ABSTRACT
Lung cancer (LC) is a leading cause of cancer-related mortality worldwide. Lung Cancer Screening (LCS) programs that use low-dose computed tomography (LDCT) have been shown to reduce LC mortality by up to 25 % and are considered cost-effective. The European Health Union has encouraged its Member States to explore the feasibility of LCS implementation in their respective countries. The task force conducted a comprehensive literature review and engaged in extensive discussions to provide recommendations. These recommendations encompass the essential components required to initiate pilot LCS programs following the guidelines established by the World Health Organization. They were tailored to align with the specific context of the Portuguese healthcare system. The document addresses critical aspects, including the eligible population, methods for issuing invitations, radiological prerequisites, procedures for reporting results, referral processes, diagnostic strategies, program implementation, and ongoing monitoring. Furthermore, the task force emphasized that pairing LCS with evidence-based smoking cessation should be the standard of care for a high-quality screening program. This document also identifies areas for further research. These recommendations aim to guarantee that the implementation of a Portuguese LCS program ensures high-quality standards, consistency, and uniformity across centres.
ABSTRACT
The deep peribiliary glands (DPBG) are a niche of progenitor cells in the wall of the biliary duct (BD) and are the second line of multiplication when severe lesion of the epithelium occurs. Previous studies have identified DPBG injury as a cause of post-liver transplant (LT) biliary stenosis; this complication is a major cause of post-LT morbidity. The incidence of biliary stenosis in our center is high (38.1%). This study evaluates the lesion of DPBG in response to ischemia. Graft BD was collected in adult LT between August 2016-July 2017, from donation after brain death. Samples of 45 grafts were collected at 2 moments: BD1-during graft preparation and BD2-before biliary anastomosis. Histological analysis of the samples was performed and then classified according to degree of lesion (0, ≤50%, and >50%). A comparison was made between the degree of lesion and graft ischemia, graft histology, donor, and procurement variables. The DPBG lesion was more frequent in BD2 (20.9% vs 7%, P = .079). BD2 lesions with DPBG lesions had higher medians and means at all times of ischemia. The difference was greater in the warm ischemia time (0: 43.3 ± 12.53 minutes vs ≤50%: 52.4 ± 14.38 minutes, P = .068). The group of BD1 with DPBG lesion presented superior median cold ischemia time (CIT). In the analysis of the remaining variables there were also no statistically significant differences. We concluded that during the period of CIT there is already lesion of the DPBG, which increases after reperfusion of the graft, in greater association with longer warm ischemia time.
Subject(s)
Bile Ducts/pathology , Cold Ischemia/adverse effects , Liver Transplantation , Warm Ischemia/adverse effects , Adult , Female , Humans , Ischemia/pathology , Liver Transplantation/adverse effects , Liver Transplantation/methods , Male , Prospective Studies , Reperfusion/adverse effectsABSTRACT
The development of predictive in vitro stem cell-derived hepatic models for toxicological drug screening is an increasingly important topic. Herein, umbilical cord tissue-derived mesenchymal stem cells (hnMSCs) underwent hepatic differentiation using an optimized three-step core protocol of 24 days that mimicked liver embryogenesis with further exposure to epigenetic markers, namely the histone deacetylase inhibitor trichostatin A (TSA), the cytidine analogue 5-azacytidine (5-AZA) and dimethyl sulfoxide (DMSO). FGF-2 and FGF-4 were also tested to improve endoderm commitment and foregut induction during Step 1 of the differentiation protocol, being HHEX expression increased with FGF-2 (4 ng/mL). DMSO (1%, v/v) when added at day 10 enhanced cell morphology, glycogen storage ability, enzymatic activity and induction capacity. Moreover, the stability of the hepatic phenotype under the optimized differentiation conditions was examined up to day 34. Our findings showed that hepatocyte-like cells (HLCs) acquired the ability to metabolize glucose, produce albumin and detoxify ammonia. Global transcriptional analysis of the HLCs showed a partial hepatic differentiation degree. Global analysis of gene expression in the different cells revealed shared expression of gene groups between HLCs and human primary hepatocytes (hpHeps) that were not observed between HepG2 and hpHeps. In addition, bioinformatics analysis of gene expression data placed HLCs between the HepG2 cell line and hpHeps and distant from hnMSCs. The enhanced hepatic differentiation observed was supported by the presence of the hepatic drug transporters OATP-C and MRP-2 and gene expression of the hepatic markers CK18, TAT, AFP, ALB, HNF4A and CEBPA; and by their ability to display stable UGT-, EROD-, ECOD-, CYP1A1-, CYP2C9- and CYP3A4-dependent activities at levels either comparable with or even higher than those observed in primary hepatocytes and HepG2 cells. Overall, an improvement of the hepatocyte-like phenotype was achieved for an extended culture time suggesting a role of the epigenetic modifiers in hepatic differentiation and maturation and presenting hnMSC-HLCs as an advantageous alternative for drug discovery and in vitro toxicology testing.
