Comparison of injection site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a Phase III study

Abstract

Injection site reactions (ISRs) are common adverse reactions to biologic drugs, consisting of itching, erythema, and induration at the injection site¹. ISRs usually appear within 24-48 hours after injection and subside within a few days. They typically occur in the first two months of treatment and subsequently decrease in frequency; incidence varies by drug. While ISRs seldom result in discontinuation of treatment, ISRs remain a safety concern when using biologic drugs.

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Quantitative analysis of multiple elements in healthy and remodeled epithelium from human upper airway mucosa by using nuclear microscopy

Abstract

Elements are vital in airway mucosal physiology and pathology; but their distribution and levels in the mucosa remain unclear. The present study uses the state-of-the-art nuclear microscopy facility to map and quantify multiple elements in the histology sections of nasal mucosa from patients with nasal polyps or inverted papilloma. Our results demonstrate that P and Ca are the most abundant elements in mucosa and their distinct difference between epithelial and sub-epithelial regions; more importantly, our results reveal decreased amounts of Cu and Zn in the remodelled epithelium as compared to the normal epithelium. These findings suggest that Cu and Zn may be beneficial targets to regulate aberrant epithelial remodeling in airway inflammation.

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Incidence and Preoperative Predictive Indicators of Incudal Necrosis in CSOM: A Prospective Study in a Tertiary Care Centre

Abstract

Both type of CSOM, tubotympanic which is considered safe as well as atticoantral which is considered unsafe may lead to erosion of the ossicular chain. Discontinuity of the ossicular chain is typically confirmed only during an operation. Knowing before surgery whether the patient has an ossicular discontinuity is important because it allows the surgeon to know the possibility of performing an ossiculoplasty and obtaining patient consent. The aims is to (1) study the incidence of incus necrosis in safe and unsafe CSOM. (2) Determine the preoperative predictive factors for incus necrosis. (3) Use angled otoscopes to determine the incidence of residual disease peroperative after conventional microscopic surgery. This is a prospective study carried out in the department of otorhinolaryngology, Govt Doon medical college, Dehradun from July 2014 to July 2016. A total of 100 patients who presented with CSOM and have not undergone any surgical procedure for the same were included in this study. Patients group was divided into cholesteatoma and non cholesteatoma group. Both groups were subdivided into intact and eroded incus group and were analysed in 11 parameters which were compared statistically. Incudal necrosis is more common in cholesteatoma group. In non cholesteatoma ears subtotal perforation with exposure of IS joint is reliable indicators of incudal necrosis. In non cholesteatoma group extension of cholesteatoma to tympanic sinus and mastoid and presence of persistent discharge are reliable indicators of necrosed incus. Moderate to moderately severe hearing loss indicate incudal necrosis in both groups therefore we conclude that these parameters can be reliably considered as predictors for incudal necrosis preoperatively.

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A new approach to treat bone gaps after midfacial and zygomatic fractures with a collagen membrane

Abstract

Purpose

The aim of the study was to analyze the eligibility of resorbable collagen membrane in the treatment of midfacial fractures to prevent gap formation and subsequent cheek tissue retraction.

Material and methods

We included nine patients (six males, three females; mean age 51; range 20–73 years; mean bone gap size 8.03 × 13.12 mm) in a retrospective study design. The defect size was assessed by ultrasound.

Results

After a healing period of 4 to 55 weeks, treatment resulted in a significant reduction of gap size (residual mean bone gap size 6.14 × 7.32 mm).

Conclusions

Native resorbable collagen membrane is a promising tool to reduce the size of bony gap in midfacial defects.

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Surgical Morbidity and Mortality in Patients after Microvascular Reconstruction for Head and Neck Cancer

Abstract

Objectives

The aim was to evaluate the importance of clinical factors in the prediction of postoperative complications in patients with microvascular reconstruction for head and neck squamous cell cancer (HNSCC).

Design

A retrospective review of case notes was performed.

Setting

Patients treated at a single institute.

Participants

The present study included 259 patients with HNSCC treated with radical surgery and microvascular reconstruction between 1993 and 2014.

Main outcome measures

We allocated the patients to three groups using a preoperative comorbidity score based on risk factors: group A (≥ 3 risk factors, n=16), group B (2 risk factors, n=49), and group C (0 or 1 risk factor, n=194).

