Treatment with low-dose prednisone in refractory obstetric antiphospholipid syndrome: A retrospective cohort study and meta-analysis.

BACKGROUND: Glucocorticoids have been suggested as a potential therapy in refractory obstetric antiphospholipid syndrome (oAPS). Our aims were to describe a cohort of patients with oAPS treated with low-dose glucocorticoids and to perform a systematic review and meta-analysis evaluating the effects of additional glucocorticoids on the pregnancy outcomes in oAPS patients. METHODS: Retrospective study that included 11 women diagnosed with primary antiphospholipid syndrome. The meta-analysis was conducted by fitting random effects models and was checked for heterogeneity. RESULTS: All women had suffered from early pregnancy losses and two also had a history of fetal deaths. We studied 47 pregnancies that resulted in 32 abortions (68.1%) and 3 fetal deaths (6.4%). Twenty-six pregnancies were under treatment, mainly LDA and LMWH. Low-dose glucocorticoids were indicated in 13 pregnancies (always in association with LDA and LMWH). There was a decrease in pregnancy loss in those patients treated with LDA and LMWH. Treatment with glucocorticoids significantly increased the rate of successful pregnancy (38.5% abortions in treated vs 85.3% abortions in non-treated pregnancies; p=0.003). After multivariate GEE analysis, only glucocorticoids remained inversely associated with pregnancy loss (OR=0.157, (CI 0.025-0.968, p=0.046)). The meta-analysis showed that glucocorticoids tended to improve the frequency of successful pregnancy (OR= 0.509 (0.252-1.028), p=0.06). Three cases of gestational diabetes and one of preeclampsia were observed in our cohort. The meta-analysis, which mostly included studies using high-dose steroids, showed that glucocorticoids increased not only the frequency of preeclampsia and gestational diabetes, but also the rate of pre-term birth. CONCLUSIONS: The efficacy of low-dose glucocorticoids in addition to the standard therapy in patients with refractory oAPS should be confirmed in well-designed clinical trials. However, high doses of steroids significantly increase the frequency of maternal and fetal morbidities, making their use strongly inadvisable.

Risk Factors for the Development of the Disease in Antiphospholipid Antibodies Carriers: A Long-term Follow-up Study.

The natural history of antiphospholipid antibodies (aPL) carriers is not well-established. The objectives of the present study were (a) to study the probability of developing clinical criteria of antiphospholipid syndrome (APS), (b) to identify potential risk factors for developing thrombosis and/or obstetric complications, (c) to study the association between the antibody profile and development of APS, and (d) to determine the efficacy of primary prophylaxis. We retrospectively analyzed 138 subjects with positive aPL who did not fulfill clinical criteria for APS. The mean follow-up time was 138 ± 63.0 months. Thirteen patients (9.4%) developed thrombosis after an average period of 73.0 ± 48.0 months. Independent risk factors for thrombosis were smoking, hypertension, thrombocytopenia, and triple aPL positivity. Low-dose acetyl salicylic acid did not prevent thrombotic events. A total of 28 obstetric complications were detected in 92 pregnancies. During the follow-up, only two women developed obstetric APS. Prophylactic treatment in pregnant women was associated with a better outcome in the prevention of early abortions. The thrombosis rate in patients with positive aPL who do not meet diagnostic criteria for APS is 0.82/100 patients-year. Smoking, hypertension, thrombocytopenia, and the aPL profile are independent risk factors for the development of thrombosis in aPL carriers. Although the incidence of obstetric complications in this population is high (31.6%), only a few of them meet APS criteria. In these women, prophylactic treatment might be effective in preventing early abortions.

The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study.

BACKGROUND: There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. METHODS: The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. DISCUSSION: This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.

Socio-economic factors do also matter: comments on the article "can climatic factors explain the differences in COVID-19 incidence and severity across the SPANISH regions?: an ecological study".

