The role of skin tests with polyethylene glycol and polysorbate 80 in the vaccination campaign for COVID-19: results from an Italian multicenter survey.

Summary: Background. International guidelines suggested skin tests with Polyethylene-glycol (PEG) and polysorbate 80 (PS-80), to investigate a possible hypersensitivity to these excipients either to identify subjects at risk of developing allergic reactions to Covid-19 vaccines, or in patients with suspected IgE mediated hypersensitivity reactions (HR) to the Covid-19 vaccine. The main purpose of this study was to investigate the prevalence of PEG and PS sensitization in patients with a clinical history of HR to drugs containing PEG/PS and in patients with a suspected Covid-19 vaccine immediate HR. Methods. This was a multicenter retrospective study conducted by allergists belonging to 20 Italian medical centers. Skin testing was performed in 531 patients with either a clinical history of suspected hypersensitivity reaction (HR) to drugs containing PEG and/or PS-80 (group 1:362 patient) or a suspected HR to Covid-19 vaccines (group 2: 169 patient), as suggested by the AAIITO/SIAAIC guidelines for the "management of patients at risk of allergic reactions to Covid-19 vaccines" [1]. Results. 10/362 (0.02%) had positive skin test to one or both excipients in group 1, 12/169 (7.1%) in group 2 (p less than 0.01). In group 2 HRs to Covid-19 vaccines were immediate in 10/12 of cases and anaphylaxis occurred in 4/12 of patients. Conclusions. The positivity of skin test with PEG and or PS before vaccination is extremely rare and mostly replaceable by an accurate clinical history. Sensitization to PEG and PS has to be investigated in patients with a previous immediate HR to a Covid-19 vaccine, in particular in patients with anaphylaxis.

Pre-clinical evaluation of a new coral-based bone scaffold.

Coral is used worldwide for bone reconstruction. The favorable characteristics that make this material desirable for implantation are (i) osteoinduction, (ii) and osteoconduction. These proprieties have been demonstrated by in vivo studies with animal models and clinical trials over a twenty-year period. Also poly(2-hydroxyethylmethacrylate) [poly(HEMA)] is a widely used biomaterial. By using coral and poly(HEMA), a scaffold for bone reconstruction application has been recently synthesized. Cytological, histological and genetic analyses were performed to characterize this new alloplastic material. Four samples were analyzed: (a) white coral (WC), (b) red coral (RC), (c) WC plus polymer (WCP) and (d) RC plus polymer (RCP). Quantification of mitochondrial dehydrogenase activity by MTT assay was performed as indirect detector of cytotoxicity. In vivo effects were revealed by implanting corals and coral-based polymers in rabbit tibia. Samples were collected after 4 weeks and subjected to histological analysis. To evaluate the genetic response of cells to corals and coral-derived polymers an osteoblastlike cell line (i.e. MG63) was cultured in wells containing (a) medium, (b) medium plus corals and (c) medium plus two types of scaffolds (RCP or WCP). RNAs extracted from cells were retro-transcribed and hybridized on DNA 19.2K microarrays. No cytotoxicity was detected in corals and coral-based biopolymers. No inflammation or adverse effect was revealed by histological examination. By microarray analysis 154 clones were differentially expressed between RC and WC (81 up and 73 down regulated) whereas only 15 clones were repressed by the polymer. Histological evaluation not only confirmed that coral is a biocompatible material, but also that the polymer has no adverse effect. Microarray results were in agreement with cytological and histological analyses and provided further data regarding the genetic effects of RC, WC and the new polymer.

Recurrent squamous cell carcinoma of the lower lip: salvage surgery outcome.

Squamous cell carcinoma (SCC) of the lip is one of the most commonly occurring oral cancers, mainly involving the lower lip. Despite a good prognosis in cases of early detection, survival rates drop dramatically in the presence of recurrence. While there are many studies in the literature regarding the management of primary tumours, the rate of recurrence in lower lip SCC is low and therefore there are few data and articles about them. We retrospectively reviewed patients affected by recurrent SCC of the lower lip treated surgically from 2011 to 2019 in a single centre. Data and results were compared with those in the literature. A total of 16 patients (mean [range] age: 78.1 [62-93] years) were eligible for inclusion. The disease-free survival rate at 2 and 5 years was 29.6% and the overall survival rate at 2 and 5 years was 14.4%. A significantly higher rate of failure and a worse prognosis was observed in patients with neck involvement. The prognosis of recurrent lower lip SCC is unfavourable with extremely low survival rates. This issue is probably linked to the oncological pathology but also to the advanced age of most patients, the presence of several comorbidities and, consequently, the high risk of perioperative mortality. For this reason, the analysis of data sets reported in the literature may help the surgeon in the management of recurrences and selection of patients.