Subject(s)
Azacitidine/pharmacology , Dimethyl Sulfoxide/pharmacology , Epigenesis, Genetic/drug effects , Hepatocytes/drug effects , Hydroxamic Acids/pharmacology , Mesenchymal Stem Cells/cytology , Cell Culture Techniques , Cell Differentiation/drug effects , Drug Evaluation, Preclinical/methods , Hepatocytes/metabolism , Humans , Infant, Newborn , Models, Biological , Multidrug Resistance-Associated Protein 2ABSTRACT
INTRODUCTION: Advances in neoadjuvant chemotherapy (NCT) have allowed surgical treatment in otherwise unresectable patients with colorectal liver metastases (CRLM). It is well known that NCT induces liver lesions such as sinusoidal obstruction syndrome (SOS) and steatohepatitis (SH). However, whether it affects postoperative morbidity remains controversial. The aim of this study was both to evaluate the impact of NCT on liver parenchyma and postoperative morbidity, and to identify preoperative predictive markers for liver injury. PATIENTS AND METHODS: Among 140 patients undergoing liver resection for CRLM between 2010 and 2013, 70 underwent systemic NCT. Liver function tests, pathology, postoperative morbidity and mortality were compared between the two groups. RESULTS: Univariate analysis revealed NCT as a cause of sinusoidal dilation (p = 0.09), peliosis (p = 0.028) and moderate and severe SOS (p = 0.004) and bevacizumab as a protective agent against moderate and severe SOS (p = 0.045). Diabetic patients were identified as having a lower incidence of sinusoidal dilation (p = 0.034) and a higher incidence of steatosis (p = 0.003). Multivariate analysis confirmed sinusoidal dilation as an independent cause for morbidity (p = 0.02) and liver-specific complications (p = 0.016). Preoperative level of GGT was identified as predictive factor for moderate and severe SOS and peliosis (p < 0.001 and p = 0.004, respectively). CONCLUSION: The administration of NCT induces SOS-lesions, but can be partially prevented by bevacizumab and diabetes. Sinusoidal dilation is associated with increased postoperative morbidity. Preoperative GGT levels can be useful to predict the presence of SOS.
Subject(s)
Angiogenesis Inhibitors/therapeutic use , Bevacizumab/therapeutic use , Colorectal Neoplasms/pathology , Hepatectomy/methods , Hepatic Veno-Occlusive Disease/etiology , Hepatic Veno-Occlusive Disease/prevention & control , Liver Neoplasms/drug therapy , Liver Neoplasms/surgery , gamma-Glutamyltransferase/blood , Adult , Aged , Aged, 80 and over , Biomarkers, Tumor/blood , Chemotherapy, Adjuvant/adverse effects , Diabetes Mellitus , Female , Humans , Liver Function Tests , Liver Neoplasms/secondary , Male , Middle Aged , Neoadjuvant Therapy/adverse effects , Survival Rate , Treatment OutcomeABSTRACT
No disponible
Subject(s)
Humans , Male , Middle Aged , Jaundice, Obstructive/diagnosis , Jaundice, Obstructive/etiology , Pancreas/pathology , Pancreatic Diseases/complications , Endoscopy , Pancreatitis/complications , Diagnosis, Differential , Jaundice, Obstructive/physiopathology , Jaundice, Obstructive , Transplantation, Heterotopic/methodsABSTRACT
Helicobacter pylori resistance to antimicrobial agents is steadily increasing. It is extremely important to be aware of the local prevalence of antibiotic resistance so as to adjust treatment strategies. During this single-centre, prospective study, we aimed to determine primary and secondary resistance rates of H. pylori to antibiotics as well as host and bacterial factors associated with this problem. Overall, 180 patients (131 female; mean age 43.4±13.5 years; primary resistance 103; secondary resistance 77) with positive (13) C-urea breath test were submitted to upper endoscopy with gastric biopsies. Helicobacter pylori was cultured and antimicrobial susceptibility was determined by Etest and molecular methods. Clinical and microbiological characteristics associated with resistance were evaluated by logistic regression analysis. Among the 180 isolates 50% were resistant to clarithromycin (primary 21.4%; secondary 88.3%), 34.4% to metronidazole (primary 29.1%; secondary 41.6%), 33.9% to levofloxacin (primary 26.2%; secondary 44.2%), 0.6% to tetracycline and 0.6% to amoxicillin. Being female was an independent predictor of resistance to clarithromycin and metronidazole. Previous, failed, eradication treatments were also associated with a decrease in susceptibility to clarithromycin. History of frequent infections, first-degree relatives with gastric carcinoma and low education levels determined increased resistance to levofloxacin. Mutations in the 23S rRNA and gyrA genes were frequently found in isolates with resistance to clarithromycin and levofloxacin, respectively. This study revealed that resistance rates to clarithromycin, metronidazole and levofloxacin are very high and may compromise H. pylori eradication with first-line and second-line empiric triple treatments in Portugal.
