Abstract：
BACKGROUND:Signal management is considered an important activity in pharmacovigilance and should be performed using any available source of data, including scientific literature. The main aim of this study was to assess the role of scientific literature in both indexed and unindexed journals and compare the relevance of both in the signal management process. METHODS:The study was a retrospective analysis of safety data. For the purposes of the study, drugs for which safety signals were evaluated by European Medicine Agency (EMA) were chosen. A match analysis of data collected in the EudraVigilance (EV) database with data from bibliographic databases such as MEDLINE, Embase or EBSCO (International Pharmaceutical Abstracts, IPA and the Allied and the Complementary Medicine Database, AMED) was performed. RESULTS:A total of 73 drug event associations (DEA) and 4160 individual case safety reports (ICSRs) were analyzed. About 33% of ICSRs were created based on scientific literature. A total of 1196 ICSRs were submitted to the EV database based on journals indexed in global bibliographic databases Embase (86.00%) or MEDLINE (81.96%) or EBSCO (IPA or AMED, 0.66%). CONCLUSION:This study underlines the importance of scientific literature for the signal management process in addition to other data sources. Most literature ICSRs from this analysis were created based on scientific journals indexed in bibliographic databases; therefore, it can be concluded that a systematic review of bibliographic databases, such as Embase or MEDLINE is highly relevant for the signal management process.
journal_name
Wien Klin Wochenschrjournal_title
Wiener klinische Wochenschriftauthors
Ochyra B,Szewczyk M,Przybylkowski Adoi
10.1007/s00508-020-01677-ysubject
Has Abstractpub_date
2020-05-26 00:00:00eissn
0043-5325issn
1613-7671pii
10.1007/s00508-020-01677-ypub_type
杂志文章abstract：:Sentinel node biopsy (SNB) has proved to be a useful and accurate procedure for lymph node staging in breast cancer and melanoma and should be standard of care in the treatment of these tumors. In other malignancies (colon, rectum, stomach, esophagus, head and neck and thyroid, cervix uteri) it is still under investig...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章,评审
doi：10.1007/s00508-005-0320-4
更新日期：2005-02-01 00:00:00
abstract：OBJECTIVE:To determine the proportion of children with an acute cough and laboratory evidence of Bordetella pertussis (B. pertussis) and B. parapertussis infection. METHODS:A prospective study was done, including children aged 0 months to 16 years who attended the outpatient clinic of the Innsbruck University Hospital...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：2002-06-14 00:00:00
abstract：:The effect of oral administration of iodine brine as used in the Austrian health resort Bad Hall on 131I uptake in thyroid, skin and serum, and on the renal radioiodine excretion was studied in 22 rats. Intake of iodine brine resulted in a marked decrease of 131I uptake by the thyroid, both in the long-term experiment...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1989-11-24 00:00:00
abstract：:Feinstein's opinion that diseases overlap does not stand up to professional criticism. Different diseases can certainly present very similarly, but they cannot overlap, in the same way as specialties cannot overlap. The specialties are separated from each other according to their different connections with the disease...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1989-03-17 00:00:00
abstract：:Autonomous and uncoordinated proliferation of epithelia leads to various well-known growth patterns such as expansive (cauliflower-like), radiating infiltrative, polycyclic, and roundish-ovoid figures. All attempts to describe such natural growth patterns graphically by Euclidean geometry have failed and remain no mor...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1996-01-01 00:00:00
abstract：:Alcoholism is usually understood as ethanolism. There is some evidence that its oxidation product acetaldehyde may condense with endogenous amines to form tetrahydroisoquinoline (TIQ) and - tetrahydro-beta-carboline (THBC) alkaloids which ultimately might be responsible for addiction. In most animal experiments pure e...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章,评审
doi：
更新日期：1988-04-29 00:00:00
abstract：:The reactions in mixed lymphocyte culture (MLC) between family members from 35 healthy families and 80 families of potential bone marrow recipients are shown. From the low MLC reactions seen in 128 pairs of HLA identical siblings, the limit of "Negative Reaction in Mixed Lymphocyte Culture" valid for our own laborator...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1986-01-24 00:00:00
abstract：:Hematogenous dissemination has long been considered an important pathogenetic event in Lyme borreliosis but has been hard to document and characterize due to insensitive blood culture methods. In a series of recent investigations involving adult patients from the United States with erythema migrans, it was concluded t...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章,评审
doi：10.1007/s00508-006-0688-9
更新日期：2006-11-01 00:00:00
abstract：OBJECTIVE:Infection of the retroperitoneum after implantation of an abdomino-femoral aortic graft remains one of the main problems in vascular surgery. On basis of a critical review of own experiences we evaluated the management of this difficult clinical situation. PATIENTS:From 1970-1996 1500 aortofemoral graft oper...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1998-10-30 00:00:00
abstract：BACKGROUND:Sucralfate enhances the anti-Helicobacter pylori activity of antimicrobials and has an inhibitory effect on H. pylori. AIM:To evaluate the efficacy and safety of one-week sucralfate-based eradication therapy for H. pylori infection in patients with duodenal ulcers, compared with treatment based on pantopraz...
