Consensus Guidelines for Influenza Vaccination in Patients with Diabetes.

Influenza is a prevalent health issue encountered in daily practice. Patients with diabetes mellitus face a higher risk of infections, including influenza, owing to the compromised immune system associated with diabetes. This susceptibility arises from the potential of diabetes mellitus to weaken the immune system. Moreover, elevated blood glucose levels can create a conducive environment for the growth of bacteria and viruses. This consensus is formulated by a multidisciplinary team to serve as practical guidance for the administration of influenza vaccinations to patients with diabetes mellitus in daily practice.

Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia.

BACKGROUND: COVID-19 is one of the most devastating pandemics of the 21st century. Vaccination is one of the most effective prevention methods in combating COVID-19, and one type of vaccine being developed was the protein subunit recombinant vaccine. We evaluated the efficacy of the CoV2-IB 0322 vaccine in Depok, Indonesia. METHODS: This study aimed to assess the humoral and cellular immune response of the CoV2-IB 0322 vaccine compared to an active control vaccine (COVOVAX™ Vaccine). A total of 120 subjects were enrolled and randomized into two groups, with 60 subjects in each group. Participants received either two doses of the CoV2-IB 0322 vaccine or two doses of the control vaccine with a 28-day interval between doses. Safety assessments were conducted through onsite monitoring and participant-reported adverse events. Immunogenicity was evaluated by measuring IgG anti-RBD SARS-CoV-2 and IgG-neutralizing antibodies. Cellular immunity was assessed by specific T-cell responses. Whole blood samples were collected at baseline, 14 days, 6 months, and 12 months after the second dose for cellular immunity evaluation. RESULTS: Both vaccines showed high seropositive rates, with neutralizing antibody and IgG titers peaking 14 days after the second dose and declining by 12 months. The seroconversion rate of anti-S IgG was 100% in both groups, but the rate of neutralizing antibody seroconversion was lower in the CoV2-IB 0322 vaccine group at 14 days after the second dose (p = 0.004). The CoV2-IB 0322 vaccine showed higher IgG GMT levels 6 and 12 months after the second dose (p < 0.001 and p = 0.01). T-cell responses, evaluated by IFN-γ, IL-2, and IL-4 production by CD4+ and CD8+ T-cells, showed similar results without significant differences between both groups, except for %IL-2/CD4+ cells 6 months after the second dose (p = 0.038). CONCLUSION: Both vaccines showed comparable B- and T-cell immunological response that diminish over time.

A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity.

BACKGROUND: Typhoid fever is commonly found until today, especially in developing countries. It has fatal complications and measures must be taken to reduce the incidence of typhoid. Vaccinations are a key factor in prevention. This is a phase II randomized observer-blind clinical trial on a novel Vi-DT conjugate vaccine on 200 subjects 12 to 40 years of age. METHODS: Subjects were screened for eligibility after which a blood sample was taken and one dose of vaccine was administered. Investigational vaccine used was Vi-DT and control was Vi-PS. Twenty-eight days after vaccination, subjects visited for providing blood sample to assess immunogenicity and were asked about local and systemic adverse reactions that occurred in the first 28 days. RESULTS: Subjects had minor adverse reactions. Pain was the most common local reaction. Muscle pain was the most common systemic reaction. There were no serious adverse events up to 28 days post vaccination. Seroconversion rates were 100% in the Vi-DT group and 95.96% in the Vi-PS group. Post vaccination GMTs were increased in both groups but it was significantly higher in the Vi-DT group (p < 0.001). CONCLUSIONS: Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years. TRIAL REGISTRATION: Approved by ClinicalTrials.gov. CLINICAL TRIAL REGISTRATION NUMBER: NCT03460405. Registered on 09/03/2018. URL: https://clinicaltrials.gov/ct2/show/NCT03460405 .

Activities and concentration of alpha-1 antitrypsin and cystatin C in serum from patients with house dust mite asthma.

