Occurrence Of Adverse Events Research Articles

Steven-Johnson Syndrome/Toxic Epidermal Necrolysis is Associated with PD-1/PD-L1 Inhibitors Usage: A Case Series.

Aims/Background The increasing adoption of inhibitors of programmed cell death-1 (PD-1) and its ligand, programmed death-ligand 1 (PD-L1), in the treatment of multiple cancer types in China has started to garner broader attention due to the occurrence of immune-related adverse events (irAEs), especially life-threatening skin reactions such as Steven-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Isolated case reports have described SJS/TEN associated with PD-1/PD-L1 inhibitors usage. In this paper, we presented a series of cases of SJS/TEN following the use of PD-1/PD-L1 inhibitors in a dermatology hospital located in Zhejiang Province of China in the past several years, summarizing characteristics of these cases and providing a reference of management. Methods We retrospectively reviewed all the medical records of inpatients diagnosed with SJS/TEN in the Hangzhou Third People's Hospital from 2012 to 2024. We analyzed and compared the situation of SJS/TEN onset, types of PD-1/PD-L1 inhibitors used, score of severity, laboratory findings, and essential therapies of the patients who had received PD-1/PD-L1. Results We identified 12 SJS/TEN patients who had been treated with PD1/PD-L1 inhibitors: sintilimab had been used in six patients; tislelizumab in two cases; toripalimab, keytruda and cadonilimab each in one case; and an unknown prescription in one case. The longest duration between the first PD-1/PD-L1 inhibitor dose and the SJS/TEN diagnosis recorded was nine months whereas the shortest was 11 days. Half of the selected patients received chemotherapy at the same time. More than two types of therapies were applied to the cases, except for two cases with mild SJS. Conclusion This study unveils a potential, under-recognized cause of SJS/TEN in the cancer patients after analyzing the cases of SJS/TEN in cancer patients with prior exposure to PD-1/PD-L1 inhibitors. This paper also provides clue about the prominent features of SJS/TEN aforesaid, offering insights on the effective management measures for optimizing clinical safety.

LOCAL ANESTHETIC-INDUCED ALLERGIC REACTIONS IN DENTISTRY: CURRENT PERSPECTIVES AND KEY CONSIDERATIONS

Background: Local anesthetics (LAs) are frequently utilized in dentistry. Despite their generally well-tolerated nature, they can occasionally induce adverse reactions of varying types and severity. The actual prevalence of allergic reactions to these agents remains unknown. The review objectives were to evaluate the occurrence of immediate adverse events in individuals undergoing local anaesthetic injections for dental procedures, observe the frequency of anaphylactic allergic reactions among documented adverse events, and scrutinize the relationship between the atopic history of these patients and documented allergic reactions

The relative and combined ability of triglyceride-glucose index and stress hyperglycemia ratio to predict major adverse cardio-cerebral events in patients with multivessel coronary artery disease

BackgroundCardiovascular disease continues to be the leading cause of global mortality and disability, particularly posing elevated risks in patients diagnosed with multivessel disease (MVD). Efficient risk stratification in MVD patients is crucial for improving prognosis, prompting investigation into novel biomarkers such as the triglyceride-glucose index (TyG index) and the stress hyperglycemia ratio (SHR).MethodsThis study enrolled a cohort comprising 679 patients diagnosed with MVD who underwent coronary angiography at Tianjin Chest Hospital. Patients were stratified into four groups based on their TyG index levels, categorized as TyG index-L and TyG index-H, and SHR levels, categorized as SHR-L and SHR-H. The primary endpoint was the occurrence of major adverse cardio-cerebral events (MACCEs). This Study conducted univariate and multivariable Cox regression analyses to assess the association between TyG index and SHR levels, both as continuous and categorical variables, in relation to MACCEs. Kaplan–Meier survival curves were employed to evaluate the correlation among patient groups.ResultsDuring a mean follow-up of 61 months, 153 cases of MACCEs were recorded. The TyG index and SHR served as independent predictors of long-term prognosis in patients with MVD, whether considered as continuous or categorical variables. Multivariable analysis revealed that patients with TyG index-H + SHR-H group exhibited the highest incidence of MACCEs (HR: 2.227; 95% CI 1.295–3.831; P = 0.004). The area under the curve (AUC) for predicting MACCEs was 0.655 for TyG index, 0.647 for SHR, and 0.674 when combined.ConclusionThis study underscores the potential of the TyG index and SHR as independent and combined predictive markers for MACCEs in patients with MVD. Their integrated assessment enhances risk stratification, providing valuable insights for personalized treatment strategies aimed at optimizing patient prognosis.

