Cutaneous reactions after SARS-CoV-2 vaccination: a cross-sectional Spanish nationwide study of 405 cases.

BACKGROUND: Cutaneous reactions after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are poorly characterized. OBJECTIVE: To describe and classify cutaneous reactions after SARS-CoV-2 vaccination. METHODS: A nationwide Spanish cross-sectional study was conducted. We included patients with cutaneous reactions within 21 days of any dose of the approved vaccines at the time of the study. After a face-to-face visit with a dermatologist, information on cutaneous reactions was collected via an online professional survey and clinical photographs were sent by email. Investigators searched for consensus on clinical patterns and classification. RESULTS: From 16 February to 15 May 2021, we collected 405 reactions after vaccination with the BNT162b2 (Pfizer-BioNTech; 40·2%), mRNA-1273 (Moderna; 36·3%) and AZD1222 (AstraZeneca; 23·5%) vaccines. Mean patient age was 50·7 years and 80·2% were female. Cutaneous reactions were classified as injection site ('COVID arm', 32·1%), urticaria (14·6%), morbilliform (8·9%), papulovesicular (6·4%), pityriasis rosea-like (4·9%) and purpuric (4%) reactions. Varicella zoster and herpes simplex virus reactivations accounted for 13·8% of reactions. The COVID arm was almost exclusive to women (95·4%). The most reported reactions in each vaccine group were COVID arm (mRNA-1273, Moderna, 61·9%), varicella zoster virus reactivation (BNT162b2, Pfizer-BioNTech, 17·2%) and urticaria (AZD1222, AstraZeneca, 21·1%). Most reactions to the mRNA-1273 (Moderna) vaccine were described in women (90·5%). Eighty reactions (21%) were classified as severe/very severe and 81% required treatment. CONCLUSIONS: Cutaneous reactions after SARS-CoV-2 vaccination are heterogeneous. Most are mild-to-moderate and self-limiting, although severe/very severe reactions are reported. Knowledge of these reactions during mass vaccination may help healthcare professionals and reassure patients.

[Study of the nutritional status of elders in Cantabria]. / Estudio del estado nutricional de los ancianos de Cantabria.

INTRODUCTION: Population ageing is a main concern under the biosanitary point of view. AIM: To assess the nutritional status of people 65 year-old and older in Cantabria (Spain) METHOD: A total of 1605 persons were studied by means of the MNA (Mini Nutritional Assessment); a) by primary care (59.9% in the unit, and 4.7% at home) and, b) in nursing homes (35.4%). RESULTS: Nutritional score (NS) was 23.4 ± 4.1 for women and 24.4 ± 4 in males (p < 0.001). We emphasize the fact that 22.3% of people studied in the nursing homes were malnourished or at risk of malnutrition, compared with 14.2% of those studied at the unit, and only 3.3% of the home visited elders. The correlation between the value of the NS and the subjective estimation of nutrition status showed a high value (0.65). We emphasize the negative correlation (-0.53) between BNI value and the incidence of skin lesions. CONCLUSION: Our results highlight the importance of identifying malnutrition or its risk in elders in order to prevent the negative consequences of this deficiency.

Lower rate of family refusal for organ donation in non-heart-beating versus brain-dead donors.

INTRODUCTION: Family refusal is an important factor that limits the number of organ donors. Cultural and religious factors as well as perception of brain death are the principal reasons for these refusals. We examined whether the type of potential donor, that is brain-dead or non-heart-beating, had an influence on family refusal. In July 2005, we initiated a program of non-heart-beating donors who had died in the street or at home. MATERIALS AND METHODS: We compared family refusals among these potential donors with those among potential brain-dead donors from July 2005 to October 2008. RESULTS: The mean time of stay in the hospital was significantly greater for brain-dead donors than those who were non-heart-beating: 4 +/- 2 versus 0.23 +/- 0.01 days (P < .01). The rate of family refusals was significantly greater among the families of potential brain-dead donors, that is 24% (24/99) than non-heart-beating donors, that is, 4% (2/47; P < .01). Donor age was similar in both groups. CONCLUSION: The rate of family refusals among potential non-heart-beating donors was significantly lower than that among families of brain-dead individuals. Greater understanding of death because the heart is not beating, less time of uncertainty about death, and shorter hospital stay could explain this difference.

Clinical implications of proteinuria in renal transplant recipients switching to rapamycin for chronic allograft dysfunction.