Subject(s)
Anti-Infective Agents/pharmacology , Drug Resistance, Bacterial , Helicobacter Infections/epidemiology , Helicobacter Infections/microbiology , Helicobacter pylori/drug effects , Adolescent , Adult , Aged , Aged, 80 and over , Biopsy , Female , Gastric Mucosa/microbiology , Genotype , Helicobacter pylori/isolation & purification , Humans , Male , Microbial Sensitivity Tests , Middle Aged , Phenotype , Portugal/epidemiology , Prevalence , Prospective Studies , Sequence Analysis, DNA , Young AdultABSTRACT
INTRODUCTION: Liver transplantation modifies the natural history of end-stage liver diseases and stabilizes the course of familial amyloidotic polyneuropathy. An evaluation of its long-term results allows insight and awareness of factors that impact survival. PATIENTS AND METHODS: We included 150 consecutive patients who underwent liver transplantation between October 1992 and January 1998. The impact of disease, cold ischemic time, ABO compatibility, acute and chronic rejection episodes, and vascular, biliary and infectious complications on survival were compared. RESULTS: We included 65 patients (43.3%) with familial amyloidotic polyneuropathy, 41 (27.3%) with cirrhosis, 12 (8%) with hepatocellular carcinoma, and 11 (7.3%) with acute hepatic failure. The mean age was 39 years. The mean cold ischemic time was 493 ± 161 minutes. There were 115 (77.2%) ABO-identical transplants; 25 (16.8%) were ABO compatible, and 9 (6%) were ABO incompatible. Acute cellular rejection occurred in 88 recipients (58.7%); chronic rejection was diagnosed in 9 (6%). Complications included vascular (16.7% patients; n = 25) and biliary (38.7%; n = 58). Infections were bacterial in 92 (61.3%), fungal in 35 (23.3%), and cytomegalovirus in 9 (6%). The survival rates were 78% at 1 year, 68.7% at 5 years, and 58% at 10 years. Of the 150 patients, 82 survived until November 2011. Follow-up ranged from 13 to 19 years. In this study, only bacterial infections had a negative influence on patients' survival (P = .014). CONCLUSION: The high frequency of biliary and vascular complications was associated with increased morbidity but not mortality. Bacterial infections were related to an ominous outcome, being responsible for short- and long-term mortality.
Subject(s)
Liver Transplantation , ABO Blood-Group System , Adult , Humans , Survival Rate , Treatment OutcomeABSTRACT
Geranium is one of the most popular ornamental plants in México. In December 2012, rust symptoms were observed on leaves of common geranium (Pelargonium × hortorum L. H. Bailey) growing in pots in garden landscapes in Morelia, Michoacán. Dark brown pustules with chlorotic halos appeared on the lower leaf surface. A center pustule surrounded by one or more partial-to-complete concentric circles of smaller pustules was observed in each lesion. Urediniospores were globose or subglobose to ovoid, light brown, echinulated, thin-walled with two more or less conspicuous subequatorial pores, and 21 to 29 × 18 to 24 µm (25.5 × 22.8 µm average). Teliospores were not observed. Based on these characters, the rust was identified as Puccinia pelargonii-zonalis Doidge (1,2). Pathogenicity tests were conducted on three healthy P. × hortorum plants that were sprayed with water droplets containing urediniospores. The inoculated plants were covered with a plastic bag and placed in a screened house. The bags were removed after 24 h. Afterwards, the plants were maintained outside the screened house in full sun at ambient temperature (24 to 30°C in the day and 5 to 10°C at night). Initial symptoms were observed 15 to 17 days post inoculation. Symptoms appeared as small light yellow spots on the upper surface of mature leaves. Urediniospores production on the lower surface of the leaves was evident 22 to 25 days post inoculation. To our knowledge, this is the first report of P. pelargonii-zonalis in the state of Michoacán, México. Geranium rust has been previously reported only in the state of Guanajuato (2). References: (1) E. M. Doidge. Bothalia 2:1, 1926. (2) H. L. Gallegos and G. B. Cummings. Uredinales (royas) de México. Vol. 1. Culiacán, Sinaloa, México, SARH, 1981.
