Therapeutics and Clinical Risk Management最新文献

Breast reconstruction can be divided into prepectoral breast reconstruction (PPBR) and subpectoral breast reconstruction (SPBR) according to the implant plane. The original prepectoral breast reconstruction was abandoned for a long time due to the frequent and severe complications. Now, advances in materials technology and improved methods of mastectomy have made safe prepectoral breast reconstruction possible. Moreover, a number of studies have gradually demonstrated the advantages of prepectoral breast reconstruction. As prepectoral breast reconstruction becomes more and more attractive, it is time to review the current advances in prepectoral breast reconstruction.

Purpose: Perioperative anaphylaxis (POA) is an acute severe systemic hypersensitivity reaction characterized by life-threatening respiratory and circulatory collapse. In our previous study, we reported the epidemiology of suspected POA in China. In the present study, we aimed to elucidate the management and outcomes of these cases and further verify the risk factors for near-fatal and fatal outcomes.

Patients and methods: This was a retrospective study of 447 cases of suspected life-threatening POA encountered at 112 tertiary hospitals in mainland China between September 2018 and August 2019. Patient characteristics, symptoms, duration of hypotension, treatments, and clinical outcomes were documented. Bivariate logistic regression was used to identify risk factors for near-fatal and fatal outcomes.

Results: Most cases of suspected POA (89.9%) were recognized and treated within 5 min. Epinephrine was administered as the initial treatment in 232 (51.9%) cases. Corticosteroids (26.6%), other vasoactive drugs (18.3%), and bronchodilators (1.6%) were also administered as the initial treatment instead of epinephrine. The initial dosage of epinephrine (median, 35 µg) was insufficient according to the anaphylaxis guidelines. On multivariable analysis, age ≥65 years (odds ratio [OR] 7.48; 95% confidence interval [CI]: 1.33-41.87, P=0.022), ASA physical status IV (OR 17.68; 95% CI: 4.53-68.94; P<0.001), and hypotension duration ≥15 min (OR 3.63; 95% CI: 1.11-11.87; P=0.033) were risk factors for fatal and near-fatal outcomes.

Conclusion: Most cases in this study were managed in a timely manner, but the epinephrine application should be optimized according to the guidelines. Age ≥65 years, ASA physical status IV, and long-term hypotension were risk factors for near-fatal and fatal outcomes.

Purpose: Hepatitis C virus (HCV) spreads from contact with blood of an infected person. HCV infections are common among people who use drugs (PWUDs), when sharing needles, syringes, or other equipment for injected drugs. The advent of pangenotypic direct-antiviral agents (DAA) in 2017 transformed the treatment landscape for HCV, but PWUDs remain a complex and hard-to-treat population with high risk of HCV reinfection. The aim of this real-world analysis was to characterize the demographic and clinical features of PWUDs in Italy, also focusing on comorbidity profile, treatment with DAAs, resource consumptions for the National Health System (NHS).

Patients and methods: During 01/2011-06/2020, administrative databases of Italian healthcare entities, covering 3,900,000 individuals, were browsed to identify PWUDs with or without HCV infection. Among HCV+ patients, a further stratification was made into treated and untreated with DAAs. The date of PWUD or HCV first diagnosis or DAA first prescription was considered as index-date. Patients were then followed-up for one year. Alcohol-dependency was also investigated.

Results: Total 3690 PWUDs were included, of whom 1141 (30.9%) PWUD-HCV+ and 2549 (69.1%) PWUD-HCV-. HCV-positive were significantly older (43.6 vs 38.5 years, p < 0.001), had a worse comorbidity profile (Charlson-index: 0.8 vs 0.4, p < 0.001), and high rates of psychiatric, respiratory, dermatological, musculoskeletal diseases and genitourinary (sexually transmitted) infections. Moreover, they received more drug prescriptions (other than DAAs, like anti-acids, antiepileptics, psycholeptics) and had undergone more frequent hospitalization, predominantly for hepatobiliary, respiratory system and mental disorders. DDA-untreated had significantly higher Charlson-index than DAA-treated (0.9 vs 0.6, p = 0.003). Alcoholism was found in 436 (11.8%) cases.

