Multicentre clinical evaluation of the new highly sensitive Elecsys® thyroglobulin II assay in patients with differentiated thyroid carcinoma.

OBJECTIVE: A highly sensitive thyroglobulin assay (Elecsys® Tg II, Roche Diagnostics, Penzberg, Germany) has become available for monitoring patients with differentiated thyroid cancer (DTC). Here, we evaluated the clinical performance of Elecsys® Tg II assay in a multicentre patients series and compare it with the established Access® Tg assay (Beckman Coulter, Brea, CA, USA). DESIGN: Retrospective analysis on prospectively selected patients in four thyroid cancer referral centres with uniform DTC management. PARTICIPANTS: All DTC cases diagnosed, treated and followed up in four tertiary referral centres for thyroid cancer since January 2005 (n = 1456) were retrieved, and predefined selection criteria were applied to prevent relevant enrolment biases. A series of 204 patients was finally selected for this study. MEASUREMENTS: Samples had been stored at -80°C. Tg was measured by fully automated immunometric Elecsys® Tg II and Access® Tg assays in a centralized laboratory. RESULTS: Two hundred and four DTC were finally included. Of these, 10.8% had structural recurrence (sREC), and 81.4% showed no evidence of disease (NED) at the end of follow-up. There was a significant analytical bias between methods that cannot be used interchangeably. Using ROC curve analysis, the best basal and rhTSH-stimulated Tg cut-offs to detect sREC were 0.41 µg/L and 1.82 µg/L for Elecsys® and 0.36 µg/L and 1.62 µg/L for Access® assay, respectively. Using Cox proportional hazard regression, Tg was the only independent predictor of cancer relapse. CONCLUSIONS: Using appropriate assay-specific cut-offs, the clinical performance of the Elecsys® Tg II assay was comparable to that provided by the well-established Access® Tg assay.

Role of serum cytokeratin 19 fragment (Cyfra 21.1) as a prognostic biomarker in patients with differentiated thyroid cancer.

Differentiated thyroid cancers (DTC) account for up to 85% of thyroid cancers and generally display an excellent prognosis. However, in a minority of cases, DTC progress toward less differentiated phenotypes leading to distant metastases and even disease-related deaths. Circulating biomarkers are warranted to complement the gold standard DTC marker thyroglobulin (Tg) in identifying and monitoring such cases. We measured serum Tg and Cyfra 21.1 6 to 12 months after primary treatment in 473 DTC patients. A complete response of Tg was related to an excellent outcome in all cases. Among patients with incomplete Tg response Cyfra 21.1 levels <2.07 ng/mL were associated to favorable outcome while higher levels greatly increased the risk of disease related recurrences and deaths. Both markers retained independent prognostic values in multivariate analysis. In conclusion, Cyfra 21.1 is a tool available to independently predict survival of DTC patients not achieving excellent response after primary treatment.

High-sensitive basal serum thyroglobulin 6-12 months after thyroid ablation is strongly associated with early response to therapy and event-free survival in patients with low-to-intermediate risk differentiated thyroid carcinomas.

OBJECTIVE: High-sensitive thyroglobulin assays (hsTg) has decreased the need for stimulated Tg measurements in patients with differentiated thyroid carcinoma (DTC). However, multiple assays analyzing the same samples may report different values. Accordingly, appropriate assay-specific cut-off levels should be selected in representative patient series. Here, we evaluate the role of a new hsTg assay in low-to-intermediate risk DTC patients and select appropriate assay-specific clinical cut-off limits. DESIGN: This was a retrospective study. The response to treatment was assessed according to ATA. METHODS: Patients with low-to-intermediate risk DTC treated and regularly followed-up in our thyroid center. Tg was measured on the Kryptor Compact Plus Instrument (BRAHMS Thermo Fisher Scientific). RESULTS: The study series comprised 201 DTC patients and excellent response (ER) was demonstrated in 184 (91.5%). Optimized threshold of basal Tg (onT4-Tg) measured 6-12 months after initial treatment was set by ROC curves analysis at 0.28 ng/mL. Having onT4-Tg <0.28 ng/mL at 6-12 months after treatment was associated with longer disease-free survival of Kaplan-Meier (P < 0.001), ER at early follow-up (odds ratio (OR): 165, P < 0.001) and absence of relapse during follow-up (OR: 328, P = 0.0001). CONCLUSIONS: Patients with low- and intermediate-risk DTC could be considered cured when they have onT4-Tg levels <0.28 ng/mL coupled with negative imaging at their first post-ablation visit.

