SARS-CoV-2 infection in patients with autoimmune rheumatic diseases in northeast Italy: A cross-sectional study on 916 patients.

BACKGROUND: Whether patients with autoimmune rheumatic diseases (ARD) have a higher risk for SARS-CoV-2 infection (COVID-19) and how SARS-CoV-2 pandemic impacts on adherence to therapy has not been fully elucidated. We assessed the rate and clinical presentation of COVID-19, and adherence to therapy in a large cohort of patients with ARD followed-up in a tertiary University-Hospital in Northeast Italy. METHODS: Between April 9th and April 25th, 2020, after SARS-CoV-2 infection peak, a telephone survey investigating the impact of COVID-19 on patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), rheumatoid arthritis (RA), ANCA-associated vasculitis (AAV), and idiopathic inflammatory myopathies (IIM) was administered. Demographics, disease activity status, therapy, occupational exposure, and adherence to social distancing advise were also collected. RESULTS: 916 patients (397 SLE, 182 AAV, 176 SSc, 111 RA, 50 IIM) completed the survey. 148 patients developed at least one symptom compatible with COVID-19 (cough 96, sore throat 64, fever 64, arthromyalgias 59, diarrhea 26, conjunctivitis 18, ageusia/hyposmia, 18). Among the 916 patients, 65 (7.1%) underwent SARS-CoV-2 nasopharyngeal swab (18 symptomatic and 47 asymptomatic), 2 (0.21%) tested positive, a proportion similar to that observed in the general population of the Veneto region. No deaths occurred. 31 patients (3.4%) withdrew ≥1 medication, mainly immunosuppressants or biologics. Adoption of social distancing was observed by 860 patients (93.9%), including 335 (36.6%) who adopted it before official lockdown. CONCLUSIONS: COVID-19 incidence seems to be similar in our cohort compared to the general population. Adherence to therapy and to social distancing advise was high.

Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in insulin-naïve type 2 diabetes: Design and population.

BACKGROUND AND AIMS: Fostering patient's self-managing of basal insulin therapy could improve glucose control, by removing patient's and physician's barriers to basal insulin initiation, titration and glucose monitoring. The Italian Titration Approaches Study (ITAS) aims at demonstrating non-inferiority (<0.3% margin) in efficacy of glucose control (change in glycated hemoglobin [HbA1c] after 24 weeks) by the same titration algorithm of insulin glargine 300 U/mL (Gla-300), managed by the (nurse assisted) patient versus the physician, in insulin naïve patients with Type 2 Diabetes Mellitus (T2DM), uncontrolled with previous treatments. METHODS AND RESULTS: ITAS is a phase IV, 24-week, national, multicenter, open label, randomized (1:1) parallel group study. 458 patients were enrolled, 359 randomized, and 339 completed the study, in 46 Italian centers. Baseline characteristics and previous medications of the ITT population (N = 355) are reported. Mean ± SD age, T2DM duration, HbA1c, FPG and BMI were 64.0 ± 9.8 years, 11.6 ± 7.6 years, 8.79 ± 0.65%, 170.9 ± 42.3 mg/dL, and 30.3 ± 5.6 kg/m2, respectively. Vascular and metabolic disorders were most frequent (73.8% and 58.3%, respectively). More than 90% of patients were on metformin. CONCLUSION: ITAS is the first study to compare two different managers (nurse-assisted patient vs physician) of the same titration algorithm of Gla-300 in insulin naïve patients with T2DM in unsatisfactory glucose control. This study might provide novel evidence on the efficacy/effectiveness of patient-managed titration algorithm of Gla-300 in a pragmatic setting and may reduce barriers to basal insulin initiation and its titration.

Diagnostic and prognostic role of renal histopathology in rheumatic diseases.

The objective was to evaluate renal involvement in several rheumatic diseases (i.e. rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, systemic sclerosis, systemic vasculitides). The method chosen was to define histopathological profiles reported in renal biopsies performed on patients with renal involvement due to different rheumatic diseases. Renal involvement observed in patients with rheumatic disease can be the direct result of the disease per se and/or a complication of drugs used in the disease treatment. The clinical-pathological correlations derived from the study of renal tissues can be useful for differential diagnosis, prognosis assessment and therapeutic decisions. Renal biopsy should be considered as an important tool for the management of nephropathies in patients with systemic rheumatic diseases.

Generalized annular granuloma associated with crowned dens syndrome, which resolved with colchicine treatment.

