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Unkomplizierte Harnwegsinfektionen Bei Frauen Theorie und Praxis der evidenzbasierten Medizin in der Antibiotikaverordnung: unkomplizierte Harnwegsinfektionen bei Frauen Dissertation zur Erlangung des akademischen Grades “Doctor Public Health” (Dr. P.H.) Universität Bremen SOCIUM (ehemals Zentrum für Sozialpolitik (ZeS)) Abteilung Gesundheitsökonomie, Gesundheitspolitik und Versorgungsforschung vorgelegt von Apothekerin Stanislava Dicheva Dicheva Bremen, September 2016 | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 2 Gutachter 1. Prof. Dr. rer. nat. Gerd Glaeske 2. PD Dr. med. Guido Schmiemann Datum der Disputation: 07.12.2016 | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 3 Danksagung Vor allem möchte ich meinem Doktorvater Herrn Prof. Dr. rer. nat. Gerd Glaeske für das in mich gesetzte Vertrauen und für die Ermöglichung dieser Arbeit danken. Zudem möchte ich mich sehr bei Herrn PD Dr. med. Guido Schmiemann für die Bereitschaft zur Erstellung des Zweitgutachtens bedanken. Ein besonderer Dank gilt meinen ehemaligen ArbeitskollegInnen an der Universität Bremen für die Unterstützung und gute Zusammenarbeit. Angela Fritsch und Dr. Christel Schicktanz danke ich für die “Unmenge” an Datenauswertungen, ohne Euch wäre diese Dissertation nicht möglich gewesen. Heike Peters und Insa Hey- de möchte ich für die freundliche Aufnahme ins Arzneimittelberatungsteam, für die guten Ratschläge in jeder Lebenslage und für das Ertragen meiner osteuropäi- schen Emotionalität (in allen Richtungen) danken. Insa Heyde gebührt zudem ein großer Dank für das minutiöse Korrekturlesen und die sprachliche „Veredelung“ dieser Arbeit. An Dr. Roland Windt und Prof. Dr. Falk Hoffmann geht der Dank dafür, dass ich jederzeit (auch unüberlegte) Fragen stellen konnte, die schnell beantwortet wur- den. Von ganzem Herzen danke ich meiner Mutter Zlatka Dicheva und meinem Bruder Nikolay Dichev für die Unterstützung in allem, was ich mir vorgenommen habe, mein ganzes Leben lang. Ohne Euch wäre ich nicht zu dem Menschen geworden, der ich heute bin. Meinem lieben Lebenspartner Evgeni gilt der Dank für das Ab- wenden hysterischer Krisen mit unerschütterlicher Ruhe und (manchmal stoisch anmutendem) Lächeln, für das Ertragen der Papierberge und für die Versorgung des heimischen Druckers und Computers, die mir das Schreiben immens erleich- tert hat. Обичам ви много! | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 4 Diese Arbeit ist meiner kürzlich verstorbenen Großmutter Maria gewidmet, die be- reits in Zeiten, in denen für Frauen andere Regeln galten, ihren eigenen, selbstbe- stimmten Weg gegangen ist. | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 5 Inhaltsverzeichnis Abkürzungsverzeichnis………………………………………………………….......... 7 1. Einführung……………………………………………………………………................ 10 2. Antibiotikaverbrauch………………………………………………………….......... 20 3. Theoretische Grundlagen und Hintergründe……………………………… 26 3.1 Evidenzbasierte Medizin………………………………………………….............. 27 3.2 Antibiotika…………………………………………………………………................. 28 3.2.1 Allgemeines………………………………………………………....................... 28 3.2.2 Substanzklassen……………………………………………………................... 32 3.2.2.1 Tetracycline........................................................................................... 35 3.2.2.2 Amphenicole......................................................................................... 36 3.2.2.3 Betalactam-Antibiotika.......................................................................... 37 3.2.2.4 Sulfonamide und Trimethoprim............................................................. 44 3.2.2.5 Makrolide.............................................................................................. 47 3.2.2.6 Lincosamide und Streptogramine......................................................... 48 3.2.2.7 Aminoglykoside..................................................................................... 49 3.2.2.8 Chinolone (Gyrasehemmer).................................................................. 52 3.2.2.9 Glycopeptid-Antibiotika, Polymyxine und Steroid-Antibiotika................ 55 3.2.2.10 Andere Antibitoika............................................................................... 56 3.2.3 Zulassung bei Harnwegsinfektionen............................................................. 60 3.2.4 Rationale Antibiotikatherapie........................................................................ 61 3.3 Bakterien und bakterielle Resistenzen........................................................... 63 4. Harnwegsinfektionen......................................................................................... 