journal_title：Wiener klinische Wochenschrift
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：2001-12-17 00:00:00
abstract：:A well-defined, characteristic disease has been observed in babies at the Department of Dermatology, Innsbruck University, over the past 7 years. On account of the localisation and probable pathogenesis of the condition the term "Windelsoor" (napkin thrush) has been coined by us for it. The clinical picture, the mycol...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1975-03-07 00:00:00
abstract：:The efficacy and safety of the fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg in the treatment of vertigo of various origins have been investigated in a prospective, noninterventional study involving private practices throughout Germany. A total of 1275 patients with an average age of 61.2 years parti...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：10.1007/s00508-015-0905-5
更新日期：2016-05-01 00:00:00
abstract：:A 53-year-old man presented with a 19-month history of gastrointestinal bleeding. Repeated endoscopic investigation of the upper and lower intestine showed no source of bleeding. When the patient collapsed due to massive gastrointestinal hemorrhage he was referred to our center. Gastroscopy showed a large, bulging tum...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：10.1007/BF03040474
更新日期：2003-09-30 00:00:00
abstract：BACKGROUND:Endoscopic sphincterotomy has a higher risk of bleeding in patients with cirrhosis. Advanced Child stage and coagulopathy are well-known risk factors. We aimed to determine the role of electrosurgical currents in the development of endoscopic sphincterotomy bleeding in cirrhotic patients. METHODS:The study ...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：10.1007/s00508-014-0677-3
更新日期：2016-08-01 00:00:00
abstract：:Skin and soft tissue infections (SSTIs) are among the most common health problems in travellers returning from tropical and subtropical countries. Importantly, the prevalence of Staphylococcus aureus, the most common pathogen for purulent SSTIs, with specific drug resistance, such as methicillin resistant Staphylococc...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：10.1007/s00508-017-1243-6
更新日期：2017-09-01 00:00:00
abstract：:A report is given of 135 panendoscopic examinations in acute upper gastrointestinal bleeding. The importance of endoscopy is underlined by the high incidence of erosions and potential bleeding sources, since these lesions are not detected by radiological examination. Nor is it possible by means of X-rays to distinguis...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1976-10-15 00:00:00
abstract：:The contribution of Albert Wiedmann (1901 to 1970) towards the development of the Viennese Dermatological School are evaluated. The following main points of interest can be focused out of a large number of scientific papers; investigations in the field of venerology, innervation and nutrition of the skin (concept of t...