There is evidence that treatment with m-TOR inhibitors can be beneficial in cases of chronic renal allograft dysfunction. However, some authors have reported poor outcomes of renal function if the switch to m-TOR inhibitors is made in the presence proteinuria > 0.8 g/d. The present study sought to provide a retrospective analysis of the clinical outcome of 63 kidney recipients diagnosed with chronic allograft dysfunction whose therapy was converted to rapamycin including 35 subjects with renal biopsy-proven chronic allograft nephropathy. At the time of conversion, patients were divided into three groups: group I (negative proteinuria), group II (proteinuria between 0.3 and 0.8 g/d), and group III (proteinuria > 0.8 g/d). On conversion, 21 recipients had no proteinuria (group I). After a follow-up of 24.6 +/- 12.8 months, they showed a significant improvement in renal function (previous MDRD4 = 39.9 +/- 11.5 mL/m/1.73 m(2), current MDRD4 50.3 +/- 13.3 mL/m/1.73 m(2), P < .05). Fifteen patients (71.4%) developed proteinuria, which was generally mild (0.8 +/- 0.7 g/d) and controlled with angiotensin-converting enzyme inhibitors (42.8%). In group II (n = 18), renal function clearly stabilized after a follow-up of 23.2 +/- 14.4 months (previous MDRD4 = 30 +/- 8.8 mL/m/1.73 m(2), current MDRD4 = 37 +/- 12.2 mL/m/1.73 m(2), NS), although there was a progressive deterioration of previous proteinuria levels (previous proteinuria 0.4 +/- 0.15 g/d, current proteinuria 1.2 +/- 2 g/d, P < .05), which was more frequent and intense in patients whose treatment with calcineurin inhibitors (CNIs) was suspended (with CNI 0.9 +/- 1.7 g/d, without CNI 1.6 +/- 2.2 g/d, P < .05). Group III (n = 24) had a greater degree of renal insufficiency and a worse outcome after 25.9 +/- 18 months of follow-up, with a frank and progressive deterioration in renal function (previous MDRD4 = 38 +/- 17 mL/m/1.73 m(2), current MDRD4 = 32.5 +/- 19.2 mL/m/1.73 m(2), P < .05) and proteinuria (previous proteinuria = 1.5 +/- 0.7 g/d, current proteinuria = 2.5 +/- 2.2 g/d, P < .05) after conversion. Again, the deterioration in proteinuria was more intense in the patients whose previous CNIs were suspended (with CNI = 1.1 +/- 0.9 g/d, without CNI = 4.2 +/- 2.3 g/d, P < .05). In conclusion, for patients with chronic allograft dysfunction who do not present with proteinuria or whose proteinuria is less than 0.8 mg/d, switching to rapamycin is useful, since it clearly improves or stabilizes renal function, although there may be a discrete increase in proteinuria in the second case. However, among patients with proteinuria greater than 0.8 mg/d accompanied by a greater degree of renal insufficiency, conversion to rapamycin leads to deterioration of proteinuria levels and renal function. These data show that conversion to rapamycin in cases of chronic allograft dysfunction must be made early when there is no proteinuria or it is minimal, and that proteinuria is a predictor of the outcome of allograft function.

Survival of patients older than 60 years with kidneys transplanted from Spanish expanded criteria donors versus patients continued on hemodialysis.

A retrospective study was performed in patients >60 years of age who had initiated hemodialysis (HD) at our hospital between 2000 and 2005 (n = 211). Of these, 47 were placed on the kidney transplantation waiting list and 164 were excluded and continued on HD. Cadaveric transplantation was performed in 31 patients using an expanded criteria donor organ (TR), while 16 remained on the waiting list (WL). We compared the 12-month survivals of patients in the 3 groups (TR/WL/HD), namely, 97%/78%/75% (P < .045). Survival at 24, 36, 48, and 60 months for TR/HD were 89%/57%; 86%/43%; 79%/32%; and 70%/16% (P < .001). HD patients showed greater comorbidity than TR patients: Charlson index >8 was 67.9% vs 19.4%. A total of 23.7% of patients were excluded solely due to advanced age. We compared survivals among the TR patients vs those excluded only because of age using paired comorbidity (Charlson index <8): 97%/95%, 89%/58%, and 86%/44% at 12, 24, and 36 months (P < .023). We concluded that kidney transplantation with an expanded criteria donor organ in elderly patients was a procedure that provided greater survival than HD for patients excluded from transplantation, for patients on the WL who did not receive a transplant, and for patients excluded solely due to advanced age who showed comorbidity comparable to the transplant recipients. According to our data, elderly patients with low comorbidity should be considered for inclusion on the WL for transplantation.

