Introduction
Lurasidone is a second-generation antipsychotic shown to have a lower risk of weight gain and a lower incidence of metabolic adverse events compared with some medications in the same ...class.
Objectives
To describe treatment patterns, clinical outcomes and adverse drug reactions (ADRs) over 12 months following lurasidone initiation in patients with schizophrenia.
Methods
This was a multi-centre observational study involving data collection from patients’ medical records, conducted in seven mental health centres in the United Kingdom (UK) and Switzerland. The study included patients aged ≥18 years who initiated lurasidone after 1 January 2016 for the treatment of schizophrenia. Data were collected from medical records both retrospectively and prospectively using a standardised data collection form. Data collected included patient characteristics, treatment history, lurasidone regimens, clinical outcomes and ADRs.
Results
Forty-eight patients participated in the study. The median (interquartile range IQR) age at lurasidone initiation was 33.5 (25.5-50.3) years and 31 (65%) patients were male. The median (range) lurasidone starting dose was 37 mg daily (9.3–148 mg). Thirty-eight (79%) patients continued lurasidone for the entire 12-month follow-up period. Among the 14 (29%) patients with documented relapse, the median (IQR) time to relapse was 3.4 (1.5–7.9) months. Five ADRs were recorded in patient notes judged as related to lurasidone: agitation, nausea, akathisia, somnolence and vomiting (one patient each).
Conclusions
In this real-world study of patients with schizophrenia in the UK and Switzerland, 79% of patients continued lurasidone for at least 12 months, and ADRs were reported rarely in patient notes.
Disclosure
This study was sponsored by CNX Therapeutics Ltd (formerly Sunovion Pharmaceuticals Europe Ltd). AJ is an employee of CNX Therapeutics. MA is an employee of OPEN HEALTH who was contracted by CNX Therapeutics for data analysis and medical writing.
Summary
Background
Accepted ‘standard practice’ for the diagnosis of immunobullous disease is a perilesional sample for direct immunofluorescence (DIF).
Objectives
To compare diagnostic outcomes of a ...normal buccal punch biopsy (NBPB) with a perilesional biopsy (PLB) for mucous membrane pemphigoid (MMP) and pemphigus vulgaris (PV).
Methods
A retrospective analysis of 251 DIF‐positive patients with MMP and 77 DIF‐positive patients with PV was undertaken. Parameters analysed included the intraoral sites of involvement and histopathological, DIF and indirect immunofluorescence (IIF) findings.
Results
For MMP, PLB was positive in 134 of 143 (93·7%) samples, compared with 129 of 144 (89·6%) by NBPB. The diagnostic sensitivities for PLB (81%, 39 of 48) and NBPB (77%, 37 of 48) among 48 patients who underwent both techniques were not significantly different (P = 0·62). In gingival‐only MMP, PLB was positive in 63 of 69 (91%) and NBPB was positive in 63 of 75 (84%). For multisite MMP, PLB was positive in 71 of 74 (96%) and NBPB was positive in 66 of 69 (96%). In gingival‐only MMP, biopsies from reflected alveolar mucosa in 17 consecutive patients were positive in 17 of 17 cases (100%). For PV, PLB was positive in 42 of 43 (98%), compared with 42 of 42 (100%) by NBPB. Histopathology was diagnostic in 93 of 134 (69·4%) cases of MMP and 38 of 41 (93%) cases of PV. IIF was positive in 126 of 197 (64·0%) MMP and 68 of 74 (92%) PV patient sera.
Conclusions
In the largest series of combined oral DIF results in patients with MMP and PV, we have shown that NBPB is equivalent to PLB for the diagnosis of PV and multisite MMP, and is more sensitive than both histology and IIF.
What's already known about this topic?
The variation in sensitivity of oral biopsy sites for direct immunofluorescence (DIF) in the diagnosis of oral MMP and PV has not been studied in detail in large series of patients.
Biopsy can be challenging due to difficult access and fragility of the oral mucosa. The diagnostic biopsy technique is therefore critical.
What does this study add?
