Category: Nevin Manimala

Cureus. 2023 Apr 17;15(4):e37732. doi: 10.7759/cureus.37732. eCollection 2023 Apr.

ABSTRACT

Introduction Non-steroidal anti-inflammatory drugs (NSAIDs) are the most prescribed analgesics for controlling post-exodontia pain, administered by various routes. The transdermal route possesses the advantages of providing sustained release of the drug, being non-invasive, bypassing first-pass metabolism, and eliminating gastrointestinal adverse effects. This study compared the analgesic efficacy of diclofenac 200 mg and ketoprofen 30 mg transdermal patches for post-orthodontic exodontia pain. Materials and methods Thirty patients who underwent orthodontic bilateral maxillary and/or mandibular premolar extractions under local anaesthesia were included in the study. Each patient received single transdermal diclofenac 200 mg patch and single transdermal ketoprofen 30 mg patch on the outer, ipsilateral upper arm immediately post-extraction in the two appointments in random order. The pain score was recorded every second hourly for the first 24 hours postoperatively using a visual analog scale (VAS). The requirement of rescue analgesics at various time points and the total number of rescue analgesics taken in the first 24 hours postoperatively were noted. Any allergic reaction to the transdermal patches was also recorded. Results The analgesic efficacy of the two transdermal patches at any given time point in 24 hours by Mann-Whitney U test showed no statistically significant (p<0.05) difference. An overall intragroup statistically significant difference (p<0.05), by Wilcoxon matched pairs test, was found by comparison of VAS pain scores at different time points to that at 0-2 hours after application of transdermal ketoprofen and diclofenac patches, respectively. The mean maximum pain intensity was slightly lower for ketoprofen (2.33) than diclofenac (2.60) transdermal patch. Patients consumed the rescue analgesic within the first 12 hours postoperatively, with the mean value of the total number of rescue analgesics taken with ketoprofen transdermal patch (0.23) slightly lower than diclofenac transdermal patch (0.27) application. Conclusion Ketoprofen and diclofenac transdermal patches provide similar analgesia post orthodontic extraction. The patients required rescue analgesics only during the initial hours of the postoperative follow-up period.

PMID:37213950 | PMC:PMC10191808 | DOI:10.7759/cureus.37732

Cureus. 2023 Apr 20;15(4):e37858. doi: 10.7759/cureus.37858. eCollection 2023 Apr.

ABSTRACT

INTRODUCTION: The troubling issues of conventional antidepressants are inadequate disease remission and potential adverse effects. There is a dearth of research findings comparing vilazodone, escitalopram, and vortioxetine. The objective of this analysis is to determinechanges in the Hamilton Depression Rating Scale (HDRS) and Montgomery-Åsberg Depression Rating Scale (MADRS) scoresand the incidence of adverse events at 12 weeks.

METHODS: This is an exploratory interim analysis of a randomized, three-arm, open-label ongoing study. The participants were randomly assigned in a 1:1:1 ratio to receive either vilazodone (20-40 mg/d), escitalopram (10-20 mg/d), or vortioxetine (5-20 mg/d). Efficacy and safety assessments were done at baseline, four weeks, eight weeks, and 12 weeks.

RESULTS: Forty-nine(69%) of the 71 enrolled participants (mean age 43.9±12.2 years; 37 men (52%)) completed the 12-week follow-up. At baseline, the three groups’ median HDRS scores were 30.0, 29.5, and 29.0 (p=0.76), respectively, and at 12 weeks, they amounted to 19.5, 19.5, and 18.0 (p=0.18), respectively. At baseline, group-wise median MADRS scores were 36, 36, and 36, respectively (p=0.79); at 12 weeks, they were 24, 24, and 23, respectively (p=0.03). In the post-hoc analysis, the inter-group comparison of the change in HDRS (p = 0.02) and MADRS (p = 0.06) scores from baseline did not reach statistical significance. No participants experienced serious adverse events.

CONCLUSION: In this initial assessment of a continuing study, vortioxetine exhibited a clinically (not statistically) significant drop in HDRS and MADRS scores, compared to vilazodone and escitalopram. The antidepressant effects need to be investigated further.

PMID:37213947 | PMC:PMC10199330 | DOI:10.7759/cureus.37858

J Educ Eval Health Prof. 2023;20:15. doi: 10.3352/jeehp.2023.20.15. Epub 2023 May 22.

ABSTRACT

PURPOSE: The number of Korean midwifery licensing examination applicants has steadily decreased due to the low birth rate and lack of training institutions for midwives. This study aimed to evaluate the adequacy of the examination-based licensing system and the possibility of a training-based licensing system.

