Clinical Efficacy Studies Research Articles

Innovative Antibiotic Therapies for Carbapenem-Resistant Gram-Negative Bacterial Infections: Clinical Efficacy, Safety, and Comparative Studies

This review provides an overview of recent research and advancements in infection prevention and the treatment of drug-resistant bacterial diseases. Cefiderocol, a novel siderophore cephalosporin, has demonstrated effectiveness against carbapenem-resistant bacteria such as Pseudomonas aeruginosa and Acinetobacter baumannii. Clinical trials, including APEKS-NP and CREDIBLE-CR, affirm its efficacy for hospital-acquired pneumonia (HAP) but highlight concerns over increased mortality due to severe renal complications. Cefiderocol has shown superior outcomes in complicated urinary tract infections (cUTI) compared to imipenem–cilastatin. A comparison of colistin monotherapy versus combination therapy with meropenem for carbapenem-resistant infections revealed no significant improvement in clinical outcomes with combination therapy but noted delays in resistance development. Colistin–rifampicin combination therapy showed potential benefits for colistin-resistant Acinetobacter baumannii, although results were not statistically significant. SPR206, a polymyxin derivative, and durlobactam, a β-lactamase inhibitor, show promise in addressing these resistant strains, with durlobactam demonstrating efficacy in combination with sulbactam and imipenem–cilastatin. Additional studies investigated antibiotic strategies for resistant infections, including cefoperazone–sulbactam versus combination therapy with tigecycline, and examined infection-prevention strategies in surgical settings, comparing chlorhexidine–alcohol and povidone–iodine. This research highlights the importance of optimizing treatment regimens and infection-control measures across various healthcare settings, including neonatology and surgical care.

Comparative study of clinical efficacy of laparoscopic proximal gastrectomy with double-channel anastomosis and tubular gastroesophageal anastomosis.

According to statistics, the incidence of proximal gastric cancer has gradually increased in recent years, posing a serious threat to human health. Tubular gastroesophageal anastomosis and double-channel anastomosis are two relatively mature anti-reflux procedures. A comparison of these two surgical procedures, tubular gastroesophageal anastomosis and double-channel anastomosis, has rarely been reported. Therefore, this study aimed to investigate the effects of these two reconstruction methods on the quality of life of patients with proximal gastric cancer after proximal gastrectomy. To compare short-term clinical results of laparoscopic proximal gastrectomy with double-channel anastomosis vs tubular gastric anastomosis. Patients who underwent proximal gastrectomy at our hospital between January 2020 and January 2023 were enrolled in this retrospective cohort study. The patients were divided into an experimental group (double-channel anastomosis, 33 cases) and a control group (tubular gastric anastomosis, 30 cases). Baseline characteristics, surgical data, postoperative morbidities, and postoperative nutrition were recorded. The differences in baseline data, surgical data, and postoperative complications (20.0% vs 21.2%) were not statistically significant between the two groups. There were no statistically significant differences in the levels of postoperative nutrition indicators between the two groups of patients during the preoperative period and at 3 months postoperatively. In addition, the levels of postoperative nutrition indicators in patients in the experimental group declined significantly less at 6 months and 12 months postoperatively compared with those of the control group (P < 0.05). At 12 months postoperatively, the difference in anastomotic reflux esophagitis between the two groups was statistically significant (P < 0.05) with the experimental group showing less reflux esophagitis. Both double-channel anastomosis and tubular gastric anastomosis after proximal gastrectomy are safe and feasible. Double-channel anastomosis has a better anti-reflux effect and is more beneficial in improving the postoperative nutritional status.

“If that would have lessened my symptoms, that would have been great...”: a qualitative study about the acceptability of tecovirimat as treatment for mpox

