scholarly journals Safety of meningococcal group B vaccination in hospitalised premature infants

2018 ◽  
Vol 104 (2) ◽  
pp. F171-F175 ◽  
Author(s):  
Alison Kent ◽  
Kazim Beebeejaun ◽  
Serena Braccio ◽  
Seilesh Kadambari ◽  
Paul Clarke ◽  
...  
Keyword(s):  
Adverse Events ◽  
Premature Infants ◽  
Antibiotic Use ◽  
Neurological Status ◽  
Serious Adverse Events ◽  
Historical Cohort ◽  
Protein Levels ◽  
Reactive Protein ◽  
Before And After ◽  
Group B

ObjectivesTo assess the risk of significant adverse events in premature infants receiving the novel 4-component group B meningococcal vaccine (4CMenB) with their routine immunisations at 2 months of age.Participants, design and settingIn December 2015, Public Health England requested neonatal units across England to voluntarily participate in a national audit; 19 units agreed to participate. Anonymised questionnaires were completed for infants receiving 4CMenB alongside their routine immunisations. For comparison, a historical cohort of premature infants receiving their primary immunisations without 4CMenB or paracetamol prophylaxis was used.Main outcome measuresParacetamol use; temperature, cardiovascular, respiratory and neurological status before and after vaccination; and management and investigations postvaccination, including serum C reactive protein levels, infection screens and antibiotic use.ResultsComplete questionnaires were returned for 133 premature infants (<35 weeks’ gestation) who received their first dose of 4CMenB at 8 weeks of age, including 108 who received prophylactic paracetamol according to national recommendations. Overall, 7% (8/108) of infants receiving 4CMenB with paracetamol had fever (>38°C) after vaccination compared with 20% (5/25) of those receiving 4CMenB without paracetamol (P=0.06) and none of those in the historical cohort. There were no significant differences between cohorts in the proportion of infants with apnoea, bradycardia, desaturation and receiving respiratory support after vaccination.Conclusions4CMenB does not increase the risk of serious adverse events in hospitalised premature infants. This audit supports the current national recommendations to offer 4CMenB with other routine vaccinations and prophylactic paracetamol to premature infants at their chronological age.

Re-induction With Intravenous Ustekinumab in Patients With Crohn’s Disease and a Loss of Response to This Therapy

2021 ◽  
Author(s):  
Fernando Bermejo ◽  
Laura Jiménez ◽  
Alicia Algaba ◽  
Milagros Vela ◽  
Guillermo Bastida ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Clinical Response ◽  
Serious Adverse Events ◽  
Protein Levels ◽  
Reactive Protein ◽  
Loss Of Response ◽  
Administration Interval ◽  
Safe Strategy

Abstract Background A significant percentage of patients treated with ustekinumab may lose response. Our aim was to evaluate the short-term efficacy and safety of intravenous re-induction with ustekinumab in patients with Crohn’s disease who have lost the response to the treatment. Methods This is a retrospective, observational, multicenter study. Treatment efficacy was measured at week 8 and 16; clinical remission was defined when the Harvey-Bradshaw Index was ≤4 points, and clinical response was defined as a decrease of ≥3 points in the index compared with the baseline. Adverse events and treatment decisions after re-induction were also collected. Results Fifty-three patients from 13 centers were included. Forty-nine percent had previously failed to respond to 2 biological treatments, and 24.5% had failed to respond to 3. The average exposure time to ustekinumab before re-induction was 17.7 ± 12.8 months. In 56.6% of patients, the administration interval had been shortened to every 4 to 6 weeks before re-induction. At week 8 and 16 after re-induction, 49.0% (n = 26) and 43.3% (n = 23), respectively, were in remission, whereas 64.1% (n = 34) and 52.8% (n = 28) had a clinical response. Patients who achieved remission at week 16 had lower C-reactive protein levels than those who did not respond (2.8 ± 1.6 vs 12.5 ± 9.5 mg/dL; P = 0.001). No serious adverse events related to re-induction were observed. Conclusion Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn’s disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.