METHODS: A survey questionnaire was developed and dispatched to 230 professionals from December 28, 2022 to January 13, 2023, through an online form using Google Surveys. Descriptive statistics were used to analyze the results.

RESULTS: Responses from 217 persons (94.3%) were analyzed after excluding incomplete responses. Out of the 217 participants, 198 (91.2%) agreed with maintaining the current examination-based licensing system; 94 (43.3%) agreed with implementing a training-based licensing system to cover the examination costs due to the decreasing number of applicants; 132 (60.8%) agreed with establishing a midwifery education evaluation center for a training-based licensing system; 163 (75.1%) said that the quality of midwifery might be lowered if midwives were produced only by a training-based licensing system, and 197 (90.8%) said that the training of midwives as birth support personnel should be promoted in Korea.

CONCLUSION: Favorable results were reported for the examination-based licensing system; however, if a training-based licensing system is implemented, it will be necessary to establish a midwifery education evaluation center to manage the quality of midwives. As the annual number of candidates for the Korean midwifery licensing examination has been approximately 10 in recent years, it is necessary to consider more actively granting midwifery licenses through a training-based licensing system.

PMID:37211982 | DOI:10.3352/jeehp.2023.20.15

J Arthroplasty. 2023 Jun;38(6):986-991. doi: 10.1016/j.arth.2023.02.018.

ABSTRACT

PRO: Nearly all new devices and drugs come from industry that provides two-thirds of the funding for medical research, and a much higher fraction of clinical research. Realistically, without corporate-funded studies, perioperative research would stagnate with little innovation and few new products. Opinions are ubiquitous and normal but do not constitute epidemiologic bias. Competent clinical research includes many protections against selection and measurement bias, and the publication process provides at least moderate protection against misinterpretation of results. Trial registries largely prevent selective data presentation. Sponsored trials are particularly protected against inappropriate corporate influence because they are usually codesigned with the US Food and Drug Administration, and analyses are based on formal predefined statistical plans, as well as being conducted with rigorous external monitoring. Novel products, which are essential for advances in clinical care, largely come from industry, and industry appropriately funds much of the required research. We should celebrate industry’s contribution to improvements in clinical care. CON: While industry funding contributes to research and discovery, examples of industry-funded research demonstrate bias. In the setting of financial pressures and potential conflict of interest, bias can influence the type of study design, hypotheses being tested, rigor and transparency in data analysis, interpretation, as well as reporting of the results. Unlike public granting agencies, industry does not necessarily provide funding based on unbiased peer review following an open call for proposals. The focus on success can influence the choice of a comparator, which might not be ideal among the possible alternatives, the language used in the publication, and even the ability to publish. Unpublished negative trials can result in selected information being withheld from the scientific community and the public. Appropriate safeguards are needed to ensure that research addresses the most important and relevant questions, that results are available even when they do not support the use of a product produced by the funding company, that populations studied reflect the relevant patients, that the most rigorous approaches are applied, that studies have the appropriate power to address the question posed, and that conclusions are presented in an unbiased manner.

PMID:37211379 | DOI:10.1016/j.arth.2023.02.018

Photodiagnosis Photodyn Ther. 2023 May 19:103621. doi: 10.1016/j.pdpdt.2023.103621. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study is to assess choroid thickness, retinal vessel density in the superficial capillary plexus layer and deep capillary plexus layer in heart failure (HF) using optical coherence tomography angiography (OCT-A).

METHODS: 36 healthy participants (group 1), 33 patients with HF were assessed for this study. HF patients had a left ventricular ejection fraction (LVEF) <50%. HF patients were divided into 2 groups according to the New York Heart Association (NYHA). 15 patients were evaluated as group 2 according to NYHA and 18 patients as group 3 according to NYHA. Choroid thickness, superficial and deep capillary plexus perfusion were analyzed between groups using OCT-A.

RESULTS: Choroid thicknesses were found to be significantly decrease in the HF groups. Superficial capillary plexus density was compared with the control group, no statistically significant difference was found between the HF groups. But among the HF groups, a statistically significant decrease was found in group 3 patients. Deep capillary plexus density was compared with the control group, a statistically significant decrease was found in group 3. In addition, deep capillary plexus density a statistically significant difference was found between the groups HF.

CONCLUSIONS: Patients with HF showed decreased flow density compared with healthy controls. In addition, significant changes were found in flow densities among the HF groups. Retinal perfusion measured using OCT-A may give an idea about the hemodynamic status and microperfusion of HF patients.