Granuloma annulare (GA) is a chronic, benign, and usually self-limiting cutaneous inflammatory disease, typically characterized by small, localized, skin-coloured papules that are usually asymptomatic or mildly pruriginous. Its aetiopathogenesis is still unknown and treatments are rarely effective. Generally, 50-70% of localized GA cases are self-limiting and show spontaneous resolution after 1-2 years, whereas disseminated GA is less likely to disappear without treatment. Treatment of generalized GA is usually based on single case reports, and only a few studies involving large case series have been published. We present the case of a patient affected by generalized GA, which resolved after colchicine treatment used for concomitant crowned dens syndrome due to calcium pyrophosphate deposition disease (CPPD). Colchicine may have worked by a direct action on GA or, alternatively, by controlling CPPD, as a possible trigger. As the low-dosage colchicine treatment was well tolerated by our patient, this could be easily used in the management of GA. However, further studies are needed to confirm the action of colchicine on GA.

Bilateral Warthin tumor in psoriatic patients in therapy with multiple immunosuppressive therapy.

Anti-TNFα drugs have strongly changed the way in which we deal with moderate and severe psoriasis. However, it is debatable whether biological drugs could increase the risk of developing cancer. The correlation between anti-TNFα drugs and lymphomas is well-known and is reported in all the technical details of biologic drugs. However, the association between anti-TNFα agents and solid tumors is still controversial. The authors report a case of bilateral salivary gland tumor in a psoriatic patient treated with several immunosuppressive therapies including anti-TNFα inhibitors.

Comparative evaluation of synergy of combinations of beta-lactams with fluoroquinolones or a macrolide in Streptococcus pneumoniae.

OBJECTIVES: Streptococcus pneumoniae has shown a great ability to develop efficacious mechanisms of resistance to the main drugs for the treatment of pneumonia, such as ß-lactams, macrolides and fluoroquinolones. The present study aimed to compare the antipneumococcal activity of combinations of respiratory fluoroquinolones with cephalosporins (either parenteral or oral) or protected penicillin versus the standard combinations (i.e. a macrolide with a protected penicillin or cephalosporin) against 100 isolates with different susceptibilities to macrolides and/or penicillin. METHODS: Chequerboard assays for all isolates and time-kill curves for nine isolates with different patterns of susceptibility were performed. Synergy between antibiotics at serum peak concentrations was also determined. RESULTS: The combination of levofloxacin with ceftriaxone produced the highest rate of synergy (54/100), mainly against macrolide-resistant strains (22/30). Antagonism was not observed for any tested combination apart from clarithromycin with amoxicillin/clavulanic acid (22/100 isolates). Although the killing activities of all antibiotics improved when they were tested in combination, synergy was observed only for some combinations after 12 and/or 24 h. Serum concentrations were effective in inhibiting the growth of the tested strains. CONCLUSIONS: Combinations of levofloxacin with parenteral cephalosporins were the most active among all the tested combinations, while antagonism occurred when clarithromycin and amoxicillin/clavulanic acid were tested.

Similar glycaemic control and risk of hypoglycaemia with patient- versus physician-managed titration of insulin glargine 300 U/mL across subgroups of patients with T2DM: a post hoc analysis of ITAS.

AIMS: The Italian Titration Approach Study (ITAS) demonstrated comparable HbA1c reductions and similarly low hypoglycaemia risk at 6 months in poorly controlled, insulin-naïve adults with T2DM who initiated self- or physician-titrated insulin glargine 300 U/mL (Gla-300) in the absence of sulphonylurea/glinide. The association of patient characteristics with glycaemic and hypoglycaemic outcomes was assessed. METHODS: This post hoc analysis investigated whether baseline patient characteristics and previous antihyperglycaemic drugs were associated with HbA1c change and hypoglycaemia risk in patient- versus physician-managed Gla-300 titration. RESULTS: HbA1c change, incidence of hypoglycaemia (any type) and nocturnal rates were comparable between patient- and physician-managed arms in all subgroups. Hypoglycaemia rates across subgroups (0.03 to 3.52 events per patient-year) were generally as low as observed in the full ITAS population. Small increases in rates of 00:00-pre-breakfast and anytime hypoglycaemia were observed in the ≤ 10-year diabetes duration subgroup in the patient- versus physician-managed arm (heterogeneity of effect; p < 0.05). CONCLUSIONS: Comparably fair glycaemic control and similarly low hypoglycaemia risk were achieved in almost all patient subgroups with patient- versus physician-led Gla-300 titration. These results reinforce efficacy and safety of Gla-300 self-titration across a range of phenotypes of insulin-naïve people with T2DM. CLINICAL TRIAL REGISTRATION: EudraCT 2015-001167-39.