scholarly journals Vedolizumab Efficacy, Safety, and Pharmacokinetics With Reduced Frequency of Dosing From Every 4 Weeks to Every 8 Weeks in Patients With Crohn’s Disease or Ulcerative Colitis

2020 ◽  
Vol 14 (8) ◽  
pp. 1066-1073 ◽  
Author(s):  
Séverine Vermeire ◽  
Milan Lukáš ◽  
Fernando Magro ◽  
Shashi Adsul ◽  
Dirk Lindner ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Clinical Remission ◽  
Serious Adverse Events ◽  
Protein Levels ◽  
Reactive Protein ◽  
Reduced Frequency ◽  
Extended Access

Abstract Background and Aims Vedolizumab was shown to be safe and effective for the treatment of Crohn’s disease [CD] and ulcerative colitis [UC] in the GEMINI Long-Term Safety [LTS] study. The vedolizumab Extended Access Program [XAP] provides patients with continued treatment. This XAP pharmacokinetics [PK] sub-study investigated vedolizumab efficacy, safety, and PK. Methods Vedolizumab dosing frequency was reduced from every 4 weeks [Q4W] to every 8 weeks [Q8W] at XAP enrolment, and patients were followed for 56 weeks. Outcomes included: efficacy, loss of clinical benefit, and re-escalation to Q4W dosing; and vedolizumab PK, immunogenicity, and adverse events. Results Among 167 enrolled patients [CD = 88, UC = 79], 80 [91%] with CD and 73 [92%] with UC completed 56 weeks; 76 [86%] and 71 [90%] with CD and UC, respectively, remained on Q8W dosing for 56 weeks. Clinical remission, corticosteroid-free clinical remission, and C-reactive protein levels were stable among patients remaining on Q8W through Week 56. Four patients with CD and two with UC resumed Q4W dosing [three with CD regained clinical response]. Patients with CD who completed Week 56 on Q8W dosing had median trough vedolizumab concentrations of 43.6 µg/mL at enrolment and 10.4 µg/mL at Week 56; concentrations were 42.4 µg/mL and 13.3 µg/mL, respectively, in patients with UC. Treatment-related adverse events were infrequent; no new or serious adverse events related to vedolizumab were reported. Conclusions In the XAP-PK sub-study, adherence to Q8W dosing was high, with no loss of efficacy; very few patients required re-escalation to Q4W. There were no new safety signals.

scholarly journals Routine Early Antibiotic use in SymptOmatic preterm Neonates (REASON): a prospective randomized controlled trial

2020 ◽  
Author(s):  
J. Lauren Ruoss ◽  
Catalina Bazacliu ◽  
Jordan T. Russell ◽  
Diomel de la Cruz ◽  
Nan Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trial ◽  
Premature Infants ◽  
Neonatal Intensive Care ◽  
Late Onset ◽  
Controlled Trial ◽  
Antibiotic Use ◽  
Preterm Neonates ◽  
Serious Adverse Events ◽  
Late Onset Sepsis

AbstractObjectiveWe aim to assess the feasibility of a pragmatic randomized trial of antibiotics vs. no antibiotics in symptomatic premature infants after birth. Most premature infants are exposed to antibiotics after birth without evidence of benefit or harm for this practice. No study to date has attempted to randomize premature infants to antibiotics vs no antibiotics after birth.Study DesignInfants <33 weeks’ gestation admitted to the University of Florida Neonatal Intensive Care Unit were assigned to one of three groups after birth: (A) high risk – antibiotics indicated (B) low risk – antibiotics not indicated (C) eligible for un-blinded randomization (no antibiotics vs antibiotics). The primary outcome is a composite of serious adverse events including (necrotizing enterocolitis, late onset sepsis, bronchopulmonary dysplasia, and death). Odds ratios (and 95% CI’s) were calculated to compare adverse event rates between the two randomized groups.Results186 subjects were enrolled (98 infants and 88 mothers) were enrolled over a 2-year period. 56% of infants (n=55) were randomized; 48% of infants randomized to the no antibiotics arm were switched and received antibiotics within the first 48 hours after birth. Serious adverse events were not significantly different between the randomization arms.ConclusionThis is the first prospective randomized trial of antibiotics vs no antibiotics after birth in symptomatic premature infants. The results of this trial establish a framework of feasibility for a larger multicentered trial that is needed to evaluate the risks and benefits of routine antibiotic exposure in premature infants.

