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Bleeding after endoscopic papillectomy and its risk factors: A single center experience of 196 cases

Hepatobiliary Pancreat Dis Int. 2024 Feb 20:S1499-3872(24)00023-7. doi: 10.1016/j.hbpd.2024.02.001. Online ahead of print.

ABSTRACT

BACKGROUND: Endoscopic papillectomy (EP) is an effective method to remove an ampulla of Vater (AoV) adenoma with minimal invasiveness. We reviewed the clinical outcomes and prognosis of patients undergoing EP, including tumor recurrence and adverse events.

METHODS: A total of 196 patients who underwent EP from January 2004 to December 2017 were included. Clinical information was collected through electronic medical records, and risk factors to predict post-procedural bleeding were analyzed using a multivariate logistic regression model.

RESULTS: A total of 93.9% patients (184/196) underwent complete resection. During the follow-up period, 14.7% patients (27/184) experienced tumor recurrence, and two of seven surgically resected tumors were malignant. A total of 45.4% patients (89/196) experienced adverse events related to EP. Delayed bleeding occurred in 16.3% of the patients (32/196), and they were all successfully treated with endoscopic hemostasis and conservative management. The most frequent site of delayed bleeding was the distal end of the papillary orifice, and 56.2% (18/32) patients of delayed bleeding were classified as having mild severity, the others had moderate severity. Familial adenomatous polyposis (FAP) [odds ratio (OR) = 3.80, 95% confidence interval (CI): 1.01-14.29; P < 0.05] and male sex (OR = 2.82, 95% CI: 1.04-7.63; P = 0.04) showed statistical significance in predicting delayed post-EP bleeding.

CONCLUSIONS: EP for AoV adenoma was a highly effective and safe procedure. The risk of post-EP delayed bleeding was increased in patients with FAP syndrome and male patients, and post-EP bleeding occurred most commonly in the distal part of the AoV.

PMID:38433066 | DOI:10.1016/j.hbpd.2024.02.001

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Effectiveness of enterovirus A71 vaccine against pediatric HFMD and disease profile of post-vaccination infection

Vaccine. 2024 Mar 2:S0264-410X(24)00172-5. doi: 10.1016/j.vaccine.2024.02.026. Online ahead of print.

ABSTRACT

BACKGROUND: Vaccination has been proven effective against infection with enterovirus A71 (EV-A71) in clinical trials, but vaccine effectiveness in real-world situations remains incompletely understood. Furthermore, it is not clear whether previous vaccination will result in symptom attenuation among post-vaccinated cases.

METHODS: Based on long-term data extracted from the only designed referral hospital for infectious diseases, we used a test-negative case-control design and multivariate logistic regression models to analyze the effectiveness of EV-A71 vaccine against hand, foot and mouth disease (HFMD). And then, generalized linear regression models were used to evaluate the associations between prior vaccination and disease profiles.

RESULTS: We selected 4883 inpatients for vaccine efficacy estimations and 2188 inpatients for disease profile comparisons. Vaccine effectiveness against EV-A71-induced HFMD for complete vaccination was 63.4 % and 51.7 % for partial vaccination. The vaccine effectiveness was higher among cases received the first dose within 12 months. No protection was observed against coxsackievirus (CV) A6-, CV-A10- or CV-A16-associated HFMD among children regardless of vaccination status. Completely vaccinated cases had shorter hospital stay and disease course compared to unvaccinated cases (P < 0.05).

CONCLUSIONS: These findings reiterate the need to continue the development of a multivalent vaccine or combined vaccines, and have implications for introducing optimized vaccination strategies.

PMID:38433065 | DOI:10.1016/j.vaccine.2024.02.026

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Low albumin combined with low-molecular-weight heparin as risk factors for liver injury using azvudine: Evidence from an analysis of COVID-19 patients in a national prospective pharmacovigilance database

Int J Clin Pharmacol Ther. 2024 Mar 3. doi: 10.5414/CP204544. Online ahead of print.

ABSTRACT

OBJECTIVE: Azvudine is an effective treatment for patients infected with common COVID-19. However, physicians have reported a series of adverse reactions, including multiple cases of liver injury, caused by azvudine in clinical practice. This study assessed the incidence, clinical features, and associated risk factors of liver injury induced by azvudine in real-world settings, offering guidance for safe clinical use.