Specific immunotherapy for allergic rhinitis in Italy: the patients points of view.

Specific immunotherapy (SIT) is the unique causal treatment for allergy, but its use is quite limited. A perspective, cross-sectional telephone interview survey was carried out in Italy to evaluate the characteristics of 500 patients with allergic rhinitis (250 of whom treated with SIT). Relevant differences were found concerning therapeutic management of allergic rhinitis, mainly regarding the use of drugs and co-morbidities. The allergist is the most important consultant who prescribes SIT. This study therefore provides evidence that the course of allergic rhinitis may depend on the therapy prescribed by and the level of allergy awareness of the physician.

Specific immunotherapy for allergic rhinitis in Italy: the doctors points of view.

Specific immunotherapy (SIT) is the unique causal treatment for allergy, but its prescription is quite restricted. A perspective and cross-sectional survey based on telephone interviews was carried out in Italy to evaluate the profile of doctors prescribing SIT for allergic rhinitis. A total of 540 doctors were interviewed, 200 of whom are GPs, 60 allergists, 60 ENT specialists, 100 familial paediatricians, 60 hospital paediatricians and 60 pulmonologists. Significant differences concern diagnostic and therapeutic management of allergic rhinitis, mainly regarding SIT prescription. The allergist is the most important consultant who prescribes SIT, as opposed to the paediatrician. This study therefore provides the evidence that doctors behaviour towards SIT depends on the type of graduate studies.

Doctors' and patients' educational levels affect immunotherapy prescription.

Cultural level appears to be a critical factor in the decision process of allergen-specific immunotherapy (SIT) both for doctors and patients. Thus, appropriate educational programs should be carried out to increase the number of allergic patients to be treated with SIT.

Early experience with in situ saphenous vein bypass for distal arterial reconstruction.

During a 36-month period 74 patients underwent infrainguinal in situ saphenous vein bypass to the popliteal or tibial vessels. The first 54 operations were performed with standard valvulotomes and valve-cutting scissors, while in the last 20 operations a new intraluminal valve-cutting device was used to incise the valves. Ninety-four percent of bypasses were performed for limb salvage, 80% of all operations were done to the tibial vessels, and 31% of bypasses were done to the ankle vessels. The operation was attempted in 81 patients and completed in 74 patients, for a vein utilization rate of 91%. Fifty-five percent of all veins had a distal diameter of less than 4 mm (average 3.6 mm). The patency rates were 92% at 3 months and 90% at 12 and 36 months for all grafts. There were six failed grafts, all within the first 6 months, and eight diabetic patients required reoperation, two for missed valve leaflets, and three needed revision of the distal anastomosis; however, all these grafts were patent at the time of reexploration. There were four perioperative deaths and two patients had nonfatal postoperative myocardial infarctions. This study demonstrates that in situ saphenous vein grafting provides for a high vein utilization rate and suggests that the technique provides for higher graft patency and limb salvage rates than do more traditional types of procedures.

Use of computer-based records, completeness of documentation, and appropriateness of documented clinical decisions.

OBJECTIVE: To investigate whether using a computer-based patient record (CPR) affects the completeness of documentation and appropriateness of documented clinical decisions. DESIGN: A blinded expert panel of four experienced internists evaluated 50 progress notes of patients who had chronic diseases and whose physicians used either a CPR or a traditional paper record. MEASUREMENTS: Completeness of problem and medication lists in progress notes, allergies noted in the entire record, consideration of relevant patient factors in the progress note's diagnostic and treatment plans, and appropriateness of documented clinical decisions. RESULTS: The expert reviewers rated the problem lists and medication lists in the CPR progress notes as more complete (1.79/2.00 vs 0.93/2.00, P < 0.001, and 1.75/2.00 vs. 0.91/2.00, P < 0.001, respectively) than those in the paper record. The allergy lists in both records were similar. Providers using a CPR documented consideration of more relevant patient factors when making their decisions (1.53/2.00 vs. 1.07/2.00, P < 0.001), and documented more appropriate clinical decisions (3.63/5.00 vs. 2.50/5.00, P < 0.001), compared with providers who used traditional paper records. CONCLUSIONS: Physicians in our study who used a CPR produced more complete documentation and documented more appropriate clinical decisions, as judged by an expert review panel. Because the physicians who used the CPR in our study volunteered to do so, further study is warranted to test whether the same conclusions would apply to all CPR users and whether the improvement in documentation leads to better clinical outcomes.

