Concomitant treatment with safinamide and antidepressant drugs: Safety data from real clinical practice / Tratamiento concomitante de safinamida y antidepresivos: Datos de seguridad sobre la práctica en la vida real

Background and purpose: The aim of this study was to assess the possible pharmacological interactions between safinamide and antidepressants, and in particular the appearance of serotonin syndrome with data from real life. Methods: We conducted a retrospective observational study of patients with Parkinson's disease from our Movement Disorders Unit, who were under treatment with any antidepressant drug and safinamide. Specifically, symptoms suggestive of serotonin syndrome were screened for. Also, we collected time of simultaneous use, doses of levodopa and other antiparkinsonian drugs. Results: Clinical records were reviewed for the study period of September 2018 to September 2019. Seventy-eight PD patients who were treated with safinamide of which 25 (32.05%) had a concomitant treatment with an antidepressant drug, being sertraline and escitalopram the most frequent. Mean age was 80 years ± 8.43 and H&Y stage was 3 [2–4]. Mean dose of levodopa used was 703.75 mg ± 233.15. Median duration of concomitant treatment with safinamide and antidepressant drug was 6 months (IQR 20.5), and over eighteen months in 5 cases. No case of serotonin syndrome was recorded, neither was any of its typical manifestations combined or in isolation. Conclusions: Our real clinical practice study suggests that concomitant use of safinamide with antidepressant drugs in PD patients seemed to be safe and well tolerated, even in the long term. However, caution is warranted, individualizing treatment regimens and monitoring the potential appearance of adverse effects.(AU)

Objetivos: El objetivo de este estudio ha sido evaluar las posibles interacciones farmacológicas entre safinamida y antidepresivos; en particular la aparición del síndrome serotoninérgico mediante datos obtenidos en la vida real. Material y métodos: Realizamos un estudio observacional retrospectivo de pacientes con enfermedad de Parkinson (EP) de nuestra unidad de trastornos del movimiento, que estaban en tratamiento con algún fármaco antidepresivo y safinamida. Específicamente, se examinaron los síntomas sugestivos de síndrome serotoninérgico. Además, se recogieron tiempos de uso simultáneo, dosis de levodopa y otros fármacos antiparkinsonianos concomitantes. Resultados: Se revisaron las historias clínicas correspondientes al período de estudio de septiembre de 2018 a septiembre de 2019. Setenta y ocho pacientes con EP se encontraban en tratamiento con safinamida, de los cuales 25 (32,05%) se encontraban recibiendo además un fármaco antidepresivo, siendo sertralina y escitalopram los más frecuentes. La edad media fue de 80 años ± 8,43 y el estadio H&Y fue de 3 [2-4]. La dosis media de levodopa utilizada fue de 703,75 mg ± 233,15. La mediana de duración del tratamiento concomitante con safinamida y un fármaco antidepresivo fue de 6 meses (IQR: 20,5), y más de 18 meses en 5 casos. No se registró ningún caso de síndrome serotoninérgico, ni tampoco ninguno de sus síntomas de forma aislada. Conclusión: Nuestro estudio de práctica clínica real sugiere que el uso concomitante de safinamida con fármacos antidepresivos en pacientes con EP parece ser seguro y bien tolerado, incluso a largo plazo. Sin embargo, es necesaria precaución, individualizando los regímenes de tratamiento, y controlando la posible aparición de efectos adversos.(AU)

Healthcare resource utilization and associated costs among patients with migraine in Finland: A retrospective register-based study.

Migraine is a common chronic brain disorder, characterized by recurring and often disabling attacks of severe headache, with additional symptoms such as photophobia, phonophobia and nausea. Migraine affects especially the working age population. The objective of this retrospective observational register-based study was to analyze the use of healthcare services and associated costs in Finnish migraine patients. Study was based on aggregate data from January 1st, 2020, to December 31st, 2021, from the Finnish Institute for Health and Welfare's national registries. Patients were grouped into nine patient groups according to medication prescriptions and diagnoses. Healthcare resource utilization in specialty, primary, and occupational healthcare was assessed and analyzed separately for all-cause and migraine related healthcare contacts from a one-year period. The total number of patients was 175 711, and most (45%) of the patients belonged to a group that had used only one triptan. Migraine related total healthcare resource utilization was greater for patients that had used two or more triptans compared to those that had used only one. The patients with three or more preventive medications had the highest total migraine related healthcare resource utilization of the studied patient cohorts. Of the total annual healthcare costs 11.5% (50.6 million €) was associated to be migraine related costs. Total per patient per year healthcare costs were highest with patients that had used three or more preventive medications (5 626 €) and lowest in those with only one triptan (2 257 €). Our findings are in line with the recent European Headache Federation consensus statement regarding the unmet need in patients who have had inadequate response to two or more triptans. When assessing the patient access and cost-effectiveness of novel treatments for the treatment of migraine within different healthcare systems, a holistic analysis of the current disease burden along with potential gains for patients and healthcare service providers are essential information in guiding decision-making.