Impact of increasing post-filter ionised calcium target on regional citrate anticoagulation efficacy in ICU continuous renal replacement therapy: the non-inferiority randomised controlled Ca-CIBLE protocol

IntroductionContinuous renal replacement therapy (CRRT) is a critical therapeutic intervention for patients with severe acute kidney injury in intensive care. However, premature filter clotting remains a significant challenge during CRRT,...

Rapid response system and mortality in intensive care unit: a nationwide cohort study in South Korea.

The beneficial effects of a rapid response system (RRS) on clinical outcomes in patients admitted to a ward have been established. However, the relationship between RRS implementation and clinical outcomes in patients in the intensive care unit (ICU) has not yet been established. Therefore, we aimed to investigate whether the RRS affects clinical outcomes in critically ill patients admitted to the ICU. As a nationwide, population-based cohort study, all adult patients who were admitted to the ICU from 1 January 2019 to 31 December 2021 in South Korea were included. Patients in hospitals with an RRS formed the RRS group; those in hospitals lacking an RRS constituted the non-RRS group. In total, 900,606 patients admitted to the ICU were included in the final analysis. Among them, 365,305 (40.6%) were assigned to the RRS group, and 535,301 (59.4%) were assigned to the non-RRS group. After propensity score (PS) matching, a total of 454,748 patients (227,374 in each group) were included in the final analysis. In the PS-matched cohort, the RRS group showed 8% (odds ratio [OR]: 0.92, 95% confidence interval [CI]: 0.91, 0.94; P < 0.001) and 11% (hazard ratio: 0.89, 95% CI: 0.88, 0.90; P < 0.001) lower in-hospital mortality rates and 1-year all-cause mortality rates than the non-RRS group, respectively. In addition, ICU readmission rates and the occurrence rate for adverse events during hospitalization in the RRS group were 3% (OR: 0.97, 95% CI: 0.95, 0.98; P < 0.001) and 21% (OR: 0.79, 95% CI: 0.78, 0.80; P < 0.001) lower than those in the non-RRS group, respectively. RRS deployment was linked to lower in-hospital and 1-year all-cause mortality rates, ICU readmission rates, and the occurrence of adverse events during hospitalization among ICU patients. The findings indicate that using the RRS could assist not only patients in the ward but also critically ill patients in the ICU.

The safety and efficacy of N-acetylcysteine as an augmentation in the treatment of obsessive-compulsive disorder in adults: a systematic review and meta-analysis of randomized clinical trials.

Obsessive-compulsive disorder (OCD) ranks as the fourth most prevalent psychiatric disorder, with selective serotonin reuptake inhibitors (SSRIs) as its mainstay pharmacological treatment. However, approximately 40 to 60% of patients do not adequately respond to initial treatment, highlighting the need for alternative options. N-acetylcysteine (NAC) is one of the several medications that have been used in augmentation with SSRIs to enhance their efficacy. We aimed to investigate the safety and efficacy of NAC, a glutamate-modulating agent, as an augmentation in the treatment of moderate to severe OCD. We conducted a thorough search across PubMed, Scopus, Web of science, and ProQuest to identify relevant trials published until December 2023. The primary outcome of interest was the mean difference between the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores before and after administrating augmented NAC among patients with moderate to severe OCD. Furthermore, we compared the occurrence of adverse drug events between the experimental and control groups. We included six randomized controlled trials with 195 patients. The results of our study indicated a positive outcome for the experimental group in terms of the total Y-BOCS score when using the medication for a period of five to eight weeks (p-Value = 0.05). However, no significant difference was observed for durations shorter than five weeks or longer than 12 weeks. Additionally, no significant difference was found between the two groups in terms of the obsession and compulsion Y-BOCS scores. Furthermore, no significant differences were observed in terms of adverse events. Augmentation of NAC with SSRIs may benefit patients with moderate to severe OCD. However, it is necessary to conduct additional multi-center trials over extended periods to develop a comprehensive strategy for action. https://www.crd.york.ac.uk/prospero/, identifier CRD42023463683.

