Significant Difference In Incidence Research Articles

Efficacy and Safety of Monotherapy with Enavogliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results of a 12-week, multi-center, randomized, double-blind, placebo-controlled, phase 2 trial.

The study aimed to evaluate and compare the efficacy and safety of enavogliflozin, a newly developed sodium-glucose cotransporter 2 inhibitor, with placebo in Korean patients with type 2 diabetes mellitus (T2DM). Patients with glycated hemoglobin (HbA1c) of 7.0-10.0%, entered a 2-week placebo run-in period, and were randomized to receive once-daily enavogliflozin (0.1, 0.3, or 0.5 mg) or placebo for 12 weeks. The primary efficacy endpoint was the change in HbA1c from baseline at week 12. Overall, 194 patients were included in the full analysis set (placebo, n=46; enavogliflozin [0.1 mg, n=49; 0.3 mg, n=50; 0.5 mg, n=49]). Patients receiving 0.1, 0.3, and 0.5 mg enavogliflozin showed significantly reduced HbA1c compared with those receiving placebo at week 12 (-0.79%, -0.89%, -0.92%, and -0.08%, respectively; P <0.001 vs. placebo). Mean changes in fasting plasma glucose from baseline at week 12 were -30.5 mg/dL, -31.1 mg/dL, -35.0 mg/dL, and 4.9 mg/dL in patients receiving enavogliflozin doses and placebo, respectively. The proportion of patients achieving HbA1c <7.0% at week 12 was significantly higher in the three enavogliflozin groups than in the placebo group (42.9%, 44.0%, 61.2%, and 17.4%, respectively). Higher proportion of patients showed HbA1c reduction by >0.5% after receiving enavogliflozin doses than those receiving placebo (61.2%, 72.0%, 65.3%, and 26.1%, respectively). There were no significant differences in incidences of adverse events of hypoglycemia and genital infection between the groups. Once-daily enavogliflozin monotherapy for 12 weeks is an effective, safe, and well-tolerated treatment for Korean patients with T2DM. This article is protected by copyright. All rights reserved.

Normal Saline vs Plasma-Lyte A Use Intra- and Post-Operatively in Adult Kidney Transplant Recipients

Fluid management intra- and post-operatively for kidney transplant recipients (KTR) is essential to maintain adequate perfusion to the kidney. 0.9% normal saline (NS) is commonly used, but it can cause hyperchloremic metabolic acidosis, which may result in hyperkalemia and lead to delayed graft function (DGF). Plasma-Lyte A (PA) is an alternative option that has a lower amount of chloride and a neutral pH, which may offset the risk of hyperkalemia. The aim of this study is to determine the incidence of DGF in KTRs comparing NS vs PA use intra- and initially post-operatively. This single-center, retrospective cohort study in adult KTRs from January 1, 2016 to February 1, 2021 consisted of two cohorts, those receiving NS vs PA. Multi-organ transplant recipients were excluded. The primary outcome was the incidence of DGF. A total of 244 KTRs in the NS group and 263 KTRs in the PA group were included. There was no significant difference in incidence of DGF between the groups, (NS 23.4% vs PA 25.9%, p = 0.537). The logistic regression for only deceased donors were not significantly different (OR 1.369 (0.819-2.288). There was no difference in the incidence of DGF when comparing NS vs PA.

Abstract 5459: Association between stomatitis and treatment efficacy with novel TROP2-directed antibody drug conjugate (ADC), datopotamab deruxtecan, in patients with metastatic cancer