MATERIALS AND METHODS: This study utilized the Chinese Hospital Pharmacovigilance System (CHPS) to retrospectively analyze the treatment of COVID-19 patients with azvudine at Changsha Central Hospital from December 19, 2022, to June 6, 2023. A case-control study was conducted to analyze the occurrence of azvudine-induced liver injury in COVID-19 patients who triggered a CHPS alert compared to normal COVID-19 patients.

RESULTS: Among the total of 2,141 COVID-19 patients, 31 (1.45%) developed azvudine-induced liver injury, which is classified as an occasional adverse reaction. Liver injury was observed in 93.55% of patients between days 4 and 12 of the azvudine treatment, with elevated transaminases as the primary clinical manifestation. Univariate and binary logistic regression analyses indicated that low albumin levels and co-administration of low-molecular-weight heparin were statistically significant risk factors (p < 0.05).

CONCLUSION: This study represents the first investigation of azvudine-induced liver injury and high-risk patients using the CHPS. The findings provide valuable insights to promote the safety of anti-COVID-19 drugs, serving as an important reference for future drug safety measures.

PMID:38431833 | DOI:10.5414/CP204544

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Network pharmacology analysis and clinical efficacy of the traditional Chinese medicine Bu-Shen-Jian-Pi. Part 3: Alleviation of hypoxia, muscle-wasting, and modulation of redox functions in amyotrophic lateral sclerosis

Int J Clin Pharmacol Ther. 2024 Mar 3. doi: 10.5414/CP204520. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this clinical study is to obtain evidence for the clinical efficacy of Bu-Shen-Jian-Pi formula (BSJP), a traditional Chinese medicine, used for the treatment of amyotrophic lateral sclerosis, a relatively rare, progressive and usually fatal disease possibly associated with alterations in tissue redox status, hypoxia, and muscular injury.

BACKGROUND: The active agents in BSJP formula† causing apoptosis, modulation of redox changes, and alterations in the immune status have been studied previously by us using cell cultures. The findings from these investigations have been incorporated into pharmacology databases employed in our analysis of BSJP using network pharmacology analysis/artifical intelligence. This information has been used here in the design of the investigation and to optimize evaluation of the clinical efficacy and usefulness of this herbal medicine, as far as possible using evidence-based medicine criteria.

MATERIALS AND METHODS: The design of the study was a randomized multi-center, controlled clinical trial in 127 patients with confirmed diagnoses of amyotrophic lateral sclerosis. Patients and investigator were double-blinded. Clinical efficacy was determined using the Amyotrophic Lateral Sclerosis Symptom Score in Integrative Treatment Scale (ALS-SSIT) and the Amyotrophic Lateral Sclerosis Rating Scale-Revised (ALSFRS-R), together with tests of limb muscle strength using the manual muscle test (MMT), forced vital capacity (FVC), and clinical chemistry laboratory tests over a 20-week observation period.

RESULTS: The scores of ALS-SSIT in the BSJP group increased significantly (22%) after treatment. The ALSFRS-R score in the BSJP group decreased significantly after treatment (19%). The rate of decrease in muscle function (MMT score) in most BSJP patients was lower than that in the control group, where the differences in the scores for the trapezius and triceps brachii were statistically significant compared to the control group. The fall in FVC in the BJSP group was significantly slower than in the control group. There were no marked differences observed in the frequency of side effects. Serum vitamin D3 levels in the BSJP group showed greater increases compared to the control group.

CONCLUSION: BSJP treatment reduced the rate of progression of amyotrophic lateral sclerosis according to the ALS-SSITS and ALSFRS scores and significantly reduced the rate of deterioration in muscle function in the limbs of amyotrophic lateral sclerosis patients. The modes of action of BSJP in treating amyotrophic lateral sclerosis are probably diverse and multi targeted, some of which may involve regulation of serum vitamin D3 and alleviation of the impairments in liver and kidney function.

PMID:38431830 | DOI:10.5414/CP204520

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Determinants of non-diabetic kidney diseases in type 2 diabetic patients: Twenty years of single center experience

Clin Nephrol. 2024 Mar 3. doi: 10.5414/CN111093. Online ahead of print.