Background: The proteolytic activities of house dust mite (HDM) allergens are involved in the pathogenesis of asthma by cleaving T-junction protein complexes, increasing the permeability of airway epithelial cells, and enabling the allergens to reach the interstitial tissue. The human body contains natural protease inhibitors such as alpha-1 antitrypsin (AAT) with antiserine protease activity and cystatin C with anticysteine protease activity. Objective: This study aimed to investigate the behavior of serum AAT and cystatin C levels in patients with HDM-allergic asthma. Methods: Ten individuals with HDM-allergic asthma and 10 healthy volunteers participated in a cross-sectional study. The serum AAT and cystatin C inhibitory activities were measured using enzymatic assays. ELISA was used to determine the serum AAT and cystatin C concentrations. Results: Serum AAT inhibitory activity (P = 0.445; P > 0.05), AAT concentration (P = 0.290; P > 0.05), and cystatin C concentration (P = 0.419; P > 0.05) did not significantly differ between the patient and control groups. However, serum cystatin C inhibitory activity in the asthmatic patient group was significantly higher than in the healthy subjects (P = 0.001; P < 0.05). There was no correlation between AAT inhibitory activity and AAT concentration or between cystatin C inhibitory activity and cystatin C concentration. Conclusion: These findings suggest that serum cystatin C activity is involved in asthma pathogenesis. Additional research is required to address this issue.

Efficacy, Immunogenicity, and Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases: A Systematic Review and Meta-Analysis.

Patients with autoimmune diseases are among the susceptible groups to COVID-19 infection because of the complexity of their conditions and the side effects of the immunosuppressive drugs used to treat them. They might show impaired immunogenicity to COVID-19 vaccines and have a higher risk of developing COVID-19. Using a systematic review and meta-analysis, this research sought to summarize the evidence on COVID-19 vaccine efficacy, immunogenicity, and safety in patients with autoimmune diseases following predefined eligibility criteria. Research articles were obtained from an initial search up to 26 September 2022 from PubMed, Embase, EBSCOhost, ProQuest, MedRxiv, bioRxiv, SSRN, EuroPMC, and the Cochrane Center of Randomized Controlled Trials (CCRCT). Of 76 eligible studies obtained, 29, 54, and 38 studies were included in systematic reviews of efficacy, immunogenicity, and safety, respectively, and 6, 18, and 4 studies were included in meta-analyses for efficacy, immunogenicity, and safety, respectively. From the meta-analyses, patients with autoimmune diseases showed more frequent breakthrough COVID-19 infections and lower total antibody (TAb) titers, IgG seroconversion, and neutralizing antibodies after inactivated COVID-19 vaccination compared with healthy controls. They also had more local and systemic adverse events after the first dose of inactivated vaccination compared with healthy controls. After COVID-19 mRNA vaccination, patients with autoimmune diseases had lower TAb titers and IgG seroconversion compared with healthy controls.

A Case Report of Hereditary Angioedema: Challenges in Diagnosis and Management.

Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder which causes bradykinin mediated angioedema. Although it can be life threatening, HAE may be underdiagnosed due to a lack of awareness of the disease and limited access to laboratory testing. Here, we report a case of HAE which was diagnosed only after the patient was referred for COVID-19 vaccination even though he had been experiencing recurrent angioedema for the past 30 years.

Factors Related to Severity, Hospitalization, and Mortality of COVID-19 Infection among Patients with Autoimmune Diseases.

Patients with an autoimmune disease could be at higher risk of a poor outcome when contracting COVID-19 infection due to aberrant immune responses and use of immunosuppressant therapies for chronic autoimmune treatment. Here, we conducted a retrospective study to identify the factors related to severity, hospitalization, and mortality among patients with autoimmune diseases. We found 165 cases of patients with pre-existing autoimmune diseases who had contracted COVID-19 between March 2020 and September 2022. Data on demographical characteristics; autoimmune diagnosis and treatment; COVID-19 vaccination status; and time, severity, and outcome of COVID-19 infection were collected. Most of the subjects were female (93.3%) and autoimmune diagnoses included systemic lupus erythematosus (54.5%), Sjogren's syndrome (33.5%), antiphospholipid syndrome (23%), vasculitis (5.5%), autoimmune thyroid disease (3.6%), rheumatoid arthritis (3.03%), and inflammatory bowel disease (3.03%) among other autoimmune diseases. There were four COVID-19-related deaths in this study. Factors associated with moderate to severe COVID-19 infection in patients with autoimmune diseases included not being vaccinated against COVID-19, taking a steroid of ≥10 mg prednisone-equivalent per day, and having a cardiovascular disease. Taking a steroid of ≥10 mg prednisone-equivalent per day was also associated with hospitalization in the event of COVID-19 infection, while cardiovascular diseases also showed a significant correlation to mortality in patients with autoimmune diseases who had been hospitalized with COVID-19 infection.