[Bacterial biofilm identification in the rhinopharingeal mucosa of children with recurrent infection of the upper respiratory tract and otitis media]. / Identificazione di biofilm batterici nella mucosa rinofaringea di bambini affetti da infezioni ricorrenti delle vie aeree superiori associate ad otite media.

OBJECTIVE: The objective of the present study was to identify bacterial biofilms in tissue samples obtained from paediatric patients undergoing surgical treatment, for recurrent upper airway infections, frequently associated to effusive otitis media, unresponsive to repeated cycles of selective medical antibiotic and anti-inflammatory therapy and assay the ability of Haemophilus influenzae strains, most frequently identified in our cultural examinations, to grow as biofilm in vitro. METHODS: We examined 18 surgical specimens (18 adenoids) from the upper respiratory tract, obtained from 18 paediatric patients. Tissues were cultured using conventional methods and subjected to scanning electron microscopy for detection of biofilm. Haemophilus influenzae strains, were cultured on 96-sterile well polystyrene microtiter plates (CELLSTAR-greiner bio-one) and stained with 1% crystal violet to quantify biofilm production. RESULTS: Bacterial cocci attached to the tissue surface and organized in colonies, with a morphology consistent with bacterial coccoid biofilms, were observed in all adenoid (18/18) samples. Haemophilus influenzae isolates from 11/18 (61.1%) of our tissue samples scored a percentual transmittance (%Tbloc) > 50, identifying a high capacity to form biofilms (level 4). CONCLUSIONS: Bacterial biofilms identified in adenoid tissue of paediatric patients with recurrent upper airway inflammatory processes, associated to chronic effusive otitis media, may represent a bacterial "reservoir" responsible of the maintenance of chronic inflammatory mucosal reactions, resistant to selective antibiotic therapy and requiring surgical treatment.

Biofilm formation by Haemophilus influenzae isolated from adeno-tonsil tissue samples, and its role in recurrent adenotonsillitis.

Aim of the present study was to identify bacterial biofilms in tissue samples obtained from paediatric patients undergoing surgical treatment, for chronic and recurrent adeno-tonsillitis, not responding to repeated cycles of selective medical antibiotic and anti-inflammatory treatment and to assay the ability of Haemophilus influenzae strains, most frequently identified in the culture examinations, to grow as biofilm in vitro. Overall, 25 surgical specimens (15 adenoids, 10 tonsils) were examined from the upper respiratory tract, from 15 paediatric patients (mean age 6 years). All patients were affected by recurrent and/or chronic adenoiditis and adenotonsillitis unresponsive to selective antibiotic and anti-inflammatory therapy. Tissues were cultured using conventional methods and subjected to scanning electron microscopy for detection of biofilm. Haemophilus influenzae strains, were cultured on 96-sterile well polystyrene microtitre plates (CELLSTAR-greiner bio-one) and stained with 1% crystal violet to quantify biofilm production. Bacterial cocci attached to the tissue surface and organized in colonies, with a morphology consistent with bacterial coccoid biofilms, were observed in all adenoid (15/15) and in 6/10 tonsil samples. Haemophilus influenzae isolates from 12/25 (48%) of our tissue samples scored a percent transmittance (%T(bloc)) > 50, displaying a high capacity to form biofilms (level 4). In conclusion identification of bacterial biofilms in chronic and/or recurrent paediatric upper airway inflammatory processes and the capacity to produce biofilm in vitro, demonstrated by Haemophilus influenzae (the most frequently identified bacteria in our samples), could be related to the aetiopathogenic role of biofilms in chronic inflammatory mucosal reactions and to the resistance of these infections to selective antibiotic therapy.

Recurrent upper airway infections and bacterial biofilms.