Renal allograft function and cardiovascular risk in recipients of kidney transplantation after successful pregnancy.

Successful pregnancy is one of the better indicators of quality of life for women who are of child-bearing age with restored fertility after kidney transplantation. Our objective was to evaluate whether pregnancy represented a risk factor for worsening of renal function or for cardiovascular disease among renal transplant recipients. From 1976 to 2007, we followed 30 successful pregnancies in 27 renal recipients in our hospital; three women had two twin gestations. We compared this population with 27 women with renal transplants who were not pregnant. They were of similar ages at transplantation (pregnant 31.1 +/- 5.4 years vs not pregnant 31.3 +/- 5.4 years, P = NS) and similar evolution time between kidney transplantation and pregnancy (51.5 +/- 36 months vs 47.2 +/- 41 months respective; P = NS). There were no acute rejection episodes or graft losses. Renal function measured by serum creatinine and MDRD4 at the end of pregnancy was lower among the pregnant compared with the control group: mainly, 1.1 +/- 0.2 mg/dL versus 0.9 +/- 0.2 mg/dL (P = .05), and 66 +/- 20 mL/min/1.73 m(2) versus 80 +/- 26 mL/min/1.73 m(2) (P = .03). At 1 and 10 years, renal function was similar among the groups. Ten pregnant women developed preeclampsia (37%) and three, gestational diabetes mellitus (11%). There was one major cardiovascular event (4%; acute myocardial infarction) among the pregnant group, whereas there were two in the control group (7.4%; stroke and severe hypertensive retinopathy). One death occurred in each group secondary to cardiovascular complications. Our results showed that successful pregnancy after renal transplantation did not represent a long-term risk factor to worsen renal function and or produce severe cardiovascular complications. Therefore, pregnancy should be promoted. for young women with renal transplants that show excellent function.

Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies.

Inhibition of cathepsin K (CatK) is a potential new treatment for osteoporosis. In two double-blind, randomized, placebo-controlled phase I studies, postmenopausal female subjects received odanacatib (ODN), an orally active, potent, and selective CatK inhibitor, once weekly for 3 weeks or once daily for 21 days. Bone turnover biomarkers, safety monitoring, and plasma ODN concentrations were assessed. These studies showed ODN to be well tolerated. Pharmacokinetic (PK) analysis revealed a long half-life (t(1/2); 66-93 h) consistent with once-weekly dosing. Pronounced reductions in C-terminal telopeptide of type I collagen (approximately 62%) and N-terminal telopeptide of type I collagen normalized to creatinine (NTx/Cr) (approximately 62%) at trough (C(168 h)) were seen following weekly administration. Robust reductions in CTx (up to 81%) and NTx/Cr (up to 81%) were seen following daily administration. ODN exhibits robust and sustained suppression of bone resorption biomarkers (CTx and NTx/Cr) at weekly doses > or = 25 mg and daily doses > or = 2.5 mg.

Carcinoma hepatocelular asociado a hepatitis crónica C no cirrótica / Hepatocellular carcinoma associated with non cirrhotic chronic hepatitis C

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Impacto de la inmunosupresión en el perfil de riesgo cardiovascular después del trasplante renal / Impact of immunossupression in the cardiovascular risk profile after renal transplantation I

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Impacto de la inmunosupresión en el perfil de riesgo cardiovascular después del trasplante renal / No disponible

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Pregnancy in renal transplant recipients.

Fertility is restored after renal transplantation when good function is achieved. Our aim was to describe the gestations of our transplanted patients, analyzing outcomes and complications as well as long-term evolution of renal function. From 1976 to 2004, 43 gestations occurred in 35 renal transplanted women: their mean age was 31.7 +/- 4.06 years, with a mean time from the transplant to pregnancy of 4.32 years (0.4-13). At conception, all showed normal renal function (SCr 1.05 +/- 0.2 mg/dL). There were 19 abortions (43.8%), 9 of them spontaneous (21%) and 10 therapeutic (six cases for noncompliance with described criteria of European Best Practice Guidelines for Renal Transplantation, especially pregnancy less than 6 months after transplantation). Excluding these six cases of therapeutic abortions, 24 successful pregnancies occurred in 37 women (65.7%), although eight (29.1%) had premature delivery with live fetuses. Arterial hypertension was the most frequently complication (64%). Preeclampsia occurred in nine (37.5%) pregnancies, with proteinuria in five and only two with mild renal function deterioration. The majority of patients received cyclosporine (n = 20) or tacrolimus (n = 19). Since 1996, mycophenolate mofetil and sirolimus were stopped before conception. Birth weight was lower than 2500 g in 33.3% of pregnancies. Every newborn baby was healthy. Afterward, of the 24 patients with successfully pregnancy, 21 (87.5%) have functioning renal transplants at 53.2 months. After delivery, all currently show good renal function (SCr 1.16 +/- 0.35 mg/dL, CrCl 91 +/- 28.45 mL/m). In conclusion, pregnancy in our renal transplant women shows a success rate of 65.6%. However, complications related to arterial hypertension such as preeclampsia are frequent. The incidence of spontaneous abortions was similar to other series (21%). Long-term graft survival does not seem to be negatively affected by pregnancy.

