technical guidance values
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Cíl: V retrospektivní studii jsme porovnali efektivitu navigace punkce portální žíly pomocí abdominální ultrasonografie oproti CO2 portografii. Efektivitu navigace jsme posuzovali dle počtu punkcí nutných k dosažení katetrizace větve vena portae, délkou skiaskopie a radiační dávkou charakterizovanou produktem dávkové plochy (DAP). Metodika: Do studie bylo zahrnuto 102 po sobě jdoucích pacientů, kterým byl proveden TIPS v období 3 let (od počátku roku 2022 do konce roku 2024). V souboru bylo 29 žen (28 %) a 73 mužů (72 %), ve věkovém rozmezí 27–81 let. Hlavní indikací k TIPS byl refrakterní ascites u 52 (51 %) a krvácení při portální hypertenzi u 50 pacientů (49 %). TIPS byl proveden jako urgentní výkon u 19 pacientů (v 18,6 %) pro nezastavené variceální krvácení. Childovo-Pughovo skóre A bylo 22 % pacientů, Childovo-Pughovo skóre B 44 % a Childovo-Pughovo skóre C 26 %, u 8 % pacientů nebyla klasifikace zjistitelná. Výsledky: Ze 102 TIPS výkonů nebyl tento zaveden u tří pacientů pro technické selhání (2,9 %). Počet vpichů nutných k dosažení portální žíly se zavedením vodiče byl v průměru 5,6 (od jednoho do 20) u 50 pacientů, jejichž punkce byla naváděna pomocí CO2 portografie. U 28 výkonů, kde byl k navádění použit UZ, bylo průměrně nutných 2,7 vpichů (od jednoho do šesti). Délka skiaskopie byla u 28 výkonů provedených pomocí navigace CO2 v průměru 28 minut (9–50 min), u 28 výkonů s navigací pod UZ to bylo 22,8 min (8–43 min). Ve skupině 19 výkonů před obměnou angiolinky a s CO2 navigací byl v průměru DAP 181 497 mGy/cm2 (27 649–399 657 mGy/cm2 ), ve skupině 17 výkonů po obměně angiolinky a navigovaných pomocí CO2 portografie byl DAP v průměru 159 339 mGy/cm2 (52 613–309 440 mGy/cm2 ) a v časově nejmladší skupině 21 výkonů navigovaných pomocí UZ byl DAP v průměru 120 731 mGy/cm 2 (38 180–315 121 mGy/cm2 ). U sedmi výkonů bylo provedeno měření dávky osobními dozimetry. V části výkonu do zavedení vodiče do portální žíly operatér měl dávku v průměru 6 μSv (0 do 12 μSv), zatímco lékař provádějící UZ navigaci v průměru 4,4 μSv (0 do 9 μSv). Celková dávka pro operatéra byla v průměru 19,5 μSv (8–35 μSv). Závěr: Z naměřených hodnot lze uzavřít, že počet vpichů při navigaci pomocí UZ klesl v průměru z 5,6 na 2,7, tento rozdíl se velmi blíží statistické významnosti (p = 0,052). Skiaskopický čas při výkonu klesl v průměru o 7 minut. Dávka druhého lékaře navigujícího punkci pomocí UZ je do doby katetrizace por- tální žíly srovnatelná s dávkou operatéra. DAP klesl po inovaci přístroje a na novém přístroji a dále ještě více klesl i u výkonů prováděných s navigací punkce pomocí UZ.