BackgroundTecovirimat, an antiviral treatment for smallpox, was approved as a treatment for mpox by the European Medicines Agency in January 2022. Approval was granted under “exceptional circumstances” based on effectiveness found in pre-clinical challenge studies in animals and safety studies in humans showing minimal side effects. As clinical efficacy studies are still ongoing, there is currently limited information with regard to the acceptability of tecovirimat to treat mpox. The aim of this study is to understand prospective acceptability of use of tecovirimat as treatment for mpox.MethodsA co-produced, qualitative, focus group study design was conducted with a theoretically informed sample of people from communities at higher risk and with experience of mpox illness. Thirteen participants took part: all self-identified as cisgender male, 1 self-identified as Black British, 1 as British Asian, 5 as White, 3 as White British, 3 as White Other. Inclusion criteria were as follows: experience of mpox illness; age 18 and over; living in the United Kingdom (UK); living in the UK during 2022 mpox outbreak. Focus groups were recorded, transcribed and thematically analysed using a combination inductive and deductive coding informed by the Treatment Acceptability Framework.ResultsVery few participants were aware of tecovirimat as a treatment option and none were offered it during their mpox illness. Key factors influencing acceptability found in this study were as follows: levels of trust in medicine; level of information; provider communication approach; quality of experience of mpox care. Marginalised communities at highest risk of mpox may have prior experience of structural discrimination which can greatly influence treatment acceptability.ConclusionsThis exploratory study suggest that offering tecovirimat (or comparable emergency-licensed treatments) to people with mpox is acceptable, although uptake will depend on knowledge of mpox treatment options, trust in medicine and medical professionals and provision of relevant information and choice. To increase acceptability of such treatments, clinicians should ensure patients are aware of mpox symptom management options, including pain relief; acknowledge and address patient concerns upfront and within the context of non-stigmatising care; and communicate offers in a consistent and supportive manner in line with locally approved eligibility criteria and protocols at the time.

First modern Russian plasma-derived coagulation factor VIII concentrate (Eytoplasm): Results of clinical study of pharmacokinetics, efficacy and safety

Introduction. Replacement therapy with coagulation factor VIII concentrates remains the standard of care for patients with hemophilia A. In 2023, the drug Eytoplasm, the first modern plasma-derived coagulation factor VIII concentrate developed in the Russian Federation, was authorized for medical use in the Russian Federation.Aim: to study the efficacy, safety, immunogenicity, and pharmacokinetic properties of Eytoplasm.Methods. A multicenter, prospective, open-label clinical trial was conducted in 55 patients over 12 years of age with severe hemophilia A who had previously received treatment with coagulation factor VIII concentrates (at least 150 exposure days). All patients received the drug for prophylactic treatment 2–3 times a week; the treatment duration was 6 months (at least 50 exposure days). In addition, the drug was used to treat bleeding. Ten patients underwent 10 surgical interventions (2 major and 8 minor). Pharmacokinetic parameters were determined after the first administration of the drug to patients and after 6 months of therapy.Results. Eytoplasm pharmacokinetics properties are comparable with other plasma-derived coagulation factor VIII concentrates. No bleeding was recorded in 75.9% of patients. In 92.3 % of patients, a single administration of the drug was sufficient to stop an episode of bleeding. In all participants who completed the study, the residual activity of coagulation factor VIII 48–72 hours after drug administration was at least 1 %. Positive dynamics of APTT was showed during the study. Serious adverse events, allergic reactions, thrombotic and thromboembolic complications were absent in patients. In 3 patients, 4 adverse events associated with the use of the drug were registered: 2 cases of increased serum concentration of direct bilirubin and 2 cases of headache. An inhibitor to coagulation factor VIII was not detected in any patient. In none of the patients who did not have antibodies to parvovirus B19 before the first dose of Eytoplasm, antibodies were detected after 6 months of therapy.Conclusion. Eytoplasm is an effective option for the prevention and treatment of bleeding, and during surgical interventions, including major ones, in patients with hemophilia A. The drug has a favorable safety profi le; its use was not associated with the formation of inhibitory antibodies, allergic reactions, thrombotic and thromboembolic complications.

Clinical efficacy study of the IBS® (Intergrated Bigatti Shaver) Tissue Removal Device in the treatment of endometrial polyps