Management of free flap failure in head and neck surgery.

Free flap surgery is overall considered the gold standard in head and neck reconstruction, with a success rate of 95%. The management of a total flap necrosis and which solution, between a pedicled or a second free flap, is safer for a salvage procedure is still controversial. Object of this study is to describe the authors' management of total free flap loss in head and neck reconstruction and compare the choices and results to those reported in the literature. From January 2012 to January 2016, 149 consecutive free flaps were performed at the Maxillo- Facial Operative Unit of the Hospital Casa Sollievo della Sofferenza in San Giovanni Rotondo (Italy) for reconstruction of head and neck defects. Of these, 6 flaps were lost due to a total necrosis. In 5 cases it was decided to harvest a second free flap, and in the remaining patient a temporalis muscle flap was used. All the free salvage flaps were successful, without complications and with a good aesthetic and functional recovery. Analysing the data obtained, and comparing them with those reported in the literature, it can be concluded that a second subsequent free flap can be considered an ideal and safe procedure in salvage surgery.

Intraoperative navigation in complex head and neck resections: indications and limits.

PURPOSE: The surgical removal of head and neck tumors often represents a highly complex surgery. The three-dimensionality and the anatomy of the head and neck area make sometimes difficult a correct intraoperative orientation and the obtaining of an adequate oncological safety. In the present pilot study, the authors propose a protocol of application of intraoperative navigation in the resection of head and neck tumors. The purpose is to develop a methodology that can be helpful to ensure oncologic free margins of resection and to facilitate the orientation of the specimen by pathologists. MATERIALS AND METHODS: A sample of 16 patients with head and neck tumors was selected, and they were differentiated into two groups: a "study group" treated with CT computer-assisted surgery and a "control group" surgically treated without the use of technology. The following data were analyzed: operative and pre-surgical planning times, issues related to the use of the technologies, respect of the planned landmarks, description and orientation of the surgical specimen and distance of the tumor from the margins of resection. RESULTS: In the "study group" were noticed a reduced rate of errors in the specimen orientation and an increased distance of the tumor from the margins of resection. Similar operative times were observed in both groups. CONCLUSIONS: Intraoperative navigation resulted to be a reliable method to improve oncological safety in a selected group of patients.

Endoscopic transnasal approach and intraoperative navigation for the treatment of isolated blowout fractures of the medial orbital wall.

The aim of this study is to describe the reduction of medial orbital wall fractures using a combination of two different techniques: the endoscopic reduction and the navigation aided reconstruction. The endoscopic approach avoids an external incision and allows the observation of the fracture site clearly. Navigation-aided reconstruction is essential to achieve precise and predictable results in orbital reconstruction. It consists in an ideal virtual reconstruction of the target area created using a mirroring tool, and superimposing and comparing the unaffected and the affected sides. This technique opens a broad spectrum of possible surgical approaches, especially in situations in which anatomical landmarks for precise positioning of bone fragments, or bone grafts, are missing. This study is the first to combine these two techniques. The study was carried out in seven patients who underwent endoscopic reduction of isolated blowout fractures of the medial orbital wall and navigation-aided reconstruction at the authors' institution. This pilot study clearly shows that a combination of the endoscopic reduction and the navigation-aided reconstruction provides functional results and great advantages in terms of anatomical preservation and postoperative morbidity.

Relationship between plasma beta 2-microglobulin and residual diuresis in continuous ambulatory peritoneal dialysis and hemodialysis patients.