Abstract Background: Incidence of toxicity with immunotherapy has been correlated with likelihood of treatment response (Hussaini, Cancer Treat Rev 2021; Schuell, Br J Cancer 2005). However, this phenomenon has not yet been demonstrated with antibody-drug conjugates. Datopotamab deruxtecan (Dato-DXd) is a novel ADC composed of an anti-Trop2 monoclonal antibody, a stable tetrapeptide-based cleavable linker, and a topoisomerase-I inhibitor payload (Bardia, Annals of Onc 2021). Early phase studies have demonstrated significant activity in heavily pretreated patients with metastatic non-small cell lung cancer (NSCLC) and metastatic breast cancer (MBC). Stomatitis was a common treatment-emergent adverse event (TEAE) observed in clinical trials. We conducted a study to evaluate the association between incidence of stomatitis and treatment response with Dato-DXd and evaluate the impact of steroid mouthwash. We hypothesized that presence and grade of mucositis would correlate with observed treatment efficacy. Methods: We included all patients treated at one academic institution (Massachusetts General Hospital) with Dato-DXd. Stomatitis was assessed by NCI-CTCAE V5.0. Objective Response Rate (ORR) was assessed by RECIST criteria with independent radiology review. Use of mouthwash was evaluated by secondary review and categorized as primary or secondary prophylaxis. A time-to-event analysis was performed to evaluate the time to onset of stomatitis. Results: 60 patients, including 19 with MBC and 41 with NSCLC, were treated with Dato-DXd between June 2018-September 2022. The median age of patients was 64 and 41/60 patients were female. The median time to onset of mucositis was 14 days (95% CI 12-42 days). There was no significant difference in incidence of stomatitis between the MBC and NSCLC cohorts. Compared to patients who had progressive disease (PD), patients who had a partial response (PR) or stable disease (SD) were 11 times more likely to have stomatitis (OR 11.0, 95% CI 3.61-44.01, p&amp;lt;0.001). Later in the trial (January 2020 onward), 28 patients received primary steroid prophylaxis - excluding these patients, those who were found to have PR/SD were 8.8 times more likely to develop stomatitis compared to patients who had PD (OR 8.8, 95% CI 1.5-73.3, p=0.023). Conclusion: The development of stomatitis may be associated with higher likelihood of therapeutic efficacy. Given that these findings are a hypothesis-generating post-hoc exploratory analysis from a single institution, this requires validation in larger studies before drawing strong conclusions and impacting clinical decision making. Further research is also needed evaluate the relationship between TEAEs and therapeutic efficacy with other ADCs. Citation Format: Rachel O. Abelman, Laura M. Spring, Phoebe K. Ryan, Geoffrey Fell, Dejan Juric, Rebecca S. Heist, Aditya Bardia. Association between stomatitis and treatment efficacy with novel TROP2-directed antibody drug conjugate (ADC), datopotamab deruxtecan, in patients with metastatic cancer. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5459.

Lyme Neuroborreliosis-Significant Local Variations in Incidence within a Highly Endemic Region in Sweden.

The aim of this study was to perform a detailed epidemiological overview of Lyme neuroborreliosis (LNB) 2008-2021 in a highly Lyme borreliosis-endemic area in Sweden using a geographic information system (GIS). Diagnosis of LNB was based on clinical symptoms and analysis of cerebrospinal fluid (CSF) according to European guidelines. From laboratory databases and medical records, we detected all patients with CSF pleocytosis and intrathecal anti-Borrelia antibody production and listed clinical features. The distribution of LNB cases within Kalmar County, Sweden was investigated using GIS. In total, 272 cases of definite LNB were confirmed with an average yearly incidence of 7.8/100,000. Significant differences in incidence were noted between children 0-17 years (16/100,000) and adults 18+ years (5.8/100,000) (p < 0.001), between rural (16/100,000) and urban areas (5.8/100,000) (p < 0.001) and between selected municipalities (p < 0.001). Distinct clinical differences in presentation of LNB were also noted between children and adults. Thus, the incidence of LNB varies significantly locally and in relation to age, and clinical presentation shows differences between children and adults. Surveillance of LNB and knowledge of local epidemiological conditions may facilitate preventive measures.

Prevalence of colorectal cancer in 2020: a comparative analysis between China and the world

Objective: To demonstrate the disease burden and epidemiological characteristics of colorectal cancer in different regions by analyzing the incidence and mortality data in China and worldwide in 2020. Methods: Estimation of the incidence and mortality data of colorectal cancer were obtained from the GLOBOCAN 2020 database. The incidence, death, age standardized incidence rate (ASIR) and age standardized mortality rate (ASMR) of colorectal cancer in China and 20 regions in the world were compared. The correlation between the Human Development Index (HDI) and ASIR/ASMR was analyzed. Results: In 2020, the number of new cases of colorectal cancer in the world reached 1 931 600, and the number of deaths reached 935 200. The incidence and mortality in all regions of the world continued to rise in the age group above 50 years old. The morbidity and mortality in male were higher than those in female. East Asia ranked the highest number of incidence cases and deaths in the world, which were 740 000 and 360 100 respectively. There were significant differences in incidence and mortality among regions in the world. The highest ASIR and ASMR were observed in Northern Europe (33.61/100 000) and Eastern Europe (14.53/100 000), whereas the lowest ASIR and ASMR were both observed in South-Central Asia (5.46/100 000 and 3.16/100 000). HDI had significant exponential relationship with ASIR (r(2)=0.59, P<0.001) and ASMR (r(2)=0.38, P<0.001). There were 555 500 new cases and 286 200 death cases of colorectal cancer in China, accounting for about 30% of the world and more than 75% of East Asia. The ASIR of China was 24.07/100 000, ranking at the medium level, while the ASMR was 12.07/100 000, ranking at the high level of world. Conclusion: The incidence and mortality of colorectal cancer are highly correlated with HDI. China is one of the countries with the heaviest disease burden of colorectal cancer in the world.