BackgroundThe IBS® Tissue Removal Device, as a new technology, currently lacks a systematic evaluation of its effectiveness in treating endometrial polyps. Furthermore, the exact cause of polyps recurrence is not yet clear. The purpose of this article is to compare the efficacy of the IBS® Tissue Removal Device with hysteroscopic cold knife resection for the treatment of endometrial polyps and analyze the recurrence factors of endometrial polyps.Methods202 patients with endometrial polyps who were admitted to Changzhou Maternal and Child Health Care Hospital from January 2019 to December 2022 were included in the retrospective studies. Based on the surgical technique, these patients were categorized into two groups: the IBS group (n = 100) and the cold knife group (n = 102). Following surgery, both groups underwent a year of follow-up. Data from the perioperative period (operation time, intraoperative blood loss, intraoperative rehydration, intraoperative complications, length of hospital stay), follow-up data (postoperative endometrial thickness, postoperative vaginal bleeding time, complication rate, menstrual recovery time, pregnancy rate, and recurrence rate) and general clinical data (age, BMI(Body mass index, BMI), number of pregnancies or miscarriages, number of hysteroscopic operations, preoperative white blood cells, fasting blood glucose, polyp diameter) were compared between the two groups.ResultsThe recurrence rate of the IBS group was 6% (6/100), which was lower than that of the cold knife group (14.7% (15/102), and the difference was statistically significant (P < 0.05). The operation time, intraoperative blood loss, and postoperative vaginal bleeding time in the IBS group were significantly lower than those in the cold knife group (P < 0.05), and the multivariate analysis of polyp recurrence showed that polyp diameter was closely related to postoperative recurrence (P < 0.05). The preoperative white blood cells and blood sugar levels have no association with the diameter of polyps. (P > 0.05). There was also no significant difference between IBS group and cold knife group in intraoperative rehydration, intraoperative complications and postoperative hospital stay, intermenstrual bleeding, recovery of menstruation and endometrial thickness and postoperative pregnancy between the IBS group and the cold knife group (P > 0.05).ConclusionThe IBS® Tissue Removal Device can reduce the recurrence rate of endometrial polyps after surgery, improve the perioperative indexes, and reduce the postoperative vaginal bleeding time, which is better than that of hysteroscopic cold knife resection.

Early clinical efficacy study on the efficacy of a three-stage conservative Chinese medicine external treatment for acute lateral ankle ligament injuries

To evaluate the clinical effect of a new three-phase Chinese medicine (CM) external treatment for acute lateral ankle ligament injuries. From July to December 2023, 64 patients with acute lateral ankle ligament injuries were randomly assigned to receive either the new three-phase CM external treatment combined with the POLICE(protect, optimal loading, ice, compression, elevation) treatment (observation group) or the POLICE treatment (control group), with 32 cases in each group. The observation group consisted of 17 males and 15 females, with an average age of(30.59±3.10) years old ranging from 25 to 36 years old, while the control group included 14 males and 18 females, with an average age of(30.03±3.19) years old ranging from 24 to 37 years old. Visual analogue scale (VAS) evaluation and Figure of 8 measurement were used to evaluate the degree of ankle joint pain and swelling of the subjects at the initial enrollment and after 1 week and sixth weeks of treatment. At the same time, the American Orthopaedic Foot and Ankle Society (AOFAS) and Karlsson Ankle Function Score System were used to evaluate the improvement of ankle joint function in patients at all stages. MRI imaging was employed to observe the degree of biological healing of the anterior talofibular ligament, with the signal to noise ratio(SNR) indicating the level of healing. A lower SNR suggests better ligament healing, as it represents lower water content in the ligament. All patients completed a 6-week follow-up. There was no significant difference in VAS, AOFAS score and Karlsson score between the two groups before treatment (P>0.05). After 1 week and 6 weeks of treatment, the VAS, AOFAS score and Karlsson score of the two groups were significantly improved (P<0.05). After 1 week of treatment, the VAS score of the observation group (3.21±0.87) was lower than that of the control group (4.21±1.50), and the difference was statistically significant (P<0.05). After 1 weeks of treatment, the AOFAS and Karlsson scores [(50.84±4.70) points, (49.97±4.00) points] of the observation group were higher than those [(46.91±5.56) points, (46.66±5.36) points]of the control group (P<0.05). MRI images showed that after 6 weeks of treatment, the SNR value of the observation group was significantly lower than that of the control group, and the difference was statistically significant(SNR of the observation group was 75.25±16.59, the contral gruop was 85.81±15.55), (P<0.05). Compared with the control group, the new three-phase CM external treatment is significantly effective in reducing pain and swelling, enhancing ligament repair quality, and promoting functional recovery of the ankle joint in patients with acute lateral malleolar ligament injuries.

Methaemoglobin as a surrogate marker of primaquine antihypnozoite activity in Plasmodium vivax malaria: A systematic review and individual patient data meta-analysis.