To evaluate whether the continuous ambulatory peritoneal dialysis (CAPD) technique is able per se to obtain lower beta 2-microglobulin (beta 2M) plasma levels than hemodialysis (HD) or whether other factors, such as residual diuresis, can make a significant contribution, we compared 69 CAPD and 38 cuprophan HD patients, matched for age and dialysis duration. Residual diuresis was 680.3 +/- 531.8 mL/day in CAPD and 285.5 +/- 381.8 mL/day in HD (p < 0.001) subjects. Daily diuresis was > 300 mL/day in 63.8% of CAPD and in 31.6% of HD patients. The beta 2M plasma levels were 26.3 +/- 9.9 mg/L and 34.9 +/- 13.3 mg/L (p < 0.001) in CAPD and HD, respectively. In both groups the difference was significant when we compared the patients with diuresis below versus above 300 mL/day (p < 0.001). Instead, the differences were not significant upon comparing the CAPD and HD patients with the same amount of daily diuresis. The comparison between beta 2M plasma levels and residual diuresis showed a significant inverse correlation in both groups (p < 0.001). We conclude that the dialysis technique itself does not affect beta 2M plasma levels. The diuresis volume may be a very important factor in lowering beta 2M levels in both CAPD and HD patients. CAPD's capacity to maintain a higher diuresis for longer than HD may account for the lower beta 2M plasma levels in CAPD patients.

Ten years of continuous ambulatory peritoneal dialysis: analysis of patient and technique survival.

The patient survival (PS) and technique survival (TS) were evaluated in 1990 patients on continuous ambulatory peritoneal dialysis (CAPD) (males: 55.9%, mean age +/- SD: 58.4 +/- 14.8 years), treated in 30 centers participating in the Italian PD Study Group, from 1980 to 1989 (follow-up: 3953 years; mean +/- SD: 2.02 +/- 1.86 years). The total PS was 50.7% at 4 years, compared to 73.3% of patients without clinical high-risk condition (HRC) at the beginning of CAPD. In this group (34.0%) PS was significantly higher (p < 0.001) compared, respectively, to patients with cardiovascular disease (30.5%), diabetes (13.1%), and age > or = 70 years (11.2%). The percentage of death reached the mean value of 11.3% per year without any statistically significant tendency to variation during the follow-up, despite the increased number of patients > or = 65 years old and those with HRC (p < 0.001). Cardiovascular diseases (47.3%) and cachexia (17.8%) were the most frequent causes of death, whereas the mortality due to peritonitis showed a progressive increase in patients with peritonitis incidence 1 ep/year (G4) compared to those with < 0.5 ep/year (G2). Peritonitis (0.68 ep/year) was the most frequent cause of technique failure (30.0%), with clinical complications (18.2%) and peritoneal membrane failure (16.4%) as the second and third causes. The dropout percentage was 8.3% per year with a significant decrease over time (p = 0.012) and a positive correlation with the reduction of peritonitis incidence (p = 0.035). The total TS was 50.1% at 7 years, and it was significantly worse in G4 compared to G2.(ABSTRACT TRUNCATED AT 250 WORDS)

Longitudinal assessment of body composition in CAPD patients using bioelectric impedance analysis. A comparison with hemodialysis patients.

The utility of bioelectric impedance analysis was assessed for longitudinal evaluation of body composition in two groups of uremic patients, one on CAPD and one on hemodialysis treatment, with no clinical marks of hyperhydration or infection. Nineteen CAPD patients (11 men 8 women) and 21 HD patients (12 men 9 women) were studied with bioelectric impedance analysis for a period of 12 months; total body water, fat free mass, and fat mass were calculated from bioelectric impedance analysis data of resistance and reactance at time 0 and 12 months later. No significant differences in body composition were found in the two groups at time 0 and 12 months later, with a similar trend for total body water, fat free mass, and fat mass. In CAPD, a significant increase in body weight was observed due mainly to a rise in fat mass, particularly evident in women with uremia. Bioelectric impedance analysis appears to be an instrument easily repeatable and reliable in CAPD and HD patients, reflecting at the same time body composition, the dialytic adequacy of a technique, and the patient's well being.

Mirror speaking after neurosurgery. A case history.

The case is reported of a 23 year old patient, who at the age of nine underwent neurosurgery for an angiomatous meningioma of the right temporal lobe, and immediately afterwards realized he was able to speak backwards nearly as well as normally. Presently, the patient still retains this ability which is associated with analogous mirror reading and writing. Neurological examination and EEG, CT data as well as the scores of some neuropsychological tests are added.

Well being in patients on CAPD and hemodialysis.