We have shown that a normal buccal punch biopsy (NBPB) from uninvolved oral mucosa is as sensitive as a perilesional biopsy (PLB) for diagnosis of oral PV, and superior to serology and histology.
For multisite MMP, NBPB is equivalent to PLB and is more sensitive than serology and histology.
The oral punch biopsy technique on uninvolved buccal mucosa tissue is a simple and safe practical method for diagnosing oral PV and MMP.
Linked Comment: Maglie and Hertl. Br J Dermatol 2020; 182:539–540.
Plain language summary available online
Aim
To clinically assess the diagnostic yield from single parallel periapical, two parallax radiographs and cone beam computed tomography (CBCT) by comparing the prevalence of periapical lesions ...associated with individual roots, and the total number of root canals in root‐treated teeth in patients referred for root canal retreatment.
Methodology
Single and parallax periapical radiographs, and CBCT scans, were taken of 100 teeth in 78 patients who had been referred for root canal retreatment. The presence of a periapical lesion associated with each specific root and the number of identifiable root canals were assessed using each imaging modality by a consensus panel of two examiners. The number of root canals was confirmed using the dental‐operating microscope during treatment. In addition, the panel was asked to decide whether they felt they had adequate information to manage each case.
Results
A total of 209 paired roots were assessed for periapical lesions. Lesions were identified in 41%, 38% and 68% of paired roots when using single radiographs, two parallax radiographs and CBCT respectively. The number of root canals identified were 186, 218, 242 and 239 when using parallel, parallax, CBCT and the dental‐operating microscope, respectively.
Conclusions
CBCT detected significantly more periapical lesions and root canals than both single and parallax periapical radiographs. There was no significant difference between CBCT and the clinical microscope in the identification of root canals. Whilst two parallax radiographs detect significantly more root canals than a single radiograph, they did not increase detection of periapical lesions when compared to a single periapical radiograph.
Aim
Part 2 of this prospective clinical study aimed to compare the 1‐year outcome of root canal retreatments, when individual roots and teeth were assessed by periapical radiographs and cone beam ...computed tomography (CBCT).
Methodology
Subjects participating in this study had been referred for management of an endodontic problem associated with one or more root filled teeth. Root canal retreatment was performed by Specialists or postgraduate students under the direct supervision of Specialist endodontic staff. A total of 98 teeth (84 patients) were reassessed clinically and radiographically 1 year after completion of root canal retreatment. The postoperative periapical radiographs and CBCT scans were compared with their respective pre‐treatment (diagnostic) periapical radiographs and CBCT scans. The increase or decrease in size of existing periapical radiolucencies and development of new radiolucencies were assessed by a consensus panel consisting of two calibrated examiners. They also determined an appropriate management plan for each case based on the radiographical findings. Comparison of the outcome diagnosis of individual roots and teeth and case management, when assessed by periapical radiographs and CBCT scans, was performed using chi‐squared and McNemar's tests.
Results
An overall favourable result of 93% success for teeth (96% roots) was recorded when the assessment was undertaken by periapicals compared with 77% success for teeth (87% roots) when assessed by CBCT. A significant difference in outcome diagnosis of single paired roots (P < 0.0001) and teeth (P = 0.0001) was observed when comparing periapicals to CBCT for the cohort of teeth as a whole. When comparing the future management plan on the basis of radiographic information alone, there was a significant difference between periapicals and CBCT‐based management (P = 0.01).
Conclusion
Diagnosis using CBCT revealed a significantly lower number of favourable outcomes than periapicals in root canal retreatment. This significantly affected the future management of cases attending for a review.
Summary
Background
Pemphigus vulgaris (PV) is a rare autoimmune bullous disease, which can present with recalcitrant oral mucosal lesions. Optimal management of PV relies upon careful clinical ...assessment and documentation.
Objectives
The primary aim of this study was to validate the Oral Disease Severity Score (ODSS) for the assessment of oral involvement in PV. A secondary aim was to compare its inter‐ and intraobserver variability and ease of use with the Physician's Global Assessment (PGA) and the oral scoring methods used in the Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) and the Pemphigus Disease Area Index (PDAI).