journal_title：Wiener klinische Wochenschrift
pub_type： 传,历史文章,杂志文章
doi：
更新日期：1981-12-25 00:00:00
abstract：:We report the first documented case of human granulocytic ehrlichiosis (HGE) in Austria. The infection was acquired near Arzl in the surroundings of Innsbruck in northern Tyrol. Except for a biphasic course of illness, presentation in this 33-year-old female patient was comparable to clinical findings observed in othe...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：10.1007/BF03040326
更新日期：2003-04-30 00:00:00
abstract：:Evidence demonstrates that medical diabetes treatment has to be accompanied by lifestyle modifications. Structured nutrition interventions and increased physical activity will help patients to normalise, respectively maintain their body weight.The main target of a medical nutrition therapy aims at achieving normal or ...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章,评审
doi：10.1007/s00508-019-1470-0
更新日期：2019-05-01 00:00:00
abstract：:Hard- and software components offered by different manufacturers are compared with regard to applicability within clinical research projects. The fact that hard- and software have to communicate intensively during A/D conversion is given special attention, and the resulting guidelines for the selection of components a...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1988-11-18 00:00:00
abstract：:Lung cancer is the most frequent cause of death from cancer in men. In addition its prevalence among women is currently rapidly increasing. Main risk factors are smoking, exposure to asbestos and genetic factors. Current screening methods do not allow early detection and, hence, lung cancer is usually diagnosed at an ...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章,评审
doi：
更新日期：1994-01-01 00:00:00
abstract：:In two groups of pts with diabetic derangements the effect of infusion therapy was investigated with regard to metabolic and endocrine functions. The rate of infusion was adapted to the height of the central venous pressure and the administration of electrolytes to their serum concentration. Insulin was withheld until...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章,评审
doi：
更新日期：1980-09-12 00:00:00
abstract：:In 44 patients with biliary obstructions, percutaneous transhepatic cholangioscopy (PTCS) was performed during percutaneous transhepatic biliary drainage procedures (PTCD). In all patients the obstruction could be decompressed via the PTCD sufficiently. 30 of these cases who had PTCS showed suspect hepatic and pancrea...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1995-01-01 00:00:00
abstract：:The efficacy of gentamicin given intravenously once daily in a single, individually-adapted dose in form of a short infusion was confirmed in 30 patients with febrile urogenitary infections, taking nephrotoxicity into consideration. Antibiotic therapy was given for 7 days in each case, the individual dose of gentamici...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1990-05-25 00:00:00
abstract：:Selective suppression of the immune system in graft recipients is now achieved in most cases by treatment with cyclosporine A. Due to large individual differences in absorption, utilization and metabolisation of this drug, therapeutic blood levels (immunosuppression/toxicity) can be maintained only by frequent measure...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1986-12-19 00:00:00
abstract：:Acute myocardial infarction induces an inflammatory reaction. We related conventional inflammatory parameters including C-reactive protein, erythrocyte sedimentation rate, white blood cell count and axillary temperature to plasma concentrations of procalcitonin in patients with acute myocardial infarction. In a prospe...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：2002-03-28 00:00:00
abstract：:Pleural effusions are found in 3 to 17% of patients with chronic pancreatitis. The most likely underlying pathogenetic mechanism is transdiaphragmatic lymphatic transfer of pancreatic secretions to the subpleural space, whilst a rare cause is the formation of pancreatico-pleural fistulae. The measurement of amylase ac...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1985-12-20 00:00:00
abstract：:The treatment of intractable pain, especially in cancer patients, often sets problems to patient and therapist. While epidural and intrathecal spinal administration of opiates is a routine treatment in pain with a sub-diaphragmatic topography it is almost ineffective in cervicocephalic or thoracic cancer. An alternati...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1996-01-01 00:00:00
abstract：:In the course of routine gastroduodenoscopic examination of 218 patients bioptic mucosal specimens were examined bacteriologically for the presence of Campylobacter (C.) pylori. The organism was isolated from 52 out of 53 patients (98%) with duodenal ulcer, 7 out of 9 with gastric ulcer (78%), 24 out of 31 with mucosa...
journal_title：Wiener klinische Wochenschrift
pub_type： 临床试验,杂志文章,随机对照试验
doi：
更新日期：1987-07-17 00:00:00
abstract：:A report is given on 154 patients subjected to reoperation of the biliary tract, including 19 cases of stricture to complete destruction of the common bile duct. The preoperative findings, indications, methods of operation and late results are described and discussed. ...
journal_title：Wiener klinische Wochenschrift
pub_type： 杂志文章
doi：
更新日期：1979-04-13 00:00:00