In the present multicenter study, 120 pts who had been treated by both hemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) for at least 6 months each, were invited to answer questions on 34 matters, to compare symptoms and their well-being while on the two treatments. Patients were invited to choose HD or CAPD and indicate the reasons for their choice. For 28 patients the first treatment was HD and for 92 CAPD. The mean time between the change of therapy and the study was 46 +/- 35 months. Their final choices were found to be strictly related to the present treatment (p < 0.001). The reasons for choice of CAPD were: more free time (21%), more freedom (67%), better well-being (44%), less worry (5%); for HD they were: more free time (53%), better well-being (39%), less worry (13%), no need for a peritoneal catheter and fewer clinical complications (19%). The catheter was considered more cumbersome than the A.V. fistula, the time involved was considered to be shorter on HD by 52 patients and on CAPD by 39, thirst and cramps were considered to be more frequent and severe on CAPD by half of the patients. The prevalence and severity of problems and symptoms and choice of treatment were not related to sex, job, education or age.

The acid-base balance and the electroencephalographic pattern in patients on biofiltration treatment.

Electroencephalogram (EEG) monitoring and arterial blood gases was performed during biofiltration (BF) treatment and during conventional acetate hemodialysis (HDA). Biofiltration is an ultrashort hemodiafiltration with 3 liters of substitution fluid (Na+ 145 mEq/l, HCO-3 100 mEq/l). Our data show a better correction of acid-base balance during BF than during HDA. Moreover, we observe a lower incidence of EEG disturbancies on BF, that suggests a better neurological tolerance of this treatment.

Peritoneal equilibration curve for beta-2-microglobulin (B2M) in CAPD patients.

To evaluate B2M removal during CAPD, the equilibration curve was determined in 9 CAPD patients (aged 67.9 +/- 6.5 years, treated for 19.0 +/- 17.4 months). The study was carried out on 2 consecutive days using 1.36% (day 1) and 3.86% (day 2) dextrose dialysis solutions for 6 hours each day. The B2M plasma value was the mean of 4 samples taken at the start and after 2, 4 and 6 hours. Dialysate values were determined on 3 ml samples taken every 30 minutes. The curve was fitted for dialysate to plasma B2M ratio (D/P) versus time to define the B2M equilibration curve. Our results showed that the value had a linear regression with both types of solution in all patients. The D/P B2M ratio was linear during the 6 hours of dwell time. Furthermore, there was no significant difference between the 2 solutions used. In conclusion, standard CAPD allows a low but constant B2M removal. An increase or a reduction in dwell time do not seem to have any influence on the B2M removal, which could be improved by methods other than varying dwell time and/or solution osmolarity.

Dialysis-related amyloidosis in a large CAPD population.

We studied 212 patients from 13 Italian dialysis centers to evaluate the clinical aspects of dialysis-related amyloidosis in continuous ambulatory peritoneal dialysis (CAPD). The mean age was 64.2 +/- 12.3 years and mean time on dialysis was 36.9 +/- 25.1 months. Residual diuresis was 615.7 +/- 554.0 mL/day and plasma beta 2-microglobulin (beta 2M) level was 27.0 +/- 12.8 mg/L. Radiological skeletal examination, neurological problems related to beta 2M, and urinary and dialytic balance of beta 2M were evaluated. Correlations between age, time on dialysis, residual diuresis, beta 2M plasma levels, beta 2M peritoneal and renal removal, carpal tunnel syndrome, and bone disease were studied. Only the number of bone lesions had a significant positive correlation with patient age and negative correlation with residual diuresis. The latter had an inverse relation with beta 2M plasma levels. Dialytic age did not correlate with any of the parameters. No other correlation was observed. Hand lesions were found in 85% of patients with bone dialysis-related amyloidosis. In conclusion, residual diuresis in our patients played a positive role in the number of bone localizations. Only age, but not time on dialysis, had a positive impact on the bone lesions. The high percentage of hand lesions suggests that the observation of this skeletal segment is a simple, safe, and effective modality of bone follow-up for dialysis-related amyloidosis.

Comparison of survival in CAPD and hemodialysis: a multicenter study.

We studied 1,622 patients who started regular dialysis treatment between 1985 and 1989 in 19 centers from the Italian CAPD Study Group. There were 962 pts (59%) and on HD; 660 pts (41%) on CAPD. CAPD pts were older and had more risk factors at the start than HD pts (p < 0.0001). Overall patient survival was not statistically different between CAPD and HD at 6 years (42% CAPD; 54% HD). Multivariate analysis (Cox's model) on all population revealed that age and pretreatment risk factors had a statistically significant impact on patient survival (p < 0.0001), but not the type of dialytic treatment (CAPD or HD). When multivariate analysis was applied separately by treatment modalities, in HD group age and risk factors had the same negative influence on survival (p < 0.0001) while in CAPD group the influence of age on survival was less significant (p 0.025). This multicenter study carried out with appropriate statistical methods in a large number of pts demonstrates that patients' survival at 6 years is not different on CAPD and HD (despite the worse patient selection on CAPD) and can be even better on CAPD for aged patients.

