L-1, TNF-α levels were (31.68±10.52) and (43.09±11.83) ng·L-1, hs-cRP levels were (6.08±1.20) and (9.56±1.57) ng·L-1, TC levels were (4.49±0.55) and (4.83±0.72) mmol·L-1, TG levels were (2.57±0.63) and (2.79±0.48) mmol·L-1, LDL-C levels were (2.71±0.63) and (3.06±0.45) mmol·L-1 respectively, and the above indicators in treatment group were significantly lower than those in control group, with statistically significant differences (all P<0.05). The total clinical effective rate in treatment group was 93.34% (42 cases/45 cases), and that in control group was 75.56% (34 cases/45 cases), with statistically significant difference (P<0.05). The adverse drug reactions in treatment group were hypotension, hypoglycemia, acute kidney injury, hyperkalemia and pruritus, and the adverse drug reactions in control group included hypoglycemia, acute kidney injury and hyperkalemia. The total incidence rates of adverse drug reactions in treatment group and control group were 22.22% (10 cases/45 cases) and 8.89% (4 cases /45 cases) respectively, without statistically significant difference (P>0.05).
Compared with dapagliflozin tablets, the combined use of finerenone tablets for elderly DN can better improve the renal function, and regulate the lipid metabolism, with good safety.
To evaluate the bioequivalence of the test preparation and the reference preparation in a single dose of vortioxetine hydrobromide tablets under fasting and fed conditions in healthy volunteers.
A randomized, open-ended, single-dose, two-cycle, double-cross bioequivalence trial design was adopted, and 28 subjects were enrolled in the fasting group and the fed group, respectively, and 1 tablet of the test preparation and the reference preparation were taken in the fasting or fed state each cycle. The concentration of vortioxetine in plasma was determined by liquid chromatography-tandem mass spectrometry （LC-MS/MS） method. The main pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.1, and the bioequivalence was evaluated.
The t1/2 for the fasting single oral administration of the test preparation and the reference preparation were （61.74±23.90） and （58.22±18.61）h, the median Tmax were （7.33±2.15） and （7.61±3.89） h, the Cmax were （7.32±1.90） and （7.46±1.98） ng·mL-1, and the AUC0-72 h were （312.61±92.95） and （310.00±93.84） h·ng·mL-1, respectively. The statistical results of the 90% confidence intervals of the main pharmacokinetic parameters Cmax and AUC0-72 h were 92.75%-103.71% and 97.47%-104.43%, respectively, all of which were within the range of 80.00%-125.00%, and the safety of the tested preparation and the reference preparation was good when taken orally on an empty stomach. The t1/2 of single oral administration after prandial administration of the tested preparation and the reference preparation were （77.60±33.87） and （81.61±45.24） h, the median Tmax were （8.06±3.02） and （7.77±2.45）h, the Cmax were （7.54±2.08） and （7.76±2.00） ng·mL-1, and the AUC0-72 h were （319.75±87.71） and （326.03±86.64） h·ng ·mL-1, respectively. The 90% confidence intervals of Cmax, AUC0-72 h were 89.00%-105.32% and 92.21%-102.72%, respectively, which were in the range of 80.00%-125.00%.
In the state of fasting and fed single oral administration, the two kinds of vortioxetine hydrobromide tablets have good bioequivalence.
Bone-related infections represent a significant challenge in orthopedic practice, and the penetration efficacy of antimicrobials into bone tissue serves as a critical determinant of therapeutic outcomes. This review systematically summarizes the bone penetration characteristics of clinically used antimicrobial agents. Current evidence indicates that most β-lactam antibiotics demonstrate bone penetration rates ranging from 10% to 50%, while fluoroquinolones exhibit higher penetration at 30%-100%. Vancomycin and teicoplanin display penetration rates between 10% and 40%. Notably, clindamycin, linezolid and rifampicin achieve penetration rates exceeding 30%. Multiple factors influence drug penetration characteristics, including anatomical bone site variations, local blood perfusion status, patients’ pathophysiological conditions, as well as administration routes and dosage regimens.
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.
Vancomycin is the first-line drug for treating infections caused by methicillin-resistant gram positive bacteria in patients with malignant hematological diseases. However, due to significant differences in the physiological and pathological characteristics of these patients compared to the general population, the pharmacokinetic behavior of vancomycin in the body may undergo significant changes. These changes may lead to unpredictable therapeutic effects, increased safety risks, and the evolution of bacterial resistance. Personalized dosing strategies may offer potential solutions to address these issues. Nevertheless, at present, there is a lack of unified, guideline-based, or consensus-driven reference standards for personalized dosing in these patients, particularly adult patients, and relevant research data remain insufficient. This review systematically summarizes the current status of pharmacokinetic studies on vancomycin in adult patients with malignant hematological diseases and focuses on the analysis of population pharmacokinetic models and their application progress. Additionally, this paper provides a detailed discussion of the current technical approaches available for vancomycin personalized dosing, including techniques based on therapeutic drug monitoring, clinical decision support systems, novel technical methods, and the latest dynamic dosing techniques developed by our research team based on individualized dosing models. Through an organized review of existing research, this paper identifies the challenges faced in achieving broader implementation of personalized dosing. It is hoped that this study will provide valuable insights for achieving personalized vancomycin dosing in patients with malignant hematological diseases, thereby advancing clinical practice and technological development in this field.
To investigate the protective effect and mechanism of astragaloside Ⅳ (AS-Ⅳ) on intestinal injury and secondary liver injury in rats with ulcerative colitis (UC) induced by trinitrobenzene sulfonic acid (TNBS).
