Effectiveness and tolerability of pegylated Interferon alpha-2a and ribavirin combination therapy in Romanian patients with chronic hepatitis C: from clinical trials to clinical practice.
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BACKGROUND AND AIM: Pegylated interferon alpha in combination with ribavirin represents nowadays the gold standard therapy in patients with chronic hepatitis C. The aim of this study was to assess early (EVR) and sustained virological response (SVR), tolerability and baseline predictive factors for SVR in patients with chronic hepatitis C treated with peginterferon alpha-2a and ribavirin combination therapy in day-to-day clinical practice. METHODS: The analysis included 174 consecutive patients with chronic hepatitis C (naive, relapsers and non-responders after standard therapy) managed in two expertise gastroenterology centers in Romania, mainly on an outpatient basis. The combination therapy was initiated between 1st of June 2002 - 30th of June 2003. RESULTS: The mean age of the study population was 47 years; 41% were men, mean BMI was 26.5 kg/sq.m. Only 7.5% of them had bridging fibrosis/cirrhosis on liver biopsy. EVR and SVR were noted in 78.7% and 51.1%, respectively. Multivariate analysis showed two independent variables associated with SVR: absence of bridging fibrosis/cirrhosis and absence of hepatic steatosis. The rate and profile of side effects associated with pegylated interferon alpha-2a and ribavirin in our clinical setting were all predictable, based on previous experience in the literature. Side effects resulted in interferon and ribavirin dose reductions in 9.2% and, respectively, 25.3%, but permanent discontinuation of the combination therapy was required in only 5.74% of patients. CONCLUSION: Combination antiviral therapy can be safely and successfully used outside clinical trials. To achieve high response rates and tolerability, similar or better than those reported in clinical trials, hepatitis C patients have to be managed in expertise centers, by experienced physicians, aiming at minimizing side effects, optimizing dosing, and enhancing compliance. (+info)
Sedation during colonoscopy.
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In order to perform a proper screening for colonic cancer, repeated colonoscopies are required. Comfort during colonoscopy is very important, so that the patient will accept repeated procedures. Currently, there are 3 types of sedation used during colonoscopy: general anesthesia performed by an anesthesiologist; sedo-analgesia performed by an anesthesiologist or by a gastroenterologist; sedo-analgesia performed by a trained nurse. Sedo-analgesia is the most frequently used type of sedation during colonoscopy worldwide. It is realized by combining midazolam with propofol and/or fentanyl (alfentanyl) or pethidine. According to the data obtained from 34 centers performing colonoscopy in Romania, in 2003, 22,162 colonoscopies were performed: 54.5% without anesthesia, 39.5% with sedation with midazolam and 6% with sedo-analgesia. In a study performed in our department we noticed a significant improvement in the outcome of the colonoscopy when sedo-analgesia was used on a regular basis. The percentage of total colonoscopies (excluding those that could not be continued due to stenosis) was 84.2% when sedation was seldomly performed and 92.3% when sedo-analgesia was regularly used (p=0.042). We believe that the strategy of sedation during colonoscopy in Romania should be changed so that all the patients should benefit from sedo-analgesia, proved to be safe and cost/efficient. (+info)
Rabies surveillance in the rural population of Cluj County, Romania.
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INTRODUCTION: The rabies virus causes an acute encephalomyelitis that progresses to coma and death within 10 days of the onset of the disease. Taking into account the fatality of the disease and the absence of a specific treatment, preventive methods are of the outmost importance. The purpose of this study was to assess the exposure of the rural population from Cluj County, Romania, to rabies risk factors. METHODS: Data regarding the exposure of the rural population from Cluj County to rabies risk factors were collected from the Vaccination Center registry at the Infectious Diseases Teaching Hospital in Cluj-Napoca. The information was treated confidentially. The data obtained were collected using an Access 2000 database and was analyzed using Epi Info. Information regarding the general population was available from the 2002 General Population and Housing Census. RESULTS: Cluj County reported 1008 cases of human exposure to potentially rabid animals between April 1998 and December 2004. The relative contributions of the major groups of aggressor animals were as follows: 882 dogs (81.55%), 51 cats (5.06%), 30 foxes (2.98%), 28 horses (2.78%), 19 rats (1.89%), and 58 other animals (5.74%). Post-exposure prophylaxis with antirabies serum immune globulin was prescribed in 9% of the cases (n = 90). Vaccine was recommended in 72% of the cases (n = 726). Two hundred and eighty-three patients out of 726 (38.98%) underwent complete vaccine prophylaxis. Diagnoses in animals suspected of having rabies were made by direct immunofluorescent antibody staining of rabies viral antigen in brain material. The number of animals that tested positive for rabies during the period April 1998 to December 2004 was 49. More than 77% (n = 38) were wild animals. The relative contributions of the major groups of animals were as follows: 33 foxes (67.35%), 7 dogs (14.29%), 2 wolves (4.08%) and 7 other animals (14.29%). CONCLUSIONS: The fatal risk of rabies in human beings, and the persistence of the virus in this geographic area, makes legitimate the recommendation of prophylactic procedures for persons exposed to potentially rabid animals. (+info)
The feasibility of FOBT tests in colorectal cancer screening in Dobrogea.