Safety and efficacy of nadifloxacin versus clindamycin observed in a tertiary care teaching hospital of Deccan Plateau

Acne vulgaris is characterised by excess sebum production and inflammatory reaction in sebaceous glands. As propionibacterium is involved in aggravation of acne, antimicrobials like nadifloxacin and clindamycin were found to be effective in treatment.Comparison of nadifloxacin with clindamycin in terms of inflammatory and non-inflammatory lesion count and global improvement rating, when given in combination with benzoyl peroxide in patients in acne vulgarisNadifloxacin 1%, benzoyl peroxide 2.5% and clindamycin 1% were used as topical treatment option. Study cohort was randomly divided into two groups: Nadifloxacin group and Clindamycin group. All subjects who were included in the study were instructed to apply a thin layer of medication over acne lesions; benzoyl peroxide 2.5% gel once daily at bedtime and clindamycin 1% gel or Nadifloxacin 1% gel twice daily. Efficacy is analysed by comparing changes in total, inflammatory and non-inflammatory lesion counts, In addition, global improvement was rated by patients using a six-point scale (worsening, no improvement, slight improvement, moderate improvement, good improvement, clearance) at end of treatment.There is progressive decline in number of inflammatory and non-inflammatory lesions in both groups. Analysis of lesion counts not showed any significant difference in between two groups. In global improvement rating scale, more number of patients using nadifloxacin with benzoyl peroxide reported good improvement compared to patients using Clindamycin with benzoyl peroxide. No patient in any group reported worsening of lesions. None of patients in study groups reported clearance. Two adverse events were reported during study, they were, burning sensation and dryness. There was no significant difference in incidence of adverse events in both treatment groups.Topical Nadifloxacin, a new fluoroquinolone is effective, tolerable and safe for mild or moderate facial acne. Its clinical effectiveness is equivalent to clindamycin when used as add-on therapy to benzoyl peroxide.

Identification and characterization of new candidates for abdominal aortic aneurysm screening in patients outside of current accepted guidelines

BackgroundPrevious studies have identified groups of patients with abdominal aortic aneurysm (AAA) that fall outside of currently accepted screening guidelines. Population-based studies have found AAA screening would be cost-effective at a prevalence of 0.5% to 1.0%. The goal of this study was to determine the prevalence of AAA in patients that fall outside of the current screening guidelines. In addition, we analyzed outcomes of the groups with a prevalence of greater than 1%. MethodsUsing the TriNetX Analytics Network, several patient cohorts were abstracted with a diagnosis of ruptured or unruptured AAA based on previously identified groups with a potentially high risk for AAA that fall outside of currently accepted screening guidelines. Groups were also stratified by sex. For groups found to have a prevalence of greater than 1%, the unruptured patients were further analyzed for long-term rates of rupture and included male ever-smokers aged 45 to 65, male never-smokers aged 65 to 75, male never-smokers aged greater than 75, and female ever-smokers aged 65 or greater. Long-term mortality, stroke, and myocardial infarction rates were compared in patients with treated and untreated AAA after propensity score matching. ResultsWe identified 148,279 patients across the four groups with a prevalence of AAA of greater than 1% with female ever-smokers aged 65 or older being the most prevalent (2.73%). In each of the four groups, the rate of AAA rupture increased every 5 years and all had rupture rates of greater than 1% at 10 years. Meanwhile, controls for each of these four subgroups without a previous AAA diagnosis had rupture rates between 0.090% and 0.013% at 10 years. Those who underwent repair of their AAA had decreased incidence of mortality, stroke, and myocardial infarction. Specifically, male ever-smokers aged 45 to 64 had a significant difference in incidence of mortality and myocardial infarction at 5 years and stroke at 1 and 5 years. ConclusionsOur analysis suggests male ever-smokers aged 45 to 65, male never-smokers aged 65 to 75, male never-smokers aged greater than 75, and female ever-smokers aged 65 or greater have a more than 1% prevalence of AAA and, therefore, may benefit from screening. Outcomes were significantly worse compared with well-matched controls in these groups.