Predicting Intention to Receive COVID-19 Vaccination in People Living with HIV using an Integrated Behavior Model.

People living with HIV (PLHIV) are considered a high-risk population for developing a severe form of COVID-19. Vaccination is still one of the most important modalities in combating the disease due to the lack of an effective treatment. This multicenter study was performed from September to December 2021 with the aim to analyze the intention of PLHIV to receive the COVID-19 vaccination based on an integrated behavior model (IBM) in Indonesia. Of a total of 470 participants, 75.6% of patients were intent to be vaccinated. The model that was designed in this study explains 43.4% of the variance in intention to be vaccinated against COVID-19 in PLHIV (adjusted R2 = 0.434). Furthermore, the determinants used included instrumental attitude (ß = 0.127, p < 0.05), subjective norm (ß = 0.497, p < 0.01), and perceived behavioral control (ß = 0.116, p < 0.01). This study concluded that an IBM could predict the intention of PLHIV to receive COVID-19 vaccination.

Incidence and Associated Factors of SARS-CoV-2 Infection Post-mRNA-1273 Booster Vaccination in Health-Care Workers.

The COVID-19 pandemic has caused significant morbidity and mortality worldwide, especially among health-care workers. One of the most important preventive measures is vaccination. This study examined factors associated with the incidence rate of SARS-CoV-2 infection after mRNA-1273 booster vaccination (preceded by the CoronaVac primary vaccination) and the antibody profile of health-care workers at one of the tertiary hospitals in Indonesia. This was a combined retrospective cohort and cross-sectional study. Three hundred health-care workers who were given the mRNA-1273 booster vaccine a minimum of 5 months prior to this study were randomly selected. Participants were then interviewed about their history of COVID-19 vaccination, history of SARS-CoV-2 infection, and comorbidities. Blood samples were taken to assess IgG sRBD antibody levels. The median antibody level was found to be 659 BAU/mL (min 37 BAU/mL, max 5680 BAU/mL, QIR 822 BAU/mL) after the booster, and this was not related to age, sex, comorbidities, or adverse events following immunization (AEFI) after the booster. SARS-CoV-2 infection after the booster was correlated with higher antibody levels. In sum, 56 participants (18.6%) experienced SARS-CoV-2 infection after the mRNA-1273 booster vaccination within 5 months. Incidence per person per month was 3.2%. Age, sex, diabetes mellitus type 2, hypertension, obesity, and post-booster AEFI were not related to COVID-19 incidence after the booster. History of SARS-CoV-2 infection before the booster vaccination was significantly associated with a reduced risk of SARS-CoV-2 infection after booster vaccination, with a relative risk (RR) of 0.21 (95% CI 0.09-0.45, p < 0.001).

COVID-19 Vaccination Intention in Patients with Autoimmune Diseases in Indonesia: An Application of the Integrated Behavioural Model.