The 8-aminoquinolines, primaquine and tafenoquine, are the only available drugs for the radical cure of Plasmodium vivax hypnozoites. Previous evidence suggests that there is dose-dependent 8-aminoquinoline induced methaemoglobinaemia and that higher methaemoglobin concentrations are associated with a lower risk of P. vivax recurrence. We undertook a systematic review and individual patient data meta-analysis to examine the utility of methaemoglobin as a population-level surrogate endpoint for 8-aminoquinoline antihypnozoite activity to prevent P. vivax recurrence. We conducted a systematic search of Medline, Embase, Web of Science, and the Cochrane Library, from 1 January 2000 to 29 September 2022, inclusive, of prospective clinical efficacy studies of acute, uncomplicated P. vivax malaria mono-infections treated with radical curative doses of primaquine. The day 7 methaemoglobin concentration was the primary surrogate outcome of interest. The primary clinical outcome was the time to first P. vivax recurrence between day 7 and day 120 after enrolment. We used multivariable Cox proportional-hazards regression with site random-effects to characterise the time to first recurrence as a function of the day 7 methaemoglobin percentage (log base 2 transformed), adjusted for the partner schizonticidal drug, the primaquine regimen duration as a proxy for the total primaquine dose (mg base/kg), the daily primaquine dose (mg/kg), and other factors. The systematic review protocol was registered with PROSPERO (CRD42023345956). We identified 219 P. vivax efficacy studies, of which 8 provided relevant individual-level data from patients treated with primaquine; all were randomised, parallel arm clinical trials assessed as having low or moderate risk of bias. In the primary analysis data set, there were 1,747 patients with normal glucose-6-phosphate dehydrogenase (G6PD) activity enrolled from 24 study sites across 8 different countries (Indonesia, Brazil, Vietnam, Thailand, Peru, Colombia, Ethiopia, and India). We observed an increasing dose-response relationship between the daily weight-adjusted primaquine dose and day 7 methaemoglobin level. For a given primaquine dose regimen, an observed doubling in day 7 methaemoglobin percentage was associated with an estimated 30% reduction in the risk of P. vivax recurrence (adjusted hazard ratio = 0.70; 95% confidence interval [CI] [0.57, 0.86]; p = 0.0005). These pooled estimates were largely consistent across the study sites. Using day 7 methaemoglobin as a surrogate endpoint for recurrence would reduce required sample sizes by approximately 40%. Study limitations include the inability to distinguish between recrudescence, reinfection, and relapse in P. vivax recurrences. For a given primaquine regimen, higher methaemoglobin on day 7 was associated with a reduced risk of P. vivax recurrence. Under our proposed causal model, this justifies the use of methaemoglobin as a population-level surrogate endpoint for primaquine antihypnozoite activity in patients with P. vivax malaria who have normal G6PD activity.

Treatment of Canine Leishmaniasis with Meglumine Antimoniate: A Clinical Study of Tolerability and Efficacy.

Antimoniate therapy, in association with allopurinol, is one of the first-line treatments of canine leishmaniasis (CanL). This study evaluates the potential adverse effects associated with aNm in the treatment of CanL through both a retrospective analysis and a long-term prospective study also aimed to investigate its efficacy. The retrospective study reviewed records of 87 dogs with CanL with at least one follow-up available during or at the end of therapy with aNm (Glucantime®) at a dose of 50 mg/kg administered subcutaneously twice a day in association with allopurinol. In total, 29.8% of dogs showed adverse effects during treatment as local reactions at the injection site (n = 6), severe systemic reaction to pain (originating from the inoculation site) with depression and anorexia (n = 4), systemic disease due to renal function worsening (n = 4), acute pancreatitis (n = 1), diarrhea (n = 5), vomiting (n = 3) and severe idiosyncratic skin reactions (n = 3). Of these dogs, 13 (14.9%) required treatment suspension. The prospective study included 16 dogs, selected among the LeishVet stages II and III CKD IRIS stage 1 (International Renal Interest Society staging of canine Chronic Kidney Disease) and treated with the same aNm plus allopurinol protocol as in the retrospective study and observed for 360 days; 2 dogs were excluded for severe reactions at the injection site. Mild and transient adverse events were reported in the other 4 dogs. The criteria used to evaluate the efficacy of treatment with aNm were as follows: a reduction in the clinical score and improvement and/or normalization of laboratory parameters, negativization of PCR on the bone marrow samples and disease-free interval time. The proportion of reduction in the clinical score reached 91.9% at D180. No animals showed clinical laboratory relapse during the whole study duration and interestingly, the PCR results showed complete negativity between D0 and D60 in 78.5% of animals. Veterinarians must be vigilant regarding the potentially serious adverse effects associated with aNm and promptly stop drug administration if unexpected clinical manifestations occur. On the other hand, they should not discard its use for CanL treatment since it is confirmed that aNm in association with allopurinol is highly effective in controlling CanL.