The impact of peritonitis on CAPD results.

The impact of peritonitis on CAPD results was evaluated in 1990 pts (mean age +/- SD:58.4 +/- 14.8 yrs, 55.9% males), treated in 30 centres participating in Italian PD Study Group, during 1980-89, with an overall observation period of 3953 years (mean +/- SD 24.1 +/- 22.3 months). The incidence of peritonitis decreases from 1.21 (1980-84) to 0.48 (1985-89) ep/year (overall:0.68) with a significant (P < 0.001) reduction of the probability of developing the first peritonitis episode (FPE) through the same periods. The probability of developing FPE and the relative risk of peritonitis were significantly lower (P < 0.001) in pts for whom CAPD has been the first treatment (80.1%); on the contrary these parameters did not gain significant difference according to sex, age 65 years, diabetes or cardiovascular disease. As far as the organisms responsible for peritonitis are concerned a significant reduction of S. epid. and an increase of S. aureus, other Gram pos. and Pseudomonas was observed in the second 5-yr periods. Peritonitis episodes caused catheter removal in 8.2% of cases and were associated with catheter infection in 10.8% of cases. Peritonitis accounted for 24.2% of hospitalization causes and for 6.7% and 30.0% of death and of drop-out respectively. The probability of death and drop-out was significantly high (p < 0.001) in pts with a peritonitis incidence > 1 ep/year than in those with < 0.5 ep/year. The probability of drop-out due to peritonitis was not higher in diabetic or older patients.

[The physician and drug dependence in Italy today. (Introduction to a round table)]. / Il medico e la tossicodipendenza, oggi, in Italia. (Introduzion alla tavola rotonda).

The today situation of the Italian physician in the fight against drug addictions is outlined. Since the medical approach to this problem is not exhaustive, and on the basis of biological aspects more clinical-therapeutic knowledge of the withdrawal syndrome is required.

[Acupuncture and adrenergic mechanisms of the autonomous nervous system]. / Agopuntura e meccanismi adrenergici del sistema nervoso autonomo.

A review of current knowledge about the involvement of peripheral adrenergic mechanisms in the action of acupuncture is presented. Apart from its undeniable effects on these mechanisms, acupuncture seems to operate in two different ways: indirect stimulation due to an aspecific response to the stress of the acupuncture and direct stimulation or depression, mainly of noradrenaline increase according to the placing of the needles and the condition being treated. During electroacupuncture anesthesia the inhibition of peripheral adrenergic mechanisms is proportional to the effectiveness of the induction.

[Acupuncture and dopamine]. / Agopuntura e dopamina.

A review of present knowledge on the connection between acupuncture and dopamine is presented. It is pointed out that clinical studies on the use of acupuncture in diseases where there is a known imbalance in the cerebral dopaminergic mechanisms almost completely ignore this connection. Similarly studies on the role of dopamine in electroacupuncture analgesia have so far produced conflicting results.

[Psychological dependence? A possible different formulation of the problem for a therapeutic rearrangement in chronic drug addictions]. / Dipendenza psichica? Una possibile diversa formulazione del problema al fine di un riordinamento terapeutico nelle tossicomanie croniche.

Disputing the concept of "psychic dependence", the Authors review six motivations to use addictive drugs, four of which pertain to the moment to assume the habit, although the latter two, which are identifiable with physical and psychic dependence, depend on te breaking the habit. While physical dependence is linked to withdrawal syndrome, psychic dependence, on the Author's opinion, is related to a long-standing previous state of true or masked endogenous depression (in this case it would be well termed as "neuropsychological dependence"), and the drug taking is only a maladaptive self-medication. This thesis is substantiated by the literature, reporting, in chronic drug addicts the use of the whole series of antidepressants (i.e. tricyclics, doxepine, lithium, etc.), with noticeable therapeutical success. According with other reports and with personal experience, the Authors maintain a great importance to drugs acting, directly or not, on GABA, i.e. l-glutamine, piracetam, and, particularly, N-dipropilacetic acid.