PMID:37211295 | DOI:10.1016/j.pdpdt.2023.103621

Int J Infect Dis. 2023 May 19:S1201-9712(23)00569-6. doi: 10.1016/j.ijid.2023.05.017. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the immunogenicity and safety of an anti-rabies monoclonal antibody (mAb), Ormutivimab, compared with human rabies immunoglobulin (HRIG).

METHODS: This phase 3 trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥ 18 years with suspected WHO category Ⅲ rabies exposures. The participants were randomized 1:1 to Ormutivimab and HRIG group. After thorough wound washing and injection of Ormutivimab/HRIG on Day 0, the vaccination was administered on Days 0, 3, 7, 14, and 28. The primary endpoint was the adjusted geometric mean concentration (GMC) of rabies virus neutralizing activity (RVNA) on Day 7. The endpoint of safety included the occurrence of adverse reactions (ARs) and serious adverse events (SAEs).

RESULTS: A total of 720 participants were recruited. The adjusted-GMC of RVNA (0.41 IU/mL) on Day 7 in Ormutivimab group was not inferior to that in HRIG group (0.41 IU/mL), with ratio of adjusted-GMC of 1.01 (95%CI: 0.91, 1.14). The seroconversion rate of the Ormutivimab-group was higher than that of the HRIG-group on Days 7, 14, and 42. The majority of local injection site and systemic ARs reported from both groups were mild to moderate in severity.

CONCLUSIONS: Ormutivimab + vaccine can protect aged ≥ 18 years victims with category Ⅲ suspected rabies exposure as a component of post-exposure prophylaxis. Ormutivimab has a weaker influence on immunity response of rabies vaccines.

CLINICAL TRIALS REGISTRATION: ChiCTR1900021478 (the Chinese Clinical Trial Registry of WHO).

PMID:37211270 | DOI:10.1016/j.ijid.2023.05.017

J Foot Ankle Surg. 2023 May 19:S1067-2516(23)00121-7. doi: 10.1053/j.jfas.2023.05.005. Online ahead of print.

ABSTRACT

Although intramedullary screw fixation is commonly performed for proximal fifth metatarsal fractures, high rates of nonunion, refracture, and hardware prominence have been reported. The Jones Specific Implant (JSI) is a novel surgical implant which contours to the native curvature of the fifth metatarsal allowing for a more anatomic fixation. The purpose of this study was to compare short-term complication rates and outcomes of patients treated with the JSI to other fixation types such as plates and intramedullary screws. Electronic records were queried for adult patients with proximal fifth metatarsal fractures who underwent primary fixation from 2010 – 2021. All patients were treated by a foot and ankle fellowship-trained surgeon with intramedullary screws, plates, or JSI (Arthrex Inc., Naples, FL). Visual analog scale (VAS) and the American Orthopedic Foot and Ankle Score (AOFAS) were recorded and compared using univariate statistics. Eighty-five patients underwent fixation using intramedullary screw (n=51, 60%), plate (n=22, 25.9%), or JSI (n=12, 14.1%) with a mean follow-up of 11.1±14.6 months. The total cohort demonstrated a significant improvement in VAS pain (p < 0.0001) as well as AOFAS (p < 0.0001) scores. When comparing the cohort treated with JSI and the cohort treated with all other types of fixation, there were no significant differences in postoperative VAS or AOFAS scores. Only three complications, one with JSI, (3.5%) required removal of the symptomatic hardware. The JSI is a novel treatment for proximal fifth metatarsal fractures, with similar early outcomes and complication rates when compared with intramedullary screw and plate fixation.

PMID:37211269 | DOI:10.1053/j.jfas.2023.05.005

Prev Med. 2023 May 19:107551. doi: 10.1016/j.ypmed.2023.107551. Online ahead of print.

ABSTRACT

Cervical, endometrial, and ovarian cancers are major gynecologic cancers in Taiwan. Although cervical cancer has received attention through nationwide screening program and the rollout of the human papillomavirus vaccine, endometrial and ovarian cancers have attracted less attention. The age-period-cohort analysis of constant-relative-variation method was used to estimate the mortality trends of cervical, endometrial, and ovarian cancers for population aged 30-84 years during 1981-2020 in Taiwan. The years of life lost was used to estimate the disease burden due to premature death from gynecological cancers. The age effect of endometrial cancer mortality was greater than those of cervical and ovarian cancers. The period effects decreased during 1996-2000 for cervical cancer and plateaued for endometrial and ovarian cancers during 2006-2020. The cohort effect decreased after the birth year 1911 for cervical cancer, increased after 1931 for endometrial cancer, and increased in all birth years for ovarian cancer. For both endometrial and ovarian cancers, the Spearman’s correlation coefficients revealed the strong negative correlations between the fertility and the cohort effects, and the strong positive correlations between the average age at first childbirth and the cohort effects. The burden of premature death from ovarian cancer was higher than those of cervical and endometrial cancers during 2016-2020. Due to increasing cohort effect and burden of premature death, endometrial and ovarian cancers will become the largest threat to women’s reproductive health in Taiwan.

