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      • KCI등재

        Complications and local relapse after intraoperative low-voltage X-ray radiotherapy in breast cancer

        Ana Alicia Tejera Hernández,Víctor Manuel Vega Benítez,Juan Carlos Rocca Cardenas,Neith Ortega Pérez,Nieves Rodriguez Ibarria,Juan Carlos Díaz Chico,Juan José García-Granados Alayón,Pedro Pérez Correa 대한외과학회 2020 Annals of Surgical Treatment and Research(ASRT) Vol.98 No.6

        Purpose: To study those factors that influence the occurrence of surgical complications and local relapse in patients intervened for breast cancer and receiving intraoperative radiotherapy. Methods: Observational study on patients intervened for breast cancer with conservative surgery and intraoperative radiotherapy with low-voltage X-ray energy source (INTRABEAM), from 2015 to 2017 with 24 months minimum followup. Variables possibly associated to the occurrence of postoperative complications were analyzed with the Student t-test and the Fisher exact test; P < 0.05 considered significant. Subsequently, the construction of multiple multivariate analysis models began, thus building a logistic regression analysis using the IBM SPSS Statistics ver. 23 software. Local relapse was described. Results: The study included 102 patients, mean age of 61.2 years; mean global size of tumor, 12.2 mm. Complications occurred in 29.4%. Fibrosis was the most frequently observed complication, followed by postoperative seroma. Using a 45 mm or larger applicator were significantly associated with the occurrence of complications. Tumor size 2 cm or larger and reintervention showed borderline significant association. Only one case of local relapse was observed. Conclusion: Certain factors may increase the risk of complication after the use of intraoperative radiotherapy. Using external complementary radiotherapy does not seem to increase the rate of complications. Select patients and the involvement of a multidisciplinary team are essential for achieving good results

      • KCI등재

        Safety and Biodistribution of Human Bone Marrow-Derived Mesenchymal Stromal Cells Injected Intrathecally in Non-Obese Diabetic Severe Combined Immunodeficiency Mice: Preclinical Study

        Mari Paz Quesada,David García-Bernal,Diego Pastor,Alicia Estirado,Miguel Blanquer,Ana Mª García-Hernández,José M. Moraleda,Salvador Martínez 한국조직공학과 재생의학회 2019 조직공학과 재생의학 Vol.16 No.6

        BACKGROUND: Mesenchymal stromal cells (MSCs) have potent immunomodulatory and neuroprotective properties, and have been tested in neurodegenerative diseases resulting in meaningful clinical improvements. Regulatory guidelines specify the need to perform preclinical studies prior any clinical trial, including biodistribution assays and tumourigenesis exclusion. We conducted a preclinical study of human bone marrow MSCs (hBM-MSCs) injected by intrathecal route in Non-Obese Diabetic Severe Combined Immunodeficiency mice, to explore cellular biodistribution and toxicity as a privileged administration method for cell therapy in Friedreich’s Ataxia. METHODS: For this purpose, 3 9 105 cells were injected by intrathecal route in 12 animals (experimental group) and the same volume of culture media in 6 animals (control group). Blood samples were collected at 24 h (n = 9) or 4 months (n = 9) to assess toxicity, and nine organs were harvested for histology and safety studies. Genomic DNA was isolated from all tissues, and mouse GAPDH and human b2M and b-actin genes were amplified by qPCR to analyze hBM-MSCs biodistribution. RESULTS: There were no deaths nor acute or chronic toxicity. Hematology, biochemistry and body weight were in the range of normal values in all groups. At 24 h hBM-MSCs were detected in 4/6 spinal cords and 1/6 hearts, and at 4 months in 3/6 hearts and 1/6 brains of transplanted mice. No tumours were found. CONCLUSION: This study demonstrated that intrathecal injection of hBM-MSCs is safe, non toxic and do not produce tumors. These results provide further evidence that hBM-MSCs might be used in a clinical trial in patients with FRDA.

