Tag: pubmed

Dokl Biochem Biophys. 2024 Aug 28. doi: 10.1134/S1607672924701084. Online ahead of print.

ABSTRACT

Netakimab has shown high efficacy in controlled clinical trials in the treatment of AS patients. This article presents results of an observational study of netakimab using in routine clinical practice.

OBJECTIVE: : To evaluate retention rates and safety of netakimab in patients with AS in real-world clinical practice. Additionally, the efficacy of netakimab was evaluated at 1-year follow-up.

MATERIALS AND METHODS: : Patients were recruited for the study from August 2020 to December 2021 at 23 centers in the Russian Federation. The study included patients who were prescribed netakimab therapy before enrollment, so clinical and medical history data for the first visit were entered retrospectively, and following visits at 12, 24, and 52 weeks of therapy were collected within the study. Drug survival rate was calculated according to Kaplan-Meier analysis.

RESULTS: : The study included 137 (93 men and 44 women) patients with AS. The average age of patients was 42.3 (11.9) years, 34.3% of patients had previously received therapy with bDMARD, mainly TNF inhibitors. At the end of the analyzed period (52 weeks of therapy), 90.4% (95% CI, 85.4-95.7) of patients continued treatment with netakimab. The BASDAI and ASDAS-CRP showed statistically significant decreases in scores from baseline at all time points. Netakimab was well tolerated by patients; AEs, related to therapy according to the investigator’s opinion, were reported in 7 (5.1%) patients. Two patients stopped taking netakimab due to AEs (terminal ileitis and chronic colitis).

CONCLUSIONS: : In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy.

PMID:39196530 | DOI:10.1134/S1607672924701084

Curr Med Sci. 2024 Aug 28. doi: 10.1007/s11596-024-2916-9. Online ahead of print.

ABSTRACT

OBJECTIVE: Qiliqiangxin (QLQX) capsule- a traditional Chinese medicine used for treating heart failure (HF), can modulate inflammatory cytokines in rats with myocardial infarction. However, its immune-regulating effect on dilated cardiomyopathy (DCM) remains unknown. The aim of this study was to investigate whether QLQX has a unique regulatory role in the imbalance of pro- and anti-inflammatory cytokines in patients with DCM.

METHODS: The QLQX-DCM is a randomized- double-blind trial conducted at 24 tertiary hospitals in China. A total of 345 patients with newly diagnosed virus-induced DCM were randomly assigned to receive QLQX capsules or placebo while receiving optimal medical therapy for HF. The primary endpoints were changes in plasma inflammatory cytokines and improvements in left ventricular ejection fraction (LVEF) and left ventricular end-diastolic diameter (LVEDd) over the 12-month treatment.

RESULTS: At the 12-month follow-up, the levels of IFN-γ, IL-17, TNF-α, and IL-4 decreased significantly, while the level of IL-10 increased in both groups compared with baselines (all P<0.0001). Furthermore-these changes, coupled with improvements in LVEF, NT-proBNP and New York Heart Association (NYHA) functional classification, excluding the LVEDd in the QLQX group, were greater than those in the placebo group (all P<0.001). Additionally, compared with placebo, QLQX treatment also reduced all-cause mortality and rehospitalization rates by 2.17% and 2.28%, respectively, but the difference was not statistically significant.

CONCLUSION: QLQX has the potential to alleviate the imbalance of inflammatory cytokines in patients with DCM, potentially leading to further improvements in cardiac function when combined with anti-HF standard medications.

PMID:39196518 | DOI:10.1007/s11596-024-2916-9

Blood Res. 2024 Aug 28;59(1):29. doi: 10.1007/s44313-024-00023-9.

ABSTRACT

PURPOSE: This study aimed to investigate the pharmacokinetics (PK) of factor VIII (FVIII) in Korean patients, as limited information is available on the PK of FVIII in this population.

METHODS: We collected the FVIII PK results from patients with moderate-to-severe hemophilia A using myPKFiT. PK variations were assessed according to age, blood type, inhibitor history, von Willebrand factor antigen (vWF:Ag) level, and body mass index. Additionally, the correlation between the PK profile and prophylaxis regimen was specifically analyzed for each product in severe cases.

RESULTS: The PK data of 48 and 81 patients treated with octocog alfa and rurioctocog alfa pegol, respectively, were obtained. The median half-lives of octocog alfa and rurioctocog alfa pegol were 9.9 (range: 6.3-15.2) h and 15.3 (range: 10.4-23.9) h, respectively. The PK profiles for each product did not differ according to age group; however, blood type-O patients had shorter half-lives and time to 1% compared to non-blood type-O patients. In regression analysis, the PK of octocog alfa showed a statistically significant difference according to age, whereas the PK of rurioctocog alfa pegol correlated with vWF:Ag. Only the frequency of rurioctocog alfa pegol use showed a statistically significant difference in relation to time to 1%, although the coefficient of determination was small.