Exploring the Therapeutic Potential of High Dose Co-amoxiclav (1 gm) in Different Clinical Conditions: A Review.

Amoxicillin/clavulanate (co-amoxiclav) is a widely used antibiotic in community healthcare settings, combining amoxicillin and clavulanate potassium to combat β-lactamase-producing bacteria. Despite its extensive use, limited pharmacokinetic/pharmacodynamic data support current dosing guidelines. This review explores the significance of high-dose co-amoxiclav (875 mg/125 mg) in treating various infections amidst rising antibiotic resistance. A comprehensive narrative literature review was conducted using MEDLINE, PubMed, and Google Scholar, focusing on co-amoxiclav 875 mg/125 mg from 1992 to 2024. Keywords included "Co-amoxiclav 875mg/125mg," "amoxicillin 875mg," "Co-amoxiclav dosing," "pharmacology," "PK," and "safety." Studies on non-safety aspects, those on cost-effectiveness, non-English articles, and those without full-text access were excluded. Clinical efficacy studies demonstrate the effectiveness of co-amoxiclav (875 mg/125 mg) in treating conditions such as cutaneous actinomycosis, actinomycetoma, lower respiratory tract infections, acute bacterial maxillary sinusitis, and community-acquired pneumonia. Comparative studies reveal similar or superior efficacy of co-amoxiclav (875 mg/125 mg) compared to other dosing regimens and antibiotics such as clindamycin, cefaclor, cefuroxime, and ciprofloxacin. Safety and tolerability assessments indicate that co-amoxiclav is generally well-tolerated, with common mild-to-moderate gastrointestinal side effects. In summary, co-amoxiclav 1 gm remains a crucial antibiotic with optimized dosing regimens enhancing clinical outcomes while addressing resistance challenges.

Clinical efficacy and safety study of Loratadine combined with glucocorticoid nasal spray in the treatment of pediatric bronchial asthma with seasonal allergic rhinitis

Objective To investigate the clinical efficacy and safety of Loratadine combined with Glucocorticoid nasal spray in the treatment of pediatric bronchial asthma with seasonal allergic rhinitis. Methods A total of 100 pediatric patients with moderate to severe bronchial asthma and seasonal allergic rhinitis admitted to our hospital between January 2020 and January 2023 were included in this study. All patients met the complete inclusion and exclusion criteria. Based on different treatment interventions, they were divided into the control group (n = 50) and the observation group (n = 50). Patients in the control group received treatment with glucocorticoid nasal spray, while patients in the observation group received combined intervention with Loratadine in addition to the treatment received by the control group. The clinical treatment outcomes, incidence of adverse reactions, as well as the scores of nasal symptoms, asthma control, and peak expiratory flow rates at different treatment time points (baseline, T1: 30 days after treatment, T2: 60 days after treatment, T3: 90 days after treatment) were compared between the two groups. The combined treatment of Loratadine with Glucocorticoid nasal spray demonstrates significant clinical efficacy in the treatment of pediatric bronchial asthma with seasonal allergic rhinitis. It further promotes the recovery of peak expiratory flow rates, improves symptoms of rhinitis and asthma in pediatric patients. Importantly, the application of this combined treatment does not increase the risk of adverse reactions in pediatric patients, indicating its high safety profile. This treatment approach is worthy of clinical application and further promotion.

Chemical Standardization of Milk Thistle (Silybum marianum L.) Extract Using UHPLC-MS/MS and the Method of Standard Addition.

Extracts prepared from the seeds of the medicinal plant milk thistle [Silybum marianum (L.) Gaertn. (Asteraceae)] are widely used as dietary supplements due to anti-inflammatory, antitumor, and hepatoprotective effects. Called silymarin, the main components of lipophilic extracts of milk thistle seeds are flavonoids and flavonolignans including silybin A, silybin B, isosilybin A, isosilybin B, silydianin, silychristin, taxifolin, and 2,3-dehydrosilybins. The aim of this study was to develop a method based on UHPLC-MS/MS for the chemical authentication and standardization of milk thistle silymarin. Validation included the method of standard addition to account for the lack of a blank matrix. Potential matrix effects were investigated by analyzing silymarin standards dissolved only in the initial UHPLC mobile phase. Measurements of six flavonolignans and taxifolin in the milk thistle extract using UHPLC-MS/MS with standard addition or external standard calibration produced similar results for all analytes except silydianin and 2,3-dehydrosilybin B, which showed significant peak enhancement during negative ion electrospray due to botanical matrix effects. The UHPLC-MS/MS-based method of standard addition requires <10 min per injection and is suitable for the standardization of silymarin from milk thistle in support of preclinical and clinical studies of safety and efficacy.