Conclusion: This Italian real-world analysis suggests that PWUDs with HCV infection, especially those untreated with DAAs, show an elevated drug consumption due to their complex clinical profile. These findings could help to ameliorate the healthcare interventions on PWUDs with HCV infection.

Objective: How well cardiovascular risk models perform in selected atherosclerosis patients for predicting outcomes is unknown. We sought to compare the performance of cardiovascular risk models (Framingham, Globorisk, SCORE2 & SCORE2-OP, and an updated new model) in predicting the 4-year outcome of patients with obstructive coronary artery disease (CAD).

Methods: Patients with suspected CAD who underwent coronary computed tomography angiography (CCTA) were recruited. Obstructive CAD was defined from CCTA as ≥ 50% stenosis. Computed tomography images, the scores of the cardiovascular risk models, and 4-year composite endpoints were assessed. Whether the patients underwent revascularization within 60 days after CCTA was also recorded. Multivariate regression analysis and receiver operating characteristics (ROC) curve analysis were performed.

Results: A total of 95 patients (mean age: 69.5 ± 10.33 years; 69 males) with obstructive CAD were included in this study. After the ROC analysis, the Framingham, Globorisk, SCORE2 & SCORE2-OP risk score showed prediction values with AUC 0.628 (95% CI: 0.532-0.725), 0.647 (95% CI: 0.542-0.742), 0.684 (95% CI: 0.581-0.776), respectively. Multivariate regression analysis showed that, among the three risk models, only SCORE2 & SCORE2-OP risk score was associated with composite endpoints (hazard ratio: 1.050; 95% CI: 1.021-1.079; p = 0.001) after adjusting for confounding factors. The AUC of the new risk model by combing SCORE2 & SCORE2-OP risk score with revascularization and the number of obstructive vessels in predicting composite endpoints reached 0.898 (95% CI: 0.819-0.951).

Conclusion: The SCORE2 & SCORE2-OP risk score combined with the number of obstructive vessels and revascularization is predictive for adverse outcomes in patients with obstructive CAD.

Lower urinary tract symptoms (LUTS), including urgency, frequency, and urgency incontinence, are highly prevalent in the general population and increase in prevalence with increasing age. All LUTS, but notable urgency and urgency incontinence, are associated with negative impact on quality-of-life (QoL), with multiple aspects of QoL affected. Urgency and urgency incontinence are most commonly caused by overactive bladder (OAB), the clinical syndrome of urinary urgency, usually accompanied by increased daytime frequency and/or nocturia in the absence of infection or other obvious etiology, which may be treated with conservative and lifestyle interventions, bladder antimuscarinic drugs, and, more recently, by mirabegron, a β3 agonist. This narrative review describes the impact of OAB on QoL, quantifies this impact, and outlines the evidence for the use of mirabegron in the treatment of, and improvement in QoL in, people with OAB.

Background: The role of immune checkpoint inhibitors in endometrial cancer is limited. At present, the anti-programmed cell death protein 1 (anti-PD-1) antibody is only used in patients with recurrence or metastasis. CD40 is an important immune checkpoint, which is expressed in tumor cells and immune cells, but its distribution characteristics in endometrial carcinoma have not been explored.

Methods: Sixty-eight cases of primary endometrial carcinoma treated in Peking University People's Hospital from January 2010 to December 2020 were collected, including 28 cases of poorly differentiated endometrioid adenocarcinoma, 23 cases of serous carcinoma and 17 cases of clear cell carcinoma. The relationship of CD40 expression and PD-L1 expression with their prognosis was analyzed by immunohistochemistry.

Results: We found that CD40 had higher expression in non-endometrioid endometrial carcinoma, which lead to the worse prognosis. The effect of high expression of CD40 on the prognosis of endometrioid adenocarcinoma was not significantly different, and most patients with good prognosis. We found that the proportion of CD40 distribution in tumor cells and immune cells may be associated with this heterogeneity.

Conclusion: The expression of CD40 in different endometrial cancers may indicate the difference prognosis, which may become a potential target for drug treatment of non-endometrioid endometrial carcinoma.