CONCLUSION: This study confirmed significant interpatient variation in the PK of FVIII among Korean patients with hemophilia A. To achieve optimized prophylaxis, personalizing the regimen based on the PK profile of each individual patient is essential.

PMID:39196490 | DOI:10.1007/s44313-024-00023-9

Eur J Clin Microbiol Infect Dis. 2024 Aug 28. doi: 10.1007/s10096-024-04921-9. Online ahead of print.

ABSTRACT

PURPOSE: Bacterial isolation is associated with worse outcomes after lung transplantation (LTx), and successful bacterial eradication is shown to improve long-term survival and pulmonary function. Outpatient Parenteral Antibiotic Therapy (OPAT) may be an effective therapeutic modality for bacterial eradication post-LTx.

METHODS: A single-center, retrospective analysis of OPAT characteristics, efficacy, safety, and costs in non-cystic fibrosis LTx recipients.

RESULTS: A total of 156 OPAT courses (from June 2019 to December 2022) were evaluated in 108 distinct LTx recipients. OPAT mainly consisted of dual antibiotic therapy (69%) for pulmonary bacterial isolation (97%), mostly Pseudomonas aeruginosa (66%). Successful eradication at 3 months post-OPAT was achieved in 71%. Eradication rate was significantly higher in patients treated after the first post-operative year (79%), compared to patients within the first year (61%) (p = 0.017). Eradication rate was similar for multidrug resistance (eradication rate 61%) versus no multidrug resistance (74%) (p = 0.116). Spirometry remained stable at 90 days post-OPAT. A statistically significant, but clinically negligible, increase in serum creatinine at 90 days post-OPAT was observed (1.33 mg/dL vs. 1.39 mg/dL, p < 0.001), yet unrelated to the antibiotic regimen used. OPAT-related hospital admissions occurred in 13% and line-related adverse events in 6%. Median number of hospitalization days saved per OPAT-course was 10 days (range 2-92), accounting for a total of 1841 avoided admission days and an estimated net cost reduction of 47% per treatment course.

CONCLUSION: OPAT is an effective and safe therapeutic modality for bacterial eradication post-LTx, associated with a significant reduction in hospitalization days and treatment costs.

PMID:39196488 | DOI:10.1007/s10096-024-04921-9

J Clin Monit Comput. 2024 Aug 28. doi: 10.1007/s10877-024-01211-9. Online ahead of print.

ABSTRACT

Pulse oximetry (SpO₂) is a critical monitor for assessing oxygenation status and guiding therapy in critically ill patients. Race has been identified as a potential source of SpO₂ error, with consequent bias and inequities in healthcare. This study was designed to evaluate the incidence of occult hypoxemia and accuracy of pulse oximetry associated with the Massey-Martin scale and characterize the relationship between Massey scores and self-identified race. This retrospective single institute study utilized the Massey-Martin scale as a quantitative assessment of skin pigmentation. These values were recorded peri-operatively in patients enrolled in unrelated clinical trials. The electronic medical record was utilized to obtain demographics, arterial blood gas values, and time matched SpO₂ values for each PaO₂ ≤ 125 mmHg recorded throughout their hospitalizations. Differences between SaO₂ and SpO₂ were compared as a function of both Massey score and self-reported race. 4030 paired SaO₂-SpO₂ values were available from 579 patients. The average error (SaO₂-SpO₂) ± SD was 0.23 ± 2.6%. Statistically significant differences were observed within Massey scores and among races, with average errors that ranged from – 0.39 ± 2.3 to 0.53 ± 2.5 and – 0.55 ± 2.1 to 0.37 ± 2.7, respectively. Skin color varied widely within each self-identified race category. There was no clinically significant association between error rates and Massey-Martin scale grades and no clinically significant difference in accuracy observed between self-reported Black and White patients. In addition, self-reported race is not an appropriate surrogate for skin color.

PMID:39196478 | DOI:10.1007/s10877-024-01211-9

Adv Health Sci Educ Theory Pract. 2024 Aug 28. doi: 10.1007/s10459-024-10365-9. Online ahead of print.

