scholarly journals Safety and immunogenicity of the BBIBP-CorV vaccine in adolescents aged 12-17 years in Thai population, prospective cohort study.

2022 ◽  
Author(s):  
Kriangkrai Tawinprai ◽  
Taweegrit Siripongboonsitti ◽  
Thachanun Porntharukchareon ◽  
Preeda Vanichsetakul ◽  
Saraiorn Thonginnetra ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Severe Form ◽  
Antibody Concentration ◽  
P Value ◽  
Serious Adverse Events ◽  
Thai Population ◽  
Thai Adolescents

Introduction: COVID-19 pandemic affects all populations worldwide, including adolescents. Adolescents can develop a severe form of COVID-19, especially with comorbidity underlying. The prior studies of the mRNA COVID-19 vaccine showed excellent effectiveness in adolescents. Therefore, this study aimed to evaluate the safety and effectiveness of the BBIBP-CorV vaccine with the immunobridging approach in Thai adolescents. Methods: This single-center, prospective cohort study compared the immunogenicity after 2 doses of the BBIBO-CorV vaccine with 21 days interval of participants aged 12-17 years with 18-30 years at Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand. The key eligible criteria were healthy or had stable pre-existing comorbidity participants, aged 12-17 years. The primary endpoint was the anti-receptor binding domain antibody concentration at 4 weeks after dose 2 of the vaccine. In addition, safety profiles were solicited adverse events within 7 days after each dose of vaccine and any adverse events through 1 month after dose 2 of the vaccine. Results: Four weeks after the second vaccination, the GMC of anti-RBD antibody in the adolescent cohort was 102.9 BAU/mL (95%CI; 91.0-116.4) and 36.9 BAU/mL (95%CI; 30.9-44.0) in the adult cohort. The GMR of the adolescent cohort was 2.79 (95%CI; 2.25-3.46, p-value; <0.0001) compared with the adult cohort which met non-inferiority criteria. The reactogenicity was slightly less reported in the adolescent cohort compared with the adult cohort. No serious adverse events were reported in both cohorts. Conclusion: Vaccination with the BBIBP-CorV vaccine in the adolescent participants was safe and effective.

scholarly journals POS0647 EFFICACY, SAFETY AND CHARACTERISTICS OF IGURATIMOD-BASED THERAPY IN THE TREATMENT OF UA, ERA AND RA PATIENTS FOR 24 WEEKS: A PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Adverse Events ◽  
Disease Activity ◽  
Prospective Cohort Study ◽  
Early Rheumatoid Arthritis ◽  
Prospective Cohort ◽  
Combined Treatment ◽  
Serious Adverse Events

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared

scholarly journals Incidence and Risk Factors of Serious Adverse Events during Antituberculous Treatment in Rwanda: A Prospective Cohort Study

PLoS ONE ◽  
2011 ◽  
Vol 6 (5) ◽  
pp. e19566 ◽  
Author(s):  
Natalie Lorent ◽  
Osee Sebatunzi ◽  
Gloria Mukeshimana ◽  
Jef Van den Ende ◽  
Joannes Clerinx
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Adverse Events ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Serious Adverse Events ◽  
Antituberculous Treatment

scholarly journals Clinical outcomes of colistin in combination with either 6-g sulbactam or carbapenems for the treatment of extensively drug-resistant Acinetobacter baumannii pneumonia with high MIC to sulbactam, a prospective cohort study

2019 ◽  
Author(s):  
Chutchawan Ungthammakhun ◽  
Vasin Vasikasin ◽  
Dhitiwat Changpradub
Keyword(s):  
Cohort Study ◽  
Length Of Stay ◽  
Acinetobacter Baumannii ◽  
Clinical Outcomes ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Mortality Rates ◽  
P Value ◽  
Drug Resistant ◽  
Extensively Drug Resistant