Comparison of conventional needle holding technique and pen holding method of needle holding for real-time ultrasound-guided internal jugular venous cannulation - A randomised parallel-group study.

Ultrasound-guided central venous (CV) cannulation is the standard of care for inserting CV catheter in the right internal jugular vein (RIJV). However, mechanical complications can still occur. The primary objective of this study was to compare the incidence of posterior vessel wall puncture (PVWP) using conventional needle holding technique with pen holding method of needle holding technique for IJV cannulation. Secondary objectives were comparison of other mechanical complications, access time and ease of the procedure. This prospective, randomised parallel-group study included 90 patients. Patients requiring ultrasound-guided RIJV cannulation under general anaesthesia were randomised into two groups P (n = 45) and C (n = 45). In group C, the RIJV was cannulated using the conventional needle holding technique. In group P, the pen holding method of needle holding technique was used. Incidence of PVWP, complications (arterial puncture, haematoma) number of attempts for successful cannulation, time to insertion of guidewire and performer's ease were compared. The data were analysed using Statistical Package for the Social Sciences (SPSS version 24.0). A P value less than 0.05 was considered statistically significant. In our study, there was no significant difference in incidence of PVWP and complications between the two groups. Number of attempts and time for successful guidewire insertion were comparable. Ease of the procedure was scored a median of 10 in both the groups. There was no significant difference in the incidence of PVWP between the two techniques in this study, necessitating further evaluation of this novel technique.

AVERAGE LONG-TERM OUTCOMES OF LAPAROSCOPIC INGUINAL HERNIA REPAIR

Objective: to determine the long-term postoperative outcomes of inguinal hernias using the TAPP approach with the internal ring suturing. Materials and methods. The design is a randomized multicentre clinical study. The study is based on a survey of 268 patients aged 18 to 84 years (mean age 59.2±10.6 years), including 46 (17.2%) women, 222 (82.8%) men with primary inguinal hernias. A total of 187 (69.8%) patients had a normal body mass index, 72 (26.9%) were overweight, 9 (3.3%) were obese. Interventions supposed the open techniques (Liechtenstein technique - 118 patients or Shouldice technique - 29 patients) and laparoscopic technique by TAPP approach (total 121), and specifically the modification with the internal ring suturing (12). The frequency and severity of chronic postoperative pain (up to 1 year) and the recurrence rate of inguinal hernia (up to 2 years) had been determined. Results.The incidence and severity of chronic pain syndromewas moderate and in most caseswere found to have no any intergroup significant differences. Single case showed the significant differences in incidence between open hernioplasty by Liechtenstein technique and TAPP (χ2 =4.241, p=0.040). The recurrence rate of hernias over the 2-year follow-up period was 3.0%. There were no significant differences whichever surgical method to be used. There was not any single case of relapse in the TAPP-IRS target group. The age of patients related to the most crucial risk factor; the intervention technique ranked number two. Account must be taken of the TAPP-IRS subgroup, where any recurrence not reported. The type of intervention had a minimal effect on the risk of recurrence, in particular due to interventions techniques restricted by open operations only. Conclusions. When performing open and laparoscopic hernioplasty for indirect inguinal hernia, the incidence and severity of postoperative pain after 1 month is lower with the laparoscopic method, and after 12 months it remits and has comparable characteristics. The TAPP-based internal ring suturing does not affect the postoperative pain syndrome. The recurrence rate of inguinal hernia after open and laparoscopic hernioplasty found to have no significant differences. When using TAPP-IRS, no relapses were reported.

Medial and lateral dual plating of native distal femur fractures: a systematic literature review.