Comparison of the Neutrophil/Lymphocyte Ratio and C-Reactive Protein Levels in Patients With Amputation for Diabetic Foot Ulcers

2017 ◽  
Vol 16 (1) ◽  
pp. 23-28 ◽  
Author(s):  
Hasan Metineren ◽  
Turan Cihan Dülgeroğlu
Keyword(s):  
Diabetic Foot ◽  
Inflammatory Marker ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
C Reactive Protein ◽  
Neutrophil Lymphocyte Ratio ◽  
Lymphocyte Ratio ◽  
Protein Levels ◽  
Reactive Protein ◽  
Before And After

This study compared the effectiveness of the neutrophil/lymphocyte ratio (NLR) versus C-reactive protein (CRP) for evaluating the prognosis and degree of inflammation in patients with amputation for a diabetic foot ulcer (DFU). This study enrolled 56 patients with amputations for DFU with gangrene and compared the CRP levels and NLR measured before and after surgery. Overall, 24 patients (42%) died within 2 weeks postoperatively. Mortality increased with a preoperative/postoperative CRP difference ≤1.5 ( P < .001) and age 73 years or older ( P < .001). The postoperative NLR was lower than the preoperative value but was not significant as a prognostic or inflammatory marker ( P = .945). An increasing serum CRP level is a significant predictor of mortality. CRP and old age are reliable prognostic factors in patients with DFU.

Childhood meningitis in the conjugate vaccine era: a prospective cohort study

2014 ◽  
Vol 100 (3) ◽  
pp. 292-294 ◽  
Author(s):  
Manish Sadarangani ◽  
Louise Willis ◽  
Seilesh Kadambari ◽  
Stuart Gormley ◽  
Zoe Young ◽  
...  
Keyword(s):  
Bacterial Meningitis ◽  
Group B Streptococcus ◽  
Bacterial Pathogen ◽  
Antibiotic Use ◽  
Viral Meningitis ◽  
Older Children ◽  
C Reactive Protein ◽  
Blood Cell Count ◽  
Reactive Protein ◽  
Group B

Bacterial conjugate vaccines have dramatically changed the epidemiology of childhood meningitis; viral causes are increasingly predominant, but the current UK epidemiology is unknown. This prospective study recruited children under 16 years of age admitted to 3 UK hospitals with suspected meningitis. 70/388 children had meningitis—13 bacterial, 26 viral and 29 with no pathogen identified. Group B Streptococcus was the most common bacterial pathogen. Infants under 3 months of age with bacterial meningitis were more likely to have a reduced Glasgow Coma Score and respiratory distress than those with viral meningitis or other infections. There were no discriminatory clinical features in older children. Cerebrospinal fluid (CSF) white blood cell count and plasma C-reactive protein at all ages, and CSF protein in infants <3 months of age, distinguished between bacterial meningitis and viral meningitis or other infections. Improved diagnosis of non-bacterial meningitis is urgently needed to reduce antibiotic use and hospital stay.

scholarly journals A Pilot Placebo Controlled Randomized Trial of Dexamethasone for Chronic Subdural Hematoma

2016 ◽  
Vol 43 (2) ◽  
pp. 284-290 ◽  
Author(s):  
Michel Prud’homme ◽  
François Mathieu ◽  
Nicolas Marcotte ◽  
Sylvine Cottin
Keyword(s):  
Conservative Treatment ◽  
Adverse Events ◽  
Small Sample Size ◽  
Chronic Subdural Hematoma ◽  
Symptomatic Patient ◽  
Placebo Treatment ◽  
Small Sample ◽  
Chi Square ◽  
Serious Adverse Events ◽  
Before And After