Measuring the effects of reminders for outpatient influenza immunizations at the point of clinical opportunity.

OBJECTIVE: To evaluate the influence of computer-based reminders about influenza vaccination on the behavior of individual clinicians at each clinical opportunity. DESIGN: The authors conducted a prospective study of clinicians' influenza vaccination behavior over four years. Approximately one half of the clinicians in an internal medicine clinic used a computer-based patient record system (CPR users) that generated computer-based reminders. The other clinicians used traditional paper records (PR users). MEASUREMENTS: Each nonacute visit by a patient eligible for an influenza vaccination was considered an opportunity for intervention. Patients who had contraindications for vaccination were excluded. Compliance with the guideline was defined as documentation that a clinician ordered the vaccine, counseled the patient about the vaccine, offered the vaccine to a patient who declined it, or verified that the patient had received the vaccine elsewhere. The authors calculated the proportion of opportunities on which each clinician documented action in the CPR and PR user groups. RESULTS: The CPR and PR user groups had different baseline compliance rates (40.1 and 27.9 per cent, respectively; P<0.05). Both rates remained stable during a two-year baseline period (P = 0.34 and P = 0.47, respectively). The compliance rates in the CPR user group increased 78 per cent from baseline (P<0.001), whereas the rates for the PR user group did not change significantly (P = 0.18). CONCLUSIONS: Clinicians who used a CPR with reminders had higher rates of documentation of compliance with influenza-vaccination guidelines than did those who used a paper record. Measurements of individual clinician behavior at the point of each clinical opportunity can provide precise evaluation of interventions that are designed to improve compliance with guidelines.

Citric acid demineralization and subepithelial connective tissue grafts.

BACKGROUND: The present study was designed to evaluate the effect, if any, of citric acid root demineralization in the outcome of subepithelial connective tissue grafts performed to cover localized gingival recessions. METHODS: Thirty-six patients participated, each providing one gingival recession; 19 received citric acid demineralization, while 17 did not. All were treated surgically with subepithelial connective tissue grafts and followed for 6 months. At baseline and 6 months, the following parameters were recorded: plaque index, gingival index, recession height, probing depth, recession width, and amount of keratinized tissue. Data were analyzed statistically to 1) evaluate the results achieved with each procedure individually over time and 2) compare the results obtained with the 2 procedures after 6 months. RESULTS: Results showed significant reductions in recession height after 6 months independently of whether citric acid was applied or not (2.79+/-0.79 versus 2.56+/-0.73). Similarly, recession width was significantly reduced (3.74+/-1.19 versus 3.50 +/-0.73), and the width of keratinized tissue was significantly increased (2.47+/-1.6 versus 2.3+/-1.2). No significant changes in probing depth were found (-0.16+/-0.06 versus -0.13+/-0.81). No significant differences were found when both techniques were compared in any one of the parameters analyzed (all P >0.30). CONCLUSIONS: It is concluded that: 1) the subepithelial connective tissue graft procedure provides a satisfactory solution in the treatment of localized gingival recessions, and 2) citric acid demineralization does not affect the clinical outcome of the surgical technique.

Clinical and histologic evaluation of submerged and nonsubmerged hydroxyapatite-coated implants: a preliminary study in dogs.

A clinical and histologic study was performed to evaluate the differences in the healing of submerged and nonsubmerged hydroxyapatite-coated 2-piece implants. Three foxhounds were used for this evaluation. Mandibular premolars 1, 2, 3, and 4 were extracted. Three months later, 2 submerged implants were placed on one side of the mandible, and 2 nonsubmerged implants were placed on the other side of the mandible. After 3 months of healing, the submerged implants were exposed, and a third implant was placed on each side of the mandible in a nonsubmerged procedure. Clinical parameters were recorded, the animals were sacrificed 6 months after placement of the first implants, and histologic and histometric analyses were performed. Results of the evaluation of the clinical parameters showed only minor differences among the different treatment groups. Regarding the percentage of bone-to-implant contact of the different treatment groups, the submerged implants showed a bone-to-implant contact of 63.4%, the nonsubmerged implants showed 70.3% contact, and the late nonsubmerged implants demonstrated a bone-to-implant contact of 58.7%. The average distance from the implant neck to the first bone-to-implant contact (fBIC) for submerged implants was 0.58 mm, for nonsubmerged implants it was 1.09 mm, and it was 1.13 mm for late nonsubmerged implants. The vertical distance between the gingival margin and the apical extent of the junctional epithelium (aJE) varied from 1.14 mm to 1.28 mm in the different groups. The distance from the aJE to fBIC was 1.00 mm for the submerged group, 1.08 mm for the nonsubmerged group, and 1.00 mm for the late nonsubmerged group. Generally, it can be concluded that the clinical and the histologic behavior of submerged or nonsubmerged 2-piece implants utilized in this experiment do not differ.