Results

Surgical mortality in this cohort was 1.9% (5 of 259 patients). The preoperative comorbidity score was associated with surgical mortality (p<0.001). Pharyngocutaneous fistula (p=0.001) and flap compromise (p=0.023) were more frequent as preoperative comorbidity score increased. Preoperative comorbidity score (p<0.001), advanced age (p=0.007), advanced pathologic T stage (p=0.028), advanced pathologic N stage (p=0.005), preoperative (chemo)radiotherapy (p<0.001), history of cardiovascular disease (p=0.015) and pulmonary disease (p=0.007), and diabetes (p<0.001) had significant adverse effects on 5-year disease-specific survival (DSS) in a univariate analysis. The 5-DSS rates of groups A, B, and C were 30%, 37%, and 70%, respectively. Multivariate analysis showed that preoperative comorbidity score was significantly correlated with 5-year DSS (hazard ratio [HR], 3.56; 95% confidence interval [CI], 1.81—6.99; p<0.001 for group A and HR, 1.91; 95% CI, 1.15—3.18; p=0.013 for group B compared with group C).

Conclusion

Patients with a high preoperative comorbidity score have an increased risk of surgical mortality and morbidity after microvascular reconstruction for HNSCC.

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Eight weeks of omeprazole 20 mg significantly reduces both laryngopharyngeal reflux and comorbid chronic rhinosinusitis signs and symptoms: randomized, double blind, placebo controlled trial

Abstract

Objectives

Gastroesophageal reflux recommended treatment (dose and duration) with proton pump inhibitor (PPI) compared to placebo significantly reduces the signs and symptoms of laryngopharyngeal reflux (LPR) and comorbid chronic rhinosinusitis (CRS).

Design

Double blind randomized placebo controlled trial.

Setting

Eight weeks of treatment with omeprazole 20 mg once daily (OD).

Participants

60 patients (28 women, aged 19-87 years) with diagnosed LPR and comorbid CRS.

Main outcome measures

Significant reduction of signs and symptoms (reflux symptom index (RSI) score as subjective, and reflux finding score (RFS) as objective measure) of LPR after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo. Secondary objectives were significant reduction of signs and symptoms of comorbid CRS after 8 weeks of treatment with omeprazole 20 mg OD when compared to placebo; and the association of the severity of signs and symptoms of LPR with the ones of CRS.

Results

RSI and RFS decreased significantly more in the active treatment group after 8 weeks compared to placebo (p<0.001 for both). CRS and endoscopy scoring decreased both significantly more in the active group after 8 weeks compared to placebo (p<0.001 for both). CRS scoring significantly correlated with RSI (R=0.312, p=0.015) but not with RFS (R=0.199, p=0.127).

Conclusions

The results of our trial suggest that omeprazole 20 mg OD for 8 weeks was effective in reducing signs and symptoms of both LPR and CRS, although in most patients still present at the end of the trial.

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Incidence and Preoperative Predictive Indicators of Incudal Necrosis in CSOM: A Prospective Study in a Tertiary Care Centre

Abstract

Both type of CSOM, tubotympanic which is considered safe as well as atticoantral which is considered unsafe may lead to erosion of the ossicular chain. Discontinuity of the ossicular chain is typically confirmed only during an operation. Knowing before surgery whether the patient has an ossicular discontinuity is important because it allows the surgeon to know the possibility of performing an ossiculoplasty and obtaining patient consent. The aims is to (1) study the incidence of incus necrosis in safe and unsafe CSOM. (2) Determine the preoperative predictive factors for incus necrosis. (3) Use angled otoscopes to determine the incidence of residual disease peroperative after conventional microscopic surgery. This is a prospective study carried out in the department of otorhinolaryngology, Govt Doon medical college, Dehradun from July 2014 to July 2016. A total of 100 patients who presented with CSOM and have not undergone any surgical procedure for the same were included in this study. Patients group was divided into cholesteatoma and non cholesteatoma group. Both groups were subdivided into intact and eroded incus group and were analysed in 11 parameters which were compared statistically. Incudal necrosis is more common in cholesteatoma group. In non cholesteatoma ears subtotal perforation with exposure of IS joint is reliable indicators of incudal necrosis. In non cholesteatoma group extension of cholesteatoma to tympanic sinus and mastoid and presence of persistent discharge are reliable indicators of necrosed incus. Moderate to moderately severe hearing loss indicate incudal necrosis in both groups therefore we conclude that these parameters can be reliably considered as predictors for incudal necrosis preoperatively.

http://ift.tt/2xxQYE8