Radiofrequency hyperthermia enhances the effect of OK-432 for Hepatocellular carcinoma by activating of TLR4-cGAS-STING pathway.

Radiofrequency ablation (RFA) has been used as an alternative to surgical management of early-stage hepatocellular carcinoma (HCC). However, when large and irregular HCCs are subjected to RFA, a safety margin is usually difficult to obtain, thus causing a sublethal radiofrequency hyperthermia (RFH) at the ablated tumor margin. This study investigated the feasibility of using RFH to enhance the effect of OK-432 on HCC, with the aim to generate a tumor-free margin during RFA of HCC. Our results showed OK-432 could activate the cGAS-STING pathway, and RFH could further enhance the activation. Meanwhile, RFH could induce a high expression of TLR4, and TLR4 might be an upstream molecular of the cGAS-STING pathway. The combined therapy of RFH with OK-432 resulted in a better tumor response, and a prolonged survival compared to the other three treatments. In conclusion, RFH in combination with OK-432 might reduce the residual and recurrent tumor after RFA of large and irregular HCCs, and serve as a new option for other solid malignancies treated by RFA.

Electrolyte disorders induced by six multikinase inhibitors therapy for renal cell carcinoma: a large-scale pharmacovigilance analysis.

To provide evidence for optimization of multi-kinase inhibitors (MKIs) use in the clinic, we use the public database to describe and evaluate electrolyte disorders (EDs) related to various MKIs treated for renal cell carcinoma. We analyzed spontaneous reports submitted to the Food and Drug Administration Adverse Events Reporting System (FAERS) in an observational and retrospective manner. Selecting electrolyte disorders' adverse events to multikinase inhibitors (axitinib, cabozantinib, lenvatinib, pazopanib, sunitinib, and sorafenib). We used Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms to analyze suspected adverse reactions of electrolyte disorders induced by MKIs (which were treated for renal cell carcinoma) between January 2004 and December 2022. As of December 2022, 2772 MKIs (which were treated for renal cell carcinoma) ICSRs were related to electrolyte disorders AEs. In general, there were more AEs cases in males, except lenvatinib and 71.8% of the cases were submitted from North America. ICSRs in this study, the age group most frequently affected by electrolyte disorders AEs was individuals aged 45-64 years for axitinib, cabozantinib, pazopanib, and sunitinib, whereas electrolyte disorders AEs were more common in older patients (65-74 years) for sorafenib and lenvatinib. For all EDs documented in ICSRs (excluding missing data), the most common adverse outcome was hospitalization(1429/2674, 53.4%), and the most serious outcome was death/life-threat(281/2674, 10.5%). The prevalence of mortality was highest for sunitinib-related EDs (145/616, 23.5%), excluding missing data (n = 68), followed by cabozantinib-related EDs (20/237, 8.4%), excluding missing data (n = 1). The distribution of time-to-onset of Each drug-related ICSRs was not all the same, and the difference was statistically significant (P = 0.001). With the criteria of ROR, the six MKIs were all significantly associated with electrolyte disorders AEs, the strongest association was the association between cabozantinib and hypermagnesaemia. MKIs have been reported to have significant electrolyte disorders AEs. Patients and physicians need to recognize and monitor these potentially fatal adverse events.

Association between fatigue, peripheral serotonin, and L-carnitine in hypothyroidism and in chronic fatigue syndrome.

Background: Fatigue of unknown origin is a hallmark symptom in chronic fatigue syndrome (CFS) and is also found in 20% of hypothyroidism patients despite appropriate levothyroxine treatment. Here, we suggest that in these disorders, peripheral serotonin levels are low, and elevating them to normal range with L-carnitine is accompanied with reduced fatigue. Methods: We conducted a retrospective analysis of follow-up clinical data (CFS N=12; hypothyroidism with fatigue N=40) where serum serotonin and fatigue levels were compared before vs. after 7 weeks of oral L-carnitine supplementation. Results: After L-carnitine, serotonin increased (8-fold in CFS, Sig. = 0.002, 6-fold in hypothyroidism, Sig. < 0.001) whereas fatigue decreased (2-fold in both CFS and hypothyroidism, Sig. = 0.002 for CFS, Sig. < 0.001 for hypothyroidism). There was a negative correlation between serotonin level and fatigue (for CFS, rho = -0.49 before and -0.67 after L-carnitine; for hypothyroidism, rho = -0.24 before and -0.83 after L-carnitine). Conclusions: These findings suggest a new link between low peripheral serotonin, L-carnitine, and fatigue.

Use of the Serum Level of Cholinesterase as a Prognostic Marker of Nonfatal Clinical Outcomes in Patients Hospitalized with Acute Exacerbations of Chronic Obstructive Pulmonary Disease.