Purpose: Erectile dysfunction (ED) contributes to a large burden and impairs the quality of life among males. Avanafil appears to be a promising treatment for ED; however, its efficacy and safety profile remain unclear. This study aimed to evaluate the efficacy and safety of avanafil for the treatment of ED.

Patients and methods: An extensive search of PubMed, ScienceDirect, Web of Science, and Embase databases with 11 publications was performed, with outcomes evaluated are International Index of Erectile Function - Erectile Function (IIEF-EF), Sexual Encounter Profile (SEP), and Treatment-Emergent Adverse Events (TEAE). Statistical parameter Mean Difference (MD) and Risk Ratio (RR) with 95% Confidence Interval (CI) were used to measure effect size.

Results: The pooled estimates demonstrated that changes in IIEF-EF function (MD=4.39, 95% CI [3.41, 5.37], p<0.001), SEP-2 (RR=3.43, 95% CI [2.79, 4.22], p<0.001), SEP-3 (RR=2.30, 95% CI [2.01, 2.62], p<0.001), and TEAE (RR=1.49, 95% CI [1.12, 1.96], p=0.005) were significantly higher in the avanafil group than in the placebo group. Moreover, 200 mg avanafil was superior to that mg 100 mg-avanafil, indicated by the IIEF-EF score (MD=-1.15, 95% CI [-1.40, -0.89], p<0.001). In contrary, there were no significant differences in SEP-2 (RR=0.90, 95% CI [0.75, 1.08], p=0.26), SEP-3 (RR=0.92, 95% CI [0.81, 1.05], p=0.21) and TEAE (RR=1.00, 95% CI [0.87, 1.15], p=0.99) for both 100 mg and 200 mg doses.

Conclusion: This review highlights the potential use of this drug in ED treatment. Further large-scale Randomized Controlled Trials investigations involving various racial groups are required to confirm these findings.

Purpose: Central venous oxygen saturation (ScvO₂) has been reported as a prognostic marker of in-hospital mortality when it is below 60% in certain situations. Nevertheless, it has not been widely reported in patients undergoing coronary artery bypass graft (CABG). The study determined the association between ScvO₂ and in-hospital mortality in patients undergoing CABG in a high-complexity health institution in Santiago de Cali, Colombia.

Patients and methods: A retrospective cohort study was conducted with patients undergoing isolated CABG. The subject sample included 515 subjects aged 18 years or older. Exposure was defined as ScvO₂ <60% upon admission to the intensive care unit (ICU) following surgery. The major outcome was mortality rates after 30 days. Furthermore, exposure variables were measured at preoperative, intra-operative, and postoperative time points.

Results: A total of 103 exposed and 412 unexposed subjects were included. The final model revealed a higher mortality risk in individuals with ScvO₂ <60% upon ICU admission compared with those with higher saturation levels (relative risk 4.2, 95% confidence interval: 2.4-7.2; p = 0.001). Values were adjusted using variables such as age (>75 years), low socioeconomic stratum, chronic kidney failure before surgery, unstable angina before surgery, ischemia time (>60 min), and intra-operative inotrope use. The primary cause of death was cardiogenic shock (54.7%), followed by sepsis (25.0%) and postoperative bleeding (17.2%).

Conclusion: The study identified an association between ScvO₂ <60% and in-hospital mortality in patients undergoing CABG.

Chronic kidney disease guidelines and disease modifying therapy have seen a dramatic shift in the last 5 years. The SGLT2 inhibitor class of medications has been catapulted from hyperglycemia management medications, to cardiovascular and kidney disease improvement therapies. Multiple trials looking at dedicated cardiovascular and kidney endpoints have resulted in favorable results. This review will target empagliflozin and the exciting journey that it has taken along this path. Empagliflozin has been studied for hyperglycemia, cardiovascular, and kidney hard outcome endpoints. Both patients with diabetes and without have been rigorously studied and shown surprising results. The major implications for patients on empagliflozin will be shown. Future studies and directions are highly anticipated to add to the growing knowledge of the SGLT2 inhibitor class, as well as discover possibilities for new disease states to benefit from empagliflozin.