ABSTRACT

To design effective instruction, educators need to know what design strategies are generally effective and why these strategies work, based on the mechanisms through which they operate. Experimental comparison studies, which compare one instructional design against another, can generate much needed evidence in support of effective design strategies. However, experimental comparison studies are often not equipped to generate evidence regarding the mechanisms through which strategies operate. Therefore, simply conducting experimental comparison studies may not provide educators with all the information they need to design more effective instruction. To generate evidence for the what and the why of design strategies, we advocate for researchers to conduct experimental comparison studies that include mediation or moderation analyses, which can illuminate the mechanisms through which design strategies operate. The purpose of this article is to provide a conceptual overview of mediation and moderation analyses for researchers who conduct experimental comparison studies in instructional design. While these statistical techniques add complexity to study design and analysis, they hold great promise for providing educators with more powerful information upon which to base their instructional design decisions. Using two real-world examples from our own work, we describe the structure of mediation and moderation analyses, emphasizing the need to control for confounding even in the context of experimental studies. We also discuss the importance of using learning theories to help identify mediating or moderating variables to test.

PMID:39196469 | DOI:10.1007/s10459-024-10365-9

Clin Oral Investig. 2024 Aug 28;28(9):503. doi: 10.1007/s00784-024-05901-1.

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the effect of remineralization agents such as fluoride varnish and P₁₁-4, alone and in combination with Er: YAG laser, on in-vitro hard tissue repair in artificial enamel lesions.

MATERIALS AND METHODS: A total of sixty enamel surfaces of 4 × 5 mm in size were created on both the buccal and lingual sides of thirty extracted wisdom teeth. Remineralization agents were applied to the specimens that were grouped as follows: Group 1, control; Group 2, fluoride varnish (FV); Group 3, P₁₁-4; Group 4, laser; Group 5, laser + FV; and Group 6, laser + P₁₁-4. The fluorescence level was determined with DiagnoDent. The enamel mineral density, area and volume, and caries lesion area and volume were determined with micro-computed tomography (µCT), surface features were evaluated using scanning electron microscopy (SEM), and elemental analysis was performed using energy dispersive x-ray spectroscopy (EDS) .

RESULTS: For specimens treated only with self-assembling peptide P₁₁-4, the caries lesion area (mm²) values were 38.19 and 21.62, and the caries lesion volume (mm³) values were 6.27 and 2.99, respectively for pre- and post-treatment. In combination usage of self-assembling peptide P₁₁-4 and laser, the caries lesion area (mm²) values were 38.39 and 16.91, and the caries lesion volume (mm³) values were 11.15 and 3.64, respectively for pre- and post-treatment. In the application of the P₁₁-4 alone and in combination with laser, there was a statistically significant decrease in DiagnoDent values, an increase in enamel volume(mm³),enamel area(mm²) and mineral density(g/cm³) values and a decrease in caries lesion volume(mm³) and area(mm²) obtained by µCT, and an increase in %Ca and %F values obtained by SEM/EDS analysis (p < 0.05). It was discovered that the samples treated with P₁₁-4 had a considerably higher rise in the Ca/P ratio than the samples treated with FV (p < 0.05). The calcium content increased significantly more when P₁₁-4 application was combined with laser irradiation (p < 0.05).

CONCLUSIONS: The combined use of self-assembling peptide P₁₁-4 and laser accelerated the remineralization process and increased the remineralization capacity.

CLINICAL RELEVANCE: FV and P₁₁-4, alone or in combination with laser, can be successfully used as remineralization agents in initial enamel caries.

PMID:39196467 | DOI:10.1007/s00784-024-05901-1

Support Care Cancer. 2024 Aug 28;32(9):615. doi: 10.1007/s00520-024-08785-9.

ABSTRACT

BACKGROUND: Complementary, alternative, and integrative medicine (CAIM) has become an increasingly popular supportive therapy option for patients with cancer. The objective of this study was to investigate how researchers and clinicians in the oncology field perceive CAIM.

METHODS: We conducted an online, anonymous, cross-sectional survey for researchers and clinicians who have published their work in oncology journals that are indexed in MEDLINE. The link to the survey was sent to 47, 991 researchers and clinicians whose contact information was extracted from their publications. The survey included various multiple-choice questions, and one open-ended question at the end to allow for any additional comments.

RESULTS: 751 respondents completed the survey, and they mostly identified themselves as researchers (n = 329, 45.13%), or as both researchers and clinicians (n = 332, 45.45%) in the field of oncology. Over half of the respondents perceive mind-body therapies (n = 354, 54.97%) to be the most promising CAIM category with regards to the prevention, treatment, and/or management of diseases related to oncology, and many respondents agreed that most CAIM therapies are safe (n = 218, 37.39%), and that clinicians should receive training on CAIM therapies via formal (n = 225, 38.59%) and supplemental education (n = 290, 49.83%). However, many respondents were unsure when asked if most CAIM therapies are effective (n = 202, 34.77%).