Aim: In our retrospective study, we compared the efficacy of portal vein puncture navigation using abdominal ultrasonography versus CO2 portography. We assessed navigation efficiency according to the number of punctures required to achieve vena portae branch catheterization, the length of the fluoroscopy, and the dose area product (DAP). Method: The study included 102 consecutive patients who underwent TIPS over a 3-year period (from the beginning of 2022 to the end of 2024). In this cohort, there were 29 women (28%) and 73 men (72%), ranging in age from 27 to 81 years. The main indications for TIPS were refractory ascites in 52 patients (51%) and bleeding with portal hypertension in 50 patients (49%). TIPS was performed as an emergency procedure in 19 patients (18.6%) for uncontrolled variceal bleeding. Child Pugh A, Child Pugh B and Child Pugh C were 22%, 44% and 26% respectively, with 8% of patients having no detectable classification. Results: Of the 102 TIPS procedures, TIPS was not inserted in 3 patients due to technical failure (2.9%). The number of punctures required to reach the portal vein with guidewire insertion averaged 5.6 (range 1 to 20) in 50 patients whose puncture was guided by CO2 portography. In the 28 procedures where ultrasound was used for guidance, the mean number of punctures required was 2.7 (range, 1 to 6). The mean duration of fluoroscopy was 28 min (9–50 min) in the 28 procedures performed with CO2 guidance and 22.8 min (8–43 min) in the 28 procedures with ultrasound guidance. In the group of 19 procedures before angiomachine exchange and with CO2 navigation, the mean DAP was 181 497 mGy/ cm2 (27 649–399 657 mGy/cm2 ), in the group of 17 procedures after angiomachine exchange and navigated by CO 2 portography, the DAP averaged 159 339 mGy/cm 2 (52 613–309 440 mGy/cm2 ) and in the youngest group of 21 procedures navigated by ultrasound, the DAP averaged 120 731 mGy/cm2 (38 180–315 121 mGy/cm 2 ). Dose measurements with personal dosimeters were performed for 7 procedures. In the part of the procedure until the insertion of the guidewire into the portal vein, the operator had a dose of 6 μSv (0 to 12 μSv) on average, while the physician performing the ultrasound navigation had a dose of 4.4 μSv (0 to 9 μSv) on average. The total dose to the operator averaged 19.5 μSv (8 to 35 μSv). Conclusion: From the measured values it can be concluded that the number of punctures during navigation with US decreased from 5.6 to 2.7 on average, this result is close to statistic significance (p = 0.052). The fluoroscopic time during the procedure decreased by 7 minutes. However, the dose of the second physician navigating the puncture using ultrasound is comparable to that of the main operator. The DAP decreased after the device upgrade, and even more decreased for procedures performed with ultrasound-guided puncture navigation.
PURPOSE: Radiotherapy delivery in the definitive management of lower gastrointestinal (LGI) tract malignancies is associated with substantial risk of acute and late gastrointestinal (GI), genitourinary, dermatologic, and hematologic toxicities. Advanced radiation therapy techniques such as proton beam therapy (PBT) offer optimal dosimetric sparing of critical organs at risk, achieving a more favorable therapeutic ratio compared with photon therapy. MATERIALS AND METHODS: The international Particle Therapy Cooperative Group GI Subcommittee conducted a systematic literature review, from which consensus recommendations were developed on the application of PBT for LGI malignancies. RESULTS: Eleven recommendations on clinical indications for which PBT should be considered are presented with supporting literature, and each recommendation was assessed for level of evidence and strength of recommendation. Detailed technical guidelines pertaining to simulation, treatment planning and delivery, and image guidance are also provided. CONCLUSION: PBT may be of significant value in select patients with LGI malignancies. Additional clinical data are needed to further elucidate the potential benefits of PBT for patients with anal cancer and rectal cancer.
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
Background and Objectives: The enteric form of omeprazole is one of the most commonly prescribed medications. Similarly to Europe, Kazakhstan relies on the localization of pharmaceutical drug production as one of its primary strategies to ensure that its population has access to affordable and good-quality medicines. This study comprehensively describes the technologically available development of bioequivalent delayed-release omeprazole. Materials and Methods: Various regimes and technological parameters were tested on laboratory- and production-scale equipment to establish a technical process where a functional and gastro-protective layer is essential. According to the ICH guidance on stability testing and Kazakhstan local rules, stability studies were conducted under conditions appropriate for climate zone II. The comparison of the rate and extent of absorption with subsequent assessment of the bioequivalence of the generic and reference drugs after a single dose of each drug at a dose of 40 mg was performed. Results: The quantitative and qualitative composition and technology of producing a new generic enteric form of omeprazole in capsules were developed and implemented at the manufacturing site of solid forms. Dissolution profiles in media with pH 1.2 and 6.8 were proven. During the accelerated six-month and long-term twelve-month studies, the developed formulation in both packaging materials at each control point passed the average weight and mass uniformity test, dissolution test, acid-resistance stage test, buffer stage test, impurity assay, and microbiological purity test and met all the specification criteria. A bioequivalence study in 24 healthy volunteers compared against the innovative drug showed the bioequivalency of the new generic system. The obtained values from the test and reference products were 1321 ± 249.0 ng/mL and 1274 ± 233 ng/mL for Cmax, 4521 ± 841 ng·h /mL and 4371 ± 695 ng·h /mL for AUC0-t, and 4636 ± 814 ng·h /mL and 4502 ± 640 ng·h /mL for AUC0-∞. Conclusions: Using affordable technologies, a bioequivalent generic delayed-release formulation of 20 and 40 mg omeprazole has been developed.
