Reviews on recent clinical trials最新文献

Introduction: Premenstrual syndrome (PMS) significantly affects women's quality of life. This study compares the effects of propolis and fennelin capsules on PMS symptoms in students.

Methods: A double-blind, randomized controlled trial (2024) was conducted with 90 students at Hamadan University of Medical Sciences, who were randomized into propolis (500 mg), fennelin (30 mg extract), or placebo groups (30 participants each). Interventions were administered over two menstrual cycles. PMS symptom severity and frequency were assessed using validated questionnaires and analyzed with SPSS-21.

Results: Propolis and fennelin reduced PMS symptom severity by 78.9% and 79.3%, respectively (p = 0.016), whereas no significant change was observed in the placebo group (p = 0.206). No side effects were reported.

Conclusion: Propolis and fennelin may serve as complementary options for short-term PMS symptom relief in young women. However, the small sample size and short duration limit the generalizability of the findings, highlighting the need for future studies with larger, more diverse populations and longer follow-up periods.

Clinical trial no: IRCT20120215009014N525.

Drug repurposing is an emerging strategy in the drug discovery arena, shedding light on new therapeutic uses for already known drugs. This strategy enormously reduces the time and cost of drug development because it utilizes existing data on safety and efficacy of drugs. This review provides basic mechanisms, strategies, and challenges related to drug repurposing. Here we discuss the role of polypharmacology, potential off-target effects in the use of computational and experimental methods for identifying repurposing opportunities, and regulatory and ethical considerations in drug repurposing. Completed cases demonstrate that this approach works effectively across various therapeutic areas, from oncology to rare diseases. Challenges include the need for regulatory and clinical data. Drug repurposing is extremely promising for the rapid delivery of new treatments to patients while cooperating in the development of a more sustainable healthcare system. In-depth knowledge of biological systems and disease mechanisms will allow for drug repurposing to potentially revolutionize new treatments and patients' outcomes.

Introduction: Urinary tract infections (UTIs) caused by multidrug-resistant, biofilmforming Klebsiella pneumoniae represent a serious global health concern. Conventional antibiotics often fail due to resistance and biofilm-associated tolerance, necessitating novel diagnostic and therapeutic strategies. This study investigated interleukin-8 (IL-8) as a diagnostic marker and evaluated the anti-virulence potential of ellagic acid against extended-spectrum β-lactamase (ESBL)-producing K. pneumoniae.

Methods: This study was a cross-sectional, experimental, and analytical investigation conducted from August 2023 to March 2024. Serum IL-8 levels were quantified in patients and healthy controls using ELISA. The antibiotic susceptibility of K. pneumoniae isolates was assessed according to CLSI guidelines, and ESBL activity was determined by the nitrocefin hydrolysis test. Biofilm formation was quantified using the crystal violet assay, with and without ellagic acid treatment. In silico docking studies were conducted using AutoDock Vina to predict interactions between ellagic acid and the CTX-M-15 β-lactamase, Wza, FabH, and SdiA proteins.

Results: IL-8 levels were significantly higher in patients (223.8 ± 43.5 pg/mL) compared with controls (47.9 ± 17.3 pg/mL; p < 0.0001). All isolates were resistant to ampicillin and showed broad resistance to other antibiotics. Ellagic acid significantly reduced biofilm biomass (p = 0.0002) but concurrently increased ESBL activity (p = 0.0001). Docking demonstrated that ellagic acid was strongly bound to CTX-M-15 (-8.3 kcal/mol), had moderate interactions with Wza and SdiA, whereas the interaction with FabH was relatively low.

Discussion: The high concentration of IL-8 supports its use as a biomarker to detect K. pneumoniae infections. The elevated resistance profile of K. pneumoniae to antibiotics highlights the urgent need for alternative treatment approaches. Though ellagic acid increased ESBL activity, it showed distinct antibiofilm activity and responses with virulence-related proteins, indicating a modulatory action that may reduce bacterial pathogenicity. Limitations include the lack of in vivo validation and the need to mechanistically elucidate the modulation of ESBL.

Conclusion: IL-8 is a valuable biomarker for ESBL-producing K. pneumoniae infection. Ellagic acid reduces biofilm formation and targets bacterial resistance and virulence proteins, supporting its potential as a natural anti-virulence agent against multidrug-resistant K. pneumoniae.

The primary function of a vaccine is to trigger a series of immune responses that are targeted at a specific pathogen. The present vaccine administration methods need to be improved, even though currently available immunisations are a remarkable success story in modern medicine and have significantly reduced global morbidity and mortality rates. Multiple immunisations were recently integrated into a single injection. This strategy is the most effective way to expedite immunisation administration and lessen the psychological burden associated with receiving multiple doses. However, safety is crucial for their widespread acceptance. Pharmacokinetics and pharmacodynamics of combination vaccination entail coordinated antigen delivery, immune activation, and effectiveness and safety. These vaccine combinations face regulatory approval of consistent manufacture, immunogenicity, and safety in various populations. Clinical studies and real-world research determine their safety and efficacy, guiding regulatory approval and post-launch monitoring. This review article discusses the pharmacokinetics and pharmacodynamics, regulatory concerns, and clinical evidence on the safety and effectiveness of combination vaccines.

