Locul medicaţiei alfablocante selective în tratamentul prostatitei cronice

Abstract Although the term “chronis prostatitis" has been used for different entities that cannot be easily separated, it has been estimated that up to half of all men suffer from symptoms of prostatitis at some point in their lives. Having these aspects in mind, the authors have tried, in this prospective study, to evaluate the impact of introducing selective alfa blockers in the treatment of chronic prostatitis(Tamsulosin and Alfuzosine).The including criterias were: age between 30 and 55; at least one episode of prostatitis in the past; a normal prostate size and a postvoid residual urine volume< 20 ml.Each patient has recived a file containing general recom andations and has filled out two questionforms (NIH-CPSID Chronic Prostatitis Symptom Index Domain), to evaluate the situation before and three months from the treatment after 3 month. Based on this we have evaluated the benefits of the treatment from the point of view of: pain, urinary symptoms and a better quality of life. The preliminary results show that urinary simptoms have been ameliorated and that almost all the patients have noticed the benefits of selective alfa blockers. The ondulant evolution of the illness raises numerous obstacles for urologists trying to find the ideal treatment for prostatitis Rezumat Pornind de la dificultăţile de diagnostic şi de tratament ale prostatitei cronice (unanim recunoscută in lumea urologică) şi de la estimarea că aproape jumătate din numărul bărbaţilor vor prezenta simptome de prostatită la un moment dat, am încercat să evaluăm într-un studiu prospectiv, aflat în desfăşurare, impactul medicaţiei alfablocante selective (Tamsulosin, Alfuzosin SR) asupra simptomatologiei acestei patologii. Au fost incluşi în studiu pacienţi cu vârsta între 30 şi 55 de ani, cu cel puţin un episod de prostatită în antecedente, dimensiunile prostatei (evaluate echografic) în limite normale, reziduu vezical d" 20ml. Fiecare pacient a primit un dosar care cuprinde o fişă cu recomandări generale şi două chestionare de evaluare (NIHCPSI) la început şi după 3 luni de la tratament. Schema de tratament a inclus: antibioterapie, tratament cu antiinflamatorii, alfablocantul selectiv (Tamsulosin sau Alfuzosin). Am introdus pentru pacienţii care admiteau un consum important de proteine animale şi tratament cu Allopurinol, dar lotul este încă prea mic pentru a trage concluzii. Pe baza chestionarelor am evaluat atât beneficiile tratamentului sub raportul durerii (totalul punctelor 1, 2, 3, 4), al simptomelor urinare (totalul punctelor 5 şi 6), cât şi impactul asupra calităţii vieţii (7, 8, 9). Rezultatele preliminare ale studiului nostru la lotul respectiv indică benefică asocierea alfablocantelor, în special pentru ameliorarea simptomelor urinare. Considerăm, totodată, că evoluţia ondulantă a bolii ridică numeroase obstacole în calea stabilirii unui tratament ideal în prostatita cronică

Predictive factors for complications in rigid and semirigid retrograde ureteroscopy

Clinica de Urologie şi Transplant Renal, Spital Clinic “Dr. CI Parhon” Iaşi, Al V-lea Congres de Urologie, Dializă şi Transplant Renal din Republica Moldova cu participare internaţională (1-13 iunie 2011)Background. Currently, ureteroscopy is a worldwide procedure with varied number of diagnostic and therapeutic possibilities, including treatment of stones, upper urinary tract tumors, strictures, placement of difficult ureteral stents, and diagnosis of filling defects or haematuria of unknown origin. However, the technique has complications including bleeding, fever and sepsis, ureteral perforation, false passage, urinoma, strictures and, rarely, ureteral avulsion. PURPOSE. Our purpose was to evaluate the ureteroscopies with long hospitalization and to analyse the preoperative predictive factors for the complications. METHODS. We retrospectively reviewed all 342 files of the patients who underwent retrograde ureteroscopy for different reasons between january 2005 and december 2009. Data were abstracted on period of hospitalization, indications for the procedure (urolithiasis – site, number and size, reno-ureteral haematuria, filling defects), bioumoral status, outcome and complications of the method. RESULTS. The mean hospitalization time was 6,53 ± 2,09 days, with a preoperative period of 3,37 ± 1,74 days and a postoperatory time of 2,16 ± 1,08 days. Only 40 patients (11,7%) have exceled this postoperatory period due to a complicated outcome, meanwhile the preoperative time was tidely corelated with the diagnostic imaging methods. The success rate of all therapeutic procedures was 84,74% and the overall and major complication rates was 23,09% and 4,97%. The analysis of preoperative factors showed that preoperative bacteriuria is statistically correlated with postoperatory complications, such as fever and sepsis (p<0.001), and persistent haematuria is linked to stone size and ureteral stent size placed at the end of the procedure (8Ch) without having statistical significance. CONCLUSIONS. Our experience suggests that carefully performed retrograde ureteroscopy is a superb tool for the urologist, either for diagnostic or therapeutic purposes. However, when performing an ureteroscopy, one should always bear in mind the possibility of serious complications, including ureteral avulsion or perforation

Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies

Background Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies. Method Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3–6) to full resolution (FR), stable (similar or reduction of EC), or worse (EC > baseline). Efficacy outcomes (ACR, PASI, HAQ-DI, SF-36 PCS, and DAS28-CRP) were assessed in patients with or without baseline enthesitis. Results are reported for secukinumab 300 and 150 mg in the overall population and by prior TNFi treatment. Results A total of 65% (466/712) of patients had baseline enthesitis. In the overall population, FR was achieved as early as week 16 in 65% (300 mg) and 56% (150 mg) versus 44% (placebo) patients, with further improvements to 91% (300 mg) and 88% (150 mg) at week 104. The majority (89%) of patients without enthesitis at baseline maintained this status at week 104. Median days to resolution of EC were shorter with secukinumab 300 and 150 mg versus placebo (57 and 85 vs 167 days, respectively). In patients with EC of 1 or 2, shift analysis from baseline to week 24 showed that more patients achieved FR with secukinumab 300 mg and 150 mg versus placebo, whereas no difference between secukinumab and placebo was shown in the more severe patients with EC of 3–6. Increases in proportions of patients with FR were observed with secukinumab irrespective of the severity of EC from baseline to week 104. Improvements in efficacy outcomes were similar in patients with or without enthesitis treated with secukinumab 300 mg. Conclusion Secukinumab provided early and sustained resolution of enthesitis in patients with PsA over 2 years. Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis. Trial registration FUTURE 2: ClinicalTrials.gov, NCT01752634 (date of study registration: December 19, 2012), and EudraCT, 2012-004439-22 (date of study registration: December 12, 2012) FUTURE 3: ClinicalTrials.gov, NCT01989468 (date of study registration: November 21, 2013), and EudraCT, 2013-004002-25 (date of study registration: December 17, 2013

Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data

Background: Secukinumab, a fully human immunoglobulin G1-kappa monoclonal antibody that directly inhibits interleukin (IL)-17A, has been shown to have robust efficacy in the treatment of moderate-to-severe psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) demonstrating a rapid onset of action and sustained long-term clinical responses with a consistently favorable safety profile in multiple Phase 2 and 3 trials. Here, we report longer-term pooled safety and tolerability data for secukinumab across three indications (up to 5 years of treatment in PsO and PsA; up to 4 years in AS). Methods: The integrated clinical trial safety dataset included data pooled from 21 randomized controlled clinical trials of secukinumab 300 or 150 or 75 mg in PsO (14 Phase 3 trials and 1 Phase 4 trial), PsA (3 Phase 3 trials), and AS (3 Phase 3 trials), along with post-marketing safety surveillance data with a cut-off date of June 25, 2017. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIRs) per 100 patient-years. Analyses included all patients who received ≥ 1 dose of secukinumab. Results: A total of 5181, 1380, and 794 patients from PsO, PsA, and AS clinical trials representing secukinumab exposures of 10,416.9, 3866.9, and 1943.1 patient-years, respectively, and post-marketing data from patients with a cumulative exposure to secukinumab of ~ 96,054 patient-years were included in the analysis. The most frequent AE was upper respiratory tract infection. EAIRs across PsO, PsA, and AS indications were generally low for serious infections (1.4, 1.9, and 1.2, respectively), Candida infections (2.2, 1.5, and 0.7, respectively), inflammatory bowel disease (0.01, 0.05, and 0.1, respectively), and major adverse cardiac events (0.3, 0.4, and 0.6, respectively). No cases of tuberculosis reactivation were reported. The incidence of treatment-emergent anti-drug antibodies was low with secukinumab across all studies, with no discernible loss of efficacy, unexpected alterations in pharmacokinetics, or association with immunogenicity-related AEs. Conclusions: Secukinumab demonstrated a favorable safety profile over long-term treatment in patients with PsO, PsA, and AS. This comprehensive assessment demonstrated that the safety profile of secukinumab was consistent with previous reports in patients with PsO, PsA, and AS, supporting its long-term use in these chronic conditions

Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data.

BACKGROUND: Secukinumab, a fully human immunoglobulin G1-kappa monoclonal antibody that directly inhibits interleukin (IL)-17A, has been shown to have robust efficacy in the treatment of moderate-to-severe psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) demonstrating a rapid onset of action and sustained long-term clinical responses with a consistently favorable safety profile in multiple Phase 2 and 3 trials. Here, we report longer-term pooled safety and tolerability data for secukinumab across three indications (up to 5 years of treatment in PsO and PsA; up to 4 years in AS). METHODS: The integrated clinical trial safety dataset included data pooled from 21 randomized controlled clinical trials of secukinumab 300 or 150 or 75 mg in PsO (14 Phase 3 trials and 1 Phase 4 trial), PsA (3 Phase 3 trials), and AS (3 Phase 3 trials), along with post-marketing safety surveillance data with a cut-off date of June 25, 2017. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIRs) per 100 patient-years. Analyses included all patients who received ≥ 1 dose of secukinumab. RESULTS: A total of 5181, 1380, and 794 patients from PsO, PsA, and AS clinical trials representing secukinumab exposures of 10,416.9, 3866.9, and 1943.1 patient-years, respectively, and post-marketing data from patients with a cumulative exposure to secukinumab of ~ 96,054 patient-years were included in the analysis. The most frequent AE was upper respiratory tract infection. EAIRs across PsO, PsA, and AS indications were generally low for serious infections (1.4, 1.9, and 1.2, respectively), Candida infections (2.2, 1.5, and 0.7, respectively), inflammatory bowel disease (0.01, 0.05, and 0.1, respectively), and major adverse cardiac events (0.3, 0.4, and 0.6, respectively). No cases of tuberculosis reactivation were reported. The incidence of treatment-emergent anti-drug antibodies was low with secukinumab across all studies, with no discernible loss of efficacy, unexpected alterations in pharmacokinetics, or association with immunogenicity-related AEs. CONCLUSIONS: Secukinumab demonstrated a favorable safety profile over long-term treatment in patients with PsO, PsA, and AS. This comprehensive assessment demonstrated that the safety profile of secukinumab was consistent with previous reports in patients with PsO, PsA, and AS, supporting its long-term use in these chronic conditions

Classical approach in duodenopancreatectomy - the key to success of a controversial intervention