Efficacy and safety of upadacitinib in the treatment of moderate-to-severe atopic dermatitis in adolescents: A systematic review and meta-analysis of randomized controlled trials.

To assess the efficacy and safety of upadacitinib in adolescents with moderate-to-severe atopic dermatitis (AD). A comprehensive search was conducted using PubMed, Medline, Embase, Web of Science, Clinical Trials Website, and Cochrane Library databases, spanning from their inception until February 18, 2024. The review incorporated all randomized controlled trials examining upadacitinib's efficacy in managing moderate to severe AD among adolescent patients. The methodological quality of the selected studies underwent thorough assessment utilizing the Cochrane systematic review methodology. Statistical analyses of the outcome measures were executed employing the Review Manager 5.3 software. The meta-analysis encompassed 4 studies in total. Compared to placebo, upadacitinib at doses of both 15 and 30 mg was associated with a significant enhancement in the eczema area and severity index-75% ([odds ratio, OR = 11.06, 95% confidence interval, CI (6.78-18.04), P < .00001]; [OR = 21.73, 95% CI (12.73-37.11), P < .00001]), a reduction in the numerical rating scale of ≥4 ([OR = 6.16, 95% CI (3.56-10.64), P < .00001]; [OR = 10.58, 95% CI (6.12-18.29), P < .00001]), and improvement in the investigator's global assessment to 0/1 ([OR = 8.85, 95% CI (4.86-16.10), P < .00001]; [OR = 21.43, 95% CI (11.64-39.46), P < .00001]). Regarding safety, upadacitinib at both 15 and 30 mg doses was linked to a statistically significant rise in the overall incidence of adverse events when juxtaposed with placebo ([OR = 1.57, 95% CI (1.01-2.44), P = .04]; [OR = 2.21, 95% CI (1.44-3.41), P = .0003]). Nevertheless, no statistically significant disparity was discovered in the occurrence of serious adverse events between upadacitinib and placebo ([OR = 1.02, 95% CI (0.27-3.84), P = .98]; [OR = 0.42, 95% CI (0.09-1.93), P = .26]). The findings from this meta-analysis indicate that upadacitinib demonstrates substantial effectiveness and tolerability in treating moderate to severe AD in adolescents. Moreover, upadacitinib provides a rapid reduction in pruritus and markedly ameliorates symptoms and signs, with the 30 mg dosage showing a more pronounced therapeutic effect relative to the 15 mg dosage.

Cardiovascular outcomes in Parkinson’s disease patients from a retrospective cohort study

Parkinson’s disease (PD) reports high rates of morbidity and mortality, but the risk of adverse cardiovascular outcomes in patients with PD has not been fully elucidated. This bi-center retrospective cohort study using the electronic health records (EHR) database of two tertiary hospitals screened a total of 327,292 subjects who visited the outpatient clinic, and 1194 patients with PD were propensity score-matched with a control population. The primary outcome was the occurrence of major adverse cardiovascular events (MACE). Key secondary outcomes included all-cause death, cardiovascular (CV) death, stroke, myocardial infarction (MI), heart failure hospitalization and 30-day CV death. After PS matching, MACE occurrence was not significantly different between PD and non-PD groups (18.2% vs. 17.5%, log-rank p = 0.98). Key secondary outcomes were also similar between the two groups. In patients with PD, MACE rate, and also CV risk score, were higher in patients with more severe PD (according to Hoehn and Yahr scale and unified Parkinson’s disease rating scale), and after multivariable analysis, PD severity was not an independent predictor of MACE. Patients with PD are at an increased risk of adverse cardiovascular outcomes, but the contribution from other common CV risk factors cannot be ignored. The management of prevalent CV risk factors is therefore important in mitigating adverse outcomes among patients with PD.