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BACKGROUND AND AIM: The high incidence of colorectal cancer in Eastern Europe and the declining mortality due to this pathology in the Western World, where screening programs for cancer are available, prove the necessity of implementing colorectal cancer screening in Romania, too. The aim of our study was to detect colorectal cancer in asymptomatic stages, where surgical treatment could be curative. METHOD: The study was conducted in the Gastroenterology Department of Emergency Hospital, Constanta County, over a period of 18 months. We recruited apparently healthy people following all criteria recommended by the guidelines. RESULTS: From the total of 1098 patients included in the study, 162 patients with FOBT test positive followed the screening program undergoing colonoscopy or barium enema investigation. The rate of acceptance regarding the screening procedures was 70.3%. Advanced colon lesions were found in 14 patients (1.27%) and cancers in 7 cases (0.63%). According to TNM classification 5 cancers (71.4%) were surgically curative (TNM I/II/III) and 2 (28.5%) were advanced (TNM IV). The positive predictive value (PPVs) of FOBT for cancer was 4.7%. CONCLUSION: Even if the effect of screening on mortality was not demonstrated, our study results confirm the necessity of colorectal cancer screening in our country, as it is worldwide, detecting cancers in curative stages. The detection rate of FOBT positive tests for neoplasia was similar to other studies. (+info)
Assessment of the quality of colonoscopy in Romania.
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We performed a national prospective multicentric study in order to assess the quality of colonoscopies performed in Romania. Between the 1st and 30th of November 2004, we performed a questionnaire-type study with regard to the practice of colonoscopy, addressed to all the centers in Romania known to perform digestive endoscopy. Thirty centers responded to our questionnaire, resulting in a number of 2,559 colonoscopies that were performed in Romania during the month of November (a mean of 85 colonoscopies/center/month). The percentage of cecal intubations performed nationwide was 70.5%, 74.1% in university hospitals, as compared to nonuniversity ones (64.6%) (p=0.000027). Regarding sedation during colonoscopy, in 46% of the cases the colonoscopy was performed without sedation and in 54% of the cases with sedation (or sedo-analgesia). (+info)
Epidemiology of renal disease in Romania: a 10 year review of two regional renal biopsy databases.
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BACKGROUND: Epidemiological data of renal disease are available from large national renal biopsy registries from Central and Western European countries; in contrast, detailed epidemiological data from Eastern European countries are missing. This report is the first review of histological data, over a period of 10 years (1995-2004), covering a population of over 6 million inhabitants and two distinct regions from an East European country - Romania. METHODS: 635 eco-guided kidney biopsies from the Moldova (North-Eastern Romania, 8 counties, 4 754 048 inhabitants) and Banat (Western Romania, 3 counties, 1 454 747 inhabitants) regions were analysed. Data on serum creatinine concentration (sCr), 24 h proteinuria, haematuria, clinical diagnosis, histological diagnosis and complications after renal biopsy were collected. RESULTS: The number of biopsies performed varied between 10.9 p.m.p./year in 1995 and 11.3 p.m.p./year in 2004. The most common clinical syndromes - as indication for performing the renal biopsy - were: nephrotic syndrome (52.3%), followed by nephritic syndrome (21.9%), acute renal failure (ARF) (12.4%), chronic kidney disease (CKD) (10.2%) and asymptomatic urinary abnormalities (AUA) (3.3% of the cases). The major histological groups identified were: primary glomerulonephritis (GN) (66.2%), secondary GN (26.4%), vascular nephropathies (2.3%), and tubulointerstitial nephropathies (TIN) (1.5%) of the cases. Among primary GN's, the most frequent diagnoses were: membranoproliferative GN (MPGN) (29.4%, incidence in 2004 - 9.3 p.m.p./year), mesangioproliferative GN (MesGN) (28.9%, incidence - 10 p.m.p./year), membranous GN (MGN) (11.2%, incidence - 5.3 p.m.p./year), minimal change disease (MCD) (8.5%, incidence - 7.3 p.m.p./year), focal and segmental glomerulosclerosis (FSGS) (11.5%, incidence - 3.3 p.m.p./year) and crescentic GN (CGN) (7.9%, incidence - 3.3 p.m.p./year). The prevalence of membranoproliferative GN significantly decreased from 1995 to 2004. The prevalence of different types of secondary GN was similar to Western and Central European countries, with the particular difference of higher infectious diseases associated GN. CONCLUSION: The present data are an important contribution to the epidemiology of renal diseases in Europe, highlighting not only numerous similarities but also significant epidemiological differences in Western and Central European countries, particularly a higher, albeit declining, incidence and prevalence of membranoproliferative GN. This report represents the basis for the future of Romanian Registry of Renal Biopsies and is intended to serve as a source of information for nephrologists concerned with East European renal pathology. (+info)
High prevalence of hepatitis B virus markers in Romanian adolescents with human immunodeficiency virus infection.