Lateral locked plating (LLP) development has improved outcomes for distal femur fractures. However, there is still a modest rate of nonunion in fractures treated with LLP alone, with higher nonunion risk in high-energy fractures, intra-articular involvement, poor bone quality, severe comminution, or bone loss. Several recent studies have demonstrated both the safety and the biomechanical advantage of dual medial and lateral plating (DP). The purpose of this study was to evaluate the clinical outcomes of DP for native distal femoral fractures by performing a systematic review of the literature. Studies reporting clinical outcomes for DP of native distal femur fractures were identified and systematically reviewed. Publications without full-text manuscripts, those solely involving periprosthetic fractures, or fractures other than distal femur fractures were excluded. Fracture type, mean follow-up, open versus closed fracture, number of bone grafting procedures, nonunion, reoperation rates, and complication data were collected. Methodologic study quality was assessed using the Coleman methodology score. The initial electronic review and reverse inclusion protocol identified 1484 publications. After removal of duplicates and abstract review to exclude studies that did not discuss clinical treatment of femur fractures with dual plating, 101 potential manuscripts were identified and manually reviewed. After final review, 12 studies were included in this study. There were 199 fractures with average follow-up time of 13.72 months. Unplanned reoperations and nonunion occurred in 19 (8.5%) and 9 (4.5%) cases, respectively. The most frequently reported complications were superficial infection (n = 6, 3%) and deep infection (n = 5, 2.5%) postoperatively. Other complications included delayed union (n = 6, 3%) not requiring additional surgical treatment and knee stiffness in four patients (2%) necessitating manipulation under anesthesia or lysis of adhesions. The average Coleman score was 50.5 (range 13.5-72), suggesting that included studies were of moderate-to-poor quality. Clinical research interest in DP of distal femoral fractures has markedly increased in the past few decades. The current data suggest that DP of native distal femoral fractures is associated with favorable nonunion and reoperation rates compared with previously published rates associated with LLP alone. In the current review, DP of distal femoral fractures was associated with acceptable rates of complications and generally good functional outcomes. More high-quality, directly comparable research is necessary to validate the conclusions of this review.

Characteristics of synchronous and metachronous duodenal tumors and association with colorectal cancer: a supplementary analysis.

We previously reported outcomes of endoscopic resection for duodenal tumors in a large cohort. This study investigated the frequency and characteristics of synchronous and metachronous lesions, and their association with colorectal advanced adenoma (CAA) and colorectal cancer (CRC). Patients underwent duodenal endoscopic resection during January 2008 to December 2018. Background and characteristics, incidence of synchronous and metachronous lesions, and incidence of CAA and CRC were investigated. Patients without synchronous lesions were classified as the single group, and those with synchronous lesions as the synchronous group. Patients were also classified as the metachronous and non-metachronous groups. The characteristics among the groups were compared. We included 2658 patients with 2881 duodenal tumors: 2472 (93.0%) patients had single, 186 (7.0%) had synchronous, and 54 (2.0%) had metachronous lesions. The 5-year cumulative incidence of metachronous lesions was 4.1%. In total, 208 (7.8%) had CAA and 127 (4.8%) patients had CRC, and colonoscopy was performed in 936 (35.2%) patients. The incidence of CAA in the synchronous groups tended to be higher compared with that in the single groups (11.8% vs 7.5%, adjusted risk ratio 1.56), and the incidence of CRC in the metachronous groups tended to be higher compared with that in the non-metachronous groups (13.0% vs 4.6%, adjusted risk ratio 2.75), but there was no difference after adjusting for colonoscopy. This study showed the incidence of synchronous and metachronous duodenal lesions. There was no significant difference in incidence of CAA and CRC among each group, but further studies are warranted.

Comparative analysis of clinical efficacy between posterior percutaneous endoscopic discectomy and anterior cervical discectomy and fusion in the treatment of cervical spondylotic radiculopathy