PMID:37211252 | DOI:10.1016/j.ypmed.2023.107551

J Lipid Res. 2023 May 19:100391. doi: 10.1016/j.jlr.2023.100391. Online ahead of print.

ABSTRACT

Immunoglobulin M (IgM) autoantibodies to oxidation-specific epitopes (OSE) can be present at birth and protect against atherosclerosis in experimental models. This study sought to determine whether high titers of IgM titers to OSE (IgM OSE) are associated with lower risk of acute myocardial infarction (AMI) in humans. IgM to malondialdehyde-low density lipoprotein (MDA-LDL), phosphocholine-modified bovine serum albumin (PC-BSA), IgM apolipoprotein B100-immune complexes (ApoB-IC) and a peptide mimotope of malondialdehyde (MDA) were measured within 24 hours of first AMI in 4559 patients and 4617 age and sex-matched controls in the Pakistan Risk of Myocardial Infarction Study. Adjustment was made for sex, age, smoking, hypertension, diabetes, LDL-C, HDL-C, and triglycerides. Logistic regression was used to estimate odds ratio (OR) and 95% confidence interval (95% CI) for AMI. All four IgM OSE were lower in AMI versus controls (p<0.001 for all). Males, smokers and individuals with hypertension and diabetes had lower levels of all 4 IgM OSE compared to unaffected individuals (p<0.001 for all). Compared to the lowest quintile, the highest quintiles of IgM MDA-LDL, PC-BSA, ApoB-IC, and MDA mimotope P1 had lower OR of AMI: OR (95% (CI)] of 0.67 (0.58-0.77), 0.64 (0.56-0.73), 0.70 (0.61-0.80) and 0.72 (0.62-0.82) (p<0.001 for all], respectively. Upon addition of IgM OSE to conventional risk factors, the C-statistic improved by 0.0062 (0.0028-0.0095) and net reclassification by 15.5% (11.4-19.6). These findings demonstrate that IgM OSE provide clinically meaningful information and support the hypothesis that higher levels of IgM OSE may be protective against AMI.

PMID:37211249 | DOI:10.1016/j.jlr.2023.100391

J Cardiol. 2023 May 19:S0914-5087(23)00112-0. doi: 10.1016/j.jjcc.2023.05.006. Online ahead of print.

ABSTRACT

BACKGROUND: Despite optimal treatment, a residual inflammatory risk often remains in patients with atherosclerotic cardiovascular disease. In a US-based phase 2 trial, ziltivekimab, a fully human monoclonal antibody targeting the interleukin-6 ligand, significantly reduced biomarkers of inflammation compared with placebo in patients at high atherosclerotic risk. Here, we report the efficacy and safety of ziltivekimab in Japanese patients.

METHODS: RESCUE-2 was a randomized, double-blind, 12-week, phase 2 trial. Participants aged ≥20 years with stage 3-5 non-dialysis-dependent chronic kidney disease and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L were randomized to receive placebo (n = 13) or subcutaneous ziltivekimab 15 mg (n = 11) or 30 mg (n = 12) at Weeks 0, 4, and 8. The primary endpoint was percentage change in hsCRP levels from baseline to end of treatment (EOT; mean of Week 10 and Week 12 values).

RESULTS: At EOT, median hsCRP levels were reduced by 96.2 % in the 15 mg group (p < 0.0001 versus placebo), by 93.4 % in the 30 mg group (p = 0.002 versus placebo), and by 27.0 % in the placebo group. Serum amyloid A and fibrinogen levels were also reduced significantly. Ziltivekimab was well tolerated and did not affect total cholesterol to high-density lipoprotein cholesterol ratios. There was a small, but statistically significant increase in triglyceride levels with ziltivekimab 15 mg and 30 mg compared with placebo.

CONCLUSIONS: The efficacy and safety results support the development of ziltivekimab for secondary prevention and the treatment of patients at high atherosclerotic risk.

CLINICALTRIALS: gov identifier, NCT04626505.

PMID:37211246 | DOI:10.1016/j.jjcc.2023.05.006