Phosri et al., commented on our previous study about the influence of climate variables at the beginning of the SARS-CoV-2 pandemic in Spain. They showed the impact of the association of gross domestic product (GDP) with the cumulative COVID-19 incidence per 105 inhabitants in our country and the rise of several methodologic issues. Here we discussed the main advantages and disadvantages of ecological studies and we advocate to test the hypothesis created in this type of studies using individual-level research designs.

Covid-19: As a Fear Factor in Response to Stroke Code and Other Interventional Radiology Emergencies?

The COVID-19 coronavirus crisis has posed an international challenge for all health systems. The first patient registered in Spain with the COVID-19 coronavirus was known on January 31, and the state of alarm was declared on March 14, 2020. The advance of the infection worldwide has caused a modification of the usual pattern in hospital emergency responses. This study describes the incidence of emergencies in the interventional radiology section of the Marqués de Valdecilla University Hospital and analyzes whether the presence of COVID-19 caused a decrease in the number of patients treated especially for ischemic strokes. A descriptive cross-sectional study was carried out on a sample of 236 patients treated at the interventional radiology on call between June 1, 2019 and May 10, 2020, at the Marqués de Valdecilla University Hospital. No specific results were found that indicate a decrease in the incidence of urgent procedures, especially mechanical thrombectomies in patients with ischemic strokes performed by the interventional radiology team since the establishment of the alarm state by COVID-19 in Cantabria. Patients' fear of contracting COVID-19 infection in the hospital environment has not led to a decrease in urgent procedures, especially for ischemic strokes.

Can climatic factors explain the differences in COVID-19 incidence and severity across the Spanish regions?: An ecological study.

BACKGROUND: Environmental factors play a central role in seasonal epidemics. SARS-CoV-2 infection in Spain has shown a heterogeneous geographical pattern This study aimed to assess the influence of several climatic factors on the infectivity of SARS-CoV-2 and the severity of COVID-19 among the Spanish Autonomous Communities (AA.CC.). METHODS: Data on coronavirus infectivity and severity of COVID-19 disease, as well as the climatic variables were obtained from official sources (Ministry of Health and Spanish Meteorological Agency, respectively). To assess the possible influence of climate on the development of the disease, data on ultraviolet radiation (UVR) were collected during the months before the start of the pandemic. To analyze its influence on the infectivity of SARS-CoV-2, data on UVR, temperature, and humidity were obtained from the months of highest contagiousness to the peak of the pandemic. RESULTS: From October 2019 to January 2020, mean UVR was significantly related not only to SARS-CoV-2 infection (cumulative incidence -previous 14 days- × 105 habitants, rho = - 0.0,666; p = 0.009), but also with COVID-19 severity, assessed as hospital admissions (rho = - 0.626; p = 0.017) and ICU admissions (rho = - 0.565; p = 0.035). Besides, temperature (February: rho = - 0.832; p < 0.001 and March: rho = - 0.904; p < 0.001), was the main climatic factor responsible for the infectivity of the coronavirus and directly contributed to a different spread of SARS-CoV-2 across the Spanish regions. CONCLUSIONS: Climatic factors may partially explain the differences in COVID-19 incidence and severity across the different Spanish regions. The knowledge of these factors could help to develop preventive and public health actions against upcoming outbreaks of the disease.

Age and low levels of circulating vitamin D are associated with impaired innate immune function.

This study investigated in vivo the influence of age and vitamin D status on innate immune function in HC. Serum 25OHD was measured in 71 HC. TLR expression on various subpopulations of PBMCs, as well as TLR function by stimulating PBMCs with specific ligands, was assessed by flow cytometry. Circulating cathelicidin levels were determined by ELISA. Serum 25OHD levels decreased with age, and there was a significant inverse correlation between 25OHD levels and age. There was a negative correlation between serum 25OHD levels and MFI expression of TLR7 on B cells, T cells, and monocytes. TLR7 function, addressed by in vitro stimulation with a specific agonist, was significantly correlated with serum 25OHD levels, and this was especially a result of the results in HC older than 60 years. MFI expression of TLR5 on T cells and TLR2 on monocytes was also negatively correlated with serum 25OHD levels. TLR1 (monocytes) and TLR2 (monocytes) expression was positively correlated with age. Furthermore, TLR4 and TLR8 function was negatively correlated with age. Circulating cathelicidin levels decreased with age and were positively correlated with 25OHD levels. Aging is accompanied by changes in expression and function of several TLRs. Serum 25OHD levels decrease with age and are also associated with a change in expression and defective function of certain TLRs, especially those involved in viral response.