Introduction: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) contributes to a poor prognosis. Reliable biomarkers to predict adverse outcomes during hospitalization are important. Aim: To investigate the relationship between the serum cholinesterase (ChE) level and adverse clinical outcomes, including hypoxemia severity, hypercapnia, duration of hospital stay (DoHS), and noninvasive ventilation (NIV) requirement, in patients with AECOPD. Methods: Patients hospitalized with AECOPD in the Wuhu Hospital of Traditional Chinese Medicine between January 2017 and December 2021 were included. Results: A total of 429 patients were enrolled. The serum ChE level was significantly lower in patients with hypercapnia, who required NIV during hospitalization and who had a DoHS of >10 days, with an oxygenation index < 300. The ChE level was correlated negatively with the C-reactive protein level and neutrophil-to-lymphocyte ratio and correlated positively with the serum albumin level. Multivariate logistic regression analysis indicated that a serum ChE level of ≤4116 U/L (OR = 2.857, 95% CI = 1.46-5.58, p = 0.002) was associated significantly with NIV requirement. Conclusions: The serum ChE level was correlated significantly with complicating severe hypoxemia, hypercapnia, prolonged DoHS, and the need for NIV in patients hospitalized with AECOPD. The serum ChE level is a clinically important risk-stratification biomarker in patients hospitalized with AECOPD.

Exploring the effectiveness of virtual and in-person instruction in culinary medicine: a survey-based study.

BACKGROUND: Culinary medicine, which has recently increased in popularity in medical education, incorporates food and nutritional interventions with principles of disease prevention and treatment. The ultimate goal is to improve overall health outcomes. The growing prevalence of diet-related chronic diseases indicates the need for physicians to have a deeper understanding of the interplay between nutrition and disease. Incorporating culinary medicine into medical education can equip medical students with the necessary skills and knowledge to promote better patient outcomes. The purpose of this study was to evaluate students' perceptions of their foundational knowledge of a culinary medicine course after completion of the course for first- and second-year medical students at the PCOM (Philadelphia College of Osteopathic Medicine). We will also examine the difference between methods of instruction in relation to constructs discussed of knowledge gained and enjoyment of the course. METHODS: This retrospective cohort study was conducted using SurveyMonkey by Momentive. Data were collected from osteopathic medical students who enrolled in a culinary medicine course at the PCOM from 2018 to 2022 through the completion of a post-course survey. The methods of instruction included either a virtual or in-person classroom. The statistical analysis for this study was conducted using IBM SPSS Statistics version 28. To compare methods of instruction, the statistical analyses used included descriptive statistics, chi-square analysis, one-way ANOVA, and independent sample one-sided t tests. RESULTS: A total of 360 out of 430 participants, spanning the years 2018 to 2022, completed the course requirements and participated in the online survey. There was a valid sample size of 249 for the in-person group and 111 for the virtual instruction group. The knowledge gained construct consisted of five survey questions, for a total possible score of 25, while the enjoyment construct consisted of two questions, for a total possible score of 10. A statistically significant difference in knowledge gained was identified by one-way ANOVA, F (4,355) = 3.853, p =.004. Additionally, there was a statistically significant difference in enjoyment of the course between class years, F (4,356) = 11.977, p <.001. Independent sample t-tests revealed a statistically significant difference in enjoyment between the two methods (p <.001) even after accounting for unequal variances, with Cohen's d equal to 0.807, indicating a moderate effect size. CONCLUSIONS: The findings of this study suggest that overall, students were highly satisfied with the Culinary Medicine course over a five-year period. The study suggested that students who participated in in-person courses benefitted more than did the virtual students in terms of knowledge gained and enjoyment. The 360 students who completed the Culinary Medicine course were highly satisfied with the information and skills they acquired.

How should hyperbilirubinemia be considered in the definition of the hearing screening protocol for neonates at risk? / Como a hiperbilirrubinemia deve ser considerada na definição do protocolo da triagem auditiva para neonatos de risco?

PURPOSE: To analyze hyperbilirubinemia as an indicator for the definition of risk protocol in newborn hearing screening (NHS) and in auditory monitoring in full-term and preterm neonates. METHODS: This is an observational, cross-sectional and retrospective study. A total of 554 children born in a public maternity hospital were included and divided into two groups: (G1) with 373 full-terms neonates; (G2) with 181 preterm neonates. Data were collected from the participant's medical records to obtain information regarding the result of the NHS, performed by recording the automated auditory brainstem response (AABR), birth conditions, clinical characteristics, interventions performed, and results of the first test of total bilirubin (TB) and indirect bilirubin (IB) as well as the peak of TB and IB. A descriptive statistical analysis of the results was performed, and the level of significance adopted was 5%. RESULTS: On the NHS test, quotes of retest referral rates were smaller in G1 when compared to G2. There was no significant difference between the groups regarding type of delivery, gender, presence of Rh and ABO incompatibility, G6PD enzyme deficiency, and performance of phototherapy. TB and IB levels at the first exam and at peak time did not differ between neonates with "pass" and "fail" results on the NHS test in both groups. CONCLUSION: Bilirubin levels in the neonatal period below the recommended values for indication of exchange transfusion are not directly related to the "fail" result on the NHS tests in term and preterm neonates.

