Balancing Benefits and Harms of COVID-19 Vaccines: Lessons from the Ongoing Mass Vaccination Campaign in Lombardy, Italy.

Background. Limited evidence exists on the balance between the benefits and harms of the COVID-19 vaccines. The aim of this study is to compare the benefits and safety of mRNA-based (Pfizer-BioNTech and Moderna) and adenovirus-vectored (Oxford-AstraZeneca) vaccines in subpopulations defined by age and sex. Methods. All citizens who are newly vaccinated from 27 December 2020 to 3 May 2021 are matched to unvaccinated controls according to age, sex, and vaccination date. Study outcomes include the events that are expected to be avoided by vaccination (i.e., hospitalization and death from COVID-19) and those that might be increased after vaccine inoculation (i.e., venous thromboembolism). The incidence rate ratios (IRR) of vaccinated and unvaccinated citizens are separately estimated within strata of sex, age category and vaccine type. When suitable, number needed to treat (NNT) and number needed to harm (NNH) are calculated to evaluate the balance between the benefits and harm of vaccines within each sex and age category. Results. In total, 2,351,883 citizens are included because they received at least one dose of vaccine (755,557 Oxford-AstraZeneca and 1,596,326 Pfizer/Moderna). A reduced incidence of COVID-19-related outcomes is observed with a lowered incidence rate ranging from 55% to 89% and NNT values ranging from 296 to 3977. Evidence of an augmented incidence of harm-related outcomes is observed only for women aged <50 years within 28 days after Oxford-AstraZeneca (being the corresponding adjusted IRR of 2.4, 95% CI 1.1−5.6, and NNH value of 23,207, 95% CI 10,274−89,707). Conclusions. A favourable balance between benefits and harms is observed in the current study, even among younger women who received Oxford-AstraZeneca.

Neurogenic bowel dysfunction in patients with multiple sclerosis: prevalence, impact, and management strategies.

Bowel dysfunction in patients with multiple sclerosis (MS) is highly prevalent. Constipation and fecal incontinence can coexist and alternate, impacting on the patient's quality of life and social interactions, as well as burdening the caregivers. The cost for the health care providers is also significant, with increased number of hospital admissions, treatment-related costs, and hospital appointments. The origin is multifactorial, and includes alteration of neurological pathways, polypharmacy, behavioral elements, and ability to access the toilet. Every patient with MS should be sensitively questioned about bowel function, and red flag symptoms should prompt adequate investigations. Manipulation of life style factors and establishment of a bowel regime should be attempted in the first place, and if this fails, other measures such as biofeedback and transanal irrigation should be included. A stoma can improve quality of life, and is not necessarily a last-ditch option. Antegrade colonic enemas can also be an effective option, whilst neuromodulation has not proved its role yet. Effective treatment of bowel dysfunction improves quality of life, reduces incidence of urinary tract infection, and reduces health care costs.

Obesity and pancreatic cancer.

BACKGROUND: Pancreatic cancer is an invariably fatal malignancy. Cigarette smoking and diabetes are established risk factors, but over the last two decades studies have shown that excess adiposity is an additional independent risk factor with 30-50% of cases thought to be attributed to nutritional factors. The aim of this narrative review is to analyze all the epidemiological evidence on the topic and possible pathophysiology. METHODS: We searched PubMed, Embase, Cochrane Library and Medline, and all available evidence was included. We firstly analyze meta- and pooled analysis. Then we discuss individual studies to identify sources of discrepancies between studies and attempt to delineate pathophysiology. RESULTS: It is estimated that obese individuals have a relative risk (RR) ranging between 1.19 and 1.47, when compared with those of normal weight, regardless of diabetes or smoking status. No significant differences were found between gender. CONCLUSION: There is a measurable increased risk of developing pancreatic cancer in obese individuals, and excess adiposity is related to the condition with a "dose-response" curve. Hyperinsulinemia and possibly hyperestrogenism secondary to a metabolic syndrome, and independently from diabetes status, appear to be the key elements of the pathogenesis in pancreatic cancer secondary to excess body fat. Increased efforts should therefore be made in tackling the epidemic levels of obesity in the Western world countries.

Surgical results of aortic valve replacement via partial upper sternotomy: comparison with median sternotomy.

BACKGROUND: the theoretical advantages of mini-invasive cardiac surgery are shorter hospitalisation, better surgical results and costs reduction. In November 1997 we started a non-coronary mini-invasive surgery program using a partial upper median sternotomy. This study has been conceived to retrospectively compare two groups of patients who underwent isolate aortic valve replacement using the conventional and the mini-invasive technique. MATERIAL AND METHODS: in Group A 100 patients (mean age 62+/-12 years; 58 male) underwent isolated aortic valve replacement through a partial upper median sternotomy. Group B was composed by the last 100 patients (mean age 63+/-8 years; 56 male) who underwent the same operation through a conventional median sternotomy. For both groups we recorded the ECC and ischaemic times, postoperative intubation time, total postoperative bleeding, intensive care unit length of stay and total hospitalisation time. Major and minor complications were reported. RESULTS: operating times, were significantly longer in Group A (p<0.001). Mechanical ventilation time, ICU and total hospital stay, and total postoperative bleeding showed no significant difference. Adjunctive statistical evidenced the absence of learning curve. Mortality and other complications failed to reveal any significant difference between the two groups. CONCLUSIONS: in our experience, partial upper median sternotomy does not increase surgical risks but failed to demonstrate clear advantages. Apart for an increase in operating times, the surgical results are similar to those of a conventional median sternotomy with only improvement in the aesthetical aspect. In our opinion, this supports the conviction that this approach can be proposed to selected patients, to obtain a better cosmethical result for the same given risk.