APITHERAPY AND APPLICATIONS IN VETERINARY MEDICINE

The use of bees and bee products for therapeutic purposes in human and veterinary medicine is called apitherapy. Natural products have been used throughout human history to protect against and treat diseases. In recent years, the emergence of drug resistance and the occurrence of adverse effects associated with the indiscriminate and irregular use of pharmacological agents have prompted humanity to pursue alternative solutions. One of the most significant solutions is the administration of bee products. The use of bee products in apitherapy applications includes honey, bee venom, pollen, propolis, beeswax, royal jelly, perga and apilarnil (bee larvae). In general, apitherapy products with a wide range of indications are widely used in various system diseases and some dermatologic problems and various effects of these products such as antibacterial, antifungal, antiviral, antioxidant, anticarcinogenic, anti-inflammatory, antidiabetic and immunomodulatory effects in vitro and in vivo have been investigated in many different studies. Apitherapy is less common in veterinary practice than in human medicine. Additionally, bee products are employed in the treatment of other animal diseases, including gastrointestinal disorders, otitis, sinusitis, ophthalmic conditions, dermatological disorders, and skin care. Additionally, bee products are employed as food supplements for animals. The most prevalent additive in animal food is bee pollen. It has been demonstrated to promote growth, reduce mortality and prevent morbidity. Apitherapy has gained importance in the field of veterinary medicine in recent years in order to prevent both human health and economic losses, especially in the treatment of animals consumed as food.

From common to unreported: a real-world study of adverse events to duloxetine in the treatment of osteoarthritis

ABSTRACT Background In a review of drug guidelines published by the International Association for the Study of Osteoarthritis, it is recommended to support the conditional use of duloxetine in patients with osteoarthritis. However, there is a lack of comprehensive research on the adverse events of duloxetine for the treatment of osteoarthritis populations. Research design and methods We used the reporting odds ratio (ROR) to determine the strength of the adverse event signal. In addition, we investigated trends in the occurrence of adverse events using the Weibull shape parameter (WSP) test. Results The results showed that 50 and 14 adverse events were detected in both Asian and American populations. Four new adverse events, Mouth ulceration, femoral neck fracture, incontinence, long QT syndrome, were identified. There was a difference in the time of adverse event induction between the North American and Asian populations (p < 0.0001). The Weibull shape parameter (WSP) test showed that the incidence of AE decreased over time. Conclusion Our study contributes to an in-depth understanding of the safety of duloxetine in the treatment of osteoarthritis.

Use of belimumab in treating patients with systemic lupus erythematosus: a single-center, real-world retrospective study

ObjectiveTo investigate the efficacy and safety of belimumab in the treatment of systemic lupus erythematosus (SLE) in a real-world setting and provide a valuable reference for clinical treatment.MethodsIn this retrospective study, 101 patients with SLE who came to our hospital from March 2020 to September 2022, 56 of whom with lupus nephritis (LN), were selected. All patients received belimumab in combination with standard of care(SoC)therapy regimen for more than 52 weeks and their clinical/laboratory data, assessment of disease activity, glucocorticoids dosage and occurrence of adverse events were recorded. Lupus Low Disease Activity State (LLDAS) and DORIS remission as a primary goal in the treatment of SLE. The groups were classified according to the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2 K): SLEDAI-2 K < 6 was categorized as the mild group (mild activity) and SLEDAI-2 K ≥ 6 was categorized as the active group (moderate-severe activity). The disease of the two groups mentioned above were assessed using the SELENA-SLEDAI Flare Index (SFI) and the SLE Responder Index-4 (SRI-4), respectively. Furthermore, we used complete remission (CR) and partial remission (PR) in the kidney as the standard for efficacy evaluation for LN patients.ResultsAfter 52 weeks of treatment with belimumab, patients’ complement levels increased significantly (p < 0.05); Other indicators such as 24-hour urine protein quantification and daily glucocorticoids dose decreased compared to pretreatment (p < 0.05). At 52 weeks, (i) after evaluation, the whole group of patients showed significant improvement in their condition; (ii) 55.4% of patients achieved LLDAS and 23.8% achieved DORIS remission; (iii) 73.2% of patients with LN achieved CR, 16.1% achieved PR. Adverse reactions were observed in 15 patients (14.9%), all of which normalized after symptomatic treatment.ConclusionsIn general, during treatment with belimumab, immunological and biochemical indices improved in SLE patients, urinary protein levels were reduced in LN patients, and the rate of renal function remission was effectively increased; At the same time, the use of belimumab is associated with a low frequency of side effects, good overall tolerability and a favorable safety profile.