ABSTRACT

BACKGROUND: Diabetic nephropathy is one of the most common complications associated with diabetes. However, non-diabetic kidney disease has been reported in patients with type 2 diabetes at varying incidence rates. The objective of our study is to investigate the occurrence, clinicopathological characteristics, and inflammatory markers linked to diabetic and non-diabetic nephropathy (NDN) in patients with type 2 diabetes mellitus (DM). Additionally, we aimed to explore the possibility of identifying non-diabetic pathology using different biopsy indications.

MATERIALS AND METHODS: A total of 159 patients with type 2 DM who underwent renal biopsy at a tertiary care nephrology clinic between January 2000 and January 2022 were enrolled in the study. We collected comprehensive data, including patient demographics, co-morbidities, diabetes duration, renal biopsy indications and results, serological markers, renal function, diabetic retinopathy (DRP), full blood count, blood biochemistry, urinalysis, and inflammatory markers. Patients were categorized based on their biopsy indications, and their biopsy results were classified into three groups: isolated NDN, isolated diabetic nephropathy (DN), and mixed nephropathy with concurrent NDN. We evaluated the relationship between biopsy indications and accompanying pathologies and statistically assessed the likelihood of each biopsy indication detecting non-diabetic renal pathology. Additionally, differences in other data, including demographic and laboratory results and medical histories, among the three groups were investigated.

RESULTS: The most frequent indication of renal biopsy was atypical presentations of nephrotic syndrome or nephrotic range proteinuria (ANS/ANP) in 25.1% of patients. Other indications included unexplained renal failure (URF) in 22.6%, atypical presentations of non-nephrotic range proteinuria (ANNP) in 18.2%, acute kidney injury or rapidly progressive kidney dysfunction (AKI/RPKD) in 16.9%, microscopic hematuria in 15.7%, URF with ANNP in 11.3%, and severe nephrotic range proteinuria (SNP) in 9.4%. Renal biopsy revealed isolated NDN in 64.8%, DN in 25.1%, and mixed nephropathy in 10.1% of patients. Primary glomerular diseases were the main non-diabetic renal pathology, predominantly focal segmental glomerulosclerosis (FSGS) (36.4%) followed by MN (10.6%) and IgA nephropathy (7.5%). In comparison with the isolated DN and mixed nephropathy groups, patients in the isolated NDN group had significantly shorter diabetes duration, fewer DRP, as well as lower serum creatinine and neutrophil-to-lymphocyte ratio (NLR). Multivariate logistic regression analysis revealed that presence of hematuria (OR 4.40; 95% CI 1.34 – 14.46, p = 0.014), acute nephrotic range proteinuria (OR 11.93; 95% CI 1.56 – 90.77, p = 0.017), and AKI/APKD (OR 41.08; 95% CI 3.40 – 495.39, p = 0.003) were strong predictors of NDN. Lower NLR (OR 0.77; 95% CI 0.60 – 0.98, p = 0.035), shorter duration of diabetes (OR 0.90; 95% CI 0.84 – 0.97, p = 0.010), and absence of DRP (OR 0.35; 95% CI 0.12 – 0.98, p = 0.046) were also found to be independent indicators of NDN. Receiver operating characteristic curve (ROC) analysis revealed a cut-off value of ≤ 3.01 for NLR (sensitivity of 63.1%, specificity of 63.5%) with regards to predicting non-diabetic renal pathology (p = 0.006).

CONCLUSION: Renal biopsy findings in patients with type 2 DM highlight that the prevalence of NDN may be higher than assumed, as presented mainly in the form of primary glomerular disease. The presence of AKI/RPKD, hematuria, and ANS/ANP serves as a reliable indicator of non-diabetic renal pathology. In more ambiguous situations, factors such as a shorter duration of diabetes, absence of DRP, and a lower NLR value may assist clinicians in biopsy decision.

PMID:38431824 | DOI:10.5414/CN111093

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The impact of mitochondrial dysfunction on the pathogenesis of atherosclerosis

Wiad Lek. 2024;77(1):153-159. doi: 10.36740/WLek202401119.

ABSTRACT

OBJECTIVE: Aim: To determine the role of mitochondrial dysfunction in the pathogenesis of atherosclerosis based on the analysis of research data and statistics from the MEDLINE, Scopus and Web of Science Core Collection electronic databases for 2007-2023.