Abstract Background: Extensively drug-resistant Acinetobacter baumannii (XDRAB) is an important cause of nosocomial pneumonia with limited therapeutic options. Colistin based regimen is recommended treatment. Which drugs should be combined with colistin remains uncertain. The aim of this study was to investigate the clinical outcomes of patients with XDRAB pneumonia who were treated with colistin, combined with either 6-g sulbactam or carbapenems, in the setting of high MIC to sulbactam. Methods: In this prospective cohort study, hospitalized patients diagnosed with XDRAB pneumonia in Phramongkutklao Hospital were enrolled. The primary outcome was the 28-day mortality. Secondary outcomes were 7 and 14-day mortality, length of stay, ventilator days and factors associated with mortality. Results: From 1 July 2016 to 30 September 2017, 192 patients were included; 92 received colistin plus sulbactam and 90 received colistin plus carbapenems. Most of the patients were male diagnosed with ventilator associated pneumonia in medical intensive care unit. Overall mortality rates at 7, 14, 28 days were 24.2%, 37.4%, 53.3%, respectively. Mortality rates did not differ between sulbactam group and carbapenems groups at 7 days (19.6% vs. 28.9%, p-value 0.424, adjusted HR 1.277; 95% CI = 0.702-2.322), 14 days (34.8% vs. 40%, p = 0.658, adjusted HR 1.109; 95% CI = 0.703-1.749) and 28 days (51.1% vs. 55.6%, p = 0.857, adjusted HR 1.038; 95% CI = 0.690-1.562). Length of stay, ICU days and ventilator days did not differ. Complications of treatment including acute kidney injury were not statistically different. Conclusions: In XDRAB pneumonia with high MIC to sulbactam, mortality rates were not statistically significant between colistin plus 6-g sulbactam and colistin plus carbapenems. Keywords: XDR A. baumannii pneumonia, mortality rate, colistin based, sulbactam, carbapenems

scholarly journals Neuropsychiatric Adverse Events During 12 Months of Treatment with Efavirenz in a Treatment-Naïve HIV-Infected Population in China: A Prospective Cohort Study

2020 ◽  
Author(s):  
Lili Dai ◽  
Sen Wang ◽  
Ying Shao ◽  
Yali Wang ◽  
Jiangzhu Ye ◽  
...  
Keyword(s):  
Cohort Study ◽  
Antiretroviral Therapy ◽  
Adverse Events ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Sleep Disturbances ◽  
Neuropsychiatric Disorders ◽  
Factors Associated ◽  
Anxiety Depression

Abstract Background: Efavirenz (EFV) is a widely used antiretroviral therapy (ART), but side effect risks of neuropsychiatric adverse events (NPAEs) have not been investigated in Chinese populations receiving rapid ART. Methods: This prospective cohort study assessed HIV-infected patients initiating antiretroviral treatment with EFV to determine prevalence of and factors associated with NPAEs over a 12-month follow-up period using the Hospital Anxiety and Depression Scale (HADS) and the Pittsburgh Sleep Quality Index (PSQI). Results: A total of 546 patients were enrolled. Prevalence of anxiety, depression, and sleep disturbances at baseline were 30.4%, 22.7%, and 68.1%, respectively. Six patients discontinued treatment due to drug related NPAEs. Treatment was associated with improvements in HADS-A, HADS-D, and PSQI scores over the 12-month follow-up, and the frequencies of patients with anxiety, depression, and sleep disturbances significantly decreased after 12 months. Abnormal baseline HADS-A, HADS-D, and PSQI scores and other factors, including high school education or lower, unemployment, divorce, and WHO III/IV stages, were associated with severe neuropsychiatric disorders over the 12 months. Conclusions: These findings suggested EFV-based first-line antiretroviral therapy was well-tolerated and associated with improvements in HADS-A, HADS-D, and PSQI scores. Certain risk factors associated with neuropsychiatric disorders may be useful in identifying HIV-infected patients at higher NPAE risk.

Gestational metabolic syndrome and neonatal anthropometric indices: a prospective cohort study

2021 ◽  
Vol 29 (7) ◽  
pp. 386-391
Author(s):  
Zeinab Hatamian ◽  
Lida Moghaddam-Banaem ◽  
Samira Mokhlesi ◽  
Marzieh Saei Ghare Naz
Keyword(s):  
Metabolic Syndrome ◽  
Cohort Study ◽  
Birth Weight ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Linear Regression Analysis ◽  
First Trimester ◽  
P Value ◽  
Anthropometric Parameters ◽  
First Trimester Of Pregnancy

Background and aim There is limited knowledge about the effect of maternal metabolic syndrome (MetS) on the anthropometric parameters of newborns. Therefore, the authors aimed to evaluate the association between MetS in the first trimester of pregnancy with weight and height of the newborn. Methods This prospective cohort study was conducted on 455 pregnant women in Tehran during their first trimester of pregnancy. MetS was defined as the coexistence of three or more of the following criteria: fasting blood sugar (FBS) level ≥92 mg/dl, blood pressure ≥130.85 mm/hg, triglyceride ≥150 mg/dl, high density lipoprotein ≤50 mg/dl, and body mass index (BMI) ≥30 kg/m2. All participants were followed up to childbirth. After birth, the baby's weight and height data were collected from the birth certificate. Results Linear regression analysis showed FBS (ß: 0.100, p-value: 0.038), BMI (ß: 0.139, p-value: 0.004), and MetS (ß: -0.122, p-value: 0.015) were significantly associated with birth weight but no statistically significant results were found for birth height. Conclusion MetS and some of its components in pregnancy can affect birth weight of neonates.

