Amerikanische Gesellschaft für Hirudotherapie

Vollständige Indikationsliste

Umfassender Katalog dokumentierter Hirudotherapie-Indikationen mit Evidenzklassifikation

Blutungs- / Transfusionsrisiko
Aeromonas-Infektionsrisiko
Nur Einmalgebrauch + Biohazard-Entsorgung

Zuletzt aktualisiert: May 27, 2026Geprüft von: Andrei Dokukin, MD
FDA-cleared indication: microsurgeryOff-label indication matrix

For tier-based clinical reasoning, see Clinical Knowledge Support. For an organ-system view, see Atlas by Organ System and Coverage Map.

This page catalogs all documented indications for hirudotherapy with regulatory tier classification based on the strength of published evidence and FDA clearance status. Each indication is classified using the ASH three-tier system.

Classification System

Tier A (FDA-Cleared): Supported by FDA 510(k) clearance and systematic review evidence. Tier B (Clinical Evidence): Supported by RCTs or controlled studies; not FDA-cleared. Tier C (Investigational): Documented in international clinical literature (case series, expert experience); requires investigational framing and appropriate disclaimers.

Stufe A — FDA 510(k)-zugelassene Indikationen

FDA-zugelassene Indikation

These are the only indications included in the FDA 510(k) clearance for medicinal leeches.

ConditionEvidenceSpecialtyTier
Venous congestion — microsurgical flap salvageOnly FDA 510(k)-cleared indicationSystematic reviews (n=277, n=407); 78% salvageSurgeryTier A
Venous congestion — digit/tissue replantationIncluded in 510(k) K040187 languageCase series; prophylactic 92% vs reactive 67%SurgeryTier A

Stufe B — Klinische Evidenz (nicht FDA-zugelassen)

Klinische Evidenz — nicht FDA-bewertet

These indications are supported by controlled clinical studies but are not included in the FDA 510(k) clearance. Use requires off-label disclosure in informed consent.

ConditionEvidenceSpecialtyTier
Knee osteoarthritisLevel I: Michalsen 2003 (n=51 RCT), Andereya 2008 (n=113 sham-RCT)RheumatologyTier B
Chronic venous insufficiencyLevel III: Multiple comparative cohortsVascularTier B
Acute thrombophlebitisLevel III: n=46+87 comparativeVascularTier B
Post-thrombotic syndromeLevel III: n=87 comparative cohortVascularTier B
Wound healingLevel III: Multiple controlled studiesDermatologyTier B
Pain syndromes (localized)Level I-II: Some RCT data for OA, epicondylitisPain MedicineTier B

Stufe C — Experimentell / Internationale Evidenz

Experimentell / Forschungspriorität

These indications are documented in international clinical literature, primarily case series and expert clinical experience. ASH supports controlled clinical investigation of these applications. Research-only context: not recommended outside institutional research governance, IRB-approved protocols, or appropriate clinical-trial frameworks. Pediatric applications additionally require pediatric specialist oversight; not for home use under any circumstance.

ConditionEvidenceSpecialtyTier
Coronary artery diseaseLevel IV: Case series (n=97, n=530)CardiologyTier C
HypertensionLevel III-IV: Gantimurova 2001 (n=94+20), Baskova cohort (n=42)CardiologyTier C
Congestive heart failureLevel IV: Case series (n=65)CardiologyTier C
Cerebrovascular diseaseLevel III: Comparative cohort (n=197+)NeurologyTier C
Acute angle-closure glaucomaLevel III: n=302 comparativeOphthalmologyTier C
Chronic glaucomaLevel III: n=340 comparativeOphthalmologyTier C
Osteoarthritis (non-knee)Level IV: Case series (n=162)RheumatologyTier C
Sensorineural hearing lossLevel IV: Case series (n=104)OtolaryngologyTier C
SinusitisLevel IV: Case series (n=60)OtolaryngologyTier C
Vasomotor rhinitisLevel IV: Case series (n=55)OtolaryngologyTier C
Inflammatory eye diseaseLevel IV: >300/yr clinical experienceOphthalmologyTier C
Inflammatory gynecological conditionsLevel IV: Case seriesGynecologyTier C
Hepatobiliary diseaseLevel IV: Case seriesGastroenterologyTier C
Endocrine/metabolic conditionsLevel IV: Limited dataEndocrinologyTier C
Dental/oral surgery congestionLevel IV: Case reportsDentistryTier C
Urological inflammatory conditionsLevel IV: Case seriesUrologyTier C
Pediatric applicationsLevel IV: Limited data; relative CI age <6PediatricsTier C

Absolute Kontraindikationen

  • Hemophilia or severe hemorrhagic diatheses
  • Severe anemia (Hb <8 g/dL)
  • Hemodynamic instability
  • Arterial insufficiency at application site
  • Cachexia
  • Documented allergy to leech salivary gland secretion
  • Patient refusal

Relative Kontraindikationen

  • Concurrent anticoagulant therapy
  • Alcohol intoxication
  • Active fever
  • Pregnancy
  • Immunocompromised state
  • Children under 6 years of age

Arzneimittelwechselwirkungen mit hohem Risiko

Thrombolytics: Absolute Contraindication

Concurrent use of thrombolytic agents with medicinal leech therapy is absolutely contraindicated due to extreme hemorrhagic risk. Other anticoagulants (warfarin, DOACs, heparin) represent high-risk interactions requiring close monitoring.

Verwandte Ressourcen

Clinical Specialties

Evidence organized by medical discipline.

Safety & Infection Control

Contraindications, drug interactions, and safety protocols.

Regulatory Framework

FDA clearance details and scope of practice.

Diese Website stellt Bildungsinformationen bereit und ist weder eine medizinische Beratung noch eine Diagnose oder Behandlungsempfehlung. Die medizinische Blutegeltherapie ist mit klinisch relevanten Risiken verbunden und sollte ausschließlich von qualifizierten Klinikerinnen und Klinikern unter institutionell genehmigten Protokollen durchgeführt werden. Die FDA-510(k)-Zulassung für medizinische Blutegel ist auf bestimmte Indikationen beschränkt; experimentelle und Off-Label-Diskussionen werden entsprechend gekennzeichnet. Für patientenspezifische Beratung wenden Sie sich an eine qualifizierte Gesundheitsfachkraft.