The efficacy and safety of lamotrigine (LTG), a new antiepileptic drug (AED), were evaluated in a multicenter, randomized, double-blind, placebo-controlled, cross-over study of 98 patients with refractory partial seizures. Each treatment period lasted 14 weeks. Most patients were titrated to a LTG maintenance dose of 400 mg/day. Seizure frequency with LTG decreased by > or = 50%, as compared with placebo, in one fifth of patients. Overall median seizure frequency decreased by 25% with LTG as compared with placebo (p < 0.001). With LTG, the number of seizure days decreased by 18% as compared with placebo (p < 0.01), and investigator global evaluation of overall patient clinical status favored LTG by 2:1 (p = 0.013). Plasma LTG concentrations appeared to be linearly related to dosage. LTG had no clinically important effects on the plasma concentrations of concomitant AEDs. Adverse experiences were generally minor and most frequently were CNS-related (e.g., ataxia, dizziness, diplopia, headache). Most were transient and resolved without discontinuing treatment. Five patients withdrew as a result of adverse experiences while receiving LTG, including 3 patients with rash. One placebo patient was also withdrawn because of rash. The addition of twice-daily LTG to an existing AED regimen was safe, effective, and well tolerated in these medically refractory partial seizure patients.
IntroductionThe aim of the work was to analyze the impact of selected factors on the incidence of seroma formation in breast cancer patients undergoing mastectomy.Material and methodsOne hundred and fifty breast cancer patients were prospectively enrolled in the study. All patients had mastectomy performed using the same operative technique with electrocoagulation. The amount of seroma formed after surgery and its duration were correlated with selected demographic, clinical and pathological parameters.ResultsThe cumulative total seroma volume collected by the end of treatment was higher and the overall time of seroma treatment was longer in patients over the age of 60 years (p = 0.001 and p = 0.001 respectively). Duration of seroma was significantly longer in obese patients (p = 0.036). The cumulative total seroma volume collected by the end of treatment was higher and the overall time of seroma treatment was longer in patients who had over 130 ml of lymph drained during the first 24 postoperative hours (p < 0.001 and p = 0.001 respectively). Additionally, longer duration of seroma was observed in patients with pathological stage I and II according to TNM-UICC (p = 0.042) and in patients with ≥ 1200 g weight resected of mammary gland (p = 0.05).ConclusionsAge and obesity are important prognostic factors influencing seroma formation in breast cancer patients undergoing mastectomy. The amount of lymph formed during first postoperative day may have predictive value in assessing cumulative total seroma volume collected during treatment and its overall duration.
A b s t r a c tVarious types of cancer are nowadays a serious medical and social problem and a great challenge for modern medicine. The majority of anticancer therapy is based on traditional chemotherapy and radiotherapy. Both of these highly non-specific types of treatment have a number of serious side effects including wound healing complications. Radiotherapy and chemotherapy mostly affect rapidly dividing skin cells (e.g. keratinocytes), as well as fibroblasts, melanocytes, endothelial and immune cells. Currently, there are many strategies to improve wound healing in oncological patients, including various types of dressings, biomaterials, growth factors, and cell therapies.
Wound healing complications affect thousands of people each year, thus constituting a profound economic and medical burden. Chronic wounds are a highly complex problem that usually affects elderly patients as well as patients with comorbidities such as diabetes, cancer (surgery, radiotherapy/chemotherapy) or autoimmune diseases. Currently available methods of their treatment are not fully effective, so new solutions are constantly being sought. Cell‐based therapies seem to have great potential for use in stimulating wound healing. In recent years, much effort has been focused on characterizing of adipose‐derived mesenchymal stromal cells (AD‐MSCs) and evaluating their clinical use in regenerative medicine and other medical fields. These cells are easily obtained in large amounts from adipose tissue and show a high proregenerative potential, mainly through paracrine activities. In this review, the process of healing acute and nonhealing (chronic) wounds is detailed, with a special attention paid to the wounds of patients with diabetes and cancer. In addition, the methods and technical aspects of AD‐MSCs isolation, culture and transplantation in chronic wounds are described, and the characteristics, genetic stability and role of AD‐MSCs in wound healing are also summarized. The biological properties of AD‐MSCs isolated from subcutaneous and visceral adipose tissue are compared. Additionally, methods to increase their therapeutic potential as well as factors that may affect their biological functions are summarized. Finally, their therapeutic potential in the treatment of diabetic and oncological wounds is also discussed.
