["Responders and non-responders" to PGE1 and alpha-cyclodextrin].
BACKGROUND
In this study we evaluated a group of 76 patients (mean age 66 +/- 12) treated with the short-term PGE1 alpha-ciclodestrina protocol (60 micrograms/die for 2 days). Responders to PGE1 alpha-ciclodestrina treatment were considered patients with an increase in flow/perfusion and an associated improvement in signs/symptoms. Moderate responders were considered patients with only flow/perfusion increase or only sign/symptoms improvement. Non-responders were characterised by no increase in flow/perfusion and no clinical improvement.


METHODS
Signs/symptoms variations were measured on an analogue scale line. Perfusion measurements (laser Doppler, transcutaneous PO2, arterial inflow with straingauge plethysmography) were recorded after the two days of the short term treatment.


RESULTS
In the group of 38 patient with claudication (200-600 m) 54% were considered responders, 12% non responders and 34% moderate responders. In the more severe claudication group (distance < 200 m) including 18 patients, 66% were responders, 8% non responders and 26% were considered moderate responders. In the rest pain group (13 patients) there were 63% responders, 9% non-responders and 28% moderate responders. In the gangrene group (10 patients) 60% were considered responders, 10% non-responders and 3% moderate responders. The overall percentages were 61.25% of responders, 10% of non-responders and 28.75% moderate responders.


CONCLUSIONS
The evaluation of the response to PGE1 alpha-ciclodestrina treatment may indicate which group of patients will benefit from the treatment and which group will have no benefits or only limited benefits. This may induce changes in treatment (i.e. increasing doses, more prolonged treatment) or other solutions (revascularisation if possible, arterial infusion or amputation).
De Sanctis
M T
MT
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Incandela
L
L
Iacobitti
P
P
D000527:Alprostadil / Q000494:pharmacology / Q000627:therapeutic use*; D001161:Arteriosclerosis / Q000188:drug therapy; D003505:Cyclodextrins / Q000494:pharmacology / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005734:Gangrene / Q000188:drug therapy; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy; D007511:Ischemia / Q000188:drug therapy; D007866:Leg / Q000098:blood supply; D016491:Peripheral Vascular Diseases / Q000188:drug therapy*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000494:pharmacology / Q000627:therapeutic use*
D003505:Cyclodextrins; D014665:Vasodilator Agents; D000527:Alprostadil