Green tea contains a bioactive polyphenol called epigallocatechin gallate (EGCG), which may be used as a therapeutic agent for breast cancer (BC). This review examines the pharmacological and chemical properties of EGCG, which may make it a valuable therapeutic agent for treating breast cancer. The distinctive physicochemical characteristics of EGCG, such as its solubility, stability, and bioavailability, are based on its molecular structure, which is also crucial for its medicinal uses. Furthermore, the availability of EGCG as a naturally occurring substance, its production in "Camellia sinensis," and the use of sophisticated extraction methods are also covered. Apoptosis is induced via caspase activation and mitochondrial failure. Metastasis-related enzymes are inhibited, and key signaling pathways, including PI3k, Akt, and MAPK, are modulated as part of EGCG's multifaceted anti-cancer actions. The synergistic benefits of EGCG with traditional chemotherapies, in combating drug resistance and enhancing their effectiveness, significantly improve the therapeutic value of these treatments. Limited bioavailability is addressed via liposomal delivery, nanoparticle encapsulation, and structural optimisation. Pharmacokinetics, toxicology, and clinical studies all support its safety and effectiveness. This study highlights the promise of EGCG as a therapeutic agent for breast cancer, exploring its molecular interactions, new formulations, and the integration of chemistry and molecular mechanisms to enhance EGCG's therapeutic applicability in clinical settings.

Introduction: Disinfection of the root canal system is crucial for the effectiveness of root canal treatment. Lasers and photoactivated disinfection (PAD) have emerged as preferred methods for eliminating pathogens from the root canal.

Method: Sixty intact, freshly extracted adult human uniradicular mature teeth with a single root canal were collected. The crowns were removed, resulting in canals measuring 14 mm in length. The root canals were prepared, sterilized, and then inoculated with broth containing Enterococcus faecalis (E. faecalis), followed by incubation for 30 days in an aerobic environment at 37°C. Biofilm formation was verified using a scanning electron microscope. The samples were randomly divided into six experimental groups (n = 10). Group 1 consisted of teeth treated only with distilled water. Group 2 teeth received 3% NaOCl and 17% EDTA as part of Conventional Chemomechanical Debridement (CCMD) but no additional treatment. Groups 3-6 also received CCMD followed by additional laser disinfection as follows: Group 3 underwent photoactivated disinfection (PAD) using riboflavin with a 450 nm laser; Group 4 underwent PAD using toluidine blue O (TBO) with a 635 nm laser; Group 5 underwent conventional laser endodontics (CLE) with an 808 nm laser; and Group 6 underwent CLE using triple wavelengths of 450 nm, 635 nm, and 808 nm.

Results: The Kruskal-Wallis test revealed significant differences in colony-forming units (CFUs) among the groups after treatment (p < 0.001). Subsequent analysis showed that the difference in mean CFUs between the PAD groups and the CLE groups was not statistically significant. The group treated with the triple laser wavelength exhibited the lowest average CFUs/mL, while the distilled water group had the highest mean value.

Discussion: The study confirms that diode laser-assisted disinfection significantly enhances bacterial reduction compared with conventional irrigation alone. Although PAD methods reduced E. faecalis, their effect was not statistically superior to conventional laser endodontics (CLE). The triplewavelength diode laser group achieved the greatest bacterial reduction, likely due to the synergistic effects of thermal and photochemical interactions. These findings support the adjunctive use of laser disinfection to improve root canal decontamination, particularly when combined with chemomechanical preparation.

Conclusion: This study demonstrates that combining an irrigating solution with a diode laser enhances the effectiveness of reducing pathogenic numbers.

Introduction: Chronic osteomyelitis is a complex and persistent orthopedic infection. Antibiotic-loaded calcium sulfate (CS) has promoted the eradication of infection and bone regeneration. To evaluate the early and mid-term clinical outcomes of antibiotic-impregnated CS in the management of chronic osteomyelitis following internal fixation.

Methods: A prospective interventional case series included (n=15) patients with chronic osteomyelitis treated at Al Yarmouk Teaching Hospital. The patient's medical, surgical history, Additionally, patients' and physical examination were recorded. inflammatory markers and microbiological culture from sinus discharge. Imaging was performed to classify the type of infection according to the Cierny and Mader classification. All patients underwent extensive surgical debridement and implantation of CS loaded with vancomycin or tobramycin, and systemic antibiotics were administered according to culture results. Patients were followed up for 1 year to assess functional scores and infection eradication.