AbstractBackground: Current opinions regarding the use of dexamethasone in the treatment of chronic subdural hematomas (CSDH) are only based on observational studies. Moreover, the use of corticosteroids in asymptomatic or minimally symptomatic patient with this condition remains controversial. Here, we present data from a prospective randomized pilot study of CSDH patients treated with dexamethasone or placebo. Methods: Twenty patients with imaging-confirmed CSDH were recruited from a single center and randomized to receive dexamethasone (12 mg/day for 3 weeks followed by tapering) or placebo as a conservative treatment. Patients were followed for 6 months and the rate of success of conservative treatment with dexamethasone versus placebo was measured. Parameters such as hematoma thickness and clinical changes were also compared before and after treatment with chi-square tests. Adverse events and complications were documented. Results: During the 6-month follow-up, one of ten patients treated with corticosteroids had to undergo surgical drainage and three of ten patients were treated surgically after placebo treatment. At the end of the study, all remaining patients had complete radiological resolution. No significant differences were observed in terms of hematoma thickness profile and impression of change; however, patients experienced more severe side effects when treated with steroids as compared with placebo. Dexamethasone contributed to many serious adverse events. Conclusions: Given the small sample size, these preliminary results have not shown a clear beneficial effect of dexamethasone against placebo in our patients. However, the number of secondary effects reported was much greater for corticosteroids, and dexamethasone treatment was responsible for significant complications.

scholarly journals The Effects ofHelicobacter pyloriEradication on Proteinuria in Patients with Primary Glomerulonephritis

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Bahar Caliskan ◽  
Halil Yazici ◽  
Yasar Caliskan ◽  
Yasemin Ozluk ◽  
Mine Gulluoglu ◽  
...  
Keyword(s):  
Iga Nephropathy ◽  
Eradication Therapy ◽  
Spontaneous Remission ◽  
Positive Staining ◽  
Stool Antigen Test ◽  
Protein Levels ◽  
Reactive Protein ◽  
Before And After ◽  
Stool Antigen ◽  
H Pylori

Background. Membranous nephropathy (MN) is a common cause of nephrotic syndrome. In most cases it is idiopathic, while it may also be secondary to many diseases. In this study, prevalence ofH. pyloriinfection and the effects ofH. pylorieradication on proteinuria levels were investigated.Methods. Thirty five patients with MN (19 male), 12 patients with IgA nephropathy (4 male) and 12 patients with focal segmental glomerulosclerosis (FSGS) (8 male) were studied. The presence ofH. pyloriantigen was investigated in renal tissues obtained by biopsy, and the effects ofH. pylorieradication on proteinuria levels were investigated.Results. Immunohistochemistry withH. pyloriantigen revealed no positive staining in the glomeruli of all patients. 19 patients (54%) with MN, 10 (83%) with IgA nephropathy and 4 (33%) with FSGS were positive forH. pyloristool antigen test(P=0.045). Patients withH. pyloriinfection were administered eradication therapy (lansoprazole, 30 mg twice daily, plus amoxicillin, 0.75 g twice daily, plus clarithromycin, 250 mg twice daily, for 14 days). Before the eradication therapy the mean proteinuria of patients with MN, IgA nephropathy and FSGS were 2.42 ± 3.24 g/day, 2.12 ± 1.63 g/day and 1.80 ± 1.32 g/day, respectively. Three months after eradication, baseline proteinuria levels of patients with MN significantly decreased to 1.26 ± 1.73 g/day(P=0.031). In all three groups there were no significant differences with regard to serum creatinine, albumin and C-reactive protein levels before and after eradication therapy.Conclusions. The eradication ofH. pyloriinfection may be effective to reduce proteinuria in patients with MN, while spontaneous remission of MN could not be excluded in this patient cohort. This trial is registered withNCT00983034.