Clinical efficacy studies of the vaccine against feline panleukopenia, calicivirus infection and viral rhinotracheitis Carnifel PCH in kittens

Clinical efficacy studies of the vaccine against feline panleukopenia, calicivirus infection and viral rhinotracheitis Carnifel PCH in kittens

Predicting Efficacy of a Purified Inactivated Zika Virus Vaccine in Flavivirus-Naïve Humans Using an Immunological Correlate of Protection in Non-Human Primates.

A traditional phase 3 clinical efficacy study for a Zika vaccine may be unfeasible because of the current low transmission of Zika virus (ZIKV). An alternative clinical development approach to evaluate Zika vaccine efficacy (VE) is therefore required, delineated in the US FDA's Accelerated Approval Program for licensure, which utilizes an anti-Zika neutralizing antibody (Zika NAb) titer correlated with non-human primate (NHP) protection as a surrogate endpoint. In this accelerated approval approach, the estimation of VE would be inferred from the percentage of phase 3 trial participants achieving the established surrogate endpoint. We provide a statistical framework to predict the probability of protection for human participants vaccinated with a purified inactivated ZIKV vaccine (TAK-426), in the absence of VE measurements, using NHP data under a single-correlate model. Based on a logistic regression (LR) with bias-reduction model, a probability of 90% protection in humans is expected with a ZIKV NAb geometric mean titer (GMT) ≥ 3.38 log10 half-maximal effective concentration (EC50). The predicted probability of protection of TAK-426 against ZIKV infection was determined using the two-parameter LR model that fit the calculated VE in rhesus macaques and the flavivirus-naïve phase 1 trial participants' ZIKV NAb GMTs log10 EC50, measured by a ZIKV reporter virus particle assay, at 1 month post dose 2. The TAK-426 10 µg dose predicted a probability of protection from infection of 98% among flavivirus-naïve phase 1 trial participants.

Shenqi Fuzheng injection hinders non-small cell lung cancer cell growth by regulating the Bax/Bcl-2 signaling pathway

IntroductionLung cancer (LC) is the most common solid tumor and is currently considered the primary cause of cancer-related deaths worldwide. In clinical efficacy studies, it was not difficult to find that the combination of SFI and chemotherapy could improve the general condition of patients, reduce the side effects of chemotherapy drugs, and have a cooperative antitumor effect in NSCLC patients. However, whether SFI can be used as a novel antitumor drug is still unknown.MethodsFirst, meta-analysis aimed to explore the efficacy of SFI in NSCLC patients, and SFI was identified by ultra-performance liquid chromatography‒mass spectrometry (UPLC‒MS). Cell proliferation, migration, and invasion were explored by Cell Counting Kit-8 (CCK-8), scratch healing, and Transwell assays, respectively. Cell cycle and apoptosis assays were performed by flow cytometry. Transcriptome sequencing analysis was performed in four NSCLC cell lines. Differential expression analysis was used to identify potential targets. Apoptosis-related protein levels were detected by Western blotting assays. The effects of SFI in NSCLC were further investigated by mouse xenografts.ResultsSFI could markedly improve the chemotherapy efficacy of NSCLC patients. The main active ingredients include flavonoids and terpenoids, which can effectively exert antitumor effects. SFI could not only inhibit tumor cell proliferation and cell migration/invasion but also regulate the cell cycle and promote tumor cell apoptosis. In NSCLC, SFI could enhance the transcription level of the CHOP gene, thereby upregulating the expression of the proapoptotic proteins Bax and caspase 3, and inhibiting the expression of the antiapoptotic protein Bcl-2. SFI hindered the growth of mouse NSCLC xenografts in vivo.ConclusionsSFI hindered tumor progression and might promote apoptosis by increasing the expression of Bax, caspase 3 and decreasing the level of Bcl-2 in NSCLC.

Antibiotic adherence in dermatologic surgery: a Multicenter prospective cohort study.