- MeSH
- klinické křížové studie MeSH
- lidé MeSH
- omeprazol * chemie MeSH
- terapeutická ekvivalence MeSH
- tobolky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa MeSH
INTRODUCTION: The exposures to hazardous antineoplastic drugs (AD) represent serious risks for health care personnel but the exposure limits are not commonly established because of the no-threshold effects (genotoxic action, carcinogenicity) of many ADs. In this study, we discussed and derived practically applicable technical guidance values (TGV) suitable for management of AD risks. METHODS: The long-term monitoring of surface contamination by eight ADs was performed in pharmacies and hospitals in the Czech Republic and Slovak Republic in 2008-2021; in total 2,223 unique samples were collected repeatedly in 48 facilities. AD contamination was studied by LC-MS/MS for cyclophosphamide, ifosfamide, methotrexate, irinotecan, paclitaxel, 5-fluorouracil and gemcitabine and by ICP-MS for total Pt as a marker of platinum-based ADs. RESULTS: The study highlighted importance of exposure biomarkers like 5-fluorouracil and especially carcinogenic and persistent cyclophosphamide, which should be by default included in monitoring along with other ADs. Highly contaminated spots like interiors of laminar biological safety cabinets represent a specific issue, where monitoring of contamination does not bring much added value, and prevention of staff and separated cleaning procedures should be priority. Rooms and surfaces in health care facilities that should be virtually free of ADs (e.g., offices, kitchenettes, daily rooms) were contaminated with lower frequency and concentrations but any contamination in these areas should be carefully examined. DISCUSSION AND CONCLUSIONS: For all other working places, i.e., majority of areas in pharmacies and hospitals, where ADs are being prepared, packaged, stored, transported, or administered to patients, the study proposes a generic TGV of 100 pg/cm2. The analysis of long-term monitoring data of multiple ADs showed that the exceedance of one TGV can serve as an indicator and trigger for improvement of working practices contributing thus to minimizing of unintended exposures and creating a safe work environment.
- MeSH
- chromatografie kapalinová MeSH
- cyklofosfamid analýza MeSH
- fluoruracil analýza MeSH
- lékárny * MeSH
- lidé MeSH
- nemocnice MeSH
- pracovní expozice * analýza MeSH
- protinádorové látky * MeSH
- tandemová hmotnostní spektrometrie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
- Slovenská republika MeSH
Kontext: Koronarografické vyšetření má pro řádné vyhodnocení lézí na koronárních tepnách jisté limitace. Použití intravaskulárního ultrazvuku (intravascular ultrasound, IVUS) před perkutánní koronární intervencí (PCI) může odhalit významné stenózy, pomáhá zvolit vhodný stent a může upozornit na možné komplikace. Cílem studie bylo hodnotit důsledky použití IVUS na klinické a angiograficky potvrzené výsledky revaskularizace nechráněného kmene levé věnčité tepny (unprotected left main, ULM) nebo proximální levé přední sestupné větve (left anterior descending, LAD) pomocí stentu při ischemické chorobě srdeční (ICHS). Materiály a metody: Byla provedena prospektivní randomizovaná kontrolovaná studie s 60 pacienty se stabilní anginou pectoris nebo s akutním koronárním syndromem bez elevací úseku ST. Koronarografické vyšetření provedené na katetrizačním pracovišti egyptského Národního ústavu zdraví odhalilo významné ischemické postižení kmene levé věnčité tepny nebo proximální LAD. U pacientů byla indikována