Pilot Study of Intraperitoneal Administration of Triamcinolone Acetonide for Cancerous Ascites in Patients With End-Stage Gynecological Cancer

2014 ◽  
Vol 24 (6) ◽  
pp. 1093-1097 ◽  
Author(s):  
Tadahiro Shoji ◽  
Eriko Takatori ◽  
Yuki Miura ◽  
Anna Takada ◽  
Hideo Omi ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Triamcinolone Acetonide ◽  
Gynecological Cancer ◽  
Intraperitoneal Administration ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Before And After ◽  
End Stage ◽  
Abdominal Paracentesis

ObjectivePatients with end-stage cancer have poorly controlled ascites retention resulting due to cancerous peritonitis. We intraperitoneally administered triamcinolone acetonide (TA) to patients with end-stage gynecological cancer as a pilot study, and our treatment results are reported herein.Patients and MethodsWe enrolled 26 patients with end-stage gynecological cancer requiring frequent abdominal paracentesis for ascites drainage between April 2010 and September 2012. The volume of ascites drainage was 2000 to 3000 mL per drainage session, and TA at 10 mg/kg was intraperitoneally administered after drainage. We compared abdominal paracentesis intervals, performance status (PS), total protein level, albumin level, white blood cell count, changes in C-reactive protein (CRP) level, and adverse events before and after TA use.ResultsTriamcinolone acetonide was administered to 26 patients for a total of 59 times. The abdominal paracentesis intervals, PS, and mean (SD) of C-reactive protein before and after TA use were 13.2 (12.6) days and 21.9 (23.6) days (P = 0.0117), 2.4 (0.7) and 1.6 (1.1) (P < 0.0001), and 7.5 (5.2) mg/dL and 5.5 (5.0) mg/dL (P = 0.007), respectively. With regard to adverse events, abdominal pain of grade 2 was observed once (1.7%), but there were no other acute adverse events. Four subjects (15.4%) had intestinal perforation.ConclusionsIntraperitoneal administration of TA after drainage was considered to be a useful treatment, as it seems to extend paracentesis intervals and improve PS while maintaining quality of life for end-stage gynecological cancer patients with massive ascites.

scholarly journals Feasibility of Non-Anesthesiologist-Administered Propofol Sedation for Emergency Endoscopic Retrograde Cholangiopancreatography

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Nobuhito Ikeuchi ◽  
Takao Itoi ◽  
Takuji Gotoda ◽  
Chika Kusano ◽  
Shin Kono ◽  
...  
Keyword(s):  
Adverse Events ◽  
Endoscopic Retrograde Cholangiopancreatography ◽  
Acute Cholangitis ◽  
Careful Monitoring ◽  
Endoscopic Retrograde ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Technical Safety

Background. The safety of non-anesthesiologist-administered propofol (NAAP) sedation in emergent endoscopic retrograde cholangiopancreatography (ERCP) has not been fully clarified. Thus, the aim of this study was to assess the safety of NAAP sedation in emergent ERCP.Materials and Methods. We retrospectively analyzed 182 consecutive patients who had obstructive jaundice and who underwent ERCP under NAAP sedation. The patients were divided into Group A (with mild acute cholangitis or without acute cholangitis) and Group B (moderate or severe acute cholangitis). And technical safety and adverse events were assessed.Results. The adverse events were hypoxia (31 cases), hypotension (26 cases), and bradycardia (2 cases). There was no significant difference in the rate of each adverse event of hypoxia and bradycardia in either group. Although the rate of transient hypotension associated in Group B was higher than that in Group A, it was immediately improved with conservative treatment. Moreover, there were no patients who showed delayed awakening, or who developed other complications.Conclusions. In conclusion, NAAP sedation is feasible even in emergent ERCP. Although some transient adverse events (e.g., hypotension) were observed, no serious adverse events occurred. Thus, propofol can be used in emergent ERCP but careful monitoring is mandatory.

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