Vaccine hesitancy can be a challenge for those with autoimmune diseases. This study investigated the acceptance of COVID-19 vaccination by patients with autoimmune diseases in Indonesia using the integrated behavioral model (IBM). This cross-sectional study was conducted from December 2021 to February 2022. A total of 404 patients with autoimmune diseases completed the survey. The majority of respondents (57.9%) said they intended to get vaccinated against COVID-19. The IBM model with added demographic variables explained 54.1% of the variance of vaccination intention (R2 = 0.541). Self-efficacy, perceived norms, experiential attitude, and instrumental attitude are significantly correlated with vaccination intention in components of health behavior theories. Self-efficacy is the most critical factor influencing vaccination intention in patients with autoimmune diseases (F(2, 401) = 96.9, p < 0.001, R2 = 0.326). In the multivariate analysis, vaccine intention was found to be positively associated with patients' occupation as health-care workers (ß = 0.105). Meanwhile, having a personal history of contracting COVID-19 and having co-morbidities other than autoimmune diseases were negatively correlated to the willingness to be vaccinated against COVID-19. This study confirms the viability of the IBM model for predicting the COVID-19 vaccination intention of patients with autoimmune diseases. It is essential to provide patients with autoimmune diseases with information that is clear and supported by evidence-based medicine.

COVID-19 vaccine provocation test outcome in high-risk allergic patients: A retrospective study from a tertiary hospital in Indonesia.

Background: High COVID-19 vaccine coverage is essential. Patients who are considered high risk for hypersensitivity reactions and have had an allergic reaction to the COVID-19 vaccine are usually referred to an allergist for assessment of vaccination. Administration of a vaccine graded challenge (also known as a provocation test) is an option that can be considered in this population. This primary objective of this study is to describe the outcome of the COVID-19 vaccine provocation test and to understand the predicting factors associated with hypersensitivity reaction after the provocation test as the secondary objective. Methods: Adult patients with a history of hypersensitivity reaction to the first COVID-19 vaccine and high-allergic patients who underwent COVID-19 vaccine provocation test up until May 2022 were included. A protocol using skin prick test (SPT), intradermal test (IDT), followed by graded challenge was developed for the determined vaccine used. Results: A total of 232 patients were included in the analysis. Twenty-eight had hypersensitivity to their first COVID-19 vaccine dose and 204 were high risk for allergic reaction. Hypersensitivity reactions occurred in 20 patients (8.6%, 95% CI: 5-12.2%), consisting of 4 reactions after SPT, 9 after IDT, 7 during or after titrated challenge. Half of the reactions were mild; however, 3 patients developed severe reactions. Patients with history of anaphylaxis were more likely to experience hypersensitivity reaction after provocation test (aRR = 2.79, 95% CI: 1.05-7.42). Conclusion: Provocation test in COVID-19 vaccination has a high success rate in patients with a history of hypersensitivity to the first COVID-19 vaccine and in high allergic patients. History of anaphylaxis is associated with hypersensitivity reaction after a COVID-19 vaccine provocation test.

Are we ready to collaborate? The interprofessional collaborative competencies of healthcare professionals in the Global South context.

Background: Current evidence of interprofessional collaboration suggests the importance of measuring and identifying the current state of the health professions' interprofessional competencies. Therefore, this study was aimed at measuring the interprofessional competencies of health professionals in the Global South context using the validated CICS29. Materials and methods: This was a cross-sectional study involving 300 healthcare professionals of a newly established teaching hospital. Prior to the measurement of interprofessional competencies, the 29-items CICS29, which has been translated into Indonesian language, was revalidated using a confirmatory factor analysis (CFA). The 29 items of CICS29 were grouped into six subscales and each item was measured using a 5-point Likert scale. Data on gender, age, type of profession, and the length of working experience was also collected to identify whether discernible differences between grouping variables exists. Results: Prior to measuring the interprofessional competencies, the validity of the instrument was established. Based on the CFA, the same six-factor model was found in the current study. The Indonesian CICS29 was reliable, with Cronbach alpha values of 0.921 for the whole instrument and that of each subscale ranged between 0.656 and 0.726. The mean total score of CICS29 was 128.53 (out of 145), ranged from 123 to 133.40 obtained by pharmacists and dentists respectively. No significant differences of CICS29 scores were found between grouping variables. Conclusion: The current study has revealed relatively good interprofessional competencies of healthcare professionals working in a newly established teaching hospital in the Global South healthcare context. Measuring the interprofessional competencies serves as baseline for further intervention to nurture and maintain collaborative practice. In addition, the current study has further proven the cross-cultural validity of CICS29, thus appropriate to be utilized in different setting and context.