OBJETIVO: Analisar a hiperbilirrubinemia como indicador para a realização do protocolo de risco na triagem auditiva neonatal (TAN) e no monitoramento auditivo em neonatos a termo e prematuros. MÉTODO: Trata-se de um estudo observacional, transversal e retrospectivo. Foram incluídas 554 crianças nascidas em uma maternidade pública, subdivididas em dois grupos: (G1) com 373 recém-nascidos a termo; (G2) com 181 neonatos prematuros. Os dados foram coletados nos prontuários dos participantes, a fim de se obter informações referentes ao resultado da TAN realizada por meio do registro do Potencial Evocado Auditivo de Tronco Encefálico, às condições de nascimento, características clínicas, intervenções realizadas, resultados do primeiro exame de bilirrubina total (BT) e bilirrubina indireta (BI) e do pico de BT e BI. Realizou-se análise estatística descritiva e inferencial dos dados, com adoção do nível de significância de 5%. RESULTADOS: No teste da TAN, foram observadas taxas de encaminhamento para reteste inferiores no G1 em relação ao G2. Não houve diferença entre os grupos quanto à ocorrência do tipo de parto, sexo, presença de incompatibilidade sanguínea Rh e ABO, deficiência de enzima G6PD e realização de fototerapia. Em relação aos níveis de BT e BI no primeiro exame e no momento do pico, não houve diferenças entre os neonatos com resultado "passa" e "falha" na TAN-teste nos dois grupos. CONCLUSÃO: Os níveis de bilirrubina no período neonatal abaixo dos valores recomendados para indicação de exsanguineotransfusão não estão diretamente relacionados ao resultado "falha" na TAN em neonatos a termo e prematuros.

Use of hyperbaric oxygen therapy in severe earthquake injuries.

BACKGROUND: Earthquakes are natural disasters that can often cause severe injuries and traumatic situations. These injuries can include crush injuries, fractures, tissue damage, and blood circulation problems. Hyperbaric oxygen therapy (HBOT) has recently become a frequently used treatment modality for individuals suffering from severe injuries. HBOT is a form of treatment that involves administering pure oxygen to the patient under high pressure. This treatment aims to promote tissue healing by increasing cellular oxygenation. It is thought to have a positive effect on factors such as accelerating tissue healing, reducing inflammation, and controlling infection in severe post-earthquake injuries, particularly crush injuries. This study aimed to retrospectively evaluate the clinical effects, contributions to the healing process, and potential advantages of HBOT in 35 patients with severe injuries after the Kahramanmaras earthquake that occurred on 06.02.2023 and to contribute to the development of emergency intervention strategies. METHODS: This study was carried out after ethics committee approval. In the study, the data of patients with a MESS Score between 7-14 who were admitted as earthquake victims and treated in the HBOT Unit due to severe earthquake-related injuries were obtained from records and retrospectively analyzed. Demographic information, general distribution of patient data, mean values, number of HBOT sessions, and functional outcomes were recorded. RESULTS: The gender distribution of the 35 patients who received HBOT was 31.4% male and 68.6% female. 45.7% of patients were aged 18 years or younger, and 54.3% were aged 19 years or older. The most common injuries in the treated patients were observed in the lower extremities. After HBOT, sensory recovery (54.3%) and functional recovery (51.4%) were achieved in the majority of patients. The minor amputation rate was 20.0% and the major amputation rate was 11.4% after HBOT. CONCLUSION: This study evaluated the possible effects of HBOT on patients with severe earthquake injuries in Türkiye, and the results showed that HBOT may have a beneficial effect on critical factors such as sensory recovery, functional recovery, and amputation rates in this particular group of patients, and that this benefit may be more pronounced in those who started treatment early.

Bilirubin Measurement and Phototherapy Use After the AAP 2022 Newborn Hyperbilirubinemia Guideline.

BACKGROUND AND OBJECTIVES: Guidelines for the management of neonatal hyperbilirubinemia have helped to reduce rates of significant hyperbilirubinemia. However, recent evidence suggesting overtreatment and potential harms of phototherapy have informed the American Academy of Pediatrics clinical practice guideline revision and the accompanying increase in phototherapy thresholds. These changes are predicted to safely reduce overuse; however, to date, the exact effect of these guidelines has not been established. METHODS: We conducted a retrospective study of newborns born at ≥35 weeks' gestation across a network of 8 hospitals between January 2022 and June 2023. Outcomes included rates of phototherapy and total serum bilirubin (TSB) measurements before and after guideline publication, as well as clinical outcomes, including length of stay, readmissions, and duration of phototherapy. RESULTS: In our cohort of >22 000 newborns, we observed a 47% decrease in phototherapy utilization, from 3.9% to 2.1% (P < .001). TSB measurements were reduced by 23%, from 712 to 551 measurements per 1000 newborns (P < .001), without an increase in outpatient TSB measurements. We did not observe an increase in readmissions receiving phototherapy, and length of stay increased by only 1 hour (P < .001). CONCLUSIONS: Our study reveals that the publication of the updated American Academy of Pediatrics 2022 hyperbilirubinemia guidelines has likely yielded a significant reduction in phototherapy use and serum bilirubin measurement. Dedicated quality improvement initiatives may help determine which implementation strategies are most effective. Further population-level studies are needed to confirm safety with ongoing guideline uptake.