revaskularizace formou PCI. Perkutánní koronární intervence navigovaná koronárním IVUS byla provedena u 30 pa- cientů (skupina A), zatímco ve skupině B nebyl při PCI koronární IVUS použit. Účastníci studie byli sledováni po dobu šesti měsíců s cílem analyzovat primární nebo sekundární sledované parametry. Výsledky: Navigace pomocí IVUS byla spojena se statisticky významně větším minimálním průsvitem cév po implantaci stentu potvrzeným kvantitativní koronarografií (quantitative coronary angiography, QCA) (p = 0,001), větším průměrem stentu (p = 0,001) a další dilatací (p = 0,02). Srovnání obou skupin prokázalo, že navigace pomocí IVUS byla spojena se statisticky významně nižším výskytem trombózy stentu v cílových lézích, nefatálního infarktu myokardu ve vztahu k počtu cílových lézí, s nižšími počty revaskularizačních výkonů na cílových lézích i s nižšími celkovými počty závažných nežádoucích srdečních příhod (major adverse cardiac events, MACE) během šestiměsíčního sledování (p = 0,038 pro všechny uvedené parametry). Závěry: Provádění PCI s implantací stentu do ULM a proximální LAD, navigované pomocí IVUS, zlepšuje klinický výsledný stav se statisticky významně nižším výskytem MACE do 6 měsíců díky významně nižšímu riziku revaskularizace cílové léze a trombózy stentu. U pacientů s ischemickým postižením ULM nebo proximální LAD doporučujeme rutinní používání navigace pomocí IVUS při revaskularizaci implantací stentu.
Background: Coronary angiography has some limitations in the proper assessment of coronary artery le- sions. Intravascular ultrasound (IVUS) before percutaneous coronary intervention (PCI) can identify significant stenosis, select the appropriate stent and detect complications. The study aimed to evaluate the impact of intravascular ultrasound on clinical and angiographic outcomes after revascularization by stenting for patients with unprotected left main (ULM) or proximal left anterior descending (LAD) coronary artery disease (CAD). Materials and methods: A prospective randomized controlled study that was carried on sixty patients presented with stable angina or non-ST elevation acute coronary syndrome. Coronary angiography that was carried out at cardiac catheterization laboratory at the National Heart Institute in Egypt revealed significant left main or proximal LAD coronary artery disease. Patients were scheduled for revascularization by PCI. Percutaneous coronary intervention guided by coronary IVUS was done in thirty patients (Group A). Whe- reas, Group B included 30 patients in which PCI was not guided by IVUS. The patients were followed for six months to detect any primary or secondary endpoints. Results: IVUS guidance was associated with a significant higher post-stent minimal lumen diameter as found by quantitative coronary angiography (QCA) (p = 0.001), stent diameter (p = 0.001), and adjunct post-dilatation (p = 0.02). By comparing both study groups it was found that IVUS guidance was associated with significant lower rates of stent thrombosis in target lesions, non-fatal myocardial infarction related to target lesions, target lesion revascularization and all cause major adverse cardiac events (MACE) within 6 months of follow-up (p-value 0.038, for all). Conclusions: IVUS guided PCI during ULM and proximal LAD coronary artery stenting improves clinical out- come with significant lower rates of MACE at 6 months which is due to significant lower risk of target lesion revascularization and stent thrombosis. We recommended routine use of IVUS during revascularization by stenting in cases of ULM or proximal LAD CAD.