A case of aseptic bilateral cavernous sinus thrombosis following a recent inactivated SARS-CoV-2 vaccination.

This case report aims to describe the first report of bilateral aseptic cavernous sinus thrombosis (CST) with a recent history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. A 50-year-old woman presented with bilateral proptosis, decreased vision, and ophthalmoplegia 16 days following CoronaVac® vaccine. The visual acuity of the left eye was 20/150, while the right eye was no light perception with a hyperemic optic nerve head. She had a history of hyperthyroidism and currently on warfarin consumption. Laboratory results depicted elevated free T4, free T3, international normalized ratio, and low protein S and C. Magnetic resonance imaging showed bilateral CST, and high-dose methylprednisolone along with fondaparinux was given. The symptoms were significantly resolved, with the visual acuity of the left eye being improved to 20/20 but not the right eye. Bilateral CST has not been previously reported following inactivated SARS-CoV-2 vaccination. The underlying systemic conditions should be taken into consideration for the possibility of the inactivated SARS-CoV-2 vaccine-related event.

Incidence and severity prediction score of COVID-19 in people living with HIV (SCOVHIV): experience from the first and second waves of the pandemic in Indonesia.

BACKGROUND: People living with HIV (PLHIV) have higher risk of COVID-19 infection and mortality due to COVID-19. Health professionals should be able to assess PLHIV who are more likely to develop severe COVID-19 and provide appropriate medical treatment. This study aimed to assess clinical factors associated with COVID-19 severity and developed a scoring system to predict severe COVID-19 infection among PLHIV. METHODS: This retrospective cohort study evaluated PLHIV at four hospitals diagnosed with COVID-19 during the first and second wave COVID-19 pandemic in Indonesia. The independent risk factors related to the severity of COVID-19 were identified with multivariate logistic regression. RESULTS: 342 PLHIV were diagnosed with COVID-19, including 23 with severe-critical diseases. The cumulative incidence up to December 2021 was 0.083 (95% CI 0.074-0.092). Twenty-three patients developed severe-critical COVID-19, and the mortality rate was 3.2% (95% CI 1.61%-5.76%). Having any comorbidity, CD4 count of < 200 cells/mm3, not being on ART, and active opportunistic infection were independent risk factors for developing severe COVID-19. SCOVHIV score was formulated to predict severity, with 1 point for each item. A minimum score of 3 indicated a 58.4% probability of progressing to severe COVID-19. This scoring system had a good discrimination ability with the area under the curve (AUC) of 0.856 (95% CI 0.775-0.936). CONCLUSION: SCOVHIV score, a four-point scoring system, had good accuracy in predicting COVID-19 severity in PLHIV.

COVID-19 Booster Vaccine Intention by Health Care Workers in Jakarta, Indonesia: Using the Extended Model of Health Behavior Theories.

In Indonesia, COVID-19 vaccination hesitancy persists among health care workers (HCWs). Understanding the motives and challenges impacting HCWs' acceptance of the booster vaccination is critical. Efforts are still needed to overcome apprehension about taking a booster dosage. This study aims to analyze the vaccine acceptance among HCWs in Jakarta using an extended, modified model of health behavior theories, namely The Health Belief Model (HBM) and The Theory of Planned Behavior (TPB). A cross-sectional survey from November 2021 to January 2022 was distributed to health care workers in Jakarta. Bivariate analysis followed by multivariate regression was used to assess factors associated with the vaccine intention and collected 1684 responses. The results have shown that the final model combining the constructs and demographic characteristics could explain 50% of the variance of intention to receive a COVID-19 booster vaccination. Moreover, anticipated regret had the most significant standardized coefficient among the constructs (ß = 0.381, p < 0.001). Other significant predictors in the model were attitude (ß = 0.243, p < 0.001), perceived benefits (ß = 0.103, p < 0.001), subjective norms (ß = 0.08, p = 0.005), and perceived susceptibility (ß = 0.051, p = 0.016). The findings can be used to strategize interventions to increase vaccine uptake.