Wistar rats were randomly divided into normal control group, UC model group and AS-Ⅳ experimental low, medium and high dose groups, with 10 rats in each group. The UC rat model was prepared by TNBS enema. AS-Ⅳ (25, 50, 100 mg·kg-1) or sulfasalazine (SASP, 300 mg·kg-1) was administered intragastrically for 6 consecutive days starting from the second day after modeling. The general condition, colonic histopathological score, and liver function of the rats were examined. The levels of inflammatory factors in serum, colon and liver tissues were detected by enzyme-linked immunosorbent assay (ELISA). The expressions of tight junction proteins (ZO-1, Occludin) in colon and antioxidant enzymes in liver tissues were detected by Western blot.
In the normal group, model group, low, medium and high dose experimental groups, the serum TNF-α levels were (246.30±23.39), (308.70±61.39), (279.10±45.76), (240.80±16.61) and (233.60±30.14) pg·mL-1, and the serum IL-1β levels were (23.93±14.82), (82.42±20.84), (69.46±22.23), (40.92±11.21) and (35.42±10.34) pg·mL-1，respectively. The intestinal TNF-α levels were (101.60±11.18), (158.70±23.47), (146.40±17.90), (115.70±21.06) and (91.84±21.57) pg·mL-1, and the intestinal IL-1β levels were (724.60±78.73), (1 043.00±106.32), (836.35±103.35), (774.60±133.68) and (694.50±40.84) pg·mL-1，respectively. The relative expression levels of tight junction protein ZO-1 in colon tissue were 1.01±0.01, 0.48±0.01, 0.46±0.01, 0.61±0.09 and 1.15±0.10, and the relative expression levels of tight junction protein Occludin in colon tissue were 1.00±0.01, 0.64±0.11, 0.57±0.13, 0.73±0.10 and 1.02±0.13，respectively. The levels of TNF-α in liver tissues were (1 727.00±223.70), (2 008.00±220.40), (1 762.00±45.19), (1 723.00±49.45), and (1 680.00±103.10) pg·mg-1, and the levels of IL-1β in liver tissues were (1 317.00±331.40), (2 158.00±730.90), (1 546.00±258.90), (1 806.00±523.40), and (1 121.00±84.62) pg·mg-1. The MDA levels in liver tissues were (0.98±0.15), (1.51±0.29), (1.29±0.30), (1.15±0.12) and (1.06±0.21) nmol·mg-1, the reduced glutathione (GSH) levels in liver tissues were (8.46±0.60), (5.84±0.49), (6.30±0.27), (7.48±0.50) and (8.07±0.60) μmol·gProt-1, the glutathione peroxidase (GSH-PX) levels in liver tissues were (666.90±68.39), (481.00±19.16), (562.80±45.61), (620.20±12.13) and (658.80±18.11) U·mgProt-1.The above indicators in the medium and high dose experimental groups were statistically significant compared with the model group (all P<0.05).
AS-IV can effectively improve intestinal and liver injury in rats with UC induced by TNBS. The mechanism may be related to repairing intestinal mucosal barrier, inhibiting inflammatory response and improving liver antioxidant function.
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.
To explore the clinical efficacy of fusidic acid ointment in patients with acne vulgaris who underwent non-ablative fractional 1 565 nm laser treatment.
Patients with common acne who received non-peeling fractional 1 565 nm laser treatment were divided into treatment group and control group. Treatment group was treated with fusidic acid ointment, 3 times a day, while control group was not treated with additional treatment.The lesion severity, skin sebum secretion, skin stratum corneum water content, clinical efficacy, matrix metalloproteinase 1 (MMP-1), matrix metalloproteinase tissue inhibitor-1 (TIMP-1), MMP-1/TIMP-1 ratio, skin elasticity indicators (R2, R5, R7), facial acne comprehensive grading system (global acne grading system, GAGS) score and acne-specific quality of life questionnaire (Acne-QOL) score were compared between the two groups.
100 patients with acne vulgaris who received non exfoliative dot matrix 1 565 nm laser were enrolled, including 50 cases in treatment group and 50 cases in control group. After treatment, the total clinical effective rate of treatment group was 96.00% (48 cases/50 cases), and that of control group was 74.00% (37 cases/50 cases), the difference was statistically significant (P<0.05). After 3 months treatment, the skin oil secretion of treatment group and control group were (53.79±7.23) and (69.21±10.67) μg·cm-2, respectively; the moisture content of cuticle were (34.21±5.15)% and (29.68±3.92)%, respectively; MMP-1 were (1.02±0.28) and (1.24±0.43) μg·mL-1, respectively; TIMP-1 were (1.62±0.24) and (1.43±0.20) μg·mL-1, respectively; MMP-1/TIMP-1 were 0.63±0.10 and 0.87±0.15, respectively; the R2 were (53.77±8.75)% and (49.11±7.64)%, respectively; the R5 were (53.88±8.58)% and (49.67±7.69)%, respectively; the R7 were (32.55±6.05)% and (28.39±5.44)%, respectively; the GAGS scores were (13.78±2.69) and (17.83±3.35) points, respectively; the Acne-QOL scores were (105.56±5.58) and (90.21±6.32) points, respectively. After treatment, the above indexes in treatment group were significantly lower than those in control group (all P<0.05). The adverse drug reactions in treatment group and control group were dry, tingling, scaling and flushing. The total incidence of adverse drug reactions in treatment group was 10.00% (5 cases/50 cases) and in control group was 16.00% (8 cases/50 cases). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05).
Fusidic acid ointment could significantly improve the dynamic balance of MMP-1/TIMP-1, skin elasticity and skin physiological indexes in patients with acne vulgaris receiving non-ablative fractional 1 565 nm laser, with good safety.
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