Background: Chronic obstructive pulmonary disease (COPD), usually caused by tobacco smoking, is one of the leading causes of morbidity and mortality. Smoking cessation at an early stage of the disease usually stops further progression. A study was undertaken to determine if diagnosis of airway obstruction was associated with subsequent success in smoking cessation, as advised by a physician. Methods: 4494 current smokers (57.4% men) with a history of at least 10 pack-years of smoking were recruited from 100 000 subjects screened by spirometric testing for signs of airway obstruction. At the time of screening all received simple smoking cessation advice. 1177 (26.2%) subjects had airway obstruction and were told that they had COPD and that smoking cessation would halt rapid progression of their lung disease. No pharmacological treatment was proposed. After 1 year all subjects were invited for a follow up visit. Smoking status was assessed by history and validated by exhaled carbon monoxide level. Results: Nearly 70% attended a follow up visit (n = 3077): 61% were men, mean (SD) age was 52 (10) years, mean (SD) tobacco exposure 30 (17) pack-years, and 33.3% had airway obstruction during the baseline examination. The validated smoking cessation rate in those with airway obstruction was 16.3% compared with 12.0% in those with normal spirometric parameters (p = 0.0003). After correction for age, sex, nicotine dependence, number of cigarettes smoked daily, and lung function, success in smoking cessation was predicted by lower lung function, lower nicotine dependence, and lower tobacco exposure. Conclusions: Simple smoking cessation advice combined with spirometric testing resulted in good 1 year cessation rates, especially in subjects with airway obstruction.
SummaryBackgroundIn this prospective, randomized, placebo-controlled, double-blinded clinical trial we tested the hypothesis that preemptive analgesia with bupivacaine applied in the area of the surgical incision in patients undergoing mastectomy for breast cancer would reduce post-operative acute pain and would reduce the amount of analgesics used during surgery and in the post-operative period.Material/MethodsParticipants were assigned into 1 of 2 groups – with bupivacaine applied in the area of surgical incision or with placebo. We assessed the intraoperative consumption of fentanyl, the postoperative consumption of morphine delivered using a PCA method, and the subjective pain intensity according to VAS score reported by patients in the early post-operative period.ResultsOut of 121 consecutive cases qualified for mastectomy, 112 women were allocated randomly to 1 of 2 groups – group A (bupivacaine) and group B (placebo). The final study group comprised 106 breast cancer cases. Between the groups, a statistically significant difference was observed with respect to: lower fentanyl consumption during surgery (p=0.011), lower morphine (delivered by means of a PCA) consumption between the 4–12th postoperative hours (p=0.02) and significantly lower pain intensity assessed according to VAS score at the 4th and 12th hours after surgery (p=0.004 and p=0.02 respectively) for the group A patients.ConclusionsPreemptive analgesia application in the form of infiltration of the area of planned surgical incisions with bupivacaine in breast cancer patients undergoing mastectomy decreases post-operative pain sensation, limits the amount of fentanyl used during surgery, and reduces the demand for opiates in the hours soon after surgery.
Adipose-derived stem cells (ASCs) have become an important research model in regenerative medicine. However, there are controversies regarding the impact of prolonged cell culture on the ASCs phenotype and their differentiation potential. Hence, we studied 10 clinical ASCs replicates from plastic and oncological surgery patients, in six-passage FBS supplemented cultures. We quantified basic mesenchymal cell surface marker transcripts and the encoded proteins after each passage. In parallel, we investigated the differentiation potential of ASCs into chondrocytes, osteocytes and adipocytes. We further determined the effects of FBS supplementation and subsequent deprivation on the whole transcriptome by comprehensive mRNA and miRNA sequencing. Our results show that ASCs maintain differentiation potential and consistent profile of key mesenchymal markers, with apparent expression of distinct isoforms, in long-term cultures. No significant differences were observed between plastic and oncological surgery cohorts. ASCs in FBS supplemented primary cultures are almost committed to mesenchymal lineages as they express key epithelial-mesenchymal transition genes including early mesenchymal markers. Furthermore, combined mRNA/miRNA expression profiling strongly supports a modulatory role for the miR-30 family in the commitment process to mesenchymal lineages. Finally, we propose improvements to existing qPCR based assays that address alternative isoform expression of mesenchymal markers.
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