      • KCI등재

        The extent of aortic lymphadenectomy in locally advanced cervical cancer impacts on survival

        Antoni Llueca,Javier Escrig,Antonio Gil-Moreno,Virginia Benito,Alicia Hernández,Berta Díaz-Feijoo 대한부인종양학회 2021 Journal of Gynecologic Oncology Vol.32 No.1

        Objective: The prognostic impact of surgical paraaortic staging remains unclear in patientswith locally advanced cervical cancer (LACC). The objective of our study was to evaluate theresults of the surgical technique of preoperative aortic lymphadenectomy in LACC related totumor burden and disease spread to assess its influence on survival. Methods: Data of 1,072 patients with cervical cancer were taken from 11 Spanishhospitals (Spain-Gynecologic Oncology Group [GOG] working group). Complete aorticlymphadenectomy surgery (CALS) was considered when the lymph nodes (LNs) were excisedup to the left renal vein. The extent of the disease was performed evaluating the LNs bycalculating the geometric means and quantifying the log odds between positive LNs andnegative LNs. The Kaplan-Meier method was used to estimate the survival distribution. A Coxproportional hazards model was used to account for the influence of multiple variables. Results: A total of 394 patients were included. Pathological analysis revealed positiveaortic LNs in 119 patients (30%). LODDS cut-off value of −2 was established as a prognosticindicator. CALS and LODDS <−2 were associated with better disease free survival and overallsurvival than suboptimal aortic lymphadenectomy surgery and LODDS ≥−2. In a multivariatemodel analysis, CALS is revealed as an independent prognostic factor in LACC. Conclusion: When performing preoperative surgical staging in LACC, it is not advisable totake simple samples from the regional nodes. Radical dissection of the aortic and pelvicregions offers a more reliable staging of the LNs and has a favorable influence on survival.

      • KCI등재

        Cinnamomum cassia on Arterial Stiffness and Endothelial Dysfunction in Type 2 Diabetes Mellitus: Outcomes of a Randomized, Double-Blind, Placebo-Controlled Clinical Trial

        Jesús S. Delgadillo-Centeno,Fernando Grover-Páez,Sandra O. Hernández-González,María G. Ramos-Zavala,David Cardona-Müller,Alicia López-Castro,Sara Pascoe-González 한국식품영양과학회 2023 Journal of medicinal food Vol.26 No.6

        Cinnamomum cassia is a medicinal plant whose use has demonstrated benefits on body weight, blood pressure, glucose, and lipids. This study aimed to evaluate the effect of C. cassia on arterial stiffness and endothelial dysfunction (ED) in patients with type 2 diabetes mellitus (T2DM). A randomized, double-blind, placebo-controlled clinical trial was carried out in 18 subjects aged 40–65 years, with a diagnosis of T2DM of one year or less since diagnosis and treated with Metformin 850 mg daily. Patients were randomly assigned to receive either C. cassia or a placebo in 1000 mg capsules, thrice a day, before each meal for 12 weeks. At baseline and after 12 weeks of intervention, brachial-ankle pulse wave velocity and Flow Mediated Dilation were measured, as well as body weight, body mass index (BMI), blood pressure (BP), fasting glucose (FG), glycated hemoglobin A1c (HbA1c), total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, and very low density lipoprotein cholesterol, respectively, triglycerides, creatinine, and transaminases. The Mann–Whitney U test for differences between groups and the Wilcoxon signed-rank test for intragroup differences were used, and a P ≤ .05 was considered statistically significant. After C. cassia administration, statistically significant reductions in body weight (81.4 ± 10.4 kg vs. 79.9 ± 9.0 kg, P = .037), BMI (30.6 ± 4.2 kg/m2 vs. 30.1 ± 4.2 kg/m2, P = .018), and HbA1c (53 ± 5.4 mmol/mol vs. 45 ± 2.1 mmol/mol, P = .036) were observed. No changes statistically significant on arterial stiffness, ED, FG, BP, and lipids were observed. C. cassia administration decreases body weight, BMI, and HbA1c without statistically significant changes on arterial stiffness, ED, FG, BP, and lipids. CTR Number: NCT04259606

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