[Clinical diagnosis and treatment of 14 cases of scar cancer ulcer wound on head and face].

Objective: To analyze the clinical characteristics of scar cancer ulcer wound of head and face, and to investigate its diagnosis and treatment. Methods: The clinical data of 14 patients with head and facial scar cancer ulcer wounds who met the selection criteria and admitted between January 2021 and March 2022 were retrospectively analyzed. There were 8 males and 6 females. The age of onset ranged from 21 to 81 years with an average age of 61.6 years. The incubation period ranged from 1 month to 70 years, with a median of 4 years. Site of the disease included 7 cases of head, 6 cases of maxillofacial region, and 1 case of neck region. Injury factors included trauma in 5 cases, scratch in 5 cases, scalding in 2 cases, burn in 1 case, and needle puncture in 1 case. Pathological results showed squamous cell carcinoma in 9 cases, basal cell carcinoma in 3 cases, sebaceous adenocarcinoma in 1 case, papillary sweat duct cystadenoma combined with tubular apocrine sweat gland adenoma in 1 case. There was 1 case of simple extensive tumor resection, 1 case of extensive tumor resection and skin grafting repair, 7 cases of extensive tumor resection and local flap repair, and 5 cases of extensive tumor resection and free flap repair. Results: All the 14 patients were followed up 16-33 months (mean, 27.8 months). Two patients (14.29%) had scar cancer ulcer wound recurrence, of which 1 patient recurred at 2 years after 2 courses of postoperative chemotherapy, and was still alive after oral traditional Chinese medicine treatment. One patient relapsed at 1 year after operation and died after 2 courses of chemotherapy. One patient underwent extensive resection of the left eye and periocular tumor and the transfer and repair of the chimaeric muscle axial flap with the perforating branch of the descending branch of the left lateral circumflex femoral artery, but the incision healing was poor after operation, and healed well after anti-infection and debridement suture. The wounds of other patients with scar cancer ulcer did not recur, and the wounds healed well. Conclusion: Scar cancer ulcer wound of the head and face is common in the middle-aged and elderly male, and the main pathological type is squamous cell carcinoma. Local extensive resection, skin grafting, or flap transfer repair are the main treatment methods. Early active treatment of wounds after various injuries to avoid scar repeated rupture and infection is the foundamental prevention of scar cancer.

Bushen Formula promotes the decrease of HBsAg levels in patients with CHB by regulating Tfh cells and B-cell subsets.

ETHNOPHARMACOLOGICAL RELEVANCE: Bushen Formula (BSF) is the effective traditional Chinese medicine (TCM) for chronic hepatitis B (CHB) according to our previous researches. However, the special effectiveness of BSF treating CHB patients in different stages and the immunoregulatory mechanisms remain to be explored. AIM OF THE STUDY: To compare the therapeutic effects of BSF in both treatment-naive patients and Peg-IFN-α-treated patients, and explore the potential mechanism of immunomodulation. MATERIALS AND METHODS: Ultra-high performance liquid chromatography-quadrupole electrostatic field-orbital trap high resolution mass spectrometry and the TCMSP database were used to determine the main components of BSF. Two hundred and sixty-six patients were enrolled in the retrospective study, and they were divided into the treatment group (T-Group, BSF plus Peg-IFN-α) and the control group (C-Group, Peg-IFN-α monotherapy). Within each group, patients were further grouped into subgroups, namely T1/C1 groups (treatment-naive patients, T1 = 34, C1 = 94) and T2/C2 groups (Peg-IFN-α-treated patients, T2 = 56, C2 = 82). Serum HBV markers, serum HBV DNA levels, serum ALT/AST and TCM symptoms were obtained from the record. Bioinformatics analysis was employed to obtain the potential immunoregulatory mechanisms of BSF treating CHB patients. Among patients in T2 and C2 group, peripheral mononuclear cells from 36 patients were used to analyze the characteristics of peripheral follicular helper T (Tfh) cells and B-cell subtypes by flow cytometry. Preparation of BSF-containing serum in rats. In vitro, the co-culture system of CXCR5+ cells and HepG2.2.15 cells was built to investigate the immunoregulatory effects of BSF. RESULTS: A total of 14 main active compounds were detected in BSF, which were deemed critical for the treatment of CHB. Our findings indicated that the T2-Group exhibited the higher percentage of HBsAg decline ≥ 1-log10 IU/ml and rate of HBeAg seroclearance compared to the C2-Group (35.7% vs. 15.9%, P = 0.033; 33.9% vs. 11.0%, P = 0.002). Additionally, the T2-Group demonstrated the higher percentage of HBsAg decline ≥ 1-log10 IU/ml and rate of HBeAg seroclearance compared to the T1-Group (35.7% vs. 14.7%, P = 0.031; 33.9% vs. 2.9%, P = 0.000). The total effective rate based on TCM clinical syndrome in T1-Group and T2-Group were significantly greater than those in C1-Group and C2-Group (85.3% vs. 61.7%, P = 0.012; 89.1% vs. 63.4%, P = 0.000). Bioinformatics analysis indicated that the immunoregulatory mechanisms of BSF treating CHB patients were mainly linked to the growth and stimulation of B-cell, T-cell differentiation, and the signaling pathway of the B-cell receptor. Furthermore, the frequencies of Tfh cells and its IL-21 level, and the IL-21R expressed by B-cell were all increased after BSF treatment. Additionally, in the co-culture system of CXCR5+ cells and HepG2.2.15 cells, HBsAg and HBeAg levels were decreased after BSF-containing serum treatment，as well as the up-regulating of Tfh cell frequencies and down-regulating of B-cell frequencies. CONCLUSIONS: BSF have the higher percentage of HBsAg decline and HBeAg seroclearance in Peg-IFN-α-treated patients compared with treatment-naive patients. The potential immunoregulatory mechanism may correlate with promoting the interaction between Tfh cells and B-cell through IL-21/IL-21R signaling pathway.