scholarly journals Prevalence and clinical predictors for early post-operative urinary retention in patients undergoing pelvic reconstructive surgeries: a prospective cohort study

2018 ◽  
Vol 7 (4) ◽  
pp. 1452
Author(s):  
Annie P. Vijjeswarapu ◽  
Vaibhav Londhe ◽  
Mahasampath Gowri ◽  
Aruna Kekre ◽  
Nitin Kekre
Keyword(s):  
Cohort Study ◽  
Pelvic Organ Prolapse ◽  
Urinary Retention ◽  
Prospective Cohort Study ◽  
Reconstructive Surgery ◽  
Prospective Cohort ◽  
Pelvic Organ ◽  
P Value ◽  
Pelvic Reconstructive Surgery ◽  
Clinical Predictors

Background: Pelvic organ prolapse (POP) has a significant impact on quality of life. Post-operative voiding dysfunction is seen in 2.5 to 24% of patients following pelvic reconstructive surgery. Risk factors like age of the patient, size of the genital hiatus and stage of prolapse are known to be associated with early post-operative voiding disorders.Methods: This is a prospective cohort study done in Christian Medical College, Vellore over one year. Patients with stage II to IV pelvic organ prolapse who underwent pelvic reconstructive surgery were observed post operatively for covert and overt urinary retention. Inability to void accompanied by pain and discomfort is defined as overt retention. Early post-operative urinary retention (POUR) is retention of urine in the first 72 hours postoperatively. Covert retention is defined as a non-painful bladder with chronic high post void residue. Chi- square test or Fisher’s exact test was used to assess the association between the clinical predictors and early post-operative urinary retention in univariate analysis.Results: In this study, 75 patients were recruited. Nine patients had POUR. Among the patients who had post-operative urinary retention, 77.78% had stage III pelvic organ prolapse (n=7). P value was 0.042. The prevalence of early POUR after pelvic reconstructive surgery was 12.85 % (n=9). A 55.55% had covert retention (n=5) and 44.44% patients had overt retention (n=4).Conclusions: The prevalence of early POUR after pelvic reconstructive surgery was 12.85%. Stage of the prolapse was an independent predictor for early postoperative urinary retention.

Multimorbidity measures were poor predictors of adverse events in patients aged ≥80 years: a prospective cohort study

2015 ◽  
Vol 68 (2) ◽  
pp. 220-227 ◽  
Author(s):  
Pauline Boeckxstaens ◽  
Bert Vaes ◽  
Gijs Van Pottelbergh ◽  
An De Sutter ◽  
Delphine Legrand ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Prospective Cohort Study ◽  
Prospective Cohort

scholarly journals Effects of frequent PATient moves on patient outcomes in a large tertiary Hospital (the PATH study): a prospective cohort study

2016 ◽  
Vol 40 (3) ◽  
pp. 324 ◽  
Author(s):  
Joan Webster ◽  
Karen New ◽  
Mary Fenn ◽  
Mary Batch ◽  
Alyson Eastgate ◽  
...  
Keyword(s):  
Patient Safety ◽  
Cohort Study ◽  
Length Of Stay ◽  
Adverse Events ◽  
Patient Outcomes ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Tertiary Hospital ◽  
Tertiary Referral Hospital ◽  
Specific Patient

Objective The aim of the present study was to investigate the incidence of and patient outcomes associated with frequent patient moves. Methods In a prospective cohort study, any bed move and the reason for the move were documented. Patients were assessed on admission for anxiety, social support and delirium. Adverse events, length of stay and satisfaction were recorded. Patients moved three or more times were compared with those moved less than three times. Results In all, 566 patients admitted to a tertiary referral hospital were included in the study. Of these, 156 patients (27.6%) were moved once, 46 (8.1%) were moved twice and 28 (4.9%) were moved at least three times. Those moved three or more times were almost threefold more likely to have an adverse event recorded compared with those moved fewer times (relative risk (RR) 2.75; 95% confidence interval (CI) 1.18, 6.42; P = 0.02) and to have a hospital stay twice as long (RR 7.10; 95% CI 2.60, 11.60; P = 0.002). Levels of satisfaction and anxiety were not affected by frequent moves and there was no effect on delirium. Conclusion Frequent bed moves affect patient safety and prolong length of stay. What is known about the topic? Retrospective and qualitative studies suggest that patient safety and costs may be affected by frequent patient moves. What does this paper add? The present study is the first prospective study to assess the negative effects of frequent patient moves on specific patient outcomes, such as adverse events, length of stay and satisfaction with care. What are the implications for practitioners? Within- and between-ward moves may affect patient safety. Patients should be moved only when there is a clear and unavoidable reason for doing so.

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