Results: The mean age was 36.86±9.41 years, with 66.7% male and 33.3% female. Tibia was involved in (46.7%). Methicillin-Resistant Staphylococcus Aureus was isolated in (66.67%) of all cases. After a one-year follow-up, all cases achieved infection resolution. Functional scores improved significantly, from 26.8 to 64.2 (P < 0.001).

Discussion: Antibiotic-loaded CS as an adjuvant to surgical debridement and systemic antibiotics shows promising results with higher rates of infection eradication and significant functional improvement.

Conclusions: Using CS loaded with antibiotics as complementary therapy with systemic antibiotics demonstrated significant infection control and functional recovery in patients with chronic osteomyelitis following internal fixation during the early and mid-term follow up. Future studies need a larger sample and a longer follow up.

Introduction: Neonatal hypoglycemia, a common metabolic condition requiring prompt recognition, timely intervention, and careful monitoring to prevent adverse neurodevelopmental outcomes, can be effectively treated with glucose intake through breast milk, a simple and cost-effective approach. This study aimed to evaluate the effectiveness of oral glucose intake by nursing mothers in increasing blood glucose levels in hypoglycemic newborns.

Methods: A parallel-group randomized control trial was conducted from July to August 2023 with 60 postnatal mothers and their newborns admitted to a government hospital in Punjab, India. Participants were randomly assigned to either the experimental or the control group using the concealed envelope method. Mothers in the experimental group received 35 g of oral glucose mixed with 200 ml of water once daily, whereas those in the control group received standard treatment. The outcome was assessed by measuring newborns' random blood glucose levels six hours post-intervention. The outcome assessors were blinded to the interventions. The study adhered to CONSORT guidelines, and statistical analysis was performed using mean, median, frequency, percentage, Chi-square, One-way ANOVA, and t-test.

Results: The post-intervention mean ± SD random blood glucose levels were 61.77 ± 7.238 in the experimental group and 53.80 ± 5.081 in the control group, showing a statistically significant difference (p ≤0.001).

Discussion: The results align with emerging evidence on maternal dietary influence on breast milk composition and neonatal health. However, limitations such as the small sample size and short-term outcome assessment necessitate further research to confirm and expand upon these findings.

Conclusion: Oral glucose intake by lactating mothers significantly increased newborn blood glucose levels, demonstrating its effectiveness as a simple, noninvasive, and cost-effective intervention for neonatal hypoglycemia.

Clinical trial registration number: CTRI -REF/2023/05/066900.

Microscopic colitis (MC) is a chronic inflammatory disorder of the colon, characterized by diarrhea, abdominal pain, and weight loss. It encompasses two different subtypes: collagenous colitis and lymphocytic colitis, distinguished by specific histopathological features. The cause of MC remains largely unknown, although genetic, environmental, and immune factors have been recognized as possible risk factors. Recent research has highlighted the potential role of the gut microbiota in the pathogenesis of MC, with an increasing body of evidence suggesting that alterations in the composition and diversity of the gut microbiota may contribute to the development and progression of the disease. This narrative review aims to summarize current findings on the relationship between the gut microbiota and microscopic colitis, exploring the mechanisms through which microbial dysbiosis could influence intestinal inflammation and affect clinical outcomes. We discuss the impact of specific bacterial taxa, the role of the gut immune system, and the potential therapeutic implications of microbiota modulation in MC. Additional investigation is required to gain a comprehensive understanding of the microbiota-associated mechanisms driving MC and to evaluate the potential of microbiota-targeted treatments for individuals affected by this condition.

Psoriasis is a chronic inflammatory skin disorder that presents ongoing challenges in its management. Current therapeutic approaches, including topical agents, phototherapy, systemic immunomodulators, and biologics, focus on symptom alleviation and improving patients' quality of life. Nonetheless, several limitations exist, such as adverse effects associated with treatments, the emergence of resistance, high costs, and significant inter-individual variability in therapeutic responses. Recent advancements in psoriasis management show promise in developing novel therapeutic agents. Biologics targeting underexploited pathways, particularly interleukin-23 inhibitors like lebrikizumab, have shown superior efficacy profiles. Small molecule inhibitors, such as RORγt and ROCK2 inhibitors, have broadened the therapeutic landscape. Combination regimens, including biologics in conjunction with methotrexate, may enhance overall treatment efficacy. Innovations in topical drug delivery systems, particularly through the use of microneedles and nanoparticle-based carriers, provide the potential for improved therapeutic outcomes. Moreover, the integration of biomarkers and multi-omics approaches holds substantial promise for personalized treatment strategies, refining diagnostic precision and predicting treatment responses while guiding therapeutic decisions. Collaborating among researchers, clinicians, and industry stakeholders is crucial to translating these scientific advancements into clinical practice. By addressing existing challenges and leveraging these emerging therapies, we can significantly enhance the management of psoriasis and improve patient outcomes for this chronic condition.