[Xanthogranulomatous pyelonephritis: conservative therapy in the para-nephritic stage. Apropos of a case]. / Pielonefrite xantogranulomatosa (PXG): terapia conservativa nello stadio paranefrico. A proposito di un caso.

Xantogranulomatous pyelonephritis is a rare disease, occuring most frequently in middle-aged woman. The patients usually present with recurrent fever, dysuria, renal colic or aspecific findings. We report a case of focal PXG (paranephric stage) treated with conservative surgery. Generally, treatment consists of nephrectomy for diffuse or advanced stage diseases, excision of the diseased renal segment for localized and low/high stage.

[Major complications of percutaneous nephrolithotripsy (PCNL). Analysis of our cases]. / Complicanze maggiori della nefrolitotrissia percutanea (PCNL). Analisi di una casistica.

The major complications occurred in 140 cases of percutaneous nephrolithotomy, from March 1988 to December 1996 are studied. They were: 1 important hemorrhage with secondary nephrectomy, 1 intestinal fistula resolved with parenteral therapy, 1 hyponatriemic syndrome which required an intraperitoneal drainage and 1 global kidney functional exclusion after 3 months. Etiopathogenesis and suggestions for prevention are discussed as well as the necessity of adequate training.

[Valsalva leak point-pressure (LPP) and maximal urethral closure pressure (MUCP) in women with stress urinary incontinence (SUI)]. / Valsalva leak point-pressure (LPP) e massima pressione di chiusura uretrale (MUCP) in donne con incontinenza urinaria da stress (IUS).

One-hundred and twenty-two women with USI have been evaluated with clinical examination and urodynamics and divided in two groups: only in 74 patients with urinary loss during the Valsalva manoeuvre, LPP was compared to MUCP by linear regression analysis and its ability (cut-off = 60 cmH2O) to predict a MUCP < or = 20 cmH2O was tested. Weak correlations were observed between MUCP and LPP (r = 0.56). Fifty-two patients presented a LPP < or = 60 cmH2O, in 6 of them MUCP was < or = 20 cmH2O; none with LPP > 60 cmH2O showed a MUCP < or = 20 cmH2O. Median MUCP and intravesical pressures at the instant of leakage of patients with LPP < or = 60 cmH2O were significantly different from those of patients with LPP > 60 cmH2O (p < 0.01). The specificity and positive predictive value of LPP < or = 60 cmH2O for the detection of a "low pressure urethra" were respectively 32% and 11.5%, while sensibility and negative predictive value were 100%. LPP can not be regarded as a specific test for urethral sphincteric deficits. For its sensibility, it can be an useful screening tool for patients at high risk of type III urinary incontinence.

[Correlation between the leak point pressure and the clinical grade of incontinence]. / Correlazione tra leak point pressure e grado clinico d'incontinenza.

We evaluated one-hundred and forty-six women with stress urinary incontinence (SUI), mean age 61.5 years, with clinical examination, urodynamics and patient history, grading the subjective degree of SUI according to SEAPI QMM classification. SUI was grade 1 in 73 pts (mean LPP 107, 7 cmH2O, mean maximal urethral closure pressure 59, 13 cmH2O), grade 2 in 36 (mLPP 55, 4 cmH2O, mMUCP 50, 3 cmH2O), grade 3 in 37 (mLPP 32, 29 cmH2O, mMUCP 33, 76 cmH2O). There is statistically significant difference in mLPP (p = 0.001) and mMUCP (p = 0.02) among three groups. The grade of SUI increases as the likelihood that LPP will be < or = 90 cmH2O or < or = 60 cmH2O (72.2% of pts with grade 2 has a LPP < or = 60 cmH2O, 100% of pts with grade 3 has a LPP < or = 60 cmH2O). Women with severe leakage and/or predisposing factor (PF) to intrinsic sphincter deficiency are likely to have a low LPP: all patients with SUI grade 3 and PF have a LPP < or = 60 cmH2O, 77% of pts with SUI grade 3 or PF has a LPP < or = 60 cmH2O. Women with higher grades of leakage and PF are significantly more likely to have a very low LPP and intrinsic sphincter deficiency.