CONCLUSIONS: The findings from this study demonstrated great current interest in the use of CAIM in oncology. This information can serve as a foundation for conducting additional research and creating customized educational materials for researchers and clinicians in oncology.

PMID:39196463 | DOI:10.1007/s00520-024-08785-9

J Robot Surg. 2024 Aug 28;18(1):329. doi: 10.1007/s11701-024-02086-3.

ABSTRACT

The aim of the study was to compare the efficacy and safety of robot-assisted (RA) percutaneous hollow screw fixation with traditional open reduction internal fixation (ORIF) for the treatment of calcaneal fractures through a systematic review and meta-analysis. An extensive search was conducted in the following databases-PubMed, CNKI, Embase, and the Cochrane Library-to gather research on patients with calcaneal fractures published up to July 2024. This search focuses on studies comparing the effectiveness of robot-assisted percutaneous cannulated screw fixation versus ORIF. We will include studies published in both English and Chinese. Our screening process adhered strictly to predefined inclusion and exclusion criteria, emphasizing randomized controlled trials (RCTs) and cohort studies. The ROBINS-I tool was utilized to evaluate the risk of bias in non-randomized studies. Meta-analysis was conducted using Review Manager 5.4.1. The final analysis incorporated six retrospective cohort studies comprising 247 patients-122 treated with robotic-assisted percutaneous cannulated screw fixation and 125 with conventional open reduction and internal fixation. The findings indicated that patients undergoing robotic-assisted percutaneous cannulated screw fixation experienced advantages over those receiving conventional treatment in terms of reduced hospital stay, lower estimated blood loss, and higher AOFAS scores at both 3 and 6 months. No statistically significant differences were observed between the two methods concerning operative time, fracture healing duration, or the frequency of intraoperative fluoroscopies. Robotic-assisted percutaneous cannulated screw fixation is a safe and viable treatment approach for patients with calcaneal fractures. When compared to ORIF methods, this robotic-assisted technique demonstrated significant benefits, including reduced hospital stay, lower estimated blood loss, and improved AOFAS scores at both 3 and 6 months.

PMID:39196425 | DOI:10.1007/s11701-024-02086-3

Clin Oral Investig. 2024 Aug 28;28(9):504. doi: 10.1007/s00784-024-05891-0.

ABSTRACT

OBJECTIVE: To study the effect of incorporating chitosan and fluoride-loaded chitosan nanoparticles into a glass-ionomer cement (GIC) to prevent secondary caries.

MATERIALS AND METHODS: A standard cervical cavity (mesio-distal width 6 mm, cervico-occlusal width 2 mm, and depth 2 mm) was prepared on 30 molars for the following restoration groups: group 1, conventional GIC restoration; group 2, chitosan (10%) modified GIC restoration; group 3, fluoride loaded chitosan nanoparticles (10%) modified GIC restoration. The restored teeth were subjected to 1,500 thermal cycles before undergoing a multi-species cariogenic biofilm challenge. The restored teeth were examined by micro-computed tomography (micro-CT), scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM/EDX). Data were analyzed by the one-way ANOVA, Tukey HDS, Kruskal Wallis, and Dunn’s test.

RESULTS: Micro-CT determined outer lesion depths for groups 1-3 were: 614 ± 20 μm, 589 ± 17 μm, and 560 ± 19 μm respectively. Both modifications with chitosan and fluoride-loaded chitosan nanoparticles significantly affected outer lesion depth (p < 0.05). The modification with fluoride-loaded chitosan nanoparticles statistically significantly decreased the outer lesion depth compared to all other groups (p < 0.05). SEM/EDX showed an increase of calcium, phosphorus, and fluoride at the root dentine adjacent to the restoration in groups 2 and 3 (modified GIC). This increase was statistically significantly higher in the group modified with fluorine-loaded nano chitosan particles compared to the other groups (p < 0.05).

CONCLUSION: Incorporation of 10% chitosan and 10% fluoride-loaded chitosan nanoparticles into GIC restorative material can prevent secondary root caries development. 10% fluoride-loaded chitosan nanoparticles were more effective.

CLINICAL SIGNIFICANCE: Glass ionomer cement modified with fluoride-loaded chitosan nanoparticles may be a promising restorative material in pediatric and preventive dentistry due to their controlled release properties.

PMID:39196417 | DOI:10.1007/s00784-024-05891-0