71 4.1 Definition, Ätiologie und Pathomechanismus................................................ 71 4.2 Prävalenz............................................................................................................ 75 4.3 Diagnostik........................................................................................................... 76 4.4 Erreger…………………………………………………............................................ 78 4.5 Resistenzen bei Erregern von Harnwegsinfektionen................................... 82 5. Therapie der Harnwegsinfektionen……………………………………………. 100 5.1 Leitlinien.…………………………………………………......................................... 101 | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 6 5.2 Weitere Empfehlungen………………………………………………….............. 142 5.3 Therapiestrategien und Problemfelder………………………………………… 149 6. Fragestellung und Ziele der Dissertation…………………………………. 165 7. Methodik………………………………………………............................................. 166 7.1 Literaturrecherche…………………………………………………………………. 166 7.2 Sekundärdatenanalysen………………………………………………………….. 170 8. Auswertungen…………………………………………………................................ 178 9. Ergebnisse der quantitativen Analyse……………………………………... 182 9.1 Prävalenz der Harnwegsinfektionen…………………………………………… 182 9.2 Untersuchungen zur medikamentösen Therapie…………………………… 186 9.2.1 Harnwegsinfektionen………………………………………............................. 189 9.2.2 Akute Zystitis………………………………………………….......................... 198 9.2.3 Akute Pyelonephritis………………………………………….......................... 205 9.2.4 Weitere Auswertungen……………………………………….......................... 213 10. Diskussion…………………………………………………..................................... 235 11. Fazit und Ausblick…………………………………………………...................... 240 12. Abbildungsverzeichnis…………………………………………………............ 243 13. Tabellenverzeichnis…………………………………………………................... 246 14. Literaturverzeichnis…………………………………………………................... 250 15. Anhang…………………………………………………............................................ 263 15.1 Lebenslauf………………………………………………….................................. 263 15.2 Publikationsverzeichnis…………………………………………………............ 265 15.3 Abstract…………………………………………………...................................... 269 | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 7 Abkürzungsverzeichnis AGENS Arbeitsgruppe "Erhebung und Nutzung DIMDI Deutsches Institut für Medizi- von Sekundärdaten" nische Dokumentation und Information AkdÄ Arzneimittelkommission der deutschen DNEbM Deutsches Netzwerk Evidenz- Ärzteschaft basierte Medizin e. V. AMG Arzneimittelgesetz EARSS European Antimicrobial Re- sistance Surveillance System ARMIN Antibiotika-Resistenz-Monitoring in EAU European Association of Uro- Niedersachsen logy ATC Anatomisch-therapeutisch-chemischer EbM Evidenzbasierte Medizin Code AVR Arzneiverordnungsreport ECDC European Centre for Disease Prevention and Control BMG Bundesministerium für Gesundheit ESAC European Surveillance of Antimicrobial Consumption BSG Blutsenkungsgeschwindigkeit ESBL Extended spectrum be- talactamases CDC Centers for Disease Control and Pre- ESIU Europäische Sektion für Infek- vention tionen in der Urologie CRP C-reaktives Protein EU Europäische Union DNA Desoxyribonukleinsäure EWR Europäischer Wirtschaftsraum DART Deutsche Antibiotika FAO Food and Agriculture Organi- Resistenzstrategie zation of the United Nations DDD Defined Daily Doses (definierte Ta- G-BA Gemeinsamer Bundesaus- gesdosen) schuss DEGAM Deutsche Gesellschaft für Allgemein- GENARS German Network for Antimi- medizin und Familienmedizin crobial Resistance Surveil- lance DGfN Deutsche Gesellschaft für Nephrologie GKV Gesetzliche Krankenversiche- e.V. rung DGGG Deutsche Gesellschaft für Gynäkologie GMG GKV-Modernisierungsgesetz und Geburtshilfe DGHM Deutsche Gesellschaft für Hygiene und GPS Gute Praxis Sekundärdaten- Mikrobiologie analyse DGI Deutsche Gesellschaft für Infektiologie HNO Hals-Nasen-Ohren DGU Deutsche Gesellschaft für Urologie e. V. | Theorie und Praxis der EbM in der Antibiotikaverordnung – unkomplizierte HWI bei Frauen 8 HTA Health Technology Assessment USD United States Dollar HWI Harnwegsinfektion VRE Vancomycin-resistenten Enterokokken ICD-10 International Classification of Dise- WHA World Health Assembly ases, Revision No. 10 (Internationale Klassifikation der Krankheiten, 10. Revision) KBE/ml Kolonie-bildende Einheiten/ml WHO World Health Organization KBV Kassenärztliche Bundesvereinigung WIdO Wissenschaftliches Institut der AOK KI Konfidenzintervall Abkürzungen Erregernamen MHK Minimale Hemmkonzentration E. coli Escherichia coli MRGN Multiresistente gramnegative H. influenzae Hämophilus influenzae Stäbchen MRSA methicillinresistente Staphylococcus H. pylori Helicobacter
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