Understanding patient non-adherence to prescribed antibiotics can inform clinical practices, patient counseling, and antibiotic efficacy study design in dermatology. The primary objective was to determine the rate of and reasons for antibiotic non-adherence in the dermatologic surgery setting. The secondary objective was to test the applicability of previously studied survey questions for antibiotic non-adherence screening in the dermatologic surgery setting. Five academic outpatient dermatologic surgery centers across the United States conducted one multicenter prospective cohort study. Dermatologic surgery patients ≥ 18 years of age who were prescribed an antibiotic were included as part of this study. 15.2% (42/276) of patients did not adhere to their antibiotic regimen after dermatologic surgery. Most common reasons for incomplete antibiotic courses included forgotten antibiotics (42.9%,18/42) and side effects (28.6%, 12/42). Previously evaluated questions to identify and predict non-adherence had modest performance in the dermatologic surgery setting (Area under the curve of 0.669 [95% CI (0.583-0.754)]). Antibiotic non-adherence after skin surgery is prevalent and commonly due to reasons that physicians can address with patients.

Development of Cosmetic Formulations Containing Olive Extract and Spirulina sp.: Stability and Clinical Efficacy Studies

Cosmetic formulations with natural antioxidants can reduce the oxidative stress caused by solar radiation and pollution. In this context, the aim of this study was to develop and evaluate the clinical efficacy of cosmetic formulations containing olive extract (OE) and Spirulina sp. (SP). For this, rheological behavior, texture, and sensory properties were evaluated. In addition, 31 healthy women with an age of 39 to 60 years, with skin phototypes II and III, and the presence of signs of photoaging on the face were recruited and divided in Group 1 (vehicle formulation) and Group 2 (vehicle with active substances) for this clinical efficacy study. Both groups applied sunscreen daily during the day. The formulations showed non-Newtonian pseudoplastic behaviors and good sensory properties. The clinical evaluation using instrumental measurements showed an increase in skin hydration, an improvement of the skin barrier, and morphological characteristics of the epidermis after 12 weeks of application of the formulations. There was a significant increase in the brightness of the stratum corneum, which suggested a film-forming effect. In addition, both groups had an improvement in the dermis echogenicity, due to the use of sunscreens. Finally, the proposed formulation was effective in protecting the skin and reducing skin changes related to photoaging.

CAR Cells beyond Classical CAR T Cells: Functional Properties and Prospects of Application.

Chimeric antigen receptors (CARs) are genetically engineered receptors that recognize antigens and activate signaling cascades in a cell. Signal recognition and transmission are mediated by the CAR domains derived from different proteins. T cells carrying CARs against tumor-associated antigens have been used in the development of the CAR T cell therapy, a new approach to fighting malignant neoplasms. Despite its high efficacy in the treatment of oncohematological diseases, CAR T cell therapy has a number of disadvantages that could be avoided by using other types of leukocytes as effector cells. CARs can be expressed in a wide range of cells of adaptive and innate immunity with the emergence or improvement of cytotoxic properties. This review discusses the features of CAR function in different types of immune cells, with a particular focus on the results of preclinical and clinical efficacy studies and the safety of potential CAR cell products.

Comparative analysis of laparoscopic and open ureteroureterostomy for the treatment of pediatric duplicated kidneys: a clinical efficacy and safety study.