ABSTRACT
Eosinophilic and herpetic esophagitis are listed as independent causes of dysphagia, especially in young adult males. However, herpetic esophagitis rarely affects immunocompetent individuals. We report the case of a young, not immunocompromised patient, admitted because of severe dysphagia secondary to herpes simplex virus esophagitis. After complete resolution, an endoscopic and histologic reevaluation established the diagnosis of eosinophilic esophagitis. The potential association between the two conditions is discussed.
Subject(s)
Eosinophilic Esophagitis/epidemiology , Esophagitis/virology , Herpes Simplex/epidemiology , Adult , Causality , Comorbidity , Endoscopy, Gastrointestinal , Eosinophilic Esophagitis/pathology , Esophagitis/pathology , Humans , MaleABSTRACT
Em 2009 o município de São Paulo desencadeou ações inter setoriais com sociedade civil e comunidade para reduzir a vulnerabilidade social, denominada Virada Social. A Secretaria Municipal de Saúde (SMS) e a Coordenadoria Regional de Saúde Sul (CRS Sul) participaram da Jornada da Saúde propiciando o acesso aos serviços de promoção e prevenção da saúde: elaboração do cartão SUS, alimentação saudável, medidas de pressão arterial, glicemia, vacinas, prevenção de gravidez precoce e doenças sexualmente transmissíveis (DST) para adolescentes, prevenção de câncer do colo de útero, dengue, saúde bucal e outras(AU)
Subject(s)
Humans , Public Health , Health Services , Family Health , Mental Health , Organization and AdministrationABSTRACT
Em 2009 o município de São Paulo desencadeou ações inter setoriais com sociedade civil e comunidade para reduzir a vulnerabilidade social, denominada Virada Social. A Secretaria Municipal de Saúde (SMS) e a Coordenadoria Regional de Saúde Sul (CRS Sul) participaram da Jornada da Saúde propiciando o acesso aos serviços de promoção e prevenção da saúde: elaboração do cartão SUS, alimentação saudável, medidas de pressão arterial, glicemia, vacinas, prevenção de gravidez precoce e doenças sexualmente transmissíveis (DST) para adolescentes, prevenção de câncer do colo de útero, dengue, saúde bucal e outras
Subject(s)
Humans , Family Health , Health Services , Mental Health , Public Health , Organization and AdministrationABSTRACT
Em 2009 o município de São Paulo desencadeou ações inter setoriais com sociedade civil e comunidade para reduzir a vulnerabilidade social, denominada Virada Social. A Secretaria Municipal de Saúde (SMS) e a Coordenadoria Regional de Saúde Sul (CRS Sul) participaram da Jornada da Saúde propiciando o acesso aos serviços de promoção e prevenção da saúde: elaboração do cartão SUS, alimentação saudável, medidas de pressão arterial, glicemia, vacinas, prevenção de gravidez precoce e doenças sexualmente transmissíveis (DST) para adolescentes, prevenção de câncer do colo de útero, dengue, saúde bucal e outras.