Anal Swab in COVID-19 Patients.

In 2020, a new type of coronavirus (SARS-CoV-2) whose disease is called Coronavirus disease 2019 (COVID-19) has been reported. This virus was first discovered in Wuhan, China and has infected 90,308 people per March 2, 2020. As of the end of October 2020, more than 40 million people have been infected, with the death toll reaching 1,150,000 worldwide. Apart from respiratory tract infections, patients infected with this virus may exhibit other symptoms, such as diarrhea, abdominal pain, nausea, or vomiting. This means that the virus can be found in feces and anus, hence the anal swab can be used as a diagnostic tool for COVID-19 infection. The results of the specimen test show that the sensitivity of the nasopharyngeal swab positive detection rate is the highest and remains the gold standard for diagnosis. This sensitivity can also be influenced by the course of the disease that can infect the gastrointestinal tract so that anal PCR is performed for the diagnosis to detect the COVID-19 virus in patients.

Using Integrative Behavior Model to Predict COVID-19 Vaccination Intention among Health Care Workers in Indonesia: A Nationwide Survey.

Background: Health care workers (HCWs) are a high-priority group for COVID-19 vaccination for several reasons. Health behavior theory-based studies on the intention or acceptability of COVID-19 vaccination among Indonesian HCWs is lacking. Using an integrated behavioral model, this research sought to identify Indonesian health care workers' intentions to obtain COVID-19 vaccines. Methods: A countrywide cross-sectional questionnaire-based survey was conducted. The questionnaire was constructed on the basis of IBM (integrated behavioral model) constructs and scored on a seven-point bipolar scale. A hierarchical multivariable regression was used to evaluate the fit of the predictor model as well as the correlations between variables in the study. Results: 3304 people responded to the survey. A model combining demographic and IBM characteristics predicted 42.5 percent (adjusted R2 = 0.42) of the COVID-19 vaccination intention. Vaccination intention was associated with favorable vaccine attitudes, perceived norms, and self-efficacy. Among the determining constructs, behavior belief predicted vaccination intention the best. Being female, being married, having a history of COVID-19 infection, living outside Java Island, and having a low income were all linked to lower vaccination intentions. Conclusions: This study confirms the IBM model's robustness in predicting health care workers' intention to vaccinate against COVID-19.

The effect of mannitol addition to hydration on acute kidney injury event after high dose cisplatin chemotherapy: an ambispective cohort study.

BACKGROUND: Saline hydration with addition of mannitol have commonly been the strategy to avoid cisplatin induced acute kidney injury (AKI). While the initial reports demonstrated that mannitol diuresis decreased cisplatin induced renal injury, others have shown renal injury to be worsened. OBJECTIVE: To compare the risk of AKI in cancer patients receiving high dose cisplatin with and without addition of mannitol. METHOD: This was an ambispective cohort study based on consecutive sampling at Cipto Mangunkusumo General Hospital (CMGH) and Mochtar Riady Comprehensive Cancer Centre (MRCCC) Siloam Hospitals. The data was obtained from September 2017 to February 2018. The choice of mannitol administration based on attending physician clinical judgement. The primary outcome was increase of serum creatinine more than 0.3 mg/dL or 1.5 times from baseline. Analysis was done by using univariate, bivariate and multivariate logistic regression to obtain crude risk ratio and adjusted risk ratio of cisplatin induced AKI probability caused by mannitol addition on top of usual saline hydration protocol. RESULT: Data from 110 patients (57.3% male) with a median age of 44.5 years (range 19 to 60 years) were collected; 63 received saline with the addition of mannitol and 47 received saline only. Incidence of AKI were higher in mannitol vs saline only group. Bivariate analysis showed higher probability of post chemotherapy AKI in mannitol group, however it was statistically insignificant (RR 2.168; 95% CI 0.839-5.6; p = 0.094). On multivariate analysis the age adjusted RR was 2.852 (95% CI 0.68-11.96; p = 0.152). CONCLUSION: The addition of mannitol to hydration did not reduce the risk of cisplatin induced AKI as compared with saline hydration only. It was also found that risk for acute kidney injury were higher in population ≥ 40 years old.