Duplicated kidneys, though rare, are common in pediatric urinary issues. For children with complete kidney duplication and symptoms or complications, surgery is often needed. Ureteroureterostomy (UU) is a common procedure for this condition. This study aims to evaluate and compare the clinical efficacy and safety of laparoscopic ureteroureterostomy (LUU) and open ureteroureterostomy (OUU) in the treatment of pediatric duplicated kidneys. A retrospective study at Children's Hospital of Anhui Province from February 2017 to January 2023 included pediatric patients who underwent LUU or OUU for completely duplicated kidneys. Comparative measures included operative time, postoperative hospital stay, intraoperative blood loss, pre- and postoperative renal pelvis anteroposterior diameter, pre- and postoperative upper renal parenchymal thickness, pre- and postoperative upper ureteral diameter, and postoperative complications. There are 30 patients, 20 in the LUU group and 10 in the OUU group. All patients underwent surgery successfully, with no conversions to open surgery in the LUU group. Comparison between the LUU group (average age 3.7±3.4 years) and the OUU group (average age 1.6±1.3 years) showed that laparoscopic surgery had a mean duration of 178.8±60.71 min, intraoperative blood loss of 4.3±0.92 mL, drainage tube removal time of 1.8±0.6 days, and postoperative hospital stay of 4.2±2.2 days. In contrast, the OUU group had a mean surgery duration of 181.6±37.8 min, drainage tube removal time of 2.3±0.7 days, intraoperative blood loss of 6.4±4.06 mL, and postoperative hospital stay of 5.8±1.8 days. Although the LUU group had a shorter surgical duration, the difference was not statistically significant. However, intraoperative blood loss, drainage tube removal time, and postoperative hospital stay were significantly reduced in the LUU group, with statistical significance (P<0.05). After surgery, one case of urinary tract infection occurred in each group. Both groups had double-J stents placed postoperatively, which were removed cystoscopically 4-6 weeks later. Preoperative examinations showed no significant differences between the LUU and OUU groups in terms of upper renal pelvis anteroposterior diameter, upper renal ureteral diameter, and upper renal parenchymal thickness. However, in terms of postoperative recovery indicators, the LUU group outperformed the OUU group significantly, including upper renal pelvis anteroposterior diameter, upper renal ureteral diameter, and upper renal parenchymal thickness, with statistical significance (P<0.05). No hydronephrosis or worsening hydronephrosis was observed in the lower kidneys and ureters of the 30 patients postoperatively. Symptoms disappeared in patients with preoperative dribbling, and pain symptoms in the waist and abdomen relieved. No postoperative febrile urinary tract infections were observed. UU is an effective and safe method for treating pediatric completely duplicated kidneys. Compared to open surgery, laparoscopic surgery is associated with less trauma, faster postoperative recovery, and superior postoperative recovery of anatomical parameters (anteroposterior diameter, ureteral diameter, and parenchymal thickness) of the upper kidneys.

Ethnobotanical study of Zhuang medicinal herbs of Ardisia: variety systematization, traditional uses, phytochemistry, pharmacology, clinical application, and toxicity.

This study aimed to systematize the Zhuang medicinal herbs of Ardisia (ZMHA) in China, to clarify the traditional use in Zhuang medicine and the dynamics of international research on phytochemistry, pharmacology, clinical application, and toxicity. There are 25 species of ZMHA, approximately 938 compounds from the different part, including triterpenoids, phenolics, volatile oils, etc. Pharmacological activity studies have also shown that this genus has anti-tumour, anti-inflammatory, anti-oxidant, anti-bacterial, anti-microbial, etc., and significant effects on respiratory, digestive, urinary, and musculoskeletal system diseases without toxic side effects. The Ardisia has a medicinal history of nearly a thousand years, mainly for treating diseases of the injuries, musculoskeletal, and symptomatic system in Zhuang medicine. Some plants, such as A. crenata, A. gigantifolia, and A. japonica, are also commonly used in folk Zhuang medicine formulas, to treat musculoskeletal, injury, respiratory, and urinate systems disease. These diseases are related to inflammation. These could provide a new direction for future new drug development research. Therefore, species identification and resource investigation should be strengthened, and conducted in vitro mechanism, in vivo pharmacology, clinical efficacy, and toxicology studies and establish a perfect quality standard system.

Natural and Synthetic Drugs Approached for the Treatment of Recurrent Aphthous Stomatitis Over the Last Decade.

Recurrent aphthous stomatitis (RAS) refers to a sore and frequently recurring inflammation of the oral tissues, distinguished by the presence of small ulcers that cause significant discomfort and cannot be attributed to any underlying disease. Different treatments have been used for RAS. This review aims to provide a comprehensive overview of the treatment options over the past decade for recurrent aphthous stomatitis (RAS), encompassing both natural and synthetic treatments. It will utilize clinical efficacy studies conducted in vivo and in vitro, along with a focus on the pharmaceutical approach through advancements in drug delivery development. We conducted a thorough literature search from 2013 to 2023 in prominent databases such as PubMed, Scopus, and Cochrane, utilizing appropriate keywords of recurrent aphthous stomatitis, and treatment. A total of 53 clinical trials with 3022 patients were included, with 35 using natural materials in their research and a total of 16 articles discussing RAS treatment using synthetic materials. All the clinical trials showed that natural and synthetic medicines seemed to benefit RAS patients by reducing pain score, ulcer size, and number of ulcers and shortening the healing duration.