Methods
Fifteen patients with mild‐to‐moderately severe oral PV were scored for disease severity by 10 oral medicine clinicians using the ODSS, the PGA and the oral sections of ABSIS and PDAI. Two clinicians rescored all patients after a minimum 2‐h interval.
Results
Interobserver reliability was assessed using an intraclass correlation coefficient (ICC). For the ODSS total score the ICC was 0·83, for PDAI (oral total activity) 0·79, ABSIS (oral total) 0·71 and PGA 0·7. Intraobserver agreement between initial scoring and rescoring of the same patient by two clinicians demonstrated an ICC for each of 0·97 and 0·96 for ODSS total score; 0·99 and 0·82 for PDAI oral activity; 0·86 and 0·45 for ABSIS total; and 0·99 and 0·64 for PGA. Convergent validity was good, with a correlation coefficient > 0·5 (P < 0·001). The mean ± SD times taken to complete each scoring method were ODSS 76 ± 37 s, PDAI 117 ± 16 s and ABSIS 75 ± 19 s.
Conclusions
This study has validated the ODSS for the assessment of oral PV. It has shown superior inter‐ and intraobserver reliability to PDAI, ABSIS and PGA and is quick to perform.
What's already known about this topic?
Current pemphigus vulgaris (PV) disease activity indices include the recently validated Pemphigus Disease Area Index (PDAI) and the Autoimmune Bullous Skin Disorder Intensity Score.
The Oral Disease Severity Score (ODSS) has been demonstrated to have good inter‐ and intraobserver reliability in both lichen planus (LP) and mucous membrane pemphigoid (MMP).
What does this study add?
The ODSS is shown to be a thorough and sensitive, yet quick assessment tool for oral involvement in PV.
Its versatility for use additionally in MMP and LP is an added advantage over previously validated methods.
What are the clinical implications of this work?
We propose that the ODSS would be a useful supplement for future multicentre studies, as well as for recording sequential disease activity in the clinic.
Linked Comment: Murrell et al. Br J Dermatol 2018; 179:816–817.
Plain language summary available online
Respond to this article
A single-blind randomized controlled clinical trial in patients with deep caries and symptoms of reversible pulpitis compared outcomes from a self-limiting excavation protocol using chemomechanical ...Carisolv gel/operating microscope (self-limiting) versus selective removal to leathery dentin using rotary burs (control). This was followed by pulp protection with mineral trioxide aggregate (MTA) and restoration with glass ionomer cement and resin composite, all in a single visit. The pulp sensibility and periapical health of teeth were assessed after 12 mo, in addition to the differences in bacterial tissue concentration postexcavation. Apical radiolucencies were assessed using cone beam computed tomography/periapical radiographs (CBCT/PAs) taken at baseline 0 mo (M0) and 12 mo (M12). In total, 101 restorations in 86 patients were placed and paired subsurface, and deep (postexcavation) dentin samples were obtained. DNA was extracted and bacteria-specific 16S ribosomal RNA gene quantitative polymerase chain reaction was performed. No significant difference was found in bacterial copy numbers normalized to mass of dentin (“bacterial tissue concentration”) between the self-limiting (96.3% reduction) and control protocols (97.1%, P = 0.33). The probability of 12-mo success was 4 times (odds ratio OR = 4.33; confidence interval CI, 1.2–15.6; P = 0.025) higher in the self-limiting protocol compared to the control (conventional excavation technique), with pulp survival rates of 73.3% and 90%, respectively (P = 0.049). Molars had a 4 times higher probability of success compared to premolars (OR, 4.17; CI, 1.17–14.9; P = 0.028), and symptom severity did not statistically predict outcome (OR, 0.41; CI, 0.12–13.9, P = 0.153). CBCT detected significantly more periapical (PA) lesions than PA radiographs at the baseline visit (P < 0.001). In conclusion, the self-limiting caries excavation protocol under magnification increased pulp survival rate compared to rotary bur excavation (ClinicalTrials.gov NCT03071588).