Immune-related [18F]FDG PET findings in patients undergoing checkpoint inhibitors treatment: correlation with clinical adverse events and prognostic implications

BackgroundDirect comparisons between [18F]FDG PET/CT findings and clinical occurrence of immune-related adverse events (irAEs) based on independent assessments of clinical and imaging features in patients receiving immune checkpoint inhibitors (ICIs) are missing. Our aim was to estimate sites, frequency, and timing of immune-related PET findings during ICIs treatment in patients with melanoma and NSCLC, and to assess their correlation with clinical irAEs. Prognostic implications of immune-related events were also investigated.MethodsFifty-one patients with melanoma (47%) or NSCLC (53%) undergoing multiple PET examinations during anti-PD1/PDL1 treatment were retrospectively included. Clinical irAEs were graded according to CTCAE v.5.0. Abnormal PET findings suggestive of immune activation were described by two readers blinded to the clinical data. Progression-free survival (PFS) and overall survival (OS) were analyzed with the Kaplan-Meier method in patients stratified according to the presence of irAEs, immune-related PET findings or both.ResultsTwenty-one patients showed clinical irAEs only (n = 6), immune-related PET findings only (n = 6), or both (n = 9). In patients whose imaging findings corresponded to clinical irAEs (n = 7), a positive correlation between SUVmax and the severity of the clinical event was observed (rs=0.763, p = 0.046). Clinical irAEs occurred more frequently in patients without macroscopic disease than in metastatic patients (55% vs. 23%, p = 0.039). Patients who developed clinical irAEs had a significantly longer PFS than patients who remained clinically asymptomatic, both in the overall cohort (p = 0.011) and in the subgroup of (n = 35) patients with metastatic disease (p = 0.019). The occurrence of immune-related PET findings significantly stratified PFS in the overall cohort (p = 0.040), and slightly missed statistical significance in patients with metastatic disease (p = 0.08). The best stratification of PFS was achieved when all patients who developed immune-related events, either clinically relevant or detected by PET only, were grouped together both in the overall cohort (p = 0.002) and in patients with metastatic disease (p = 0.004). In the whole sample, OS was longer in patients who developed any immune-related events (p = 0.032).ConclusionPatients with melanoma or NSCLC under ICI treatment can develop clinical irAEs, immune-related PET findings, or both. The occurrence of immune-related events has a prognostic impact. Combining clinical information with PET assessment improved outcome stratification.

The composition of the stent microbiome is associated with morbidity and adverse events during endoscopic drainage therapy of pancreatic necroses and pseudocysts.