Prevalence of Micronutrient Deficiencies in Preoperative Bariatric Patients in a New Zealand Tertiary Centre.

PURPOSE: A potential complication of bariatric surgery is development of nutritional deficiencies. Study aims were to assess prevalence of micronutrient deficiencies in preoperative bariatric patients and to examine for ethnic differences. METHODS: Retrospective analysis of 573 patients that underwent bariatric surgery at Counties Manukau District Health Board was carried out. Mean preoperative levels of albumin, calcium, phosphate, folate, vitamin B12, vitamin D, magnesium, haemoglobin, haematocrit, mean cell volume, mean cell haemoglobin, ferritin, iron, and transferrin were calculated. Chi square, fisher exact test, and multiple logistic regression was used to assess for differences in prevalence of micronutrient deficiencies across ethnicities. RESULTS: The most common micronutrient deficiency was vitamin D (30.85%). There were statistically significant differences in vitamin D deficiency across ethnicities (p < 0.0001). Asians had the highest prevalence of vitamin D deficiency (60%), followed by Pacifica (44.57%), and Maori (31.68%). Asians were more likely to have vitamin D deficiency compared to NZ/Other Europeans (OR = 14.93, p < 0.001). Vitamin D deficiency was associated with higher BMI (OR = 1.05, p = 0.008). The second most common deficiency was iron (21.1%). Asians had the highest prevalence of iron deficiency (44%), followed by Maori (27.95%), and Pacifica (19.57%) (p = 0.0064). Compared to NZ/Other Europeans, Asians (OR = 4.26) and Maori (OR = 1.78) were more likely to be iron deficient (p = 0.004). Female gender was associated with iron deficiency (OR = 2.12, p = 0.007). CONCLUSION: Vitamin D and iron are the most common micronutrient deficiencies among preoperative bariatric patients in this cohort and ethnic differences were seen. There may be a role for preoperative supplementation in these at-risk ethnic groups.

Health-related quality of life for pediatric patients with end-stage kidney disease: A systematic review and meta-analysis of the Pediatric Quality of Life Inventory (PedsQL).

INTRODUCTION: Health-related quality of life (HRQoL) studies demonstrate the impact of end-stage renal disease (ESRD) on the physical and psychosocial development of children. While several instruments are used to measure HRQoL, few have standardized domains specific to pediatric ESRD. This review examines current evidence on self and proxy-reported HRQoL among pediatric patients with ESRD, based on the Pediatric Quality of Life Inventory (PedsQL) questionnaires. METHODS: Following PRISMA guidelines, we conducted a systematic review and meta-analysis on HRQoL using the PedsQL 4.0 Generic Core Scale (GCS) and the PedsQL 3.0 ESRD Module among 5- to 18-year-old patients. We queried PubMed, Embase, Web of Science, CINAHL, and Cochrane databases. Retrospective, case-controlled, and cross-sectional studies using PedsQL were included. FINDINGS: Of 435 identified studies, 14 met inclusion criteria administered in several countries. Meta-analysis demonstrated a significantly higher total HRQoL for healthy patients over those with ESRD (SMD:1.44 [95% CI: 0.78-2.09]) across all dimensional scores. In addition, kidney transplant patients reported a significantly higher HRQoL than those on dialysis (PedsQL GCS, SMD: 0.33 [95% CI: 0.14-0.53]) and (PedsQL ESRD, SMD: 0.65 [95% CI: 0.39-0.90]) concordant with parent-proxy reports. DISCUSSION: Patients with ESRD reported lower HRQoL in physical and psychosocial domains compared with healthy controls, while transplant and peritoneal dialysis patients reported better HRQoL than those on hemodialysis. This analysis demonstrates the need to identify dimensions of impaired functioning and produce congruent clinical interventions. Further research on the impact of individual comorbidities in HRQoL is necessary for developing comprehensive, integrated, and holistic treatment programs.