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BACKGROUND: We evaluated the frequency of hepatitis coinfection in Romanian adolescents who were diagnosed with human immunodeficiency virus (HIV) infection prior to 1995. METHODS: One hundred sixty-one adolescents (13-18 years of age) with symptomatic HIV infection, but without signs of hepatic dysfunction, and 356 age-matched, HIV-uninfected controls underwent laboratory testing for markers of parenterally acquired hepatitis virus infection. RESULTS: Seventy-eight percent of HIV-infected adolescents had markers of past or present hepatitis B virus (HBV) infection, as compared with 32% of controls ( P = .0001). The prevalence of HBV replicative markers was more than 5-fold higher in HIV-infected adolescents as compared with controls: 43.4% vs 7.9% ( P = .0001), respectively, for hepatitis B surface antigen (HBsAg); and 11.2% vs 2.2% ( P = .0001), respectively, for hepatitis B e antigen (HBeAg). The prevalence of HBsAg chronic carriers and the presence of HBV replicative markers was significantly higher in patients with immunologically defined AIDS (CD4+ cell counts < 200 cells/mcL): 59.6% vs 34.6% ( P = .02) for HBsAg and 22.8% vs 5.7 %, ( P = .002) for HBV DNA. After 1 year of follow-up, the proportion of those who cleared the HBeAg was considerably lower in severely immunosuppressed coinfected patients: 4.7% vs 37.1% ( P = .003). Four additional HIV-infected adolescents became HBsAg-positive over the term of follow-up (incidence rate, 24.9/1000 person-years), despite a record of immunization against hepatitis B. CONCLUSIONS: A substantial percentage of HIV-infected and HIV-uninfected Romanian adolescents have evidence of past or present HBV infection. In HIV-infected adolescents, the degree of immunosuppression is correlated with persistence of HBV replicative markers, even in the absence of clinical or biochemical signs of liver disease. (+info)
Prevalence and significance of perinuclear anti-neutrophil antibodies (pANCA) in Romanian patients with Crohn's disease and ulcerative colitis.
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INTRODUCTION: Antineutrophil cytoplasmic antibodies (ANCA) are known as a serologic marker of immune disturbances in IBD. The most specific are perinuclear ANCA (pANCA). The aim of this study was to investigate their significance for the diagnosis of inflammatory bowel disease (IBD) in Romania. MATERIAL AND METHODS: A prospective longitudinal study, comprising all patients admitted to our Center in 2000 with ulcerative colitis--UC group (33 patients) and with Crohn's disease--CD group (40 patients). The control group (C) included 22 healthy individuals, with similar age and sex distribution. ANCA was tested in serum by indirect immunofluorescence at Leuven University, Belgium. RESULTS: ANCA prevalence in UC group was 12/33 (36.4%), in CD group was 6/40 (15%), while in the C group all sera tested negative (p=0.004). All ANCA antibodies in patients with IBD were perinuclear type. In the UC group, the prevalence of pANCA was higher in females compared to males (52.9% versus 16.7%, p=0.04). The phenotype pANCA+ did not correlate with disease extension, severity, the evolutive form or complications. In the CD group, the phenotype pANCA+, although more frequently found in colonic involvement and in non-obstructive non-fistulizing forms to associate with pANCA+, did not reach statistical significance (p=0.59). A higher severity of CD was associated with higher pANCA titers (p=0.05). CONCLUSION: pANCA prevalence in UC in Romania was lower in comparison with other studies (36.4% versus 50-80%). The highest prevalence was found in females with UC. In CD, pANCA+ was associated with a higher severity. pANCA assessment remains at a research level, further in-vestigations being necessary in order to demonstrate its clinical importance. (+info)