BACKGROUND: Bacterial biofilms identified in various medical devices used in otorhinolaryngology, including tympanostomy tubes, voice prostheses, and cochlear implants, can directly colonise mucosal tissues. The upper airways seem to be at high risk for this type of colonisation. Chronic and/or recurrent upper airway infections may be related to the complex structural and biochemical (quorum sensing) organisation of the biofilm which interferes with the activity of antibiotics (including those with proven in vitro efficacy), thus promoting the establishment of a chronic infection eradicable only by surgical treatment. Biofilm formation plays a role in upper respiratory infections: it not only explains the resistance of these infections to antibiotic therapy but it also represents an important element that contributes to the maintenance of a chronic inflammatory reaction. OBJECTIVES: To document the presence of biofilms in surgical tissue specimens from patients with recurrent infection diseases, and identify their possible role in the chronicity of these infectious processes. METHOD: We examined 32 surgical specimens from the upper respiratory tract (tonsils, adenoids, mucosa from the ethmoid and maxillary sinuses) of 28 patients (20 adults, eight children) with upper airway infections that had persisted despite repeated treatment with anti-inflammatory agents and antibiotics with demonstrated in vitro efficacy. Tissues were cultured using conventional methods and subjected to scanning electron microscopy for detection of biofilm formation. RESULTS: Over 80 per cent (26/32; 81.3 per cent) of the tissue specimens were culture-positive. Bacterial biofilms (associated in most cases with coccoid bacteria) were observed in 65.6 per cent of the tissue samples.

Nasal application of immunotherapy.

BACKGROUND: In patients with allergic rhinitis local nasal immunotherapy (LNIT) appears to offer considerable advantages over other hyposensitization methods. The aim of our study was to obtain further confirmation of the validity of LNIT. METHODS: A randomized, double-blind, placebo-controlled study of LNIT in patients allergic to Parietaria and Dermathophagoides was performed. Patients were evaluated, before and after treatment, with symptom and medication scores, specific nasal provocation tests, anterior rhinomanometry and mucociliary clearance time. RESULTS: Compared to placebo the clinical efficacy of LNIT was confirmed by a reduction of clinical symptoms and drug intake. In the active group the reduction of allergen-specific nasal reactivity was significant. No local or systemic side effects were observed. CONCLUSIONS: The clinical efficacy of LNIT suggests that this therapy is effective in the prophylaxis of allergic rhinitis. Finally, there is no conflict between LNIT and drug treatment.

CO2 laser treatment of bilateral vocal cord paralysis in adduction.

This study presents results obtained from 83 patients with bilateral vocal cord paralysis in adduction treated between 1982 to 2001, with CO(2) laser microlaryngoscopy. In relation to the different types of surgery followed, three distinct treatment groups were included: group 1 (1982-1984) included 5 patients treated with vaporization of the vocal process of the arytenoid and the homolateral posterior third of the true vocal cord. Group 2 (1983-1990) contained 19 patients who were treated with arytenoidectomy and removal of the homolateral posterior half of the true vocal cord and group 3 (1990-2001), including 59 patients who were treated with arytenoidectomy and removal of the homolateral posterior half or two thirds of both the true and false vocal cord. Functional results were assessed by means of spirometry, spectrography and aerophonic examinations performed at 5, 90, 180, and 240 days postoperatively. The results show that removal of the posterior third of the true vocal cord and false vocal cord, combined with arytenoidectomy, is the surgical treatment of choice to resolve respiratory insufficiency in these patients.

Personality, hypnotic susceptibility and EEG responses: preliminary study.

22 men and women, students in psychology, were given the Eysenck Personality Questionnaire, also percent theta, alpha and beta EEG spectral powers were evaluated during an hypnotic induction induced according to Barber's method. The EEG performance was compared with two baseline eyes-open, eyes-closed conditions and with a neutral control situation of listening to a weather report. No relation was found between Extraversion-Introversion scores and scores on the Barber Suggestibility Scale. The difference in EEG powers was nonsignificant for groups high and low in suggestibility, while a significant interaction was found for eyes open or closed X suggestibility groups when extreme scores of Extraversion-Introversion and Neuroticism were considered according to Eysenck's (1966) method. The right theta power of the stable extraverts and neurotic introverts, high in susceptibility in eyes-open condition was higher than the neurotic extraverts, and stable introverts who were low in susceptibility to hypnosis. The right theta power of the neurotic extraverts and stable introverts who were low in susceptibility to hypnosis showed a tendency to increase in eyes-closed conditions, while an opposite observation was made for the stable extraverts and neurotic introverts, subjects who were high in susceptibility. It is interesting to notice, according to Galbraith, et al. (1970) that it was the eyes-open condition which yielded the best EEG predictor of hypnotic susceptibility.