Secția IV Chirurgie, Secția Radiologie, Secția Gastoenterologie, Spital ”Sf. Spiridon”, U.M.F. “Grigore T. Popa”, Iași, România, Al XIII-lea Congres al Asociației Chirurgilor „Nicolae Anestiadi” și al III-lea Congres al Societății de Endoscopie, Chirurgie miniminvazivă și Ultrasonografie ”V.M.Guțu” din Republica MoldovaIntroducere: Duodenopancreatectomia cefalică (DPC) este considerată tratamentul standard pentru tumorile periampulare. În pofida evoluției în chirurgia pancreatică, morbiditatea postoperatorie după DPC rămâne crescută. În timp ce rata mortalității asociate intervenției chirurgicale a scăzut la mai puțin de 4%, morbiditatea postoperatorie se menține la mai mult de 50%, datorate în special anastomozei pancreaticojejunale, principala vulnerabilitate a chirurgiei pancreatice. Material și metode: Autorii prezintă un studiu pe 5 ani, între ianuarie 2014 și aprilie 2019, pe un lot de 17 pacienți la care s-a practicat DPC cu reconstrucție clasică tip Whipple Child, cu 2 variante de anastomoză pancretico-jejunală. Media de vârstă a fost de 58,5. Rezultate: Mortalitatea imediat postoperatorie în lotul studiat a fost de 0%, iar morbiditatea a fost reprezentată de 1 caz de fistulă pancreatică și 2 cazuri de hemoragii postoperatorii. Supraviețuirea la 1 an a fost de 64,7%, 5 pacienți fiind pierduți din supraveghere și 1 deces. Concluzii: Fistula pancreatică, prin complicațiile cu pericol vital ca de exemplu hemoargia și peritonita, este principala cauză de morbiditate și mortalitate după duodenopancreatectomie cefalică. Factorii care contribuie la această complicație sunt reprezentați de textura moale a țesutului pancratic și de diametrul subțire al ductului pancreatic.Introduction: Pancreaticoduodenectomy (PD) is considered the standard treatment for periampullary tumors. Despite progresses in pancreatic surgery, the postoperative morbidity after PD remains high. While the operation-associated mortality rate of pancreatic surgery has decreased to less than 4%, the postoperative morbidity rate is reported to be as high as 50%, largely due to the pancreaticojejunal anastomosis, the major vulnerability of pancreatic surgery. Material and methods: The authors present a study between January 2014 and April 2019, on a series of 17 patients with PD with classical reconstruction type Whipple Child, with 2 types of pancreaticojejunal anatomosis. The median age was 58,5. Results: Postoperative mortality in the study was 0%, and morbidity was 1 case of pancreatic fistula and 2 postoperative bleeding. The survival at 1 year was about 64,7%, 5 patients were lost under surveillance and one death. Conclusions: Pancreatic fistula, with life-threatening complications, such as postoperative hemorrhage and peritonitis, is the most important cause of morbidity and mortality in PD. Factors contributing to this complication are: soft pancreatic tissue texture and small pancreatic duct diameter

Death by SARS-CoV 2: a Romanian COVID-19 multi-centre comorbidity study

Evidence regarding the relation between SARS-CoV-2 mortality and the underlying medical condition is scarce. We conducted an observational, retrospective study based on Romanian official data about location, age, gender and comorbidities for COVID-19 fatalities. Our findings indicate that males, hypertension, diabetes, obesity and chronic kidney disease were most frequent in the COVID-19 fatalities, that the burden of disease was low, and that the prognosis for 1-year survival probability was high in the sample. Evidence shows that age-dependent pairs of comorbidities could be a negative prognosis factor for the severity of disease for the SARS-CoV 2 infection

Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis

Objectives: Identify distinct clusters of psoriatic arthritis (PsA) patients based on their baseline articular, entheseal and cutaneous disease manifestations and explore their clinical and therapeutic value. Methods: Pooled baseline data in PsA patients (n=1894) treated with secukinumab across four phase 3 studies (FUTURE 2–5) were analysed to determine phenotypes based on clusters of clinical indicators. Finite mixture models methodology was applied to generate clinical clusters and mean longitudinal responses were compared between secukinumab doses (300 vs 150 mg) across identified clusters and clinical indicators through week 52 using machine learning (ML) techniques. Results: Seven distinct patient clusters were identified. Cluster 1 (very-high (VH) – SWO/TEN (swollen/tender); n=187) was characterised by VH polyarticular burden for both tenderness and swelling of joints, while cluster 2 (H (high) – TEN; n=251) was marked by high polyarticular burden in tender joints and cluster 3 (H – Feet – Dactylitis; n=175) by high burden in joints of feet and dactylitis. For cluster 4 (L (Low) – Nails – Skin; n=209), cluster 5 (L – skin; n=283), cluster 6 (L – Nails; n=294) and cluster 7 (L; n=495) articular burden was low but nail and skin involvement was variable, with cluster 7 marked by mild disease activity across all domains. Greater improvements in the longitudinal responses for enthesitis in cluster 2, enthesitis and Psoriasis Area and Severity Index (PASI) in cluster 4 and PASI in cluster 6 were shown for secukinumab 300 mg compared with 150 mg. Conclusions: PsA clusters identified by ML follow variable response trajectories indicating their potential to predict precise impact on patients’ outcomes. Trial registration numbers: NCT01752634, NCT01989468, NCT02294227, NCT02404350