To explore the clinical efficacy of posterior percutaneous endoscopic discectomy(PPECD) in the treatment of cervical spondylotic radiculopathy. A total of 56 patiens with single segment cervical spondylotic radiculopathy from December 2017 to October 2020, were randomly divided into observation group and control group. In observation group, there were 16 males and 11 females, including 8 cases of C4,5, 13 cases of C5,6 and 6 cases of C6,7 performed posterior percutaneous endoscopic discectomy, aged from 34 to 61 years old with an average of (51.15±6.29) years old. In control group, there were 19 males and 10 females with single segment cervical spondylotic radiculopathy including 10 cases of C4,5, 14 cases of C5,6 and 5 cases of C6,7 performed anterior cervical discectomy and fusion, aged from 40 to 65 years old with an average of (53.24±5.31) years old. The operative time, intraoperative blood loss, postoperative time of lying in bed and length of postoperative hospital stay were recorded. Visual analogue scale(VAS) and neck disability index(NDI) were used to evaluate the clinical efficacy. Cervical plain films or MRIs, CTs were taken for re-visiting patients. All patients were followed up more than 2 years. The observation group patients were followed up, the duration ranged from 24 to 42 months with an average of (30.48±4.91) months. The control group patients were followed up, the duration ranged from 25 to 47 months, with an average of (32.76±4.53) months. Compared with control group, operative time, intraoperative blood loss, postoperative time of lying in bed and length of postoperative hospital stay were decreased(P<0.05). Compared with pre-operation, VAS of neck and upper limb and NDI at the latest follow-up between two groups were significantly improved(P<0.05). Compared with control group, VAS of neck and upper limb at 1 day after operation in observation group were significantly reduced(P<0.05). There was no significant difference in VAS of neck and upper limb and NID at 1, 3 months and the latest follow-up after operation between two groups(P>0.05). In the observation group, one patient's deltoid muscle strength was weakened to grade 4 after operation, and returned to normal after 12 weeks of conservative treatment. In control group, there was 1 case of postoperative adjacent spondylosis with symptoms of spinal compression after 2 years operation, then underwent cervical artificial intervertebral disc replacement. And there was 1 case of dysphagia after operation in control group and improved after 1 year. There was no significant difference in incidence of complications between two groups. PPECD has advantages of shortening operative time, decreasing intraoperative blood loss, reducing postoperative time of lying in bed and length of postoperative hospital stay. However, applicable age range of patients and long-term clinical efficacy needs further study.

A retrospective review of the benefits vs. safety implications of prednisolone during docetaxel chemotherapy alongside androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC).

132 Background: A key difference between the landmark trials for docetaxel chemotherapy alongside ADT for mHSPC was the addition of prednisolone in the STAMPEDE but not CHAARTED or GETUG-AFU 15 trials, resulting in varied use in clinical practice. Potential toxicity from prolonged steroid use was recognised in a 2020 NHS England safety alert. This retrospective study compared toxicities in patients treated with docetaxel +/- prednisolone. Methods: Electronic notes of patients treated with docetaxel and ADT +/- prednisolone (per consultant preference) Feb 2018 - Sept 2020, were reviewed. Data was collected on common toxicities using CTCAE v5 grading. Analysis of incidence and severity were carried out using paired T-tests and logistic regression due to small sample sizes at each severity grade. Results: Data on 299 patients was collected; 167 received docetaxel and ADT, 132 also received prednisolone. There was no significant difference in the number of cycles completed between the 2 groups; 66.5% (no prednisolone) v 70.4% (with prednisolone) of patients completed 6 cycles (p=0.41). There was a significant difference in both the incidence and severity of anaemia between patients treated +/- prednisolone. There was no significant difference in the incidence of neutropenia or alopecia between patients treated +/- prednisolone, but prednisolone use was predictive of lower severity scores in neutropenia and alopecia. In contrast, there was a significant difference seen in incidence of neuropathy between the 2 groups, with no impact on severity. There was no significant difference in incidence or severity of thrombocytopenia, neutropenic sepsis, fatigue or nausea/vomiting. The prednisolone group had a significant increase in contacts with an advice hotline or general practitioner (p values &lt;0.001). Review of interactions found many were requesting support with administration of prednisolone. Conclusions: These findings suggest limited clinical benefit in the addition of prednisolone to docetaxel and ADT in patients with mHSPC. Prednisolone is associated with significant potential harms e.g., impaired blood glucose and adrenal insufficiency (blood glucose was not routinely recorded in this group). These preliminary findings would benefit from further study with a larger sample size. [Table: see text]

Comparing Outcomes in the Therapeutic and Prophylactic Breast for Bilateral Mastectomy With Implant-Based Breast Reconstruction.

Increasingly patients with unilateral breast cancer elect to undergo bilateral mastectomy with subsequent reconstruction. Studies have aimed to better identify the risks associated with performing mastectomy on the noncancerous breast. Our study aims to identify differences in complications between therapeutic and prophylactic mastectomy in patients undergoing implant-based breast reconstruction. A retrospective analysis of implant-based breast reconstruction from 2015 to 2020 at our institution was completed. Patients with less than 6-month follow-up after final implant placement had reconstruction using autologous flaps, expander or implant rupture, metastatic disease requiring device removal, or death before completion of reconstruction were excluded. McNemar test identified differences in incidence of complications for therapeutic and prophylactic breasts. After analysis of 215 patients, we observed no significant difference in incidence of infection, ischemia, or hematoma between the therapeutic and prophylactic sides. Therapeutic mastectomies had higher odds of seroma formation ( P = 0.03; odds ratio, 3.500; 95% confidence interval, 1.099-14.603). Radiation treatment status was analyzed for patients with seroma; 14% of patients unilateral seroma of the therapeutic side underwent radiation (2 of 14), compared with 25% patients with unilateral seroma of the prophylactic side (1 of 4). For patients undergoing mastectomy with implant-based reconstruction, the therapeutic mastectomy side has an increased risk of seroma formation.