Development of pancreatic necroses or pseudocysts are typical complications of pancreatitis and may require endoscopic drainage therapy using metal or plastic stents. Microbial infection of these lesions poses a major challenge. So far, the composition and significance of the microbial colonization on drainage stents are largely unknown although it may impact outcomes during endoscopic drainage therapy. A total of 26 stents used for drainage of pancreatic lesions were retrieved and the stent microbiome was determined by 16S rRNA gene sequencing. Additional analysis included comparison of the stent microbiome to the intracavitary necrosis microbiome as well as scanning electron microscopy (SEM) and micro-computed tomography (μCT) imaging of selected metal or plastic stents. The stent microbiome comprises a large proportion of opportunistic enteric pathogens such as Enterococcus (14.4%) or Escherichia (6.1%) as well as oral bacteria like Streptococcus (13.1%). Increased levels of opportunistic enteric pathogens were associated with a prolonged hospital stay (r = 0.77, p = 3e-06) and the occurrence of adverse events during drainage therapy (p = 0.011). Higher levels of oral bacteria were associated (r = -0.62, p = 8e-04) with shorter durations of inpatient treatment. SEM and μCT investigations revealed complex biofilm networks on the stent surface. The composition of the stent microbiome is associated with prolonged hospital stays and adverse events during endoscopic drainage therapy, highlighting the need for effective infection control to improve patient outcomes. In addition to systemic antibiotic therapy, antimicrobial stent coatings could be a conceivable option to influence the stent microbiome and possibly enhance control of the necrotic microflora.

A Comparative Study of the Effects of Bupropion and Amantadine on the Improvement of Sexual Function in Methadone-Dependent Males

Background: Methadone-induced sexual dysfunction in men can significantly impair their quality of life and reduce methadone adherence, thereby interfering with its therapeutic benefits. Objectives: This study aimed to compare the effects of bupropion and amantadine on reducing sexual dysfunction in methadone-dependent males. Methods: This clinical trial included 47 methadone-dependent males attending the Addiction Treatment Center in Babol, Iran. Participants were randomly assigned to either the amantadine group (n = 23) or the bupropion group (n = 24). Demographic data and addiction history were collected using a checklist, and sexual dysfunction was assessed with the International Index of Erectile Function (IIEF) Questionnaire before and after the intervention. Paired t-tests, independent t-tests, and chi-squared tests were used to compare the two groups. Results: Both groups had similar demographic variables and sexual function scores before the intervention (P &gt; 0.05). However, there was a significant difference between the two groups in terms of total sexual dysfunction scores (52.13 ± 13.07 for bupropion vs. 60.79 ± 4.47 for amantadine; P = 0.006). Additionally, significant differences were observed in sexual desire (P = 0.003), satisfaction with intercourse (P = 0.001), and overall satisfaction (P = 0.034), with higher scores in the bupropion group. Adverse medication-related effects were less prevalent in the bupropion group (54.2%) compared to the amantadine group (60.9%). Conclusions: Bupropion appears to be more effective in improving sexual function in methadone-dependent males undergoing methadone treatment, with patients in the bupropion group achieving better scores than those in the amantadine group. Additionally, the occurrence of adverse effects was lower in the bupropion group compared to the amantadine group.

Anakinra in the management of adult-onset still's disease: a single-center experience.

Adult-onset Still's disease (AOSD) is a rare systemic autoinflammatory disorder of unknown etiology characterized by systemic inflammation, high fever, salmon-colored skin rash, arthralgia, and arthritis. Patients with AOSD may also present with elevated inflammatory markers, hyperferritinemia, anemia, leukocytosis, hepatosplenomegaly, and lymphadenopathy. Glucocorticoids and biological disease-modifying anti-rheumatic drugs, including the anti-interleukin-1 agent anakinra, are used in the management of AOSD. This retrospective single-center study included patients with AOSD who were registered at our tertiary center, and received anakinra treatment. The primary outcome of our study was the proportion of patients who achieved complete remission of disease-related clinical and laboratory complications. The glucocorticoid treatment profiles of the included patients before and after anakinra treatment were also analyzed. The occurrence of serious and non-serious adverse events was recorded to analyze the safety profile of anakinra. Thirty-four patients with AOSD, including 25 females (73.5%), were enrolled in the study. Twelve patients (35.3%) achieved complete remission and 14 patients (41.2%) achieved partial remission after anakinra treatment. Eight patients (23.5%) did not response to anakinra. Anakinra significantly decreased the number of patients receiving glucocorticoid treatment [33 (97%) vs. 22 (64.7%), p < 0.001] and the mean daily glucocorticoid dose [19 ± 13.5mg vs. 4.6 ± 5.8mg, p < 0.001]. Mild adverse events occurred in 11 patients (32.3%) with injection site reactions being the most common. One patient (2.9%) was diagnosed with tuberculosis within the treatment period. Anakinra is an effective and generally safe option for biological treatment initiation in the management of AOSD.