To identify students' perceptions of barriers to effective study and the relationship between these and demographic characteristics, levels of perceived stress and examination performance.
A ...questionnaire was distributed to first (BDS1) and final year (BDS5) King's College London dental undergraduates, during Spring 2013. Data were collected on students' social and working environment using a Likert scale from zero to four. Levels of perceived stress and end-of-year examination results were collected. Statistical analyses were undertaken using SPSS® and Stata® software.
A response rate of 83.0% (BDS1) and 82.9% (BDS5) was achieved. Social distractions were perceived to hinder study, with median scores of two and three for females and males respectively. The mean perceived stress score differed significantly (p=0.001) between males and females. Difficulties with journey was a significant predictor of perceived stress (p=0.03) as were family responsibilities (p=0.02). Social distractions were significantly related to examination performance (p=0.001).
Social distractions were the barrier most highly rated as hindering effective study. Levels of perceived stress were high and were significantly associated with gender, a difficult journey to university and family responsibilities. Social distractions were significantly related to examination performance; students rating social distractions highly, performed less well.
Background Adults with dental phobia have been reported to have poorer oral health and oral health-related quality of life. The aim of this study is to explore the social and demographic correlates ...of oral health and oral health-related quality of life (OH-QoL) of people with dental phobia compared to the non-phobic population in the United Kingdom using the data from Adult Dental Health Survey (ADHS, 2009).Method Secondary analysis of data from the ADHS, 2009. A series of logistic regression analyses was performed with outcome measures of: presence of decayed teeth; presence of missing teeth; pulp exposure ulceration fistula abscess (PUFA) score; periodontal health indices (plaque, bleeding and loss of attachments); and quality of life (oral health impact profile OHIP14 and oral impacts on daily performance OIDP). Predictors included in the models were: the presence of dental phobia; age; gender; occupational status; oral health-related behaviour; dietary intake of sugars; and perception of their last visit.Results People with dental phobia are more likely to have one or more decayed (caries) teeth/missing teeth. Furthermore, their self-reported oral health-related quality of life (OH-QoL) is poorer. There were no differences in PUFA scores or periodontal disease.Conclusion The impact of dental phobia on oral health appears to operate largely through the increased likelihood of the presence of caries, since there is an increased likelihood of the presence of teeth with active caries and missing teeth when other predictors of disease experience are controlled in the analysis.
Summary
Pemphigus vulgaris (PV) and mucous membrane pemphigoid (MMP) are rare and potentially serious conditions that cause painful blisters or erosions to develop in the mouth, nose, throat, ...oesophagus, genitalia and skin. One of the main complications unique to MMP is that it may scar affected sites, particularly the eyes. Both diseases generally occur in older adults.
To confirm the diagnosis of PV and MMP, a biopsy has traditionally been taken from near the affected area (perilesional). Where only mucosal surfaces are involved, the mouth is the most accessible site, however this can be difficult because the lining of the mouth is fragile.
The aim of this study was to compare outcomes of a biopsy of normal healthy‐looking tissue lining the inner cheek (buccal mucosa) with a perilesional biopsy. The authors, based in the U.K., analysed the biopsy location and results of 251 MMP and 77 PV patients.
They have shown that a biopsy of normal buccal mucosa tissue is as good as a perilesional biopsy for diagnosis of oral PV. For MMP patients with multiple oral surfaces affected, biopsy of normal buccal mucosa was almost equal to taking a perilesional sample for diagnosis. For MMP patients with only the gums affected, neither a perilesional biopsy from the gum nor a normal buccal mucosal biopsy were reliable enough to always confirm the diagnosis. Importantly for this group of patients, the authors have shown that a biopsy from the junction between the lining of the cheek and gum gave a positive result in all cases.
A punch biopsy taken from normal buccal mucosa tissue is a simple and safe practical method for diagnosing all patients with oral PV and all MMP patients, with the exception of those with gum only lesions.
This is a summary of the study: The optimal oral biopsy site for diagnosis of mucous membrane pemphigoid and pemphigus vulgaris
Linked Article: Carey et al. Br J Dermatol 2020; 182:747–753
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