- MeSH
- intervenční ultrasonografie * metody přístrojové vybavení MeSH
- koronární angioplastika metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen * diagnostické zobrazování terapie MeSH
- prospektivní studie MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři MeSH
- statistika jako téma MeSH
- stenty MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Geografické názvy
- Egypt MeSH
OBJECTIVE: Analysis of the effect of technical factors, i.e. the type of stone targeting and shock wave generator, on ESWL efficacy. Evaluation of secondary outcomes to determine an optimal strategy for performing the procedure. PATIENTS AND METHOD: In the period from 01/2016 to 07/2021, we analyzed data from patients indicated for ESWL for nephrolithiasis and proximal or distal ureterolithiasis. This was a tricenter retrospective study to evaluate stone-free rates (SFR) while taking into account the number of ESWL sessions in four selected groups of patients with comparable characteristics. A patient is considered stone-free in the absence of residual lithiasis or with an asymptomatic residue of up to 2 mm. The real-time ultrasound-guided (USG) arm consisted of a group of 120 patients on the electromagnetic STORZ SLK lithotripter in the period from 02/2017 to 02/2020. A total of three comparison arms with x-ray guidance were created: A: 68 patients between 01/2016 and 03/2017 on the Medilit 7 electrohydraulic lithotripter. B: 72 patients from 04/2017 to 10/2017 on the Sonolith i-sys electroconductive lithotripter (EDAP). C: 120 patients from 03/2018 to 07/2021 on the STORZ SLK electromagnetic lithotripter. By comparing the US and x-ray guidance using the STORZ SLK lithotripter, the effect of targeting when using an identical device (electromagnetic generator) was evaluated. By comparing the arms A, B, and C, the efficacy in different types of generators - electromagnetic, electroconductive, electrohydraulic - was assessed when the same type of targeting (fluoroscopy) was used. The secondary parameters that were monitored included: the rate of use of auxiliary techniques in stone management; radiation exposure for the patient and/or operator; analgesic consumption; and the time required to perform the procedure. RESULTS: When US versus x-ray guidance was compared in an electromagnetic lithotripter, SFRs of 90% vs. 85% (P=0.329), i.e. statistically comparable results, were obtained. By comparing electromagnetic, electroconductive, and electrohydraulic generators with fluoroscopy, SFRs of 85%, 88.9%, and 88.2% were obtained, respectively (P=0.727). When the degree of need for intraoperative analgesic administration was assessed, the electromagnetic generator was found to have a significantly lower consumption (20.8% vs. 30.6% vs. 48.5%) (P=0.0005). Values less than 1095 HU and 108.5 mm were shown to be optimal cut-off values for stone density and skin-to-stone distance, respectively. CONCLUSION: Based on our comparative analysis, the noninferiority of US stone targeting was demonstrated compared to fluoroscopic targeting. No significant differences in ESWL efficacy were found using electrohydraulic, electroconductive or electromagnetic shock wave generators. With the electromagnetic lithotripter, there was a significantly lower analgesic consumption than with the electrohydraulic type.
- MeSH
- analgetika MeSH
- ledvinové kameny * terapie MeSH
- lidé MeSH
- litotripse * metody MeSH
- retrospektivní studie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Intraductal carcinoma of the prostate (IDC-P) has been recently recognized by the World Health Organization classification of prostatic tumors as a distinct entity, most often occurring concurrently with invasive prostatic adenocarcinoma (PCa). Whether documented admixed with PCa or in its rare pure form, numerous studies associate this entity with clinical aggressiveness. Despite increasing clinical experience and requirement of IDC-P documentation in protocols for synoptic reporting, the specifics of its potential contribution to assessment of grade group (GG) and cancer quantitation of PCa in both needle biopsies (NBx) and radical prostatectomy (RP) specimens remain unclear. Moreover, there are no standard guidelines for incorporating basal cell marker immunohistochemistry (IHC) in the diagnosis of IDC-P, either alone or as part of a cocktail with AMACR/racemase. An online survey containing 26 questions regarding diagnosis, reporting practices, and IHC resource utilization, focusing on IDC-P, was undertaken by 42 genitourinary subspecialists from 9 countries. The degree of agreement or disagreement regarding approaches to individual questions was classified as significant majority (>75%), majority (51% to 75%), minority (26% to 50%) and significant minority (≤25%). IDC-P with or without invasive cancer is considered a contraindication for active surveillance by the significant majority (95%) of respondents, although a majority (66%) also agreed that the clinical significance/behavior of IDC-P on NBx or RP with PCa required further study. The majority do not upgrade PCa based on comedonecrosis seen only in the intraductal component in NBx (62%) or RP (69%) specimens. Similarly, recognizable IDC-P with GG1 PCa was not a factor in upgrading in NBx (78%) or RP (71%) specimens. The majority (60%) of respondents include readily recognizable IDC-P in assessment of linear extent of PCa at NBx. A significant majority (78%) would use IHC to confirm or exclude intraductal carcinoma if other biopsies showed no PCa, while 60% would use it to confirm IDC-P with invasive PCa in NBx if it would change the overall GG assignment. Nearly half (48%, a minority) would use IHC to confirm IDC-P for accurate Gleason pattern 4 quantitation. A majority (57%) report the percentage of IDC-P when present, in RP specimens. When obvious Gleason pattern 4 or 5 PCa is present in RP or NBx, IHC is rarely to almost never used to confirm the presence of IDC-P by the significant majority (88% and 90%, respectively). Most genitourinary pathologists consider IDC-P to be an adverse prognostic feature independent of the PCa grade, although recommendations for standardization are needed to guide reporting of IDC-P vis a vis tumor quantitation and final GG assessment. The use of IHC varies widely and is performed for a multitude of indications, although it is used most frequently in scenarios where confirmation of IDC-P would impact the GG assigned. Further study and best practices recommendations are needed to provide guidance with regards to the most appropriate indications for IHC use in scenarios regarding IDC-P.
- MeSH
- biopsie dutou jehlou trendy MeSH
- duktální karcinom chemie patologie terapie MeSH
- imunohistochemie trendy MeSH
- lékařská praxe - způsoby provádění trendy MeSH
- lidé MeSH
- nádorové biomarkery analýza MeSH
- nádory prostaty chemie patologie terapie MeSH
- prediktivní hodnota testů MeSH
- průzkumy zdravotní péče MeSH
- reprodukovatelnost výsledků MeSH
- specializace trendy MeSH
- stupeň nádoru MeSH
- zdravotnické zdroje trendy MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
Very low or very high concentrations of calcium (Ca) and magnesium (Mg) or total hardness in drinking water have been empirically recognized as the cause of the problems with corrosion, scaling, or taste of water. A large body of scientific evidence over the last 60 years has also attributed health problems to both extremes of these minerals in water. For example, drinking water low in Mg significantly increases the likelihood of cardiovascular mortality. This knowledge is not properly considered in the drinking water quality regulations, especially as more and more water is now produced by desalination disturbing its natural mineral composition. Although the current EU Drinking Water Directive does not include limits for hardness, Ca or Mg, most member states regulate these parameters either through law (12 countries) or technical guidance (7 countries), and several countries have issued educational information for the public. However, the regulations in most countries are not based on current research and not comparable because some provide a recommended range while others provide mandatory minimum or maximum limit values. This summary of the situation in 28 European Union countries is intended to provide information that can contribute to the implementation of the revised EU Directive.
... Technical specifications for procurement 4 -- References 7 -- Selected further reading 8 -- Annex 1. ... ... Tables of standards and values: respirators; medical face masks; isolation and surgical gowns; medical ...
v, 30 stran : tabulky
- MeSH
- Betacoronavirus MeSH
- COVID-19 MeSH
- epidemický výskyt choroby MeSH
- osobní ochranné prostředky MeSH
- Konspekt
- Veřejné zdraví a hygiena
- NLK Obory
- veřejné zdravotnictví
- infekční lékařství
- NLK Publikační typ
- publikace WHO
... Contents -- 1 Introduction to Forensic Toxicology and the Value of a Nationwide Database 1 -- Alan Wayne ... ... - 13.7 Psychoactive Medicines 269 -- 13.8 Poly-substance Use 270 -- References 271 -- 14 Alcohol Technical ... ... 18.10 Certificates of Analysis 381 -- 18.11 Structural Confirmation 382 -- 18.12 Purity 383 -- 18.13 Guidance ...
xx, 569 stran : ilustrace
- Klíčová slova
- forensní toxikologie,
- MeSH
- toxikologie MeSH
- uživatelé drog MeSH
- NLK Obory
- toxikologie
- adiktologie