Rapamycin at six years can exhibit normal renal function without proteinuria or neoplasia after renal transplantation. A single-center experience.

Currently, long-term experience with Rapamune (RAPA) after renal transplantation is scarce. We present our experience with RAPA in patients who were included in clinical trials. Between 1996 and 1999, 27 renal transplant patients received RAPA alone or in combination with cyclosporine (CyA). We study 15 of them (9 males, 6 females; mean age 36 years) who are currently functioning with a mean follow-up of 6 years (range, 5.2-8 years). The presence of delayed graft function was 40% and acute rejection 26.6%, all of them controlled with steroids. Notably, no patients experienced an acute rejection episode after the first year. Among 15 patients, 12 received steroids, RAPA and CyA; and 3 received steroids, RAPA, azathioprine (AZA) or mycophenolate mofetil (MMF) for immunosuppression. At the end of follow-up, the situation was the opposite: 12 patients received steroids (2.5-5 mg/d) and RAPA associated with or without AZA/MMF, and 3 were maintained with steroids, RAPA and CyA. Renal function was excellent in the entire group: mean SCr 1.1 mg/dL (range, 0.7-1.8) with mean RAPA blood levels (HPLC) of 11 ng/dL (range 8-16). Hyperlipidemia was universal with all patients (100%) receiving statins maintaining acceptable levels of cholesterol (mean 209 +/- 28 mg/dL) and tryglycerides (mean 154 +/- 76 mg/dL). Arterial hypertension present in 12 of 15 (80%) patients was controlled with a mean of 1.5 drugs. Notably, no patient presented with proteinuria, neoplasia, posttransplant diabetes, or cardiovascular events. In conclusion, these single-center results suggest that Rapamune may be useful in the long-run after renal transplantation. The presence of normal renal function and the absence of proteinuria and neoplasia in these renal transplant patients may have important clinical implications.

Anti-CD25 monoclonal antibody sequential immunosuppressive induction therapy in renal transplants with high risk of delayed graft function.

There is little experience on the use of monoclonal antibodies that block the high-affinity interleukin-2 receptor (basiliximab and daclizumab) in sequential therapy in renal transplants with risk of delayed graft function. This study sougth to test the efficacy and safety of the substitution of anticalcineurins with two doses of basiliximab or daclizumab in the immediate posttransplant period for recipients at risk of delayed renal graft function. Immunosuppression consisted of steroids, mycophenolate mofetil, and two doses of basiliximab (20 mg/day) on days 0 and 4 posttransplant or daclizumab (1 mg/kg per day) on days 0 and 15 posttransplant. Anticalcineurins were not administered until the beginning of graft function. Among 49 recipients (mean age 63.5 +/- 10.5 years), 40 received a kidney from a donor over 60 years of age, three from a non-heart-beating donor, and six from donors with an acute elevation of serum creatinine to 2.4 +/- 0.86 (1.7-3.7). At a mean follow-up of 14.2 +/- 8.4 months, five patients experienced acute rejection episodes. Only 15 patients needed posttransplant dialysis (2.7 +/- 1.6). In 11 patients, cyclosporine (CsA) was introduced at 6 +/- 2.9 days posttransplant and in 37, tacrolimus on 8.6 +/- 3.6 days posttransplant. The incidence of kidney graft loss was 16.3%. Patient survival was 96%. Thirty-nine recipients are alive with functioning grafts, with mean serum creatinine of 1.4 mg/dL. In conclusion, substitution for anticalcineurins with interleukin-2-receptor blockade in the immediate posttransplant period for patients at risk of delayed graft function minimizes nephrotoxicity and reduces tubular necrosis, without increasing the risk of an acute rejection episode.