Efficacy of the combination of carbamazepine and pulsed-radiofrequency in the treatment of trigeminal neuralgia

Purpose: To investigate the effect of the combination of carbamazepine and pulsed-radiofrequency therapy on trigeminal neuralgia (TN) and changes in inflammation status in vivo.&#x0D; Methods: Ninety-seven trigeminal neuralgia patients treated in Wuhan Fourth Hospital from January 2018 to January 2021 were analyzed retrospectively. Forty-five patients treated with pulsed-radiofrequency therapy alone were designated as the control group (CG), while 52 who underwent carbamazepine and pulse-radiofrequency combination therapy were enrolled in the study group (SG). Changes in serum inflammatory factors, viz, interleukin (IL)-6, IL-1β, and tumor necrosis factor α (TNF-α), were recorded before and after treatment. Similarly, changes in pain visual analog scale (VAS) score, quality of life score, and oxidative stress index were assessed before and after treatment; so also were changes in clinical efficacy and incidence of adverse reactions.&#x0D; Results: After treatment, VAS score, and levels of IL-6, IL-1β, and TNF-α in SG were lower than those in CG, while the score of quality of life in SG was higher (p &lt; 0.05). The clinical efficacy of SG was higher than that of CG, but there was no significant difference in incidence of adverse reactions (p &lt; 0.05).&#x0D; Conclusion: The therapeutic combination of carbamazepine and pulsed-radiofrequency is more effective than pulsed-radiofrequency alone in the short-term treatment of TN in patients. It produces better relief of pain, reduces inflammation and improves patients’ quality of life. However, it does not affect the incidence of adverse reactions.

Retrospective analysis of COVID-19 patients developing otherwise rare complications

BackgroundOver the last 2 years, it has been felt that there was a disproportionate incidence of complications including pneumothorax, pneumomediastinum, and renal disease necessitating dialysis in patients with COVID-19 as compared to patients without COVID-19.MethodsIn a retrospective cohort, all patients were admitted to St. Joseph Mercy Oakland Hospital in Pontiac, Michigan, between March 2020 and November 2021. The data collected included age, sex, BMI, length of stay, COVID-19 PCR result, diagnosis of pneumothorax, diagnosis of pneumomediastinum, diagnosis of renal failure, orders for dialysis, and orders for mechanical ventilation.ResultsNine thousand five hundred twenty-two patients are included in this study, with 35.6% (3,392 patients) COVID-19 suspected or confirmed positive and 64.4% (6130 patients) confirmed COVID-19 negative. There were 29 cases of pneumomediastinum and 24 cases of pneumothorax, none of which occurred in intubated patients. The incidence of pneumomediastinum (p = 0.001), CODE BLUE (p = 0.01), and mechanical ventilation (p = 0.001) was significantly higher in the COVID-19 positive/suspected group. There was no significant difference in incidence of pneumothorax (p = 0.294). The incidence of dialysis was significantly higher (p < 0.0001) in the COVID-19 negative group.ConclusionsIn review of prior literature and proposed mechanisms, we believe that it was possibly the damage that SARS-CoV-2 inflicts upon lung parenchyma that led to the increased incidence of pneumomediastinum. Given our mixed findings of incidences of pneumomediastinum, pneumothorax, and dialysis, our hope is to remain vigilant to uncover further disease associations and/or complications as more COVID-19 case data becomes available.

A non-manufacturer-sponsored, retrospective study to assess 2-year safety outcomes of the BellaGel® SmoothFine as compared with its competitors in the context of the first Korean case of a medical device fraud.