Subject(s)
Humans , Family Health , Health Services , Mental Health , Public Health , Organization and AdministrationSubject(s)
Carcinoma, Squamous Cell/pathology , Esophageal Neoplasms/pathology , Glycogen/metabolism , Aged , Carcinoma, Squamous Cell/therapy , Chelation Therapy , Esophageal Neoplasms/therapy , Esophagoscopy , Esophagus/surgery , Humans , Lead Poisoning/complications , Lead Poisoning/pathology , MaleABSTRACT
The endocannabinoids anandamide and 2-arachidonoylglycerol, and the anandamide-congener, palmitoylethanolamide, are all substrates for the enzyme fatty acid amide hydrolase, and are endowed with anti-inflammatory actions exerted via cannabinoid receptors or, in the case of palmitoylethanolamide, also via other targets. We investigated the role of the endocannabinoid system during granuloma formation, a model of chronic inflammation sustained by neoangiogenesis, in rats. Granuloma was induced by subcutaneous lambda-carrageenin-soaked sponge implants on the back of male Wistar rats. After 96h, granulomas were detached and tissue formation was evaluated as wet weight; the endocannabinoid system was evaluated by the measurement of endocannabinoid levels, by LC-MS, and of cannabinoid receptor expression, by western blot analysis. Moreover, angiogenesis was evaluated by the measurement of both hemoglobin content and CD31 protein expression. Arachidonoylserotonin (AA-5-HT, 12.5-50mug/ml), an inhibitor of FAAH, and palmitoylethanolamide (PEA, 200-800mug/ml) were given locally only once at the time of implantation. Granuloma formation was accompanied by a significant decrease in endocannabinoid and palmitoylethanolamide levels paralleled by increased levels of the fatty acid amide hydrolase, responsible for their breakdown. Moreover, an increase of cannabinoid receptor expression was also observed. Pharmacological elevation of endocannabinoids and palmitoylethanolamide, obtained separately by arachidonoylserotonin and exogenous palmitoylethanolamide treatment, dose-dependently reduced inflammatory hallmarks including tumor necrosis factor-alpha as well as granuloma-dependent angiogenesis. The effect of arachidonoylserotonin was accompanied by near-normalization of 2-arachidonoylglycerol and palmitoylethanolamide levels in the tissue. These findings suggest that chronic inflammation might develop also because of endocannabinoid and palmitoylethanolamide tissue concentration impairment, the correction of which might be exploited to develop new anti-inflammatory drugs.
Subject(s)
Arachidonic Acids/therapeutic use , Cannabinoid Receptor Modulators/metabolism , Endocannabinoids , Granuloma/drug therapy , Inflammation/drug therapy , Palmitic Acids/therapeutic use , Serotonin/analogs & derivatives , Amides , Amidohydrolases/metabolism , Animals , Carrageenan/pharmacology , Chronic Disease , Disease Models, Animal , Dose-Response Relationship, Drug , Ethanolamines , Granuloma/chemically induced , Granuloma/metabolism , Hemoglobins/metabolism , Inflammation/metabolism , Male , Neovascularization, Pathologic/metabolism , Palmitic Acids/metabolism , Phospholipase D/metabolism , Platelet Endothelial Cell Adhesion Molecule-1/metabolism , Rats , Rats, Wistar , Receptors, Cannabinoid/metabolism , Serotonin/therapeutic use , TRPV Cation Channels/metabolismABSTRACT
Cytomegalovirus (CMV) infections are common in immunocompromised patients but rare in immunocompetent individuals. Gastrointestinal disease is frequent in systemic CMV infections but the small bowel is the least common site of involvement. We present the case of a 66 years-old man, with no evidence of immunological deficiency, hospitalized for unspecific symptoms of diarrhea, fever and abdominal pain, which developed massive mid-gastrointestinal bleeding during hospitalization. Enteroscopy revealed congestive, oedematous mucosa with multiple ulcers in the small bowel. Cytomegalic cells with intranuclear inclusions were found on histologic examination, allowing the diagnosis of CMV infection. Ganciclovir in full therapeutic dose was started and surgery was performed as a last resource treatment, but the patient died. This case highlights the rare condition of massive gastrointestinal bleeding due to CMV disease of the small bowel, the major importance of enteroscopy and pathologic evaluation for diagnosis and the poor prognosis of this situation.
Subject(s)
Cytomegalovirus Infections/complications , Enteritis/complications , Gastrointestinal Hemorrhage/etiology , Immunocompetence , Aged , Fatal Outcome , Humans , MaleABSTRACT
BACKGROUND: Laparoscopic antireflux surgery (LARS) represents the gold standard in the treatment of gastroesophageal reflux disease with or without hiatal hernia. It offers excellent long-term results and high patient satisfaction. Nevertheless, several studies have reported a high rate of intrathoracic wrap migration or paraesophageal hernia recurrence. To reduce the incidence of this complication, the use of prosthetic meshes has been advocated. This study retrospectively evaluated the long-term results of LARS with or without the use of a mesh in a series of patients treated from 1992 to 2007. METHODS: From November 1992 to May 2007, 297 patients underwent laparoscopic antireflux surgery in the authors' department. Crural closure was performed by means of two or three interrupted nonabsorbable sutures for 93 patients (group A), by tailored 3 x 4-cm polypropylene mesh placement for 113 patients (group B), and by nonabsorbable suture plus superimposed tailored mesh for 91 patients (group C). RESULTS: The mean follow-up period for the entire group was 95.1 +/- 38.7 months, specifically 95.2 +/- 49 months for group A, 117.6 +/- 18 months for group B, and 69.3 +/-.17.6 months for group C. Intrathoracic Nissen wrap migration or hiatal hernia recurrence occurred for nine patients (9.6%) in group A, two patients (1.8%) in group B, and only one patient (1.1%) in group C. Esophageal erosion occurred in only one case (0.49%). Functional results and the long-term quality-of-life evaluation after surgery showed a significant and durable improvement with no significant differences related to the type of hiatoplasty. CONCLUSION: Over a long-term follow-up period, the use of a prosthetic polypropylene mesh in the crura for hiatal hernia proved to be effective in reducing the rate of postoperative intrathoracic wrap migration or hernia recurrence, with a very low incidence of mesh-related complications.