Usefulness and safety of new ultrasmall-diameter colonoscope for cases with difficult insertion: a retrospective study

Colonoscopies are widely available, but there are cases where insertion can be difficult, even for experienced endoscopists. EC-760XP/L, a new ultrasmall-diameter long scope, may be useful in such cases. This single-center retrospective study included 39 cases where colonoscope insertion was difficult even when previously conducted by an experienced endoscopist. The primary outcome was the cecal intubation time using EC-760XP/L compared to the time used in a previous examination with a standard scope. The secondary outcomes were the cecum intubation rate, intestinal cleanliness level, adenoma detection rate, polyp detection rate, sedative use rate, occurrence of adverse events, and pain experience. A comparison of cecal intubation times between EC-760XP/L and the standard scope showed that insertion times were significantly lower with EC-760XP/L (9.5 min) compared to the standard scope (19 min) (p < 0.01). The standard scope achieved cecal intubation in 30 cases (76.9%), whereas EC-760XP/L reached the cecum in all cases (p < 0.01). Pain was observed in 3 cases (8.3%) with the EC-760XP/L, which was significantly lower than the 22 cases (56.4%) with the standard scope (p < 0.01). In conclusion, EC-760XP/L proved to be useful in cases where colonoscope insertion was difficult.

Prolonged operative time significantly impacts on the incidence of complications in spinal surgery

BackgroundIn spinal surgery adverse events (AE) and surgical complications (SC) significantly affect patient’s outcome and quality of life. The duration of surgery has been investigated in different surgical field as risk factor for complications. The aim of this study is to analyze the correlation between operative time and adverse events in spinal surgery.MethodsWe retrospectively analyzed data collected prospectively in a cohort of 336 patients surgically treated for spinal diseases of oncological and degenerative origin in a single center, between January 2017 to January 2018. Demographics and clinical data were collected. Adverse events were classified using Spinal Adverse Events Severity System version 2 (SAVES-V2) capture system. Focusing on degenerative patients, bivariate analysis and univariate logistic regression were used to determine the association between operative time and complications.ResultsA total of 105/336 patients experienced an AE related to surgery, respectively 38% in the oncological group and 28% in the degenerative group. The average age at surgery was 60.3 years (SD 17.1) and the mean operative time was 164.8 ± 138 min. A total of 206 adverse events (30 intraoperative, 135 early postoperative and 41 late postoperative AEs) were recorded. Early post-operative complications accounted for the most recorded AEs (55.5% in the oncological group and 73.2% in the degenerative group). Univariate logistic regression analyses confirmed that operative time correlated with increased risk of intra-operative (p-value = 0.0008), early post-operative (p-value < 0.001) and late post-operative (p-value < 0.001) adverse events.ConclusionsThis study highlights the strong correlation between the occurrence of adverse events in spinal surgery and prolonged operative time and suggests that efforts should be made to minimize the duration of surgical procedures while prioritizing patient’s safety, without compromising the technical achievement of the procedure.

Efficacy and Safety of Pembrolizumab plus Axitinib combination for Metastatic Renal Cell Carcinoma in a Real-World Scenario: Data From the Prospective ProPAXI Study