Computer-aided detection system applied to full-field digital mammograms.

BACKGROUND: although mammography remains the mainstay for breast cancer screening, it is an imperfect examination with a sensitivity of 75-92% for breast cancer. Computer-aided detection (CAD) has been developed to improve mammographic detection of breast cancer. PURPOSE: to retrospectively estimate CAD sensitivity and false-positive rate with full-field digital mammograms (FFDMs). MATERIAL AND METHODS: CAD was used to evaluate 151 cases of ductal carcinoma in situ (DCIS) (n=48) and invasive breast cancer (n=103) detected with FFDM. Retrospectively, CAD sensitivity was estimated based on breast density, mammographic presentation, histopathology type, and lesion size. CAD false-positive rate was estimated with screening FFDMs from 200 women. RESULTS: CAD detected 93% (141/151) of cancer cases: 97% (28/29) in fatty breasts, 94% (81/86) in breasts containing scattered fibroglandular densities, 90% (28/31) in heterogeneously dense breasts, and 80% (4/5) in extremely dense breasts. CAD detected 98% (54/55) of cancers manifesting as calcifications, 89% (74/83) as masses, and 100% (13/13) as mixed masses and calcifications. CAD detected 92% (73/79) of invasive ductal carcinomas, 89% (8/9) of invasive lobular carcinomas, 93% (14/15) of other invasive carcinomas, and 96% (46/48) of DCIS. CAD sensitivity for cancers 1-10 mm was 87% (47/54); 11-20 mm, 99% (70/71); 21-30 mm, 86% (12/14); and larger than 30 mm, 100% (12/12). The CAD false-positive rate was 2.5 marks per case. CONCLUSION: CAD with FFDM showed a high sensitivity in identifying cancers manifesting as calcifications or masses. CAD sensitivity was maintained in small lesions (1-20 mm) and invasive lobular carcinomas, which have lower mammographic sensitivity.

Cloxacillin-based therapy in severe septic bursitis: retrospective study of 82 cases.

OBJECTIVE: The purpose of this retrospective study was to describe a tertiary care center experience with different antibiotic strategies that include cloxacillin (C) in patients with severe septic bursitis (SB). METHODS: A severe SB was considered when the patient needed hospitalization and/or intravenous (i.v.) antibiotics. Patients were treated with bursal aspiration and one of these antibiotic options: C, 2 g/4 h per day i.v. until improvement, and afterwards 1 g/6 h per day v.o. until resolution; (C+G), gentamicin i.v. was added to C for 5 to 7 days (initial dose 240 mg/d); (C+R), rifampicin was added at a dose of 600 mg/d v.o. RESULTS: The study comprised 82 patients with severe SB. The mean delay to diagnosis was 6.1+/-6.9 days, and the most frequent location was the prepatellar bursa. In 67%, the bursal fluid culture yield a positive result, being Staphylococcus aureus the most frequent bacteria isolated (94.4%). At admission, fever and extensive cellulites were more frequent in the C+G group. Patients in the C+G had a longer duration of i.v. antibiotics compared with the C group (p=0.008), although the total duration of antibiotics was not different. There was a tendency in the C+R group to need more surgery. All patients except one had a complete resolution and there were no differences in side effects. CONCLUSION: In patients with severe SB without extensive cellulites i.v., C alone may be sufficient. In patients with a more severe presentation, C plus gentamicin seems to be an appropriate option in the majority of them.