Vascular access device type for systemic anti-cancer therapies in cancer patients: A scoping review.

BACKGROUND: Patients with cancer can expect to receive numerous invasive vascular access procedures for intravenous therapy and clinical diagnostics. Due to the increased incidence and prevalence of cancer globally there will be significantly more people who require first-line intravenous chemotherapy over the next ten years. METHODS: Our objective was to determine the types of evidence that exist for the vascular access device (VAD) type for the delivery of systemic anti-cancer therapy (SACT) in cancer patients. We used JBI scoping review methodology to identify the types of VADs used for SACT and with a specific search strategy included articles from 2012-2022 published in the English language. We identify (i) type of VADs used for SACT delivery (ii) the type of insertion and post-insertion complications (iii) the geographical location and clinical environment (iv) and whether VAD choice impacts on quality of life (QOL). Findings were presented using the PAGER framework. MAIN FINDINGS: Our search strategy identified 10,390 titles, of these, 5318 duplicates were removed. The remaining 5072 sources were screened for eligibility, 240 articles met the inclusion criteria. The most common design include retrospective study designs (n = 91) followed by prospective study designs (n = 31). We found 28 interventional studies with 21 registered in a clinical trial registry and identified no core outcome sets papers specific to VAD for SACT. The most prevalent publications were those that featured two or more VAD types (n = 70), followed by tunnelled intravenous VADs (n = 67). Of 38 unique complications identified, the most frequent catheter related complication was catheter related thrombosis (n = 178, 74%), followed by infection (n = 170, 71%). The county where the most publications originated from was China (n = 62) with one randomized controlled multicenter study from a comprehensive cancer centre. Of the thirty three studies that included QOL we found 4 which reported on body image. No QOL measurement tools specific to the process of SACT administration via VAD are available INTERPRETATION: Our findings suggest a systematic review and meta-analysis of VAD use for intravenous SACT can be considered. However, the development of a core outcome set for SACT should be prioritised. Funding for high quality programs of research for VAD in cancer are needed. Comprehensive cancer centres should lead this research agenda.

A Potential Therapeutic Approach According to Traditional Thai Medicine Theory for Post-COVID-19 Syndrome Treatment: An Observational Retrospective Clinical Study.

Background: Most post-COVID-19 patients had physiological health problems, which differed for each patient. The potential treatment for post-COVID-19 syndrome must require multi-disciplinary approaches that focus on individualized treatment. Therefore, traditional Thai Medicine (TTM) clinical practice guidelines for post-COVID-19 treatment are developed by the Traditional Thai Medicine Hospital, Prince of Songkla University, to care for post-COVID-19 patients. Objective: This current study aimed to investigate the effect of the guidelines on post-COVID-19 patient's physical health. Methods: This research was a retrospective clinical study, carried out from June 2022 to July 2022. Setting: The study was conducted at the Traditional Thai Medicine Hospital, Prince of Songkla University, and La Flora Khao Lak TTM clinic, Thailand. Participants: Data (n=17) were collected from the medical record. They were included if they met the following criteria: patients were more than 18 years old, had a medical history of COVID-19 disease, had fully recovered from the disease (ATK for COVID-19 is negative) at least a week before starting the guideline, and had complete medical information such as post-COVID-19 symptoms, vital signs, pain score, cough severity score, and quality of life examination. Intervention: Approaches for post-COVID-19 treatment included herbal Thai medicine recipes, Thai massage, herbal steam inhalation, herbal hot steam, herbal hot water immersion, acupressure massage for breathing stimulation, and a breathing exercise. All procedures were applied for 7 days continually or until they have recovered. Primary Outcome Measures: The effects of TTM approaches on the symptoms of post-COVID-19 patients on pain score, quality of life, cough severity were measured using a visual analog score (VAS), SF-36 questionnaire, and cough severity index (CSI), respectively. Results: The average duration time of post-COVID-19 syndrome was 25.76 days, and the most common symptom was muscle pain/stress (10; 71.43%). Yahom-Navakot (6; 42.86%) is the most common recipe used for the treatment. Interestingly, the pain score was significantly reduced by 3 days of the treatment (4.88±2.03 vs 2.29±2.08 ). Moreover, the cough severity index (12.86±11.55 vs 3.31±6.38) was significantly lessened by 7 days of the treatment. Remarkably, most symptoms vanished entirely after 7 days of the intervention, leading to a better quality of life for the patients (53.24±22.15 vs 65.59±23.64). Conclusions: The TTM clinical practice guideline for treating post-COVID-19 syndrome effectively improved the overall physical health capacity and symptoms associated with post-COVID-19 syndrome. Therefore, the implementation of this guideline, together with other approaches, could strengthen the treatment for post-COVID-19 to be more effective.