PATIENTS AND METHODS: Materials and Methods: A comprehensive review of literature sources from the MEDLINE, Scopus and Web of Science Core Collection electronic databases was conducted to critically analyse the data and determine the role of mitochondrial dysfunction in the pathogenesis of atherosclerosis.

CONCLUSION: Conclusions: In this review, we have summarized the latest literature data on the association between mitochondrial dysfunction and the development of atherosclerosis. Mitochondria have been recognized as a novel therapeutic target in the development of atherosclerosis. However, the presence of current gaps in therapeutic strategies for mitochondrial dysfunction control still hinders clinical success in the prevention and treatment of atherosclerosis. Both antioxidants and gene therapy are appealing approaches to treating atherosclerosis. Nevertheless, further research is needed to determine the proper therapeutic strategy to reduce the impact of mitochondrial dysfunction on the progression of atherosclerosis.

PMID:38431820 | DOI:10.36740/WLek202401119

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COVID-19 associated anosmia in pediatric patients: subject publications review

Wiad Lek. 2024;77(1):114-119. doi: 10.36740/WLek202401114.

ABSTRACT

OBJECTIVE: Aim: To review the publications subject to the problem of COVID-19 associated anosmia incidence in pediatric patients as well as its pathogenesis, diagnostics, treatment and recovery. The peculiarity of pediatric COVID-19 anosmia is due to children accounting for very low percentage of COVID-19 patients (comparing to one in adults), mostly with milder course of the disease. Awareness of anosmia and its proper diagnostics is crucial in children and adolescents, considering it can be the only manifestation in COVID-19 positive pediatric patients.

PATIENTS AND METHODS: Materials and Methods: In order to achieve this goal a meta-analysis of information from databases followed by statistical processing and generalisation of the obtained data was carried out.

CONCLUSION: Conclusions: Publications on COVID-19 anosmia in children and adolescents are less numerous than those concerning adult patients, so it is important to use every single trustworthy one. Anosmia/ageusia may be the only symptom, early identifier and the strongest predictor of COVID-19 infection in pediatric patients. Prospects for further scientific researches. Further researches regarding differential diagnostics of COVID-19 and other infections, including seasonal influenza, manifesting with both olfactory and taste dysfunction as well as anosmia diagnostics in children and adolescents with autistic spectrum and different types of mental disorders are possible.

PMID:38431815 | DOI:10.36740/WLek202401114

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Public management of public healthcare under the COVID-19 outbreak: experience of Ukraine

Wiad Lek. 2024;77(1):94-104. doi: 10.36740/WLek202401112.

ABSTRACT

OBJECTIVE: Aim: The research is aimed to study certain aspects and experience of functioning of the Ukrainian Public Healthcare public management mechanisms during an outbreak of the acute respiratory disease COVID19.

PATIENTS AND METHODS: Materials and Methods: The studied materials include personal observations and accumulated practical material, as well as generalization of the collected data and their empirical treatment, conducted by the scientists, according to the present legislation requirements. The study was held using general scientific methods, including observation, description of results, specification and statistical data generalization.

CONCLUSION: Conclusions: Generalization, arrangement and analysis of the Ukrainian experience of the Public Healthcare public management during the outbreak of the acute respiratory disease COVID19, provides exchange of experience between all subjects of the process. This helps to produce certain practical decisions, aimed at effective responding of the state healthcare system onto management of the COVID19 outbreak. Such activities are also directed at detection of flaws in the whole system, with their subsequent correction, and elimination or neutralization of possible negative outcomes. To adopt the priority activity directions within public relations, which make the subject of the study, the authors have studied a complex of activities against spread of the COVID19 in 2019-2020. These activities include issues, related to prompt responding onto the infection spread and approving quick professional decisions; fulfilling epidemiological supervision and introducing anti-epidemic activities; providing diagnostics, and accessibility of the safe and high-quality vaccine.

PMID:38431813 | DOI:10.36740/WLek202401112

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Reparative osteogenesis in mandible in cases of filling a bone defect with hydroxyapatite-containing osteotropic material and injecting the surrounding soft tissues with thymalin: experimental and morphological study

Wiad Lek. 2024;77(1):68-76. doi: 10.36740/WLek202401110.