Subject(s)
Fundoplication/methods , Gastroesophageal Reflux/surgery , Hernia, Hiatal/surgery , Laparoscopy/methods , Quality of Life , Surgical Mesh , Adult , Cohort Studies , Female , Follow-Up Studies , Fundoplication/adverse effects , Gastroesophageal Reflux/complications , Hernia, Hiatal/complications , Humans , Intraoperative Complications/diagnosis , Intraoperative Complications/epidemiology , Laparoscopy/adverse effects , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Probability , Recurrence , Retrospective Studies , Risk Assessment , Suture Techniques , Tensile Strength , Time Factors , Treatment OutcomeABSTRACT
SUMMARY: Infection of the snail, Biomphalaria glabrata, by the free-swimming miracidial stage of the human blood fluke, Schistosoma mansoni, and its subsequent development to the parasitic sporocyst stage is critical to establishment of viable infections and continued human transmission. We performed a genome-wide expression analysis of the S. mansoni miracidia and developing sporocyst using Long Serial Analysis of Gene Expression (LongSAGE). Five cDNA libraries were constructed from miracidia and in vitro cultured 6- and 20-day-old sporocysts maintained in sporocyst medium (SM) or in SM conditioned by previous cultivation with cells of the B. glabrata embryonic (Bge) cell line. We generated 21 440 SAGE tags and mapped 13 381 to the S. mansoni gene predictions (v4.0e) either by estimating theoretical 3' UTR lengths or using existing 3' EST sequence data. Overall, 432 transcripts were found to be differentially expressed amongst all 5 libraries. In total, 172 tags were differentially expressed between miracidia and 6-day conditioned sporocysts and 152 were differentially expressed between miracidia and 6-day unconditioned sporocysts. In addition, 53 and 45 tags, respectively, were differentially expressed in 6-day and 20-day cultured sporocysts, due to the effects of exposure to Bge cell-conditioned medium.
Subject(s)
Gene Expression Profiling , Gene Expression Regulation, Developmental , Helminth Proteins/metabolism , Schistosoma mansoni/growth & development , Animals , Base Sequence , Biomphalaria/parasitology , DNA, Helminth/analysis , Gene Library , Helminth Proteins/genetics , Host-Parasite Interactions , Larva/genetics , Larva/growth & development , Larva/metabolism , Molecular Sequence Data , Oocysts/growth & development , Oocysts/metabolism , Schistosoma mansoni/genetics , Schistosoma mansoni/metabolism , Sequence Analysis, DNAABSTRACT
BACKGROUND: The BioEnterics Intragastric Balloon (BIB) System in association with restricted diet has been used for the short-term treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study. METHODS: Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean +/- s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or chi (2) with Yates correction; P < 0.05 was considered significant. RESULTS: A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.2 +/- 5.6 years, range 25-50 years; mean BMI 43.7+/-1.5 kg/m(2), range 40-45 kg/m(2); mean %EW: 43.1 +/- 13.1, range: 35-65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 15 +/- 2 min, range 10-20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (P < 0.001) lowered from 43.5 +/- 1.1 to 38.0 +/- 2.6 kg/m(2), while in Group B patients the decrease was not significant (from 43.6 +/- 1.8 to 43.1 +/- 2.8 kg/m(2)). The mean %EWL was significantly higher in Group A than in Group B (34.0 +/- 4.8 vs 2.1 +/- 1%; P < 0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.0 +/- 2.6 to 37.1 +/- 3.4 kg/m(2) and from 43.1 +/- 2.8 to 38.8 +/- 3.1 kg/m(2) in Groups A and B, respectively. CONCLUSIONS: The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.