Validation of the IMPEDE VTE score for prediction of venous thromboembolism in Chinese patients with multiple myeloma: A single-center retrospective cohort study.

Multiple myeloma (MM) significantly increases the risk of venous thromboembolism (VTE) within 6 months of treatment initiation. The IMPEDE VTE score is a VTE risk prediction model which is recently incorporated into the National Comprehensive Cancer Network (NCCN) guidelines, but it lacks validation among Asians, including Chinese MM patients. We performed a retrospective chart review of 405 Chinese with newly diagnosed MM who started therapy at Beijing Jishuitan Hospital between April 2013 to October 2022. The 6-month cumulative incidence of VTE was 3.8 % (95 % CI:1.6-7.6), 8.6 % (95 % CI: 5.3-21.9) and 40.5 % (95 % CI: 24.9-55.7) in the low-, intermediate- and high-risk groups (P < 0.001), respectively. The C-statistic of the IMPEDE VTE scores for predicting VTE within 6 months of treatment initiation was 0.74 (95 % CI: 0.65-0.83). Of note, in this single-center cohort study, we propose that the anticoagulant LMWH may be more effective than the antiplatelet aspirin in potentially preventing VTE in newly diagnosed MM patients. Our findings suggest that the IMPEDE VTE score is a valid evidence-based risk stratification tool in Chinese patients with newly diagnosed MM.

Evaluation of mortality, prognostic parameters, and treatment efficacy in mycosis fungoides.

BACKGROUND AND OBJECTIVES: Mycosis fungoides (MF), the most common primary cutaneous T-cell lymphoma, is characterized by a variable clinical course, presenting either as indolent disease or showing fatal progression due to extracutaneous involvement. Importantly, the lack of prognostic models and predominantly palliative therapy settings hamper patient care. Here, we aimed to define survival rates, disease prediction accuracy, and treatment impact in MF. PATIENTS AND METHODS: Hundred-forty MF patients were assessed retrospectively. Prognosis and disease progression/survival were analyzed using univariate Cox proportional hazards regression model and Kaplan-Meier estimates. RESULTS: Skin tumors were linked to shorter progression-free, overall survival and a 3.48 increased risk for disease progression when compared to erythroderma. The Cutaneous Lymphoma International Prognostic Index identified patients at risk in early-stage disease only. Moreover, expression of Ki-67 >20%, CD30 >10%, CD20+, and CD7- were associated with a significantly worse outcome independent of disease stage. Only single-agent interferon-α and phototherapy combined with interferon-α or retinoids/bexarotene achieved long-term disease control in MF. CONCLUSIONS: Our data support predictive validity of prognostic factors and models in MF and identified further potential parameters associated with poor survival. Prospective studies on prognostic indices across disease stages and treatment modalities are needed to predict and improve survival.

Nomogram predicting the efficacy of transurethral surgery in benign prostatic hyperplasia patients.

PURPOSE: This study aimed to develop and validate a nomogram for predicting the efficacy of transurethral surgery in benign prostatic hyperplasia (BPH) patients. METHODS: Patients with BPH who underwent transurethral surgery in the West China Hospital and West China Shang Jin Hospital were enrolled. Patients were retrospectively involved as the training group and were prospectively recruited as the validation group for the nomogram. Logistic regression analysis was utilized to generate nomogram for predicting the efficacy of transurethral surgery. The discrimination of the nomogram was assessed using the area under the receiver operating characteristic curve (AUC) and calibration plots were applied to evaluate the calibration of the nomogram. RESULTS: A total of 426 patients with BPH who underwent transurethral surgery were included in the study, and they were further divided into a training group (n = 245) and a validation group (n = 181). Age (OR 1.07, 95% CI 1.02-1.15, P < 0.01), the compliance of the bladder (OR 2.37, 95% CI 1.20-4.67, P < 0.01), the function of the detrusor (OR 5.92, 95% CI 2.10-16.6, P < 0.01), and the bladder outlet obstruction (OR 2.21, 95% CI 1.07-4.54, P < 0.01) were incorporated in the nomogram. The AUC of the nomogram was 0.825 in the training group, and 0.785 in the validation group, respectively. CONCLUSION: The nomogram we developed included age, the compliance of the bladder, the function of the detrusor, and the severity of bladder outlet obstruction. The discrimination and calibration of the nomogram were confirmed by internal and external validation.