Suspected adverse reactions to medications and food supplements containing Serenoa repens: A worldwide analysis of pharmacovigilance and phytovigilance spontaneous reports.

The safety of Serenoa repens (SR)-containing products was evaluated conducting a retrospective worldwide analysis of pharmaco- and phytovigilance report forms of suspected adverse reactions (SARs) collected up to 31 January 2022. Multivariate logistic regression was performed to estimate the odds ratios (ORs) of serious SAR. A total of 1810 report forms were analysed; 92% of subjects were males, with a median age of 69 years; 44% of cases were defined as serious. Subjects exposed to dietary supplements had a higher risk of developing serious SARs (OR: 1.60 [95% CI: 1.20-2.15]), as subjects exposed to 2-5 (OR: 1. 83 [95% CI: 1.30-2.58]) or more than 5 (OR: 3.45 [95% CI: 2.36-5.06]) suspect/interacting products. The probability of experiencing serious SAR was higher for subjects exposed to concomitant products (OR: 1.55 [95% CI: 1.15-2.08]), to more than four active compounds (OR: 4.38 [95% CI: 3.21-5.99]) and to SR for more than 14 days (OR: 1.89 [95% CI: 1.10-3, 22]), and lower for subjects exposed to higher doses of SR (OR: of 0.34 [95% CI: 0.20-0.58]). This evidence improves awareness on safety of SR containing products, suggesting the need of a further update of periodic reviews by national and international regulatory agencies.

The University of Florence Technique for Robot-Assisted Kidney Transplantation: 3-Year Experience.

Objective: To report the University of Florence technique for robot-assisted kidney transplantation (RAKT) from living donor (LD) and deceased donor (DD), highlighting the evolution of surgical indications and technical nuances in light of a single surgeon's learning curve. Materials and Methods: A dedicated program for RAKT from LDs was developed at our Institution in 2017 and implemented later with a specific framework for DDs. All RAKTs were performed by a single highly experienced surgeon. Data from patients undergoing RAKT between January 2017 and December 2019 were prospectively collected in a dedicated web-based data platform. In this report we provide a comprehensive step-by-step overview of our technique for RAKT, focusing on the potential differences in peri-operative and mid-term functional outcomes between LDs vs. DDs. Results: Overall, 160 KTs were performed in our center during the study period. Of these, 39 (24%) were performed with a robot-assisted laparoscopic technique, both from LDs (n = 18/39 [46%]) and from DDs (n = 21/39 [54%]). Eleven (11/39 [18%]), 13(13/39 [26%]), and 15 (15/39 [30%]) RAKTs were performed in 2017, 2018, and 2019, respectively, highlighting an increasing adoption of robotics for KT over time at our Institution. Median time for arterial (19 min for LD and 18 min for DD groups), venous (21 min for LD, 20 min for DD) and uretero-vesical (18 min for LD and 15 for DD) anastomosis were comparable between the two groups (all p > 0.05), as the median rewarming time (59 min vs. 56 min, p = 0.4). The rate of postoperative surgical complications according to Clavien-Dindo classification did not differ between the two study groups, except for Clavien-Dindo grade II complications (higher among patients undergoing RAKT from DDs, 76 vs. 44%, p = 0.042). Overall, 7/39 (18%) patients (all recipients from DDs) experienced DGF; two of them were on dialysis at last FU. Conclusions: Our experience confirms the feasibility, safety, and favorable mid-term outcomes of RAKT from both LDs and DDs in appropriately selected recipients, highlighting the opportunity to tailor the technique to specific recipient- and/or graft-characteristics. Further research is needed to refine the technique for RAKT and to evaluate the benefits and harms of robotics for kidney transplantation from DDs.