ABSTRACT

OBJECTIVE: Aim of the study was to identify the morphological features of reparative osteogenesis in the lower jaw bone of rats in cases of filling a bone defect with hydroxyapatite-containing osteotropic material (bone graft “Biomin GT”) and injecting the surrounding soft tissues with thymalin.

PATIENTS AND METHODS: Materials and Methods: An experiment was conducted on 48 mature rats of the WAG population weighing 160-180 grams which were divided into four groups. Group 1 included 12 rats with a simulated holey defect in the lower jaw. Group 2 included 12 rats with a simulated holey defect in the lower jaw followed by its closure with hydroxyapatite-containing osteotropic material (bone graft “Biomin GT”). Group 3 included 12 rats with a simulated holey defect in the lower jaw with injecting the surrounding soft tissues with thymalin. Group 4 included 12 rats with a simulated holey defect in the lower jaw followed by its closure with hydroxyapatite-containing osteotropic material (bone graft “Biomin GT”) and injecting the surrounding soft tissues with thymalin. The material for the morphological study was a fragment of the lower jaw from the area of the simulated holey defect. Histological, morphometric and statistical research methods were used.

RESULTS: Results: In this study, it was shown by the authors an activation of reparative osteogenesis in the lower jaw under conditions of simultaneous filling the bone defect with hydroxyapatite-containing osteotropic material (bone graft “Biomin GT”) and injection the surrounding bone defect soft tissue with thymalin. Stimulation of reparative osteogenesis in the lower jaw of rats occurred due to rapid cleaning of the bone defect cavity from necrotic tissues and hematoma fragments; a decrease in the number of neutrophil leukocytes, an increase in the number and morphofunctional state of monocytes, macrophages, lymphocytes, cells of fibroblastic differon; balanced change (increase or decrease) in the number and morphofunctional state of bone forming osteoblasts and bone resorbing osteoclasts depending on the stage of reparative osteogenesis; activation of hematopoietic processes in lamellar bone tissue from the regenerate; activation of bone tissue mineralization processes.

CONCLUSION: Conclusions: Thymalin injection in the soft tissues surrounding the bone defect in the lower jaw, filled with hydroxyapatite-containing osteotropic material (bone graft “Biomin GT”), significantly stimulates the process of reparative osteogenesis, which makes it possible to recommend this technique in dentistry for treatment the patients with mandible bone tissue defects.

PMID:38431810 | DOI:10.36740/WLek202401110

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International classification of functioning, disability and health with long-term consequences of cranio-brain injury

Wiad Lek. 2024;77(1):29-34. doi: 10.36740/WLek202401104.

ABSTRACT

OBJECTIVE: Aim: To describe health status and related functioning of patients with different severity of traumatic brain injury (TBI) in past medical history in Ukraine and determining the feasibility of using the International Classification of Functioning, Disability and Health (ICF) Brief Core Set for TBI.

PATIENTS AND METHODS: Materials and Methods: A total of 102 patients, who were treated in the neurological department of Dnipropetrovsk regional clinical hospital and State Institution ≪Ukrainian State Scientific Research Institute of Medical and Social Problems of Disability of Health Ministry of Ukraine≫, had been examined. Patients were divided into three groups: mild, moderate and severe TBI in past history and evaluated using ICF Brief Core Set for TBI.

RESULTS: Results: Тhe most common problems in the functioning and health of patients in remote period of TBI, along with the influencing factors have been identified in the study. The most frequent categories from ≪Body Functions≫ and ≪Activity and Participation≫ sections in which patients had alterations were: memory functions, emotional functions, sensation of pain, functions of attention, brain structure, complex interpersonal interactions, family relationships. The increase in the amount and severity of disturbances with increasing severity of TBI had been established in all categories, except complex interpersonal interactions and family relationships.

CONCLUSION: Conclusions: Patients of all groups identified the family and close relatives, healthcare service and social welfare services, as the most frequent relieving factors of life activity. The use of the ICF Brief Core Set for assessing the subjects with TBI in past history provides a convenient procedure to standardize and structure functioning description. Information collected by the ICF Brief Core Set may be used for different purposes: clinical assessment, administration of medical services, planning and implementation of rehabilitation and evaluation of results, in scientific research, reports and health care statistics.

PMID:38431804 | DOI:10.36740/WLek202401104