We conducted this study to assess preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud. Our clinical series of the patients (n = 579; 1,158 breasts) received augmentation using the BellaGel® SmoothFine, Naturgel™, Motiva Ergonomix™, Eurosilicone Round Collection™, Natrelle® INSPIRA™, Natrelle® 410, Mentor® MemoryGel Xtra or Microthane®. The patients were evaluated for incidences of postoperative complications and Kaplan-Meier survival and hazards. Overall, there were a total of 101 cases (17.4%) of postoperative complications; these include 31 cases (5.4%) of shape deformity, 21 cases (3.6%) of CC, 18 cases (3.1%) of early seroma, 8 cases (1.4%) of infection, 5 cases (0.9%) of early hematoma, 1 case (0.2%) of delayed hematoma, 1 case (0.2%) of rupture and 1 case (0.2%) of ripping. Moreover, there were also 15 cases (2.6%) of other complications. There were significant differences in incidences of postoperative complications between the breast implants from different manufacturers (P = 0.034). The Natrelle® 410 showed the longest survival (333.3±268.2 [141.5-525.1] days). A subgroup analysis showed that there were no significant differences in incidences of postoperative complications between the breast implants (P = 0.831). Moreover, the Natrelle® INSPIRA™ showed the longest survival (223.7±107.1 [-42.3-489.6] days). Here, we describe preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud.

Trends in Gynecologic Carcinosarcoma Based on Analysis of the Surveillance Epidemiology End Result (SEER) Database.

Carcinosarcomas (malignant mixed Mullerian tumors) of a female genital organ are rare tumors associated with a poor survival. The purpose of this study was to identify site-specific differences in the incidence and prognosis in carcinosarcomas originating in the uterus, cervix, or ovary. The data of patients with gynecologic carcinosarcomas were extracted from the Surveillance, Epidemiology, and End Results (SEER) database between 2000 and 2016. The characteristics of gynecologic carcinosarcomas were compared using Pearson X2 and Fisher's exact tests. Kaplan-Meier models were used for cause-specific survival (CSS) analysis. The cohort included 7086 females, including 5731 cases of uterine carcinosarcoma, 161 cervical carcinosarcomas, and 1193 ovarian carcinosarcomas. The age-adjusted incidence rates of uterine, cervical, and ovarian carcinosarcoma were 3.9, 0.1, and 0.6 per 1,000,000, respectively. In the distribution of carcinosarcoma incidence by race, compared with the uterus or cervix, those originating from the ovary were unequally distributed in Caucasians (84.4% versus 69.6%, 67.7%; p < 0.001). The incidence of uterine carcinosarcoma steadily increased over time, from 2.2 in 2000 to 5.5 in 2016 (per 1,000,000), while cervical or ovarian carcinosarcoma showed no significant difference in incidence. The five-year CSS rates based on the site of origin (uterus, cervix, and ovary) were 39.9%, 33.1%, and 25.8%, respectively. The incidence rates of gynecologic carcinosarcoma, especially uterine carcinosarcoma, are gradually increasing. Although uterine carcinosarcoma is associated with a higher incidence than the others, it has a better prognosis compared with ovarian and cervical carcinosarcoma. The survival rates were worst in ovarian carcinosarcoma.

Intravenous immunoglobulin for the treatment of Kawasaki disease.

Intravenous immunoglobulin for the treatment of Kawasaki disease.

The infection, cervical and perineal lacerations in relation to postpartum hemorrhage following vaginal delivery induced by Cook balloon catheter.

To identify whether infection, cervical laceration and perineal laceration are associated with postpartum hemorrhage in the setting of vaginal delivery induced by Cook balloon catheter. The retrospective study included 362 women who gave birth vaginally at or beyond 37weeks of gestation with a diagnosis of postpartum hemorrhage between February 2021 to May 2022, of which including 216 women with induction of labor (Cook balloon catheter followed by oxytocin or oxytocin) and 146 women with spontaneous delivery. Risk factors for postpartum hemorrhage were collected and compared. 362 women were divided into three groups, group 1 with spontaneous delivery, group 2 with oxytocin, group 3 with Cook balloon catheter followed by oxytocin. There was no significant difference in incidence of infection within three groups (P > 0.05). The rate of cervical laceration and perineal laceration was significantly higher in group 3 compared with groups 2 and 1 (P < 0.05); Multivariate logistic regression analysis found that compared with group 1, either group 3 or group 2 was associated with increased risks of cervical laceration and perineal laceration (P < 0.05), and compared with group 2, group 3 was not associated with increased risks of cervical laceration and perineal laceration (P > 0.05). Infection, cervical laceration and perineal laceration are identified not to be independent risk factors for postpartum hemorrhage for women undergoing labor with Cook balloon catheter; Cervical laceration and perineal laceration increase the risk of postpartum hemorrhage in women with labor induction.