A randomized controlled trial to evaluate the effect of influenza vaccination and probiotic supplementation on immune response and incidence of influenza-like illness in an elderly population in Indonesia.

AIM: To investigate the effect of influenza vaccination with or without probiotic supplementation on the immune response and incidence of influenza-like illness (ILI) in the elderly. METHODS: A randomized double-blind, placebo-controlled trial with a modified factorial design was conducted in 554 healthy elderly subjects aged 67 ± 5.6 (ranging from 60-90) years old in the Primary Health Care Center (Puskesmas area) of the Pulo Gadung District East Jakarta. Subjects received either a trivalent influenza vaccine or placebo at the start of the study, and a probiotic supplement (Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011) or a placebo for 6 months. Subjects were randomly assigned into four intervention groups: influenza vaccine and probiotics (n = 141), influenza vaccine and placebo (n = 136), placebo and probiotics (n = 140), and both placebo (n = 137). The primary outcome was ILI incidence within 6 months. The secondary outcomes were seroprotection and seroconversion rates at 1, 4, and 6 months after administering the interventions. RESULTS: This study showed that the trivalent influenza vaccine increased seroprotection (RR 3.6 [95%CI 2.92-4.47]; p<0.010) and seroconversion (RR 29.8 [95%CI 11.1-79.5]; p<0.010) rates 1 month after vaccination in elderly people while the probiotic supplement did not alter influenza antibody titers (p = 1.000 and p = 0.210). The relative ILI incidence risk was similar between vaccinated and non-vaccinated groups, as well as in the probiotic group compared to the non-probiotic group. CONCLUSION: The tested trivalent influenza vaccine significantly induced seroprotection and seroconversion in the vaccinated subjects, while probiotics administration did not influence these parameters. Vaccinated individuals displayed a similarly low ILI incidence as those in the Control Group. However, the observed trend towards a reduction of ILI incidence with probiotics supplementation warrants further assessments in a larger, at-risk population. CLINICAL TRIAL REGISTRY NUMBER: NCT03695432.

The association between 24-h blood pressure variability and major adverse cardiac events (MACE) in hospitalized patients with acute myocardial infarction: a retrospective cohort study.

BACKGROUND: Acute myocardial infarction (AMI) is major cardiovascular disease that causes high morbidity and mortality. In AMI, ischemia and necrosis affected some cardiomyocytes leading to a decrease in myocardial contractility which is followed by an acute proinflammation reaction and increased sympathetic tone. Meanwhile, high blood pressure variability (BPV) causing an increased left ventricular workload, heart rate, myocardial oxygen demand and induces proinflamations and endothelial dysfunction. Therefore a high BPV and its associated pathological effects are likely to aggravate the physiological function of the heart and affect the emergence of acute cardiac complications in AMI patients. This study aims to investigate the association's between short-term BPV and major adverse cardiac events (MACE) in AMI patients. This retrospective cohort study used simple random sampling to identify AMI patients who were hospitalized at Cipto Mangunkusumo National Hospital between January 2018 and December 2019. Mann Withney was performed to investigate the association between BPV and MACE. RESULTS: The average systolic BPV value which was calculated as standard deviation (SD) and average real variability (ARV) was higher in the MACE group than in the non-MACE group. Systolic SD and systolic ARV in the MACE group were 13.28 ± 5.41 mmHg and 9.88 ± 3.81 mmHg respectively. In the non-MACE group, systolic SD and systolic ARV were 10.76 (4.59-26.17) mmHg and 8.65 (3.22-19.35) mmHg respectively. There was no significant association between BPV and MACE. However, there were significant differences between systolic SD and systolic ARV in patients with hypertension who experienced MACE and patients without hypertension who experienced MACE. CONCLUSIONS: The BPV of AMI patients who experience MACE was higher than that of non-MACE AMI patients. There was no significant association between BPV ​​and MACE during the acute phase of AMI.