BackgroundPembrolizumab/Axitinib combination is approved as first-line therapy in mRCC. The aim of this study is to evaluate outcomes of PAXI combo in the real-world in Italy. MethodsThis is a prospective study including patients diagnosed with mRCC who received combination as first-line therapy in recruiting Italian Centers. Data about patient characteristics, safety and outcome were collected. Results170 pts have been treated from December 2020 to September 2023. The majority had clear-cell histology (83%). Sarcomatoid feature was present in 33%of available cases. About one half of patients (55%) had synchronous metastasis. In 58% of cases nephrectomy was performed, of which 27% were cytoreductive and 4% were deferred nephrectomies. Lung metastases were identified in 106 patients (62%), bone and liver involvement in 66 and 29 patients (38.8% and 17.1%) respectively. Stratifying by IMDC criteria, 32 patients (18.8%) were at favorable-risk, 106 (62.4%) at intermediate-risk, and 32 (18.8%) at poor-risk. At time of analysis, treatment was ongoing in 49% of patients. Progression occurred in 45% of patients. Median PFS was 19.2 months (95% CI: 15-NR). With a median follow-up of 19.3 months (range 1.3-34.5), at 24-months and 36-months landmark analysis 62% (95% CI, 53-70) and 58% (95% CI, 47-69) of treated patients are still alive respectively. Disease control rate was achieved in 84.6% of patients: 4.3% reached a complete response, 52% had a partial response and 28.8% a stable disease. Primary progression was observed in 15.3% of patients. In the multivariate analysis, the prognostic significance of age ≥ 65 years, non-clear cell histology, IMDC score, and adverse events and gender interaction as predictors of worse OS were confirmed. ConclusionThis is the first available prospective study on first-line Pembrolizumab/Axitinib combination in real world scenario. Our findings support the effectiveness and safety of first-line this combination in mRCC and reveal that gender emerged as a prognostic factor in relation to the occurrence of adverse events.

Dose reduction and discontinuation due to the combination of CDK4/6 inhibitors and endocrine drugs: a systematic review and meta-analysis.

With the widespread use of CDK4/6 inhibitors, the number of discontinuations and reductions due to adverse events is increasing. Therefore, we examined the risk of dose reduction, discontinuation, and occurrence of serious adverse events and death due to adverse events when CDK4/6 inhibitors are combined with endocrine drugs. We searched English-language articles published up to February 10, 2024, using RR values (risk ratio) to indicate the risk of discontinuation, dose reduction, death, and the risk of serious adverse events. When CDK4/6 inhibitors were used in combination with endocrine drugs, abemaciclib resulted in the highest risk of discontinuation, dose reduction, and serious adverse events. Ribociclib caused the highest risk of death. When using CDK4/6 inhibitors in the clinical setting, a comprehensive evaluation should be performed to avoid dosage reductions and discontinuations and to choose the most appropriate treatment regimen.

B - 63 Performance on Cognitive Flexibility Measures Predict the Occurrence of Adverse Driving Events among Adults

Abstract Objective To explore whether adults’ cognitive flexibility performance predicted adverse driving events. Methods Adult participants (n = 297; Mage = 27.48, SD = 9.29; Med = 16.07, SD = 2.01, 63% female) were selected from a de-identified outpatient database. Participants reported having no neurological/neuropsychological or psychological/psychiatric diagnoses. Participants identified as 60.3% white, 17.8% Hispanic, 12.8% African American, and 9.1% other. A multiple linear regression analysis was conducted to examine whether measures of cognitive flexibility significantly predicted adverse driving events as measured by the reported number of motor vehicle accidents and moving violations (tickets). Results The results revealed that performance on the CPT-3 detectability (B = 0.04), Hit Reaction Time (HRT, B = 0.03), variability (B = −0.08); CATA detectability (B = 0.06), HRT (B = 0.08); WCST total number of trials (B = −0.04), total number of errors (B = −0.08); and Stroop interference scores (B = −0.03) significantly predicted the occurrence of adverse driving events, (F (8, 296) = 3.72, p &amp;lt; 0.001, R2 = 0.09), albeit to a small effect. Conclusions Poorer performance on measures of cognitive flexibility predicted higher rates of motor vehicle accidents and moving violations. Participants who exhibited better reaction time, attention focus, ability to set shift and discriminate target information, as well as ability to inhibit cognitive interference reported less adverse driving events. Consistent with previous research, these findings indicate that cognitive abilities, specifically cognitive flexibility, can predict driving outcomes/performance. Future research could investigate findings with individuals across the lifespan and with executive function deficits.